Clinical trial NCT03248479
Conditions: Hematological Malignancies
Keywords: CD47
Sponsor: Gilead Sciences
Start date: 2017-09-08; Completion date: 2023-09-05
Enrollment: 258 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objectives of this study are:

* To confirm the safety and tolerability of magrolimab monotherapy in a relapsed/refractory (R/R) acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) population, and of magrolimab in combination with azacitidine in previously untreated participants with AML or MDS and participants with R/R AML and MDS
* To evaluate the efficacy of magrolimab monotherapy in R/R AML/MDS, and of magrolimab in combination with azacitidine in previously untreated participants with AML/MDS, or R/R AML/MDS as measured by complete remission (CR) rate for participants with AML and higher-risk MDS, and duration of complete response for participants with AML and higher-risk MDS, and duration of CR for participants with AML and higher-risk MDS
* To evaluate the safety, tolerability, and efficacy of magrolimab monotherapy or combination with azacitidine in low-risk MDS participants as measured by red blood cell (RBC) transfusion independence rate

Detailed description:

Arms: arm 1: Participants who are treatment-naive (TN) with higher risk myelodysplastic syndrome (MDS) will receive 1 mg/kg magrolimab on Cycle 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Days 11, 15, 22, and then weekly (QW) starting Cycle 2 up to end of the study. Participants will receive azacitidine 75 mg/m\^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years. arm 2: Participants who are TN with higher risk MDS will receive 1 mg/kg magrolimab on Cycle 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Days 11, 15, 22, and then weekly starting Cycle 2 and given every 2 weeks (Q2W) from Cycle 3 up to end of the study. Participants will receive azacitidine 75 mg/m\^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years. arm 3: Participants who are treatment-naive or unfit (TN/U) with acute myeloid leukemia (AML) will receive 1 mg/kg magrolimab on Cycle 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Days 11, 15, 22, and then QW starting Cycle 2 and then given QW and Q2W from Cycle 3 up to end of the study. Participants will receive azacitidine 75 mg/m\^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years. arm 4: Participants with relapsed/refractory (r/r) AML will receive magrolimab 1 mg/kg for Cycle 1 Week 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8, 30 mg/kg on Cycle 1 Days 11, 15 and 22 through end of Cycle 2 and then 30 mg/kg QW in Cycle 2 and then 30 mg/kg QW and Q2W starting Cycle 3 and thereafter (each cycle was of 28 days). Participants will receive azacitidine 75 mg/m\^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years. arm 5: Participants with r/r AML will receive magrolimab 1 mg/kg for Cycle 1 Week 1 (Days 1, Day 4); 15 mg/kg on Cycle 1 Day 8, 30 mg/kg on Cycle 1 Day 11 and Day 15, 30 mg/kg weekly on Cycle 1 Day 22 through end of Cycle 2, and 30 mg/kg Q2W starting Cycle 3 and thereafter (each cycle was of 28 days). Maximum treatment duration was up to 4 years. arm 6: Participants may receive the same dose level and schedule (30 mg/kg) (i.e., twice weekly) of magrolimab monotherapy in each cycle (each cycle was of 28 days) as previously received on the Phase 1 AML study (SCI-CD47-002), or may transition to once-weekly dosing in this study at the discretion of the Investigator in each 28-day cycle and with Sponsor approval. Maximum treatment duration was up to 4 years. arm 7: Participants with r/r MDS will receive magrolimab 1 mg/kg for Cycle 1 Week 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8, 30 mg/kg on Cycle 1 Days 11, 15 and 22 through end of Cycle 2 and then 30 mg/kg QW in Cycle 2 and then 30 mg/kg Q2W starting Cycle 3 and thereafter (each cycle was of 28 days). Participants will receive azacitidine 75 mg/m\^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years. arm 8: Participants with r/r MDS will receive magrolimab 1 mg/kg for Cycle 1 Week 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8, 30 mg/kg on Cycle 1 Days 11, 15 and 22 through end of Cycle 2 and then 30 mg/kg QW in Cycle 2 and then 30 mg/kg Q2W starting Cycle 3 and thereafter (each cycle was of 28 days). Participants will receive azacitidine 75 mg/m\^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.

Participants with r/r MDS who do not have an objective response with magrolimab at the first protocol response assessment can have azacitidine added to magrolimab for subsequent cycles. arm 9: Participants with r/r MDS will receive 1 mg/kg magrolimab on Cycle 1 Week 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Days 11, 15, 22, through end of Cycle 2 and then 30 mg/kg QW in Cycle 2 and then 30 mg/kg Q2W starting Cycle 3 and thereafter (each cycle was of 28 days). Maximum treatment duration was up to 4 years. arm 10: Participants with low risk MDS will receive 1 mg/kg magrolimab on Cycle 1 Week 1 Day 1; 30 mg/kg on Cycle 1 Days 8, 15 and 22; 60 mg/kg on Day 1 of Cycle 2 and subsequent cycles (each cycle was of 28 days) (each cycle was of 28 days) up to the end of the study. Participants will receive azacitidine 75 mg/m\^2 on Days 1 to 5 of each cycle. For participants who could not tolerate 60 mg/kg dose, the dose of magrolimab was reduced to 45 mg/kg. Maximum treatment duration was up to 4 years. arm 11: Participants with low risk MDS will receive 1 mg/kg magrolimab on Cycle 1 Week 1 Day 1; 30 mg/kg on Cycle 1 Days 8, 15 and 22; 60 mg/kg on Day 1 of Cycle 2 and subsequent cycles (each cycle was of 28 days) (each cycle was of 28 days) up to the end of the study. Participants will receive azacitidine 75 mg/m\^2 on Days 1 to 5 of each cycle. For participants who could not tolerate 60 mg/kg dose, the dose of magrolimab was reduced to 45 mg/kg. Maximum treatment duration was up to 4 years.

Participants with r/r MDS who do not have an objective response with magrolimab at the first protocol response assessment can have azacitidine added to magrolimab for subsequent cycles. arm 12: Participants with low risk MDS will receive 1 mg/kg magrolimab on Cycle 1 Week 1 Day 1; 30 mg/kg on Cycle 1 Days 8, 15 and 22; 60 mg/kg on Day 1 of Cycle 2 and subsequent cycles (each cycle was of 28 days) (each cycle was of 28 days) up to the end of the study. Maximum treatment duration was up to 4 years.
Interventions: intervention 1: Magrolimab intervention 2: Azacitidine
Intervention descriptions: intervention 1: Administered intravenously intervention 2: Administered according to region-specific drug labeling either subcutaneously or intravenously

Protocol documents:
Prot_000.pdf: 
Magrolimab 
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Protocol Title: 
Protocol Number: 
lnvestigational 
Product: 
Indication: 
Development Phase: 
Sponsor: 
Medical Monitor: 
Lead Investigator: 
Amendment 9 Date: 
Amendment 8 Date: 
Amendment 7 Date: 
Amendment 6 Date: 
Amendment 5 Date: 
Amendment 4 Date: 
Amendment 3 Date: 
Amendment 2 Date: 
Amendment 1 Date: 
Original Protocol: 
CLINICAL STUDY PROTOCOL 
A Phase 1 b Trial of Magrolimab Monotherapy or 
Magrolimab in Combination with Azacitidine in Patients 
with Hematological Malignancies 
5F9005 
Magrolimab (previously known as Hu5F9-G4) 
Hematological Malignancies 
1b 
Gilead Sciences 
333 Lakeside Drive 
Foster City, CA 94404 USA 
PPD 
Director, Clinical Development 
Gilead Sciences 
email: 
PD 
PPD 
MRC Molecu arAaematology Onil & Dept of 
Haematology 
Weatherall of Institute of Molecular Medicine 
University of Oxford 
Oxford OX3 9DS United KinQdom 
Telephone: PD 
email: 
PD 
----------
21 July 2022 
31 March 2022 
25 August 2021 
10 February 2020 
18 July 2019 
01 August 2018 (UK only) 
06 March 2018 
20 July 2017 
22 May 2017 
09 March 2017 
Confidentiality Statement: 
The concepts and information contained herein are confidential and proprietary and shall 
not be disclosed in whole or part without the express written consent of Gilead Sciences. 
Compliance Statement: 
This study will be conducted in accordance with this Protocol, the International 
Conference on Harmonisation (ICH), Guideline for Good Clinical Practice (GCP), and the 
applicable country and regional (local) regulatory requirements. 
Gilead Sciences 
Confidential 


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PROTOCOL APPROVAL PAGE
I have read the document described above, and my signature below indicates my 
approval:
[See appended electronic signature]
[See appended 
electronic signature]
Medical Monitor, Gilead Sciences
Date
PPD-


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PROTOCOL ACCEPTANCE PAGE
I have read and agree to the protocol, as detailed in this document.  I am aware of 
my responsibilities as an Investigator under the guidelines of Good Clinical Practice 
(GCP), the Declaration of Helsinki, my local and regional clinical trial regulatory 
requirements (including the Code of Federal Regulations [CFR] Title 21 for US 
Investigators), and the clinical trial protocol.  I agree to conduct the trial according to 
these regulations and guidelines and to appropriately direct and assist the staff 
under my control who will be involved in the trial, and ensure that all staff members 
are aware of their clinical trial responsibilities.
Investigator’s Name:
Name of 
Institution/Site:
Signature:
Date:


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PROTOCOL SYNOPSIS
Sponsor:  Gilead Sciences
Investigational Agents:  Magrolimab (previously known as Hu5F9-G4)
Protocol Number:  5F9005 Amendment 9
Study Title:  A Phase 1b Trial of Magrolimab Monotherapy or Magrolimab in 
Combination with Azacitidine in Patients with Hematological Malignancies
Scientific Rationale and Background
Acute myeloid leukemia (AML) is a common hematological malignancy whose 
incidence rises from 3:100,000 in young adults to greater than 20:100,000 in older 
adults.  For patients < 60 years of age, overall survival (OS) is 40 to 50%, but is only 
5% for patients > 60 years of age.  The majority of newly diagnosed patients with 
AML are over the age of 60.  In this patient population, standard induction 
chemotherapy is often not an option due to increased treatment-related mortality as 
a result of age and co-morbidities.  Standard of care (SOC) for AML patients unfit for 
combination chemotherapy is treatment with hypomethylating agents (azacitidine or 
decitabine) or low dose cytarabine.  Despite these frontline treatments, median OS 
is only about 10 months.  In all types of AML, disease relapse is common despite an 
initial therapeutic response and is the most common reason for death.  Standard 
chemotherapy and allogeneic stem cell transplant (when used) often fail to eradicate 
all tumor-propagating cells and select for chemotherapy-resistant 
leukemia-propagating subclones.  Patients refractory to salvage therapy are treated 
palliatively, as current treatment options are extremely limited.  These patients have 
a median survival of 2 months.  In addition, patients with newly diagnosed 
intermediate or higher-risk myelodysplastic syndrome (MDS) and those who relapse 
after standard care have a poor prognosis and high risk of progression to AML.  
MDS patients who relapse or are refractory to hypomethylating agents have no 
SOC, and prognosis is poor.  In red blood cell (RBC) transfusion-dependent low-risk 
MDS patients who fail erythropoiesis-stimulating agents (ESAs) or lenalidomide, no 


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SOC exists, and well-tolerated and effective therapies are needed.  Therefore, there 
is an urgent need for new treatment modalities for relapsed/refractory (R/R) AML 
and MDS patients, newly diagnosed AML patients ineligible for induction 
chemotherapy based on age and co-morbidities, RBC transfusion-dependent 
low-risk MDS, and newly diagnosed intermediate/high/very high risk MDS patients.
Magrolimab (previously known as Hu5F9-G4) is a humanized monoclonal antibody 
that blocks the anti-phagocytic signal CD47, which is highly expressed on cancer 
cells including AML and serves as a key immune evasion signal for cancers.  
Magrolimab binds CD47 and blocks it from interacting with its ligand, signal 
regulatory protein alpha (SIRPα), on phagocytic cells, leading to phagocytic 
elimination of cancer cells.  Magrolimab treatment in nonclinical xenograft models of 
human AML leads to robust elimination of leukemic disease in the peripheral blood 
and bone marrow which results in long term remissions in a high percentage of mice 
treated.  Magrolimab has been tested in Phase 1 trials of solid tumors and AML.  In 
a Phase 1 trial in R/R AML (Study SCI-CD47-002), magrolimab monotherapy has 
been well tolerated and a maximum tolerated dose (MTD) has not been reached.  
Based on nonclinical testing, it is hypothesized that magrolimab will demonstrate 
significant anti-leukemic activity in patients with AML or intermediate/high/very high 
risk MDS.  Furthermore, the addition of magrolimab to standard-of-care 
hypomethylating agents (azacitidine) may enhance anti-leukemic activity.  This trial 
will evaluate the anti-leukemic activity of magrolimab monotherapy in patients with 
relapsed or refractory AML or MDS, and will provide continued treatment for patients 
on a Phase 1 AML trial (Study SCI-CD47-002) who are deriving ongoing clinical 
benefit from magrolimab monotherapy.  In addition, the safety and anti-leukemic 
activity of magrolimab in combination with azacitidine will be investigated in patients 
with R/R AML or MDS, previously untreated AML patients who are ineligible for 
standard induction chemotherapy, newly diagnosed intermediate/high/very high risk 
MDS patients, and RBC transfusion-dependent low-risk MDS patients.


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Study Objectives
Primary Objectives

To confirm the safety and tolerability of magrolimab monotherapy in R/R AML 
and MDS and of magrolimab in combination with azacitidine in previously 
untreated patients with AML or MDS and patients with R/R AML and MDS

To evaluate the safety, tolerability, and efficacy of magrolimab monotherapy in 
R/R AML/MDS, and of magrolimab in combination with azacitidine in previously 
untreated patients with AML/MDS or R/R AML/MDS as measured by complete 
remission (CR) rate for patients with AML and higher-risk MDS 

To evaluate the safety, tolerability, and efficacy of magrolimab monotherapy or in 
combination with azacitidine in low-risk MDS patients as measured by RBC 
transfusion independence rate
Secondary Objectives

To evaluate the pharmacokinetic (PK) profile of magrolimab alone and in 
combination with azacitidine

To evaluate the immunogenicity of magrolimab 

To evaluate the efficacy of magrolimab alone or in combination with azacitidine 
as measured by duration of CR (DCR); objective response rate (ORR); CR with 
partial hematologic recovery; duration of response (DOR) for patients with AML; 
DCR for higher-risk MDS; ORR and DOR for patients with MDS; RBC transfusion 
independence; mean hemoglobin increase on treatment; progression-free 
survival (PFS); relapse-free survival (RFS), event-free survival (EFS); and OS

To assess the level of minimal residual disease (MRD) negativity
 
 
CCI


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Overall Study Design
This trial is an open label, multicenter Phase 1b trial investigating the following:

Magrolimab monotherapy or in combination with azacitidine in patients with R/R 
AML or MDS (including R/R low-risk RBC transfusion-dependent MDS patients)

Magrolimab in combination with azacitidine in newly diagnosed 
intermediate/high/very high-risk MDS patients

Magrolimab in combination with azacitidine in newly diagnosed AML patients 
ineligible for standard induction chemotherapy (including TP53 mutant AML) 

Magrolimab monotherapy or in combination with azacitidine for RBC 
transfusion-dependent low-risk MDS patients  
The study includes 4 groups of patients:  

R/R Cohorts:  R/R AML or MDS patients who have not previously received 
magrolimab, who will receive magrolimab monotherapy in the safety run-in cohort 
or magrolimab monotherapy in the R/R MDS Magrolimab Monotherapy Cohort, 
and who will receive magrolimab in combination with azacitidine in the R/R 
expansion cohort on this study.  The R/R MDS Magrolimab Monotherapy 
Expansion Cohort has been added to further define the activity of magrolimab 
alone in MDS.

Treatment-naïve/Unfit (TN/U) Cohorts:  AML patients ineligible for standard 
induction chemotherapy or previously untreated intermediate/high/very high-risk 
MDS patients by Revised International Prognostic Scoring System (IPSS-R) 
(Greenberg 2012), who will receive magrolimab in combination with azacitidine 
on this study.  A subcohort of untreated AML patients ineligible for standard 
induction chemotherapy that have a TP53 gene mutation is included here.


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
RBC Transfusion-dependent Low-risk MDS Cohort:  RBC 
transfusion-dependent very low- to low-risk MDS patients by IPSS-R who are 
either of the following:
1) relapsed/refractory/intolerant to or ineligible for  ESA therapy
2) have a deletion in chromosome 5q who are relapsed/refractory/intolerant 
to or ineligible for lenalidomide therapy 

Rollover Cohort:  Patients who received magrolimab in the Phase 1 R/R AML 
study (SCI-CD47-002), who will continue magrolimab monotherapy on this study.
Regarding magrolimab dosing for these cohorts, preliminary PK/pharmacodynamic 
(PD) and RO data suggest that doses higher than 20 mg/kg may be associated with 
greater target CD47 saturation on leukemic cells and higher free drug exposures.  
Higher magrolimab dose exposures may thus lead to enhanced clinical efficacy.  
Based on this potential benefit and the current safety profile where an MTD has not 
been reached, exploration of higher magrolimab dose levels represents an adequate 
risk-benefit profile.  Therefore, a magrolimab maintenance dose of 30 mg/kg, once 
weekly (QW), twice weekly, every 2 weeks (Q2W), or every 4 weeks (Q4W) will be 
evaluated.  A 60 mg/kg Q4W dosing will also be evaluated in the RBC 
Transfusion-dependent Low-risk MDS Cohort.
The R/R Cohorts consist of 2 cohorts: 1) an R/R Safety and Expansion Cohort, and 
2) an R/R MDS Magrolimab Monotherapy Expansion Cohort.  The R/R Safety and 
Expansion Cohort consists of an initial evaluation of magrolimab monotherapy in 
R/R MDS/AML patients, followed by an expansion cohort of magrolimab + 
azacitidine in R/R MDS/AML patients.  As of Amendment 3, in the first stage, 
patients in the R/R Safety Cohort have been treated at the maintenance dose of 
30 mg/kg twice weekly; going forward, these patients will be treated weekly at the 
maintenance dose of 30 mg/kg, as determined by the Clinical Trial Steering 
Committee (CTSC) based on clinical, PK, and PD data.  This safety run-in will 
confirm the safety profile of magrolimab monotherapy at this dose level in an 
expanded R/R population.  Approximately 30 days after enrollment is completed in 
the R/R Safety Cohort, the CTSC will assess the safety data to determine whether 


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enrollment may begin in the TN/U Dose Evaluation Cohort.  In addition, the CTSC 
will also determine whether enrollment will proceed to an initial 36-patient R/R 
Expansion Cohort, based on safety and efficacy data, which will be conducted with 
magrolimab in combination with azacitidine as per Amendment 5.  Based on 
emerging data, the CTSC may decide to enroll additional patients beyond 36 for 
further safety, efficacy, or dosing information.
The R/R MDS Magrolimab Monotherapy Cohort was added in Amendment 6.  Per 
Food and Drug Administration (FDA) feedback, a magrolimab monotherapy cohort in 
R/R MDS will be evaluated to further define the activity of magrolimab to the 
contribution of magrolimab+azacitidine in MDS to support a potential single-arm 
approval of magrolimab+azacitidine in MDS.  Patients will be enrolled in a Simon’s 
2-stage design to evaluate for potential futility.  Patients who do not achieve an 
objective response with magrolimab monotherapy at the protocol-defined first 
response assessment may have azacitidine added by discretion of the Principal 
Investigator with Sponsor approval, according to the schedule of azacitidine outlined 
in the R/R cohorts.
The TN/U Cohort will be enrolled in 2 stages.  In the first stage, the study will 
investigate the safety and tolerability of magrolimab and azacitidine in a 3+3 dose 
evaluation design, in previously untreated AML patients who are unfit for standard 
combination chemotherapy, and previously untreated intermediate/high/very/high 
risk MDS patients.  The same dose level of magrolimab used in the R/R Safety 
Cohort will be initially evaluated in combination with the standard dose of azacitidine 
in the TN/U Dose Evaluation Cohort.  Optional additional dose cohorts may explore 
higher or lower doses in increments of up to 50% of the maximum prior dose, as 
determined by the CTSC based on emerging PK, PD, and clinical data.  A total of up 
to 18 patients may be treated in the TN/U Dose Evaluation Cohort.  In the second 
stage, a recommended Phase 2 dose and schedule will be selected by the CTSC for 
treatment in the TN/U Expansion Cohort, which will be evaluated for efficacy of 
magrolimab in combination with azacitidine.  As of Amendment 3, the recommended 
Phase 2 dose and regimen (RP2DS) and recommended dose for expansion was 


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determined to be magrolimab dosing at 1 mg/kg on Days 1 and 4; 15 mg/kg on 
Day 8; 30 mg/kg on Days 11, 15, and 22; and 30 mg/kg QW Cycle 2 and beyond.  
As of Amendment 6, the RP2DS, as selected by the CTSC in November 2019, was 
determined to be magrolimab dosing at 1 mg/kg on Days 1 and 4; 15 mg/kg on 
Day 8; 30 mg/kg on Days 11, 15, and 22; 30 mg/kg QW for Cycle 2; and 30 mg/kg 
Q2W starting Cycle 3 and thereafter.  In addition, based on Amendment 5, the TN/U 
Expansion Cohort was expanded to a total of 122 patients, which will include at least 
92 patients with MDS (see the Sample Size Justification section), including MDS 
patients enrolled in the original 30 TN/U Expansion (n = 30).  For a higher-risk, 
untreated, MDS-only expansion under Amendment 6, an evaluation will occur after 
36 patients have been enrolled at magrolimab Q1W C3+ and reached the first 
response assessment.  During this evaluation, enrollment will continue, and at least 
56 additional patients at a magrolimab Q2 week dosing schedule will be enrolled in 
the higher-risk, untreated, MDS-only expansion.  Therefore, the number has 
increased to at least 92 patients with MDS in the TN/U Expansion Cohort.  This 
addition is based on initial encouraging efficacy data observed in the TN/U Cohort in 
patients and FDA feedback for a potential single-arm approval path.  The overall 
MDS expansion to 92 patients will be considered the MDS Registrational Cohort.  
The CTSC may decide to enroll additional patients beyond 92 (36 QW and 56 Q2W 
dosing) for further safety, efficacy, and/or dosing data.  A subcohort of at least 
32 TN/U AML patients with a TP53 gene mutation will be enrolled.  This cohort 
addition is based on encouraging clinical efficacy observed with TP53 mutant AML 
patients in the TN/U Expansion Cohort, of which 12 slots were allotted prior to 
Amendment 6 by CTSC decision.  Based on emerging data, the CTSC may decide 
to enroll additional TP53 mutant AML patients beyond the initial 32 for further safety, 
efficacy, and/or dosing data.  In July 2020, the CTSC agreed to add an additional 
30 slots (cohort n = 62) in the TN/U Expansion Cohort for TP53 mutant AML 
patients.  This decision was based on encouraging efficacy data in this cohort. The 
total study numbers are adjusted in Amendment 7 to reflect this decision.
The RBC Transfusion-dependent Low-risk MDS Cohort will consist of approximately 
20 patients and be based on a Q4W magrolimab dosing schedule administered 


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starting Cycle 2.  Given that a higher dose of magrolimab (60 mg/kg) will be tested in 
this cohort, the first 6 patients will be treated in a safety run-in cohort.  These 
6 patients will be treated with magrolimab monotherapy for the first 2 cycles, 
followed by a response assessment.  Patients who do not respond to magrolimab 
monotherapy by this time may have azacitidine added to their treatment regimen.  
Based on the initial safety and efficacy data for these 6 patients, the CTSC will 
determine whether the remaining 14 patients will be treated with magrolimab 
monotherapy or in combination with azacitidine, as well as the dose of magrolimab.  
After a safety evaluation of these 6 patients by the CTSC, the remaining 14 patients 
can be simultaneously enrolled.  Based on emerging data, the CTSC may decide to 
enroll additional patients for further safety, efficacy, or dosing information.  These 
additional patients may be treated with either magrolimab monotherapy or 
magrolimab in combination with azacitidine.  Patients may have their magrolimab 
dose interval changed (i.e., to more frequent [Q2W] or less frequent [> Q4W]) at any 
time on therapy based on CTSC recommendations or Sponsor requirement.
The Rollover Cohort will be open to all patients (maximum of 8) on the existing 
Phase 1 AML trial (Study SCI-CD47-002) who are deriving ongoing clinical benefit 
from magrolimab therapy.  Patients in the Rollover Cohort may receive the same 
dose level and schedule (i.e., twice weekly) of magrolimab monotherapy as 
previously received on the Phase 1 AML study (SCI-CD47-002), or may transition to 
once-weekly dosing in this study at the discretion of the Investigator and with 
Sponsor approval.  At the discretion of the CTSC for this study, rollover patients who 
are receiving lower doses may be escalated to a higher dose deemed to be safe by 
the CTSC for this study.
Patient participation will include screening, treatment, and follow-up.  Screening will 
last up to 30 days before first dose of study treatment (magrolimab and/or 
azacitidine), during which time the patient’s eligibility and baseline characteristics will 
be determined.  Study treatment may be continued until an unacceptable 
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For all cohorts, response assessments will occur every 8 weeks or as otherwise 
detailed in the Schedule of Assessments.
Post treatment, patients will be observed for disease progression and survival until 
death, withdrawal of consent, or the end of the study, whichever occurs first.  For 
patients who come off study treatment to receive a bone marrow transplant, 
follow-up for disease progression and collection of standard-of-care bone marrow 
biopsy/aspirate results will continue until documented disease progression occurs.
The end of study is defined as the date on which the last patient completes the last 
study visit (follow-up for safety, disease progression or survival), or when the CTSC 
or Sponsor decides to end the study.
Duration of Treatment
Patients enrolled in the R/R, TN/U, and Transfusion-dependent Low-risk MDS 
Cohorts will receive study treatment until disease progression or unacceptable 
toxicity.  Patients enrolled in the Rollover Cohort will be treated with magrolimab until 
loss of clinical benefit.  
Planned Number of Patients:  
Total Number of Patients:  Approximately 287 patients evaluable for efficacy:

R/R Safety Cohort:  10 patients

R/R Expansion Cohort:  Up to 36 patients 

R/R MDS Magrolimab Monotherapy Cohort: 23 patients

TN/U Dose Evaluation Cohort:  Up to 18 patients 

TN/U Expansion Cohort:  Up to 172 patients, including 

Original 30 TN/U Expansion (enrolled 18 AML and 16 MDS patients, 
including 4 replacement patients)


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
At least 92 MDS patients (including the original 16 MDS patients enrolled 
in original TN/U Expansion), of whom at least 56 patients will be on Q2W 
dosing.  The overall MDS expansion to 92 patients will be considered the 
MDS Registrational Cohort.

Up to 62 TP53 mutant AML patients (i.e., 12 original TP53 mutation AML 
patients, plus 20 additional TP53 mutant AML patients added per CTSC 
decision in September 2019, plus 30 additional TP53 mutant AML patients 
per CTSC decision July 2020)

RBC Transfusion-dependent Low-risk MDS Cohort:  Up to 20 patients

Rollover Cohort:  Up to 8 patients
Inclusion Criteria:  All Patients 
1. Meets the criteria below for the appropriate cohort:
a) All R/R Cohorts:
i.
Pathologically confirmed AML (defined by 2017 European Leukemia 
Net [ELN] classification) relapsed or refractory to a prior therapy with 
either a hypomethylating agent (such as azacitidine or decitabine), 
non-intensive chemotherapy (such as low-dose cytarabine 
arabinoside), and/or venetoclax.  Treatment is limited to 1 prior line of 
therapy.  Hematopoietic stem cell transplant for patients in remission 
would not be counted as a line of therapy for AML, or 
ii.
Confirmed MDS defined according to World Health Organization 
(WHO) classification that is either refractory to hypomethylating agent 
(defined as disease progression per the International Working Group 
[IWG] MDS response criteria at any time after initiation of a 
hypomethylating agent or failure to achieve an objective response by 
IWG 2006 criteria after 4 cycles) or is relapsed or intolerant to prior 
therapy with either a hypomethylating agent, non-intensive 
chemotherapy, or targeted therapy.  Treatment is limited to 1 prior line 


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of hypomethylating agent therapy (including investigational 
hypomethylating agents) for all R/R MDS patients. 
iii.
R/R MDS Magrolimab Monotherapy Cohort:  Inclusion criterion ii above 
applies.
b) All TN/U Cohorts (meets i or ii):  
i.
Previously untreated patients with MDS defined according to WHO 
classification, with an IPSS-R risk category of intermediate, high, or 
very high risk.  Prior and concurrent therapy with hydroxyurea, oral 
etoposide, erythroid and/or myeloid growth factors is allowed.
ii.
Previously untreated patients with histological confirmation of AML by 
WHO criteria who are ineligible for treatment with a standard 
cytarabine and anthracycline induction regimen due to co-morbidity, 
age or other factors, or who refuse such therapy; or 
c) TP53 Mutant AML Subcohort:  Previously untreated patients with 
histological confirmation of AML by WHO criteria who are ineligible for 
treatment with a standard cytarabine and anthracycline induction regimen 
due to co-morbidity, age, or other factors, or who refuse such therapy and 
who have presence of at least 1 TP53 gene mutation by next-generation 
sequencing based on local evaluation.
d) RBC Transfusion-dependent Low-risk MDS Cohort:  MDS patients with 
very low or low risk by IPSS-R who are RBC transfusion-dependent 
(requiring ≥ 2 RBC units within 8 weeks prior to screening) and meet at 
least one of the following:
i.
R/R to ESA:  documented non-response or response that is no 
longer maintained to prior ESA-containing regimen
ii.
Intolerant to ESA:  documentation of discontinuation of prior 
ESA-containing regimen at any time after initiation due to 
intolerance or adverse event (AE)
iii.
ESA ineligible:  endogenous serum erythropoietin level 
> 500 U/L for patients who have not been previously treated 
with ESAs 


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iv.
Have a deletion in chromosome 5q and who are 
relapsed/refractory/intolerant to or ineligible for lenalidomide 
therapy
e) Rollover Cohort:  Patients on active magrolimab therapy on the Phase 1 
AML (SCI-CD47-002) trial who are deriving clinical benefit by Investigator 
assessment.
2. White blood cell (WBC) count ≤ 20 × 103/mcL pre-first dose of study treatment 
and prior to each magrolimab dose for Cycle 1.  Patients with WBC 
> 20 × 103/mcL can be treated with hydroxyurea (up to 4 g/day) throughout 
the trial to reduce the WBC to ≤ 20 × 103/mcL.  Oral etoposide (up to 200 mg 
orally [PO] /day) may be given as an alternative to hydroxyurea for patients 
who are intolerant to hydroxyurea or cannot achieve sufficient WBC lowering 
on hydroxyurea.
3. Patient has provided informed consent.
4. Must be willing and able to comply with clinic visits and procedures outlined in 
dosing.
R/R Cohorts (including the R/R MDS Magrolimab Monotherapy Cohort), TN/U 
Cohorts (including the MDS Registrational Cohort and the TP53 Mutant TN/U 
AML Subcohort), and RBC Transfusion-dependent Low-risk MDS Cohort only
(Criteria 5 through 9 DO NOT apply to the Rollover Cohort):
5. Male or female, age ≥ 18 years.
6. Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 2
7. Hemoglobin must be ≥ 9 g/dL within 24 hours prior to the first 2 doses of 
magrolimab infusion; patient must be willing to undergo blood transfusions as 
deemed clinically necessary. NOTE: Transfusions are allowed to meet 
hemoglobin eligibility (see Section 6.2.2.1 for anemia management) 
8. Pretreatment blood crossmatch completed (as detailed in Section 6.2.2.1 and 
Section 7.3.4)


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9. Biochemical indices within the ranges shown below:
a) Aspartate aminotransferase (AST)/serum glutamic oxaloacetic 
transaminase (SGOT) and alanine aminotransferase (ALT)/serum 
glutamic pyruvic transaminase (SGPT) ≤ 5× upper limit of normal (ULN)
b) Bilirubin ≤ 1.5× ULN or ≤ 3.0 × ULN and primarily unconjugated if patient 
has a documented history of Gilbert’s syndrome or genetic equivalent
c) Serum creatinine ≤ 1.5× ULN or calculated glomerular filtration rate (GFR) 
≥ 40 mL/min/1.73 m2
10.Female patients of childbearing potential must not be nursing or planning to 
be pregnant and must have a negative urine or serum pregnancy test within 
30 days before enrollment and within 72 hours before the first administration 
of study drug. 
11.Female patients of childbearing potential must be willing to use 1 highly 
effective method of contraception during the study and continue for 6 months 
after the last dose of magrolimab or azacitidine, whichever ends later 
(Section 4.5.2 of the protocol).
12.Male patients who are sexually active with a woman of childbearing potential 
(WOCBP) and who have not had vasectomies must be willing to use a barrier 
method of contraception during the study and for 3 months after the last dose 
of magrolimab or azacitidine, whichever ends later (Section 4.5.4 of the 
protocol).
13.Willing to consent to mandatory pretreatment and on-treatment bone marrow 
biopsies (trephines), unless not feasible as determined by the Investigator.
Exclusion Criteria
1. Prior treatment with CD47 or SIRPα-targeting agents (with exception of 
magrolimab for patients in the Rollover Cohort)
2. Prior anti-leukemic therapies including, but not limited to, chemotherapy (with 
the exception of hydroxyurea or oral etoposide), targeted therapies, 
immunotherapy, or radiotherapy within 4 weeks prior to Day 1 magrolimab 


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dosing.  NOTE:  Localized non-central nervous system (non-CNS) 
radiotherapy, previous hormonal therapy with luteinizing hormone-releasing 
hormone (LHRH) agonists for prostate cancer, and treatment with 
bisphosphonates and receptor activator of nuclear factor kappa-B ligand 
(RANKL) inhibitors are not criteria for exclusion.
3. TN/U Cohorts only:  Any prior anti-leukemic therapy (excluding hydroxyurea 
or oral etoposide), prior treatment with hypomethylating agents and/or low 
dose cytarabine
4. R/R Expansion Cohort, R/R MDS Magrolimab Monotherapy Cohort, TN/U 
Cohorts, and RBC Transfusion-dependent Low-risk MDS Cohort only:  
Contraindications to azacitidine, including advanced malignant hepatic tumors 
or known hypersensitivity to azacitidine or mannitol
5. Acute promyelocytic leukemia
6. Known inherited or acquired bleeding disorders
7. Previous allogeneic hematopoietic stem cell transplant within 6 months prior 
to enrollment, active graft versus host disease (GVHD), or requiring 
transplant-related immunosuppression
8. Clinical suspicion of active CNS involvement by leukemia.
9. Significant medical diseases or conditions, as assessed by the Investigators 
and Sponsor, that would substantially increase the risk-benefit ratio of 
participating in the study.  This includes, but is not limited to, acute myocardial 
infarction within the last 6 months, unstable angina, uncontrolled diabetes 
mellitus, significant active infections, and congestive heart failure New York 
Heart Association (NYHA) Class III-IV.
10.Second malignancy, except treated basal cell or localized squamous skin 
carcinomas, localized prostate cancer, or other malignancies for which 
patients are not on active anti-cancer therapy as defined in Exclusion 
Criterion 2.
11.History of psychiatric illness or substance abuse likely to interfere with the 
ability to comply with protocol requirements or give informed consent
12.Pregnancy or active breastfeeding


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13.Known active or chronic hepatitis B or C infection or human 
immunodeficiency virus (HIV)
Test Product, Dose, and Mode of Administration
Magrolimab is a humanized monoclonal antibody against CD47, which is 
administered intravenously (IV).

R/R Safety and Expansion Cohorts:  In the R/R Safety Cohort, magrolimab 
monotherapy will be administered twice weekly on an intrapatient dose 
escalation schedule:  1 mg/kg twice weekly for Week 1 (Day 1 and Day 4); 
15 mg/kg on Day 8; 30 mg/kg on Day 11 and Day 15; and 30 mg/kg weekly 
thereafter.  For the R/R Expansion Cohort, magrolimab will be administered on a 
different dose schedule: 1 mg/kg twice weekly for Week 1 (Day 1 and Day 4); 
15 mg/kg on Day 8; 30 mg/kg on Day 11 and Day 15; and 30 mg/kg weekly on 
Day 22 through end of Cycle 2, then 30 mg/kg Q2W starting Cycle 3 and 
thereafter.  For R/R Expansion, azacitidine will be administered according to 
approved labeling, either subcutaneously (SC) or IV, at the standard dose of 
75 mg/m2 on Days 1 to 7 of each 28-day cycle.

R/R MDS Magrolimab Monotherapy Cohort:  Magrolimab will be administered 
twice weekly through Cycle 1 Day 11, and then weekly beginning Cycle 1 Day 15 
and thereafter using a similar intrapatient dose escalation schedule as used for 
the R/R Safety Cohort (1 mg/kg on Day 1 and Day 4, 15 mg/kg on Day 8, 
30 mg/kg on Day 11 and Day 15, 30 mg/kg weekly through end of Cycle 2).  
However, for this subcohort, patients will receive magrolimab after intrapatient 
dose escalation at 30 mg/kg Q2W starting Cycle 3 and thereafter).

TN/U Dose Evaluation Cohort:  Magrolimab will be administered twice weekly 
through Cycle 1, Day 11, and then weekly beginning Cycle 1, Day 15, and 
thereafter using a similar intrapatient dose escalation schedule as used for the 
R/R Safety Cohort (1 mg/kg on Days 1 and 4; 15 mg/kg on Day 8; 30 mg/kg on 
Days 11 and 15; and 30 mg/kg weekly thereafter).  Azacitidine will be 
administered according to approved labeling, either SC or IV, at the standard 
dose of 75 mg/m2 on Days 1 to 7 of each 28-day cycle.


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
TN/U Expansion Cohort (including MDS Registrational Cohort):  As of 
Amendment 5, RP2DS for magrolimab as determined in the TN/U Dose 
Evaluation Cohort, is identical to that tested in the R/R Safety Cohort.  
Magrolimab will be administered twice weekly through Cycle 1, Day 11, and then 
weekly beginning Cycle 1, Day 15 and thereafter using a similar intrapatient dose 
escalation schedule as used for the R/R Safety Cohort (1 mg/kg on Day 1 and 
Day 4, 15 mg/kg on Day 8, 30 mg/kg on Day 11 and Day 15, 30 mg/kg weekly 
through end of Cycle 2).  However, as of Amendment 6, patients will receive 
magrolimab after intrapatient dose escalation at 30 mg/kg Q2W starting Cycle 3 
and thereafter.  Azacitidine SC or IV will be administered at the standard dose of 
75 mg/m2 on Days 1 to 7 of each 28-day cycle. 

TP53 Mutant TN/U AML Subcohort:  Magrolimab will be administered as 
1 mg/kg twice weekly for Week 1 (Day 1 and Day 4); 15 mg/kg on Day 8; 
30 mg/kg on Day 11 and Day 15; and 30 mg/kg weekly from Day 22 through end 
of Cycle 2, then 30 mg/kg Q2W starting Cycle 3 and thereafter.  Azacitidine will 
be administered according to approved labeling, either SC or IV, at the standard 
dose of 75 mg/m2 on Days 1 to 7 of each 28-day cycle.

RBC Transfusion-dependent Low-risk MDS Cohort:  Magrolimab will be 
administered as 1 mg/kg on Cycle 1 Day 1; at 30 mg/kg on Cycle 1 Days 8, 15, 
and 22; and at 60 mg/kg Q4W starting on Cycle 2 Day 1 and thereafter.  
Azacitidine will be administered either SC or IV at the dose of 75 mg/m2 on 
Days 1 to 5 of each 28-day cycle.  The dosing regimen for magrolimab and 
azacitidine is specific for low-risk MDS to maximize patient convenience/quality 
of life as well as the safety/efficacy risk/benefit.  Patients may have their 
magrolimab dose interval changed (i.e., to more frequent [Q2W] or less frequent 
[> Q4W]) at any time on therapy based on CTSC recommendations or Sponsor 
requirement.

Rollover Cohort:  Patients may continue to receive magrolimab monotherapy at 
the same dose level and schedule (i.e., twice weekly) they were receiving in the 
previous study (SCI-CD47-002), or may transition to once-weekly dosing at the 
discretion of the Investigator and with Sponsor approval; dose escalation up to 


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the highest dose deemed to be safe on this study by the CTSC may occur at the 
discretion of the CTSC for those rollover patients receiving a lower dose level.  
Study Endpoints
Primary Endpoints

Measurement of AEs according to NCI CTCAE Version 4.03 or customized AE 
severity grading as defined in the protocol (Appendix A of the protocol)

CR rate for patients with AML as defined by the Investigator according to 
protocol-specified criteria (Appendix B of the protocol), which are based on 
European Leukemia Net (ELN) AML recommendations, CR rate for patients with 
MDS as defined by the IWG 2006 MDS response criteria

8-week RBC transfusion independence rate for patients with low-risk MDS as 
defined by the lack of RBC transfusions for at least an 8-week consecutive period 
at any time after starting therapy
Secondary Endpoints

Magrolimab concentration versus time measurements 

Anti-drug antibodies to magrolimab

Objective response in AML based on ELN AML recommendations and IWG AML 
response criteria, or ORR in MDS as defined by the IWG 2006 MDS response 
criteria; CRh; DCR and DOR for patients with AML; DCR and DOR for patients 
with MDS; RBC transfusion independence (no RBC transfusions for at least an 
8-week consecutive period); 12-week RBC transfusion independence rates; 
mean hemoglobin increase on therapy; and, where appropriate, PFS, RFS, EFS, 
and OS for patients with AML or MDS

Level of MRD negativity using a multiparameter flow cytometry-based assay for 
patients on therapy


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Statistical Methods and Analyses
Time-to-event data will be analyzed by the Kaplan-Meier method.  Continuous 
variables will be summarized with descriptive statistics (n, mean, standard deviation, 
range, and median).  Frequency counts and percentage of patients within each 
category will be provided for categorical data.  
The safety and efficacy analysis will be conducted on all enrolled patients who 
receive at least 1 dose of magrolimab.  An evaluable patient efficacy analysis will 
also be performed on all patients who receive at least 1 dose of magrolimab and 
have at least 1 disease response assessment or who died before the first disease 
response assessment.
The PK analysis set (PAS), defined as all treated patients who have at least 1 blood 
sample that provides evaluable PK data, will be used for summaries of PK 
concentration data and PK parameters.  
The rate and magnitude of anti-magrolimab antibody positivity will be evaluated.
CCI


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PD and correlative studies will be conducted on patient samples, and both tissue 
and blood samples may be biobanked for future analyses.
Sample Size Justification
A total of approximately 287 efficacy evaluable patients may be enrolled.
For the R/R Safety Cohort and Expansion Cohort, approximately 46 patients may be 
enrolled, including 10 patients treated in the safety run-in cohort and 36 patients 
treated in the expansion cohort.  For the R/R Safety Cohort, 10 patients were 
enrolled, and this cohort was closed to further enrollment as of Amendment 3.  
Based on safety and efficacy data, the CTSC may decide to expand the R/R 
Expansion Cohort to include additional patients.  An ORR of 17% has been reported 
in patients with R/R AML who have been treated with azacitidine (Itzykson 2015).  
For an estimated response rate of 33% or higher, 36 patients would provide a 95% 
confidence interval, with the lower bound to exclude 18.6%, the azacitidine 
monotherapy efficacy rate.
For the TN/U Dose Evaluation Cohort, up to 18 patients can be enrolled based on a 
3+3 dose de-escalation design assuming 3 potential dose cohorts with a maximum 
of 6 patients treated per cohort.  For the TN/U Dose Evaluation Cohort, 8 patients 
were enrolled, and this cohort was closed to further enrollment as of Amendment 5.  
For the TN/U Expansion Cohort, an initial sample size of 30 patients was proposed 
so that the 95% confidence interval of the desired 35% or higher CR rate would 
exclude a known CR rate of 17.85% for azacitidine alone.  This sample size 
calculation was based on inclusion of both TN/U AML and higher-risk MDS patients.  
For the higher-risk, untreated, MDS-only Expansion Cohort added in Amendment 5 
(16 originally enrolled MDS patients + 76 additional patients for n = 92), an 
evaluation will occur after 36 patients have reached the first response assessment 
(Cycle 3 Day 1); however, enrollment will continue and will not be paused in the 
interim.  A sample size of 36 patients provides 80% power to reject the null 
hypothesis that the CR rate is 16.5% or lower at 2-sided 0.05 significant level, 
assuming the true magrolimab+azacitidine CR rate is at least 35.5% (19% 


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improvement).  The null CR rate of 16.5% is based on the pivotal randomized trial 
leading to azacitidine approval in MDS reanalyzed by IWG 2000 criteria 
(Silverman 2006), where the upper bound of the 1-sided 95% confidence interval for 
azacitidine CR rate is 16.5%, with a point estimate of 10%.  Based on Amendment 6, 
per discussion with the FDA in November 2019, the primary endpoint for this 
untreated, higher-risk MDS cohort was changed from CR+PR to CR rate to support 
a potential single-arm approval.  In accordance with this CR endpoint and a 
transition to a Q2W magrolimab dosing regimen, a cohort of 56 patients at Q2W 
magrolimab dosing was added.  A sample size of 56 patients provides 80% power to 
reject the null hypothesis that the CR rate is 16.5% or lower at a 2-sided 0.05 
significant level, assuming the true CR rate is at least 31.5% (i.e., a 15% 
improvement).  A combined planned sample size of 92 patients for the MDS 
Registrational Cohort will provide an 80% power to reject the updated null CR rate of 
23.5% at a 2-sided 0.05 significant level, assuming the true magrolimab+azacitidine 
CR rate is 36.5%.
For the R/R MDS Magrolimab Monotherapy Cohort, patients will be enrolled in a 
Simon’s 2-stage design.  With 1-sided significance level of 0.05 and 80% power, the 
null hypothesis that the magrolimab monotherapy response rate is 9% will be tested 
against the alternative of 30%.  In the first stage, 11 patients will be enrolled.  If there 
are 1 or fewer responses observed in these 11 patients, the cohort will be stopped.  
Otherwise, 12 additional patients will be accrued, for a total of 23.  This cohort was 
stopped after 11 patients enrolled per CTSC decision in October 2020.  The null 
hypothesis will be rejected if 5 or more responses are observed in 23 patients.  For 
patients who do not achieve an objective response at their first protocol-defined 
response assessment, azacitidine can be added on subsequent cycles at the 
discretion of the PI with Sponsor approval.  Azacitidine will be administered in the 
identical dosing schedule as the R/R expansion cohort.  
Per CTSC decision in September 2019 and Amendment 6, a subcohort of TP53 
mutant TN/U AML patients was added.  Initially, up to 32 patients will be enrolled.  
Analysis of these patients will include all TP53 mutant patients meeting subcohort 


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eligibility criteria enrolled prior to the Amendment/CTSC decision.  A sample size of 
32 patients was selected to evaluate the initial efficacy of magrolimab+azacitidine as 
compared to available therapies (most notably venetoclax+hypomethylating agents) 
in TP53 mutant AML.  While venetoclax in combination with hypomethylating agents 
(azacitidine or decitabine) is approved in newly diagnosed AML patients who are 
ineligible for intensive chemotherapy, its efficacy in TP53 mutant AML patients is 
limited.  Per a recent report, the CR+ complete remission with incomplete blood 
count recovery (CRi) rate of venetoclax+hypomethylating agent in TP53 mutant AML 
was 47% with a median duration of CR of 5.6 months and a median overall survival 
of 7.2 months (DiNardo 2019).  In contrast, in all-comer AML patients, the CR+CRi 
rate was 67% with a median duration of CR of 11.3 months and a median overall 
survival of 17.5 months.  Assuming an observed magrolimab+azacitidine ORR of 
59% for a sample size of 32 patients, the 1-sided 90% confidence interval will have a 
lower bound of 46.5%, which excludes a control ORR of 46%.  Based on emerging 
data, the CTSC may decide to enroll additional patients for further safety, efficacy, or 
dosing information.  Per CTSC decision in July 2020 and captured in Amendment 7, 
an additional 30 TP53 mutant AML patients were enrolled for the TN/U Expansion 
TP53 AML Cohort.
For the RBC Transfusion-dependent Low-risk MDS Cohort, approximately 
20 patients will be enrolled.  Initially, 6 patients will be enrolled with a safety 
evaluation after all 6 patients complete at least Cycle 2 Day 15 treatment.  This 
safety evaluation is being conducted given that a 60 mg/kg dose of magrolimab will 
be administered starting in Cycle 2, of which this highest dose has not yet been 
tested in patients.  However, an equivalent dose of 60 mg/kg given in 1 week 
(30 mg/kg twice weekly) has already been administered to MDS and AML patients in 
this trial and has been well tolerated.  The CTSC will then evaluate based on the 
aggregate safety profile in these 6 patients and determine whether enrollment 
should proceed to the remaining 14 patients.  If so, these 14 patients can be 
simultaneously enrolled.  The sample size of 20 patients is to be enrolled to evaluate 
an initial efficacy signal in this population, with further enrollment based on this 
signal.  Based on emerging data, the CTSC may decide to enroll additional patients 


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for further safety, efficacy, or dosing information.  These may be enrolled as either 
magrolimab monotherapy or in combination with azacitidine.  Patients may have 
their magrolimab dose interval changed (i.e., to more frequent [Q2W] or less 
frequent [> Q4W]) at any time on therapy based on CTSC recommendations or 
Sponsor requirement.
For the Rollover Cohort, 1 eligible patient from the Phase 1 study (SCI-CD47-002) 
was enrolled in this study, and this cohort was closed to further enrollment as of 
Amendment 3.  


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STUDY DESIGN SCHEMA
Figure 1.
Study Schema: Relapsed/Refractory AML and TN/U Cohorts
Abbreviations:  AML = acute myeloid leukemia; CTSC = Clinical Trial Steering Committee; D = day; IPSS-
R = Revised International Prognostic Scoring System; MDS = myelodysplastic syndrome; Q2W = every 2 
weeks; Q8 week = every 8 weeks; R/R = relapsed/refractory; TN/U = treatment-naïve/unfit; WHO = World 
Health Organization 
a
Dosing will be 1 mg/kg twice weekly for 1 week (Cycle 1 Days 1 and 4) followed by 15 mg/kg on 
Cycle 1 Day 8; then 30 mg/kg on Cycle 1 Days 11, 15, and 22; then 30 mg/kg QW in Cycle 2 (Days 1, 
8, 15, and 22); then Q2W (Days 1, 15) starting Cycle 3 and thereafter, as per dosing schedule.
b There will be 92 MDS patients in total, inclusive of those 16 MDS patients treated in the original 
30-patient TN/U Expansion Cohort.
Pathologically 
confirmed 
relapsed or 
R 
refractory 
E 
(primary 
G 
refractory and 
I 
relapsed 
s 
refractory) AML, 
T 
or intermediate/ 
E 
high risk MOS as 
R 
defined by WHO 
criteria 
Previously untreated 
AML patients who 
are ineligible for 
R 
standard cytarabine E 
+ anthracycline 
G 
induction 
I 
chemotherapy due s 
to co-morbidity, age T 
or other factors, or 
E 
previously untreated R 
intermediate to very 
high risk MOS 
patients by IPSS-R 
Relapsed/Refractory AML/MDS Cohorts 
Magrolimab monotherapy or in combination with azacitidine 
--------;> 
R/R Safety Cohort* 
(10 patients) 
Week 4 
1, 15, 30' mg/kg twice 
weekly magrolimab 
CTSC 
Decision 
to Proceed 
*R/R Safety Cohort closed to enrollment as of 
Amendment 3 
R/R Expansion Cohort 
(36 patients) 
1, 15, 30' mg/kg QJ.W 
Yes --------;> 
magrolimab + 75 mg/m' 
azacitidine D1-7 
Q8 week response assessments 
\
Treatment until progression 
R/R MDS Magrolimab Monotherapy Cohort 
Simon Stage 1 
(11 patients) 
1, 15, 30' mg/kg 
Q2W magrolimab 
Treatment-na"ive Unfit (TN/U} Cohorts 
Magrolimab + azacitidine 
TN/U Dose Evaluation 
TN/U Expansion 
TP53 mutant TN/U 
AML Expansion 
----3> 
(up to 18 patients)* 
Level 1: 1, 15, 30' 
mg/kg twice 
weekly magrolimab 
+ 75 mg/m' 
azacitidine D1-7 
28-day cycles 
RP2D 
----3> 
Q8 week response assessments 
Treatment until progression 
*TN/U Evaluation Cohort closed to 
Enrollment as of Amendment 5 
(30 patients) 
1, 15, 30' mg/kg 
(62 patients) 
magrolimab weekly+ 
1, 15, 30' mg/kg 
75 mg/m2 azacitidine 
/-----7 
D1-7 
magrolimab Q2W + 
75 mg/m2 
1 
azacitidine D1-7 
TN/U Expansion: 
MDS registrational cohort 
(92 total patientsb) 
(36 patients) 
(56 patients) 
CR 
1, 15, 30' mg/kg 
> 35.5% 
magrolimab weekly + 
---:o> 
1, 15, 30' rng/kg 
magrolimab Q2W + 
(23 patients) 
If> 1/11 
ORR 
J No 
Yes 
----;> 
No further 
enrollment 
75 mg/m2 azacitidine D1-7 
75 mg/m2 azacitidine D1-7 
Simon Stage 2 
(12 patients) 
1, 15, 30' mg/kg 
OJ.W magrolimab 


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Figure 2.
Study Schema: Rollover AML and RBC Transfusion-dependent 
Low-risk MDS Cohorts
Abbreviations:  AML = acute myeloid leukemia; CTSC = Clinical Trial Steering Committee; D =day; 
del5q = deletion in chromosome 5q; ESA = erythropoiesis-stimulating agent; MDS = myelodysplastic 
syndrome; Q4W = every 4 weeks; R/R = relapsed/refractory; TN/U = treatment-naïve/unfit; RBC = red 
blood cell
a Dosing will be 1 mg/kg on Cycle 1 Day 1; 30 mg/kg on Cycle 1 Days 8, 15, and 22; and 60 mg/kg Q4W 
starting Cycle 2 and thereafter.
b The safety cohort will be treated with magrolimab monotherapy.  For patients who do not respond after 
Cycle 2, azacitidine may be added on subsequent cycles.
c
The expansion cohort will be treated with magrolimab or magrolimab+azacitidine based on CTSC 
evaluation of the safety cohort.
RBC transfusion 
dependent low risk 
MOS patients R/R 
to ESAs or R/R to 
lenalidomide for 
patients with del5q 
Rollover Cohort* 
Magrolimab monotherapy 
Patients on 
*Rollover Cohort Closed to Enrollment as of 
AML Phase 1 Rollover Amendment 5 
(SCI-CD4 7-002) 
---'---'(U'---'-p:._t:...co--=8'----'p=--=a=--=ti=--=e.:.:.nt=s_,_) __ 
Trial L 
R 
E 
with clinical 
benefit on 
magrolimab 
Continued magrolimab 
treatment until progression 
RBC Transfusion Dependent 
Low Risk MDS Cohort 
Magrolimab + azacitidine 
Safety Cohort 
(6 patients) 
Week 6 
Expansion Cohort 
(14 patients) 
G ---:;> 
1, 30, Go• mg/kg 
Q4W magrolimab 
+ 
CTSC 
Decision 
to Proceed 
--;'> 
Yes 
1, 30, 60• mg/kg 
Q4W magrolimab 
+ 
I 
s 
T 
E 
R 
75 mg/m2 
azacitidine D1-5b 
75 mg/m2 
azacitidine D1-5c 


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TABLE OF CONTENTS
PROTOCOL APPROVAL PAGE................................................................................2
PROTOCOL ACCEPTANCE PAGE...........................................................................3
PROTOCOL SYNOPSIS.............................................................................................4
STUDY DESIGN SCHEMA.......................................................................................26
TABLE OF CONTENTS............................................................................................28
LIST OF TABLES .....................................................................................................32
LIST OF FIGURES....................................................................................................33
ABBREVIATIONS AND DEFINITIONS ....................................................................34
1. BACKGROUND...................................................................................................39
1.1.
Acute Myeloid Leukemia and Myelodysplastic Syndrome .......................39
1.2.
Study Drug:  Magrolimab .........................................................................41
1.2.1.
Nonclinical Background...............................................................41
1.2.2.
Clinical Background ....................................................................46
1.3.
Azacitidine................................................................................................54
1.4.
Correlative Studies Background...............................................................55
1.5.
Study Rationale and Risk-Benefit ............................................................56
1.5.1.
MDS Expansion Scientific Rationale...........................................59
1.5.2.
MDS Expansion Risk-Benefit Assessment .................................60
1.6.
Dose Rationale.........................................................................................60
1.6.1.
Magrolimab .................................................................................60
1.6.2.
Azacitidine...................................................................................64
2. STUDY OBJECTIVES AND ENDPOINTS ..........................................................65
2.1.
Study Objectives ......................................................................................65
2.1.1.
Primary Objectives......................................................................65
2.1.2.
Secondary Objectives .................................................................66
2.2.
Study Endpoints.......................................................................................66
2.2.1.
Primary Endpoints.......................................................................66
2.2.2.
Secondary Endpoints..................................................................67
3. STUDY DESIGN ..................................................................................................68
3.1.
Overall Study Design ...............................................................................68
3.2.
Study Design - R/R Cohort.......................................................................72
3.3.
Study Design - Treatment-naïve/Unfit (TN/U) Cohort ..............................75
3.3.1.
TN/U Cohort Dose Levels ...........................................................75
3.3.2.
TN/U Cohort Dose Evaluation.....................................................77
3.3.3.
TN/U Cohort Dose-limiting Toxicity Evaluation ...........................78
3.3.4.
TN/U Cohort Definition of DLT-evaluable Patients......................78
3.3.5.
TN/U Cohort Definition of Dose-limiting Toxicity.........................79
3.3.6.
TN/U Expansion Cohort ..............................................................80
3.4.
Study Design - RBC Transfusion-dependent Low-risk MDS Cohort........82
CCI
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3.4.1.
RBC Transfusion-dependent Low-risk MDS Cohort Definition of 
Dose-limiting Toxicity ..................................................................83
3.5.
Study Design - Rollover Cohort................................................................85
3.6.
Number of Sites .......................................................................................85
3.7.
Estimated Study Duration and End of Study............................................86
4. PATIENT SELECTION AND ENROLLMENT .....................................................86
4.1.
Study Entry Criteria..................................................................................86
4.1.1.
Inclusion Criteria .........................................................................86
4.1.2.
Exclusion Criteria ........................................................................90
4.2.
Patient Screening and Enrollment Procedures ........................................91
4.3.
Informed Consent Process.......................................................................91
4.4.
Registration Process................................................................................92
4.5.
Contraception Requirements ...................................................................92
4.5.1.
Definition of Childbearing Potential.............................................92
4.5.2.
Definition of Male Fertility............................................................92
4.5.3.
Female Patients ..........................................................................93
4.5.4.
Male Patients ..............................................................................93
5. STUDY DRUG INFORMATION...........................................................................94
5.1.
Magrolimab ..............................................................................................94
5.2.
Azacitidine................................................................................................95
6. TREATMENT PLAN ............................................................................................95
6.1.
Study Drug Administration .......................................................................95
6.1.1.
Magrolimab .................................................................................96
6.1.2.
Azacitidine...................................................................................99
6.1.3.
Premedication ...........................................................................100
6.2.
Dose Modifications, Dose Delays, and Safety Management Guidelines100
6.2.1.
Dose Modification and Delay Guidelines ..................................100
6.2.2.
Specific Safety Management Guidelines ..................................107
6.3.
Duration of Therapy ...............................................................................112
6.4.
Patient Completion of the Study.............................................................112
6.5.
Concomitant Therapy.............................................................................113
6.5.1.
COVID-19 Vaccine....................................................................114
7. STUDY EVALUATIONS ....................................................................................114
7.1.
Schedule of Assessments......................................................................114
7.2.
Assessments by Study Period ...............................................................138
7.2.1.
Screening Assessments............................................................138
7.3.
Description of Study Procedures............................................................139
7.3.1.
Pregnancy Test.........................................................................139
7.3.2.
Complete Blood Counts ............................................................140
7.3.3.
Peripheral Blood Smear Assessment .......................................140
7.3.4.
Type and Screen (ABO/Rh) and Direct Antiglobulin Test (DAT)140
7.3.5.
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7.3.6.
Physical Examination................................................................141
7.3.7.
Electrocardiographs ..................................................................141
7.3.8.
Bone Marrow Assessments ......................................................141
7.3.9.
Adverse Events.........................................................................143
7.3.10. Concomitant Medication Monitoring..........................................144
7.4.
End-of-treatment Visit ............................................................................144
7.5.
Safety Follow-up Visit.............................................................................144
7.6.
Long-term Follow-up for Disease Progression.......................................146
7.7.
Survival Follow-up..................................................................................146
7.8.
Safety Assessments...............................................................................147
7.9.
Efficacy Assessments ............................................................................148
7.10. Pharmacokinetics...................................................................................148
7.11. Immunogenicity (Anti-drug Antibodies) ..................................................149
7.12. Pharmacodynamics and Biomarker Assessments.................................149
7.12.1. CD47 Receptor Occupancy ......................................................149
7.12.2. Correlative Blood Samples........................................................150
7.12.3. Minimal Residual Disease Monitoring.......................................151
8. STUDY DISCONTINUATION ............................................................................154
8.1.
Discontinuation of Study Drug Treatment ..............................................154
8.2.
Withdrawal of Patients From Study........................................................155
8.3.
Termination of the Study........................................................................156
9. ASSESSMENT OF SAFETY .............................................................................156
9.1.
Safety Parameters and Definitions.........................................................156
9.1.1.
Adverse Event...........................................................................157
9.1.2.
Serious Adverse Event..............................................................157
9.2.
Methods and Timing for Capturing and Assessing Safety Parameters..158
9.2.1.
Adverse Event Reporting Period...............................................158
9.2.2.
Eliciting Adverse Events............................................................159
9.2.3.
Assessment of Severity and Causality of Adverse Events........159
9.3.
Procedures for Recording Adverse Events............................................161
9.3.1.
Recording Adverse Events on the eCRF ..................................161
9.4.
Expedited Reporting Requirements for Serious Adverse Events...........166
9.5.
Type and Duration of Follow-up of Patients after Adverse Events.........167
9.6.
Post-treatment Adverse Events .............................................................168
10.MEASUREMENT OF EFFECT..........................................................................168
11.STATISTICAL CONSIDERATIONS ..................................................................171
11.1. Safety Analysis.......................................................................................171
11.2. Efficacy Analysis ....................................................................................171
11.3. Pharmacokinetics Analysis ....................................................................172
11.4. Sample Size Determination....................................................................172
11.5. Clinical Trial Steering Committee...........................................................175
11.6. Data Monitoring Committee ...................................................................176
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11.7. Analysis of the Conduct of the Study .....................................................176
11.8. Statistical Methods.................................................................................176
11.8.1. Efficacy Analyses......................................................................177
11.8.2. Additional Secondary Endpoints ...............................................178
11.8.3. Safety Analyses ........................................................................180
11.9. Handling of Missing Data .......................................................................182
11.10. Interim Safety Review ............................................................................182
12.ETHICAL AND ADMINISTRATIVE CONSIDERATIONS .................................182
12.1. Compliance Statement...........................................................................182
12.2. Investigator Responsibilities...................................................................182
12.3. Institutional Review Board or Independent Ethics Committee ...............184
12.4. Informed Consent and Human Subject Protection.................................184
12.5. Confidentiality.........................................................................................185
12.6. Urgent Safety Measures ........................................................................186
12.7. Serious Breaches and Fraud .................................................................187
12.8. Study Monitoring ....................................................................................187
12.9. Audits and Inspections...........................................................................188
12.10. Data Collection and Handling.................................................................188
12.11. Maintenance of Source Documents and Record Retention...................189
12.12. Long-term Retention of Samples for Additional Future Research..........190
12.13. Financing and Insurance........................................................................191
12.14. Study Reports and Publications.............................................................192
13.REFERENCES ..................................................................................................193
14.APPENDICES....................................................................................................197
Appendix A: National Cancer Institute Common Terminology Criteria For 
Adverse Events..................................................................................197
Appendix B: Disease Response Assessment Based On European Leukemianet 
And International Working Group Criteria..........................................198
Appendix C: ECOG Performance Status ...............................................................202
Appendix D: Peripheral Smear Assessment ..........................................................203
Appendix E: Decitabine Prescribing Information....................................................204
Appendix F: Schedules Of Dosing And Assessments For Completed Cohorts.....205
Appendix G: Pandemic Risk Assessment And Mitigation Plan ..............................225


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LIST OF TABLES
Table 3-1.
Dose and Schedule for R/R AML/MDS Cohorts ..................................74
Table 3-2.
Dose Level and Schedule for TN/U AML/MDS Cohorts (Including 
TP53 Mutant AML)...............................................................................77
Table 3-3.
Dose Level and Schedule for RBC Transfusion-dependent Low-risk 
MDS Cohort .........................................................................................84
Table 6-1.
Magrolimab/Azacitidine Re-priming/Re-escalation Dosing Schedule..99
Table 6-2.
Azacitidine Dose Modification - Patients Without Reduced Baseline 
Blood Counts .....................................................................................105
Table 6-3.
Azacitidine Dose Modification - Patients With Reduced Baseline 
Blood Counts .....................................................................................106
Table 7-1.
Schedule of Assessments, R/R Cohort (Expansion) Note: Cohort 
Closed to Enrollment .........................................................................116
Table 7-2.
Schedule of Assessments, TN/U Expansion Cohort (Including TP53 
TN/U AML) Note: Cohort Closed to Enrollment .................................120
Table 7-3.
Schedule of Assessments, RBC Transfusion-dependent Low-risk 
MDS Cohort Note: Cohort Closed to Enrollment ...............................124
Table 7-4.
Schedule of Assessments, Magrolimab Monotherapy During 
Azacitidine Hold(s).............................................................................128
Table 7-5.
Post-treatment Assessments, All Cohorts .........................................130
Table 7-6.
Correlative Studies Sample Time Points, R/R Cohorts (Expansion 
and R/R MDS Monotherapy), TN/U Cohorts (Expansion and TP53 
Mutant AML Subcohort), and RBC Transfusion-dependent Low-risk 
MDS Cohort .......................................................................................131
Table 7-7.
Pharmacokinetic Assessments, R/R Cohorts (Expansion and MDS 
Monotherapy) Note: Cohorts Closed to Enrollment ...........................132
Table 7-8.
Pharmacokinetic Assessments, TN/U Expansion Cohort..................133
Table 7-9.
Pharmacokinetic Assessments, Magrolimab Monotherapy During 
Azacitidine Hold(s).............................................................................133
Table 7-10.
Pharmacokinetic Assessments, RBC Transfusion-dependent 
Low-risk MDS Cohort.........................................................................134
Table 7-11.
CD47 Receptor Occupancy Sample Time Points, R/R Expansion 
Cohort Note: Cohort Closed to Enrollment ........................................134
Table 7-12.
CD47 Receptor Occupancy Sample Time Points,  TN/U Expansion 
Cohort ................................................................................................135
Table 7-13.
CD47 Receptor Occupancy Sample Time Points, RBC 
Transfusion-dependent Low-risk MDS Cohort...................................135
Table 7-14.
Re-priming/Re-escalation Assessments:  R/R Cohort and 
TN/U Cohort.......................................................................................136
Table 7-15.
Re-priming/Re-escalation Assessments:  RBC Transfusion-
dependent Low-risk MDS Cohort.......................................................137
Table 7-16.
Laboratory Analyte Listing .................................................................147
Table 9-1.
Adverse Event Grade (Severity) Scale ..............................................160
Table 9-2.
Causal Attribution Guidance ..............................................................160
Table 14-1.
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Table 14-2.
Additional Response Definitions Used in This Trial 
(2003 IWG Criteria)............................................................................200
Table 14-3.
Response Criteria for Hematologic Improvement..............................200
Table 14-4.
Response Criteria in MDS (IWG 2006 Criteria With Modifications)...201
Table 14-5.
Dose and Schedule for Rollover AML Cohort....................................205
Table 14-6.
Schedule of Assessments, R/R Cohort (Safety)................................206
Table 14-7.
Schedule of Assessments, R/R MDS Magrolimab Monotherapy 
Cohort ................................................................................................210
Table 14-8.
Schedule of Assessments, TN/U Dose Evaluation Cohort ................214
Table 14-9.
Schedule of Assessments, Rollover Cohort ......................................218
Table 14-10. Correlative Studies Sample Time Points, R/R Safety Cohort ............221
Table 14-11. Pharmacokinetic Assessments, R/R Safety Cohort...........................221
Table 14-12. Pharmacokinetic Assessments, TN/U Dose Evaluation Cohort ........222
Table 14-13. Pharmacokinetic Assessments, Rollover Cohort...............................222
Table 14-14. CD47 Receptor Occupancy Sample Time Points, R/R Safety 
Cohort ................................................................................................223
Table 14-15. CD47 Receptor Occupancy Sample Time Points, TN/U Dose 
Evaluation Cohort ..............................................................................224
LIST OF FIGURES
Figure 1.
Study Schema: Relapsed/Refractory AML and TN/U Cohorts ............26
Figure 2.
Study Schema: Rollover AML and RBC Transfusion-dependent 
Low-risk MDS Cohorts.........................................................................27
Figure 1-1.
Magrolimab Eliminates Leukemic Disease in Patient-derived AML 
Mouse Xenograft Models.....................................................................43
Figure 1-2.
Combination Treatment With Azacitidine and Magrolimab 
Enhances Phagocytic Elimination of Acute Myelogenous 
Leukemia Cancer Cells by Human Macrophages ...............................45
Figure 1-3.
Treatment-related Adverse Events in AML/MDS Patients Treated 
With Magrolimab in Combination With Azacitidine in Study 5F9005 ...50
Figure 1-4.
Magrolimab Priming/Maintenance Dose Regimen in AML/MDS 
Patients Treated With Magrolimab in Combination With Azacitidine 
in Study 5F9005...................................................................................51


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ABBREVIATIONS AND DEFINITIONS
ABO
any of the four blood groups A, B, AB, and O comprising the ABO 
system
ADA
anti-drug antibodies
ADL
activities of daily life
AE
adverse event
ALT
alanine aminotransferase
AML
acute myeloid leukemia
ANC
absolute neutrophil count
API
active pharmaceutical ingredient
aPTT
activated partial thromboplastin time
AST
aspartate aminotransferase
AUC
area under the curve
AUCtau
the area under concentration curve during a dosing interval
Aza
azacitidine
BLA
Biologics License Application
BUN
blood urea nitrogen
CBCs
complete blood counts
CFR
Code of Federal Regulations
cCR
cytogenetic complete remission
CI
confidence interval
CL
clearance
Cmax
maximum plasma concentration
CMV
cytomegalovirus
CNS
central nervous system
CR
complete remission
CRC
colorectal cancer
CRF
case report form
CRh
complete remission with partial hematologic recovery
CRi
complete remission with incomplete blood count recovery
CRMRD-
complete remission without minimal residual disease
CSR
clinical study report
CTSC
Clinical Trial Steering Committee


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CV
coefficient of variation
CyTOF
mass cytometry
DAT
direct antiglobulin test
DCR
duration of complete remission
DLT
dose-limiting toxicity
DNA
deoxyribonucleic acid
DOR
duration of response
ECG
electrocardiogram
ECOG
Eastern Cooperative Oncology Group
eCRF
electronic case report form
EDC
electronic data capture
EFS
event-free survival
EGA
4-bromobenzaldehyde N-(2,6-dimethylphenyl)semicarbazone (a 
compound that protects cells from multiple toxins and viruses)
ELN
European Leukemia Net
EOT
end-of-treatment
ESA
erythropoiesis-stimulating agent
FAB
French-American-British classification
FDA
Food and Drug Administration
GCP
Good Clinical Practice
GFR
glomerular filtration rate
GVHD
graft versus host disease
Hgb
hemoglobin
HI
hematologic improvement
HIV
human immunodeficiency virus
HSCT
hematopoietic stem cell transplant
IB
Investigator’s Brochure
ICF
informed consent form
ICH
International Conference on Harmonisation
IEC
Independent Ethics Committee
IHC
immunohistochemistry
INR
international normalized ratio
IPSS-R
Revised International Prognostic Scoring System


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IRB
Institutional Review Board
IUD
intra-uterine device
IUS
intrauterine hormone-releasing system
IV
intravenous
IWG
International Working Group
kg
kilogram
KM
Kaplan-Meier
L
liters
LDH
lactate dehydrogenase
LHRH
luteinizing hormone-releasing hormone
LISS
low ionic strength solution
M1
macrophages that suppress tumor progression
M2
macrophages that promote tumor progression
mAb
monoclonal antibody
mCR
molecular complete remission
MDS
myelodysplastic syndrome
MedDRA
Medical Dictionary of Regulatory Activities
mg
milligram
MHRA
Medicines and Healthcare products Regulatory Agency (UK)
MLFS
morphologic leukemia-free state
MNS
A human blood group system based upon two genes (glycophorin A 
and glycophorin B) on chromosome 4
MOA
mechanism of action
MRD
minimal residual disease
MTD
maximum tolerated dose
NCCN
National Comprehensive Cancer Network
NCI CTCAE
National Cancer Institute Common Terminology Criteria for Adverse 
Events
NHL
non-Hodgkin’s lymphoma
NYHA
New York Heart Association
ORR
objective response rate
OS
overall survival
PAS
pharmacokinetics (PK) analysis set


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PBMC
peripheral blood mononuclear cell
PCD
programmed cell death
PD
pharmacodynamics
PE
physical examination
PeG
polyethylene glycol
PFS
progression-free survival
PK
pharmacokinetics
PO
per os; orally
PR 
partial remission
PrCR
programmed cell removal
PT
prothrombin time
QW
once weekly
Q2
every 2
Q2C
every 2 cycles
Q2W
every 2 weeks
Q3C
every 3 cycles
Q4W
every 4 weeks
RANKL
receptor activator of nuclear factor kappa-B ligand
RBC
red blood cell
REC
Research Ethics Committee
RFS
relapse-free survival
Rh
Rhesus factor
RNA
ribonucleic acid
RO 
receptor occupancy
RP2DS
recommended Phase 2 dose and schedule
R/R
relapsed/refractory 
SAE
serious adverse event
SAP
statistical analysis plan
SC
subcutaneous
SD
stable disease or standard deviation
SDV
source data verification
SGOT
serum glutamic oxaloacetic transaminase


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SGPT
serum glutamic pyruvic transaminase
SIRPα
signal regulatory protein alpha
SOC
standard of care
S-P
Ser-Pro
t1/2
terminal half-life
TEAE
treatment-emergent adverse event
Tmax
time to maximum concentration
TN/U
treatment-naïve/unfit (for standard induction chemotherapy)
TP53
tumor protein 53
ULN
upper limit of normal
UK
United Kingdom
US
United States
Vz
volume of distribution during the terminal phase
WBC
white blood cell
WOCBP
woman of childbearing potential
WHO
World Health Organization


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1.
BACKGROUND
1.1.
Acute Myeloid Leukemia and Myelodysplastic Syndrome
Acute myeloid leukemia (AML) is a common hematological malignancy whose incidence 
rises from 3:100,000 in young adults to greater than 20:100,000 in older adults.  
Approximately 80% of AML patients are > 60 years of age, so in an aging population, 
the disease is becoming more common.  For patients < 60 years of age, 5-year overall 
survival (OS) is 40 to 50%, but is only 5% for patients > 60 years of age.  Thus, most 
adult AML patients die of their disease.  For patients who are fit for combination therapy, 
initial treatment consists of induction chemotherapy with cytarabine and an 
anthracycline (idarubicin or daunorubicin).  Despite an initial therapy response, in most 
patients the disease relapses.  Presumably, therapy often fails to eradicate all 
tumor-propagating cells and indeed selects for chemotherapy-resistant 
leukemia-propagating sub-clones.  AML patients who are relapsed and/or refractory to 
conventional therapies have limited options for treatment.  Prognosis is poor in this 
population with median OS of approximately 3 to 5 months (Roboz 2014; 
Feldman 2005).  Patients refractory to salvage therapy are treated palliatively, as 
current treatment options are extremely limited.  These patients have a median survival 
of 2 months and long-term survival rates of 5 to 10%.  No standard of care (SOC) exists 
for AML patients who are either relapsed and/or refractory to therapies.  Therefore, 
there is an urgent need for new treatment modalities for this patient population.
In the newly diagnosed setting, standard therapy is induction chemotherapy followed by 
either consolidation therapy or hematopoietic stem cell transplant (HSCT) based on 
baseline characteristics, disease risk factors, and response to initial therapy.  However, 
a significant percentage of newly diagnosed patients are ineligible for these therapies.  
Due to age-related co-morbidities, these patients often are ineligible for aggressive 
induction chemotherapy and HSCT due to a significantly increased risk of treatment-
related mortality.  Instead, SOC for these patients are treatment with hypomethylating 
agents (e.g., azacitidine), which have a lower risk of toxicity, or supportive care 
measures.  However, these treatments are rarely curative and provide a treatment 
benefit of median OS of approximately only 10 months (Dombret 2015).  Thus, there is 


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intense interest to improve the current SOC with therapies that can be combined with 
azacitidine to augment anti-leukemic activity.
A growing body of evidence indicates that in AML there is a subpopulation of leukemic 
stem cells that are relatively resistant to therapy (Craddock 2013; Gerber 2012).  Thus, 
novel agents that target leukemic stem cells have the potential to improve clinical 
outcomes compared to the current SOC (Gupta 2009; Majeti 2011).  The anti-CD47 
antibody magrolimab has demonstrated potent anti-leukemic stem cell activity and 
broad preclinical activity in AML (Liu 2015b; Majeti 2009).
Myelodysplastic syndrome (MDS) is a pre-malignant condition characterized by 
peripheral cytopenias due to production of dysfunctional, dysplastic bone marrow cells.  
Low and very low risk patients, as defined by the Revised International Prognostic 
Scoring System (IPSS-R; Greenberg 2012), are often treated with erythroid and myeloid 
growth factor support and carry a low risk of leukemic progression.  In the untreated 
lower-risk MDS setting, erythropoiesis-stimulating agents (ESAs) and lenalidomide for 
patients with a deletion in chromosome 5q are standard of care.  The main treatment 
goal for these patients is to improve their symptomatic cytopenias, most frequently their 
transfusion requirements for RBCs.  For lower-risk MDS patients who fail ESAs or 
lenalidomide, limited options exist and achieving RBC transfusion independence is 
generally seen in less than a third of patients (Thepot 2016; Santini 2016).  In addition, 
these treatment options are generally not disease modifying and only address 
symptomatic improvement.  Thus, novel agents that are well tolerated and disease 
modifying are needed in lower-risk MDS patients, especially those that fail ESAs and 
lenalidomide.  In contrast to lower-risk MDS, intermediate-, high-, and very high-risk 
MDS patients are generally treated with hypomethylating agents, mostly azacitidine, 
and carry a high risk of leukemic progression.  Azacitidine is SOC for newly diagnosed 
MDS patients with specific high risk subtypes.  However, complete remission (CR) rates 
are low and OS is only around 13 months (Silverman 2002).  Thus, novel therapies that 
replace or augment the efficacy of azacitidine are needed to extend survival for MDS 
patients.  Furthermore, no SOC exists for patients who fail frontline therapy with 


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hypomethylating agents.  Thus, MDS patients who fail frontline therapy also have a poor 
prognosis with need for more effective treatment modalities.
Magrolimab has been investigated in a Phase 1 AML trial (Study SCI-CD47-002) 
operating in the United Kingdom (UK) and is being further investigated in this study in 
multiple subtypes of AML, very low/low-risk MDS, and intermediate/high/very high-risk 
MDS, both as monotherapy and in combination with azacitidine.
1.2.
Study Drug:  Magrolimab
1.2.1.
Nonclinical Background
1.2.1.1.
Nonclinical Introduction
CD47 is a key molecule mediating cancer cell evasion of phagocytosis by the innate 
immune system.  CD47 appears to be an indispensable means by which cancer cells, 
including cancer stem cells, overcome intrinsic expression of their prophagocytic “eat 
me” signals (Jaiswal 2009; Majeti 2009).  The progression from normal cell to cancer 
cell involves changes in genes and gene expression that trigger programmed cell death 
(PCD) and programmed cell removal (PrCR; Chao 2012).  Many of the steps in cancer 
progression subvert the multiple mechanisms of PCD, and the expression of the 
dominant antiphagocytic signal, CD47, may represent an important checkpoint 
(Chao 2012).  Increased CD47 expression was identified first on leukemic stem cells in 
human AML (Majeti 2009), and since then it has been found that CD47 expression is 
increased on the surface of cancer cells from a large number of diverse human tumor 
types.
In mouse xenografts, CD47-blocking monoclonal antibodies (mAbs) inhibit human 
xenograft tumor growth and metastasis by enabling the phagocytosis and elimination of 
cancer cells from various hematologic malignancies and solid tumors (Majeti 2009; 
Chao 2010a; Chao 2011a; Chao 2011b; Edris 2012; Kim 2012; Willingham 2012).  
Binding of CD47 on cancer cells to its ligand signal-regulatory protein alpha (SIRPα) 
expressed on phagocytes leads to inhibition of tumor phagocytosis.  Thus, blockade of 
the CD47-SIRPα signaling pathway by an anti-CD47 antibody leads to phagocytosis 
and elimination of tumor cells.  Selective targeting of tumor cells by an anti-CD47 


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antibody is due to the presence of pro-phagocytic signals expressed mainly on tumor 
cells and not on normal cell counterparts (Chao 2010b).  In addition, the anti-CD47 
antibody induces an anti-cancer T-cell response through cross-presentation of tumor 
antigens by macrophage and antigen-presenting cells after tumor cell phagocytosis 
(Tseng 2013; Liu 2015a).  Furthermore, CD47-blocking mAbs have shown synergistic 
efficacious activity with cancer-specific targeting antibodies, including anti-CD20 
antibody rituximab in non-Hodgkin’s lymphoma (NHL) (Chao 2010a).
The nonclinical studies referred to in the publications referenced in this section have 
been conducted with a commercially available CD47-blocking mAb (clone B6H12, 
mouse IgG1), and additional nonclinical studies have been conducted with the 
humanized CD47-blocking mAb magrolimab.
1.2.1.2.
Nonclinical Efficacy
Magrolimab is an anti-human CD47 mAb that blocks the interaction of CD47 with its 
receptor and enables phagocytosis of human cancer cells (Liu 2015b).  The activity of 
magrolimab is primarily dependent on blocking CD47 binding to SIRPα and not on the 
recruitment of Fc-dependent effector functions, although the presence of the IgG4 Fc 
domain is required for its full activity.  For this reason, magrolimab was engineered with 
a human IgG4 isotype that is relatively inefficient at recruiting Fc-dependent effector 
functions that might enhance toxic effects on normal CD47 expressing cells (Liu 2015b).  
Nonclinical studies using xenograft cancer models provide compelling evidence that 
magrolimab triggers phagocytosis and elimination of cancer cells from human solid 
tumors and hematologic malignancies.  Based on this mechanism of action (MOA) and 
its potent nonclinical activity, magrolimab is being developed as a novel therapeutic 
candidate for solid tumors and hematologic malignancies.
The magrolimab anti-CD47 program represents a novel strategy for the treatment of 
cancer and is the first therapeutic agent to target the CD47-SIRPα axis.  Extensive 
nonclinical studies have demonstrated activity against both human solid tumors (breast, 
ovarian, pancreas, colon, leiomyosarcoma, bladder, prostate, and others) and 
hematologic malignancies (AML, acute lymphoblastic leukemia, NHL, myeloma, MDS, 
and others).


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Specifically in AML, magrolimab treatment eliminated both circulating leukemic and 
bone marrow disease in nonclinical mouse models engrafted with human patient AML 
cells (Liu 2015b; Figure 1-1 ). The anti-leukemic effect of magrolimab was rapid, as 
elimination of leukemic blasts in the bone marrow occurred as early as 14 days after 
start of treatment. Regeneration of normal hematopoiesis in the bone marrow occurred, 
with 80 to 100% of mice treated achieving long term durable remissions. Furthermore, 
anti-CO47 antibody specifically eliminated leukemic stem cells and inhibited the ability 
for leukemic re-growth (Majeti 2009). The anti-leukemic effect of anti-CO47 antibody 
therapy is broad in AML, as efficacy is observed in nonclinical studies across 
cytogenetic, molecular, and morphologic AML subtypes (Liu 2015b; Majeti 2009). 
Anti-CO47 antibody may also have therapeutic efficacy in MOS. Blockade of CO47 may 
be therapeutic in patients with higher-risk MOS as CO47 expression increases with 
progression from low risk to high risk MOS to AML. In preclinical models, dysplastic 
cells from high risk MOS patients were eliminated by phagocytosis with an anti-CO47 
antibody (Pang 2013). 
Figure 1-1. Magrolimab Eliminates Leukemic Disease in Patient-derived AML 
Mouse Xenograft Models 
Figure 1-1 Part A 
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Figure 1-1 Part B
Source:  Liu 2015b
Abbreviations:  AML = acute myeloid leukemia
In addition to magrolimab monotherapy activity in AML, the therapeutic potential for 
combination with magrolimab has been explored in nonclinical studies.  It has been 
shown that certain chemotherapies induce pro-phagocytic signal expression on tumor 
cells (Obeid 2007), which can potentially augment the anti-tumor activity of magrolimab 
through simultaneous blockade of the “don’t eat me” signal CD47 and upregulation of 
pro-phagocytic signals on tumor cells.  Hypomethylating agents, notably azacitidine, are 
standard-of-care frontline therapy for AML patients who are unfit for induction 
chemotherapy.  Since a major MOA of azacitidine is leukemic cell cytotoxicity, it is 
hypothesized that the addition of magrolimab to azacitidine will augment phagocytic 
clearance of dying leukemic cells induced by azacitidine, thereby leading to enhanced 
anti-leukemic activity.  Thus, the therapeutic activity of combination treatment with 
magrolimab and azacitidine was recently explored by the Sponsor in nonclinical models.  
Cells from the leukemia cell line HL60 were incubated for 24 hours with human 
macrophages differentiated from two independent human donors in the presence of 
3 µM azacitidine, 10 mcg/mL magrolimab, or control IgG4 antibody, or the combination.  
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The 3 µM azacitidine dose was selected since this is the approximate peak plasma 
concentration of azacitidine in patients (Marcucci 2005; Garcia-Manero 2008). 
Consistent with this hypothesis, the combination of magrolimab and azacitidine led to a 
statistically significant increase in leukemic cell phagocytosis in vitro compared to either 
monotherapy (Figure 1-2). 
Figure 1-2. Combination Treatment With Azacitidine and Magrolimab Enhances 
Phagocytic Elimination of Acute Myelogenous Leukemia Cancer 
Cells by Human Macrophages 
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Abbreviations: AML = acute myeloid leukemia; Aza = azacitidine. 
Note: Figure represents phagocytosis of HL60 AML cells by human macrophages. 
Nonclinical Toxicology 
In general, magrolimab selectively eliminates tumor cells while sparing normal cell 
counterparts. Most normal cells lack expression of pro-phagocytic signals and are thus 
unaffected by magrolimab binding to and blocking CD47. RBCs are a notable exception 
because CD47 expression protects RBCs from elimination by splenic red pulp 
macrophages, as well as sinusoidal macrophages, in liver and bone marrow. As RBCs 
age, they gradually lose CD47 expression and reorganize membrane phospholipids in a 
manner that enhances pro-phagocytic signaling, ultimately leading to their elimination 
by phagocytosis. Administration of magrolimab accelerates this process by substituting 
gradual loss of CD47 with immediate blockade of CD47 on aging RBCs, changing the 
balance between anti-phagocytic and pro-phagocytic signals in the RSC pool. In 
nonclinical studies, the premature loss of aging RBCs is compensated by an ensuing 
reticulocytosis, and the initial anemia resolves as aged RBCs are replaced with younger 
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cells.  Moreover, the potential for severe anemia in these nonclinical studies is 
ameliorated by administration of a low priming dose of the antibody that results in mild 
to moderate anemia and stimulates reticulocytosis.
The safety profile of magrolimab was specifically evaluated in nonclinical models of 
AML.  One key AML-specific safety finding was observed in these models.  In mice 
xenografted with high circulating leukemic disease burden, early death was observed in 
a fraction of mice within 1 hour of magrolimab administration.  This early death 
exclusively occurred in cases of high burden circulating leukemia cells (> 50% of 
circulating peripheral white cell burden due to AML).  Extensive clinical pathology and 
histologic analyses have failed to identify the cause of early death.  There was no 
evidence of (i) tumor lysis and biochemical perturbations that could cause sudden 
death; (ii) emboli/immune complexes of AML cells/antibody in vital organs (lung, heart, 
endocrine organs - full autopsies were performed on the mice); (iii) bleeding, e.g., within 
the central nervous system (CNS); or (iv) cytokine-mediated perturbation in cardiac 
output, airways or gas exchange.  Importantly, early death with high circulating and 
marrow burden of disease could be completely avoided by first lowering the circulating 
burden of disease with an initial low dose of magrolimab (< 0.3 mg/kg dose equivalent) 
and then gradual weekly intrasubject dose escalation.  This intrasubject dose escalation 
regimen not only completed mitigated early death, but also cleared leukemic disease in 
the bone marrow in 100% of the mice treated.  Thus, based on this nonclinical data, an 
intrapatient dose escalation regimen was utilized for the Phase 1 trial of magrolimab in 
AML (SCI-CD47-002).
1.2.2.
Clinical Background
1.2.2.1.
Summary of Magrolimab Clinical Safety
Magrolimab has been administered as monotherapy and in combination with other 
antitumor compounds in clinical trials.  A summary of the clinical safety and efficacy 
data from ongoing human clinical trials with magrolimab is presented in the most recent 
magrolimab Investigator’s Brochure (IB), including data from Studies SCI-CD47-001 
(solid tumors), SCI-CD47-002 (AML), 5F9003 (NHL), 5F9004 (colorectal cancer [CRC]), 
and 5F9006 (ovarian cancer).  Refer to the IB for additional information.


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Based on the patient experience in trials across multiple oncology indications, 
magrolimab has been well tolerated.  The most common treatment-associated effects 
across both solid tumor and AML patients are related to the targeting of CD47 on 
erythrocytes, with anemia and RBC agglutination being most prominent.
The recommended priming dose of 1 mg/kg of magrolimab was defined by the 
dose-limiting toxicities (DLTs) seen in patients with solid tumors:  acute abdominal pain 
and headache associated with hemagglutination.  However, using a priming and 
maintenance dose schedule in these patients has allowed for the further escalation of 
the maintenance dose to 10 to 30 mg/kg weekly.
In the trial in solid tumor patients (SCI-CD47-001), as expected, the most common, 
clinically relevant toxicity has been an acute anemia manifested as an 
approximately 2 g/dL fall in hemoglobin observed during the first 1 to 2 weeks of 
treatment.  This is followed by a compensatory reticulocytosis and a gradual return to 
baseline by Week 3 or 4 despite continued dosing.  These clinical observations are 
completely consistent with the known MOA of magrolimab and the physiologic role of 
CD47 in regulating the turnover of aging erythrocytes.  The degree of anemia is 
mitigated by use of a priming and maintenance dose regimen.  An initial low priming 
dose eliminates aged RBCs that are susceptible to CD47-blockade mediated clearance, 
which induces a reticulocytosis and shifts the RBC pool to younger cells which are not 
susceptible to magrolimab clearance.  Subsequent higher maintenance doses can then 
be administered without further anemia.  Other associated laboratory abnormalities 
including reticulocytosis, spherocytosis, transient hyperbilirubinemia (predominantly 
unconjugated), and decreased haptoglobin are all indicative of extravascular hemolysis 
consistent with phagocytic removal of RBCs due to blockade of CD47.
A second treatment-related effect on erythrocytes is hemagglutination, which is 
presumed to result from the direct interaction of magrolimab with CD47 on RBCs.  
Hemagglutination, when present, has been typically observed within 24 hours of study 
drug administration and is transient and reversible.  Although D-dimer elevation was 
also common, there was no evidence of disseminated intravascular coagulation, 


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coagulopathy, microangiopathy, thromboembolic disease, or other clinical sequelae 
associated with the hemagglutination findings.  Because RBC agglutination may be 
related to the early, rapid rise in magrolimab concentration in the blood of 
treatment-naïve patients, the duration of infusion of the initial two 1 mg/kg priming doses 
has been extended from 1 to 3 hours (± 30 minutes) in all patients starting in the 
maintenance dose phase of the solid tumor Phase 1 study.  Hemagglutination has been 
observed in 21 of 36 (58%) patients treated using the 3-hour priming dose infusion.  In 
contrast, hemagglutination was observed in 6 of 6 (100%) previous patients treated with 
a 1-hour priming infusion (1 mg/kg).  The duration of the maintenance dose infusions 
remains the same at 2 hours starting at Week 2.
Other common treatment-related adverse events (AEs) in solid tumor patients include 
infusion-related reactions, mild headache, dizziness, fatigue, nausea, photopsia, fever, 
chills, urine discoloration, mild transient visual changes, low back pain, and abdominal 
pain.  The majority of these findings have occurred following the first infusion, with very 
few study drug-related toxicities reported beyond the first cycle.  Several patients have 
been treated with consecutive weekly magrolimab therapy for over 6 months without 
evidence of long-term toxicities.
In the Phase 1 AML trial (SCI-CD47-002), 15 patients have been treated across 5 dose 
cohorts.  In addition, as of 31 December 2017, 10 AML and MDS patients have been 
treated in the R/R AML Cohort at up to 30 mg/kg of magrolimab in this study.  Overall, 
magrolimab has been well tolerated in patients in both the Phase 1 AML trial 
(Study SCI-CD47-002) and this Phase 1b trial.  An MTD has not been reached.  Similar 
to the solid tumor experience, the main toxicities associated with magrolimab have been 
RBC-related (specifically anemia and hemagglutination).
Anemia has been observed throughout magrolimab dosing in AML patients, with an 
average 1 to 2 g/dL decrease in hemoglobin observed with each dose.  Similar to solid 
tumor patients, a mild transient increase in unconjugated bilirubin has been observed 
which is consistent with antibody-mediated extravascular hemolysis of RBCs.  In 
contrast to solid tumor patients, AML patients lack adequate bone marrow function.  


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Thus, reticulocytosis post-magrolimab dosing has rarely been observed in the AML 
patients treated to date.  However, RBC and/or platelet transfusions have been 
well-tolerated in all AML patients treated with magrolimab.  Patients have been able to 
be successfully typed and crossmatched and have had no adverse safety findings 
during RBC transfusions while on magrolimab therapy.  RBC transfusion frequencies 
have generally been consistent with transfusion requirements typically observed in AML 
patients.
Hemagglutination on peripheral smear has been observed at multiple time points and 
generally occurs post-magrolimab dosing in AML patients.  Similar to the solid tumor 
experience, there has been no evidence of associated disseminated intravascular 
coagulation, treatment-related thrombocytopenia, coagulopathy, microangiopathy, 
thromboembolic disease, or other clinical sequelae associated with the 
hemagglutination findings.  A 3-hour infusion duration of magrolimab for doses 1 mg/kg 
or less was used to potentially reduce frequency of hemagglutination, as observed in 
the solid tumor trial.  In contrast to the experience in solid tumor patients, 
hemagglutination has been observed across multiple time points, which is likely due in 
part to ongoing RBC transfusions that contain a fraction of untreated, aged RBCs that 
are still susceptible to magrolimab-mediated clearance and agglutination.  Lastly, mild 
infusion-related reactions manifested as fevers, chills, headache, and pain, have been 
observed in a less than 10% of patients during the initial first several doses of 
magrolimab.  Apart from these expected toxicities, magrolimab treatment has been well 
tolerated in AML patients with no other significant treatment-related toxicities observed.
As of May 2019, 49 patients were enrolled and 46 patients with AML/MDS were treated 
with either magrolimab monotherapy or in combination with azacitidine in Study 5F9005 
(Sallman 2019).  Of the 49 patients enrolled, 21 patients had MDS and 28 patients had 
AML.  Ten R/R AML/MDS patients were treated with magrolimab monotherapy.  
Thirty-six patients with AML/MDS who were treatment-naïve/unfit (TN/U) were 
administered magrolimab in combination with azacitidine.  The safety profile of 
magrolimab in combination with azacitidine was well tolerated and consistent with 
azacitidine monotherapy, with no apparent increased toxicities in combination.  No 


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maximum tolerated dose was reached with magrolimab dosing of 30 mg/kg weekly.  
The most common treatment-related AEs with magrolimab and/or azacitidine were 
anemia (36%), thrombocytopenia/platelet count decreased (26%), neutropenia (25%), 
nausea (17%), infusion-related reaction (14%), and hemagglutination (14%) 
(Figure 1-3).  
Figure 1-3.
Treatment-related Adverse Events in AML/MDS Patients Treated With 
Magrolimab in Combination With Azacitidine in Study 5F9005
There were 36 patients treated with magrolimab in combination with azacitidine.
Abbreviations:  5F9+AZA = magrolimab in combination with azacitidine; AML = acute myeloid leukemia; 
ALT = alanine aminotransferase; MDS = myelodysplastic syndrome. 
On-target anemia due to CD47 blockade-mediated RBC clearance was mitigated with a 
priming/maintenance dose strategy (Figure 1-4).  The average hemoglobin drop with the 
first (priming) dose was 0.5 g/dL, with many patients improving their hemoglobin on 
therapy with a decrease in RBC transfusion requirements. 
Infections 
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Figure 1-4.
Magrolimab Priming/Maintenance Dose Regimen in AML/MDS 
Patients Treated With Magrolimab in Combination With Azacitidine in 
Study 5F9005
Abbreviations:  5F9+AZA = magrolimab in combination with azacitidine; AML = acute myeloid leukemia; 
MDS = myelodysplastic syndrome; RBC = red blood cell.
Only 1 of 46 (2%) patients discontinued treatment due to an AE, which was a Grade 4 
DLT of hemagglutination observed in the TN/U Dose Evaluation Cohort with 
magrolimab in combination with azacitidine.  This patient experienced an 
infusion-related reaction (fevers, chills, and extremity tremulousness) with the first 
magrolimab dose, with hemagglutination on peripheral smear.  The patient underwent a 
full neurologic work-up including a computed tomography scan, magnetic resonance 
imaging, and magnetic resonance angiography of the brain, which were all negative.  
The patient fully recovered within 24 hours; however, the patient discontinued therapy.  
While hemagglutination has been observed on peripheral smear in multiple patients on 
study, there have been no other clinically significant sequelae that have occurred on 
study. 
In summary, the expected adverse effects of anemia and hemagglutination have been 
observed in studies of solid tumor and AML patients treated with magrolimab, and the 
overall safety profile to date is manageable and consistent with nonclinical toxicology 
studies.  All non-hematological magrolimab-associated toxicities have been transient 
and manageable.  Supportive care with frequent RBC and/or platelet transfusions has 
been safely and successfully administered to AML patients who were concurrently 
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treated with magrolimab.  The intrapatient dose escalation regimen of magrolimab used 
in AML patients has been well tolerated and has prevented acute death or related 
toxicities observed in nonclinical models.
1.2.2.2.
Summary of Magrolimab Clinical Pharmacology
No formal clinical pharmacology trials have been completed with magrolimab; however, 
PK data are available for magrolimab doses from 0.1 to 45 mg/kg for patients on the 
ongoing solid tumor Phase 1 study (SCI-CD47‐001).  In the solid tumor trial, patients 
have been treated with weekly magrolimab doses ranging from 0.1 to 45 mg/kg, with 
increasing plasma concentrations associated with increasing dose.  Nonlinear PK 
consistent with target-mediated clearance has been observed over this dose range.  
However, at maintenance doses of 10 mg/kg and above, target-mediated clearance was 
saturated within the dosing regimen and trough levels associated with magrolimab 
efficacy in nonclinical studies have been achieved.  Evidence of sustained target trough 
levels have been observed at doses 10 mg/kg weekly and higher.  Across all trials with 
available data, 21 out of 264 (7.95%) evaluable patients tested positive for anti-drug 
antibodies (ADA) against magrolimab, with no impact of ADA on PK or AE profile.  In 
Studies SCI-CD47-002 and 5F9005 so far, 3 out of 20 (15%) and 4 out of 41 (9.76%) 
patients had anti-magrolimab antibodies, respectively.
1.2.2.3.
Summary of Magrolimab Clinical Efficacy
In both Phase 1 clinical studies, magrolimab treatment is ongoing and efficacy data from 
patients with systemic magrolimab exposures in the range associated with nonclinical 
activity is pending.  As of 31 December 2017, 2 objective responses have been 
observed in the solid tumor Phase 1 study.  Multiple patients have had prolonged stable 
disease on study drug.  However, the number of patients treated at the highest dose 
levels of 30 mg/kg evaluable for anti-tumor efficacy are relatively few.
In the AML Study SCI‐CD47‐002, 15 patients have been treated across 5 dose 
escalation cohorts as of 31 December 2017.  Initial signs of biologic activity have been 
observed.  Of 15 patients evaluable to date, no responses have been observed.  
However, several patients have had bone marrow blast reduction and prolonged stable 


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disease for up to 1 year on study treatment.  In addition, biologic anti-leukemic activity 
has been observed in 2 patients (including 1 patient on study treatment for 1 year).  
These 2 patients, treated in Cohort 3, (1 mg/kg-10 mg/kg twice weekly) exhibited 
markedly hypocellular bone marrow, a finding similar to the magrolimab anti-leukemic 
activity observed in nonclinical murine xenograft models (Majeti 2009; Liu 2015b).  Both 
of these patients have an antecedent history of MDS or dysplastic features, suggesting 
that magrolimab may also be effective in MDS patients.  While the sample size is small, 
the initial response and biologic activity seen in AML patients at doses anticipated to be 
associated with clinical efficacy is encouraging.  
Two combination trials with magrolimab have been enrolling patients, and clinical 
efficacy data are preliminary.  In the 5F9003 trial of magrolimab in combination with 
rituximab for patients with B-cell NHL, 23 patients have been treated as of 
31 December 2017 in a dose escalation phase.  Multiple clinical responses have been 
observed, including both complete and partial responses.  Treatment is ongoing for the 
majority of patients achieving responses, with at least 1 patient continuing to receive 
treatment for over 1 year.  In the 5F9004 trial of magrolimab in combination with 
cetuximab in CRC, 23 patients have been treated and 1 partial response has been 
observed as of 31 December 2017.  Enrollment is ongoing for both trials.
As of May 2019 in Study 5F9005, clinical activity was assessed for magrolimab 
monotherapy in R/R AML/MDS and for magrolimab in combination with azacitidine in 
TN/U AML/MDS (Sallman 2019).  Magrolimab monotherapy induced an objective 
response in 1 of 10 (10%) R/R AML/MDS patients (with 1 AML patient achieving 
morphologic leukemia-free state [MLFS]).  With magrolimab in combination with 
azacitidine, 11 of 11 (100%) MDS patients achieved an objective response, with a 
CR+partial remission (PR) rate of 55%.  In untreated AML patients, magrolimab in 
combination with azacitidine induced an objective response in 9 of 14 (64%) of patients, 
with 36% achieving a CR and 14% achieving a CR with incomplete blood count 
recovery (CRi).  Median time to response at 1.9 months for the combination treatment 
was more rapid than that expected for azacitidine alone (4 to 6 months).  In MDS 
patients, 3 of 7 (43%) responding patients with abnormal cytogenetics at baseline 


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achieved a complete cytogenetic response, with 2 of 10 responders with minimal 
residual disease (MRD) assessment achieving MRD negativity by flow cytometry.  In 
summary, in a limited sample size, magrolimab in combination with azacitidine has 
meaningful clinical activity that appears to be enhanced compared to azacitidine 
monotherapy.  Further results are found in the IB.
1.3.
Azacitidine
Azacitidine is a nucleoside analog, specifically a chemical analog of cytidine.  
Azacitidine has two known primary anti-neoplastic mechanisms of action:  1) inhibition 
of deoxyribonucleic acid (DNA) methyltransferase leading to hypomethylation of DNA 
and 2) direct cytotoxicity of malignant hematopoietic cells through cell death via its 
incorporation into DNA and ribonucleic acid (RNA).  As a hypomethylating agent, 
azacitidine is a standard-of-care therapy for newly diagnosed AML patients who are 
ineligible for induction chemotherapy or HSCT based on age, co-morbidities, or other 
factors.  Azacitidine is also SOC and approved in the United States (US) for treatment 
of subtypes of MDS including, but not limited to, MDS with refractory anemia excess 
blasts, a subtype that is mostly comprised of intermediate to very high risk MDS patients 
by IPSS-R criteria.  In Europe azacitidine is approved for AML patients who are 
ineligible for HSCT and for intermediate-2 and high risk MDS patients according to IPSS 
criteria.  While not approved for the indication of AML by the Food and Drug 
Administration (FDA) in the US, azacitidine is a recommended treatment option for AML 
patients 60 years or older who are not candidates for intensive chemotherapy according 
to the guidelines of the National Comprehensive Cancer Network (NCCN 2017).  Data 
supporting azacitidine as SOC for this population is primarily based on a large 
international randomized Phase 3 study comparing azacitidine to conventional care 
regimens in newly diagnosed AML patients 65 years or older (Dombret 2015).  
Azacitidine 75 mg/m2 per day was administered subcutaneously (SC) for 7 consecutive 
days per 28-day treatment cycle for at least 6 cycles.  Median OS for azacitidine was 
10.4 months, which was statistically significant improvement over conventional care 
regimens (6.5 months).


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The AE profile of azacitidine primarily includes myelosuppression (anemia, leukopenia, 
and thrombocytopenia) and clinical sequelae of myelosuppression (neutropenic fever, 
infections, bleeding, and fatigue).  Common non-hematologic AEs include 
gastrointestinal events (diarrhea, nausea, constipation, and decreased appetite), skin 
disorders (rash, pruritus, petechiae, ecchymosis), injection site/infusion-related 
reactions (injection site erythema and/or pain for SC administration) and fever.  
Generally these toxicities can be managed with supportive care interventions, 
pharmacologic treatment, or dose delays and/or adjustments.  Further information on 
the safety profile of azacitidine is outlined in the Summary of Product Characteristics for 
SC and the Prescribing Information for SC or intravenous (IV) use.
1.4.
Correlative Studies Background
Blockade of the CD47-SIRPα signaling axis on tumor cells by a monoclonal blocking 
anti-CD47 antibody leads to tumor elimination by activation of both the innate and 
adaptive immune system.  Anti-CD47 antibody-mediated tumor elimination by the innate 
immune system occurs through phagocytic elimination of tumor cells by macrophage 
and other phagocytes.  It is well known that macrophages are a common immune cell 
infiltrate in many tumor types, with degree of intratumoral macrophage infiltrate 
correlating with clinical prognosis.  Correlation of macrophage infiltration to clinical 
disease course is often dependent on the presence of either classically activated (M1) 
type macrophages that suppress tumor progression or alternatively, activated (M2) type 
macrophages that promote tumor progression (Pollard 2004).  Given the frequent 
infiltration of M2 macrophages in many tumor types and its role in promoting 
tumorigenesis, there is widespread interest in developing therapies that shift tumor 
macrophage polarization from the pro-tumorigenic M2 to the anti-tumorigenic M1 
macrophages.  In nonclinical studies, anti-CD47 antibody-mediated tumor cell 
phagocytosis has been demonstrated to occur through both M1 and M2 macrophages 
(Zhang 2016).  In addition, in vivo treatment of human xenograft tumors with an 
anti-CD47 antibody demonstrated increased M1 intratumoral macrophages 
post-treatment (Zhang 2016), suggesting that an anti-CD47 antibody can also shift the 
phenotype of macrophages from the M2 towards the M1 phenotype in vivo.  Since the 


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recruitment of macrophage effectors is a key mechanism for anti-tumor activity by 
anti-CD47 antibody, the characterization of macrophage tumor infiltration pre- and 
post-treatment in patients treated with anti-CD47 antibody may provide insights into 
patient and cancer subtypes and macrophage biomarkers that will enrich for anti-tumor 
efficacy.
In addition to modulating the innate immune system, anti-CD47 antibody therapy also 
activates the adaptive immune system towards an anti-tumor response.  Phagocytosis 
of tumor cells by phagocytes (macrophages and/or dendritic cells) leads to 
cross-presentation of tumor antigens to T-cells, enabling a T-cell anti-tumor response 
(Tseng 2013; Liu 2015a).  In one nonclinical study, anti-CD47 antibody mediated a 
specific CD8 T-cell anti-tumor response without proliferation of regulatory T-cells (which 
are generally thought to be tumor-promoting; Tseng 2013).  Currently, there is intense 
interest in investigating the relationship between T-cell subsets that infiltrate the tumor 
and clinical response with the use of immune-oncology therapeutics.  Indeed, increased 
T-cell infiltration in the tumor has been associated with clinical response in oncology 
patients treated with T-cell checkpoint inhibitors (Herbst 2014; Tumeh 2014).  Given the 
role of anti-CD47 antibody in mediating an anti-tumor T-cell response, the clinical 
investigation of the contribution of T-cell effectors to anti-CD47 antibody-mediated 
efficacy is important to select for patients and tumor subtypes that respond to therapy.
1.5.
Study Rationale and Risk-Benefit
SOC therapy for AML patients involves cytotoxic chemotherapies which can lead to 
significant treatment-related morbidity and mortality.  In addition, prognosis for newly 
diagnosed patients and those who relapse or are refractory to these therapies is 
generally poor.  The development of targeted leukemic therapies has the potential to 
improve efficacy and minimize toxicity in order to provide meaningful clinical benefit in 
this patient population.  Monoclonal antibodies targeting leukemia-associated antigens 
have the potential for maximizing the efficacy to toxicity ratio through selective 
elimination of leukemic cells.


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A monoclonal antibody targeting CD47 enables selective phagocytosis and elimination 
of leukemic cells, but not normal cells, and is a potentially beneficial therapy for AML as 
well as MDS.  In murine patient xenograft studies, magrolimab has demonstrated rapid 
elimination of leukemic disease in the peripheral blood and bone marrow, resulting in 
long term and durable remissions in a high percentage of patients (Liu 2015b).  The 
anti-leukemic activity of magrolimab and other anti-CD47 antibodies has been broadly 
observed across AML cytogenetic, molecular, and morphologic subtypes (Liu 2015b; 
Majeti 2009).  In addition, recent nonclinical studies by the Sponsor demonstrated that 
combination therapy with magrolimab and azacitidine demonstrated enhanced 
anti-leukemic activity compared to either agent alone.  The combination of magrolimab 
and azacitidine led to significantly increased macrophage phagocytosis of leukemic 
cells in vitro compared to monotherapy alone (Figure 1-2).  Lastly, anti-CD47 antibody 
has been shown to induce phagocytic elimination of refractory anemia excess blast 
MDS patient samples, comprising both intermediate and higher-risk patients 
(Pang 2013).  These nonclinical experiments provide the rationale for the use of 
magrolimab for the treatment of relapsed and/or refractory (R/R) AML and MDS patients 
and the use of magrolimab in combination with azacitidine for the treatment of newly 
diagnosed AML patients who are TN/U and newly diagnosed intermediate-/high-/very 
high-risk MDS patients.
AML patients who are relapsed and/or refractory to conventional therapies have limited 
options for treatment.  Prognosis is poor in this population with median overall survival 
approximately 3 to 5 months (Roboz 2014; Feldman 2005).  There is no SOC for 
patients in this setting.  Thus, patients with R/R AML represent a significant unmet 
medical need.  In the previous Phase 1 study in AML patients (SCI-CD47-002), 
magrolimab monotherapy has been well tolerated.  The expected adverse effects of 
anemia and hemagglutination have been manageable and consistent with nonclinical 
toxicology studies, and supportive care with frequent RBC and/or platelet transfusions 
has been safely and successfully administered to all AML patients who were 
concurrently treated with magrolimab.


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MDS is a pre-malignant condition characterized by peripheral cytopenias due to 
production of dysfunctional, dysplastic bone marrow cells.  Low and very low risk 
patients, as defined by the IPSS-R, are often treated with erythroid and myeloid growth 
factor support and carry a low risk of leukemic progression.  In RBC 
transfusion-dependent low-risk MDS patients who fail ESAs or lenalidomide, no 
standard of care exists, and well-tolerated and effective therapies are needed.  Initial 
data show that patients treated with magrolimab and azacitidine can achieve RBC 
transfusion independence, and thus this combination has potential efficacy in this 
population.  In contrast, intermediate, high, and very high risk MDS patients are 
generally treated with hypomethylating agents, mostly azacitidine, and carry a high risk 
of leukemic progression.  However, prognosis is poor, and agents that augment the 
activity of azacitidine are needed.  Thus, the combination of magrolimab and azacitidine 
may have potential clinical benefit in these MDS patients.
The majority of patients newly diagnosed with AML are over 60 years of age.  However, 
due to age-related co-morbidities, these patients often are ineligible for aggressive 
induction chemotherapy and HSCT due to a significantly increased risk of 
treatment-related mortality.  Instead, SOC for these patients is treatment with 
hypomethylating agents (e.g., azacitidine), which have a lower risk of toxicity.  However, 
these treatments are rarely curative and provide a treatment benefit of a median overall 
survival around only 10 months (Dombret 2015).  Furthermore, AML patients harboring 
a TP53 mutation have a particularly poor prognosis and are refractory to available 
therapies.  To this point, median survival in TP53 mutant AML patients ineligible for 
induction chemotherapy is only 7 months (DiNardo 2019).  Thus, there is intense 
interest to improve the current SOC with therapies that can be combined with 
azacitidine to augment anti-leukemic activity in both the general TN/U AML population 
as well as those patients harboring a TP53 mutation.
This study will evaluate the safety profile of magrolimab monotherapy in an expanded 
group of AML/MDS patients to enable a potentially broader use of magrolimab in AML 
and MDS patients.


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Treatment with the proposed combination therapy of magrolimab and azacitidine is not 
anticipated to pose a significantly increased risk to patients enrolled on this trial 
compared to the risk of treatment with either agent alone.  Based on the clinical profiles 
of magrolimab and azacitidine, overlapping toxicities (with the exception of anemia) are 
not anticipated with the combination.  Based on the high frequency of disease-related 
anemia in AML patients and the ability to safely manage patients with anemia on 
magrolimab with transfusions in the previous Phase 1 trial in AML patients, the potential 
overlapping toxicity of anemia can be managed to ensure patient safety in this trial.  In 
addition, specific clinical and laboratory monitoring of magrolimab and 
azacitidine-related toxicities will be implemented to closely monitor potential AEs.
Magrolimab alone or in combination with azacitidine will be investigated in R/R AML and 
MDS, newly diagnosed AML patients who are unfit for induction chemotherapy 
(including those with TP53 mutation), newly diagnosed intermediate-/high-/very 
high-risk MDS patients, and RBC transfusion-dependent low-risk MDS patients.  The 
nonclinical evidence of magrolimab activity (alone or in combination with azacitidine), 
the safety profile of magrolimab in AML patients, and preliminary clinical efficacy as 
summarized in Section 1.2.2 suggest that magrolimab has an acceptable risk-benefit 
profile for both AML and MDS patients.
1.5.1.
MDS Expansion Scientific Rationale
Azacitidine upregulates pro-phagocytic signals in leukemia cells and results in 
increased phagocytosis when combined with magrolimab’s blockade of CD47, a major 
anti-phagocytic signal.  Nonclinical data have demonstrated enhanced phagocytosis of 
leukemia cells in vitro and long-term remissions in AML-engrafted mice with magrolimab 
in combination with azacitidine compared to either single agent alone.  Magrolimab in 
combination with azacitidine is being developed in several indications within MDS and 
AML, specifically in a potential pivotal single-arm study in untreated intermediate to very 
high risk MDS patients as assessed by IPSS-R criteria.  The standard-of-care therapy 
for this population is hypomethylating agents (azacitidine and decitabine); however, 
efficacy is limited, with CR+PR rates approximately 15% to 20% with a median OS of 
approximately 18 months (Appendix E).  Novel effective therapies that can be combined 


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with hypomethylating agents while maintaining an acceptable safety profile and 
improving durable remissions and, ultimately, survival are needed.  No new therapies 
have been approved in MDS for over a decade, which underscores a high unmet 
medical need in this population.  Patients with MDS experience frequent co-morbidities 
and mortalities as a result of cytopenias due to the disease and to hypomethylating 
agents.  The need for combination therapies that can induce hematologic improvement 
and disease remission leading to a clear clinical benefit is quite evident.  Magrolimab in 
combination with azacitidine is being developed in untreated MDS patients to improve 
clinical activity and maintain a well-tolerated safety profile.
1.5.2.
MDS Expansion Risk-Benefit Assessment
Based on the scientific rationale, nonclinical data, and acceptable safety profile, and 
encouraging clinical activity data obtained for magrolimab in combination with 
azacitidine, the risk-benefit ratio is acceptable for proceeding forward with further 
development and a potential Biologics License Application (BLA) in untreated 
higher-risk MDS.
1.6.
Dose Rationale
1.6.1.
Magrolimab
Magrolimab selectively eliminates tumor cells while sparing normal cells through 
blockade of the CD47-SIRPα phagocytic signaling axis.  Most normal cells are spared 
due to the expression of pro-phagocytic signals that are expressed on tumor cells, but 
not on normal cells (Chao 2010b).  RBCs are a notable exception because CD47 
expression protects RBCs from elimination by macrophages in the reticuloendothelial 
system.  As RBCs age, they gradually lose CD47 expression and reorganize membrane 
phospholipids in a manner that enhances pro-phagocytic signaling, ultimately leading to 
their elimination by phagocytosis.  Administration of magrolimab accelerates this 
process by substituting gradual loss of CD47 with immediate blockade of CD47 on 
aging RBCs, changing the balance between anti-phagocytic and pro-phagocytic signals 
in the RBC pool.  In nonclinical and clinical studies, the premature loss of aging RBCs is 
compensated by an ensuing reticulocytosis, and the initial anemia resolves as aged 


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RBCs are replaced with younger cells.  Nonclinical studies show that the potential for 
severe anemia is ameliorated by administration of a low priming dose of the antibody 
that results in mild to moderate anemia and stimulates reticulocytosis.  
In patients with a lack of adequate bone marrow reserve and ability to produce 
reticulocytes, as is observed in AML patients, a priming dose to mitigate anemia may 
not be as effective.  Furthermore, additional safety risks may be present in AML patients 
in contrast to solid tumor patients.  Specifically, in AML nonclinical mouse models only, 
early death of mice was observed within 1 hour of magrolimab administration in cases 
with a high burden of circulating leukemia cells (> 50% of circulating blood comprised of 
leukemia cells).  However, early death with high circulating burden of disease could be 
completely avoided in this nonclinical study by first lowering the circulating burden of 
disease with a low dose of magrolimab (< 0.3 mg/kg dose equivalent) and then 
proceeding with gradual intrapatient dose escalation.  This intrapatient dose escalation 
regimen was utilized in the Phase 1 trial in R/R AML (SCI-CD47-002) and has been well 
tolerated with no acute death observed in any AML patients treated.  No MTD has been 
reached on that trial.  The highest dose tested to date (1 mg/kg twice weekly for Week 
1, 10 mg/kg twice weekly for Week 2, and 15 mg/kg twice weekly for Week 3 and 
beyond) was determined to be well tolerated by the Clinical Trial Steering Committee 
(CTSC) in the Phase 1 trial.  In addition, a dose regimen of 1 mg/kg twice weekly for 
Week 1, 15 mg/kg on Day 8, 30 mg/kg on Day 11, and 30 mg/kg twice weekly 
thereafter, has been tested in several AML patients.  Preliminary safety and PK/PD data 
suggest that intrapatient dose escalation from 1 mg/kg twice weekly in Week 1 to 
30 mg/kg on Day 11 is well tolerated and achieves potential therapeutic concentrations.  
Dose concentrations higher than 20 mg/kg may be associated with greater target CD47 
saturation on leukemic cells and higher free drug exposures.  Higher magrolimab dose 
exposures may thus lead to enhanced clinical efficacy.  Based on this potential benefit 
and the current safety profile where an MTD has not been reached, exploration of 
higher magrolimab dose levels represents an adequate risk-benefit profile.  Thus, a 
higher dose regimen of 1 mg/kg on Days 1 and 4, 15 mg/kg on Day 8, and 30 mg/kg on 
Day 11 and twice weekly thereafter has been proposed for evaluation in the Phase 1 


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AML trial, Study SCI-CD47-002, and will be the initial magrolimab dose regimen 
explored in this study.
Based on results from the Phase 1 study of magrolimab in AML, this study is designed 
to employ an intrapatient dose escalation regimen for both magrolimab monotherapy in 
R/R AML and MDS patients and for magrolimab in combination with azacitidine in TN/U 
AML and MDS patients.  The intrapatient dose escalation regimen uses twice-weekly 
dosing at a starting magrolimab dose of 1 mg/kg for Week 1, with escalation to higher 
doses in Week 2, up to a maximum of 30 mg/kg in Week 2 and beyond.  The strategy of 
intrapatient dose escalation was found to result in both mitigation of acute death seen in 
nonclinical models and in expected RBC toxicities that were manageable for this patient 
population.
The recommended magrolimab dose regimen has been amended based on emerging 
PK, PD, and clinical safety and efficacy data in the ongoing Phase 1 study in AML and 
MDS patients (Study SCI-CD47-002).  Based on the data from ongoing clinical trials 
with magrolimab, including the ongoing Phase 1 trial in AML (SCI-CD47-002), twice 
weekly magrolimab dosing of 30 mg/kg is anticipated to exceed the target effective 
concentrations predicted by PK/PD modeling.  Based on preliminary PK data and PK 
modelling, this dose is expected to result in concentrations in the range of 
1000 mcg/mL, much greater than the target range of 100 to 250 mcg/mL seen in 
preclinical studies and the target of 200 mcg/mL predicted by PK modelling.  Therefore, 
a maintenance dose of 30 mg/kg once weekly (QW) is proposed.  As of December 
2017, the 30 mg/kg dosing has been demonstrated to be safe in at least 6 AML patients 
treated.  In the TN/U Cohort of this study, twice-weekly dose escalation from 1 mg/kg to 
30 mg/kg through Week 2 will continue to be used to mitigate potential safety concerns 
and rapidly achieve effective drug target concentrations.  Starting with Week 3, 
magrolimab will be dosed weekly at 30 mg/kg to enable sustained effective target 
concentrations while providing a less frequent and more convenient dosing schedule for 
patients.  In the R/R Safety Cohort, the same magrolimab dose regimen as that in the 
TN/U Cohort was explored and was well tolerated.  In the R/R Expansion Cohort, a 
change to magrolimab dosing was made to evaluate an every 2 week (Q2W) dosing 


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regimen beginning in Cycle 3 based on clinical, PK, and PD data and for evaluation of a 
more convenient dosing regimen.  Specifically, this dose regimen is 1 mg/kg twice 
weekly for Week 1 (Day 1 and Day 4); 15 mg/kg on Day 8; 30 mg/kg on Day 11 and 
Day 15; and 30 mg/kg weekly on Day 22 through end of Cycle 2, then 30 mg/kg Q2W 
starting Cycle 3 and thereafter.  In the Rollover Cohort, patients may continue their 
current dose level and maintenance schedule (i.e., twice weekly) of magrolimab 
monotherapy as previously received in the Phase 1 AML study (SCI-CD47-002), or 
patients may transition to the QW dosing schedule at the discretion of the Investigator 
and with Sponsor approval.
Rationale for a Magrolimab Q2W Dosing Regimen
Per Amendment 6, the magrolimab dosing regimen for all cohorts (excluding the RBC 
Transfusion-dependent Low-risk MDS Cohort) was transitioned to a 30 mg/kg Q2W 
dosing schedule starting Cycle 3 and beyond, in contrast to a 30 mg/kg weekly dosing 
regimen utilized in prior amendments.  This change to a Q2W dosing regimen is based 
on clinical safety/efficacy and PK/PD data obtained in MDS/AML and other cancer types 
treated with magrolimab. 
Based on the entirety of safety data in multiple oncology populations including the 
proposed study population, magrolimab doses up to 30 mg/kg twice weekly as a 
monotherapy and up to 45 mg/kg in combination with tumor-targeted antibodies have 
been found to have a safe and well-tolerated safety profile.  In Studies SCI-CD47-002 
and 5F9005, near-maximal CD47 receptor occupancy was observed in blood and in the 
bone marrow at the maintenance dose of 30 mg/kg twice weekly and QW, respectively, 
in AML and MDS patients.  An exposure-receptor occupancy PK/PD model was built 
using these data.  Simulations with the model predicted that >90% receptor occupancy 
would be achieved in the bone marrow cells after switching to 30 mg/kg Q2W from 
Cycle 3 onward.  In addition, in NHL patients, a dose of 30 mg/kg Q2W from Cycle 3 
onward was also shown to result in efficacy similar to that of a higher dose of 45 mg/kg 
Q2W, indicating that this is an optimal dose of magrolimab.


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Transfusion-dependent Low-risk MDS Dosing Rationale:
For patients with low-risk MDS, dosing convenience and quality of life are particularly 
important considerations for novel treatments.  In addition, the low tumor burden 
observed in low-risk MDS patients indicates that intrapatient dose escalation may not be 
required.  To this effect, the following dosing regimen is proposed: priming dose of 
1 mg/kg on Day 1, followed by 30 mg/kg QW for Cycle 1, followed by 60 mg/kg every 
4 weeks (Q4W) from Cycle 2 onward.  This dosing regimen is similar in the overall 
dosing rate (in mg/kg) to what is proposed above in the high-risk population.  Based on 
existing receptor occupancy (RO) data and PK/PD modeling, it is anticipated that this 
Q4W dosing regimen will maintain ≥ 90% CD47 receptor occupancy on bone marrow 
cells and therefore maximize efficacy and patient convenience.
1.6.2.
Azacitidine
Azacitidine has been approved in Europe for AML patients who are not eligible for 
HSCT using a dosing regimen of 75 mg/m2 SC daily for Days 1 to 7 of a 28-day 
treatment cycle.  This approval was based on a clinical trial of newly diagnosed AML 
patients older than or equal to 65 years of age comparing azacitidine against 
conventional care regimens (Dombret 2015).  Median OS was increased with 
azacitidine versus conventional care regimens (10.4 months versus 6.5 months, 
respectively).  Based on this result and others, azacitidine is currently SOC for newly 
diagnosed AML patients who are unfit for induction chemotherapy or ineligible for 
HSCT.  While not approved in the US for this indication, azacitidine (administered either 
SC or IV) is approved for certain subtypes of MDS in the US, is approved for TN/U AML 
patients in Europe, and is considered SOC in the US for this AML population in 
combination with other hypomethylating agents (decitabine) or low dose cytarabine 
(NCCN 2017).  In accordance with the azacitidine drug label, it is recommended that 
patients be treated for a minimum of 6 cycles.  Treatment should be continued as long 
as the patient continues to benefit or until disease progression, as described in the 
azacitidine prescribing information.  Based on these data and guidance, azacitidine will 
be dosed in this study at the standard clinical dose of 75 mg/m2 on Days 1 to 7 of a 28-
day cycle.  Azacitidine is also approved in Europe for intermediate-2 and high-risk MDS 


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patients by IPSS criteria and in the US for MDS patients with refractory anemia excess 
blasts, among other MDS subtypes.  MDS patients enrolled on this study will consist of 
patients in both the US- and EU-based azacitidine approval indications.  
For low-risk MDS patients, patient convenience and minimizing toxicity while 
maintaining efficacy are important.  Thus, a 5-day azacitidine schedule every cycle will 
be utilized specifically for the RBC Transfusion-dependent Low-risk MDS Cohort.  This 
dose selection is based on prior data, including a randomized trial that evaluated 5-, 7-, 
and 10-day regimens of azacitidine and found that the efficacy was similar across 
regimens but the 5-day regimen had lower toxicity (Lyons 2009).
Rationale for the use of magrolimab and azacitidine in AML and MDS patients is 
presented in Section 1.2.1.2.  Treatment with magrolimab and azacitidine may continue 
as long as the patient continues to benefit, until disease progression, or until 
unacceptable toxicities occur.
2. STUDY OBJECTIVES AND ENDPOINTS
2.1.
Study Objectives
2.1.1.
Primary Objectives
The primary objectives for this study are:

To confirm the safety and tolerability of magrolimab monotherapy in R/R AML and 
MDS and of magrolimab in combination with azacitidine in previously untreated 
patients with AML or MDS and patients with R/R AML and MDS

To evaluate the safety, tolerability, and efficacy of magrolimab monotherapy in R/R 
AML/MDS, and of magrolimab in combination with azacitidine in previously 
untreated patients with AML/MDS or R/R AML/MDS as measured by complete 
remission (CR) rate for patients with AML and higher-risk MDS

To evaluate the safety, tolerability, and efficacy of magrolimab monotherapy or in 
combination with azacitidine in low-risk MDS patients as measured by RBC 
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2.1.2.
Secondary Objectives
The secondary objectives for this study are:

To evaluate the PK profile of magrolimab alone and in combination with azacitidine

To evaluate the immunogenicity of magrolimab 

To evaluate the efficacy of magrolimab alone or in combination with azacitidine as 
measured by duration of CR (DCR); objective response rate (ORR); CR with partial 
hematologic recovery; duration of response (DOR) for patients with AML; DCR for 
higher-risk MDS; ORR and DOR for patients with MDS; RBC transfusion 
independence; mean hemoglobin increase on treatment; progression-free survival 
(PFS); relapse-free survival (RFS), event-free survival (EFS); and OS

To assess the level of MRD negativity 
 
2.2.
Study Endpoints
2.2.1.
Primary Endpoints
The primary endpoints for this study are:

Measurement of AEs according to National Cancer Institute Common Terminology 
Criteria for Adverse Events (NCI CTCAE) Version 4.03 or customized AE severity 
grading as defined in the protocol (Appendix A)

CR rate for patients with AML as defined by the Investigator according to 
protocol-specified criteria (Appendix B), which are based on European Leukemia Net 
(ELN) AML recommendations (Döhner 2017), CR rate for patients with MDS as 
defined by the IWG 2006 MDS response criteria (Cheson 2006)
CCI-


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
8-week RBC transfusion independence rate for patients with low-risk MDS as 
defined by the lack of RBC transfusions for at least an 8-week consecutive period at 
any time after starting therapy
2.2.2.
Secondary Endpoints
The secondary endpoints for this study are:

Magrolimab concentration versus time measurements

ADA to magrolimab

Objective response in AML based on ELN AML recommendations (Döhner 2017) 
and IWG AML response criteria, or ORR (Cheson 2003) in MDS as defined by IWG 
2006 MDS response criteria (Cheson 2006); CRh; DCR and DOR for patients with 
AML; DCR and DOR for patients with MDS; RBC transfusion independence (no 
RBC transfusions for at least an 8-week consecutive period); 12-week RBC 
transfusion independence rates; mean hemoglobin increase on therapy; and, where 
appropriate, PFS, RFS, EFS, and OS for patients with AML or MDS

Level of MRD negativity using a multiparameter flow cytometry-based assay for 
patients on therapy
 
 
 
 
 
 
CCI


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3. STUDY DESIGN
3.1.
Overall Study Design
This trial is an open label, multicenter Phase 1b trial investigating the following:

Magrolimab monotherapy or in combination with azacitidine in patients with relapsed 
and/or refractory AML or MDS (including R/R low-risk RBC transfusion-dependent 
MDS patients)

Magrolimab in combination with azacitidine in newly diagnosed 
intermediate/high/very high-risk MDS patients

Magrolimab in combination with azacitidine in newly diagnosed AML patients 
ineligible for standard induction chemotherapy (including TP53 mutant AML)

Magrolimab monotherapy or in combination with azacitidine for RBC 
transfusion-dependent low-risk MDS patients
The study includes 4 groups of patients:

R/R Cohorts:  AML or MDS patients who have not previously received magrolimab, 
who will receive magrolimab monotherapy in the safety run-in cohort or magrolimab 
in combination with azacitidine in the expansion cohort on this study, as well as an 
R/R MDS Magrolimab Monotherapy Cohort that will enroll up to 23 R/R MDS 
patients.

TN/U Cohorts:  AML patients ineligible for standard induction chemotherapy and 
previously untreated intermediate/high/very high-risk MDS patients by IPSS-R, who 
will receive magrolimab in combination with azacitidine on this study, with at least 
92 intermediate- to very high-risk MDS patients treated (with a combination of 
magrolimab 30 mg/kg weekly [n = 36] and 30 mg/kg Q2W [n = 56] dosing, plus 
azacitidine) and approximately 62 TP53 mutant TN/U AML patients 
(approximately 172). 

RBC Transfusion-dependent Low-risk MDS Cohort:  RBC transfusion-dependent 
very low- to low-risk MDS patients who have failed or are intolerant to ESAs or 
lenalidomide (for del5q patients) who will receive magrolimab monotherapy or in 
combination with azacitidine on this study (approximately 20).


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
Rollover Cohort:  Patients who received magrolimab in the Phase 1 R/R AML study 
(SCI-CD47-002), who will continue magrolimab monotherapy on this study (total 
N = up to 8).
The R/R Cohorts consist of 2 cohorts: 1) an R/R Safety and Expansion Cohort, and 
2) an R/R MDS Magrolimab Monotherapy Expansion Cohort.  The R/R Safety and 
Expansion Cohort consists of an initial evaluation of magrolimab monotherapy in R/R 
MDS/AML patients, followed by an expansion cohort of magrolimab + azacitidine in R/R 
MDS/AML patients.  As of Amendment 3, in the first stage, patients in the R/R Safety 
Cohort have been treated at the maintenance dose of 30 mg/kg twice weekly; going 
forward, these patients will be treated weekly at the maintenance dose of 30 mg/kg, as 
determined by the Clinical Trial Steering Committee (CTSC) based on clinical, PK, and 
PD data.  This safety run-in will confirm the safety profile of magrolimab monotherapy at 
this dose level in an expanded R/R population.  Approximately 30 days after enrollment 
is completed in the R/R Safety Cohort, the CTSC will assess the safety data to 
determine whether enrollment may begin in the TN/U Dose Evaluation Cohort.  In 
addition, the CTSC will also determine whether enrollment will proceed to an initial 
36-patient R/R Expansion Cohort, based on safety and efficacy data, which will be 
conducted with magrolimab in combination with azacitidine as per Amendment 5.  
Based on emerging data, the CTSC may decide to enroll additional patients beyond 36 
for further safety, efficacy, or dosing information.
The R/R MDS Magrolimab Monotherapy Cohort was added in Amendment 6.  Per FDA 
feedback, a magrolimab monotherapy cohort in R/R MDS will be evaluated to further 
define the activity of magrolimab to the contribution of magrolimab + azacitidine in MDS 
to support a potential single-arm approval of magrolimab + azacitidine in MDS.  Patients 
will be enrolled in a Simon’s 2-stage design to evaluate for potential futility.  Patients 
who do not achieve an objective response with magrolimab monotherapy at the 
protocol-defined first response assessment may have azacitidine added by discretion of 
the Principal Investigator with Sponsor approval, according to the schedule of 
azacitidine outlined in the R/R cohorts.


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The TN/U Cohort will be enrolled in 2 stages.  In the first stage, the study will investigate 
the safety and tolerability of magrolimab and azacitidine in a 3+3 dose evaluation 
design, in previously untreated AML patients who are unfit for standard combination 
chemotherapy and previously untreated intermediate/high/very high-risk MDS patients.  
The same dose level of magrolimab used in the R/R Safety Cohort will be initially 
evaluated in combination with the standard dose of azacitidine in the TN/U Dose 
Evaluation Cohort.  Optional additional dose cohorts may explore higher or lower doses 
in increments of up to 50% of the maximum prior dose, as determined by the CTSC 
based on emerging PK, pharmacodynamic, and clinical data.  A total of up to 
18 patients may be treated in the TN/U Dose Evaluation Cohort.  In the second stage, a 
recommended dose and schedule will be selected by the CTSC for treatment of up to 
30 patients in the TN/U Expansion Cohort, which will be evaluated for efficacy of 
magrolimab in combination with azacitidine.  The same dose level of magrolimab used 
in the R/R Safety Cohort will be initially evaluated in combination with the standard dose 
of azacitidine in the TN/U Dose Expansion Cohort.  Per CTSC and Amendment 6, the 
magrolimab dosing was changed to 1 mg/kg on Days 1 and 4; 15 mg/kg on Day 8; 
30 mg/kg on Days 11, 15, and 22; 30 mg/kg weekly for Cycle 2; and 30 mg/kg Q2W 
starting Cycle 3 and thereafter.  In addition, based on Amendments 5 and 6, the TN/U 
Expansion Cohort was expanded to a total of 122 patients, which will include at least 
92 patients with MDS and an additional 12 slots for TP53 AML per CTSC decision 
September 2019.  For a higher-risk, untreated, MDS-only expansion, an evaluation will 
occur after 36 patients have undergone the first response assessment.  If the CR rate 
for magrolimab+azacitidine is at least 35.5%, then subsequent enrollment can continue.  
After this initial efficacy evaluation (as a part of Amendment 6), at least 56 additional 
patients will be enrolled at a magrolimab 30 mg/kg Q2W dosing regimen in the 
higher-risk untreated MDS expansion.  Enrollment does not need to be paused during 
the 36-patient evaluation prior to the additional 56-patient expansion.  As part of 
Amendment 6, a subcohort of approximately 32 TN/U AML (12 patients plus an 
additional 20) patients with a TP53 gene mutation was added.  This addition is based on 
initial encouraging efficacy data observed in the TN/U Cohort in patients with a TP53 
gene mutation.  Based on emerging data, the CTSC may decide to enroll additional 


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patients beyond the 20 patients for further safety, efficacy, and/or dosing data.  Per 
CTSC decision in July 2020 and captured in Amendment 7, an additional 30 TP53 
mutant AML patients were added to the TN/U Expansion Cohort (n = 62).
The RBC Transfusion-dependent Low-risk MDS cohort will consist of approximately 
20 patients and be based on a Q4W magrolimab dosing schedule administered starting 
Cycle 2.  Given that a higher dose of magrolimab (60 mg/kg) will be tested in this 
cohort, the first 6 patients will be treated in a safety run-in cohort.  These 6 patients will 
be treated with magrolimab monotherapy for the first 2 cycles, followed by a response 
assessment.  Patients who do not respond to magrolimab monotherapy by this time 
may have azacitidine added to their treatment regimen.  Based on the initial safety and 
efficacy data for these 6 patients, the CTSC will determine whether the remaining 
14 patients will be treated as magrolimab monotherapy or in combination with 
azacitidine, as well as the dose of magrolimab.  After a safety evaluation of these 
6 patients by the CTSC, the remaining 14 patients can be simultaneously enrolled.  
Based on emerging data, the CTSC may decide to enroll additional patients for further 
safety, efficacy, or dosing information.  These additional patients may be treated with 
either magrolimab monotherapy or magrolimab in combination with azacitidine.  
Patients may have their magrolimab dose interval changed (i.e., to more frequent [Q2W] 
or less frequent [> Q4W]) at any time on therapy based on CTSC recommendations or 
Sponsor requirement.
The Rollover Cohort will be open to all patients (maximum of 8) on the existing Phase 1 
AML trial (study SCI-CD47-002) who are deriving ongoing clinical benefit from 
magrolimab therapy.  Patients in the Rollover Cohort may receive the same dose level 
and schedule (i.e., twice weekly) of magrolimab monotherapy as previously received on 
the Phase 1 AML study (SCI-CD47-002), or may transition to once-weekly dosing in this 
study at the discretion of the Investigator and with Sponsor approval.  At the discretion 
of the CTSC for this study, Rollover patients who are receiving lower doses may be 
escalated to a higher dose deemed to be safe by the CTSC for this study.


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Patient participation will include screening, treatment, and follow-up.  Screening will last 
up to 30 days before first dose of study treatment (magrolimab and/or azacitidine), 
during which time the patient’s eligibility and baseline characteristics will be determined.  
Study treatment may be continued until an unacceptable drug-related toxicity occurs or 
until disease progression or loss of clinical benefit.  Post treatment, patients will be 
observed for disease progression and survival until death, withdrawal of consent, or the 
end of the study, whichever occurs first.  For patients who come off study treatment to 
receive a bone marrow transplant, follow-up for disease progression and collection of 
SOC bone marrow biopsy/aspirate results will continue until documented disease 
progression occurs.
The end of the entire study for all patients is defined as the date on which the last 
patient completes the last study visit (follow-up for safety, disease progression or 
survival), or when the CTSC or Sponsor decides to end the study.
3.2.
Study Design - R/R Cohort
The R/R Cohort will be evaluated in 3 stages.  As of Amendment 3, in the first stage, 
10 patients (the R/R Safety Cohort) have been treated in a safety run-in to evaluate the 
safety profile of magrolimab monotherapy in this R/R population.  Based on aggregate 
clinical, safety, PK, and pharmacodynamic data in the R/R Safety Cohort, the CTSC will 
determine whether enrollment may begin in an Expansion stage of the initial R/R 
Cohort, in which a total of up to 36 additional patients in the R/R Expansion Cohort will 
be treated to evaluate the clinical activity of magrolimab in combination with azacitidine.  
In the R/R Expansion Cohort, magrolimab will be administered 1 mg/kg twice weekly for 
Cycle 1 Week 1 (Day 1 and Day 4); 15 mg/kg on Cycle 1 Day 8, 30 mg/kg on Cycle 1 
Day 11 and Day 15, 30 mg/kg weekly on Cycle 1 Day 22 through end of Cycle 2, and 
30 mg/kg Q2W starting Cycle 3 and thereafter, as shown in Table 3-1, based on clinical, 
PK, and pharmacodynamic data and for evaluation of a more convenient dosing 
regimen.  If a patient has only received Day 1 treatment for a cycle, the patient may 
transfer to the Q2W dosing regimen with that cycle, for the balance of the cycle and 
beyond, even if they were previously receiving magrolimab QW at Cycle 3 and beyond.


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If an increased dose or frequency of dosing is explored, additional cohorts will use a 
standard 3+3 design.  Based on emerging clinical data, the CTSC may expand this 
cohort beyond the initial 36 patients for further safety, efficacy, and/or dosing data.  In 
addition, individual patients may be transitioned from a magrolimab Q2W to Q4W 
dosing regimen by the Investigator with approval from the Medical Monitor.  As of 
Amendment 6, up to 23 R/R MDS patients may be enrolled in an additional R/R MDS 
Magrolimab Monotherapy cohort.  Patients will be enrolled in this cohort in a Simon’s 
2-stage design.  With a 1-sided significance level of 0.05 and 80% power, the null 
hypothesis that the magrolimab monotherapy ORR is 9% will be tested against the 
alternative of 30%.  In the first stage, 11 patients will be enrolled.  If there are 1 or fewer 
responses observed in these 11 patients, the cohort will be stopped.  Otherwise, 
12 additional patients will be accrued, for a total of 23.  This cohort was stopped after 
11 patients enrolled per CTSC decision in October 2020.  The null hypothesis will be 
rejected if 5 or more responses are observed in 23 patients.  R/R MDS patients who do 
not achieve an objective response after the first protocol response assessment may 
have azacitidine added to magrolimab for subsequent cycles.  For patients who respond 
to magrolimab monotherapy and then progress, azacitidine may be added to 
magrolimab and patients can still be continued to be treated with the combination.
The Schedule of Assessments tables for the R/R Expansion Cohort and the R/R MDS 
Magrolimab Monotherapy Cohort are provided in Section 7.1.  The Schedule of 
Assessments table for the R/R Safety Cohort, which is now closed, is provided in 
Appendix F.


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Table 3-1.
Dose and Schedule for R/R AML/MDS Cohorts
Dose Schedule (Day per 28-day Cycle)
Cohort
Drug/Dose/Route
Cycle 1
Cycle 2
Cycle 3+
Magrolimab - 1 mg/kg IV
Day 1, 4
—
—
Magrolimab - 15 mg/kg IV
Day 8
—
—
R/R AML/MDS
(Safety Cohort)
Magrolimab - 30 mg/kg IV
Day 11, 15, 22
Day 1, 8, 15, 22
Day 1, 8, 15, 
22
Magrolimab - 1 mg/kg IV
Day 1, 4
—
—
Magrolimab - 15 mg/kg IV
Day 8
—
—
Magrolimab - 30 mg/kg IV
Day 11, 15, 22
Day 1, 8, 15, 22
Day 1 and 15
R/R AML/MDS
(Expansion 
Cohort)a
Azacitidine - 75 mg/m2 SC 
or IVb
Day 1-7
Day 1-7
Day 1-7
Magrolimab - 1 mg/kg IV
Day 1, 4
—
—
Magrolimab - 15 mg/kg IV
Day 8
—
—
R/R MDS
(Magrolimab 
Monotherapy 
Cohort)a,c
Magrolimab - 30 mg/kg IV
Day 11, 15, 22
Day 1, 8, 15, 22
Day 1 and 15
Abbreviations:  AML = acute myeloid leukemia; CTSC = Clinical Trial Steering Committee; 
IV = intravenous; MDS = myelodysplastic syndrome; Q2 = every 2; R/R = Relapsed/Refractory; 
SC = subcutaneous; UK = United Kingdom; US = United States.
a.
The magrolimab maintenance dose in R/R Expansion and R/R MDS Monotherapy will be changed 
to Q2 weeks beginning at Cycle 3.
b.
Azacitidine administered per region-specific labeling:  SC in UK or US; IV in US only.
c.
R/R MDS patients who do not have an objective response with magrolimab at the first protocol   
response assessment may have azacitidine added to magrolimab for subsequent cycles.  The 
azacitidine dosing schedule given is identical to that of the R/R AML/MDS expansion cohort.  For 
patients who respond to magrolimab monotherapy and then progress, azacitidine may be added to 
magrolimab and patients can still be continued to be treated with the combination.


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3.3.
Study Design - Treatment-naïve/Unfit (TN/U) Cohort
3.3.1.
TN/U Cohort Dose Levels
All patients in the TN/U Cohort will receive magrolimab in combination with azacitidine.  
Magrolimab will be administered twice weekly through Cycle 1 Day 11; weekly 
beginning Cycle 1 Day 15 through end of Cycle 2; and then 30 mg/kg either weekly (for 
the TN/U Dose Evaluation Cohort) or Q2W (for the TN/U Expansion Cohort) starting 
Cycle 3 and thereafter, as shown in Table 3-2.  This dose regimen was selected based 
on emerging clinical, PK, and pharmacodynamic data.  Because dosing changed from 
twice weekly to weekly (beginning Week 3 of Cycle 1 and thereafter) with the previous 
Amendment 3, patients who are being treated under a previous Amendment may 
transition to the new (weekly) dosing schedule at the next cycle, or as determined by 
the Investigator.  If a patient has only received Day 1 treatment for a cycle, the patient 
may transfer to the Q2W dosing regimen for the balance of the cycle and beyond.  As of 
Amendment 6, a TP53 mutant TN/U AML subcohort was added to the TN/U Expansion 
Cohort.  This TP53 mutant TN/U AML subcohort will have magrolimab administered on 
a Q2W dosing regimen starting Cycle 3 and thereafter (see Table 3-2).  In addition, 
Amendment 6 reflects the CTSC decision to transition all TN/U Expansion Cohort 
patients (both existing and new) to a magrolimab dose of 30 mg/kg Q2W starting 
Cycle 3 and beyond.  
Azacitidine will be administered according to region-specific drug labeling, either SC or 
IV, at the standard dose of 75 mg/m2 on Days 1 to 7 of each 28-day cycle for both dose 
levels.  Magrolimab will be given at least 1 hour after the azacitidine infusion/injection is 
completed.
Dose evaluation of magrolimab will begin with the designated dose level shown in 
Table 3-2.  Decisions related to potential dose escalation or de-escalation will be based 
on the first 4 weeks of treatment in the current cohort, referred to as the “Dose-Limiting 
Toxicity (DLT) Assessment Period,” in conjunction with ongoing assessments for 
patients on prior cohorts who continued therapy beyond 4 weeks.  Decisions regarding 
additional cohorts to further refine the MTD or recommended Phase 2 dose and 


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schedule (RP2DS) will be made by the CTSC.  The CTSC may create additional dose 
cohorts to be evaluated using a 3+3 design including, but not limited to, adding 
additional dose cohorts, adding intermediate dose steps (e.g., an additional intrapatient 
dose escalation step), reducing intermediate dose steps (e.g., removal of an intrapatient 
dose escalation step), or exploring a dose schedule of weekly or up to Q4W, if 
supported by emerging PK and clinical data.  In addition, individual patients may be 
transitioned to a magrolimab Q2W to Q4W dosing regimen by the Investigator with 
approval from the Medical Monitor.
It should be noted that treatment with azacitidine as monotherapy is recommended for a 
minimum of 6 cycles (refer to the azacitidine prescribing information).  All patients 
without evidence of treatment failure, relapse after CR or CRi, or unacceptable toxicity 
should continue study treatment for at least 6 cycles.  Patients may be discontinued 
from the treatment per Investigator’s discretion prior to reaching the recommended 
minimum cycles for any of these reasons detailed in Section 8.1.
The Schedules of Assessments for the TN/U Dose Evaluation Cohort and the 
TN/U Expansion Cohort are provided in Section 7.1.


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Table 3-2.
Dose Level and Schedule for TN/U AML/MDS Cohorts (Including 
TP53 Mutant AML)
Dose Schedule (Day per 28-day Cycle)
Cohort/Dose 
Level
Drug/Dose/Route
Cycle 1
Cycle 2
Cycle 3+
Magrolimab - 1 mg/kg IV
Day 1, 4
—
—
Magrolimab - 15 mg/kg IV
Day 8
—
—
Magrolimab - 30 mg/kg IV
Day 11, 15, 
22
Day 1, 8, 15, 22
Day 1, 8, 15, 22
TN/U Dose 
Evaluation 
Cohort:
Level 1b
Azacitidine - 75 mg/m2 SC 
or IVa
Days 1-7
Days 1-7
Days 1-7
Magrolimab - 1 mg/kg IV
Day 1, 4
—
—
Magrolimab - 15 mg/kg IV
Day 8
—
—
Magrolimab - 30 mg/kg IV
Day 11, 15, 
22
Day 1, 8, 15, 22
Day 1, 15
TN/U Expansion 
Cohort (including 
TP53 mutant 
AML subcohort):
30 mg/kg IVb
Azacitidine - 75 mg/m2 SC 
or IVa
Days 1-7
Days 1-7
Days 1-7
Abbreviations:  AML = acute myeloid leukemia; IV = intravenous; MDS = myelodysplastic syndrome; 
R/R = Relapsed/Refractory; SC = subcutaneous; TN/U = Treatment-naïve/Unfit; UK = United Kingdom; 
US = United States. 
a. Azacitidine administered per region-specific labeling:  SC in UK or US; IV in US only.
b. As of Amendment 6, all existing and newly enrolled TN/U cohort patients are to follow 30 mg/kg 
Q2W magrolimab dosing starting Cycle 3 and beyond. 
3.3.2.
TN/U Cohort Dose Evaluation
Dose evaluation will follow a 3+3 dose evaluation design.  Up to 6 evaluable patients 
may be enrolled in each dose cohort.  If none or 1 of the first 3 patients experiences a 
DLT, the cohort will be expanded to 6 patients.  If 2 or more patients experience DLTs, 
the MTD dose level will have been exceeded, enrollment to that cohort will halt.  CTSC 
will determine whether to treat additional patients at lower or higher dose levels or 
evaluate alternative dose regimens.  The MTD for the TN/U Cohort is the maximum 
dose level at which at least 6 patients are treated with magrolimab and azacitidine and 
less than 34% of these patients experience a DLT.  The RP2DS will be determined by 
the CTSC (Section 11.6) based on review of all available safety, efficacy, and PK data.  


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Dose escalation/de-escalation and cohort expansion decisions will be reviewed and 
approved by the CTSC.  Dose escalation or de-escalation may occur at dose 
increments or decrements, respectively, of up to 50% of the maximum prior dose as 
determined by the CTSC.  The CTSC may add additional patients to any dose level to 
collect additional safety and PK information.
3.3.3.
TN/U Cohort Dose-limiting Toxicity Evaluation
Dose evaluation decisions will be made by the CTSC based on the first 4 weeks of 
treatment for each patient, referred to as the “Dose-limiting Toxicity (DLT) Assessment 
Period.”  The first patient in each 3+3 dose evaluation cohort must complete at least 
2 weeks of treatment before additional patients may be enrolled in the cohort.  
Subsequent patients may be enrolled simultaneously.  The third patient in a cohort must 
complete the DLT Assessment Period prior to enrolling the next 3 patients at the same 
dose level.  A new patient may be enrolled whenever a patient becomes nonevaluable 
for DLT.  The CTSC may decide whether a fourth patient can be enrolled to the same 
cohort prior to the first 3 patients completing the DLT Assessment Period, in order to 
have an extra patient in case that 1 of the 3 earlier patients are not evaluable for DLT or 
if there is a DLT within the cohort requiring cohort expansion.
3.3.4.
TN/U Cohort Definition of DLT-evaluable Patients
Patients in the TN/U Dose Evaluation cohort are considered evaluable for assessment 
of DLT if EITHER of the following criteria are met during the DLT Assessment Period:

The patient experienced a DLT at any time after initiation of the first infusion/injection 
of magrolimab.

The patient completed at least 4 infusions of magrolimab and 4 infusions/injections 
of azacitidine.
For the TN/U Dose Evaluation cohort, patients who withdraw before completing the 
4-week DLT Assessment Period for reasons other than a DLT, or who do not fulfill 
either of the criteria above, will not be evaluable for assessment of DLT for dose review 
decisions and will be replaced in the cohort.


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3.3.5.
TN/U Cohort Definition of Dose-limiting Toxicity
All toxicities will be graded according to the NCI CTCAE, Version 4.03 (Appendix A) or 
protocol-specified AE severity grading scales (Appendix D).  A DLT is defined as any 
Grade 4 or higher hematologic toxicity or Grade 3 or higher non-hematologic toxicity 
that has worsened in severity from pretreatment baseline during the 4-week DLT 
Assessment Period.  These AEs will be considered DLTs unless they are clearly and 
incontrovertibly related to other causes, including underlying disease.
DLTs apply only to patients in the TN/U Dose Evaluation Cohort and RBC 
Transfusion-dependent Low-risk MDS Cohort.
The following are exceptions to the DLT definition and are NOT considered a DLT:

Myelosuppression (Grade 3 anemia, Grade 3 and 4 thrombocytopenia, and/or 
Grade 3 and 4 neutropenia, leukopenia, or lymphopenia) lasting no longer than 
42 days from the start of study treatment.  Complications within the first 4 weeks 
associated with myelosuppression such as fevers, infections, bleeding, and related 
hospitalizations will also not be considered DLTs.
However, prolonged myelosuppression lasting longer than 42 days from the start of 
study treatment, without evidence of leukemia (< 5% blasts), will be considered a 
DLT.  Absence of malignant disease must be verified by peripheral blood count and 
bone marrow aspirate and biopsy at Day 43 (+ 10 days).

Grade 3 indirect/unconjugated hyperbilirubinemia that resolves to ≤ Grade 2 with 
supportive care within 7 days and is not associated with other clinically significant 
consequences.

Grade 3 isolated electrolyte laboratory abnormalities that resolve to ≤ Grade 2 with 
supportive care within 7 days and are not associated with other clinically significant 
consequences.

Grade 3 elevation in alanine aminotransferase, aspartate aminotransferase, or 
alkaline phosphatase that resolves to ≤ Grade 2 with supportive care within 7 days 
and is not associated with other clinically significant consequences.

Grade 3 nausea, vomiting, or diarrhea that resolves to ≤ Grade 2 with supportive 
care within 7 days.


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
Grade 3 fatigue that resolves to ≤ Grade 2 within 2 weeks.

Grade 3 magrolimab infusion-related reactions in the absence of an optimal 
pretreatment regimen, which is defined as acetaminophen or a comparable 
non-steroidal anti-inflammatory agent, plus an antihistamine and corticosteroids.

Other single laboratory values out of normal range that have no clinical correlate, 
and resolve to Grade ≤ 2 or to baseline within 7 days with adequate medical 
management.

Transient Grade 3 nausea, vomiting, diarrhea, local reactions, influenza-like 
symptoms, myalgia, fever, headache, acute pain, or skin toxicity that resolves to 
≤ Grade 2 within ≤ 72 hours after medical management (e.g., supportive care, 
including immunosuppressant treatment) has been initiated.

Grade 3 or 4 tumor lysis syndrome or related electrolyte disturbances (hyperkalemia, 
hypophosphatemia, hyperuricemia) that resolve to ≤ Grade 2 within 14 days.
3.3.6.
TN/U Expansion Cohort
Patients in the Expansion stage of the TN/U Expansion Cohort will receive the RP2DS 
determined in the TN/U Dose Evaluation Cohort.  For the TN/U Expansion stage, 
patients may be enrolled simultaneously without an observation time between patients.  
The CTSC may alter the dosing scheme including, but not limited to, exploring a dose 
schedule of weekly or up to Q4W, if supported by emerging PK and clinical safety and 
efficacy data.  Based on emerging clinical data, including efficacy data, the TN/U 
Expansion Cohort may be increased beyond 30 patients as determined by the CTSC.
Based on a Type B End of Phase 1 meeting with the FDA in May 2019, the TN/U 
Expansion Cohort was expanded in Amendment 5 to include untreated intermediate to 
very high-risk MDS patients, as assessed by IPSS-R, to include at least 91 patients as a 
single-arm trial for a potential BLA in higher-risk untreated MDS.  These 91 patients are 
inclusive of MDS patients already treated in the TN/U Dose Evaluation and Expansion 
Cohorts.  In a Type A meeting with the FDA in November 2019, it was agreed that the 
primary endpoint for potential approval can be CR rate with duration of CR.


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An efficacy evaluation will be made after 36 evaluable MDS patients have undergone 
the first response assessment.  If the CR rate for magrolimab and azacitidine is at least 
35.5%, then an additional 56 patients will be treated in expansion at a magrolimab 
dosing regimen of Q2W.  Enrollment does not need to be paused during the 36-patient 
evaluation prior to the additional 56-patient expansion.  The 56-patient expansion would 
bring the total number of MDS patients in the TN/U Expansion Cohort to n = 92.  The 
overall MDS expansion to 92 patients will be considered the MDS Registrational Cohort.
In Amendment 6, for all dosing cohorts except the RBC Transfusion-dependent Low-risk 
MDS Cohort, magrolimab dosing was transitioned from a 30 mg/kg weekly dosing 
regimen after Cycle 3 to a 30 mg/kg Q2W dosing regimen after Cycle 3 based on 
PK/PD and clinical data to maintain efficacy but maximize patient convenience.  This 
dosing decision was made per CTSC recommendation on 05 November 2019.  In 
addition, per discussion with the FDA in November 2019, the primary endpoint for this 
untreated higher-risk MDS cohort was changed from CR+PR to CR rate.  In accordance 
with this CR endpoint and a transition to a Q2W magrolimab dosing regimen, a cohort of 
56 patients at Q2W magrolimab dosing was added.  A sample size of 56 patients 
provides 80% power to reject the null hypothesis that the CR rate is 16.5% or lower at a 
2-sided 0.05 significance level, assuming the true CR rate is at least 31.5% (i.e., a 15% 
improvement).  The null CR rate of 16.5% is the upper bound of the 95% confidence 
interval (point estimate of 10%) based on the pivotal randomized trial leading to 
azacitidine approval in MDS in which efficacy was reanalyzed according to the 
International Working Group (IWG) MDS criteria (Silverman 2006).  
For more details on the expansion, refer to the scientific rationale (Section 1.5.1), 
clinical safety and efficacy data (Section 1.2.2), risk-benefit ratio (Section 1.5.2), and 
statistical analysis plan (SAP) (Section 11.8).
As per Amendment 6, a subcohort of TN/U AML patients with a TP53 gene mutation was 
added based on initial clinical data demonstrating activity of magrolimab + azacitidine in 
this patient population.  As of July 2019, in 6 TP53 mutant AML patients, 5/6 (83%) 
achieved a CR/CRi with magrolimab + azacitidine.  Based on these data, the CTSC met 


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in September 2019 and initiated an expansion of TN/U TP53 mutant patients with 
magrolimab + azacitidine.  For this subcohort, magrolimab will be dosed Q2W after 
Cycle 2 (Table 3-2).  With the exception of the magrolimab dosing regimen difference, 
the Schedule of Assessments for the TP53 mutant TN/U AML cohort is identical to the 
TN/U cohort (Table 7-2).  After enrollment of up to 32 patients, additional patients may 
be enrolled to collect further safety, efficacy, and/or dosing data based on 
recommendations by the CTSC.  Based on encouraging efficacy data in this cohort, the 
CTSC met in July 2020 and decided an additional 30 TP53 AML patients would be 
enrolled for the TN/U Expansion Cohort, this update is captured in Amendment 7.
It should be noted that treatment with azacitidine as monotherapy is recommended for a 
minimum of 6 cycles.  All patients without evidence of treatment failure, relapse after 
CR/CRi, or unacceptable toxicity should continue study treatment for at least 6 cycles.  
Patients may be discontinued from the treatment per Investigator’s discretion prior to 
reaching the recommended minimum cycles for any of these reasons detailed in 
Section 8.1.  The Schedule of Assessments for the TN/U Expansion Cohort is provided 
in Section 7.1.
3.4.
Study Design - RBC Transfusion-dependent Low-risk MDS Cohort
The RBC Transfusion-dependent Low-risk MDS Cohort consists of a safety run-in 
phase and an expansion phase.  In the safety run-in phase, 6 patients will be enrolled 
and will receive magrolimab monotherapy, with a safety evaluation after all 6 patients 
complete at least Cycle 2 Day 15 treatment.  For this cohort, after the first patient is 
enrolled, subsequent patients in this initial 6-patient group can be enrolled 
simultaneously 1 week later.  This safety evaluation is being conducted given that a 
60 mg/kg dose of magrolimab will be administered starting in Cycle 2, of which this 
highest dose has not yet been tested in MDS patients.  However an equivalent dose of 
60 mg/kg given in 1 week (30 mg/kg twice weekly) has already been administered to 
MDS and AML patients in this trial and has been well tolerated.  If 1 or fewer DLTs are 
observed in these 6 patients, then expansion may proceed.


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If the DLT rate is ≥ 33% in at least 6 patients enrolled, then dose de-escalation to a 
lower magrolimab dosing regimen (i.e., 45 mg/kg Q4 weekly or alternative) can be 
explored as determined by the CTSC in an additional cohort of 6 patients with 
subsequent expansion.  Patients may have their magrolimab dose interval changed 
(i.e., to more frequent [Q2W] or less frequent [> Q4W]) at any time on therapy based on 
CTSC recommendations or Sponsor requirement.
3.4.1.
RBC Transfusion-dependent Low-risk MDS Cohort Definition of Dose-
limiting Toxicity
DLT definitions for the RBC Transfusion-dependent Low-risk MDS Cohort are similar to 
those for the TN/U Safety Evaluation Cohort and are defined in Section 3.3.5 with the 
exception that the DLT period is through the first 6 weeks (Cycle 2 Day 15).  If the DLT 
rate is ≥ 33% in at least 6 patients enrolled, then the 60 mg/kg magrolimab dose would 
be considered to have exceeded the MTD.  In this case, the CTSC may decide to 
proceed with expansion at a magrolimab dose regimen of 30 mg/kg QW for Cycle 2 
followed by Q2W from Cycle 3 onward or explore a dose de-escalation to a lower 
magrolimab dosing regimen.  The CTSC may decide to enroll additional patients in the 
safety run-in to further evaluate safety of the magrolimab 60 mg/kg dosing regimen or a 
lower dosing regimen.  Patients may have their magrolimab dose interval changed 
(i.e., to more frequent [Q2W] or less frequent [> Q4W]) at any time on therapy based on 
CTSC recommendations or Sponsor requirement.
An efficacy assessment for the first 6 patients will be assessed at Cycle 3 Day 1.  For 
patients who do not respond to magrolimab monotherapy, azacitidine can be 
subsequently added for continuation of therapy according to the dose schedule in 
Table 7-3.  After the 6 patients have completed their post-Cycle 2 efficacy assessment, 
the CTSC will determine based on safety and efficacy data whether further expansion to 
14 additional patients will occur with magrolimab monotherapy or magrolimab in 
combination with azacitidine.  Expansion of these 14 patients can be simultaneously 
enrolled.  Based on emerging safety, PK/PD, and/or efficacy data, the CTSC may 
expand this cohort to additional patients beyond the 20 total with either magrolimab 
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Table 3-3.
Dose Level and Schedule for RBC Transfusion-dependent Low-risk 
MDS Cohort
Dose Schedule (Day per 28-day Cycle)
Cohort/Dose 
Level
Drug/Dose/Route
Cycle 1
Cycle 2
Cycle 3+
Magrolimab - 1 mg/kg IV
Day 1
—
—
Magrolimab - 30 mg/kg IV
Day 8, 15, 22
—
—
Magrolimab - 60 mg/kg IV
—
Day 1
Day 1
Safety Run-in 
(Magrolimab 
60 mg/kg)
Azacitidine - 75 mg/m2 SC or 
IVa
—
—
Days 1-5
Magrolimab - 1 mg/kg IV
Day 1
—
—
Magrolimab - 30 mg/kg IV
Day 8, 15, 22
—
—
Magrolimab - 60 mg/kg IVd
—
Day 1
Day 1
Expansion
Azacitidine - 75 mg/m2 SC or 
IVa,b
Days 1-5
Days 1-5
Days 1-5
Magrolimab - 1 mg/kg IV
Day 1
—
—
Magrolimab - 30 mg/kg IV
Day 8, 15, 22
—
—
Magrolimab - 45 mg/kg IVc
—
Day 1
Day 1
Dose 
De-escalation 
(Magrolimab 
45 mg/kg)c
Azacitidine - 75 mg/m2 SC or 
IVa
—
—
Days 1-5
Abbreviations:  CTSC = clinical trial steering committee; IV = intravenous; MDS = myelodysplastic 
syndrome; MTD = maximum tolerated dose; Q2W = every 2 weeks; Q4W = every 4 weeks; 
SC = subcutaneous. 
a. The first 6 patients will be treated with magrolimab monotherapy.  If no response is observed after 
Cycle 2, then azacitidine can be added starting Cycle 3 and beyond.
b. Based on data from the safety run-in, the CTSC will decide whether the expansion cohort will 
receive magrolimab monotherapy or magrolimab+azacitidine.
c. If the MTD is exceeded for the safety run-in 60 mg/kg cohort, then a dose de-escalation to a 
magrolimab 45 mg/kg Q4W dosing regimen or alternative magrolimab dose regimen lower than 
60 mg/kg (i.e., 30 mg/kg Q2W) can be explored per CTSC decision.
d. The magrolimab expansion dosing may be 60 mg/kg, 45 mg/kg, or 30 mg/kg Q4W or Q2W based on 
the safety run-in CTSC decision.
A 5-day azacitidine dosing regimen will be utilized specifically for this low-risk MDS 
cohort to maximize efficacy and patient convenience while minimizing toxicities in this 
patient population.  The selection of this 5-day dosing regimen is based on a 
randomized trial demonstrating similar hematologic responses and RBC transfusion 
independence and lower AE rates for the 5-day regimen compared to a 7-day regimen 
(Lyons 2009).  It should be noted that treatment with azacitidine as monotherapy is 
recommended for a minimum of 6 cycles.  All patients without evidence of treatment 


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failure, relapse after CR/CRi, or unacceptable toxicity should continue study treatment 
for at least 6 cycles.  Reduction of azacitidine dose frequency to a Day 1 to 3 
administration per month may be considered for individual patients based on 
safety/efficacy or individual patient circumstances with approval by the Medical Monitor 
or with CTSC approval for this change for all patients.  Patients may be discontinued 
from the treatment per Investigator’s discretion prior to reaching the recommended 
minimum cycles for any of these reasons detailed in Section 8.1.  
3.5.
Study Design - Rollover Cohort
In the Phase 1 trial of magrolimab in R/R AML (SCI-CD47-002), patients who have 
derived clinical benefit from magrolimab have been continuously receiving magrolimab 
dosing.  These patients may continue to receive magrolimab therapy under this protocol 
in the Rollover Cohort.  Patients in the Rollover Cohort may receive the same dose level 
and schedule (i.e., twice weekly) of magrolimab monotherapy as previously received in 
the Phase 1 AML study or may transition to once-weekly dosing at the discretion of the 
Investigator and with Sponsor approval.  Patients who are receiving twice-weekly 
dosing may transition to the new (weekly) dosing schedule at the next cycle, or as 
determined by the Investigator.  If a patient has only received Day 1 treatment for a 
cycle, the patient may transfer to the new dosing regimen with that cycle, for the 
balance of the cycle and beyond.  Patients on the Rollover Cohort who progress on 
therapy, no longer derive clinical benefit, or demonstrate unacceptable toxicity to 
magrolimab will be taken off study treatment. (Section 8.1).  The Schedule of 
Assessments for the Rollover Cohort is provided in Appendix F.
3.6.
Number of Sites
Approximately 1 site located in the UK and 26 sites in the US will be included in this 
trial.  Additional sites in the UK, US, and/or other countries may be included based on 
enrollment and study timelines.


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3.7.
Estimated Study Duration and End of Study
It is anticipated that this study will take approximately 5 years to complete, assuming 
16 months for enrollment plus 1 month screening, 6 or more cycles of study treatment, 
and 1 month safety follow-up for each patient, and up to 3 years of survival follow-up 
after the last patient is enrolled.  
Patient participation will include screening, treatment, and follow-up.  Screening will last 
up to 30 days before first dose of study treatment (magrolimab and/or azacitidine), 
during which time the patient’s eligibility and baseline characteristics will be determined.  
Study treatment may be continued until an unacceptable drug-related toxicity occurs or 
until disease progression.  For patients who come off study treatment to receive a bone 
marrow transplant, follow-up for disease progression and collection of SOC bone 
marrow biopsy/aspirate results will continue until documented disease progression 
occurs.  Post treatment, patients will be observed for disease progression and survival 
until death, withdrawal of consent, or the end of the study, whichever occurs first.
The end of study is defined as the date on which the last patient completes the last 
study visit (follow-up for safety, disease progression or survival), or when the CTSC or 
Sponsor decides to end the study.
4. PATIENT SELECTION AND ENROLLMENT
4.1.
Study Entry Criteria
4.1.1.
Inclusion Criteria
All Patients:
1. Meets the criteria below for the appropriate cohort:
a. All R/R Cohorts (meets i or ii):  
i.
Pathologically confirmed AML (defined by 2017 ELN classification; 
Döhner 2017) relapsed or refractory to a prior therapy with either a 
hypomethylating agent (such as azacitidine or decitabine), non-intensive 
chemotherapy (such as low-dose cytarabine arabinoside), and/or 
venetoclax.  Treatment is limited to 1 prior line of therapy.  Hematopoietic 


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stem cell transplant for patients in remission would not be counted as a line 
of therapy for AML, or
ii. Confirmed MDS defined according to World Health Organization (WHO) 
classification that is either refractory to hypomethylating agent (defined as 
disease progression per IWG 2006 criteria [Cheson 2006] at any time after 
initiation of a hypomethylating agent or failure to achieve an objective 
response by IWG 2006 criteria after 4 cycles) or is relapsed or intolerant to 
prior therapy with either a hypomethylating agent, non-intensive 
chemotherapy, or targeted therapy.  Treatment is limited to 1 prior line of 
hypomethylating agent therapy (including investigational hypomethylating 
agents) for all R/R MDS patients.
iii. R/R MDS Magrolimab Monotherapy Cohort:  Inclusion criterion ii above 
applies.
b. All TN/U Cohorts (meets i or ii):  
i.
Previously untreated patients with MDS defined according to WHO 
classification, with an IPSS-R (Greenberg 2012) risk category of 
intermediate, high, or very high risk.  Prior and concurrent therapy with 
hydroxyurea, oral etoposide, erythroid, and/or myeloid growth factors is 
allowed.  
ii. Previously untreated patients with histological confirmation of AML by 
WHO criteria who are ineligible for treatment with a standard cytarabine 
and anthracycline induction regimen due to co-morbidity, age or other 
factors, or who refuse such therapy.
c. TP53 Mutant AML Subcohort:  Previously untreated patients with histological 
confirmation of AML by WHO criteria who are ineligible for treatment with a 
standard cytarabine and anthracycline induction regimen due to co-morbidity, 
age, or other factors, or who refuse such therapy and who have presence of 
at least 1 TP53 gene mutation by next-generation sequencing based on local 
evaluation.


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d. RBC Transfusion-dependent Low-risk MDS Cohort:  MDS patients with very 
low or low risk by IPSS-R who are RBC transfusion-dependent (requiring 
≥ 2 RBC units within 8 weeks prior to screening) and meet at least one of the 
following:
i.
Relapsed/refractory to ESA:  documented non-response or 
response that is no longer maintained to prior ESA-containing 
regimen
ii.
Intolerant to ESA:  documentation of discontinuation of prior 
ESA-containing regimen at any time after initiation due to 
intolerance or adverse event
iii.
ESA ineligible:  endogenous serum erythropoietin level > 500 U/L 
for patients who have not been previously treated with ESAs 
iv.
Have a deletion in chromosome 5q and who are 
relapsed/refractory/intolerant to or ineligible for lenalidomide 
therapy
e. Rollover Cohort:  Patients on active magrolimab therapy on the Phase 1 AML 
(SCI-CD47-002) trial who are deriving clinical benefit by Investigator 
assessment.
2. WBC count ≤ 20 × 103/mcL pre-first dose of study treatment and prior to each 
magrolimab dose for Cycle 1.  Patients with WBC > 20 × 103/mcL can be treated 
with hydroxyurea (up to 4 g/day) throughout the trial to reduce the WBC to 
≤ 20 × 103/mcL.  Oral etoposide (up to 200 mg orally [PO] /day) may be given as an 
alternative to hydroxyurea for patients who are intolerant to hydroxyurea or cannot 
achieve sufficient WBC lowering on hydroxyurea.
3. Patient has provided informed consent.
4. Must be willing and able to comply with clinic visits and procedures outlined in the 
study protocol.


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R/R Cohorts (including the R/R MDS Magrolimab Monotherapy Cohort), TN/U 
Cohorts (including the MDS Registrational Cohort and the TP53 Mutant TN/U AML 
Subcohort), and RBC Transfusion-dependent Low-risk MDS Cohort only
(Criteria 5 through 9 DO NOT apply to the Rollover Cohort): 
5. Male or female, age ≥ 18 years.
6. Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 2.
7. Hemoglobin must be ≥ 9 g/dL within 24 hours prior to the first 2 doses of magrolimab 
infusion; patient must be willing to undergo blood transfusions as deemed clinically 
necessary. NOTE: Transfusions are allowed to meet hemoglobin eligibility (see 
Section 6.2.2.1 for anemia management)
8. Pretreatment blood crossmatch completed (as detailed in Section 6.2.2.1 and 
Section 7.3.4).
9. Biochemical indices within the ranges shown below:
a. Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase 
(SGOT) and alanine aminotransferase (ALT)/serum glutamic pyruvic 
transaminase (SGPT) ≤ 5× upper limit of normal (ULN)
b. Bilirubin ≤ 1.5× ULN, or 3.0× ULN and primarily unconjugated if patient has a 
documented history of Gilbert’s syndrome or genetic equivalent
c. Serum creatinine ≤ 1.5× ULN or calculated glomerular filtration rate (GFR)
≥ 40 mL/min/1.73 m2
10. Female patients of childbearing potential must not be nursing or planning to be 
pregnant and must have a negative urine or serum pregnancy test within 30 days 
before enrollment and within 72 hours before the first administration of study drug.
11. Female patients of childbearing potential must be willing to use 1 highly effective 
method of contraception during the study and continue for 6 months after the last 
dose of magrolimab or azacitidine, whichever ends later (Section 4.5.1).
12. Male patients who are sexually active with a WOCBP and who have not had 
vasectomies must be willing to use a barrier method of contraception during the 
study and for 3 months after the last dose of magrolimab or azacitidine, whichever 
ends later (Section 4.5.4).
13. Willing to consent to mandatory pretreatment and on-treatment bone marrow 
biopsies (trephines), unless not feasible as determined by the Investigator.


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4.1.2.
Exclusion Criteria
1. Prior treatment with CD47 or SIRPα-targeting agents (with exception of magrolimab 
for patients in the Rollover Cohort).
2. Prior anti-leukemic therapies including, but not limited to, chemotherapy (with the 
exception of hydroxyurea or oral etoposide), targeted therapies, immunotherapy, or 
radiotherapy within 4 weeks prior to Day 1 magrolimab dosing.  NOTE:  Localized 
non-central nervous system (non-CNS) radiotherapy, previous hormonal therapy 
with luteinizing hormone-releasing hormone (LHRH) agonists for prostate cancer, 
and treatment with bisphosphonates and receptor activator of nuclear factor kappa-B 
ligand (RANKL) inhibitors are not criteria for exclusion.
3. TN/U Cohorts only:  Any prior anti-leukemic therapy (excluding hydroxyurea or oral 
etoposide), prior treatment with hypomethylating agents and/or low dose cytarabine.
4. R/R Expansion Cohort, R/R MDS Magrolimab Monotherapy Cohort, TN/U 
Cohorts, and RBC Transfusion-dependent Low-risk MDS Cohort only:  
Contraindications to azacitidine, including advanced malignant hepatic tumors or 
known hypersensitivity to azacitidine or mannitol.
5. Acute promyelocytic leukemia.
6. Known inherited or acquired bleeding disorders.
7. Previous allogeneic hematopoietic stem cell transplant within 6 months prior to 
enrollment, active graft versus host disease (GVHD), or requiring transplant-related 
immunosuppression.
8. Clinical suspicion of active CNS involvement by leukemia.
9. Significant medical diseases or conditions, as assessed by the Investigators and 
Sponsor, that would substantially increase the risk-benefit ratio of participating in the 
study.  This includes, but is not limited to, acute myocardial infarction within the last 
6 months, unstable angina, uncontrolled diabetes mellitus, significant active infections, 
and congestive heart failure New York Heart Association (NYHA) Class III-IV.
10.Second malignancy, except treated basal cell or localized squamous skin 
carcinomas, localized prostate cancer, or other malignancies for which patients are 
not on active anti-cancer therapy as defined in Exclusion Criterion 2.


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11.History of psychiatric illness or substance abuse likely to interfere with the ability to 
comply with protocol requirements or give informed consent.
12.Pregnancy or active breastfeeding.
13.Known active or chronic hepatitis B or C infection or human immunodeficiency virus 
(HIV).
4.2.
Patient Screening and Enrollment Procedures
All patients who enter the screening period for the study, which starts when the patient 
signs the informed consent form (ICF), receive a unique patient identification number 
before any study procedures are performed.  This number is used to identify the patient 
throughout the clinical trial and must be used on all study documentation related to that 
patient, including if a patient is rescreened.
Patient screening laboratory assessments may be repeated beyond the initial screening 
assessments within the 30-day screening period.  Patients who screen fail may undergo 
repeated screening if the patient’s medical condition has changed.
All patients who provide informed consent must be registered in the electronic data 
capture (EDC) system, including any screen failures.
A patient is defined as enrolled in the study once all eligibility criteria have been 
satisfied and the Sponsor has approved the cohort or study arm assignment.  After 
signing the ICF, eligible patients are expected to receive the first dose of study 
treatment (Study Day 1) within 30 days.
4.3.
Informed Consent Process
All participants must be provided an ICF describing the study with sufficient information 
for participants to make an informed decision regarding their participation.  Participants 
must sign the Institutional Review Board/Research Ethics Committee 
(IRB/REC)-approved ICF prior to participation in any study specific procedure.  Data 
from assessments performed as part of SOC prior to ICF signature may be used if they 
are within the required screening period.  The participant must receive a copy of the 
signed and dated consent documents.  A signed copy (in paper or electronic format) of 


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the consent documents must be retained in the medical record or research file.  The first 
dose of magrolimab is to be given within 30 days of signing the ICF.
4.4.
Registration Process
Patient will be assigned a patient identification number at the time of consent.
Prior to being assigned a dose cohort or treatment arm, patients must have signed the 
informed consent and satisfied all of the eligibility criteria.  The Investigator and clinical 
team will determine the eligibility of the patient.  Once a patient has been assigned to a 
dose cohort, they will be considered enrolled.
4.5.
Contraception Requirements
4.5.1.
Definition of Childbearing Potential
For the purposes of this study, a female-born patient is considered of childbearing 
potential following the initiation of puberty (Tanner stage 2) until becoming 
postmenopausal unless the patient is permanently sterile or has medically documented 
ovarian failure.
Women are considered to be in a postmenopausal state when they are at least 54 years 
of age with cessation of previously occurring menses for at least 12 months without an 
alternative cause.
Permanent sterilization includes hysterectomy, bilateral oophorectomy, or bilateral 
salpingectomy in a female patient of any age.
4.5.2.
Definition of Male Fertility
For the purposes of this study, a male-born patient is considered fertile after the 
initiation of puberty unless the patient is permanently sterile by bilateral orchidectomy or 
medical documentation.


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4.5.3.
Female Patients
Female patients of childbearing potential who have a negative serum or urine 
pregnancy test before enrollment must agree to use 1 of the following highly effective 
forms of contraception (defined as methods that can achieve a failure rate of less than 
1% per year when used consistently and correctly):

Bilateral tubal occlusion

Vasectomized partner

Intrauterine device (IUD)

Intrauterine hormone-releasing system (IUS)

Combined hormonal contraception (estrogen- and progestogen-containing) 
associated with inhibition of ovulation (oral, intravaginal, transdermal)

Progestogen-only hormonal contraception associated with inhibition of ovulation 
(oral, injectable, implantable)

Abstinence
Defined as:  refraining from heterosexual intercourse for the entire period of risk 
associated with the study treatments.  Periodic abstinence is not acceptable 
(calendar, symptothermal, post-ovulation methods), nor is the withdrawal method 
(coitus interruptus), spermicides only, and lactational amenorrhea method.  The 
reliability of sexual abstinence needs to be evaluated in relation to the duration of 
the clinical trial and the preferred and usual lifestyle of the patient.
Contraception must be effective at the first administration of study treatment 
(magrolimab or azacitidine), throughout the trial, and for 6 months after the last dose of 
magrolimab or azacitidine, whichever ends later.
4.5.4.
Male Patients
A man who is sexually active with a woman of childbearing potential (WOCBP) and has 
not had a vasectomy must agree to use a barrier method of birth control (e.g., either 
condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap 
[diaphragm or cervical/vault caps] with spermicidal foam/gel/film/cream/suppository) 
during the study. A female condom and a male condom should not be used together.


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Contraception must be effective at the first administration of study drug (magrolimab or 
azacitidine), throughout the trial, and for 3 months after the last dose of magrolimab or 
azacitidine, whichever ends later.
It should be explained to the patient that if his partner is pregnant or breastfeeding when 
he is enrolled on the trial, the patient should use barrier method contraception (condom) 
to prevent the unborn fetus or the baby being exposed to investigational product.
Male patients must also refrain from sperm donation and cryopreservation of cells 
during treatment and until the end of contraception requirement. If needed, male 
participants should be advised to seek advice about sperm donation and 
cryopreservation prior to treatment..
5. STUDY DRUG INFORMATION
Detailed instructions for magrolimab and azacitidine preparation and handling are 
provided in the Pharmacy Manual.
5.1.
Magrolimab
The active pharmaceutical ingredient (API) is magrolimab, a humanized IgG4 
monoclonal antibody of the IgG4 kappa isotype containing a Ser-Pro (S-P) substitution 
in the hinge region (position 228) of the heavy chain to reduce Fab-arm exchange.  It 
comprises a disulfide-linked glycosylated tetramer, consisting of 2 identical 444 amino 
acid heavy gamma chains and 2 identical 219 amino acid kappa light chains.  
Magrolimab targets the human CD47 antigen.  Magrolimab drug product is a sterile, 
clear, colorless, preservative-free liquid intended for IV infusion.
Magrolimab API is manufactured under current Good Manufacturing Practices.
Magrolimab is supplied in single-use, 10-mL vials containing 200 mg of the antibody in a 
formulation of 10 mM sodium acetate, 5% (w/v) sorbitol, 0.01% (w/v) polysorbate 20, at 
pH of 5.0.
The labeling complies with the requirements of the applicable regulatory agencies.


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Vials containing magrolimab should be stored under refrigeration at 2 to 8°C (36°F 
to 46°F) in an appropriate, locked room and/or locked refrigerator, accessible only to 
pharmacy personnel, the Principal Investigator, or a duly designated person.  
Magrolimab should not be frozen.  Protect from light during storage.  DO NOT SHAKE.
Additional details about magrolimab are provided in the Pharmacy Manual.
5.2.
Azacitidine
Azacitidine is a nucleoside metabolic inhibitor.  Azacitidine is a white to off-white solid 
supplied in a sterile form for reconstitution as a suspension for SC injection or (in the US 
only) reconstitution as a solution with further dilution for IV infusion.
Single-use vials of azacitidine contain 100 mg of azacitidine and 100 mg mannitol as a 
sterile lyophilized powder.
Storage and handling of azacitidine should follow local prescribing information.  
Additional details about azacitidine are provided in the Pharmacy Manual.
6. TREATMENT PLAN
6.1.
Study Drug Administration
Patients should be premedicated in accordance with Section 6.1.3.  Magrolimab and 
azacitidine should be prepared as outlined in the Pharmacy Manual for the study.
The dose of each study drug will be calculated based on actual weight at enrollment 
(using weight obtained either at screening or on Day 1) and remains constant 
throughout the study, unless there is a > 10% change in weight from baseline.  
Modifications to the study drug doses administered should be made for a > 10% change 
in body weight and according to local and regional prescribing standards.  Dose 
modifications for changes in body weight < 10% may be made according to local 
institutional guidelines.
Patients may continue study treatment with magrolimab and/or azacitidine until they 
show evidence of disease progression (treatment failure or relapse after CR/CRi), no 


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longer derive clinical benefit, or demonstrate unacceptable toxicity (further details about 
treatment discontinuation in Section 8.1).  If the treating physician and Sponsor agree 
that it is in the best interest of the patient to continue treatment with either magrolimab 
or azacitidine alone, the patient may continue to participate in the study provided that 
other protocol stipulations are met.
6.1.1.
Magrolimab
All patients will receive magrolimab administered IV as described below:

R/R Cohort (all stages):  Magrolimab will be dosed using an intrapatient dose 
escalation schedule as shown in Table 3-1.

TN/U Dose Evaluation Cohort:  Magrolimab will be given according to an 
intrapatient dose escalation schedule, with continued weekly dosing after Cycle 2 as 
shown in Table 3-2.

TN/U Expansion Cohort (including the MDS Registrational Cohort):  
Magrolimab will be given according to the dose schedule with continued Q2W 
dosing starting Cycle 3 and thereafter, as shown in Table 3-2.

TP53 mutant TN/U AML Subcohort:  Magrolimab will be given according to an 
intrapatient dose escalation schedule with continued Q2W dosing starting Cycle 3 
and thereafter, as shown in Table 3-2.

RBC Transfusion-dependent Low-risk MDS Cohort:  Magrolimab will be given 
according to the dose schedule with continued Q4W dosing starting Cycle 2 and 
thereafter, as shown in Table 3-3. 

Rollover AML Cohort:  The Rollover Cohort will receive the dose and schedule of 
magrolimab monotherapy as shown in Appendix F.  At the discretion of the CTSC for 
this study, patients who are receiving lower doses may be escalated to the highest 
dose determined to be safe by the CTSC for this study.
The duration of each magrolimab infusion will be 3 hours (± 30 minutes) for the first 
week of treatment in the R/R and TN/U cohorts.  Starting the second week of treatment, 
the magrolimab infusion will be 2 hours (± 30 minutes).  The reduced infusion time to 
2 hours is utilized based on prior data demonstrating majority CD47 RO on peripheral 
blood cells, thus mitigating anticipated RBC toxicities from magrolimab.  


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Magrolimab doses given twice weekly are to be at least 24 hours apart, with a window 
of ± 3 days for each dose; however, magrolimab doses are not to be given on 
consecutive days.  Based on clinical, PK, and pharmacodynamic data, the CTSC 
decided to change dosing from twice weekly to weekly (beginning Week 3 of Cycle 1 
and thereafter) with Amendment 3.  Patients who are being treated under the previous 
Amendment may transition to the new (weekly) dosing schedule at the next cycle, or as 
determined by the Investigator.  In the Rollover Cohort, the patient may continue the 
same twice-weekly schedule as the patient previously received in the Phase 1 AML 
study (SCI-CD47-002) or may transition to once-weekly dosing of magrolimab 
monotherapy at the discretion of the Investigator and with Sponsor approval.  If a 
patient has only received Day 1 treatment for a cycle, the patient may transfer to the 
new dosing regimen with that cycle, for the balance of the cycle and beyond.  In 
addition, patients in the R/R Expansion Cohort will transition from a magrolimab weekly 
dosing schedule to a Q2 week dosing schedule beginning in Cycle 3. 
When both study drugs are given on the same visit day, magrolimab will be 
administered at least 1 hour after the completion of azacitidine administration.  
During the first cycle (Cycle 1) (28 days) of treatment, WBC count must be 
≤ 20 × 103/mcL prior to each magrolimab dose.  Patients with WBC > 20 × 103/mcL can 
be treated with hydroxyurea (up to 4 g/day) throughout the trial to reduce the WBC to 
≤ 20 × 103/mcL.  Oral etoposide (up to 200 mg PO/day) may be given as an alternative 
to hydroxyurea for patients who are intolerant to hydroxyurea or cannot achieve 
sufficient WBC lowering on hydroxyurea.  
All patients must have documented hemoglobin ≥ 9 g/dL within 24 hours prior to each of 
the first 2 doses of magrolimab infusion during initial treatment. Patients who do not 
meet these criteria must be transfused and have their hemoglobin rechecked to meet 
9 g/dL prior to each of the first 2 doses of magrolimab. 
Hemoglobin must be checked again 3 to 6 hours after the initiation of the first and 
second doses of magrolimab during initial treatment. The patient should be transfused 
as clinically appropriate. Investigators should consider additional hemoglobin monitoring 


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during the first week of treatment in patients with symptoms of anemia or at increased 
risk for complications of anemia.
All patients should be monitored for 1 hour post-infusion for priming, 
re-priming/re-escalation, and maintenance doses during Cycle 1.  Post-infusion 
monitoring should begin after the infusion is complete.  Post-infusion monitoring is not 
required for doses after Cycle 1, Day 22.  Patients who experience any 
treatment-related AEs during the observation period should be further monitored, as 
clinically appropriate.
Re-priming/Re-escalation for Magrolimab 
Given the large CD47 antigen sink on red blood cells, patients who have a long dose 
delay of magrolimab are required to be re-primed with magrolimab dosing to resaturate 
the CD47 antigen sink.
R/R and TN/U Cohorts:  For patients who had a dose delay of greater than 4 weeks for 
magrolimab, re-priming/re-escalation is needed with magrolimab.  For patients who 
have not received at least one 30 mg/kg dose of magrolimab (i.e., for patients who have 
either not received their first dose of 30 mg/kg or patients who have received doses 
< 30 mg/kg), a dose delay of only 2 weeks is allowed until re-priming is needed.  
Table 6-1 illustrates the re-priming/re-escalation magrolimab dosing regimen and 
schedule of assessments.
RBC Transfusion-dependent Low-risk MDS Cohort:  For patients who had a dose delay 
of greater than 6 weeks for magrolimab, re-priming/re-escalation is needed with 
magrolimab.  For patients who have not received at least one 30 mg/kg dose of 
magrolimab, a dose delay of only 2 weeks is allowed until re-priming is needed.  For 
patients who have not received at least one 60 mg/kg dose of magrolimab, a dose delay 
of 4 weeks is allowed until re-priming is needed.  Table 6-1 illustrates the 
re-priming/re-escalation magrolimab dosing regimen and schedule of assessments.
The re-priming/re-escalation dosing regimen for magrolimab is shown below in 
Table 6-1.


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Table 6-1.
Magrolimab/Azacitidine Re-priming/Re-escalation Dosing Schedule
Dose Schedule (Day per 28-day Cycle)
Cohort
Drug/Dose/Route
Re-priming Cycle
Subsequent 
Cycles
Magrolimab - 1 mg/kg IV
Day 1, 4
—
Magrolimab - 15 mg/kg IV
Day 8
—
Magrolimab - 30 mg/kg IV
Day 11, 15, 22
Day 1, 15
R/R Cohort and TN/U 
Cohort (including the 
TP53 Mutant TN/U 
AML Subcohort)
Azacitidine - 75 mg/m2 SC or 
IVb
Day 1-7
Day 1-7
Magrolimab - 1 mg/kg IV
Day 1, 4
—
Magrolimab - 15 mg/kg IV
Day 8
—
R/R MDS Magrolimab 
Monotherapy Cohortc
Magrolimab - 30 mg/kg IV
Day 11, 15, 22
Day 1, 15
Magrolimab - 1 mg/kg IV
Day 1
—
Magrolimab - 30 mg/kg IV
Day 8, 15, 22
—
Magrolimab - 60 mg/kg IVa
—
Day 1
RBC Transfusion-
dependent Low-risk 
Cohort
Azacitidine - 75 mg/m2 SC or 
IVb
Day 1-5
Day 1-5
Abbreviations:  CTSC = Clinical Trial Steering Committee; IV = intravenous; MDS = myelodysplastic 
syndrome; RBC = red blood cell; R/R = relapsed/refractory; SC = subcutaneous; TN/U = treatment-naïve/unfit 
(for standard induction chemotherapy); UK = United Kingdom; US = United States.
a. The magrolimab dosing of 60 mg/kg, 45 mg/kg, or other alternative dose will be utilized based on the 
safety run-in data and CTSC decision for expansion.
b. Azacitidine will be administered per region-specific labeling:  SC in UK or US; IV in US only.
c. For R/R MDS Magrolimab Monotherapy patients who require repriming, and are receiving both 
magrolimab and azacitidine post Cycle 3, the repriming schedule is Azacitidine - 75 mg/m2 SC or IV,  
Day 1-7 of the repriming Cycle.   
6.1.2.
Azacitidine
Azacitidine will be administered according to region-specific drug labeling, either SC or 
IV, at the standard dose of 75 mg/m2 on Days 1 to 7 of each 28-day cycle for the R/R 
(except the magrolimab monotherapy cohort, which will allow the addition of azacitidine 
after the first response assessment with Investigator and Sponsor agreement) and TN/U 
cohorts (including TP53 mutant cohort) for all dose levels of magrolimab when 


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azacitidine is scheduled to be administered (for patients assigned to combination 
treatment).  For the RBC Transfusion-dependent Low-risk MDS Cohort, azacitidine will 
be administered either SC or IV at the dose of 75 mg/m2 on Days 1 to 5 of each 28-day 
cycle (see Table 3-3) for all dose levels of magrolimab when azacitidine is scheduled to 
be administered (for patients assigned to combination treatment).  When administered 
IV, the total dose of azacitidine (diluted in a 50-100 mL infusion bag of either 0.9% 
Sodium Chloride Injection or Lactated Ringer’s Injection solution) is infused over a 
period of 10 to 40 minutes (refer to the azacitidine prescribing information for detailed 
instructions for preparation and administration).
6.1.3.
Premedication
Premedication is required prior to the administration of the first 4 doses of magrolimab 
and in case of reintroduction with re-priming for all cohorts except the RBC 
Transfusion-dependent Low-risk Cohort, for which premedication is required for the first 
2 doses of magrolimab and the first 2 doses in case of reintroduction with re-priming.  
Premedication for subsequent magrolimab treatments may be continued based on the 
treating physician’s clinical judgement and the presence/severity of prior infusion-related 
reactions.  In the case of a Grade 3 infusion-related reaction, a premedication regimen 
for subsequent treatments is required (Section 6.2.2.1).
Recommended premedications are oral acetaminophen 650 to 1000 mg and oral or IV 
diphenhydramine 25 to 50 mg, or comparable regimen.  If less than 4 hours has 
elapsed since a prior dose of acetaminophen has been given, the dose of 
acetaminophen premedication may be omitted.
6.2.
Dose Modifications, Dose Delays, and Safety Management Guidelines
6.2.1.
Dose Modification and Delay Guidelines
6.2.1.1.
Magrolimab
Dose Modifications
Magrolimab may be withheld if treatment-emergent and/or magrolimab-related AEs 
occur, which include all AEs that constitute a DLT, as defined in Section 3.3.5.  


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Magrolimab may be reintroduced at a 50% dose reduction if the severity has recovered 
to Grade ≤ 2 within 4 weeks and in the absence of disease progression, with approval 
from the Medical Monitor.  A dose delay for up to 3 days may be permissible if the 
patient’s WBC count is greater than 20 × 109/L (which is applicable to Cycle 1), to allow 
for oral hydroxyurea or etoposide treatment to reduce the WBC count.  Further dose 
delay due to elevated WBC counts must be discussed and approved by the Medical 
Monitor.
Patients who experience a Grade 4 or higher AE of hemagglutination and/or 
microangiopathy related to magrolimab will permanently discontinue magrolimab 
treatment.  Patients who experience Grade 3 hemagglutination and/or microangiopathy 
will have magrolimab dosing withheld, and may be reintroduced at a 50% dose 
reduction if the event severity recovers to Grade ≤ 1 within 4 weeks and there is no 
evidence of disease progression.
With one exception, patients who experience a DLT will have their treatment held for up 
to 4 weeks to allow sufficient time for recovery, but may restart dosing at a lower dose 
level if they still meet study eligibility criteria.  Patients who experience a DLT of Grade 4 
non-hematological toxicity will not restart magrolimab and will be withdrawn from study 
drug treatment.  Data from patients who restart dosing after the recovery period will not 
contribute to the MTD evaluation at the lower dose level.  Treatment delays of more 
than 4 weeks (such as for an unrelated medical condition with expected recovery) must 
be discussed with the Medical Monitor and approved by the Sponsor.
Treatment Interruption and Delays
A magrolimab treatment interruption is defined as a nonprotocol-specified interruption 
from treatment, assessments, and procedures. Ongoing data analysis across 
magrolimab + azacitidine trials shows that Q2W dosing of magrolimab without 
significant interruptions is important to yield optimal efficacy.  Therefore, when a patient 
has an azacitidine treatment delay due solely to azacitidine-related toxicities, 
magrolimab should continue with Q2W dosing as scheduled (Table 7-4) or Q4W dosing 
as scheduled (Table 3-3).  Re-initiation of azacitidine will start at the next cycle (which is 


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numerically after the azacitidine cycle which the patient most recently received 
azacitidine prior to the dose delay).  Patients will proceed with this cycle starting on 
Day 1.  Response assessments should occur at time points associated with cycles of 
azacitidine per Schedules of Assessments (Table 7-1, Table 7-2, and Table 7-3) (e.g., 
Cycle 3 Day 1 response assessment should only occur after a patient has received 
2 cycles of azacitidine).  Additionally, in the event that magrolimab dosing is decoupled 
from azacitidine dosing, collection of PK and ADA should always coincide with 
magrolimab dosing at time points specified in Table 7-4.  Patients in Cycle 1 of the TN/U 
Expansion or RBC Transfusion-dependent Low-risk MDS Cohorts should follow dosing 
guidelines and collections for that cycle.  Patients in Cycle 2 of TN/U Expansion Cohort 
should follow dosing schedule and collections for that cycle.  Patients in Cycle 3 or 
beyond should follow Q2C collection of PK and ADA. 
Patients with a magrolimab interruption of longer than 4 weeks (4 weeks is maximum 
allowed for an elective drug delay) or a treatment delay of longer than 4 weeks must 
undergo intrapatient dose escalation of magrolimab again based on their original dosing 
regimen (e.g., for patients on once-weekly dosing, 1 mg/kg priming dose on Days 1 and 
4, 15 mg/kg on Day 8, and 30 mg/kg on Days 11, 15, and 22; or for Rollover patients 
who remain on twice-weekly maintenance dosing, 1 mg/kg priming dose on Days 1 and 
4, 15 mg/kg on Day 8, and 30 mg/kg on Days 11, 15, 18, 22, and 25). 
Any treatment delays/interruptions should be discussed with the Medical Monitor and 
approved by the Sponsor.
Maintenance Dose Schedule Modification
Patients in the R/R and TN/U Cohorts who have completed at least 8 weeks of therapy 
may stay at the same infusion dose and will have their magrolimab schedule of 
administration modified to weekly as decided by the CTSC based on clinical, PK, and 
pharmacodynamic data.  Patients in the Rollover Cohort may continue the same dose 
level and schedule (i.e., twice weekly) of magrolimab monotherapy as previously 
received in the Phase 1 AML study or may transition to once-weekly dosing.  Patients 
who are being treated under the previous Amendment may transition to the new 


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(weekly) dosing schedule at the next cycle, or as determined by the Investigator.  If a 
patient has only received Day 1 treatment for a cycle, the patient may transfer to the 
Q2W dosing regimen with that cycle, for the balance of the cycle and beyond.
Intrapatient Dose Escalation
When the recommended dose has been determined, patients enrolled in the Rollover 
Cohort or TN/U Dose Evaluation Cohort of the study who have been on study for at 
least 8 weeks may have their current dose escalated to the dose level that has been 
previously determined to be safe in this study, at the discretion of the CTSC.
6.2.1.2.
Azacitidine
Dose Modifications
Dose modification or dose delay of azacitidine may not occur for patients in the initial 
28-day DLT Assessment Period in the TN/U Dose Evaluation Cohort or for the first 
cycle for patients in the TN/U Expansion Cohort.  Dose modifications described below 
are in accordance with the azacitidine prescribing information with modifications.  While 
the US prescribing information allows for dose escalation to 100 mg/m2 after the first 2 
cycles, a consistent azacitidine dose of 75 mg/m2 is planned throughout this study.  
Azacitidine dose increases are not allowed without prior approval from the Medical 
Monitor.  The azacitidine dose modifications described below are per prescribing 
information and serve as general recommendations.  However, in standard clinical 
practice, azacitidine label instructions for dose reduction (based on nadir blood counts 
and bone marrow assessment) are not routinely followed in the clinical setting, and it 
appears that this part of the label has not been updated since the first approval of 
azacitidine in 2004.  Recommendations from international groups underline the 
importance of maintaining azacitidine dose intensity in higher-risk MDS patients and 
AML patients and to avoid dose reductions, if possible (Fenaux 2010; Santini 2014; 
Wells 2014).  Therefore, azacitidine dose modifications will follow the prescribing 
information below or institutional practice supported by international recommendations.  


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Azacitidine Dose Modifications Due to Non-Hematological Toxicity
Renal abnormalities ranging from elevated serum creatinine to renal failure have been 
reported in rare frequency in patients treated with azacitidine.  In addition, renal tubular 
acidosis, defined as a fall in serum bicarbonate to < 20 mmol/L in association with an 
alkaline urine and hypokalemia (serum potassium < 3 mmol/L) have been rarely 
observed.  If unexplained reductions in serum bicarbonate (< 20 mmol/L) occur, the 
azacitidine dose should be reduced by 50% on the next cycle.  Similarly, if unexplained 
elevations in serum creatinine or blood urea nitrogen (BUN) to ≥ 2-fold above baseline 
values and above the ULN occur, the next cycle should be delayed until values return to 
normal or baseline and the azacitidine dose should be reduced by 50% on the next 
treatment cycle.  The reduced dose should be maintained during subsequent cycles 
unless toxicity develops.
Azacitidine Dose Modifications Due to Hematological Toxicity
Treatment with azacitidine is associated with anemia, neutropenia, and 
thrombocytopenia.  Thus, complete blood counts (CBCs) will be performed as described 
in the Schedule of Assessments (Section 7.1) and as needed to monitor toxicity.  
Importantly, these cytopenias are often a result of underlying hematological disease.  It 
is thus critical to distinguish between cytopenias due to azacitidine compared to 
underlying disease, as to not limit potential treatment benefit.  In accordance to this 
distinction, azacitidine will not be dose-reduced if hematologic cytopenias are observed 
in the presence of persistent AML; i.e., evidence of:  

> 5% blasts in the bone marrow; 

blasts with Auer rods; 

circulating blasts; 

persistent cytogenetic/molecular abnormality related to AML; or 

positive minimal residual disease.
Hematologic cytopenias in this circumstance are not defined as hematologic toxicities.  
However, if hematologic cytopenias are observed without evidence of AML disease, this 
would be defined as hematologic toxicity and azacitidine dose reduced accordingly as 


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below.  Guidance for azacitidine dose modifications due to hematologic toxicities are 
outlined below for 2 patient populations.
Patients without reduced baseline blood counts (i.e., WBC ≥ 3.0 × 109/L, absolute 
neutrophil count [ANC] ≥ 1.5 × 109/L, and platelets ≥ 75 × 109/L) prior to first treatment.
If hematological toxicity is observed following azacitidine treatment, the next cycle of 
therapy should be delayed until the platelet count and the ANC have recovered.  
If recovery is achieved within 14 days, no dose adjustment is necessary.  However, if 
recovery has not been achieved within 14 days, the dose should be reduced according 
to Table 6-2.  Following dose modifications, the cycle duration should return to 28 days.  
The reduced dose should be maintained during subsequent cycles that are given unless 
toxicity develops.
Table 6-2.
Azacitidine Dose Modification - Patients Without Reduced Baseline 
Blood Counts
Nadir Counts
ANC (×109/L)
Platelets (×109/L)
% Dose in the Next Cycle If Recoverya Is Not 
Achieved Within 14 Days
≤ 1.0
≤ 50.0
50%
> 1.0
> 50.0
100%
Abbreviation:  ANC = absolute neutrophil count.
a.  Recovery = counts ≥ nadir count + (0.5 × [baseline count - nadir count]). 
Patients with reduced baseline blood counts (i.e., WBC < 3.0 × 109/L or ANC 
< 1.5 × 109/L or platelets < 75.0 × 109/L) prior to the first treatment 
Following azacitidine treatment, if the decrease in WBC or ANC or platelets from that 
prior to treatment is ≤ 50 %, or greater than 50% but with an improvement in any cell 
line differentiation, the next cycle should not be delayed and no dose adjustment made.  
If the decrease in WBC or ANC or platelets is greater than 50% from that prior to 
treatment, with no improvement in cell line differentiation, the next cycle of azacitidine 
therapy should be delayed until the platelet count and the ANC have recovered.  If 
recovery is achieved within 14 days, no dose adjustment is necessary.  However, if 


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recovery has not been achieved within 14 days, bone marrow cellularity should be 
determined.  If the bone marrow cellularity is > 50%, no dose adjustments should be 
made.  If bone marrow cellularity is ≤ 50%, treatment should be delayed and the dose 
reduced according to Table 6-3.
Following dose modifications, the cycle duration should return to 28 days.  The reduced 
dose should be maintained during subsequent cycles that are given unless toxicity 
develops.
Table 6-3.
Azacitidine Dose Modification - Patients With Reduced Baseline 
Blood Counts
% Dose in the Next Cycle if Recoverya Is Not Achieved Within 
14 Days
Bone Marrow Cellularity
Recoverya ≤ 21 days
Recoverya ≥ 21 days
15-50%
100%
50%
< 15%
100%
33%
a.  Recovery = counts ≥ nadir count + (0.5 × [baseline count - nadir count]) 
Treatment Interruption and Delays
If hematological toxicity is observed following azacitidine treatment, the next cycle of 
therapy should be delayed until the platelet count and the ANC have recovered.  
If recovery is achieved within 14 days, no dose adjustment is needed.  However, if 
recovery has not been achieved within 14 days, the dose should be reduced according 
to the azacitidine dose modification guidelines above.  Additionally, azacitidine dosing 
may be delayed for up to 4 weeks based on an individual patient basis, which must be 
approved by the Medical Monitor.  Following dose modifications, the cycle duration 
should return to 28 days.  
In the event 2 or fewer doses of azacitidine are missed during the 7-day dosing period 
for the R/R and TN/U cohorts, dosing should continue so that the patient receives the 
full 7 days of therapy.  In the event that 3 or more days are missed during the 7-day 


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dosing period, the Investigator should contact the Sponsor and a dosing decision should 
be made on an individual case basis.
For the RBC Transfusion-dependent Low-risk MDS Cohort, in the event that 1 dose of 
azacitidine is missed during the 5-day dosing period, dosing should continue so that the 
patient receives the full 5 days of therapy.  In the event that 2 or more days are missed 
during the 5-day dosing period, the Investigator should contact the Sponsor and a 
dosing decision should be made on an individual case basis.
6.2.2.
Specific Safety Management Guidelines
6.2.2.1.
Magrolimab
For all cohorts except the RBC Transfusion-dependent Low-risk Cohort, premedication 
is required before administration of the first 4 doses of magrolimab with oral 
acetaminophen 650 to 1000 mg and oral or IV diphenhydramine 25 to 50 mg, or 
comparable regimen.  It is also required in case of reintroduction with re-priming.  For 
the RBC Transfusion-dependent Low-risk Cohort, premedication is required for the first 
2 doses of magrolimab and the first 2 doses in case of re-introduction with re-priming.  
In addition, premedications are to be used to manage infusion-related reactions as 
described below.
Management of Infusion-related Reactions
Infusion-related reactions are defined by the NCI CTCAE (under the category “General 
disorders and administration site conditions”) as “a disorder characterized by adverse 
reaction to the infusion of pharmacological or biological substances” (Appendix A).  
For the purposes of this study, the time frame for infusion-related reaction assessment 
is the 24-hour period beginning from the start of the infusion.  Recommendations for the 
management of infusion-related reactions are provided below.

For Grade 1 infusion-related reactions, described as mild transient reaction, infusion 
interruption is not indicated and intervention not indicated:
o
Remain at bedside and monitor patient until recovery from symptoms.


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
For Grade 2 infusion-related reaction , infusion interruption is indicated, but patient 
responds promptly to symptomatic treatment (e.g., antihistamines, non-steroidal 
anti-inflammatory drugs, narcotics, corticosteroids, IV fluids); and prophylactic 
medications are indicated for ≤ 24 hours:
o
Stop the magrolimab infusion, begin an IV infusion of normal saline, and consider 
treating the patient with diphenhydramine 50 mg IV (or equivalent) and/or 
500-750 mg oral acetaminophen.
o
Remain at bedside and monitor patient until resolution of symptoms.
o
Corticosteroid therapy may also be given at the discretion of the Investigator.
o
If the infusion is interrupted, wait until symptoms resolve, then restart the infusion 
at 50% of the original infusion rate.
o
If no further complications occur after 1 hour (± 10 minutes), the rate may be 
increased to 100% of the original infusion rate.  Monitor the patient closely.
o
If symptoms recur, stop infusion and disconnect patient from the infusion 
apparatus.  No further magrolimab will be administered at that visit.
o
Premedications should be considered before any future infusions.
o
The amount of magrolimab infused must be recorded on the electronic Case 
Report Form (eCRF).
o
Patients who experience a Grade 2 infusion-related reaction during the 
post-infusion observation period that does not resolve to ≤ Grade 1 during that 
time should be observed until the AE resolves or stabilizes, with vital sign 
measurements as medically indicated for the management of the AE.

For Grade 3 or Grade 4 infusion-related reaction, where:  
Grade 3 is described as prolonged infusion-related reactions (e.g., not rapidly 
responsive to symptomatic medication and/or brief interruption of infusion), or 
recurrence of symptoms following initial improvement, or where hospitalization is 
indicated for other clinical sequelae (e.g., renal impairment, pulmonary infiltrates).
Grade 4 is described as having life-threatening consequences and where urgent 
intervention is indicated.
o
Immediately discontinue infusion of magrolimab.


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o
Begin an IV infusion of normal saline, and consider treating the patient as follows:
Administer bronchodilators, epinephrine 0.2 to 1 mg of a 1:1,000 solution for SC 
administration or 0.1 to 0.25 mg of a 1:10,000 solution injected slowly for IV 
administration and/or diphenhydramine 50 mg IV with methylprednisolone 
100 mg IV (or equivalent), as needed.
o
The patient should be monitored until the Investigator is comfortable that the 
symptoms will not recur.
o
Patients who have Grade 4 infusion-related reactions occurring with the first dose 
(priming dose) will be permanently discontinued from study treatment.
o
Patients who experience Grade 3 infusion-related reactions must be given 
premedication prior to subsequent doses.  In this setting, premedication with oral 
acetaminophen (650-1000 mg), oral or IV diphenhydramine (25-50 mg), and IV 
dexamethasone (4-20 mg), or a comparable regimen, is recommended for the 
subsequent 2 doses.  Continued premedication with corticosteroids beyond these 
2 doses may be administered at the discretion of the treating physician.
o
Patients who receive premedication (with the regimen above, including 
corticosteroids) and still experience a Grade 3 or 4 infusion-related reaction will 
be permanently discontinued from study treatment.
o
For anaphylaxis, Investigators should follow their institutional guidelines for 
treatment.
o
All patients with Grade 3 or greater infusion-related reactions will be observed 
until the AE resolves or stabilizes, with vital sign measurements and additional 
evaluations as medically indicated for the management of the AEs.
Thromboembolic Events
Thromboembolic events, including deep vein thromboses and pulmonary embolisms, 
have been reported in some patients receiving magrolimab, sometimes early in therapy. 
Available data for magrolimab do not support a clear or consistent relationship between 


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clinical thromboembolic events and magrolimab use. Patients should be closely 
monitored for the symptoms of thromboembolic events and treated accordingly.
Anemia, Blood Crossmatching, and Packed RBC Transfusion Procedures
Magrolimab binds to RBCs and leads to erythrophagocytosis. CD47 is a member of the 
Rh complex in the RBC’s membrane. Therefore, when magrolimab binds to CD47, it is 
likely to interfere with routine blood bank tests needed in case of transfusion. Notify 
blood transfusion centers/blood banks of this interference with blood bank testing and 
inform them that a patient will receive magrolimab.
In clinical studies, anemia is the most common treatment-related AE and is typically 
manifested as a decline in hemoglobin of about 0.5 g/dL to 1.5 g/dL observed in the first 
1 to 2 weeks of treatment. This decrease in hemoglobin level is acceptable in patients 
with no other significant diseases or medical conditions. However, for patients with 
significant diseases or medical conditions, such as unstable angina, ischemic heart 
disease, or uncontrolled diabetes mellitus, complications from treatment‐related anemia 
could be life‐threatening or fatal. Significant drops (2 to 3 g/dL or higher) have been 
observed in early doses.
Patients with a low baseline hemoglobin level, especially those with cardiac history or 
risk factors, must be monitored closely after initial administrations of magrolimab as 
preexisting anemia could be exacerbated. Red blood cell transfusions are permitted 
prior to study treatment to ensure adequate hemoglobin level per the investigator’s 
clinical judgment.
All patients must have documented hemoglobin ≥ 9 g/dL within 24 hours prior to each of 
the first 2 doses of magrolimab infusion during initial treatment. Patients who do not 
meet these criteria must be transfused and have their hemoglobin rechecked to meet 
9 g/dL prior to each of the first 2 doses of magrolimab.
Prior to initiation of magrolimab, ABO/Rh type, antibody screen, DAT, and extended 
RBC phenotyping (including minor antigens such as CcDEe, Cw, MNSs, Kk, FyaFyb, 
and JkaJkb) will be performed for each patient (Section 7.3.4). Red blood cell 


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genotyping instead of extended RBC phenotyping is acceptable for any patient. Red 
blood cell genotyping (instead of an extended RBC phenotyping) must be performed if a 
patient received any RBC or whole blood transfusion within the previous 3 months 
(unless laboratory has availability for special techniques for performing phenotyping for 
patients with recent transfusion). Results must be available before the first dose of 
magrolimab.
Hemoglobin must be checked again 3 to 6 hours after the initiation of the first and 
second doses of magrolimab during initial treatment. The patient should be transfused 
as clinically appropriate. Investigators should consider additional hemoglobin monitoring 
during the first week of treatment in patients with symptoms of anemia or at increased 
risk for complications of anemia.
For Patients After Exposure to Magrolimab:
For all elective RBC and platelet transfusions, use leukocyte-reduced and gamma-
irradiated units per institutional guidelines. For RBCs, phenotype/genotype matched 
units are preferred. However, CMV-seronegative units for CMV-seronegative patients 
will not be required for this study.
For instances where the ABO/Rh type cannot be resolved, use pretreatment (historical) 
phenotype/genotype matched units for minor RBC antigens (CcDEe and Kk, to the 
extent feasible). Regarding the ABO type, historical blood group or O type can be used 
as per the institutional guidelines.
For emergency transfusions, the transfusion centers may consider using emergency 
Group O RBCs if phenotype/genotype matched units are not available. 
Whenever possible, blood plasma therapy should be blood type specific. Platelets 
should be blood type compatible whenever possible and, if not, should have been 
tested and found not to have high titer anti-A or anti-B. Otherwise, plasma and platelet 
products can be provided as per the institutional policy. 


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A recent report has suggested that crossmatch interference by RBCs due to treatment 
with magrolimab may be resolved by use of gamma-clone anti-IgG and multiple 
alloadsorptions with papain-treated RBC sample cells, pooled single donor apheresis 
platelets, or commercial human platelet concentrate product if required (Velliquette 
2019) (Troughton 2018). 
Tumor Lysis Syndrome
In the case of evidence for tumor lysis syndrome associated with magrolimab and/or 
azacitidine, patients will be admitted to the hospital as clinically indicated.  Standard 
management will include vigorous IV hydration; correction of acidosis, if present; 
hypouricemic agents; and close monitoring of serum uric acid, phosphorus, and 
electrolytes in accordance with local institutional guidelines.
6.2.2.2.
Azacitidine
Safety management guidelines for azacitidine are described in Section 6.2.1.2.  
Additional safety guidelines are provided in the azacitidine prescribing information.
6.3.
Duration of Therapy
Study treatment (magrolimab and/or azacitidine) will be administered continuously until 
disease progression, loss of clinical benefit, or unacceptable toxicity.  It should be noted 
that treatment with azacitidine as monotherapy is recommended for a minimum of 
6 cycles.  All patients in the TN/U Cohort without evidence of treatment failure, relapse 
after CR/CRi, or unacceptable toxicity should continue study treatment for at least 6 
cycles.  Patients may be discontinued from the treatment per Investigator’s discretion 
prior to reaching the recommended minimum cycles for any of these reasons detailed in 
Section 8.1.
6.4.
Patient Completion of the Study
Patients are expected to remain on study treatment until at least completion of Cycle 6.  
Patients who have not demonstrated disease progression or unacceptable toxicity may 
continue to receive study treatment beyond 6 cycles.


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Patients are considered to have completed the study treatment period when they finish 
the Safety Follow-up Visit 30 days (± 7 days) after their last dose of study treatment, 
unless they are experiencing ongoing serious adverse events (SAEs) or treatment-
related AEs.  For patients being followed for ongoing SAEs or treatment-related AEs, 
follow-up visits will continue at least Q4W until resolution to baseline or stabilization of 
these events, unless the patient starts another anti-cancer treatment.  Follow-up for 
ongoing SAEs or treatment-related AEs after the Safety Follow-up Visit will stop if a 
patient begins another anti-cancer therapy.
After the Safety Follow-up Visit, patients will enter long-term follow-up for disease 
progression (Section 7.6) and survival follow-up (Section 7.7).
All patients, including those who discontinue study treatment early, will be followed for 
response until disease progression or initiation of new anti-cancer therapy, whichever 
happens first, and followed for survival until death or 3 years after the date of enrollment 
of the last patient, whichever happens first.  For patients who come off study treatment 
to receive a bone marrow transplant, follow-up for disease progression and collection of 
SOC bone marrow biopsy/aspirate results will continue until documented disease 
progression occurs.  For any patient who dies during this period, the cause of death 
must be reported to the Sponsor.  All patients must also be followed through completion 
of all study treatment.  
Patients are considered to have completed study participation altogether when they are 
no longer followed for disease progression or survival (refer to Section 8 for additional 
details about study discontinuation).
6.5.
Concomitant Therapy
Anti-leukemic therapies including chemotherapy (with the exception of hydroxyurea or 
oral etoposide), targeted therapies and immunotherapy are not permitted while patients 
are on study treatment.  Localized non-CNS radiotherapy, erythroid and/or myeloid 
growth factors, hormonal therapy with LHRH agonists for prostate cancer, and 
treatment with bisphosphonates RANKL inhibitors are permitted.


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6.5.1.
COVID-19 Vaccine
There are no substantial safety data regarding the concomitant administration of the 
COVID‐19 vaccines and magrolimab. There is no contraindication to the COVID-19 
vaccine with magrolimab. Patients are allowed to receive the COVID‐19 vaccine, and 
study visits should continue as planned if vaccination occurs while the patient is on the 
study. Given that immunocompromised individuals on myelosuppressive treatment may 
have attenuated responses to vaccines, Investigators should, after consultation with 
local guidelines, consider delay of COVID-19 vaccination for patients (receiving 
magrolimab/placebo + azacitidine therapy) until recovery of a neutropenic individual’s 
ANC and determine the ideal timing of the subsequent dose of vaccine based on count 
recovery. If patients are neutropenic, Investigators may use clinical judgement in 
determining the timing of the COVID-19 vaccine. Investigators should document 
vaccinations. Investigators should notify patients of the risks of delaying the COVID-19 
vaccination and document this along with any mitigation strategies for preventing 
COVID-19 infection in the source. Investigators should follow local guidelines for 
concomitant administration of the COVID-19 vaccines with the study drug(s).
7. STUDY EVALUATIONS
7.1.
Schedule of Assessments
The Schedule of Assessments for the R/R Expansion Cohort is presented in Table 7-1.  
The Schedule of Assessments for the TN/U Expansion Cohort is provided in Table 7-2.  
The Schedule of Assessments for the RBC Transfusion-dependent Low-risk MDS 
Cohort is provided in Table 7-3.  The Schedule of Assessments for all cohorts for 
magrolimab monotherapy during azacitidine hold(s) is provided in Table 7-4.  The 
Schedules of Assessments for cohorts that have been completed as of Amendment 7 
(the R/R Safety Cohort, the R/R MDS Magrolimab Monotherapy Cohort, the TN/U Dose 
Evaluation Cohort, and the Rollover Cohort) are presented in Appendix F.
Unless otherwise noted, procedures are to be completed prior to any study drug 
infusion/injection.


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Table 7-5 details post-treatment assessments for all patients in this study.  Correlative 
studies sample time points for all cohorts ongoing as of Amendment 7 (R/R Expansion, 
TN/U Expansion TP53 Mutant AML Subcohort, and RBC Transfusion-dependent Low 
risk MDS Cohort) are presented in Table 7-6.  The time points for PK assessments are 
presented in Table 7-7 for the R/R Expansion Cohort (including the R/R MDS 
Magrolimab Monotherapy Cohort), Table 7-8 for the TN/U Expansion Cohort, Table 7-9 
for all cohorts for magrolimab monotherapy during azacitidine hold(s), and Table 7-10 
for the RBC Transfusion-dependent Low-risk Cohort.  CD47 RO sample time points are 
presented in Table 7-11 for the R/R Expansion Cohort, Table 7-12 for the TN/U 
Expansion Cohort, and Table 7-13 for the RBC Transfusion-dependent Low-risk Cohort.  
The assessments required during magrolimab re-priming/re-escalation are presented in 
Table 7-14 and Table 7-15.  Tables of PK assessments and CD47 RO sample time 
points for cohorts that have been completed as of Amendment 7 (the R/R Safety 
Cohort, the R/R MDS Magrolimab Monotherapy Cohort, the TN/U Dose Evaluation 
Cohort, and the Rollover Cohort) are presented in Appendix F.


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Table 7-1.
Schedule of Assessments, R/R Cohort (Expansion) Note: Cohort Closed to Enrollment
Assessment
Study 5F9005:  A Phase 1b Trial of Magrolimab Monotherapy or Magrolimab in Combination
with Azacitidine in Patients with Hematological Malignancies – R/R Cohort (Expansion)
Cycle (28-day 
Cycles)
1
2
3+
Visit Window (Days)
-30
None
± 3a
± 3a
± 3a
Cycle Day
SC
1
2
3
4
5
6
7
8
11
15
22
1
2
3
4
5
6
7
8
15
22
1
2
3
4
5
6
7
15
Informed consent
Xb
Demographics
X
Medical and cancer 
history
X
Entry criteria
X
Enrollment cohort 
assignment
Xb
Pregnancy test
X
Xc
X
X
Donor chimerismd
X
CBC with differential, 
platelets, 
reticulocytese,f
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Peripheral blood 
smeare,g
X
X
X
X
X
X
X
X
Serum or plasma 
chemistrye
X
X
X
X
X
X
X
X
X
X
X
X
Serum uric acid, 
phosphoruse
X
X
X
X
X
Haptoglobin, 
D-dimer, thrombin, 
fibrinogene
X
X
X
X
X
X
X
PT/INR, aPTTe
X
X
X
X
Type and screen 
(ABO/Rh), DAT 
X
Urinalysise
X
X
Correlative studiesh
X
X
X
X
X
I 


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Assessment
Study 5F9005:  A Phase 1b Trial of Magrolimab Monotherapy or Magrolimab in Combination
with Azacitidine in Patients with Hematological Malignancies – R/R Cohort (Expansion)
Cycle (28-day 
Cycles)
1
2
3+
Visit Window (Days)
-30
None
± 3a
± 3a
± 3a
Cycle Day
SC
1
2
3
4
5
6
7
8
11
15
22
1
2
3
4
5
6
7
8
15
22
1
2
3
4
5
6
7
15
PK (Expansion 
Cohort)i
X
X X
X
X
X
X
X
Q2Cu
Anti-drug antibodiesj
X
X
X
X
Q2Cu
CD47 RO bloodk
X
X
X
X
X
X
Q2C-
Q3Cu
Bone marrow 
aspirate/biopsy for 
CD47 RO/
 
X
X  
Q2C-
Q3Cq,r
Bone marrow biopsy 
and cytogeneticsp,q
X
X
Q2C-
Q3Cq,r
MRD monitorings
X
X
Q2C-
Q3Cq,r
Response 
assessment
X
Q2C-
Q3Cq,r
ECOGe
X
X
X
X
X
X
X
Vital signsm
X
X
X
X
X
X
X
X
X
X
X
X
Physical 
examinatione,n
X
X
X
X
X
X
X
X
ECGo
X
X
X
X
Adverse events
Concomitant 
medications
Study Drug 
Administration
Magrolimab 
premedication
X
X
X
X
CCI
I 
- -
-
-


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Assessment
Study 5F9005:  A Phase 1b Trial of Magrolimab Monotherapy or Magrolimab in Combination
with Azacitidine in Patients with Hematological Malignancies – R/R Cohort (Expansion)
Cycle (28-day 
Cycles)
1
2
3+
Visit Window (Days)
-30
None
± 3a
± 3a
± 3a
Cycle Day
SC
1
2
3
4
5
6
7
8
11
15
22
1
2
3
4
5
6
7
8
15
22
1
2
3
4
5
6
7
15
Magrolimab:  
Expansion Cohortt,w
X
X
X
X
X
X
X
X
X
X
X
X
Azacitidinev
X
X
X X
X X X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Abbreviations:  ABO = any of the 4 blood groups A, B, AB, and O comprising the ABO system; ADA = anti-drug antibodies;  aPTT = activated 
partial thromboplastin time; C = cycle; CBC = complete blood count; CTSC = Clinical Trial Steering Committee; DAT = direct antiglobulin test; 
ECG = electrocardiogram; ECOG = Eastern Cooperative Oncology Group; MIN = minute; MRD = minimal residual disease; PE = physical 
examination; PK = pharmacokinetics; PT/INR = prothrombin time/international normalized ratio; Q2W = every 2 weeks; Q2C = every 2 cycles; 
Q3C = every 3 cycles; Rh = Rhesus factor; RO = receptor occupancy; R/R = relapsed/refractory; SC = screening; US = United States; 
W = week(s); WBC = white blood cell.
a.
Note that ± 3-day visit window does not apply to specimen collection for correlative, PK, or RO assessments in Cycles 1 and 2 – refer to 
Table 7-6, Table 7-7, and Table 7-11 for details.
b.
First dose of magrolimab must be given within 30 days of signing informed consent.
c.
Screening pregnancy test may be used if performed within 72 hours of first dose; pregnancy tests will be conducted on Day 1 of every cycle; 
additional guidance is provided in Section 7.3.1.
d.
Donor chimerism only applicable to patients with prior allogeneic hematopoietic stem cell transplant.
e.
Pretreatment assessments for the initial dose (Cycle 1 Day 1) may be collected up to 72 hours before administration of either study drug 
(magrolimab or azacitidine); thereafter, pretreatment assessments are to be collected within 24 hours prior to study drug administration.
f.
Samples for CBC must be collected at least once per cycle.  However, CBC sample collection to ensure a WBC level < 20×103/mcL may be 
deferred based on Investigator assessment of the patient’s WBC kinetics.  Additional samples for CBC may be collected outside of the 
protocol-specified time points to ensure a WBC level < 20×103/mcL.
g.
Peripheral smears will be collected prior to selected study drug infusions/injections and assessed for the presence of hemagglutination in 
addition to standard cell morphology assessment.  Details are provided in Section 7.3.3.
h.
Time point details for correlative studies are provided in Table 7-6.
i.
Time point details for PK studies (Expansion Cohort) are provided in Table 7-7.
j.
Samples to be collected before administration of either study drug (magrolimab or azacitidine), within 72 hours for initial dose and within 
24 hours for subsequent doses.
k.
Time point details for RO studies (Expansion Cohort, US only) are provided in Table 7-11.  For visits that include bone marrow 
assessments, RO blood specimen (US only) should be collected on same day as RO bone marrow specimen is collected.
l.
Bone marrow aspirate and biopsy required for RO/
 (not a response assessment) on Day 15 in US patients only; however 
bone marrow aspirate only is required in the UK at this time point.  Bone marrow study must be done prior to magrolimab infusion.  The 
CTSC may remove this assessment during the R/R Expansion Cohort based on emerging data.
CCI
I 


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m. Vital signs prior to infusion/injection and within 30 minutes after the end of each infusion/injection, before and after administration of each 
study drug (magrolimab or azacitidine).  Weight at screening and Day 1 of each cycle.  Details are provided in Section 7.3.5.
n.
Full PE at screening, symptom-directed PE thereafter.  For Cycles 4 and beyond, PEs may be done only on Day 1 of each cycle, at the 
discretion of the Investigator.
o.
Single ECG at all visits for all patients within 2 hours prior to dosing and within 30 minutes of the end of magrolimab infusion.  Details are 
provided in Section 7.3.7.
p.
At each bone marrow time point, both trephine (biopsy) and aspirate samples are to be collected for response assessment as well as CD47 
receptor occupancy (US only), MRD assessment, correlative studies, and biobanking.  Conventional cytogenetics to be tested per 
institutional standards.  
q.
Response assessments may be adjusted by ± 4 weeks to coordinate with treatment cycle timing.  After Cycle 3, window is ± 14 days.
r.
After Cycle 7 Day 1, bone marrow biopsies will be collected every 3 cycles (i.e., Cycle 10 Day 1, Cycle 13 Day 1, etc.).
s.
MRD monitoring to be performed on bone marrow aspirate samples obtained at the bone marrow biopsy time points.
t.
Magrolimab should not be given on consecutive days.  On Cycle 1 Day 1 and Day 4, infuse magrolimab over 3 hours (± 30 min); starting on 
Cycle 1 Day 8 and thereafter, infuse over 2 hours (± 30 min).
u.
RO blood samples (US only) collected on Day 1 of every other cycle during Cycles 3-7, then every 3 cycles (same day as bone marrow RO 
samples) after Cycle 7 through Cycle 13.  Beginning at C3 Day 1, pretreatment PK and ADA samples to be collected every other cycle 
through Cycle 13.
v.
Azacitidine administration should be completed at least 1 hour before magrolimab administration, on days when both drugs are 
administered.
w. Patients will have their magrolimab dosing schedule changed from weekly to Q2W beginning at Cycle 3. 


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Table 7-2.
Schedule of Assessments, TN/U Expansion Cohort (Including TP53 TN/U AML) Note: Cohort Closed 
to Enrollment
Assessment
Study 5F9005:  A Phase 1b Trial of Magrolimab Monotherapy or Magrolimab in Combination 
with Azacitidine in Patients with Hematological Malignancies – TN/U Expansion Cohort (Including TP53 TN/U AML)
Cycle
(28-day Cycles)
1
2
3+
Visit Window (Days)
-30
None
± 3a
± 3a
± 3
Cycle Day
SC
1
2
3
4
5
6
7
8
11
15
22
1
2
3
4
5
6
7
8
15
22
1
2
3
4
5
6
7
15
Informed consent
Xb
Demographics
X
Medical and cancer 
history
X
Entry criteria
X
Enrollment cohort 
assignment
Xb
Pregnancy test 
X
Xc
X
X
CBC with differential, 
platelets, 
reticulocytesd,e
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Peripheral blood 
smeard,f
X
X
X
X
X
X
X
X
Serum or plasma 
chemistryd
X
X
X
X
X
X
X
X
X
X
X
X
Serum uric acid, 
phosphorusd
X
X
X
X
X
Haptoglobin, D-dimer, 
thrombin, fibrinogend
X
X
X
X
X
X
X
PT/INR, aPTTd
X
X
X
X
Type and screen 
(ABO/Rh), DAT 
X
Urinalysisd
X
X
Correlative studiesg
X
X
X
X
X
I 
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Assessment
Study 5F9005:  A Phase 1b Trial of Magrolimab Monotherapy or Magrolimab in Combination 
with Azacitidine in Patients with Hematological Malignancies – TN/U Expansion Cohort (Including TP53 TN/U AML)
Cycle
(28-day Cycles)
1
2
3+
Visit Window (Days)
-30
None
± 3a
± 3a
± 3
Cycle Day
SC
1
2
3
4
5
6
7
8
11
15
22
1
2
3
4
5
6
7
8
15
22
1
2
3
4
5
6
7
15
PK (Expansion 
Cohort)h
X
X X
X
X
X
X
X
Q2Cu
Anti-drug antibodiesi
X
X
X
X
Q2Cu
CD47 RO blood 
(Expansion Cohort)j
X
X
X
X
X
X
Q2C-
Q3Cu
Bone marrow 
aspirate/biopsy for 
CD47 RO/
 
X
X
Q2C-
Q3Cl,r
Bone marrow biopsy + 
cytogeneticsk,l
X
X
Q2C-
Q3Cl,r
MRD monitoringm
X
Q2C-
Q3Cl,r
Response assessment
Q2C-
Q3Cl,r
ECOGd
X
X
X
X
X
X
X
Vital signsn
X
X
X
X
X
X
X
X
X
X
X
X
Physical 
examinationd,o
X
X
X
X
X
X
X
X
DLT assessmentp
X
ECGq
X
X
X
X
Adverse events
Concomitant 
medications
CCI
I 
I 
- -


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Assessment
Study 5F9005:  A Phase 1b Trial of Magrolimab Monotherapy or Magrolimab in Combination 
with Azacitidine in Patients with Hematological Malignancies – TN/U Expansion Cohort (Including TP53 TN/U AML)
Cycle
(28-day Cycles)
1
2
3+
Visit Window (Days)
-30
None
± 3a
± 3a
± 3
Cycle Day
SC
1
2
3
4
5
6
7
8
11
15
22
1
2
3
4
5
6
7
8
15
22
1
2
3
4
5
6
7
15
Study Drug 
Administration
Magrolimab 
premedication
X
X
X
X
Magrolimabs,v
X
X
X
X
X
X
X
X
X
X
X
X
Azacitidinet
X
X
X
X
X
X X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Abbreviations:  ABO = any of the 4 blood groups A, B, AB, and O comprising the ABO system; ADA = anti-drug antibodies; aPTT = activated 
partial thromboplastin time; C = cycle; CBC = complete blood count; CR = complete remission; CTSC = Clinical Trial Steering Committee; 
DAT = direct antiglobulin test; DLT = dose-limiting toxicity; ECG = electrocardiogram; ECOG = Eastern Cooperative Oncology Group; 
MRD = minimal residual disease; PE = physical examination; PK = pharmacokinetics; PT/INR = prothrombin time/international normalized ratio; 
Q2 = every 2; Q2C = every 2 cycles; Q3C = every 3 cycles; Rh = Rhesus factor; RO = receptor occupancy; SC = Screening; 
TN/U = treatment-naïve/unfit; US = United States; W = week(s); WBC = white blood cell.
a.
Note that ± 3 day visit window does not apply to specimen collection for correlative, PK, and RO assessments in Cycles 1 and 2.
Refer to Table 7-6, Table 7-8, and Table 7-12 for details.
b.
First dose of magrolimab must be given within 30 days of signing informed consent.
c.
Screening pregnancy test may be used if performed within 72 hours of first dose; pregnancy tests will be conducted on Day 1 of every cycle; 
additional guidance is provided in Section 7.3.1.
d.
Pretreatment assessments for the initial dose (Cycle 1 Day 1) may be collected up to 72 hours before administration of either study drug 
(magrolimab or azacitidine); thereafter, pretreatment assessments are to be collected within 24 hours prior to study drug administration.
e.
Samples for CBC must be collected at least once per cycle.  However, CBC sample collection to ensure a WBC level < 20×103/mcL may be 
deferred, based on Investigator assessment of the patient’s WBC kinetics.  Additional samples for CBC may be collected outside of the 
protocol-specified time points to ensure a WBC level < 20×103/mcL.
f.
Peripheral smears will be collected prior to selected study drug infusions/injections and assessed for the presence of hemagglutination in 
addition to standard cell morphology assessment.  Details are provided in Section 7.3.3.
g.
Time point details for correlative studies are provided in Table 7-6.
h.
Time point details for PK studies (Expansion Group) are provided in Table 7-8.
i.
Samples to be collected before administration of either study drug (magrolimab or azacitidine), within 72 hours for initial dose and within 
24 hours for subsequent doses.
j.
Time point details for RO studies (Expansion Group, US only) are provided in Table 7-12.
I 
I 


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k.
At each bone marrow time point, both trephine (biopsy) and aspirate samples are to be collected for response assessment as well as CD47 
receptor occupancy (US only), MRD assessment, correlative studies, and biobanking.  Conventional cytogenetics to be tested per 
institutional standards.
l.
Response assessments may be adjusted by ± 4 weeks to coordinate with treatment cycle timing.  After Cycle 3, the window is ± 14 days.
m. MRD monitoring to be performed on bone marrow aspirate samples obtained at the bone marrow biopsy time points.
n.
Vital signs prior to infusion/injection and within 30 minutes after the end of each infusion/injection, before and after administration of each 
study drug (magrolimab or azacitidine).  Weight at screening and Day 1 of each cycle.  Details are provided in Section 7.3.5.
o.
Full PE at screening, symptom-directed PE thereafter.  For Cycles 4 and beyond, PEs may be done only on Day 1 of each cycle, at the 
discretion of the Investigator.  
p.
DLT will be assessed throughout the first 4 weeks of study treatment for the Dose Evaluation Cohort only.
q.
Single ECG at all visits for all patients within 2 hours prior to infusion of study drug and within 30 minutes of the end of magrolimab infusion.  
Details are provided in Section 7.3.7.
r.
After Cycle 7 Day 1, bone marrow biopsies will be collected every 3 cycles (i.e., Cycle 10 Day 1, Cycle 13 Day 1, etc.).
s.
Magrolimab should not be given on consecutive days.  On Cycle 1 Day 1 and Day 4, infuse magrolimab over 3 hours (± 30 min); starting on 
Cycle 1 Day 8 and thereafter, infuse over 2 hours (± 30 min).
t.
Azacitidine administration should be completed at least 1 hour before magrolimab administration, on days when both drugs are 
administered.
u.
RO blood samples (US only) collected on Day 1 of every other cycle during Cycle 3-7, then every 3 cycles (same day as bone marrow RO 
samples) after Cycle 7 through Cycle 13.  Beginning at Cycle 3 Day 1, pretreatment PK and ADA samples to be collected every other cycle 
through Cycle 13.
v.
Patients may have their magrolimab dose changed from weekly to every 2 weeks at any time on therapy based on CTSC recommendations  
or Sponsor requirement.


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Table 7-3.
Schedule of Assessments, RBC Transfusion-dependent Low-risk MDS Cohort Note: Cohort Closed 
to Enrollment
Assessment
Study 5F9005:  A Phase 1b Trial of Magrolimab Monotherapy or Magrolimab in Combination 
with Azacitidine in Patients with Hematological Malignancies – RBC Transfusion-dependent Low-risk MDS Cohort
Cycle
(28-day Cycles)
1
2
3+
Visit Window (Days)
-30
None
± 3a
± 3a
± 3
Cycle Day
SC
1
2
3
4
5
8
15
22
1
2
3
4
5
15
1
2
3
4
5
15
Informed consent
Xb
Demographics
X
Medical and cancer history
X
Entry criteria
X
Enrollment cohort assignment
Xb
Pregnancy test 
X
Xc
X
X
CBC with differential, platelets, 
reticulocytesd,e,x
X
Xx
X
Xx
X
X
X
X
X
X
X
Xf
Peripheral blood smeard,g
X
X
X
X
X
X
Serum or plasma chemistryd
X
X
X
X
X
X
X
X
Xf
Serum uric acid, phosphorusd
X
X
X
X
X
Haptoglobin, D-dimer, thrombin, 
fibrinogend
X
X
X
X
X
X
PT/INR, aPTTd
X
X
X
X
Type and screen (ABO/Rh), DAT, 
phenotyping/genotypingy
X
Urinalysisd
X
X
Correlative studiesh
X
X
X
X
X
PKi
X
X
X
X
X
Q2C-
Q3Cj
Anti-drug antibodiesk
X
X
X
X
Q2Cj
I 
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Assessment
Study 5F9005:  A Phase 1b Trial of Magrolimab Monotherapy or Magrolimab in Combination 
with Azacitidine in Patients with Hematological Malignancies – RBC Transfusion-dependent Low-risk MDS Cohort
Cycle
(28-day Cycles)
1
2
3+
Visit Window (Days)
-30
None
± 3a
± 3a
± 3
Cycle Day
SC
1
2
3
4
5
8
15
22
1
2
3
4
5
15
1
2
3
4
5
15
CD47 RO bloodl
X
X
X
X
X
Q2C, 
Q4C, 
Q6Cj
Bone marrow aspirate/biopsy for 
CD47 RO/
X
X
Q2C, 
Q4C, 
Q6Cm,o
Bone marrow biopsy + 
cytogeneticsm,o
X
X
Q2C, 
Q4C, 
Q6Cm,o
MRD monitoringn
X
Q2C-
Q6Cm,o
Response assessmentp
Q2C-
Q6Cp,o
ECOGd
X
X
X
X
X
X
X
Vital signsq
X
X
X
X
X
X
X
X
Physical examinationd,r
X
X
X
X
X
DLT assessments
X
ECGt
X
X
Adverse eventsf
Concomitant medicationsf
Study Drug Administration
Magrolimab premedication
X
X
CCI
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Assessment
Study 5F9005:  A Phase 1b Trial of Magrolimab Monotherapy or Magrolimab in Combination 
with Azacitidine in Patients with Hematological Malignancies – RBC Transfusion-dependent Low-risk MDS Cohort
Cycle
(28-day Cycles)
1
2
3+
Visit Window (Days)
-30
None
± 3a
± 3a
± 3
Cycle Day
SC
1
2
3
4
5
8
15
22
1
2
3
4
5
15
1
2
3
4
5
15
Magrolimabu
Xz
Xz
X
X
X
X
Azacitidinevw
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Abbreviations:  ABO = any of the 4 blood groups A, B, AB, and O comprising the ABO system; ADA = anti-drug antibodies; aPTT = activated 
partial thromboplastin time; C = cycle; CBC = complete blood count; CR = complete remission; CTSC = Clinical Trial Steering Committee; 
DAT = direct antiglobulin test; DLT = dose-limiting toxicity; ECG = electrocardiogram; ECOG = Eastern Cooperative Oncology Group; 
MDS = myelodysplastic syndrome; MRD = minimal residual disease; PE = physical examination; PK = pharmacokinetics; PT/INR = prothrombin 
time/international normalized ratio; Q2 = every 2; Q2C = every 2 cycles; Q2W = every 2 weeks; Q3C = every 3 cycles; Q4W = every 4 weeks; 
RBC = red blood cell; Rh = Rhesus factor; RO = receptor occupancy; SC = Screening; TN/U = Treatment-naïve/Unfit; US = United States; 
W = week(s); WBC = white blood cell.
a.
Note that ± 3-day visit window does not apply to specimen collection for correlative, PK, and RO assessments in Cycles 1 and 2.
Refer to Table 7-6, Table 7-10, and Table 7-13 for details.
b.
First dose of magrolimab must be given within 30 days of signing informed consent. 
c.
Screening pregnancy test may be used if performed within 72 hours of first dose; pregnancy tests will be conducted on Day 1 of every cycle; 
additional guidance is provided in Section 7.3.1.
d.
Pretreatment assessments for the initial dose (Cycle 1 Day 1) may be collected up to 72 hours before administration of either study drug 
(magrolimab or azacitidine); thereafter, pretreatment assessments are to be collected within 24 hours prior to study drug administration.
e.   Samples for CBC must be collected at least once per cycle.  However, CBC sample collection to ensure a WBC level < 20 × 103/mcL may 
be deferred, based on Investigator assessment of the patient’s WBC kinetics.  Additional samples for CBC may be collected outside of the 
protocol-specified time points to ensure a WBC level < 20×103/mcL.
f.    After Cycle 6, these laboratory tests can be omitted if the patient is clinically well and does not need Q2W CBC/chemistry lab checks as per 
the discretion of the PI. If C7+ D15 laboratory tests are omitted, no visit will occur on that day, and AEs and Con-Meds do not need to be 
collected.
g.
Peripheral smears will be collected prior to selected study drug infusions/injections and assessed for the presence of hemagglutination in 
addition to standard cell morphology assessment.  Details are provided in Section 7.3.3.
h.
Time point details for correlative studies are provided in Table 7-6.
i.
Time point details for PK studies are provided in Table 7-10.
j.
RO blood samples (US only) collected on Day 1 of every other cycle during Cycles 3 to 7, then every 4 cycles through Cycle 19, and then 
starting Cycle 23 and onwards every 6 cycles (same day as bone marrow RO samples).  Beginning at Cycle 3 Day 1, pretreatment PK and 
ADA samples to be collected every other cycle through Cycle 7 and then every third cycle to Cycle 13.
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k.
Samples to be collected before administration of either study drug (magrolimab or azacitidine), within 72 hours for initial dose and within 
24 hours for subsequent doses.
l.
Time point details for RO studies are provided in Table 7-13.
m. At each bone marrow time point, both trephine (biopsy) and aspirate samples are to be collected for response assessment as well as CD47 
receptor occupancy (US only), MRD assessment, correlative studies, and biobanking.  Conventional cytogenetics to be tested per 
institutional standards.
n.
MRD monitoring to be performed on bone marrow aspirate samples obtained at the bone marrow biopsy time points.
o.
The first bone marrow assessment will occur at Cycle 3 Day 1 (± 3 days), approximately 8 weeks after the start of study treatment.  
Subsequent bone marrow assessments while on study treatment will occur every other cycle through Cycle 7 (i.e., Cycle 5 Day 1 and 
Cycle 7 Day 1).  After Cycle 7 Day 1, bone marrow biopsies will be collected every 4 cycles through Cycle 19 (i.e., Cycle 11 Day 1, Cycle 15 
Day 1, and Cycle 19 Day 1) and then starting Cycle 23 and onwards, bone marrow biopsies will be collected every 6 cycles (Cycle 23 Day 1, 
Cycle 29 Day 1, etc.).
p.
Response assessments may be adjusted by ± 4 weeks to coordinate with treatment cycle timing.  After Cycle 3, the window is ± 14 days.
q.
Vital signs prior to infusion/injection and within 30 minutes after the end of each infusion/injection, before and after administration of each 
study drug (magrolimab or azacitidine).  Weight at screening and Day 1 of each cycle.  Details are provided in Section 7.3.5.
r.
Full PE at screening, symptom-directed PE thereafter.  For Cycles 4 and beyond, PEs may be done only on Day 1 of each cycle, at the 
discretion of the Investigator.  
s.
DLT will be assessed throughout the first 6 weeks of study treatment for the safety run-in part only.
t.
Single ECG at all visits within 2 hours prior to infusion of study drug and within 30 minutes of the end of magrolimab infusion.  Details are 
provided in Section 7.3.7.
u.
For the 1 mg/kg Cycle 1 Day 1 and Day 8 doses, infuse magrolimab over 3 hours (± 30 min); starting Cycle 1 Day 8 and for subsequent 
doses, infuse over 2 hours (± 30 min).
v.
Azacitidine administration should be completed at least 1 hour before magrolimab administration, on days when both drugs are 
administered.
w. For the first 6 patients in the Safety part of the cohort on magrolimab monotherapy, azacitidine administration may begin in Cycle 3, based 
on patient response, and with Investigator and Sponsor agreement.
x.
Within 24 hours prior to each of the first 2 doses of magrolimab infusion during initial treatment (Days 1 and 8), all subjects must have a 
documented hemoglobin ≥ 9 g/dL. Patients who do not meet these criteria must be transfused and have their hemoglobin rechecked to meet 
9 g/dL prior to each of the first 2 doses of magrolimab. 
y.
ABO/Rh type, antibody screen, DAT, and extended RBC phenotyping (including minor antigens such as CcDEe, Cw, MNSs, Kk, FyaFyb, 
and JkaJkb) will be performed for each patient. Red blood cell genotyping instead of extended RBC phenotyping is acceptable for any 
patient.  Red blood cell genotyping (instead of an extended RBC phenotyping) must be performed if a patient received any RBC or whole 
blood transfusion within the previous 3 months (unless laboratory has availability for special techniques for performing phenotyping for 
patients with recent transfusion).  Results must be available before the first dose of magrolimab.
z.
Hemoglobin must be checked again 3 to 6 hours after the initiation of the first and second doses of magrolimab during initial treatment 
(Days 1 and 8). The patient should be transfused as clinically appropriate. Investigators should consider additional hemoglobin monitoring 
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Table 7-4.
Schedule of Assessments, Magrolimab Monotherapy During Azacitidine Hold(s)
Assessment 
Study 5F9005:  A Phase 1b Trial of Magrolimab Monotherapy or Magrolimab 
in Combination with Azacitidine in Patients with Hematological Malignancies – 
Magrolimab Monotherapy During Azacitidine Hold(s)
Visit Window (Days)
Cycle X
Cycle Day
1
15
Pregnancy test
Xa
CBC with differential, platelets, reticulocytesb,c
X
X
Serum or plasma chemistryb
X
X
Haptoglobin, D dimer, thrombin, fibrinogenb
X
PT/INR, aPTTb
X
PKd
X
Q2Ce
Anti-drug antibodiesf
X
Q2Ce
ECOGb
X
Vital signsg
X
Xk
Physical examinationb,h
X
Xk
Adverse events
X
X
Concomitant medications
X
X
Study Drug Administration
Magrolimabi,j
X
Xk
Abbreviations:  aPTT = activated partial thromboplastin time; CBC = complete blood count; ECG = electrocardiogram; ECOG = Eastern 
Cooperative Oncology Group; PE = physical examination; PK = pharmacokinetics; PT/INR = prothrombin time/international normalized ratio; 
Q2C = every 2 cycles; Q2W = every 2 weeks; WBC = white blood cell count.
a.
Screening pregnancy test may be used if performed within 72 hours of first dose; pregnancy tests will be conducted on Day 1 of every cycle; 
additional guidance is provided in Section 7.3.1.
b.
Pretreatment assessments for the initial dose (Cycle 1 Day 1) may be collected up to 72 hours before administration of study drug 
(magrolimab); thereafter, pretreatment assessments are to be collected within 24 hours prior to study drug administration.
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c.
Samples for CBC must be collected at least once per cycle.  However, CBC sample collection to ensure a WBC level < 20×103/mcL may be 
deferred based on Investigator assessment of the patient’s WBC kinetics.  Additional samples for CBC may be collected outside of the 
protocol-specified time points to ensure a WBC level < 20×103/mcL.
d.
Time point details for PK studies are provided in Table 7-9.
e.
Patients in Cycle 1 of the TN/U Expansion or RBC Transfusion-dependent Low-risk MDS Cohorts should follow dosing guidelines and 
collections for that cycle.  Patients in Cycle 2 of TN/U Expansion Cohort should follow dosing schedule and collections for that cycle.  Patients 
in Cycle 3 or beyond should follow Q2C collection of PK and ADA. 
f.
Samples to be collected before administration of study drug (magrolimab), within 72 hours for initial dose and within 24 hours for subsequent 
doses.
g.
Vital signs prior to infusion/injection and within 30 minutes after the end of each infusion/injection, before and after administration of study drug 
(magrolimab).  Weight at screening and Day 1 of each cycle.  Details are provided in Section 7.3.5.
h.
Full PE at screening, symptom-directed PE thereafter.  For Cycles 4 and beyond, PEs may be done only on Day 1 of each cycle, at the 
discretion of the Investigator.  
i.
Magrolimab should not be given on consecutive days.  On Cycle 1 Day 1 and Day 4, infuse magrolimab over 3 hours (± 30 min); starting on 
Cycle 1 Day 8 and thereafter, infuse over 2 hours (± 30 min).
j.
Patients will have their magrolimab dosing schedule changed from weekly to Q2W beginning at Cycle 3.
k.
Not performed Day 15 in RBC Transfusion-dependent Low-risk MDS Cohort.


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Table 7-5.
Post-treatment Assessments, All Cohorts
Assessment
Study 5F9005:  A Phase 1b Trial of Magrolimab Monotherapy or 
Magrolimab in Combination with Azacitidine in Patients with
Hematological Malignancies – ALL COHORTS
Cycle (28-day Cycles)
End-of-
treatment Visit
Safety 
Follow-up 
Visit
Long-term Follow-up
Survival 
Follow-up
After last dose or 
within 7 Days
of EOT Decision
30 Days
After Last 
Dose
Monthly until disease 
progression or new 
anti-cancer therapya
Every 
2 months up 
to 60 months 
from LSE
Visit Window
7-14 Days
± 7 Days
± 14 Days
± 1 Month
Serum or urine pregnancy test
Xb
CBC with differential, platelet 
count, reticulocytes
X
Peripheral Blood Smear
X
Serum or plasma chemistry
X
Haptoglobin, D-dimer, 
thrombin time and plasma 
fibrinogen
X
PT/INR, aPTT
X
Pharmacokinetics 
X
X
Correlative studies
X
Xc
Anti-drug Antibodies 
X
X
CD47 Receptor Occupancyd 
X
X
ECOG performance status
X
Vital signs 
X
Physical examination
(symptom-directed)
X
Bone marrow biopsy (core 
and aspirates) and 
cytogeneticse
X
Xf
Q8W
Response assessment
Xg
X
Q8W
Adverse events
Xh
Xh
Xh
Concomitant medications
X
X
New anti-cancer therapy
X
Xi
Survival follow-up
Q2M
Abbreviations:  AE = adverse event; aPTT = activated partial thromboplastin time; CBC = complete 
blood count; CR = complete remission; EOT = end-of-treatment; LSE = last subject enrolled; 
M = month(s); PT/INR = prothrombin time/international normalized ratio; Q2M = every 2 months; 
Q8W = every 8 weeks; SAE = serious adverse event; SOC = standard of care; US = United States.
a.
For patients who come off study treatment to receive a bone marrow transplant, follow-up for 
disease progression and collection of SOC bone marrow biopsy/aspirate results will continue until 
documented disease progression occurs.
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b.
Pregnancy tests should be taken at monthly intervals until end of contraception requirement.
c.
Collected at time of disease progression or relapse.
d. CD47 receptor occupancy is a US-only sub-study.
e.
Conventional cytogenetic testing (per institutional standards) is required for all patients, with one 
exception:  In the Rollover Cohort, cytogenetic assessments are required only for patients who had 
prior cytogenetic assessments in the previous Phase 1 study (SCI-CD47-002).
f.
Required if patient discontinues treatment without documented disease progression, only if not 
completed within the last 4 weeks.
g.
Response Assessment at EOT visit not required if performed within the last 7 days or progressive 
disease has been documented.
h.
Report all AEs through the Safety Follow-up Visit, and any treatment-related SAEs thereafter.  
i.
Collect new anti-cancer therapy data following the last dose of study drug, if not documented 
previously.
Table 7-6.
Correlative Studies Sample Time Points, R/R Cohorts
(Expansion and R/R MDS Monotherapy), TN/U Cohorts
(Expansion and TP53 Mutant AML Subcohort), and RBC Transfusion-
dependent Low-risk MDS Cohort
Study 5F9005:  A Phase 1b Trial of Magrolimab Monotherapy or Magrolimab in Combination 
with Azacitidine in Patients with Hematological Malignancies
R/R Cohorts (Expansion and R/R MDS Monotherapy), TN/U Cohorts (Expansion and TP53 
Mutant AML Subcohort), and RBC Transfusion-dependent Low-risk MDS Cohort 
Phase 1b
Cycle 1
Cycle 2
C3+
EOT
LTFU
Day
1
8
15
1
1
—
—
Pretreatment (or non-treatment 
day)a
Xb
X
Xc
Xb
Xb,c
X
Xd
1 hour (± 15 min) after end of 
magrolimab infusion
X
X
Abbreviations:  C = cycle; EOT = end-of -treatment; LTFU = long-term follow-up; min = minute(s); 
R/R = Relapsed/Refractory; TN/U = treatment-naïve/unfit.
a.
Pretreatment specimens may be collected up to 72 hours before administration of either study drug 
(magrolimab or azacitidine).
b.
Sample to be collected before azacitidine infusion.
c.
When bone marrow biopsies are performed, collect blood samples ± 7 days from bone marrow 
collection date; otherwise, collect blood samples ± 7 days from Day 1 of each treatment cycle.
d.
Obtained at the time of disease progression or relapse.
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Table 7-7.
Pharmacokinetic Assessments, R/R Cohorts (Expansion and MDS 
Monotherapy) Note: Cohorts Closed to Enrollment
Study 5F9005:  A Phase 1b Trial of Magrolimab Monotherapy or Magrolimab in Combination 
with Azacitidine in Patients with Hematological Malignancies
R/R Cohorts (Expansion and MDS Monotherapy)
Cycle 1
Cycle 2
C3+
EOT
SFU
Day
1
7
8
15
22
1
8
1
—
—
Pretreatmenta
Xb
X
X
X
Xb
X
X
Q2Cc
X
X
30 min (± 15 min) 
after end of 
azacitidine 
infusion/injectiond
X
X
X
X
Q2Cc
1 hour (± 15 min) 
after end of 
magrolimab infusion
X
X
X
X
Q2Cc
Abbreviations:  C = cycle; EOT = end-of-treatment; min = minute(s); PK = pharmacokinetic; 
R/R = Relapsed/Refractory; SFU = safety follow-up, Q2C = every 2 cycles.
Note:  PK samples are to be collected from the arm opposite from infusion site, or alternatively, infusion 
site must be flushed with 10 mL of saline.
a.
Collect pretreatment specimens within 12 hours prior to study drug administration.
b.
Pretreatment sample to be collected before either study drug (azacitidine or magrolimab) is started.
c.
Samples to be collected every other cycle beginning with Cycle 3 through Cycle 13.  No PK 
samples will be collected after Cycle 13.
d.
Azacitidine will be given before magrolimab on days on which both treatments are to be given.  For 
patients in the R/R MDS Magrolimab Monotherapy Cohort, post-azacitidine sampling time points 
are not applicable unless patients later transition to combination therapy.
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Table 7-8.
Pharmacokinetic Assessments, TN/U Expansion Cohort
Study 5F9005:  A Phase 1b Trial of Magrolimab Monotherapy or Magrolimab in Combination 
with Azacitidine in Patients with Hematological Malignancies
TN/U Expansion Cohort
Cycle 1
Cycle 2
C3+
EOT
SFU
Day
1
7
8
15
22
1
8
1
—
—
Pretreatment a
Xb
X
X
X
Xb
X
X
Q2Cd
X
X
30 min (± 15 min) 
after end of 
azacitidine 
infusion/injectionc
X
X
X
X
Q2Cd
1 hour (± 15 min) 
after end of 
magrolimab infusion
X
X
X
X
Q2Cd
Abbreviations:  C = cycle; EOT = end-of-treatment; min = minute(s); PK = pharmacokinetic; 
Q2C = every 2 cycles; SFU = safety follow-up; TN/U = Treatment-naïve/Unfit.
Note:  PK samples are to be collected from the arm opposite from infusion site, or alternatively, 
infusion site must be flushed with 10 mL of saline.
a.
Collect pretreatment specimens within 12 hours prior to study drug administration.
b.
Pretreatment sample to be collected before either study drug (azacitidine or magrolimab) is started.
c.
Azacitidine will be given before magrolimab on days on which both treatments are to be given.
d.
Samples to be collected every other cycle beginning with Cycle 3 through Cycle 13.  No PK 
samples will be collected after Cycle 13.
Table 7-9.
Pharmacokinetic Assessments, Magrolimab Monotherapy During 
Azacitidine Hold(s)
Study 5F9005:  A Phase 1b Trial of Magrolimab Monotherapy or Magrolimab in Combination 
with Azacitidine in Patients with Hematological Malignancies
Magrolimab Monotherapy During Azacitidine Hold(s)
Cycle X
Day 
1
15
Pretreatmenta
Xb,c
Abbreviations:  MRD = minimal residual disease; PK = pharmacokinetic; RO = receptor occupancy.
Note:  PK samples are to be collected from the arm opposite from infusion site.
a.
Collect pretreatment specimens within 12 hours prior to study drug (magrolimab) administration 
using Cycle 3+ Day 1 kits. Do NOT collect bone marrow, MRD, RO, or correlative studies.
b.
Pretreatment sample to be collected before study drug (magrolimab) is started. Samples to be 
collected every other cycle beginning with Cycle 3 through Cycle 13.  No PK samples will be 
collected after Cycle 13.
c.
In RBC Transfusion-dependent Low-risk MDS Cohort, samples to be collected every other cycle 
beginning with Cycle 3 through Cycle 13.  No PK samples will be collected after Cycle 13.
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Table 7-10.
Pharmacokinetic Assessments, RBC Transfusion-dependent 
Low-risk MDS Cohort
Study 5F9005:  A Phase 1b Trial of Magrolimab Monotherapy or Magrolimab in Combination 
with Azacitidine in Patients with Hematological Malignancies
RBC Transfusion-dependent Low-risk MDS Cohort
Cycle 1
Cycle 2
Cycle 3+
EOT
SFU
Day
1
8
15
1
15
1
—
—
Pretreatment a
Xb
X
X
Xb
X
Q2C-Q3Cd
X
X
15 min (± 15 min) after end of 
magrolimab infusion
X
Abbreviations:  C = cycle; EOT = end-of-treatment; min = minute(s); PK = pharmacokinetic; 
Q2C = every 2 cycles; RBC = red blood cell; SFU = safety follow-up.
Note:  PK samples are to be collected from the arm opposite from infusion site, or alternatively, 
infusion site must be flushed with 10 mL of saline.
a.
Collect pretreatment specimens within 12 hours prior to study drug administration.
b.
Pretreatment sample to be collected before either study drug (azacitidine or magrolimab) is started.
c.
Azacitidine will be given before magrolimab on days on which both treatments are to be given.
d.
Samples to be collected every other cycle beginning with Cycle 3 through Cycle 7 and then every 
third cycle through Cycle 13.  No PK samples will be collected after Cycle 13 until EOT and/or 
SFU.
Table 7-11.
CD47 Receptor Occupancy Sample Time Points,
R/R Expansion Cohort Note: Cohort Closed to Enrollment
Study 5F9005:  A Phase 1b Trial of Magrolimab Monotherapy or Magrolimab in Combination 
with Azacitidine in Patients with Hematological Malignancies
R/R Expansion Cohort
Phase 1b
Cycle 1
Cycle 2
C3+
EOT
SFU
Day
1
8
11
15
1
1
—
—
Pretreatment (or non-treatment day)a
X
X
X
Xb
Xb
X
Q2C-
Q3Cb,c,d
X
X
Abbreviations:  C = cycle; EOT = end-of-treatment; RO = receptor occupancy; Q2C = every 2 cycles; 
Q3C = every 3 cycles; R/R = Relapsed/Refractory; SFU = safety follow-up; UK = United Kingdom; 
US = United States.
Note:  RO is a US-only sub-study; RO specimens are not required for UK patients.
a.
Collect pretreatment specimens within 12 hours prior to study drug administration.
b.
Pretreatment sample to be collected before either study drug (azacitidine or magrolimab) is started.
c. For visits that include bone marrow assessments, RO blood specimen should be collected on the 
same day as RO bone marrow specimen is collected.
d.
RO blood samples collected on Day 1 of every other cycle during Cycles 3 through 7, then every 
3 cycles (same day as bone marrow RO samples) after Cycle 7 through Cycle 13.
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Table 7-12.
CD47 Receptor Occupancy Sample Time Points, 
TN/U Expansion Cohort
Study 5F9005:  A Phase 1b Trial of Magrolimab Monotherapy or Magrolimab in Combination 
with Azacitidine in Patients with Hematological Malignancies
TN/U Expansion Cohort
Phase 1b
Cycle 1
Cycle 2
C3+
EOT
SFU
Day
1
8
11
15
1
1
—
—
Pretreatment (or non-treatment 
day)a
Xb
X
X
X
Xb
X
Q2C-
Q3C a,b,c
X
X
Abbreviations:  C = cycle; EOT = end-of-treatment; Q2C = every 2 cycles; Q3C = every 3 cycles; 
RO = receptor occupancy; SFU = safety follow-up; TN/U = Treatment-naïve/Unfit; UK = United 
Kingdom; US = United States.
Note:  RO is a US-only sub-study; RO specimens are not required for UK patients.
a. Pretreatment sample to be collected within 12 hours prior to administration of either study drug 
(azacitidine or magrolimab).
b. For visits that include bone marrow assessments, RO blood specimen should be collected on same 
day as RO bone marrow specimen is collected.  
c. RO blood samples will be collected on Day 1 of every other cycle during Cycles 3 through 7, then 
every 3 cycles (same day as bone marrow RO samples) after Cycle 7 through Cycle 13.
Table 7-13.
CD47 Receptor Occupancy Sample Time Points, RBC 
Transfusion-dependent Low-risk MDS Cohort
Study 5F9005:  A Phase 1b Trial of Magrolimab Monotherapy or Magrolimab in Combination 
with Azacitidine in Patients with Hematological Malignancies
RBC Transfusion-dependent Low-risk MDS Cohort 
Phase 1b
Cycle 1
Cycle 2
C3+
EOT
SFU
Day
1
8
15
1
1
—
—
Pretreatment (or non-treatment 
day)a
Xb
X
X
Xb
X
Q2C, 
Q4C, 
Q6C a,b,c
X
X
Abbreviations:  C = cycle; EOT = end-of-treatment; Q2C = every 2 cycles; Q3C = every 3 cycles; 
RO = receptor occupancy; SFU = safety follow-up; TN/U = Treatment-naïve/Unfit; UK = United 
Kingdom; US = United States.
Note:  RO is a US-only sub-study; RO specimens are not required for UK patients.
a. Pretreatment sample to be collected within 12 hours prior to administration of either study drug 
(azacitidine or magrolimab).
b. For visits that include bone marrow assessments, RO blood specimen should be collected on same 
day as RO bone marrow specimen is collected.  
c. For the TN/U Expansion Cohort, RO blood samples will be collected on Day 1 of every other cycle 
during Cycles 3 through 7, then every 3 cycles (same day as bone marrow RO samples) after 
Cycle 7 through Cycle 13.  For the RBC Transfusion-dependent Low-risk Cohort, RO blood samples 
(US only) will be collected on Day 1 of every other cycle during Cycles 3 to 7, then every 4 cycles 
through Cycle 19, and then starting Cycle 23 and onwards every 6 cycles (same day as bone 
marrow RO samples).
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Table 7-14.
Re-priming/Re-escalation Assessments:  R/R Cohort and 
TN/U Cohort
Visit Window
Assessment
None
± 3 Days
Cycle Day 
(Cycle: 28 Days)
1
2
3
4
5
6
7
8
11
15
22
CBC with differential, 
platelets, reticulocytesa,b
X
X
X
X
X
X
X
Peripheral blood smeara,c
X
X
X
X
Serum or plasma chemistrya
X
X
X
X
X
Serum uric acid, phosphorusa
X
X
X
X
Haptoglobin, D-dimer, 
thrombin, fibrinogena
X
X
X
X
PT/INR, aPTTa
X
Anti-drug antibodiesd
X
CD47 RO bloode
X
X
X
X
ECOGa
X
X
X
Vital signsf
X
X
X
X
Physical examinationa,g
X
X
X
Adverse events
Concomitant medications
Magrolimab premedication
X
X
X
X
Magrolimab:  
Re-priming/re-escalationh
X
X
X
X
X
X
Azacitidineh,i
X
X
X
X
X
X
X
Abbreviations:  aPTT = activated partial thromboplastin time; CBC = complete blood count; 
ECOG = Eastern Cooperative Oncology Group; IV = intravenous; PE = physical examination; 
PT/INR = prothrombin time/international normalized ratio; Rh = Rhesus factor; RO = receptor 
occupancy; SC = subcutaneous; US = United States; WBC = white blood cell.
a. Pretreatment assessments for the initial dose (Cycle 1 Day 1) may be collected up to 72 hours 
before study drug administration; thereafter, pretreatment assessments are to be collected within 
24 hours prior to study drug administration.
b. Samples for CBC must be collected at least once per cycle.  However, CBC sample collection to 
ensure a WBC level < 20 × 103/mcL may be deferred, based on Investigator assessment of the 
patient’s WBC kinetics.  Additional samples for CBC may be collected outside of the protocol-
specified time points to ensure a WBC level < 20 × 103/mcL.
c. Peripheral smears will be collected prior to selected study drug infusions/injections and assessed for 
the presence of hemagglutination in addition to standard cell morphology assessment.  Details are 
provided in Section 7.3.3.
d. Samples to be collected before dose administration (within 72 hours for initial dose and within 
24 hours for subsequent doses).
e. Time point details for RO studies (US-only sub-study) are provided in Table 7-11 and Table 7-12.  
Note that the ±3 day visit window does not apply to specimen collection for RO assessments.
f. Vital signs prior to infusion and within 30 minutes after the end of each infusion.  Weight at 
screening and Day 1 of each cycle.  Details are provided in Section 7.3.5.
g. Full PE at screening, symptom-directed PE thereafter.  For Cycles 4 and beyond, PEs may be done 
only on Day 1 of each cycle, at the discretion of the Investigator.
h. Magrolimab/azacitidine dosing for re-priming/re-escalation is shown in Table 6-1.
i. For patients on combination therapy, dosing with azacitidine should follow azacitidine 75 mg/m2 SC 
or IVa on Days 1 to 7.


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Table 7-15.
Re-priming/Re-escalation Assessments:  RBC Transfusion-
dependent Low-risk MDS Cohort
Visit Window
Assessment
None
± 3 Daysa
Cycle Day (Cycle: 28 Days)
1
2
3
4
5
8
15
22
CBC with differential, 
platelets, reticulocytesb,c
X
X
X
X
Peripheral blood smearb,d
X
X
X
X
Serum or plasma 
chemistryb
X
X
X
X
Serum uric acid, 
phosphorusb
X
X
X
Haptoglobin, D-dimer, 
thrombin, fibrinogenb
X
X
X
PT/INR, aPTTb
X
Anti-drug antibodiese
X
CD47 RO bloodf
X
X
X
ECOGb
X
X
Vital signsg
X
X
X
X
Physical examinationb,h
X
X
X
Adverse events
Concomitant medications
Magrolimab premedication
X
X
Magrolimab:  
Re-priming/re-escalationi
X
X
X
X
Azacitidinei
X
X
X
X
X
Abbreviations:  aPTT = activated partial thromboplastin time; CBC = complete blood count; 
ECOG = Eastern Cooperative Oncology Group; MDS = myelodysplastic syndrome; PE = physical 
examination; PT/INR = prothrombin time/international normalized ratio; RBC = red blood cell; 
Rh = Rhesus factor; RO = receptor occupancy; US = United States; WBC = white blood cell.
a. Note that ± 3-day visit window does not apply to specimen collection for RO assessments.
b. Pretreatment assessments for the initial dose (Cycle 1 Day 1) may be collected up to 72 hours 
before study drug administration; thereafter, pretreatment assessments are to be collected within 
24 hours prior to study drug administration.
c. Samples for CBC must be collected at least once per cycle.  However, CBC sample collection to 
ensure a WBC level < 20 × 103/mcL may be deferred, based on Investigator assessment of the 
patient’s WBC kinetics.  Additional samples for CBC may be collected outside of the protocol-
specified time points to ensure a WBC level < 20 × 103/mcL.
d. Peripheral smears will be collected prior to selected study drug infusions/injections and assessed for 
the presence of hemagglutination in addition to standard cell morphology assessment.  Details are 
provided in Section 7.3.3.
e. Samples to be collected before dose administration (within 72 hours for initial dose and within 
24 hours for subsequent doses).
f. Time point details for RO studies (US-only sub-study) are provided in Table 7-13.
g. Vital signs prior to infusion and within 30 minutes after the end of each infusion.  Weight at 
screening and Day 1 of each cycle.  Details are provided in Section 7.3.5.
h. Full PE at screening, symptom-directed PE thereafter.  For Cycles 4 and beyond, PEs may be done 
only on Day 1 of each cycle, at the discretion of the Investigator.
i. Magrolimab/azacitidine dosing for re-priming/re-escalation is shown in Table 6-1.


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7.2.
Assessments by Study Period
7.2.1.
Screening Assessments
The following procedures are to be completed during the screening period for the R/R 
Cohorts and the TN/U Cohorts:
R/R Cohorts, TN/U Cohorts, and RBC Transfusion-dependent Low-risk Cohort:

Confirmation that the ICF has been signed and consent process has been 
documented.

Confirmation that all inclusion/exclusion criteria have been met.

Demographic data including sex, date of birth, age, race, and ethnicity.

Relevant medical and cancer history through Day 1 (first dose of study treatment) 
with all findings recorded on the Medical History eCRF.

Enrollment cohort assignment

Urine or serum pregnancy test (in WOCBP).

Donor chimerism, for patients with prior allogeneic hematopoietic stem cell 
transplant only (not applicable to the TN/U Cohort or RBC Transfusion-dependent 
Low-risk Cohort)

Local laboratory values, including hematology, serum or plasma chemistry, and 
urinalysis (Table 7-16)

Local laboratory peripheral blood smears (Section 7.3.3).

Local laboratory type and screen (ABO/Rh) and DAT (Section 6.2.2.1 and 
Section 7.3.4).

Physical examination (complete) and ECOG (Appendix C).

Vital signs:  blood pressure, heart rate, respiration, temperature, height and weight.

Single electrocardiogram (ECG).

Bone marrow core biopsy (trephine) and aspirate (within 30 days prior to first dose of 
drug), with conventional cytogenetic testing per institutional standard and for CD47 
RO (US only)/

MRD monitoring assessments (Section 7.12.3).
CCI


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
AEs related to screening procedures or protocol-mandated interventions (e.g., AEs 
related to invasive procedures such as biopsies) and any SAE reporting.  

Documentation of concomitant and prior medications.
For the Rollover Cohort, assessments performed during the previous study 
(SCI-CD47-002) may be used as baseline values for this study as long as they meet the 
criteria for this study with respect to timing.  Ongoing AEs and concomitant medications 
from the previous study will be transferred to the database for this study.  The following 
procedures are to be completed during the screening period for the Rollover Cohort:
Rollover Cohort:

Confirmation that the ICF has been signed and consent process has been 
documented.

Confirmation that all inclusion/exclusion criteria have been met.
Screening assessments will be completed within a 30-day screening period prior to 
enrollment.  Patients may qualify for enrollment at any time during the 30-day screening 
period.  Assessments performed as part of SOC prior to ICF signature may be used if 
they are within the required screening period.
7.3.
Description of Study Procedures
Study procedure timing is provided in Section 7.1, Schedule of Assessments tables.
7.3.1.
Pregnancy Test
Pregnancy tests are required only for female patients of childbearing potential.  Note 
that a woman is considered to be of childbearing potential (WOCBP), i.e., fertile, 
following the initiation of puberty (Tanner stage 2) until becoming postmenopausal 
unless permanently sterile or has medically documented ovarian failure.  Permanent 
sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral 
oophorectomy.  Women are considered to be in a postmenopausal state when they are 
at least 54 years of age with cessation of previously occurring menses for at least 
12 months without an alternative medical cause.  A high follicle stimulating hormone 
(FSH) level in the postmenopausal range may be used to confirm a post-menopausal 
state in women not using hormonal contraception or hormonal replacement therapy.  


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However, in the absence of 12 months of amenorrhea, a single FSH measurement is 
insufficient.  A urine or serum pregnancy test is required at Screening (except for the 
Rollover Cohort) and within 72 hours before study drug administration on Day 1.  The 
Day 1 pregnancy test does not need to be repeated if the Screening pregnancy test was 
performed within the 72 hours before study drug administration.  Pregnancy tests will be 
performed on Day 1 of each cycle.
7.3.2.
Complete Blood Counts
Samples for CBCs should be collected per the Schedule of Assessments in Section 7.1, 
and must be collected at least once per cycle.  However, CBC sample collection to 
ensure a WBC level ≤ 20 × 103/mcL may be deferred, based on Investigator 
assessment of the patient’s WBC kinetics.  Additional samples for CBC may be 
collected outside of the protocol-specified time points to ensure a WBC level 
≤ 20 × 103/mcL.
All participants must have a documented hemoglobin ≥ 9 g/dL prior to administering the 
first 2 doses of magrolimab. Participants who do not meet these criteria must be 
transfused and have their hemoglobin rechecked to meet the minimum hemoglobin 
threshold prior to administering each of the first 2 doses of magrolimab.
7.3.3.
Peripheral Blood Smear Assessment
Peripheral smears will be collected prior to selected study drug infusions/injections and 
assessed for the presence of hemagglutination in addition to standard cell morphology 
assessment.  These samples should be collected from the arm contralateral to the arm 
being used for drug infusion/injection, if possible.  Peripheral smears will be evaluated 
according to the guidelines provided in Appendix D.  
7.3.4.
Type and Screen (ABO/Rh) and Direct Antiglobulin Test (DAT)
Magrolimab may interfere with RBC phenotyping due to expected coating of the RBC’s 
membrane. Due to the risk of developing anemia, and because magrolimab may make 
phenotyping difficult, ABO/Rh type, antibody screen, blood phenotyping or genotyping, 
and DAT need to be performed at screening before exposure to magrolimab, as 
described in Section 6.2.2.1. 


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Red blood cell phenotyping/genotyping, ABO type, and DAT need not be repeated if 
results dated before screening are available. Antibody screen need not be repeated if 
results dated before screening are available, unless the patient was transfused since 
that time. 
7.3.5.
Vital Signs
Vital signs should include heart rate, respiratory rate, blood pressure, temperature, and 
weight.  Height should be recorded during screening only (except for Rollover Cohort).  
Weight should be recorded during screening (except for Rollover Cohort) and on Day 1 
of each cycle.  Vital signs are to be recorded prior to magrolimab infusion and within 
30 minutes of the end of the magrolimab infusion.  On visits that include infusions of 
both study drugs, vital signs are to be recorded prior to infusion/injection and within 
30 minutes of the end of infusion/injection of each study drug (magrolimab and 
azacitidine).
7.3.6.
Physical Examination
Complete physical examination should be performed at screening (except for Rollover 
Cohort).  Thereafter, symptom-directed physical examinations are acceptable and may 
also include routine examination of the skin (including fingers, toes, and ears) and CNS.  
For Cycles 4 and beyond, physical examinations may be done only on Day 1 of each 
cycle, at the discretion of the Investigator.
7.3.7.
Electrocardiographs
One ECG will be performed at screening for all patients (except for Rollover Cohort).  
For the R/R Safety Cohort, R/R Expansion Cohort, TN/U Dose Evaluation Cohort, and 
RBC Transfusion-dependent Low-risk MDS Cohort, single pre-dose ECG will be 
performed within 2 hours prior to dosing with either study drug (magrolimab or 
azacitidine) and within 30 minutes of the end of magrolimab infusion.
7.3.8.
Bone Marrow Assessments
Bone marrow assessments are required for response assessments (refer to 
Section 7.9, Section 10, and Appendix B), including conventional cytogenetic analysis 
per institutional standards.  In addition, bone marrow specimens may be used for 


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correlative studies, CD47 RO (for US patients only), MRD monitoring, 
 
, and biobanking.  MRD testing will be performed by a central laboratory.  
Details for preparation and distribution of aspirate and biopsy/trephine specimens to the 
testing laboratories will be provided in the Laboratory Manual for this study.  
Bone marrow assessments include collection of both aspirate and core biopsy 
(trephine) specimens at each time point, according to the Schedule of Assessments in 
Section 7.1.  For the R/R Safety the first bone marrow response assessment will occur 
at Cycle 2 Day 1 (± 3 days), followed by a second bone marrow assessment on Cycle 3 
Day 1 (± 3 days).  For the R/R Expansion Cohort, TN/U Dose Evaluation and Expansion 
Cohorts, and the Rollover Cohort, the first bone marrow assessment will occur at Cycle 
3 Day 1 (± 3 days), approximately 8 weeks after the start of study treatment.  
Subsequent bone marrow assessments while on study treatment will occur for the R/R 
and TN/U cohorts every other cycle through Cycle 7 (i.e., Cycle 5 Day 1 and Cycle 7 
Day 1), and then every 3 cycles thereafter (i.e., Cycle 10 Day 1, Cycle 13 Day 1, etc.).  
For the RBC Transfusion-dependent Low-risk Cohort, the first bone marrow assessment 
will occur at Cycle 3 Day 1 (± 3 days), approximately 8 weeks after the start of study 
treatment.  Subsequent bone marrow assessments while on study treatment will occur 
for the RBC Transfusion-dependent Low-risk Cohort every other cycle through Cycle 7 
(i.e., Cycle 5 Day 1 and Cycle 7 Day 1).  After Cycle 7 Day 1, bone marrow biopsies will 
be collected every 4 cycles through Cycle 19 (i.e., Cycle 11 Day 1, Cycle 15 Day 1, and 
Cycle 19 Day 1) and then starting Cycle 23 and onward, bone marrow biopsies will be 
collected every 6 cycles (Cycle 23 Day 1, Cycle 29 Day 1, etc.).  An additional bone 
marrow assessment is required in the event of prolonged myelosuppression lasting 
longer than 42 days from the start of study treatment, as described in Section 3.3.5, 
Definition of DLT.
In addition to these response assessments, for the R/R Safety Cohort at US sites, a 
Day 15 bone marrow aspirate and biopsy will be required prior to magrolimab infusion to 
evaluate CD47 RO and other correlative studies that will aid in magrolimab dose 
optimization.  This bone marrow procedure time point may not be performed for patient 
safety issues as determined by the Investigator.  The Day 15 bone marrow must be 
CCI-
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collected prior to study drug infusion; if sites do not have the capability to do a bone 
marrow biopsy and study drug infusion on the same day, the bone marrow may be done 
on the day prior to infusion (i.e., Day 15 infusion could be done on Day 16 within the 
allowed dosing windows).  The CTSC removed this Day 15 assessment during the R/R 
Expansion Cohort based on emerging data.  As of Amendment 3, no Cycle 1 Day 15 
bone marrow will be collected in any cohort.
Bone marrow biopsies for response assessments may be adjusted by ± 4 weeks to 
coordinate with treatment cycle timing.  After Cycle 3, the window is ± 14 days.
For visits that include both bone marrow assessments and RO assessments, the RO 
blood specimen should be collected on the same day as the RO bone marrow specimen 
is collected.  
If the patient discontinues treatment without documented progressive disease, a bone 
marrow assessment should be done at the Safety Follow-up visit if one has not been 
done within the prior 4 weeks.  Bone marrow response assessments should continue 
during long-term follow-up approximately every 8 weeks until progressive disease is 
documented or the patient starts a new anti-cancer therapy.  
7.3.9.
Adverse Events
At each visit all AEs observed by the Investigator or reported by the patient that occur 
after the first dose of study drug through 30 days after the last dose of study drug, are to 
be reported using the applicable eCRF (Section 9).  AEs that occur prior to assignment 
of study treatment that are assessed as related to a protocol-mandated intervention 
(e.g., invasive procedures such as biopsies) must also be reported.
Following 30 days after the last dose of investigational product, Investigators should 
report any SAEs that are felt to be related to study treatment (magrolimab and/or 
azacitidine).


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7.3.10.
Concomitant Medication Monitoring
All concomitant medications taken by a patient while on study are to be documented.  
Changes in baseline concomitant medication information is to be collected after consent 
through the end of 30-day Safety Follow-up Period.  Concomitant medication associated 
with procedure-related AEs will be captured from the time of informed consent on.  
Information to be collected includes therapy name, indication, dose, unit, frequency, 
route, start date, and stop date, and are to be reported using the applicable eCRF.
7.4.
End-of-treatment Visit
The end-of-treatment (EOT) visit is to be completed after last dose or within 7 days of 
the decision to end treatment with magrolimab for all cohorts.

PK sample collection

Anti-drug antibodies 

CD47 RO (US only)

Correlative studies 

Response assessment (Section 7.9), unless performed within the last 7 days or 
progressive disease has been documented

Adverse events

Concomitant medications
7.5.
Safety Follow-up Visit
Safety Follow-up visit to be completed within 30 days (± 7 days) after the last dose of 
study drug. 

Serum or urine pregnancy test (in WOCBP)


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
Local laboratory
o
CBC (with differential, platelets, reticulocytes)
o
Peripheral blood smear
o
Serum or plasma chemistry
o
Haptoglobin, D-Dimer, thrombin time and plasma fibrinogen
o
Prothrombin time/ international normalized ratio (PT/INR), activated partial 
thromboplastin time (aPTT)

PK sample collection

Anti-drug antibodies

CD47 RO (US only)

ECOG performance status (Appendix C)

Vital signs
o
blood pressure
o
heart rate
o
respiration
o
temperature
o
weight 

Physical examination (symptom-directed)

Bone marrow biopsy for response assessment (including cytogenetics) if patient 
discontinued treatment without documented disease progression and biopsy was not 
performed within the last 4 weeks (Section 7.3.8 and Section 7.9).  For patients who 
come off study treatment to receive a bone marrow transplant, follow-up for disease 
progression and collection of SOC bone marrow biopsy/aspirate results will continue 
until documented disease progression occurs.

Response assessment (± 7 days) (Section 7.9)

Adverse events (Report all AEs through the Safety Follow-up Visit, and any 
treatment-related SAEs thereafter.)

Concomitant medications


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7.6.
Long-term Follow-up for Disease Progression
Patient will be followed until disease progression or until they begin a new anti-cancer 
therapy, whichever happens first.

Correlative studies (at time of disease progression)

Bone marrow biopsy for response assessment (Section 7.3.8 and Section 7.9)

Response Assessment (± 14 days), every 8 weeks (Section 7.9)
Following the Safety Follow-up Visit, patients with ongoing SAEs and study drug-related 
AEs will be followed for safety.  If any SAEs or study drug-related AEs are ongoing after 
the Safety Follow-up Visit, follow-up with the patient will occur at least Q4W until 
resolution to baseline or stabilization of these events, unless the patient starts another 
anti-cancer treatment.  Follow-up will stop when a patient begins another anti-cancer 
treatment.  For patients who come off study treatment to receive a bone marrow 
transplant, follow-up for disease progression and collection of SOC bone marrow 
biopsy/aspirate results will continue until documented disease progression occurs.
The long-term care of the patient will remain the responsibility of his/her primary treating 
physician.
7.7.
Survival Follow-up
All patients who permanently discontinue all study treatment will be contacted during a 
clinic visit or by telephone to assess survival, and the commencement of new 
anti-cancer therapy following the last administration of study drug (if not documented 
previously).  Patients will be contacted every 2 months (± 1 month) from the date of the 
Safety Follow-up Visit, until 3 years from the date that the last patient is enrolled in the 
study, unless there is full withdrawal of consent.  The patient’s primary physician or 
family may be contacted by the Investigator in order to obtain survival information in 
case the patient cannot be reached.  For any patient who dies during this period, the 
cause of death must be reported to the Sponsor.


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7.8.
Safety Assessments
Analytes to be assessed by the local laboratory or specialty laboratories are presented 
in Table 7-16.
Table 7-16.
Laboratory Analyte Listing
Chemistry 
(Serum or Plasma)
Hematology
Urinalysis
Other Laboratory 
Measurements
Sodium
Potassium
Chloride
Bicarbonate
Total protein
Albumin
Calcium
Magnesium
Phosphorus c
Glucose
BUN or urea
Creatinine
Uric acid c
Total bilirubin
Direct bilirubin
Indirect bilirubin
Alkaline phosphatase
LDH
AST (SGOT)
ALT (SGPT)
Alkaline phosphatase
RBC
Hemoglobin
Hematocrit
Platelets
WBC Differential

Neutrophils

Eosinophils

Basophils

Lymphocytes

Monocytes
Reticulocytes
Haptoglobin c
D-dimer c
PT, aPTT, and INR c
Thrombin c
Plasma fibrinogen c
Peripheral blood smear
RBC
Glucose
Protein 
Urine pH 
Ketones 
Bilirubin 
Urine specific gravity 
Pregnancy
Correlative studies a
Pharmacokinetics a
CD47 receptor 
occupancy a,b
Anti-drug antibodies a
Type and screen 
(ABO/Rh), DAT
Phenotyping/genotyping 
(genotyping required for 
patients who were 
transfused in the 
previous 3 months)
Donor chimerism 
(for patients with prior 
allogeneic hematopoietic 
stem cell transplant)
Cytogenetics
Minimal residual disease 
(MRD)a
Abbreviations:  ABO = any of the four blood groups A, B, AB, and O comprising the ABO system; 
ALT = alanine aminotransferase; aPTT = activated partial thromboplastin time; AST = aspartate 
aminotransferase; BUN = blood urea nitrogen; DAT = direct antiglobulin test;  INR = international 
normalized ratio; LDH = lactate dehydrogenase; PT = prothrombin time; RBC = red blood cell; 
Rh = Rhesus factor; SGOT = serum glutamic oxaloacetic transaminase; SGPT = serum glutamic 
pyruvic transaminase; WBC = white blood cells; US = United States.
a. These assays may be performed at a specialty laboratory.
b. CD47 receptor occupancy is a US-only sub-study.
c. Refer to Section 7.1 Schedule of Assessments tables for collection time points.


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7.9.
Efficacy Assessments
Clinical response will be assessed using the guidelines in Appendix B, which are based 
primarily on 2017 ELN recommendations (Döhner 2017) and IWG criteria (Cheson 2003 
and Cheson 2006), as described in Section 10.
Response assessments will be done in conjunction with bone marrow assessments, 
according to the Schedule of Assessments in Section 7.1.  Accompanying laboratory 
results ± 2 weeks from the protocol-specified bone marrow efficacy assessment can be 
used to support an efficacy assessment of CR for both AML and MDS.  These 
supporting lab results will be entered into the clinical database to capture response.  
Response assessments are scheduled on Day 1 of every other treatment through 
Cycle 7 and then every third cycle during study treatment for all cohorts, with an 
additional response assessment on Day 1 of Cycle 2 for the R/R Cohorts only.  
If a patient achieves a CR (including morphologic CR, CRMRD-, cCR, and mCR), 
subsequent bone marrow biopsies are still required to be performed as per the 
Schedule of Assessments (Section 7.1).  
Response assessment will be obtained at the EOT visit (within 7 days of the decision to 
end treatment), unless a prior response assessment has been performed within the last 
7 days or progressive disease has been documented.  If the patient discontinues 
treatment without documented progressive disease, a response assessment should be 
done at the Safety Follow-up visit if one has not been done within the prior 4 weeks.  
Response assessments should continue during long-term follow-up approximately every 
8 weeks until progressive disease is documented or the patient starts a new anti-cancer 
therapy.  
7.10. Pharmacokinetics
The PK profile will be evaluated for magrolimab in all patients, and for azacitidine in 
TN/U Cohort patients receiving combination study treatment.  The evaluation of PK for 
magrolimab and azacitidine will be conducted to investigate any potential drug-drug PK 
interactions, which is predicted to be unlikely.  Serum magrolimab and/or azacitidine will 


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be measured by ELISA or other appropriate assays.  At the discretion of the CTSC at 
any point in the study, PK studies may be eliminated or the scheduled time points may 
be changed if the CTSC determines that sufficient data have been generated.
Specimens will be collected for PK analysis at multiple time points during Cycles 1 and 
2, at Day 1 of each subsequent cycle, and at the EOT visit, according to the Schedule of 
Assessments tables in Section 7.1.  Residual samples used for PK and ADA analysis 
may also be used for 
 PK or pharmacodynamics analyses related to 
magrolimab treatment alone as well as combination therapy with azacitidine.  This could 
include using leftover serum for 
 alternative PK assay development and 
analysis.
7.11. Immunogenicity (Anti-drug Antibodies)
Peripheral blood for immunogenicity assessments for ADA against magrolimab will be 
collected as described in the Schedule of Assessments in Section 7.1 in all patients.  
When collected on the day of study drug dosing, the blood sample must be collected at 
the same time as the pre-dose PK specimen.  For patients who have tested positive for 
ADA, the impact of ADA on PK, safety, and biologic activity will be assessed.  
Neutralizing antibodies to magrolimab will also be assessed for patients who test 
positive for ADA.  
7.12. Pharmacodynamics and Biomarker Assessments
7.12.1.
CD47 Receptor Occupancy
Testing for CD47 RO on select target cells enables pharmacodynamic testing of 
magrolimab to inform both safety and efficacy parameters.  First, the degree of 
saturation of CD47 receptors on RBCs serves as a pharmacodynamic assessment for 
degree of anemia.  Second, CD47 RO on WBCs and circulating or bone 
marrow-resident leukemia cells provides information on the level of CD47 saturation of 
the internal CD47 tissue sink and drug exposures on leukemia cells, respectively.
Samples for CD47 RO studies in the peripheral blood will be collected at US sites only, 
according to the Schedule of Assessments presented in Section 7.1.  Bone marrow 
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aspirate samples will be collected at all bone marrow biopsy time points to assess CD47 
RO in the bone marrow (US only), additional correlative study assessments, and 
biobanking.  At the discretion of the CTSC at any point in the study, CD47 RO testing 
may be eliminated or the scheduled time points may be changed if the CTSC 
determines that sufficient data have been generated.
7.12.2.
Correlative Blood Samples
Correlative studies will be performed on peripheral blood samples to determine the 
biologic activity of magrolimab alone or magrolimab in combination with azacitidine in 
AML.  These studies may include, but are not limited to, investigations of plasma 
cytokine levels, characterization of circulating T-cells, and other studies.  Samples for 
correlative studies in the peripheral blood will be collected according to the Schedule of 
Assessments presented in Section 7.1.  At the discretion of the CTSC at any point in the 
study, correlative studies may be eliminated or the scheduled time points may be 
changed if the CTSC determines that sufficient data have been generated.
7.12.2.1.
Measurement of Plasma Cytokines
Cytokine release by immune cells is one surrogate measure of immune cell activation 
(including T-cells and macrophages).  Since magrolimab activates both macrophages 
and T-cells, it is hypothesized that a specific cytokine profile relating to immune cell 
activation will correlate with clinical response to therapy.  The platform allows for a 
high-throughput analysis of a multitude of cytokines and chemokines with high 
sensitivity (Swartzman 1999).  This predefined multiplex panel of human cytokines will 
be measured from a small thawed vial of plasma, detecting and quantifying the soluble 
proteins and peptides which help control cellular function.  The observed systemic 
biochemical changes in the blood may provide a further correlate with tumor 
progression and therapeutic response and help provide a much broader understanding 
of disease.  A specific focus on cytokines involved in macrophage, dendritic cell, and 
T-cell activation/repression will be explored given the nonclinical mechanism for 
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7.12.2.2. 
Characterization of Circulating T-Cells 
In nonclinical studies, macrophage-mediated phagocytosis of tumor cells by an 
anti-CD47 antibody leads to cross-presentation of antigens and subsequent T-cell 
activation (Tseng 2013). It is therefore predicted that magrolimab administration may 
lead to T-cell activation in patients. Peripheral blood samples will be collected and 
T-cell activation/repression markers/studies may be performed on CyTOF, in vitro T-cell 
activation assays, and T-cell receptor sequencing. 
7.12.3. 
Minimal Residual Disease Monitoring 
MRD monitoring has become a powerful prognostic factor that is beginning to play a 
central role in the treatment of AML patients both in the pre- and post-transplant setting. 
In multiple large studies of newly diagnosed AML patients, MRD positivity post-therapy 
was an independent poor prognostic factor and predictor of relapse (Buccisano 2012; 
Freeman 2013; Sievers 2003). In addition, MRD positivity also appears to be a poor 
prognostic factor in the post-transplant setting. In a retrospective study, patients with 
morphologic remission undergoing allogeneic HSCT, the presence of MRD prior to 
transplant was an independent predictor of relapse as 67% of patients with MRD-
positive remission relapsed within 3 years post-transplant as compared to 22% in 
MRD-negative remission (Araki 2016). Several methods for MRD monitoring have been 
utilized in AML including 1) multi parameter flow cytometry for detection of aberrant 
hematopoietic surface antigens; 2) molecular monitoring of leukemia-specific mutational 
burden; 3) cytogenetic monitoring of leukemia-associated chromosomal abnormalities. 
MRD assessments will be performed on bone marrow aspirate specimens collected at 
time points as specified in the Schedule of Assessments in Section 7.1 . Multiparameter 
flow cytometry will be utilized as the main method of MRD analysis, and when available, 
may be compared to molecular or cytogenetic approaches to MRD monitoring. MRD 
testing by flow cytometry will be performed by a central laboratory, Hematologies, Inc., 
and incorporated for response assessments, where appropriate. This MRD assay is 
based on a "difference from normal" technique, which is based on correlating the 
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quantitative expression of multiple cell surface antigens (gene products) in the 
specimens using standardized antibody panels.  This approach identifies all the normal 
regenerating cells within the specimen first, subtracts them away, and then detects 
clusters of abnormal cells within the remaining data set.  Using this technique, it is 
possible to define the precise composition of the specimen, identifying cells of all 
lineages and maturational stages as well as assessing specimen quality in addition to 
detecting and quantifying any abnormal cell population.  The lower limit of detection is 
0.02% and is performed in a College of American Pathologists/Clinical Laboratory 
Improvement Amendments licensed clinical laboratory. 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
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8. STUDY DISCONTINUATION
8.1.
Discontinuation of Study Drug Treatment
Patients (or a legally acceptable representative) may decline to continue receiving study 
drug at any time during the study, but will continue follow-up study visits unless they 
withdraw completely from the study (Section 8.2).  The patient’s health and welfare is 
the primary consideration in any determination to discontinue study drug treatment.  
Patients who discontinue study drug during the treatment period are to return for an 
EOT visit for evaluation of safety within 7 days of the decision to end magrolimab 
treatment if no evaluation was done within 7 days of the decision.  In addition, patients 
are to return for a Safety Follow-up Visit 30 days (± 7 days) after their last dose of study 
drug.  All patients who discontinue study drug treatment will participate in long-term 
follow-up for disease response until documented disease progression or initiation of 
new anti-cancer therapy, unless the patient withdraws consent for such follow-up and 
withdraws completely from the study (Section 8.2).  For patients who come off study 
treatment to receive a bone marrow transplant, follow-up for disease progression and 
collection of SOC bone marrow biopsy/aspirate results will continue until documented 
disease progression occurs.  All patients will be followed for survival until the end of the 
study.  The assessments to be performed at each of the post-treatment visits are listed 
in the Schedule of Assessments, Section 7.1.
Reasons for discontinuation of study drug treatment may include, but are not limited to, 
the following:  

Disease progression with confirmation in subsequent assessment at least 4 weeks 
apart (i.e., disease worsening compared to the previous assessment)

Unacceptable toxicity

Clinically significant change in the patient’s status that precludes further treatment 
(e.g., pregnancy or other AE)

Patient request, with or without a stated reason

Bone marrow transplant

Investigator or treating physician decision in the absence of any of the above.


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Although disease progression is considered a sufficient reason for discontinuing a 
patient from study treatment, given the delayed treatment benefit commonly seen in 
immune therapies, the Investigator is advised to continue to treat the patient until the 
confirmation of disease progression through a subsequent response assessment at 
least 4 weeks apart (i.e., disease worsening compared to the previous assessment), or 
until the Investigator considers the study treatment to be no longer clinically beneficial to 
the patient or the change of disease state renders the patient unacceptable for further 
treatment in the judgement of the Investigator.  The decision to discontinue a patient 
remains the responsibility of the treating Investigator, which will not be delayed or 
refused by the Sponsor.  However, prior to discontinuing a patient, the Investigator may 
contact the Medical Monitor and forward appropriate supporting documents to the 
Medical Monitor for review and discussion.
8.2.
Withdrawal of Patients From Study
Patients have the right to withdraw completely from the study and end study data 
collection at any time and for any reason without prejudice to his or her future medical 
care.  Patients (or a legally acceptable representative) may decline to continue receiving 
study drug and/or other protocol-required therapies or procedures at any time during the 
study, but are encouraged to continue follow-up study visits and study data collection 
per Section 8.1 if possible.  Patient data up to withdrawal of consent will be included in 
the analysis of the study.  The Investigator is to discuss with the patient the appropriate 
procedures for withdrawal from the study.  The Investigator or Sponsor has the right to 
discontinue any patient from study participation.
Reasons for patient withdrawal from study participation may include, but are not limited 
to, the following:

Death

Withdrawal of consent

Lost to follow-up

Study termination


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8.3.
Termination of the Study
Gilead Sciences reserves the right to terminate the study at any time.  Both 
Gilead Sciences and the Investigator reserve the right to terminate the Investigator’s 
participation in the study according to the study contract.  The Investigator is to notify 
the IRB/independent ethics committee (IEC) in writing of the study’s completion or early 
termination and send a copy of the notification to Gilead Sciences.
The study may also be terminated for safety reasons, as described in Section 11.10 
(Interim Safety Review).
9. ASSESSMENT OF SAFETY
9.1.
Safety Parameters and Definitions
Safety assessments will consist of recording all AEs and SAEs; protocol-specified 
hematology and clinical chemistry variables; measurement of protocol-specified vital 
signs; and the results from other protocol-specified tests that are deemed critical to the 
safety evaluation of the study drug.  
Gilead Sciences or its designee is responsible for reporting relevant SAEs to the 
Competent Authority, other applicable regulatory authorities, and participating 
Investigators, in accordance with ICH guidelines, FDA regulations, European Clinical 
Trials Directive, and/or local regulatory requirements.
Gilead Sciences or its designee is responsible for reporting, in writing, all unexpected 
fatal or life-threatening events associated with the use of the study drug to the 
regulatory agencies and competent authorities within 7 calendar days after being 
notified of the event.  Gilead Sciences or its designee will report other relevant SAEs 
associated with the use of the study medication to the regulatory agencies and 
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9.1.1.
Adverse Event
An AE is any unfavorable and unintended sign, symptom, or disease temporally 
associated with the use of an investigational product or other protocol-imposed 
intervention, regardless of attribution.
This includes the following:

AEs not previously observed in the patient that emerge during the protocol-specified 
AE reporting period, including signs or symptoms associated with a patient’s cancer 
that were not present prior to the AE reporting period (Section 9.2.1).

Complications that occur as a result of protocol-mandated interventions 
(e.g., invasive procedures such as biopsies), including AEs that occur prior to 
assignment of study treatment that are related to protocol-mandated interventions.

Preexisting medical conditions, judged by the Investigator to have worsened in 
severity or frequency or changed in character during the protocol-specified AE 
reporting period.
9.1.2.
Serious Adverse Event
An SAE is any AE that is any of the following:

Fatal (i.e., the AE actually causes or leads to death)

Life threatening (i.e., the AE, in the view of the Investigator, places the patient at 
immediate risk of death at the time of the event; it does not refer to an event which 
might hypothetically have caused death if more severe) 

Requires or prolongs inpatient hospitalization

Results in persistent or significant disability/incapacity (i.e., the AE results in 
substantial disruption of the patient’s ability to conduct normal life functions)

A congenital anomaly/birth defect in a neonate/infant born to a mother exposed to 
the investigational product(s)

Considered a significant medical event by the Investigator (i.e., may jeopardize the 
patient or may require medical/surgical intervention to prevent one of the outcomes 
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All AEs that do not meet any of the criteria for serious should be regarded as 
non-serious AEs.
The terms “severe” and “serious” are not synonymous.  Severity refers to the intensity of 
an AE (as in mild, moderate, or severe pain); the event itself may be of relatively minor 
medical significance (such as severe headache).  “Serious” is a regulatory definition and 
is based on patient or event outcome or action criteria usually associated with events 
that pose a threat to a patient’s life or vital functions.  Seriousness (not severity) serves 
as the guide for defining regulatory reporting obligations.
Severity and seriousness should be independently assessed when recording AEs and 
SAEs on the eCRF.
9.2.
Methods and Timing for Capturing and Assessing Safety Parameters
The Investigator is responsible for ensuring that all AEs and SAEs are recorded on the 
eCRF and that SAEs are recorded on the SAE report form and reported to the Sponsor 
in accordance with protocol instructions.  SAEs must be reported to the Sponsor or 
designee within 24 hours of the Investigator becoming aware of the event.
9.2.1.
Adverse Event Reporting Period
After signing of informed consent, but prior to initiation of study medications, all events 
deemed by the Investigator as caused by a protocol-mandated intervention (e.g., 
invasive procedures such as biopsies) will be collected as AEs (or SAEs if any of the 
serious criteria apply).
After initiation of the study treatment, all AEs and SAEs regardless of attribution will be 
collected until 30 days following the last administration of study treatment or the Safety 
Follow-up Visit, whichever occurs later, or the patient begins an alternate anti-cancer 
therapy.  After this period, Investigators are to report only SAEs that they assess to be 
related to study treatment (magrolimab and/or azacitidine received as part of this study).
Refer to Section 9.6 for post-treatment AE reporting.


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9.2.2.
Eliciting Adverse Events
A consistent methodology of non-directive questioning for eliciting AEs at all patient 
evaluation time points should be adopted.  Examples of non-directive questions include:
“How have you felt since your last clinic visit?”
“Have you had any new or changed health problems since you were last here?”
9.2.3.
Assessment of Severity and Causality of Adverse Events
Investigators will seek information on AEs and SAEs at each patient contact.  All AEs 
and SAEs, whether reported by the patient or noted by authorized study personnel, will 
be recorded in the patient’s medical record and on the Adverse Event eCRF and on the 
SAE report form, if applicable.
For each AE and SAE, the Investigator will make an assessment of seriousness 
(Section 9.1.2), severity (Table 9-1), and causality.  For each AE and SAE, causal 
relationship to magrolimab and to azacitidine will be assessed, as applicable.  Table 9-2 
provides guidance for assessing the causal relationship to the study drug(s).
The AE grading (severity) scale NCI CTCAE v4.03 (Appendix A) will be used for AE 
reporting as shown in Table 9-1.  A customized severity grading for hemagglutination 
and microangiopathy AEs is described in Section 6.2.2.1.  Regardless of severity, some 
events may also meet regulatory serious criteria (Section 9.1.2).


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Table 9-1.
Adverse Event Grade (Severity) Scale
Grade
Severity
Alternate Description a
1
Mild (apply event-specific 
NCI CTCAE grading criteria)
Mild; asymptomatic or mild symptoms; clinical or 
diagnostic observations only; intervention not 
indicated.
2
Moderate (apply event-specific 
NCI CTCAE grading criteria)
Moderate; minimal, local or noninvasive 
intervention indicated; limiting age-appropriate 
instrumental ADL.
3
Severe (apply event-specific 
NCI CTCAE grading criteria)
Severe or medically significant but not immediately 
life-threatening; hospitalization or prolongation of 
hospitalization indicated; disabling; limiting self-care 
ADL.
4
Very severe, life threatening, 
or disabling (apply event-specific
NCI CTCAE grading criteria)
Life-threatening consequences; urgent intervention 
indicated.
5
Death related to adverse event
Death related to adverse event.
Source:  National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), 
Version 4.03 (Appendix A).
Abbreviation:  ADL = activities of daily life.
a. Use the alternative descriptions for Grade 1, 2, 3, and 4 events when the observed or reported AE 
does not appear in the NCI CTCAE listing.
To ensure consistency of causality assessments for either study drug, Investigators 
should apply the following general guidelines:
Table 9-2.
Causal Attribution Guidance
Is the AE/SAE suspected to be caused by the investigational product based on facts, 
evidence, science-based rationales, and clinical judgment?
YES
The temporal relationship of the AE/SAE to investigational product administration 
makes a causal relationship possible, AND other drugs, therapeutic interventions or 
underlying conditions do not provide sufficient explanation for the AE/SAE.
NO
The temporal relationship of the AE/SAE to investigational product administration 
makes a causal relationship unlikely, OR other drugs, therapeutic interventions or 
underlying conditions provide a sufficient explanation for the AE/SAE.
Abbreviations:  AE = adverse event; SAE = serious adverse event.
Note:
The Investigator’s assessment of causality for individual AE reports is part of the study 
documentation process.  Regardless of the “Yes” or “No” causality assessment for individual AE 
reports, Gilead Sciences or its designee, will promptly evaluate all reported SAEs against cumulative 
product experience to identify and expeditiously communicate possible new safety findings to 
Investigators and applicable regulatory authorities.


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9.3.
Procedures for Recording Adverse Events
9.3.1.
Recording Adverse Events on the eCRF
Investigators should use correct medical terminology/concepts when recording AEs and 
SAEs.  Avoid colloquialisms and abbreviations.
A separate log line in the Adverse Event eCRF should be used for each medical 
concept that needs to be recorded.  Causal relationship of AEs and SAEs attributed to 
each treatment (magrolimab, azacitidine) should be recorded individually.
9.3.1.1.
Diagnosis Versus Signs and Symptoms
If known, a diagnosis should be recorded on the eCRF rather than individual signs and 
symptoms (e.g., record only liver failure or hepatitis rather than jaundice, asterixis, and 
elevated transaminases).  However, if a constellation of signs and/or symptoms cannot 
be medically characterized as a single diagnosis or syndrome at the time of reporting, 
each individual event should be recorded as an AE on a separate eCRF.  If a diagnosis 
is subsequently established, it should be reported to Gilead Sciences by subsuming the 
symptoms under the reported diagnosis according to the CRF Completion Guidelines.
9.3.1.2.
Adverse Events Occurring Secondary to Other Events
In general, AEs occurring secondary to other events (e.g., cascade events or clinical 
sequelae) should be identified by their primary cause.  For example, if severe diarrhea 
is known to have resulted in dehydration, it is sufficient to record only diarrhea as an AE 
on the eCRF.  However, medically significant AEs occurring secondary to an initiating 
event that are separated in time should be recorded as independent events on the 
eCRF.  For example, if a severe gastrointestinal hemorrhage leads to renal failure, both 
events should be recorded separately on the eCRF.
9.3.1.3.
Persistent or Recurrent Adverse Events
A persistent AE is one that extends continuously, without resolution between patient 
evaluation time points.  Such events should only be recorded once in the eCRF unless 
their severity changes.  If a persistent AE increases or decreases in severity, it should 
be recorded again on the Adverse Event eCRF with each change in CTCAE grade.


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A recurrent AE is one that occurs and resolves between patient evaluation time points 
and subsequently recurs.  All recurrent AEs should be recorded on Adverse Event 
eCRF each time they occur.
9.3.1.4.
Abnormal Laboratory Values
Only clinically significant laboratory abnormalities that require active management will 
be recorded as AEs on the eCRF (e.g., abnormalities that require study drug dose 
modification, discontinuation of study treatment, more frequent follow-up assessments, 
further diagnostic investigation, etc.).
If the clinically significant laboratory abnormality is a sign of a disease or syndrome 
(e.g., alkaline phosphatase and bilirubin 5 × ULN associated with cholecystitis), only the 
diagnosis (e.g., cholecystitis) needs to be recorded on the Adverse Event eCRF.
If the clinically significant laboratory abnormality is not a sign of a disease or syndrome, 
the abnormality itself should be recorded as an AE on the eCRF.  If the laboratory 
abnormality can be characterized by a precise clinical term, the clinical term should be 
recorded as the AE.  For example, an elevated serum potassium level of 7.0 mEq/L 
should be recorded as “hyperkalemia.”
Observations of the same clinically significant laboratory abnormality from visit to visit 
should not be repeatedly recorded as AEs or SAEs on the eCRF, unless their severity, 
seriousness, or etiology changes.
9.3.1.5.
Deaths
All deaths that occur during the protocol-specified AE reporting period (Section 9.2.1), 
regardless of attribution, will be recorded on an eCRF and SAE Report Form and 
reported to the Sponsor within 24 hours of awareness and not later than the next 
business day.  This includes death attributed to progression of disease.
If the death is attributed to progression of disease, especially in the absence of other 
signs and symptoms, record “[specific disease type] progression” as the SAE term on 
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When recording a death on an eCRF or SAE Report Form, the event or condition that 
caused or contributed to the fatal outcome should be recorded as the single medical 
concept whenever possible.
9.3.1.6.
Worsening of Disease
Worsening of and/or progression of disease should not routinely be recorded as an AE 
or SAE if it does not result in death.  These data will be captured as efficacy 
assessment data.  However, worsening and/or progression of disease must be recorded 
as an AE/SAE if the investigator assesses the disease progression to be related to 
study treatment.
9.3.1.7.
Hospitalization, Prolonged Hospitalization, or Surgery
Any AE that results in hospitalization or prolonged hospitalization should be 
documented and reported as an SAE unless specifically instructed otherwise in this 
protocol.
There are some hospitalization scenarios that do not require reporting as an SAE when 
there is no occurrence of an AE.  These scenarios include a planned hospitalization or 
prolonged hospitalization to:

Perform an efficacy measurement for the study

Undergo a diagnostic or elective surgical procedure for a preexisting medical 
condition that has not changed

Receive scheduled therapy for the target disease of the study

Hospitalization for social reason (e.g., respite case, waiting for insurance 
authorization)
9.3.1.7.1.
Other Reportable Information
Certain information, although not considered an SAE, must be recorded, reported, and 
followed up as indicated for an SAE.  This includes the following:


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9.3.1.7.1.1.
Pregnancy
Female patients who become pregnant during the treatment period must be withdrawn 
from study treatment immediately.
Any pregnancy occurring in a patient or a patient’s partner during treatment with either 
study drug or within 6 months of last study drug administration must be reported to the 
Sponsor or designee (Section 9.4) within 24 hours of the site staff becoming aware of it, 
using a Pregnancy Notification Form (provided in the Investigator Trial File).  It is the 
Investigator’s responsibility to obtain consent for follow-up from the patient or the 
patient’s partner.  The Sponsor or designee will follow-up on all pregnancies for the 
pregnancy outcome through the Investigator, using a Pregnancy Outcome Form.  Data 
will be collected about the pregnancy, fetal status, and neonate status.  In the event that 
the neonate has abnormalities at birth, additional data will be collected about those 
abnormalities.  Spontaneous abortion should always be classified as serious (as the 
Sponsor considers this medically significant), recorded on a Serious Adverse Event 
Form (SAE Form), and expeditiously reported to the Sponsor or designee, as described 
in Section 9.4.  Any congenital anomaly/birth defect in a child born to a female patient or 
female partner of a male patient exposed to study drug should be recorded and 
reported as an SAE within 24 hours of awareness of the event.
9.3.1.7.1.2.
Overdose
An overdose is a dose higher than that indicated in the protocol, with or without an AE.
9.3.1.7.1.3.
Abuse or Misuse
Abuse or misuse of a study drug is use for nonclinical reasons, with or without 
experiencing an AE.
9.3.1.7.1.4.
Special Situations
Special situations reports include all reports of medication error, abuse, misuse, 
overdose, occupational exposure, drug interactions, exposure via breastfeeding, 
unexpected benefit, transmission of infectious agents via the product, counterfeit of 
falsified medicine, and pregnancy regardless of an associated AE. 


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Medication error is any unintentional error in the prescribing, dispensing, preparation for 
administration or administration of a study drug while the medication is in the control of 
a health care professional, patient, or consumer.  Medication errors may be classified as 
a medication error without an AE, which includes situations of missed dose, medication 
error with an AE, intercepted medication error, or potential medication error.
Abuse is defined as persistent or sporadic intentional excessive use of a study drug by 
a patient.
Misuse is defined as any intentional and inappropriate use of a study drug that is not in 
accordance with the protocol instructions or the local prescribing information.
An overdose is defined as an accidental or intentional administration of a quantity of a 
study drug given per administration or cumulatively that is above the maximum 
recommended dose as per protocol or in the product labeling (as it applies to the daily 
dose of the patient in question).  In cases of a discrepancy in drug accountability, 
overdose will be established only when it is clear that the patient has taken the excess 
dose(s).  Overdose cannot be established when the patient cannot account for the 
discrepancy, except in cases in which the Investigator has reason to suspect that the 
patient has taken the additional dose(s).
Occupational exposure is defined as exposure to a study drug as a result of one’s 
professional or nonprofessional occupation.
Drug interaction is defined as any drug/drug, drug/food, or drug/device interaction.
Unexpected benefit is defined as an unintended therapeutic effect where the results are 
judged to be desirable and beneficial. 
Transmission of infectious agents is defined as any suspected transmission of an 
infected agent through a Gilead study drug.
Counterfeit or falsified medicine is defined as any study drug with a false representation 
of (a) its identity, (b) its source, or (c) its history.


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Site personnel will record all special situations report (SSR) data on the special 
situations report form and transmit the SSR information by emailing or faxing the report 
form within 24 hours of the Investigator’s knowledge of the event to the attention of 
Gilead Global Patient Safety from study drug initiation throughout the duration of the 
study, including the protocol required post-treatment follow up period.
9.4.
Expedited Reporting Requirements for Serious Adverse Events
Investigators will submit reports of all SAEs, regardless of attribution, within 24 hours of 
awareness according to the instructions provided by the Sponsor.  All SAEs will be 
recorded on the SAE report form and transmitted by emailing or faxing the report form 
within 24 hours of the Investigator’s knowledge of the event to the attention of Gilead 
Global Patient Safety.
Gilead Global Patient Safety: 
Email: Safety_FC@gilead.com
or
Fax: 1-650-522-5477
Safety_FC@gilead.com
Medical Monitor Contact Information for Sites:
Medical Monitor: 
Email:  
 
The Sponsor or designee will report SAEs and/or suspected unexpected serious 
adverse reactions as required to regulatory authorities, Investigators/institutions, and 
central IRBs/IECs in compliance with reporting requirements according to local 
regulations and Good Clinical Practice (GCP) guidelines.  
Depending on relevant local legislation or regulations, including the applicable US FDA 
Code of Federal Regulations (CFR), the European Union Clinical Trials Directive 
(2001/20/EC) and relevant updates, and other country-specific legislation or regulations, 
Gilead may be required to expedite to worldwide regulatory agencies reports of SAEs, 
which may be in the form of line listings, serious adverse drug reactions, or suspected 
PPD
PPD


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unexpected serious adverse reactions.  In accordance with the European Union Clinical 
Trials Directive (2001/20/EC), Gilead or a specified designee will notify worldwide 
regulatory agencies and the relevant IEC in concerned Member States of applicable 
suspected unexpected serious adverse reactions as outlined in current regulations.
The Investigator is to notify the appropriate local IRB/IEC of SAEs occurring at the site 
and other AE reports received from the Sponsor or designee in accordance with local 
procedures and statutes.
For fatal or life-threatening events, copies of hospital case reports, autopsy reports, and 
other documents are also to be transmitted by email or fax when requested and 
applicable. Transmission of such documents should occur without personal patient 
identification, maintaining the traceability of a document to the patient identifiers.
Additional information may be requested to ensure the timely completion of accurate 
safety reports.
Any medications necessary for treatment of the SAE must be recorded onto the 
concomitant medication section of the patient’s eCRF.
9.5.
Type and Duration of Follow-up of Patients after Adverse Events
The Investigator should follow all unresolved SAEs and study-related AEs until the 
events are resolved or stabilized, the events are determined to be irreversible by the 
Investigator, the patient initiates new anti-cancer therapy, or the patient is lost to 
follow-up.  Resolution of AEs and SAEs (with dates) should be documented on the 
Adverse Event eCRF, the SAE report form, and in the patient’s medical record to 
facilitate source data verification (SDV).
The Sponsor or its designee may follow up by telephone, fax, electronic mail, and/or a 
monitoring visit to obtain additional case details deemed necessary to appropriately 
evaluate the SAE report (e.g., hospital discharge summary, consultant report, or 
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9.6.
Post-treatment Adverse Events
For patients who discontinue the study treatment and have completed the 30-day Safety 
Follow-up visit, Investigators are to report any death or other SAE occurring beyond 
30 days following the last administration of study treatment (magrolimab and/or 
azacitidine) that the Investigator assesses as related to study treatment.
Investigators are to report these events as described in Section 9.4.
10.MEASUREMENT OF EFFECT
Assessment of response will be conducted by the Investigator using the criteria in 
Appendix B, which are based primarily on the 2017 ELN recommendations for AML 
(Döhner 2017) and the 2003 IWG criteria (Cheson 2003) for AML patients.  Response 
classifications include:  complete remission (CR) rate, morphologic CR, complete 
remission without minimal residual disease (CRMRD-), cytogenetic complete remission 
(cCR), molecular complete remission (mCR), complete remission with incomplete 
hematologic recovery (CRi), complete remission with partial hematologic recovery 
(CRh), marrow complete remission (CR), morphologic leukemia-free state (MLFS), PR, 
and stable disease (SD).
In addition, hematologic improvement (HI) will be assessed by 2006 IWG criteria 
(Cheson 2006) to compare with disease response assessed by 2017 ELN criteria 
(Döhner 2017) and 2003 IWG criteria (Cheson 2003).
Response will be assessed in MDS patients using the criteria in Appendix B Table 14-4, 
which are based on the 2006 IWG criteria (Cheson 2006) with the added caveat that the 
impact of anemia must be deemed disease-related and not due to study treatment.
Response assessments will be performed at the time points specified in the Schedule of 
Assessments in Section 7.1 and as described in Section 7.9.


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The following summary measures for endpoints will be evaluated:
Objective Response Rate for Patients with AML:  The ORR is the proportion of 
patients who reach CR (including morphologic CR, CRMRD-, cCR, and mCR), CRi, CRh, 
PR, or MLFS while on study. 
CR Rate for Patients with AML:  The CR rate is the proportion of patients who 
achieved CR, as defined by the Investigator based on ELN AML recommendations 
(Döhner 2017; Appendix B).
CR Rate for Patients with MDS:  The CR rate is the proportion of MDS patients who 
reach morphologic CR while on study per IWG 2006 criteria (Cheson 2006).
Duration of Complete Remission (DCR) for AML:  The DCR is measured from the 
time measurement criteria are first met for CR (including morphologic CR, CRMRD-, cCR, 
and mCR) until the first date that recurrent disease or death with evidence of no disease 
recurrence is objectively documented.  Those who are not observed to have recurrent 
disease or die with evidence of no recurrence during the trial active period will be 
censored at their last response assessment date with evidence of no 
progression/recurrence.
Duration of Response (DOR) for Patients with AML:  The duration of response is 
measured from the time measurement criteria are met for CR (including morphologic 
CR, CRMRD-, cCR, and mCR), CRi, CRh, PR, marrow CR, or MLFS, whichever is first 
recorded, until the first date that recurrent or progressive disease, or death with 
evidence of no disease progression is objectively documented.  Those who are not 
observed to have recurrent or progressive disease or die with evidence of no disease 
progression during the trial active period will be censored at their last response 
assessment date with evidence of no progression/recurrence.
Duration of CR for Patients with MDS:  The duration of CR for MDS patients is 
measured from the time measurement criteria are first met for CR until the first date that 
recurrent disease or death with evidence of no disease recurrence is objectively 
documented.  Patients who are not observed to have recurrent disease or die with 


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evidence of no recurrence during the trial active period will be censored at their last 
response assessment date with evidence of no progression/recurrence.
Duration of Response for Patients with MDS:  The DOR for MDS patients is 
measured from the time measurement criteria are first met for objective response 
(including CR, PR, marrow CR, and HI) as assessed by IWG MDS criteria 
(Cheson 2006) until the first date that recurrent disease or death with evidence of no 
disease recurrence is objectively documented.  Those who are not observed to have 
recurrent disease or die with evidence of no recurrence during the trial active period will 
be censored at their last response assessment date with evidence of no 
progression/recurrence.
Overall Survival (OS):  The length of OS is measured from the date of study treatment 
initiation until the date of death from any cause.  Those who are not observed to die 
during the trial active period will be censored at their last known alive date from survival 
follow-up.
Progression-free Survival (PFS):  The length of PFS is defined as the time from the 
date of study treatment initiation until the date of documented disease progression or 
relapse or death from any cause, whichever occurs first (Cheson 2003).  Those who are 
not observed to have one of these events during the time the overall trial remains active 
will be censored at their last known progression-free follow-up date.
Event-free Survival (EFS):  For AML, the length of EFS is defined as the time from the 
date of study treatment initiation until the date of documented disease progression, 
death from any cause, or treatment failure (defined as failure to achieve CR/CRi by 
Cycle 5 Day 1), whichever occurs first (Cheson 2003).  For MDS, EFS is defined as the 
time from the date of study treatment initiation to transformation to AML or death from any 
cause, whichever occurs first.  Those who are not observed to have one of these events 
during the time the overall trial remains active will be censored at their last known 
progression-free follow-up date.


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11.STATISTICAL CONSIDERATIONS
The final analysis will be based on patient data collected through study discontinuation.  
The statistical analyses will be based on all patients who receive at least 1 dose of 
magrolimab.  In general, data will be described and summarized as warranted by the 
sample size, and listings will be used in place of tables when the sample sizes are 
small.  All summaries will be presented by indication (AML or MDS) and cohort (R/R or 
TN/U), and by treatment, when appropriate.
11.1. Safety Analysis
All patients who receive at least 1 dose of magrolimab will be included in the safety 
analysis.
The DLT analysis will be conducted in the TN/U Dose Evaluation Cohort in patients who 
completed either at least 4 infusions of magrolimab or 4 infusions/injections of 
azacitidine and have been followed for the 4-week DLT Assessment Period or have 
experienced a DLT within 4 weeks after initiating study drug treatment.
Safety will be assessed through summaries of deaths, DLTs, AEs, changes in 
laboratory test results, and exposure to magrolimab.
Adverse events leading to treatment discontinuation will be listed.  AEs leading to the 
declaration of DLTs will be listed.
11.2. Efficacy Analysis
All patients who receive at least 1 dose of magrolimab will be included in the efficacy 
analysis except for those endpoints that are applicable only to patients who achieved a 
response.  In addition, an evaluable patient efficacy analysis will also be performed on 
all enrolled patients who receive at least 1 dose of magrolimab and have at least 
1 disease response assessment or who died before the first disease response 
assessment.


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11.3. Pharmacokinetics Analysis
The PK analysis will be conducted on all enrolled patients treated with magrolimab 
(and/or azacitidine if appropriate) whose PK blood samples are collected during the 
study and who have measurable concentrations of magrolimab (and/or azacitidine if 
appropriate).
11.4. Sample Size Determination
The number of patients planned for inclusion in this trial is up to a total of approximately 
287 patients evaluable for efficacy, as follows:  

R/R Safety Cohort:  10 patients

R/R Expansion Cohort:  Up to 36 patients

R/R MDS Magrolimab Monotherapy Cohort: 23 patients

TN/U Dose Evaluation Cohort:  Up to 18 patients 

TN/U Expansion Cohort: Up to 172 patients, including

Original 30 TN/U Expansion (enrolled 18 AML and 16 MDS patients, including 
4 replacement patients)

At least 92 MDS patients (including the original 16 MDS patients enrolled in 
the original TN/U Expansion), of whom at least 56 patients will be on Q2W 
dosing.  The overall MDS expansion to 92 patients will be considered the 
MDS Registrational Cohort.

Up to 62 TP53 mutant AML patients (i.e., 12 original TP53 mutation AML 
patients, plus 20 additional TP53 mutant AML patients added per CTSC 
decision in September 2019, plus 30 additional TP53 mutant AML patients 
per CTSC decision July 2020)

RBC Transfusion-dependent Low-risk MDS Cohort:  Up to 20 patients

Rollover Cohort:  Up to 8 patients
For the R/R Safety Cohort, 10 patients have been enrolled as of the approval of 
Amendment 5 for evaluation of safety of magrolimab monotherapy.


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For the R/R Safety Cohort and Expansion Cohort, approximately 46 patients may be 
enrolled, including 10 patients treated in the safety run-in cohort and 36 patients treated 
in the expansion cohort.  For the R/R Safety Cohort, 10 patients were enrolled and this 
cohort was closed to further enrollment as of Amendment 3.  Based on safety and 
efficacy data, the CTSC may decide to expand the R/R Expansion Cohort to include 
additional patients.  An ORR of 17% has been reported in patients with R/R AML who 
have been treated with azacitidine (Itzykson 2015).  For an estimated response rate of 
33% or higher, 36 patients would provide a 95% confidence interval, with the lower 
bound to exclude 18.6%, the azacitidine monotherapy efficacy rate.
Per FDA feedback, a magrolimab monotherapy cohort in R/R MDS will be evaluated to 
further define the activity of magrolimab to the contribution of magrolimab+azacitidine in 
MDS to support a potential single-arm approval of magrolimab+azacitidine in MDS.  
Patients will be enrolled in a Simon’s 2-stage design.  With a 1-sided significance level 
of 0.05 and 80% power, the null hypothesis that the magrolimab monotherapy ORR is 
9% will be tested against the alternative of 30%.  In the first stage, 11 patients will be 
enrolled.  If there are 1 or fewer responses observed in these 11 patients, the cohort will 
be stopped.  Otherwise, 12 additional patients will be accrued, for a total of 23.  This 
cohort was stopped after 11 patients enrolled per CTSC decision in October 2020.  The 
null hypothesis will be rejected if 5 or more responses are observed in 23 patients.
For the TN/U Dose Evaluation Cohort, up to 18 patients can be enrolled based on a 
3+3 dose de-escalation design, assuming 3 potential dose cohorts with a maximum of 
6 patients treated per cohort.  For the TN/U Dose Evaluation Cohort, 8 patients were 
enrolled and this cohort was closed to further enrollment as of Amendment 5.  
For the TN/U Expansion Cohort, a total of up to 172 patients may be enrolled.  An initial 
sample size of 30 patients was proposed so that the 95% confidence interval of the 
desired 35% or higher CR rate would exclude a known CR rate of 17.85% for 
azacitidine alone.  This sample size calculation was based on inclusion of both TN/U 
AML and higher-risk MDS patients.  For the higher-risk, untreated, MDS-only Expansion 
Cohort, an evaluation will occur after 36 patients have reached the first response 


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assessment (Cycle 3 Day 1); however, enrollment will continue and not be paused in 
the interim.  A sample size of 36 patients provides 80% power to reject the null 
hypothesis that the CR rate is 16.5% or lower at 2-sided 0.05 significant level, assuming 
the true magrolimab + azacitidine CR rate is at least 35.5% (19% improvement).  The 
null CR rate of 16.5% is based on the pivotal randomized trial leading to azacitidine 
approval in MDS reanalyzed by IWG 2000 criteria (Silverman 2006), where the upper 
bound of the 1-sided 95% confidence interval for azacitidine CR rate is 16.5%, with a 
point estimate of 10%.  Based on Amendment 6 and FDA feedback for a single-arm trial 
to support a potential BLA, the sample size of the TN/U MDS-only Expansion Cohort for 
untreated, higher-risk MDS patients was further increased to include a cohort of 
56 patients with MDS at a magrolimab Q2W dosing regimen.  A sample size of 
56 patients provides 80% power to reject the null hypothesis that the CR rate is 16.5% 
at a 2-sided 0.05 significant level, assuming the true magrolimab+azacitidine CR rate is 
at least 31.5%.  The null CR rate of 16.5% is based on the same assumption for 
azacitidine monotherapy as above. A combined planned sample size of 92 patients for 
the MDS Registrational Cohort will provide an 80% power to reject the updated null CR 
rate of 23.5% at a 2-sided 0.05 significant level, assuming the true 
magrolimab+azacitidine CR rate is 36.5%.
Per the CTSC decision in September 2019 and Amendment 6, a subcohort of TP53 
mutant TN/U AML patients was added.  Initially, 12 patients and then an additional 
20 patients will be enrolled.  Analysis of these patients will include all TP53 mutant 
patients meeting subcohort eligibility enrolled prior to the Amendment/CTSC decision.  
A sample size of 32 patients was selected to evaluate the initial efficacy of 
magrolimab+azacitidine as compared to available therapies (most notably 
venetoclax+hypomethylating agents) in TP53 mutant AML.  While venetoclax in 
combination with hypomethylating agents (azacitidine or decitabine) is approved in 
newly diagnosed AML patients who are ineligible for intensive chemotherapy, their 
efficacy in TP53 mutant AML patients is limited.  Per a recent report, the CR+CRi rate of 
venetoclax+hypomethylating agent in TP53 mutant AML was 47%, with a median 
duration of CR of 5.6 months and a median overall survival of 7.2 months 
(DiNardo 2019).  In contrast, in all-comer AML patients, the CR+CRi rate was 67% with 


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a median duration of CR of 11.3 months and a median overall survival of 17.5 months.  
Assuming an observed magrolimab+azacitidine ORR of 59% for a sample size of 
32 patients, the 1-sided 90% confidence interval will have a lower bound of 46.5%, 
which excludes a control ORR of 46%.  Based on emerging data, the CTSC may decide 
to enroll additional patients for further safety, efficacy, or dosing information.  Per CTSC 
decision in July 2020 and captured in Amendment 7, an additional 30 TP53 mutant AML 
patients were enrolled for the TN/U Expansion Cohort (n = 62).
For the RBC Transfusion-dependent Low-risk MDS Cohort, approximately 20 patients 
will be enrolled.  Initially, 6 patients will be enrolled with a safety evaluation after all 
6 patients complete at least Cycle 2 Day 15 treatment.  This safety evaluation is being 
conducted given that a 60 mg/kg dose of magrolimab will be administered starting in 
Cycle 2, of which this highest dose has not yet been tested in MDS patients.  However, 
an equivalent dose of 60 mg/kg given in 1 week (30 mg/kg twice weekly) has already 
been administered to MDS and AML patients in this trial and has been well tolerated.  
The CTSC will then evaluate based on the aggregate safety profile in these 6 patients 
and determine whether enrollment should proceed to the remaining 14 patients.  If so, 
these 14 patients can be simultaneously enrolled.  Based on emerging data, the CTSC 
may decide to enroll additional patients for further safety, efficacy, or dosing information.  
These may be enrolled as either magrolimab monotherapy or in combination with 
azacitidine.
For the Rollover Cohort, 1 eligible patient from the Phase 1 study (SCI-CD47-002) is 
now enrolled in this study, and this cohort was closed to further enrollment as of 
Amendment 3.  
11.5. Clinical Trial Steering Committee
The CTSC will oversee the conduct of the clinical trial.  A representative from the 
Sponsor, usually the Study Medical Monitor or designee, will chair the CTSC.  
The CTSC will have representation from each participating site in the study.  The CTSC 
will review safety and efficacy data generated during the trial and make decisions about 
patient recruitment, trial management, initiation of protocol specific amendments, 


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expansion of cohorts, using higher or lower dose levels or different dosing schedules, 
defining any new dose cohorts, and identification of the recommended dose and 
schedule for Phase 2 trials.  The CTSC will meet at a minimum at the completion of 
each dosing cohort during safety run-in and dose evaluation phase of the trial and when 
emergent critical safety data are reported.  The composition, structure, and function of 
the CTSC are defined in the CTSC Charter.
CTSC decisions in this study are included in the following sections of this document:  
Section 3.1 Overall Study Design; Section 3.2 Study Design - R/R Cohort; Section 3.3 
Study Design - TN/U Cohort; Section 3.4 Study Design – RBC Transfusion-dependent 
Low-risk MDS Cohort; Section 3.5 Study Design - Rollover Cohort; Section 3.7 
Estimated Study Duration and End of Study; Section 6.1 Study Drug Administration; 
Section 6.2.1.1 Dose Modification and Delay Guidelines, magrolimab; Section 7.3.8 
Bone Marrow Assessments; Section 7.10 Pharmacokinetics; Section 7.12 
Pharmacodynamic and Biomarker Assessments; and Section 11.8.2 Additional 
Secondary Endpoints.
11.6. Data Monitoring Committee
Data Monitoring Committee functions for this trial will be performed by the CTSC, as 
defined and described in Section 11.5.
11.7. Analysis of the Conduct of the Study
The CTSC, in conjunction with the Sponsor, will be the main body responsible for the 
analysis of the conduct of the study, as outlined in the CTSC Charter.
11.8. Statistical Methods
All analyses will be conducted separately for patients by indication in the R/R Cohorts, 
the TN/U Cohorts, and the Rollover Cohort, unless otherwise mentioned.  Additional 
analyses may be conducted separately for the R/R Safety Cohort alone and TN/U Dose 
Evaluation Cohorts.  Combined safety analyses may be conducted for patients in both 
monotherapy cohorts (the R/R Safety Cohort, R/R MDS Cohort, and Rollover Cohort, 
where applicable), as well across the study on all treated patients.  Statistical analyses 


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will be performed separately for the patients treated with magrolimab in combination 
with azacitidine in the TP53 TN/U AML Cohort and RBC Transfusion-dependent 
Low-risk MDS Cohort, as well as in the untreated higher-risk MDS cohort as a potential 
pivotal single-arm study to support a potential BLA in higher-risk untreated MDS. 
For continuous variables, the mean, standard deviation, median, and ranges will be 
provided.  For categorical variables, the frequency and percentage in each category will 
be provided, along with 95% confidence intervals for primary and secondary efficacy 
endpoints.  For time-to-event variables, the Kaplan-Meier (KM) estimates and 
corresponding 2-sided 95% confidence intervals for the median will be provided, when 
appropriate.  The KM plots may also be provided.  Details regarding the statistical 
analysis to be conducted, including the handling of missing data and patient withdrawal, 
will be provided in the SAP.
11.8.1.
Efficacy Analyses
11.8.1.1.
Primary Efficacy Endpoint:  CR Rate 
The primary efficacy endpoint for both AML and MDS is CR rate as assessed by 
Investigators.  The analysis of CR rate will be conducted on all enrolled patients who 
receive at least 1 dose of the investigational drug magrolimab.  In addition, an evaluable 
patient efficacy analysis will be performed on all enrolled patients who receive at least 
1 dose of magrolimab and have at least 1 disease response assessment or who died 
before the first post-treatment disease response assessment.  The point estimate of the 
CR rate and the corresponding 2-sided 95% confidence interval will be generated. 
For the primary analysis of TN/U higher-risk MDS patients, the percentage of patients 
achieving a CR will be estimated based on all TN/U higher-risk MDS patients who 
received at least 1 dose of magrolimab, with exact 95% CI using the Clopper and 
Pearson method.  Formal hypothesis testing will be performed to test the statistical 
hypothesis of:
H0:  CR rate = 23.5%; vs.
H1:  CR rate ≠ 23.5%.
The Chi-square test will be performed at 2-sided 0.05 significance level.


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11.8.1.2.
Secondary Efficacy Endpoints
Additional parameters of objective response, including CRh, will be evaluated in a 
similar manner as the primary efficacy endpoints.  For the time-to-event endpoints listed 
here, the Kaplan-Meier (KM) estimates and corresponding 95% intervals for the median 
will be provided when appropriate.  The KM plots may also be provided when 
appropriate.  RBC transfusion independence is defined as no transfusions for at least 
an 8-week consecutive period.  The percent of patients who become RBC 
transfusion-independent will be estimated based on the number of patients who 
received at least 1 dose of HuF59-G4 and are RBC transfusion-dependent at baseline.
Duration of Complete Remission (DCR)
The analysis of DCR will be conducted using the Kaplan-Meier method.
Progression-free Survival (PFS) 
The analysis of PFS will be conducted on all treated patients.
Overall Survival (OS)
The analysis of OS will be conducted on all treated patients.
Objective Response Rate (ORR) and Duration of Response (DOR)
Analysis of ORR and DOR will be conducted in the R/R MDS Magrolimab Monotherapy 
Cohort.
11.8.2.
Additional Secondary Endpoints
Pharmacokinetic Analyses
PK analysis will be conducted for magrolimab on the PK analysis set (PAS).  Based on 
the distinct MOAs of magrolimab and azacitidine, overlapping drug PK interactions are 
not expected.  Thus, samples for PK analysis for azacitidine will be banked and will be 
conducted based on CTSC recommendation.


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The PAS consists of all treated patients who have at least 1 blood sample that provides 
evaluable PK data.  The PAS will be used for summaries of PK concentration data, and 
PK parameters.  Individual patients may be removed from the estimation of particular 
PK parameters based on the number of available blood samples for them.  These 
patients will be identified at the time of analysis.
Depending on availability of data, the following PK parameters after the first and after 
multiple doses may be calculated using noncompartmental analysis:

AUCtau (the area under concentration curve during a dosing interval)

Cmax (maximum observed serum concentration)

CL (clearance)
Additional PK parameters may also be calculated, if relevant.
Biofluid concentrations will be expressed in mass per volume units.  All concentrations 
below the limit of quantification or missing data will be reported as such in the 
concentration data listings.  Concentrations below the limit of quantification will be 
treated as zero in summary statistics.
Descriptive statistics of all PK parameters will include arithmetic and geometric mean, 
median, SD, CV, geometric coefficient of variation (CV), minimum and maximum.  Zero 
concentrations will not be included in the geometric mean calculation.  Since time to 
maximum concentration (Tmax) is generally evaluated by a nonparametric method, 
median values and ranges will be provided for this parameter.
Summary statistics will be presented for magrolimab serum concentrations at each 
scheduled time point.  Descriptive graphical plots of individual serum 
concentration-versus-time profiles and mean concentration-versus-time profiles will be 
generated.
Missing concentration values will be reported as is in data listings.  Concentration 
values below lower limit of quantitation will be handled as zero in summary statistics, 
and reported as is in data listings.  Any missing PK parameter data will not be imputed.


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All data from this study may be combined with PK data from other company-sponsored 
clinical studies and analyzed using a population PK model.  Such an analysis would be 
reported separately.
Immunogenicity Analyses
The rate and magnitude of anti-magrolimab antibody incidence and prevalence will be 
evaluated for individual patients, for all patients in each of the study cohorts, and for the 
pooled patient population.  
 
 
  
Immunogenicity analysis may also be performed for azacitidine.  However, it is not 
expected that magrolimab will impact the immunogenicity of azacitidine and vice versa.
Immunogenicity:  Exposure and/or Adverse Event Relationship
The concentration-versus-adverse event/immunogenicity relationship will be explored 
graphically, tabulated, and, if appropriate, evaluated by a mixed effects model in order 
to characterize a relationship between the changes from screening immunogenicity 
presence and serum concentration of magrolimab.
In addition, the potential correlation between immunogenicity and other endpoints 
(major safety, efficacy, and biomarker parameters) may be evaluated.  This will be done 
in 2 steps.  First, a descriptive analysis will be performed graphically between 
immunogenicity change from screening values and major safety, efficacy, and 
biomarker parameters.  Second, for any potential correlation identified, further 
investigation will be performed using a mechanism-based modeling approach, as 
appropriate.
11.8.3.
Safety Analyses
The statistical analysis of safety data will be conducted in patients who received at least 
1 dose of magrolimab.  Safety variables may include, but are not limited to:  DLTs, 
treatment-emergent adverse events (TEAEs; AEs worsening or occurring during or after 
a patient’s first exposure to study drug), vital signs, physical examinations, laboratory 
tests, RO (US only), and anti-drug antibody assessments.
CCI


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Data will be presented by cohort (R/R or TN/U) and by treatment, when appropriate, as 
well as all cohorts combined.  Some safety data may be summarized across multiple 
study cohorts or over all cohorts.  Data may be graphed, summarized, or listed, 
depending on the amount of data to be reported.  Where relevant, safety data will also 
be presented by the study day/study day interval corresponding to dose administrations 
within each dose cohort.
11.8.3.1.
Adverse Events
Adverse events will be coded using Medical Dictionary for Regulatory Activities 
(MedDRA) version 17.1 or later and the NCI CTCAE v 4.03 (Appendix A) will be used to 
grade severity of AEs and laboratory toxicities.  Patient incidence of TEAEs and 
treatment-related TEAEs will be summarized by system organ class and preferred term.  
TEAEs will also be summarized using Investigator assessment of the relationship to 
study drug (related or not related).  SAEs, including deaths, will be summarized and/or 
listed for each cohort and for all cohorts combined.  TEAEs resulting in withdrawal from 
study drug or further study participation will be tabulated and/or listed.  DLTs will also be 
listed.
Adverse events that occurred during screening, but before exposure to study drug will 
be reported in the AE line listings and appropriately identified as non-TEAEs.
Adverse events and SAEs occurring during screening will be reported separately for 
patients who were screened, but not entered in the study, with line listings and/or 
summary tables, along with relevant demographic data collected.
11.8.3.2.
Analysis of Other Safety Endpoints
For select laboratory parameters, changes of laboratory values over time, grade shifts in 
laboratory value from baseline to worst on-study value and Grade 3 or higher laboratory 
toxicities will be summarized.  The number and incidence of patients developing RO 
(US only) and ADAs at any time will be summarized.  Vital signs and physical 
examination will be summarized at select time points.  Details will be provided in the 
SAP.


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11.9. Handling of Missing Data
Details regarding the handling of missing data will be described in the SAP.
11.10. Interim Safety Review
An interim safety review will be performed for patients in the R/R Cohort, TN/U AML 
Expansion Cohort, and the RBC Transfusion-dependent Low-risk MDS Cohort.  After 
the first 10 patients are enrolled in each cohort, if >33% of patients experience an AE 
that qualifies as a DLT and results in permanent study drug discontinuation, withdrawal, 
or death, then that cohort will be stopped for unacceptable toxicity.  If a study 
drug-related death occurs on study, a safety review will be conducted by the CTSC to 
determine whether enrollment should be interrupted.  The trial may also be stopped at 
any time if the CTSC deems that there is an unacceptable safety risk to patients with 
the study treatment.
12.ETHICAL AND ADMINISTRATIVE CONSIDERATIONS
12.1. Compliance Statement
This study will be conducted in accordance with the protocol and with US FDA and the 
ICH GCP guidelines, the Declaration of Helsinki, and any applicable local health 
authority and IRB/ IEC requirements.
To the extent applicable, all references to the FDA, Federal Food, Drug, and Cosmetic 
Act, CFR, ICH, GCP, and the like shall be interpreted as also referring to any 
corresponding requirements of local regulatory agencies, regulations, and laws.  If there 
is any discrepancy between FDA, ICH, and local requirements, the most stringent 
standard shall apply.
12.2. Investigator Responsibilities
As required by FDA regulation (21 CFR Part 56) and ICH guidelines for GCP, the 
Investigator at each study site must obtain IRB/IEC review and approval of the study 
protocol, ICFs, patient recruitment materials, and any other pertinent documents before 
any study-related activities involving patients are performed.


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As required in 21 CFR Part 50 and ICH guidelines for GCP, the Investigator or designee 
must comply with the informed consent process, and ensure that each patient enrolled 
in this clinical study understands the information presented in the IRB/IEC approved ICF 
and agrees voluntarily to participate in the clinical study.
The Investigator or designee must submit to the IRB/IEC any written safety report or 
update (e.g., amended IB or safety amendments and updates) provided by the Sponsor 
or representative, according to the IRB/IEC specific reporting requirements.
The Investigator must inform the IRB/IEC of the progress of the clinical study and report 
any non-administrative changes made to the protocol; in any case, the Investigator must 
provide an update to the IRB/IEC at least once a year or in accordance with IRB/IEC 
continuing approval requirements.
The Investigator must maintain a list of appropriately qualified persons to whom he/she 
has delegated study duties.  All persons authorized to make entries and/or corrections 
on CRFs will be included on the Gilead Sciences.  Delegation of Authority Form.
The clinical study report must be signed by the Investigator or, in the case of 
multi-center studies, the Coordinating Investigator.  The Coordinating Investigator, 
identified by Gilead Sciences, will be any or all of the following:

A recognized expert in the therapeutic area.

An Investigator who provided significant contributions to either the design or 
interpretation of the study.

An Investigator contributing a high number of eligible patients.
The Investigator is responsible for ensuring adequate accountability of all used and 
unused study drug.  This includes acknowledgment of receipt of each shipment of study 
drug (quantity and condition).  All used and unused study drug dispensed to patients 
must be returned to the site and/or destroyed.


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Each investigational site must keep accountability records that capture:

The date received, quantity, and condition of study drug 

The date, patient number, and the study drug number dispensed

The date, quantity of used and unused study drug destroyed on site or returned, 
along with the initials of the person recording the information
12.3. Institutional Review Board or Independent Ethics Committee
A copy of the protocol, proposed ICF, other written patient information, and any 
proposed advertising material must be submitted to the IRB/IEC for written approval.  A 
copy of the written approval of the protocol and ICF must be received by Gilead 
Sciences before recruitment of patients in the study and shipment of magrolimab.
Protocol modifications, except those intended to reduce immediate risk to study 
patients, may be made only by Gilead Sciences.  The Investigator must submit and, 
where necessary, obtain approval from the IRB/IEC for all subsequent protocol 
amendments and changes to the ICF.  The Investigator is to notify the IRB/IEC of 
deviations from the protocol or SAEs occurring at the site and other AE reports received 
from Gilead Sciences, in accordance with local procedures.
The Investigator is responsible for obtaining annual IRB/IEC approval/renewal as 
applicable throughout the duration of the study.  Copies of the Investigator’s reports and 
the IRB/IEC continuance of approval must be sent to Gilead Sciences.
12.4. Informed Consent and Human Subject Protection
An initial sample ICF is provided for the Investigator to prepare the ICF to be used at his 
or her site.  Updates to the template are to be communicated formally in writing from the 
Gilead Sciences.  Study Monitor to the Investigator.  The written ICF is to be prepared in 
the language(s) of the potential patient population.
Before a patient’s participation in the clinical study, the Investigator is responsible for 
obtaining written informed consent from the patient or legally acceptable representative 
after adequate explanation of the aims, methods, anticipated benefits, and potential 


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hazards of the study and before any protocol-specific screening procedures or any 
investigational products are administered.  A legally acceptable representative is an 
individual or other body authorized under applicable law to consent, on behalf of a 
prospective subject, to the subject’s participation in the clinical study.
The Investigator is also responsible for asking the patient if the patient has a primary 
care physician and if the patient agrees to have his/her primary care physician informed 
of the patient’s participation in the clinical study.  If the patient agrees to such 
notification, the Investigator is to inform the patient’s primary care physician of the 
patient’s participation in the clinical study.  If the patient does not have a primary care 
physician and the Investigator will be acting in that capacity, the Investigator is to 
document such in the patient’s medical record.  The acquisition of informed consent and 
the patient’s agreement or refusal of his/her notification of the primary care physician is 
to be documented in the patient’s medical records, and the ICF is to be signed and 
personally dated by the patient, or a legally acceptable representative, and by the 
person who conducted the informed consent discussion.  The original signed ICF is to 
be retained in accordance with institutional policy, and a copy of the signed consent 
form is to be provided to the patient or legally acceptable representative.
If a potential patient is illiterate or visually impaired and does not have a legally 
acceptable representative, the Investigator must provide an impartial witness to read the 
ICF to the patient and must allow for questions.  Thereafter, both the patient and the 
witness must sign the ICF to attest that informed consent was freely given and 
understood.
12.5. Confidentiality
The Investigator must ensure that the patient’s confidentiality is maintained for 
documents submitted to Gilead Sciences, including the following.

Patients are to be identified by a unique patient identification number.

Where permitted, date of birth is to be documented and formatted in accordance 
with local laws and regulations.


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
On the CRF demographics page, in addition to the unique patient identification 
number, include the age at time of enrollment.

For SAEs reported to Gilead Sciences, patients are to be identified by their unique 
patient identification number, initials (for faxed reports, in accordance with local laws 
and regulations), and date of birth (in accordance with local laws and regulations).

Documents that are not submitted to Gilead Sciences (e.g., signed ICFs) are to be 
kept in confidence by the Investigator, except as described below.
In compliance with the CFR/ICH GCP Guidelines, it is required that the Investigator and 
institution permit authorized representatives of the company, of the regulatory 
agency(s), and the IRB/IEC direct access to review the patient’s original medical 
records for verification of study-related procedures and data.  Direct access includes 
examining, analyzing, verifying, and reproducing any records and reports that are 
important to the evaluation of the study.  The Investigator is obligated to inform and 
obtain the consent of the patient to permit such individuals to have access to his/her 
study-related records, including personal information.
12.6. Urgent Safety Measures
The Sponsor or Investigator may take appropriate urgent safety measures to protect 
trial participants from any immediate hazard to their health or safety.  Urgent safety 
measures may be taken without prior authorization.  The trial may continue with the 
urgent safety measures in place.  The Investigator must inform Gilead Sciences 
IMMEDIATELY if the study site initiates an urgent safety measure.
The notification must include:

Date of the urgent safety measure;

Who made the decision; and

Why the action was taken.
The Investigator will provide any other information that may be required to enable 
Gilead Sciences to report and manage the urgent safety measure in accordance with 
the current regulatory and ethical requirements for expedited reporting and closeout.


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12.7. Serious Breaches and Fraud
Within the UK, the Medicines for Human Use (Clinical Trials) Regulations require the 
Sponsor to notify any "serious breaches" to the Medicines and Healthcare products 
Regulatory Agency (UK) (MHRA) within 7 days of the Sponsor becoming aware of the 
breach.  A serious breach is defined as “A breach of GCP or the trial protocol which is 
likely to effect to a significant degree:

the safety or physical or mental integrity of the patients of the trial; or

the scientific value of the trial”
Investigators must notify Gilead Sciences immediately if any serious breach of GCP is 
suspected.
If there is any proof of fraud this must also be reported to Gilead Sciences.  All 
instances of confirmed clinical trial fraud occurring at sites in the UK will be treated 
according to the procedure for dealing with a serious breach and must be reported to 
the MHRA within 7 days of the Sponsor becoming aware.
12.8. Study Monitoring
The Gilead Sciences representative(s) are responsible for contacting and visiting the 
Investigator for the purpose of inspecting the facilities and, upon request, inspecting the 
various records of the clinical study (e.g., eCRFs/CRFs and other pertinent data) 
provided that patient confidentiality is respected.
The Gilead Sciences representative(s) are responsible for verifying the CRFs at regular 
intervals throughout the study to verify adherence to the protocol; completeness, 
accuracy, and consistency of the data; and adherence to local regulations on the 
conduct of clinical research.  The Gilead Sciences representative(s) are to have access 
to patient medical records and other study-related records needed to verify the entries 
on the CRFs.
The Investigator agrees to cooperate with the Gilead Sciences representative(s) to 
ensure that any problems detected in the course of these monitoring visits, including 
delays in completing CRFs, are resolved.


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12.9. Audits and Inspections
As stipulated by 21 CFR §312.58 and ICH guidelines for GCP, a representative of the 
Sponsor, the FDA, or other regulatory agencies may conduct periodic site audits or 
inspections.  The Investigator or designee will provide these representatives with 
access to all requested materials, including CRFs and supporting source documents.  In 
addition, the Investigator or other qualified study site personnel are to be available to 
answer questions, hold interviews, and provide facility tours if requested.
12.10. Data Collection and Handling
The Investigator is responsible for complying with the requirements for all assessments 
and data collection (including patients not receiving protocol-required therapies), as 
stipulated in the protocol for each patient in the study.  For patients who withdraw prior 
to completion of all protocol-required visits and are unable or unwilling to continue the 
schedule of study assessments (as described in Section 7.1), the Investigator may 
search publically available records (where permitted) to ascertain survival status.  This 
ensures that the data set(s) produced as an outcome of the study is/are as 
comprehensive as possible.
The Investigator agrees to maintain adequate case histories for the patients treated as 
part of the research under this protocol.  Data collection will involve the use of the EDC 
system, to which only authorized personnel will have access.  The Investigator agrees 
to maintain accurate eCRFs and/or paper CRFs and source documentation as part of 
the case histories.  Gilead Sciences will supply the eCRF, which will be completed in 
English.
The Investigator or designee must enter all results collected during the clinical study into 
eCRFs/CRFs).  Guidelines for completion of eCRFs/CRFs will be reviewed with study 
site personnel at the site initiation visits.  Investigators are responsible for approval of 
the entered/corrected data.  Detailed instructions are provided in the other 
study-specific documents.


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All entries made on the eCRF/CRFs must be verifiable against source documents.  
In addition to periodic monitoring occurring within the system by study monitors, 
programmatic edit checks and data listings will be used to review the data for 
completeness, logic, and adherence to study protocol.  As a result of this monitoring 
and these checks, queries may be electronically issued to the clinical study sites and 
electronically resolved by those sites.
All data collected in the context of this study will be stored and evaluated according to 
regulatory requirements and applicable guidance for electronic records.  Also, data will 
be stored and evaluated in such a way as to assure patient confidentiality in accordance 
with the legal and regulatory requirements applying to protected health information.  
Study records (e.g., copies of eCRFs, regulatory documents) will be retained at the 
study site, along with adequate source documentation.  The study file and all source 
data must be retained for the time period required by applicable regulatory requirements 
and will not be destroyed until written notification is given by the Sponsor or designee 
for destruction.
12.11. Maintenance of Source Documents and Record Retention
As stipulated by 21 CFR §312.57 and ICH E6 GCP Consolidated Guidance Section 8, 
the Investigator or designee will maintain source documentation for this clinical study 
that documents the treatment and study course of patients as described in the study 
manual.
Source documents are original documents, data, and records from which the patient’s 
CRF data are obtained.  These include, but are not limited to, hospital records, clinical 
and office charts, laboratory and pharmacy records, diaries, microfiches, radiographs, 
and correspondence.
The Investigator and study staff are responsible for maintaining a comprehensive and 
centralized filing system of all study-related (essential) documentation, suitable for 
inspection at any time by representatives from Gilead Sciences and/or applicable 
regulatory authorities.


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The Investigator must retain all essential documents for this clinical study until at least 
2 years after the last approval of a marketing application in an ICH region and until there 
are no pending or contemplated marketing applications in an ICH region, or until at least 
2 years have elapsed since the formal discontinuation of clinical development of 
magrolimab.  However, the Investigator may need to retain these documents for a 
longer period, if required by the applicable regulatory requirements or by an agreement 
with the Sponsor.  A Sponsor representative will be responsible for informing the 
Investigator and study site regarding when they no longer need to retain these 
documents.  Before destroying any records, the Investigator must notify the Sponsor 
and reach agreement on record destruction, or the Sponsor may request an additional 
retention period.
  
 
 
 
 
 
 
 
 
 
 
 
 
 
CCI


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12.13. Financing and Insurance
The Sponsor maintains clinical trial insurance coverage for this study in accordance with 
the laws and regulations of the country in which the study is performed.
CCI
CCI
CCI
CCI
-


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12.14. Study Reports and Publications
A clinical study report (CSR) will be prepared and provided to the regulatory agency(ies) 
when applicable and in accordance with local regulatory requirements. Gilead will 
ensure that the report meets the standards set out in the ICH Guideline for Structure 
and Content of Clinical Study Reports (ICH E3). Note that an abbreviated report may be 
prepared in certain cases. For studies with sites in countries following the, a CSR will be 
submitted within 1 year (6 months for pediatric studies, in accordance with Regulation 
[EC] No. 1901/2006) after the global end of study (as defined in Section 3.7). 
Investigators in this study may communicate, orally present, or publish study data in 
scientific journals or other scholarly media in accordance with the Gilead clinical trial 
agreement.


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acute myeloid leukemia:  time to move toward a minimal residual disease-based 
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Chao MP, Alizadeh AA, Tang C, et al. Anti-CD47 antibody synergizes with rituximab to 
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Chao MP, Alizadeh AA, Tang C, et al. Therapeutic antibody targeting of CD47 
eliminates human acute lymphoblastic leukemia. Cancer Res. 2011a;71(4):1374-1384.
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Chao MP, Majeti R, Weissman IL. Programmed cell removal:  a new obstacle in the 
road to developing cancer. Nat Rev Cancer. 2012;12(1):58-67.
Cheson BD, Bennett JM, Kopecky KJ, et al; International Working Group for Diagnosis, 
Standardization of Response Criteria, Treatment Outcomes, and Reporting Standards 
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modification of the International Working Group (IWG) response criteria in 
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Craddock C, Quek L, Goardon N, et al. Azacitidine fails to eradicate leukemic 
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Döhner H, Estey E, Grimwade D, et al. Diagnosis and management of AML in adults:  
2017 ELN recommendations from an international expert panel. Blood. 2017 Jan 
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Dombret H, Seymour JF, Butrym A, et al. International phase 3 study of azacitidine vs 
conventional care regimens in older patients with newly diagnosed AML with >30% 
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Feldman EJ, Brandwein J, Stone R, et al. Phase III randomized multicenter study of a 
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myelodysplastic syndromes: an expert panel opinion. Leuk Res. 2010 Nov;34(11):1410-
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measured by flow cytometric residual disease detection in older patients with acute 
myeloid leukemia. J Clin Oncol. 2013 Nov 10;31(32):4123-31.
Garcia-Manero G, Stoltz ML, Ward MR, Kantarjian H, Sharma S. A pilot 
pharmacokinetic study of oral azacitidine. Leukemia. 2008 Sep;22(9):1680-4.
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CD34(+)CD38(-) cells in acute myeloid leukemia. Blood. 2012 Apr 12;119(15):3571-7.
Greenberg PL, Tuechler H, Schanz J, et al. Revised international prognostic scoring 
system for myelodysplastic syndromes. Blood. 2012 Sep 20;120(12):2454-65.
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2009 Aug 7;5(2):125-6. 
Herbst RS, Soria JC, Kowanetz M, et al. Predictive correlates of response to the anti-
PD-L1 antibody MPDL3280A in cancer patients. Nature. 2014;515:563-567.
Itzykson R, Thépot S, Berthon C, et al. Azacitidine for the treatment of relapsed and 
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Liu J, Wang L, Zhao F, et al. Pre-clinical development of a humanized anti-CD47 
antibody with anti-cancer therapeutic potential. PLoS One. 2015b;10(9):e0137345.
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Sievers EL, Lange BJ, Alonzo TA, et al. Immunophenotypic evidence of leukemia after 
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14.APPENDICES
Appendix A:National Cancer Institute Common Terminology Criteria For Adverse 
Events
Common Terminology Criteria for Adverse Events (CTCAE) of the National Cancer 
Institute (NCI), Version 4.03
Publication date:  28 May 2009 (v4.03:  14 June 2010)
http://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03_2010-06-14_QuickReference_8.5x11.pdf
Accessed 7 June 2016
Hemagglutination and microangiopathy will be graded using the scale below, which is 
adapted from the CTCAE Version 4.03 general guidance:
AE Severity Grading for Hemagglutination and Microangiopathy
Grade 1: Evidence of hemagglutination and/or microangiopathy on peripheral blood 
smear AND associated clinical sequelae that are asymptomatic or mild, 
not requiring intervention 
Grade 2: Evidence of hemagglutination and/or microangiopathy on peripheral blood 
smear AND associated clinical sequelae that require medical intervention 
Grade 3: Evidence of hemagglutination and/or microangiopathy on peripheral blood 
smear AND associated clinical sequelae that are medically significant, 
requiring hospitalization or prolongation of existing hospitalization, 
disabling, or limiting self-care activities of daily living 
Grade 4: Evidence of hemagglutination and/or microangiopathy on peripheral blood 
smear AND associated clinical sequelae that are life threatening or require 
urgent intervention
Grade 5: Evidence of hemagglutination and/or microangiopathy on peripheral blood 
smear AND associated clinical sequelae that result in death


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Appendix B:Disease Response Assessment Based On European Leukemianet 
And International Working Group Criteria
Assessment of leukemia response in AML patients will be conducted primarily using the 
European Leukemia Net (ELN) 2017 recommendations for AML (Döhner 2017) 
(Table 14-1) and the 2003 IWG criteria (Cheson 2003) (Table 14-2).  Response 
classifications include:  complete remission (CR), complete remission without minimal 
residual disease (CRMRD-), cytogenetic complete remission (cCR), molecular complete 
remission (mCR), complete remission with incomplete hematologic recovery (CRi), 
partial remission (PR) and stable disease (SD).
Accompanying laboratory results ± 2 weeks from the protocol-specified bone marrow 
efficacy assessment can be used to support an efficacy assessment of CR for both AML 
and MDS.
In addition, CR with partial hematologic recovery will be assessed for AML and MDS, 
defined as patients who achieve a CR per AML ELN 2017 recommendations 
(Döhner 2017) or MDS IWG 2006 criteria (Cheson 2006), with the exception of requiring 
partial hematologic recovery as defined by a platelet count of > 50 × 109/L and an 
absolute neutrophil count of > 500/µL.  
In addition, hematologic improvement (HI) will be assessed by 2006 IWG criteria 
(Cheson 2006) (Table 14-3) to compare with disease response assessed by 2017 ELN 
criteria (Döhner 2017) and 2003 IWG criteria (Cheson 2003).
Response will be assessed in MDS patients using the 2006 IWG criteria (Cheson 2006) 
as shown in Table 14-4, with the added caveat that the impact of anemia must be 
deemed disease-related and not due to study treatment.


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Table 14-1.
Response Criteria in AML (ELN 2017 Recommendations)
Response Criteria
Definitions
Neutrophils 
Platelets
Bone Marrow 
Blasts 
Other
Complete Remission 
without minimal 
residual disease 
(CRMRD-)
≥ 1.0 × 109/L
≥ 100  × 
109/L
< 5%
If studied pretreatment, CR with 
negativity for a genetic marker by real-
time quantitative polymerase chain 
reaction (RT-qPCR) or similar modality 
or CR with negativity by multi-color 
flow cytometry
Complete Remission 
(CR)
≥ 1.0 × 109/L
≥ 100  × 
109/L
< 5%
Absence of circulating blasts and 
blasts with Auer rods; absence of 
extramedullary disease; MRD positive 
or unknown
Complete Remission 
with Incomplete 
Hematologic 
Recovery (CRi)
Neutrophils ≥ 1.0  × 109/L or
Platelets ≥ 100  × 109/L
< 5%
Absence of circulating blasts and 
blasts with Auer rods; absence of 
extramedullary disease; MRD positive 
or unknown
(All CR criteria except residual 
neutropenia [< 1.0 × 109/L] or 
thrombocytopenia [< 100 × 109/L])
Morphologic 
Leukemia-Free State 
(MLFS)
< 5%
Absence of blasts with Auer rods; 
absence of extramedullary disease; no 
hematologic recovery required; 
marrow should not merely be 
“aplastic”; at least 200 cells should be 
enumerated or cellularity should be at 
least 10%
Partial Remission 
(PR)
≥ 1.0  × 109/L
≥ 100  × 
109/L
Decrease of 
bone marrow 
blast percentage 
to 5% to 25%; 
and decrease of 
pretreatment 
bone marrow 
blast percentage 
by at least 50%
Blasts < 5% with Auer rods may also 
be considered a PR
Stable Disease (SD)
Absence of CRMRD-, CR, CRi, PR, MLFS; and criteria for progressive disease not met
Progressive Disease 
(PD)

Evidence for an increase in bone marrow blast percentage and/or increase of 
absolute blast counts in the blood:
o
> 50% increase in marrow blasts over baseline (a minimum 15% point increase is 
required in cases with < 30% blasts at baseline; or persistent marrow blast 
percentage of > 70% over at least 3 months; without at least a 100% 
improvement in ANC to an absolute level (> 0.5 × 109/L [500/μL]), and/or platelet 
count to > 50 × 109/L (50,000/μL) non-transfused]; or
o
> 50% increase in peripheral blasts (WBC × % blasts) to > 25 × 109/L 
(> 25,000/μL) (in the absence of differentiation syndrome); or

New extramedullary disease
Source:  Döhner 2017
Abbreviations:  AML = acute myeloid leukemia; ANC = absolute neutrophil count; CR = complete remission; 
MRD = minimal residual disease; WBC = white blood cell count.


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Table 14-2.
Additional Response Definitions Used in This Trial 
(2003 IWG Criteria)
Response Criteria
Definitions
Neutrophils 
Platelets
Bone Marrow 
Blasts 
Other
Cytogenetic CR (cCR)
≥ 1.0  × 109/L
≥ 100  × 
109/L
< 5%
Cytogenetics normal and 
no evidence of 
extramedullary disease 
Molecular CR (mCR)
≥ 1.0  × 109/L
≥ 100  × 
109/L
< 5%
Molecular investigations 
normal and no evidence of 
extramedullary disease 
Treatment Failurea
Lack of response/Progressive Disease + loss of clinical benefit
Source:  Cheson 2003
Abbreviations:  IWG = International Working Group.
a.
Treatment failure defined for this protocol
Table 14-3.
Response Criteria for Hematologic Improvement
Hematologic Improvement (HI) 
Categorya
Response Criteria (all responses must last ≥ 8 weeks)
Erythroid Response (HI-E)
(pretreatment < 110 g/L)

Pre-transfusion increase in hemoglobin by 15 g/L
or

Compared to an 8-week pretreatment period, a reduction 
in transfusion requirements by 4 units in an 8-week 
post-treatment period 
Platelet Response (HI-P)
(pretreatment < 100 × 109/L)

Absolute increase of ≥ 30 × 109/L for patient starting with 
a platelet count > 20 × 109/L pretreatment
or

Increase from < 20  × 109/L pretreatment to > 20 × 109/L 
post-treatment and by at least 100%
Neutrophil Response (HI-N)
(pretreatment < 1.0 × 109/L)
At least 100% increase and an absolute increase of 
> 0.5 × 109/L
Progression/relapse after 
Hematological Improvementb
One or more of the following

≥ 50% decrement from maximum response in neutrophils 
or platelets

Reduction in hemoglobin by ≥ 15 g/L

Transfusion dependence
Source:  Cheson 2006
a. Pretreatment counts should be an average of at least 2 measurements (not influenced by 
transfusions) performed ≥ 1 week apart
b. In the absence of another explanation.  For example, including, but not restricted to, acute 
infection, gastrointestinal bleeding and hemolysis


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Table 14-4.
Response Criteria in MDS (IWG 2006 Criteria With Modifications)
Category
Response Criteria
Complete 
Remission 
Bone marrow ≤ 5% myeloblasts with normal maturation of all cell linesa
Persistent dysplasia will be noteda,b
Peripheral bloodc

Hgb ≥ 11 g/dL

Platelets ≥ 100 × 109/L

Neutrophils ≥ 1.0 × 109/Lb

Blasts 0%
Partial Remission
All CR criteria if abnormal before treatment except:

Bone marrow blasts decreased by ≥ 50% over pretreatment but still > 5%

Cellularity and morphology not relevant
Marrow CRb

Bone marrow ≤ 5% myeloblasts and decrease by ≥ 50% over pretreatmentb

Peripheral blood:  if HI responses, they will be noted in addition to marrow CRb
Stable Disease

Failure to achieve at least PR, but no evidence of progression for > 8 weeks
Failure
Death during treatment or disease progression characterized by worsening 
cytopenias, increase in percentage of bone marrow blasts, or progression to a 
more advanced MDS FAB subtype than pretreatment
Relapse after CR 
or PR
At least 1 of the following:

Return to pretreatment bone marrow blast percentage

Decrement of ≥ 50% from maximum remission/response levels in granulocytes 
or platelets

Reduction in Hgb concentration by ≥ 1.5 g/dL or transfusion dependenced
Cytogenetic 
Response

Complete:  Disappearance of chromosomal abnormality without appearance of 
new ones

Partial:  At least 50% reduction of the chromosomal abnormality
Disease 
Progression
For patients with:

Less than 5% blasts:  ≥ 50 increase in blasts to > 5% blasts

5%-10% blasts:   ≥ 50% increase in blasts to > 10% blasts

10%-20% blasts:  ≥ 50% increase in blasts to > 20% blasts

20%-30% blasts:  ≥ 50% increase in blasts to > 30% blasts
Any of the following:

At least 50% decrement from maximum remission/response in granulocytes or 
platelets

Reduction in Hgb by ≥ 2 g/dLd

Transfusion dependenced
Source:  Cheson 2006
Abbreviations:  CR = complete remission; FAB = myelodysplastic syndrome French-American-British 
classification; Hgb = hemoglobin; IWG = International Working Group; MDS = myelodysplastic 
syndrome; PR = partial remission.
a. Dysplastic changes should consider the normal range of dysplastic changes
b. Modification to IWG response criteria
c. Transient cytopenias during repeated chemotherapy courses should not be considered as 
interrupting durability of response, as long as they recover to the improved counts of the previous 
course.
d. Impact of anemia must be deemed disease-related and not due to study treatment.


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Appendix C:ECOG Performance Status
Eastern Cooperative Oncology Group Scale of Performance Status
Publication:
Oken M, Creech R, Tormey D, et al.  Toxicity and response criteria of the Eastern 
Cooperative Oncology Group.  Am J Clin Oncol.  1982;5:649-655.
Available online:
http://ecog-acrin.org/resources/ecog-performance-status
Accessed 7 June 2016


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Appendix D:Peripheral Smear Assessment
Peripheral smears will be assessed by the designated hematopathology service using 
the following guidelines:
RBC Agglutination
0-9% 
Not reported
10-19%
1+
20-50%
2+
51-75%
3+
> 75%
4+
Spherocytes
0-1 cells/100 RBCs
Not reported
2-5 cells/100 RBCs
1+
> 5-10 cells/100 RBCs
2+
> 10-30 cells/100 RBCs
3+
> 30 cells/100 RBCs
4+
RBC Fragments/Schistocytes
0 cells/100 RBCs
Not reported
1-2 cells/100 RBCs
1+
> 2-5 cells/100 RBCs
2+
> 5-10 cells/100 RBCs
3+
> 10 cells/100 RBCs
4+
All other observed findings:  report according to local laboratory hematopathology 
standard procedures.
These guidelines are based on the Stanford Health Care Peripheral Blood Slide Review 
Manual, Version 3.0, 2015, modified by Gilead Sciences for clarification of the following 
items in the original manual:

RBC agglutination, 1+ = 10%, 3+ = 60-75%

Spherocytes, 2+ = 5-10 cells/100 RBCs, 3+ = 10-30 cells/100 RBCs

RBC Fragments/Schistocytes, 2+ = 2-5 cells, 3+ = 5-10 cells
If sites are not able to quantify the degree of peripheral smear findings noted above, 
then the presence or absence of RBC agglutination, spherocytes, and/or RBC 
fragments/schistocytes must be reported at a minimum.


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Appendix E: Decitabine Prescribing Information
Decitabine for injection - prescribing information
Available online:
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=c155d6ba-9a16-406c-
919e-65a149689ab9&type=display
Accessed 9 July 2019


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Appendix F: Schedules Of Dosing And Assessments For Completed Cohorts
This appendix contains schedules of dosing and assessments for completed cohorts.  
These tables are maintained here for archival purposes but should not be followed for 
any patients currently enrolled.
Table 14-5.
Dose and Schedule for Rollover AML Cohort
Dose Schedule (Day per 28-day Cycle)
Cohort
Drug/Dose/Route
All Cycles
Rollover AML
Magrolimab - continue 
same dose level as 
previous study 
(up to 30a mg/kg) IV
Dosing schedule may be twice weekly (Day 1, 
4, 8, 11, 15, 18, 22, and 25), once weekly 
(Day 1, 8, 15, 22), or in accordance with a 
modified recommended Phase 2 dose and 
schedule determined by the CTSC.
Abbreviations:  AML = acute myeloid leukemia; CTSC = Clinical Trial Steering Committee; 
IV = intravenous.
a.
At the discretion of the CTSC, patients who are receiving lower doses may be escalated to 
a higher dose deemed to be safe on this study by the CTSC.  


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Table 14-6.
Schedule of Assessments, R/R Cohort (Safety)
Assessment
Study 5F9005:  A Phase 1b Trial of Hu5F9-G4 Monotherapy or Hu5F9-G4
in Combination with Azacitidine in Patients with Hematological Malignancies – R/R Cohorts (Safety)
Cycle
(28-day Cycles)
1
2
3+
Visit Window 
(Days)
-30
None
± 3a
± 3a
± 3
Cycle Day
SC
1
2
4
8
11
15
16
17
18
22
25
1
2
3
4
8
11
15
18
22
25
1
8
15
22
Informed consent
Xb
Demographics
X
Medical and 
cancer history
X
Entry criteria
X
Enrollment cohort 
assignment
Xb
Pregnancy test
X
Xc
X
X
Donor chimerismd
X
CBC with 
differential, 
platelets, 
reticulocytese,f
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Peripheral blood 
smeare,g
X
X
X
X
X
X
X
X
Serum or plasma 
chemistrye
X
X
X
X
X
X
X
X
X
X
X
X
Serum uric acid, 
phosphoruse
X
X
X
X
X
Haptoglobin, 
D-dimer, thrombin, 
fibrinogene
X
X
X
X
X
X
X
PT/INR, aPTTe
X
X
X
X
Type and screen 
(ABO/Rh), DAT 
X
I 


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Assessment
Study 5F9005:  A Phase 1b Trial of Hu5F9-G4 Monotherapy or Hu5F9-G4
in Combination with Azacitidine in Patients with Hematological Malignancies – R/R Cohorts (Safety)
Cycle
(28-day Cycles)
1
2
3+
Visit Window 
(Days)
-30
None
± 3a
± 3a
± 3
Cycle Day
SC
1
2
4
8
11
15
16
17
18
22
25
1
2
3
4
8
11
15
18
22
25
1
8
15
22
Urinalysise
X
X
Correlative 
studiesh
X
X
X
X
X
PK (Safety Cohort)i
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X 
Q2Cy
Anti-drug 
antibodiesk
X
X
X
X
CD47 RO bloodl
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Q2C-
Q3Cy
Bone marrow 
aspirate/ biopsy for 
CD47 
RO/
 
studiesx
X
X
X
X 
Q2C-
Q3Cs,t
Bone marrow 
biopsy and 
cytogeneticsr,s
X
X
X 
Q2C-
Q3Cs,t
MRD monitoringu
X
X
X 
Q2C-
Q3Cs,t
Response 
assessment
X
X 
Q2C-
Q3Cs,t
ECOGe
X
X
X
X
X
X
X
Vital signsn
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Physical 
examinatione,o
X
X
X
X
X
X
X
X
Visual acuitye
X
X
X
X
X
X
X
CCI
I 
-


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Assessment
Study 5F9005:  A Phase 1b Trial of Hu5F9-G4 Monotherapy or Hu5F9-G4
in Combination with Azacitidine in Patients with Hematological Malignancies – R/R Cohorts (Safety)
Cycle
(28-day Cycles)
1
2
3+
Visit Window 
(Days)
-30
None
± 3a
± 3a
± 3
Cycle Day
SC
1
2
4
8
11
15
16
17
18
22
25
1
2
3
4
8
11
15
18
22
25
1
8
15
22
ECGq
X
X
X
X
Adverse events
Concomitant 
medications
Study Drug 
Administration
Hu5F9-G4 
premedicationz
Hu5F9-G4:  Safety 
Cohortv
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Abbreviations:  ABO = any of the four blood groups A, B, AB, and O comprising the ABO system; aPTT = activated partial thromboplastin time; 
C = cycle; CBC = complete blood count; CR = complete remission; CTSC = Clinical Trial Steering Committee; DAT = direct antiglobulin test; 
ECG = electrocardiogram; ECOG = Eastern Cooperative Oncology Group; MRD = minimal residual disease; PE = physical examination; 
PK = pharmacokinetics; PT/INR = prothrombin time/international normalized ratio; Q2C = every 2 cycles; Q3C = every 3 cycles; Rh = Rhesus 
factor; RO = receptor occupancy; R/R = Relapsed/Refractory; SC = Screening; W = week(s); WBC = white blood cell.
a.
Note that ± 3 day visit window does not apply to specimen collection for correlative, PK, or RO assessments in Cycles 1 and 2 – refer to 
Table 7-6, Table 7-8, and Table 7-13 for details.
b.
First dose of Hu5F9-G4 must be given within 30 days of signing informed consent.
c.
Screening pregnancy test may be used if performed within 72 hours of first dose; pregnancy tests will be conducted on Day 1 of every 
cycle; additional guidance is provided in Section 7.3.1.
d.
Donor chimerism only applicable to patients with prior allogeneic hematopoietic stem cell transplant.
e.
Pretreatment assessments for the initial dose (Cycle 1 Day 1) may be collected up to 72 hours before study drug administration; thereafter, 
pretreatment assessments are to be collected within 24 hours prior to study drug administration.
f.
Samples for CBC must be collected at least once per cycle.  However, CBC sample collection to ensure a WBC level < 20×103/mcL may 
be deferred, based on Investigator assessment of the patient’s WBC kinetics.  Additional samples for CBC may be collected outside of the 
protocol-specified time points to ensure a WBC level < 20×103/mcL.
g.
Peripheral smears will be collected prior to selected study drug infusions/injections and assessed for the presence of hemagglutination in 
addition to standard cell morphology assessment.  Details are provided in Section 7.3.3.
I 


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h.
Time point details for correlative studies are provided in Table 7-6.
i.
Time point details for PK studies (Safety Cohort) are provided in Table 7-8.
j.
Not applicable to this cohort.
k.
Samples to be collected before dose administration (within 72 hours for initial dose and within 24 hours for subsequent doses).
l.
Time point details for RO studies (Safety Cohort – US only) are provided in Table 7-13.  For visits that include bone marrow assessments 
(e.g., Cycle 2 Day 1), RO blood specimen should be collected on same day as RO bone marrow specimen is collected.
m. Not applicable to this cohort.
n.
Vital signs prior to infusion and within 30 minutes after the end of each infusion.  Weight at screening and Day 1 of each cycle.  Details are 
provided in Section 7.3.5.
o.
Full PE at screening, symptom-directed PE thereafter.  For Cycles 4 and beyond, PEs may be done only on Day 1 of each cycle, at the 
discretion of the Investigator.
p.
Not applicable to this cohort.
q.
Single ECG at screening for all patients.  Triplicate ECGs within 2 hours prior to dosing and within 30 minutes of the end of Hu5F9-G4 
infusion.  Details are provided in Section 7.3.7.
r.
If a patient is in CR, a bone marrow biopsy for response assessment is not needed unless there are clinical signs of relapse.  At each bone 
marrow time point, both trephine (biopsy) and aspirate samples are to be collected for response assessment as well as CD47 receptor 
occupancy (US only), MRD assessment, correlative studies, and biobanking.  Conventional cytogenetics to be tested per institutional 
standards.  
s.
Response assessments may be adjusted by ± 4 weeks to coordinate with treatment cycle timing.  After Cycle 3, window is ± 14 days.
t.
After Cycle 7 Day 1, bone marrow biopsies will be collected every 3 cycles (i.e., Cycle 10 Day 1, Cycle 13 Day 1, etc.).
u.
MRD monitoring to be performed on bone marrow aspirate samples obtained at the bone marrow biopsy time points.
v.
Hu5F9-G4 should not be given on consecutive days.  During Cycle 1, infuse Hu5F9-G4 over 3 hours (± 30 min); thereafter, infuse over 
2 hours (± 30 min).  Ongoing patients who continue in this cohort after Amendment 3 approval will go from twice weekly dosing to once 
weekly dosing, which is reflected in Cycle 3+ in this schedule of assessments.
w. Not applicable to this cohort.
x.
Bone marrow aspirate and biopsy required for RO/
 studies (not a response assessment) on Day 15 for US patients only; 
however, bone marrow aspirate only is required in the UK at this time point.  Bone marrow study must be done prior to Hu5F9-G4 infusion.  
The CTSC may remove this assessment during the R/R Expansion Cohort based on emerging data.
y.
RO blood samples collected on Day 1 of every other cycle during Cycles 3 through 7, then every 3 cycles (same day as bone marrow RO 
samples) after Cycle 7 through Cycle 13 for US patients only. Beginning at Cycle 3 Day 1, pretreatment PK samples to be collected every 
other cycle through Cycle 13.
z.
Premedication was not required for R/R Cohort (Safety) prior to Amendment 3 approval.  For ongoing patients who continue in this cohort, 
premedication for subsequent Hu5F9-G4 treatments may be started or continued based on the treating physician’s clinical judgement and 
the presence/severity of prior infusion-related reactions.
CCI-


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Table 14-7.
Schedule of Assessments, R/R MDS Magrolimab Monotherapy Cohort
Assessment
Study 5F9005:  A Phase 1b Trial of Magrolimab Monotherapy or Magrolimab
in Combination with Azacitidine in Patients with Hematological Malignancies – R/R MDS Magrolimab Monotherapy Cohort
Cycle (28-day 
Cycles)
1
2
3+
Visit Window (Days)
-30
None
± 3a
± 3a
± 3a
Cycle Day
SC
1
2
3
4
5
6
7
8
11
15
22
1
2
3
4
5
6
7
8
15
22
1
2
3
4
5
6
7
15
Informed consent
Xb
Demographics
X
Medical and cancer 
history
X
Entry criteria
X
Enrollment cohort 
assignment
Xb
Pregnancy test
X
Xc
X
X
Donor chimerismd
X
CBC with differential, 
platelets, 
reticulocytese,f
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Peripheral blood 
smeare,g
X
X
X
X
X
X
X
X
Serum or plasma 
chemistrye
X
X
X
X
X
X
X
X
X
X
X
X
Serum uric acid, 
phosphoruse
X
X
X
X
X
Haptoglobin, 
D-dimer, thrombin, 
fibrinogene
X
X
X
X
X
X
X
PT/INR, aPTTe
X
X
X
X
Type and screen 
(ABO/Rh), DAT 
X
Urinalysise
X
X
Correlative studiesh
X
X
X
X
X
PK (Expansion 
Cohort)i
X
X
X
X
X
X
X
X
Q2Cv
Anti-drug antibodiesj
X
X
X
X
Q2Cv
I 


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Assessment
Study 5F9005:  A Phase 1b Trial of Magrolimab Monotherapy or Magrolimab
in Combination with Azacitidine in Patients with Hematological Malignancies – R/R MDS Magrolimab Monotherapy Cohort
Cycle (28-day 
Cycles)
1
2
3+
Visit Window (Days)
-30
None
± 3a
± 3a
± 3a
Cycle Day
SC
1
2
3
4
5
6
7
8
11
15
22
1
2
3
4
5
6
7
8
15
22
1
2
3
4
5
6
7
15
CD47 RO bloodk
X
X
X
X
X
X
Q2C-
Q3Cv
Bone marrow 
aspirate/biopsy for 
CD47 RO/
 
studiesl
X
X  
Q2C-
Q3Cn,s
Bone marrow biopsy 
and cytogeneticsm,n
X
X
Q2C-
Q3Cn,s
MRD monitoringo
X
X
Q2C-
Q3Cn,s
Response 
assessment
X
Q2C-
Q3Cn,s
ECOGe
X
X
X
X
X
X
X
Vital signsp
X
X
X
X
X
X
X
X
X
X
X
X
Physical 
examinatione,q
X
X
X
X
X
X
X
X
ECGr
X
X
X
X
Adverse events
Concomitant 
medications
Study Drug 
Administration
Magrolimab 
premedication
X
X
X
X
Magrolimabt,u
X
X
X
X
X
X
X
X
X
X
X
X
Azacitidine (may be 
given if no response 
at first response 
X
X
X
X
X
X
X
CCI
I 
-
. 


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Assessment
Study 5F9005:  A Phase 1b Trial of Magrolimab Monotherapy or Magrolimab
in Combination with Azacitidine in Patients with Hematological Malignancies – R/R MDS Magrolimab Monotherapy Cohort
Cycle (28-day 
Cycles)
1
2
3+
Visit Window (Days)
-30
None
± 3a
± 3a
± 3a
Cycle Day
SC
1
2
3
4
5
6
7
8
11
15
22
1
2
3
4
5
6
7
8
15
22
1
2
3
4
5
6
7
15
assessment to 
magrolimab 
monotherapy)x
Abbreviations:  ABO = any of the four blood groups A, B, AB, and O comprising the ABO system; ADA = anti-drug antibodies; aPTT = activated 
partial thromboplastin time; C = cycle; CBC = complete blood count; CTSC = Clinical Trial Steering Committee; DAT = direct antiglobulin test; 
ECG = electrocardiogram; ECOG = Eastern Cooperative Oncology Group; MIN = minute; MRD = minimal residual disease; PE = physical 
examination; PK = pharmacokinetics; PT/INR = prothrombin time/international normalized ratio; Q2 = every 2; Q2C = every 2 cycles; Q3C = every 
3 cycles; Rh = Rhesus factor; RO = receptor occupancy; R/R = relapsed/refractory; SC = screening; US = United States; W = week(s); 
WBC = white blood cell.
a.
Note that ± 3-day visit window does not apply to specimen collection for correlative, PK, or RO assessments in Cycles 1 and 2 – refer to 
Table 7-6, Table 7-7, and Table 7-11 for details.
b.
First dose of magrolimab must be given within 30 days of signing informed consent.
c.
Screening pregnancy test may be used if performed within 72 hours of first dose; pregnancy tests will be conducted on Day 1 of every cycle; 
additional guidance is provided in Section 7.3.1.
d.
Donor chimerism only applicable to patients with prior allogeneic hematopoietic stem cell transplant.
e.
Pretreatment assessments for the initial dose (Cycle 1 Day 1) may be collected up to 72 hours before administration of either study drug 
(magrolimab or azacitidine); thereafter, pretreatment assessments are to be collected within 24 hours prior to study drug administration.
f.
Samples for CBC must be collected at least once per cycle.  However, CBC sample collection to ensure a WBC level < 20×103/mcL may be 
deferred based on Investigator assessment of the patient’s WBC kinetics.  Additional samples for CBC may be collected outside of the 
protocol-specified time points to ensure a WBC level < 20×103/mcL.
g.
Peripheral smears will be collected prior to selected study drug infusions/injections and assessed for the presence of hemagglutination in 
addition to standard cell morphology assessment.  Details are provided in Section 7.3.3.
h.
Time point details for correlative studies are provided in Table 7-6.
i.
Time point details for PK studies (Expansion Cohort and MDS Magrolimab Monotherapy Cohort) are provided in Table 7-7.
j.
Samples to be collected before administration of either study drug (magrolimab or azacitidine), within 72 hours for initial dose and within 
24 hours for subsequent doses.
k.
Time point details for RO studies (US only) are provided in Table 7-11.  For visits that include bone marrow assessments, RO blood specimen 
(US only) should be collected on same day as RO bone marrow specimen is collected.
l.
Bone marrow aspirate and biopsy required for RO/
 studies (not a response assessment) on Day 15 in US patients only; however, 
bone marrow aspirate only is required in the UK at this time point.  Bone marrow study must be done prior to magrolimab infusion.  The CTSC 
may remove this assessment during the R/R Expansion Cohort based on emerging data.
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m. At each bone marrow time point, both trephine (biopsy) and aspirate samples are to be collected for response assessment as well as CD47 
receptor occupancy (US only), MRD assessment, correlative studies, and biobanking.  Conventional cytogenetics to be tested per institutional 
standards.  
n.
Response assessments may be adjusted by ± 4 weeks to coordinate with treatment cycle timing.  After Cycle 3, window is ± 14 days.
o.
MRD monitoring to be performed on bone marrow aspirate samples obtained at the bone marrow biopsy time points.
p.
Vital signs prior to infusion/injection and within 30 minutes after the end of each infusion/injection, before and after administration of each 
study drug (magrolimab or azacitidine).  Weight at screening and Day 1 of each cycle.  Details are provided in Section 7.3.5.
q.
Full PE at screening, symptom-directed PE thereafter.  For Cycles 4 and beyond, PEs may be done only on Day 1 of each cycle, at the 
discretion of the Investigator.
r.
Single ECG at all visits for all patients within 2 hours prior to dosing and within 30 minutes of the end of magrolimab infusion.  Details are 
provided in Section 7.3.7.
s.
After Cycle 7 Day 1, bone marrow biopsies will be collected every 3 cycles (i.e., Cycle 10 Day 1, Cycle 13 Day 1, etc.).
t.
Magrolimab should not be given on consecutive days.  On Cycle 1 Day 1 and Day 4, infuse magrolimab over 3 hours (± 30 min); starting on 
Cycle 1 Day 8 and thereafter, infuse over 2 hours (± 30 min).
u.
Patients will have their magrolimab dosing schedule changed from weekly to Q2 weeks beginning at Cycle 3. 
v.
RO blood samples (US only) collected on Day 1 of every other cycle during Cycles 3-7, then every 3 cycles (same day as bone marrow RO 
samples) after Cycle 7 through Cycle 13.  Beginning at C3 Day 1, pretreatment PK and ADA samples to be collected every other cycle through 
Cycle 13.
x.
R/R MDS patients who do not achieve an objective response with magrolimab monotherapy at the first protocol response assessment may 
have azacitidine added to magrolimab for subsequent cycles.  For patients who respond to magrolimab monotherapy and then progress, 
azacitidine may be added to magrolimab and patients can still be continued to be treated with the combination.


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Table 14-8.
Schedule of Assessments, TN/U Dose Evaluation Cohort
Assessment
Study 5F9005:  A Phase 1b Trial of Hu5F9-G4 Monotherapy or Hu5F9-G4
in Combination with Azacitidine in Patients with Hematological Malignancies – TN/U Dose Evaluation Cohort
Cycle
(28-day Cycles)
1
2
3+
Visit Window (Days)
-30
None
± 3a
± 3a
± 3
Cycle Day
SC
1
2
3
4
5
6
7
8
11
15
22
1
2
3
4
5
6
7
8
15
22
1
2
3
4
5
6
7
8
15
22
Informed consent
Xb
Demographics
X
Medical and cancer 
history
X
Entry criteria
X
Enrollment cohort 
assignment
Xb
Pregnancy test 
X
Xc
X
X
CBC with differential, 
platelets, 
reticulocytese,f
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Peripheral blood 
smeare,g
X
X
X
X
X
X
X
X
Serum or plasma 
chemistrye
X
X
X
X
X
X
X
X
X
X
X
X
Serum uric acid, 
phosphoruse
X
X
X
X
X
Haptoglobin, 
D-dimer, thrombin, 
fibrinogene
X
X
X
X
X
X
X
PT/INR, aPTTe
X
X
X
X
Type and screen 
(ABO/Rh), DAT 
X
Urinalysise
X
X
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Assessment
Study 5F9005:  A Phase 1b Trial of Hu5F9-G4 Monotherapy or Hu5F9-G4
in Combination with Azacitidine in Patients with Hematological Malignancies – TN/U Dose Evaluation Cohort
Cycle
(28-day Cycles)
1
2
3+
Visit Window (Days)
-30
None
± 3a
± 3a
± 3
Cycle Day
SC
1
2
3
4
5
6
7
8
11
15
22
1
2
3
4
5
6
7
8
15
22
1
2
3
4
5
6
7
8
15
22
Correlative studiesh
X
X
X
X
X
PK (Evaluation 
Cohort)i
X
X
X
X
X
X
X
X
Q2Cy
PK (Expansion 
Cohort)j
X
X X
X
X
X
X
X
Q2Cy
Anti-drug antibodiesk
X
X
X
X
Q2Cy
CD47 RO blood 
(Evaluation Cohort) l
X
X
X
X
X
X
Q2Cy
CD47 RO blood 
(Expansion Cohort)m
X
X
X
X
X
X
Q2C-
Q3Cy
Bone marrow 
aspirate/biopsy for 
CD47 RO/
 
studies
X
X
Q2C-
Q3Cs,t
Bone marrow biopsy 
+ cytogeneticsr,s
X
X
Q2C-
Q3Cs,t
MRD monitoringu
X
Q2C-
Q3Cs,t
Response 
assessment
Q2C-
Q3Cs,t
ECOGe
X
X
X
X
X
X
X
Vital signsn
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Physical 
examinatione,o
X
X
X
X
X
X
X
X
DLT assessmentp
X
CCI
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Assessment
Study 5F9005:  A Phase 1b Trial of Hu5F9-G4 Monotherapy or Hu5F9-G4
in Combination with Azacitidine in Patients with Hematological Malignancies – TN/U Dose Evaluation Cohort
Cycle
(28-day Cycles)
1
2
3+
Visit Window (Days)
-30
None
± 3a
± 3a
± 3
Cycle Day
SC
1
2
3
4
5
6
7
8
11
15
22
1
2
3
4
5
6
7
8
15
22
1
2
3
4
5
6
7
8
15
22
Visual acuitye
X
X
X
X
X
X
X
ECGq
X
X
X
X
Adverse events
Concomitant 
medications
Study Drug 
Administration
Hu5F9-G4 
premedication
X
X
X
X
Hu5F9-G4v,z
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Azacitidinew
X
X
X
X
X
X X
X
X
X
X
X
X
X
X
X
X X
X
X
X
Abbreviations:  ABO = any of the four blood groups A, B, AB, and O comprising the ABO system; ADA = anti-drug antibodies; aPTT = activated 
partial thromboplastin time; C = cycle; CBC = complete blood count; CR = complete remission; CTSC = Clinical Trial Steering Committee; 
DAT = direct antiglobulin test; DLT = dose-limiting toxicity; ECG = electrocardiogram; ECOG = Eastern Cooperative Oncology Group; 
MRD = minimal residual disease; PE = physical examination; PK = pharmacokinetics; PT/INR = prothrombin time/international normalized ratio; 
Q2 = every 2; Q2C = every 2 cycles; Q3C = every 3 cycles; Rh = Rhesus factor; RO = receptor occupancy; SC = Screening; 
TN/U = Treatment-naïve/Unfit; US = United States; W = week(s); WBC = white blood cell.
a.
Note that ± 3 day visit window does not apply to specimen collection for correlative, PK, and RO assessments in Cycles 1 and 2.
Refer to Table 7-7, Table 7-10, Table 7-11, Table 7-15, and Table 7-16 for details.
b.
First dose of Hu5F9-G4 must be given within 30 days of signing informed consent.
c.
Screening pregnancy test may be used if performed within 72 hours of first dose; pregnancy tests will be conducted on Day 1 of every cycle; 
additional guidance is provided in Section 7.3.1.
d.
Not applicable to this cohort.
e.
Pretreatment assessments for the initial dose (Cycle 1 Day 1) may be collected up to 72 hours before administration of either study drug 
(Hu5F9-G4 or azacitidine); thereafter, pretreatment assessments are to be collected within 24 hours prior to study drug administration.
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f.
Samples for CBC must be collected at least once per cycle.  However, CBC sample collection to ensure a WBC level < 20×103/mcL may be 
deferred, based on Investigator assessment of the patient’s WBC kinetics.  Additional samples for CBC may be collected outside of the 
protocol-specified time points to ensure a WBC level < 20×103/mcL.
g.
Peripheral smears will be collected prior to selected study drug infusions/injections and assessed for the presence of hemagglutination in 
addition to standard cell morphology assessment.  Details are provided in Section 7.3.3.
h.
Time point details for correlative studies are provided in Table 7-7.
i.
Time point details for PK studies (Dose Evaluation Group) are provided in Table 7-10.
j.
Time point details for PK studies (Expansion Group) are provided in Table 7-11.
k.
Samples to be collected before administration of either study drug (Hu5F9-G4 or azacitidine), within 72 hours for initial dose and within 
24 hours for subsequent doses.
l.
Time point details for RO studies (Dose Evaluation Group, US only) are provided in Table 7-15.  For visits that include bone marrow 
assessments (e.g., Cycle 3 Day 1), RO blood specimen (US only) should be collected on same day as RO bone marrow specimen is 
collected.
m. Time point details for RO studies (Expansion Group, US only) are provided in Table 7-16.
n.
Vital signs prior to infusion/injection and within 30 minutes after the end of each infusion/injection, before and after administration of each 
study drug (Hu5F9-G4 or azacitidine).  Weight at screening and Day 1 of each cycle.  Details are provided in Section 7.3.5.
o.
Full PE at screening, symptom-directed PE thereafter.  For Cycles 4 and beyond, PEs may be done only on Day 1 of each cycle, at the 
discretion of the Investigator.  
p.
DLT will be assessed throughout the first 4 weeks of study treatment for the Dose Evaluation Cohort only.
q.
Single ECG at screening for all patients.  For TN/U Dose Evaluation Cohort only, triplicate ECGs within 2 hours prior to infusion study drug 
and within 30 minutes of the end of Hu5F9-G4 infusion.  Details are provided in Section 7.3.7.
r.
If a patient is in CR, a bone marrow biopsy for response assessment is not required unless there are clinical signs of relapse.  At each bone 
marrow time point, both trephine (biopsy) and aspirate samples are to be collected for response assessment as well as CD47 receptor 
occupancy (US only), MRD assessment, correlative studies, and biobanking.  Conventional cytogenetics to be tested per institutional 
standards.
s.
Response assessments may be adjusted by ± 4 weeks to coordinate with treatment cycle timing.  After Cycle 3, the window is ± 14 days.
t.
After Cycle 7 Day 1, bone marrow biopsies will be collected every 3 cycles (i.e., Cycle 10 Day 1, Cycle 13 Day 1, etc.).
u.
MRD monitoring to be performed on bone marrow aspirate samples obtained at the bone marrow biopsy time points.
v.
Hu5F9-G4 should not be given on consecutive days.  During Cycle 1, infuse Hu5F9-G4 over 3 hours (± 30 min); thereafter, infuse over 
2 hours (± 30 min).
w. Azacitidine administration should be completed at least 1 hour before Hu5F9-G4 administration, on days when both drugs are administered.
x.
Not applicable to this cohort.
y.
RO blood samples (US only) collected on Day 1 of every other cycle during Cycle 3-7, then every 3 cycles (same day as bone marrow RO 
samples) after Cycle 7 through Cycle 13.  Beginning at Cycle 3 Day 1, pretreatment PK and ADA samples to be collected every other cycle 
through Cycle 13.
z.
Patients will have their Hu5F9-G4 dosing schedule changed from weekly to Q2 weeks beginning at Cycle 3.


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Table 14-9.
Schedule of Assessments, Rollover Cohort
Assessment
Study 5F9005:  A Phase 1b Trial of Magrolimab Monotherapy or Magrolimab
 in Combination with Azacitidine in Patients with Hematological Malignancies – Rollover Cohort
Cycle (28-day Cycles)
1
2
3+
Visit Window (Days)
-30
± 3a
± 3a
± 3
Cycle Day
SC
1
8
15
22
1
8
15
22
1
8
15
22
Informed consent
Xb
Entry criteria
X
Enrollment 
Xb
Pregnancy testc
X
X
X
CBC with differential, 
platelets, reticulocytese,f
X
X
X
X
X
X
Peripheral blood smeare,g
X
X
X
Serum or plasma 
chemistrye
X
X
X
Haptoglobin, D-dimer, 
thrombin, fibrinogene
X
X
X
PT/INR, aPTTe
X
X
X
PKi
X
X
X
Q2Ci
Anti-drug antibodiesk
X
X
X
Bone marrow
biopsy and cytogeneticsr,s
Q2Cs,t
Response assessment
Q2C-
Q3Cs,t
ECOG e
X
X
X
Vital signsn
X
X
X
Physical
examinatione,o
X
X
X
Adverse events
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Assessment
Study 5F9005:  A Phase 1b Trial of Magrolimab Monotherapy or Magrolimab
 in Combination with Azacitidine in Patients with Hematological Malignancies – Rollover Cohort
Cycle (28-day Cycles)
1
2
3+
Visit Window (Days)
-30
± 3a
± 3a
± 3
Cycle Day
SC
1
8
15
22
1
8
15
22
1
8
15
22
Concomitant medications
Study drug administration 
– once weekly or twice 
weeklyv
Cycle Day
SC
1
8
15
22
1
8
15
22
1
8
15
22
Magrolimab – once 
weeklyv
X
X
X
X
X
X
X
X
X
X
X
X
Cycle Day
SC
1
4
8
11
15
18
22
25
1
4
8
11
15
18
22
25
1
4
8
11
15
18
22
25
Magrolimab – twice 
weeklyv
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Abbreviations:  ABO = any of the four blood groups A, B, AB, and O comprising the ABO system; aPTT = activated partial thromboplastin time; 
C = cycle; CBC = complete blood count; CR = complete remission; DAT = direct antiglobulin test; DLT = dose-limiting toxicity; 
ECG = electrocardiogram; ECOG = Eastern Cooperative Oncology Group; MRD = minimal residual disease; PE = physical examination; 
PK = pharmacokinetics; PT/INR = prothrombin time/international normalized ratio; Q2C = every 2 cycles; Q3C = every 3 cycles; Rh = Rhesus 
factor; SC = Screening; W = week(s); WBC = white blood cell.
a.
Note that ± 3 day visit window does not apply to specimen collection for PK assessments in Cycle 2 – refer to Table 14-13 and Table 14-9 
for details.
b.
First dose of magrolimab on this study must be given within 30 days of signing informed consent.
c.
Patient must have a negative pregnancy test within 72 hours before study drug administration on Day 1 of each cycle.
d.
Not applicable to this cohort.
e.
Pretreatment assessments for the initial dose on this study may be collected up to 72 hours before study drug administration; thereafter, 
pretreatment assessments are to be collected within 24 hours prior to study drug administration.
f.
Samples for CBC must be collected at least once per cycle.  However, CBC sample collection to ensure a WBC level < 20×103/mcL may be 
deferred, based on Investigator assessment of the patient’s WBC kinetics.  Additional samples for CBC may be collected outside of the 
protocol-specified time points to ensure a WBC level < 20×103/mcL.
g.
Peripheral smears will be collected prior to selected study drug infusions/injections and assessed for the presence of hemagglutination in 
addition to standard cell morphology assessment.  Details are provided in Section 7.3.3.
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h.
Not applicable to this cohort.
i.
Time point details for PK studies are provided in Table 7-14.  Starting with Cycle 3 Day 1, samples will be collected every other cycle 
through Cycle 13 while patient is receiving magrolimab treatment.
j.
Not applicable to this cohort.
k.
Samples to be collected before dose administration (within 72 hours for initial dose and within 24 hours for subsequent doses).
l.
Not applicable to this cohort.  
m. Not applicable to this cohort.
n.
Vital signs prior to infusion and within 30 minutes after the end of infusion.  Weight at Day 1 of each cycle.  Details are provided in 
Section 7.3.5.
o.
Full PE at screening, symptom-directed PE thereafter.
p.
Not applicable to this cohort.
q.
Not applicable to this cohort.
r.
At each bone marrow time point, both trephine (biopsy) and aspirate samples are to be collected for response assessment, MRD 
assessment, correlative studies, and biobanking.  Cytogenetic assessments (per institutional standards) are required only for MDS patients 
or those who had prior cytogenetic assessments in the previous Phase 1 study (SCI-CD47-002).  
s.
Response assessments may be adjusted by ± 4 weeks to coordinate with treatment cycle timing.  After Cycle 3, window is ± 14 days.
t.
After Cycle 7 Day 1, bone marrow biopsies will be collected every 3 cycles (i.e., Cycle 10 Day 1, Cycle 13 Day 1, etc.).
u.
Not applicable to this cohort.
v.
Magrolimab should not be given on consecutive days.  For Rollover patients, magrolimab may be infused over 2 hours (± 30 min).  Rollover 
patients may continue twice-weekly dosing from their previous study or transition to once-weekly dosing as described in Section 3.4.
w. Not applicable to this cohort.
x.
Not applicable to this cohort.
y.
Not applicable to this cohort.


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Table 14-10. Correlative Studies Sample Time Points, R/R Safety Cohort
Study 5F9005:  A Phase 1b Trial of Hu5F9-G4 Monotherapy or Hu5F9-G4
in Combination with Azacitidine in Patients with Hematological Malignancies
R/R Safety Cohort
Phase 1b
Cycle 1
Cycle 2
C3+
EOT
LTFU
Day
1
8
15
1
1
—
—
Pretreatment (or non-treatment day)a
Xb
X
Xc
X
Xb,c
X
Xd
1 hour (± 15 min) after end of 
Hu5F9-G4 infusion
X
X
Abbreviations:  C = cycle; EOT = end-of-treatment; LTFU = long-term follow-up; min = minute(s); 
R/R = Relapsed/Refractory.
a.
Pretreatment specimens may be collected up to 72 hours before administration of either study 
drug (Hu5F9-G4 or azacitidine).
b.
Sample to be collected before azacitidine infusion.
c.
When bone marrow biopsies are performed, collect blood samples ± 7 days from bone marrow 
collection date; otherwise, collect blood samples ± 7 days from Day 1 of each treatment cycle.
d.
Obtained at the time of disease progression or relapse.
Table 14-11. Pharmacokinetic Assessments, R/R Safety Cohort
Study 5F9005:  A Phase 1b Trial of Magrolimab Monotherapy or Magrolimab
in Combination with Azacitidine in Patients with Hematological Malignancies
R/R Safety Cohort
Cycle 1
Cycle 2
C3+
EOT
SFU
Day
1 4 8
11
15
16
17
18 22 25
1
2 3 4
8
15 22
1
—
—
Pretreatment
(or non-
treatment day)a
X X X
X
X
X
X
X
X
X X X X X X
X
X
X 
Q2Cb
X
X
1 hour (± 15 min) 
after end of 
magrolimab infusion
X X X
X
X
X
X X
X
Abbreviations:  C = cycle; EOT = end-of-treatment; min = minute(s); R/R = Relapsed/Refractory; 
SFU = safety follow-up, Q2C = every 2 cycles.
Note:  PK samples are to be collected from the arm opposite from infusion site, or alternatively, 
infusion site must be flushed with 10 mL of saline.
a.
On days when study treatment is administered, collect pretreatment specimens within 
12 hours prior to study drug administration; on days when no study drug is administered, 
collect specimens at the same time of day (± 8 hours) as the previous collection day.
b.
Pretreatment samples to be collected every other cycle beginning with Cycle 3 through 
Cycle 13.
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Table 14-12. Pharmacokinetic Assessments, TN/U Dose Evaluation Cohort
Study 5F9005:  A Phase 1b Trial of Hu5F9-G4 Monotherapy or Hu5F9-G4
in Combination with Azacitidine in Patients with Hematological Malignancies
TN/U Dose Evaluation Cohort
Cycle 1
Cycle 2
C3+
EOT
SFU
Day
1
7
8
15
22
1
8
1
—
—
Pretreatment a
Xb
X
X
X
Xb
X
X 
Q2Cd
X
X
30 min (± 15 min) 
after end of 
azacitidine 
injection/ infusionc
X
X
X
X 
Q2Cd
1 hour (± 15 min) 
after end of 
Hu5F9-G4 infusion
X
X
X
X
X
X 
Q2Cd
Abbreviations:  C = cycle; EOT = end-of-treatment; min = minute(s); Q2C = every 2 cycles; 
SFU = safety follow-up; TN/U = Treatment-naïve/Unfit.
Note:  PK samples are to be collected from the arm opposite from infusion site, or alternatively, 
infusion site must be flushed with 10 mL of saline.
a.
Collect pretreatment specimens within 12 hours prior to study drug administration.
b.
Pretreatment sample to be collected before either study drug (azacitidine or Hu5F9-G4) is 
started.
c.
Azacitidine will be given at least 1 hour before Hu5F9-G4 on days on which both treatments 
are to be given.
d.
Samples to be collected every other cycle beginning with Cycle 3 through Cycle 13.
Table 14-13. Pharmacokinetic Assessments, Rollover Cohort
Study 5F9005:  A Phase 1b Trial of Hu5F9-G4 Monotherapy or Hu5F9-G4
in Combination with Azacitidine in Patients with Hematological Malignancies
Rollover Cohort
Cycle 1
Cycle 2+
EOT
SFU
Day
1
1
—
—
Pretreatmenta
X
X
Q2Cb
X
X
Abbreviations:  EOT = end-of-treatment; PK = pharmacokinetic, Q2C = every 2 cycles; 
SFU = safety follow-up.
Note:  PK samples are to be collected from the arm opposite from infusion site, or alternatively, 
infusion site must be flushed with 10 mL of saline.
a.
Collect pretreatment specimens within 12 hours prior to study drug administration.
b.
Starting with Cycle 3 Day 1, pretreatment PK samples are to be collected every other cycle 
while the patient is receiving Hu5F9-G4 treatment through Cycle 13.
I 
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Table 14-14. CD47 Receptor Occupancy Sample Time Points,
R/R Safety Cohort
Study 5F9005:  A Phase 1b Trial of Hu5F9-G4 Monotherapy or Hu5F9-G4
in Combination with Azacitidine in Patients with Hematological Malignancies
R/R Safety Cohort
Phase 1b
Cycle 1
Cycle 2
C3+
EOT
SFU
Day
1 4 8
11
15
16
17
18
22
25
1
2
3 4 8
1
5
22
1
—
—
Pre-
treatment 
(or non-
treatment 
day)a
X X X
X
Xb
X
X
X
X
X
Xb
X X X X
X
X
X
Q2C-
Q3Cb
,c
X
X
1 hour 
(± 15 min) 
after end 
of 
Hu5F9-G
4 infusion
X X X
X
X
X
X
X
X
Abbreviations:  C = cycle; EOT = end-of-treatment; min = minute(s); Q3C = every 3 cycles; 
RO = receptor occupancy; R/R = Relapsed/Refractory; SFU = safety follow-up; UK = United 
Kingdom; US = United States.
Note:  RO is a US-only sub-study; RO specimens are not required for UK patients.
a.
On days when study treatment is administered, collect pretreatment specimens within 
12 hours prior to study drug administration; on days when no study drug is administered, 
collect specimens at the same time of day (± 8 hours) as the previous collection day.  
b.
For visits that include bone marrow assessments, RO blood specimen should be collected on 
same day as RO bone marrow specimen is collected.  
c.
RO blood samples collected on Day 1 of every other cycle during Cycles 3 through 7, then 
every 3 cycles (same day as bone marrow RO samples) after Cycle 7 through Cycle 13.
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Table 14-15. CD47 Receptor Occupancy Sample Time Points,
TN/U Dose Evaluation Cohort
Study 5F9005:  A Phase 1b Trial of Hu5F9-G4 Monotherapy or Hu5F9-G4
in Combination with Azacitidine in Patients with Hematological Malignancies
TN/U Dose Evaluation Cohort
Phase 1b
Cycle 1
Cycle 2
C3+
EOT
SFU
Day
1
8
11
15
1
1
—
—
Pretreatment (or non-treatment day)a
Xb
X
X
X
Xb
X
Q2C-
Q3Cb,c,d
X
X
1 hour (± 15 min) after end of 
Hu5F9-G4 infusion
X
Abbreviations:  C = cycle; EOT = end-of-treatment; min = minute(s); RO = receptor occupancy; 
SFU = safety follow-up; TN/U = Treatment-naïve/Unfit.
Note:  RO is a US-only sub-study; RO specimens are not required for UK patients.
a.
Collect pretreatment specimens within 12 hours prior to study drug administration.  
b.
Pretreatment sample to be collected before either study drug (azacitidine or Hu5F9-G4) is 
started.
c.
For visits that include bone marrow assessments, RO blood specimen should be collected on 
same day as RO bone marrow specimen is collected.
d.
RO blood samples collected on Day 1 of every other cycle during Cycles 3 through 7, then 
every 3 cycles (same day as bone marrow RO samples) after Cycle 7 through Cycle 13.
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Appendix G:Pandemic Risk Assessment And Mitigation Plan
During an ongoing pandemic, potential risks associated with patients being unable to 
attend study visits have been identified for this study. 
These risks can be summarized as follows:
1. Study drug supplies to patients and sites:
a. Patients may be unable to return to the site for a number of visits to get 
the study drug, or the site may be unable to accept any patient visits. 
Without study drugs, the patient would not be able to continue receiving 
the study drug as planned per protocol.
Mitigation plan: Study drug supplies may be provided to the patient from 
the site without a clinic visit, once it is confirmed that the patient may 
safely continue on study drug as determined by the Principal Investigator. 
A remote study visit, via phone or video conferencing, must be performed 
before remote study drug resupply. At the earliest opportunity, the site will 
schedule in-person patient visits and return to the protocol’s regular 
schedule of assessments. A qualified courier may be utilized to ship the 
study drug from sites to study patients if permitted by the local ethics 
committee/institutional review board/regulatory authority as applicable and 
with Sponsor's approval.
b. Shipments of study drug could be delayed because of transportation 
issues. Without study drug, the patient would not be able to continue 
receiving the study drug as planned per protocol.
Mitigation plan: The site’s study drug inventory should be closely 
monitored. Site staff should notify the Sponsor or delegate if they foresee 
shortage in study drug inventory or if there is any interruption in local 
shipping service. The Sponsor will continue to monitor inventory at the 
study drug depot and investigational sites. Manual shipments will be 
triggered as necessary.


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2. Patient safety monitoring and follow-up:
a. Patients may be unable or unwilling to come to the investigational site for 
their scheduled study visits as required per protocol.
Mitigation plan: For patients who may be unable or unwilling to visit the 
investigational site for their scheduled study visits as required per protocol, 
the Principal Investigator or qualified delegate will conduct a remote study 
visit, via phone or video conferencing, to assess the patient within the 
target visit window date whenever possible. During the remote study visit, 
the following information at minimum will be reviewed: 
i.
Confirm if patient has experienced any adverse events (AEs)/serious 
adverse events (SAEs)/special situations (including pregnancy) and 
follow up on any unresolved AEs/SAEs.
ii. Review the current list of concomitant medications and document any 
new concomitant medications.
iii. If applicable, confirm electronic diary questionnaires and 
patient-reported outcomes have been completed and transmitted.
iv. If applicable, confirm the patient’s study drug supply is sufficient to last 
until the next planned visit date. If study drug resupply is needed, it will 
be provided as described above in (1).
v. If applicable, remind the patient to maintain current dosing and to keep 
all dispensed study drug kits for return at the next on-site visit.
b. Patients may be unable or unwilling to travel to the site for planned 
assessments (e.g., safety blood draws); hence samples may not be sent 
for central laboratory analyses.
Mitigation plan: Local laboratories or other vendors may be utilized as 
appropriate to monitor patient safety until the patient can return to the site for 
their regular follow-up per protocol. Any changes in the party conducting 
laboratory assessments for the study because of the pandemic will be 
documented accordingly. Pregnancy testing may be performed using a home 
urine pregnancy test if local laboratory pregnancy testing is not feasible.


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c. Patients may be unable or unwilling to attend the study visit to sign an 
updated informed consent form version.
Mitigation plan: The site staff will follow their approved consent process 
and remain in compliance with the local ethics committee/institutional 
review board and national laws and regulations. Remote consent will be 
allowed if has been approved by the local ethics committee/institutional 
review board. The consent process will be documented and confirmed by 
normal consent procedure at the earliest opportunity.
d. The safety of trial participants is important and testing of COVID-19 
infection will be based on local clinical guidelines for testing based on 
signs/symptoms and or suspected exposure to COVID-19.
Mitigation plan: If patient has a diagnosis of COVID-19 while on this 
clinical study, study drugs may be held until clinical improvement or 
resolution in accordance with the treating physician’s judgement and 
general magrolimab/azacitidine dose delay guidance in the protocol. 
Additional supportive care and treatment measures for COVID-19 infection 
on the study will be performed in accordance with local institutional 
guidelines. Patients with a COVID-19 infection while participating in a 
clinical trial will have this event documented as an adverse event in the 
clinical database.
3. Protocol and monitoring compliance:
a. Protocol deviations may occur in case scheduled visits cannot be 
conducted as planned per protocol.
Mitigation plan: If it is not possible to complete a required procedure, an 
unscheduled visit should be conducted as soon as possible when 
conditions allow. The situation should be recorded and explained as a 
protocol deviation. Any missed patient visits or deviation to the protocol 
because of the pandemic must be reported in the eCRF and described in 
the clinical study report. Any remote study visits that are conducted in lieu 


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of clinic visits because of the pandemic will be documented as a protocol 
deviation related to the pandemic.
b. Study monitors may be unable to carry out source data review or source 
data verification, or study drug accountability or assess protocol and Good 
Clinical Practice compliance. This may lead to delays in source data 
verification, an increase in protocol deviations, or underreporting of AEs.
Mitigation plan: The study monitor is to remain in close communication 
with the site to ensure data entry and query resolution. Remote source 
data verification may be arranged if allowed by local regulation and the 
Study Monitoring Plan. The study monitor is to reference the Study 
Monitoring Plan for guidance on how to conduct an off-site monitoring 
visit. The study staff is to save and document all relevant communication 
in the study files. The status of sites that cannot accept monitoring visits 
and/or patients on site, must be tracked centrally and updated on a regular 
basis.
4. Missing data and data integrity:
There may be an increased amount of missing data because of patients 
missing visits/assessments. This could have an impact on the analysis and 
the interpretation of clinical study data. 
Mitigation plan: Implications of a pandemic on methodological aspects for the 
study will be thoroughly assessed and documented, and relevant actions will 
be taken as appropriate (e.g., modification of the statistical analysis plan) and 
in compliance with regulatory authorities’ guidance. Overall, the clinical study 
report will describe the impact of the pandemic on the interpretability of study 
data.  
Risks will be assessed continuously, and temporary measures will be 
implemented to mitigate these risks as part of a mitigation plan, as described 
above. These measures will be communicated to the relevant stakeholders as 
appropriate and are intended to provide alternate methods that will ensure the 
evaluation and assessment of the safety of patients who are enrolled in this 
study. 


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Since these potential risks are considered mitigated with the implementation 
of these measures, the expected benefit risk assessment of magrolimab in 
study patients remains unchanged. 


Protocol 5F9005-Amendment 9
ELECTRONIC SIGNATURES
Signed by
Meaning of Signature
Server Date
(dd-MMM-
yyyy hh:mm:ss)
Clinical Research eSigned
PPD
PPD
-
--

SAP_001.pdf: 
STATISTICAL ANALYSIS PLAN
Study Title:
A Phase 1b Trial of Magrolimab Monotherapy or Magrolimab 
in Combination with Azacitidine in Patients with 
Hematological Malignancies 
Name of Test Drug:
Magrolimab (previously known as Hu5F9-G4) 
Study Number:
5F9005
Protocol Version (Date):
Amendment 9 (21 July 2022)
Analysis Plan Version:
3.0
Analysis Plan Date:
06 February 2023
Analysis Plan Author(s):
CONFIDENTIAL AND PROPRIETARY INFORMATION
PPD
[r) GILEAU 
-


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TABLE OF CONTENTS
STATISTICAL ANALYSIS PLAN ...............................................................................................................................1
TABLE OF CONTENTS................................................................................................................................................2
LIST OF IN-TEXT TABLES .........................................................................................................................................3
LIST OF IN-TEXT FIGURES........................................................................................................................................4
LIST OF ABBREVIATIONS.........................................................................................................................................5
1.
INTRODUCTION..................................................................................................................................................7
1.1.
Study Objectives........................................................................................................................................7
1.2.
Study Design .............................................................................................................................................8
1.3.
Sample Size and Power ...........................................................................................................................10
2.
TYPE OF PLANNED ANALYSIS......................................................................................................................14
2.1.
Primary Analysis .....................................................................................................................................14
2.2.
Follow-up Analysis .................................................................................................................................14
2.3.
Final Analysis..........................................................................................................................................14
3.
GENERAL CONSIDERATIONS FOR DATA ANALYSES.............................................................................15
3.1.
Analysis Sets ...........................................................................................................................................15
3.1.1.
All Enrolled Analysis Set ......................................................................................................15
3.1.2.
Full Analysis Set....................................................................................................................15
3.1.3.
Efficacy Evaluable Analysis Set ...........................................................................................15
3.1.4.
Safety Analysis Set................................................................................................................16
3.1.5.
Pharmacokinetic Analysis Set ...............................................................................................16
3.1.6.
Immunogenicity Analysis Set................................................................................................16
3.2.
Subject Grouping.....................................................................................................................................16
3.3.
Strata and Covariates...............................................................................................................................16
3.4.
Examination of Subject Subgroups .........................................................................................................16
3.5.
Missing Data and Outliers.......................................................................................................................17
3.5.1.
Missing Data..........................................................................................................................17
3.5.2.
Outliers ..................................................................................................................................17
3.6.
Data Handling Conventions and Transformations ..................................................................................17
3.7.
Analysis Visit Windows..........................................................................................................................18
3.7.1.
Definition of Study Day ........................................................................................................18
3.7.2.
Analysis Visit Windows........................................................................................................18
3.7.3.
Selection of Data in the Event of Multiple Records in an Analysis Visit 
Window .................................................................................................................................19
4.
SUBJECT DISPOSITION ...................................................................................................................................20
4.1.
Subject Enrollment and Disposition........................................................................................................20
4.2.
Extent of Study Drug Exposure and Adherence......................................................................................20
4.2.1.
Duration of Exposure to Study Drug.....................................................................................21
4.2.2.
Adherence to Study Drug ......................................................................................................21
4.3.
Protocol Deviations .................................................................................................................................22
5.
BASELINE CHARACTERISTICS .....................................................................................................................23
5.1.
Demographics and Baseline Characteristics ...........................................................................................23
5.2.
Other Baseline Characteristics ................................................................................................................23
5.3.
Medical History.......................................................................................................................................23
5.4.
Prior Anti-cancer Therapy.......................................................................................................................24
6.
EFFICACY ANALYSES.....................................................................................................................................25


Magrolimab 
5F9005 Statistical Analysis Plan 
Version 3.0 
6.1. 
Pri1nruy Efficacy Endpoint ...................................................................................................................... 25 
6.1. 1. 
Definition of the Prima1y Efficacy Endpoint ........................................................................ 25 
6.1.2. 
Statistical Hypothesis for the Primruy Efficacy Endpoint ..................................................... 25 
6.1.3. 
Analyses of the Prima1y Efficacy Endpoint .......................................................................... 25 
6.1.4. 
Sensitivi Anal ses of the Primru Efficac End oint.. ...................................................... 25 
-
6.2. 
Secondruy Efficacy Endpoints ................................................................................................................ 26 
6.2.1. 
Definition of Seconda1y Efficacy Endpoints ......................................................................... 26 
6.2.2. 
Anal sis Methods for Seconda1 Efficac End oints ........................................................... 27 
6.4. 
Changes from Protocol-Specified Efficacy Analyses ............................................................................. 29 
7. 
SAFETY ANALYSES ......................................................................................................................................... 30 
7.1. 
Adverse Events and Deaths ..................................................................................................................... 30 
7.1. 1. 
Adverse Event Dictiona1y ..................................................................................................... 30 
7.1.2. 
Adverse Event Severity ......................................................................................................... 30 
7.1.3. 
Relationship of Adverse Events to Study Dmg ..................................................................... 30 
7.1.4. 
Serious Adverse Events ......................................................................................................... 30 
7.1.5. 
Treatinent-Emergent Adverse Events .................................................................................... 30 
7.1.6. 
SUllllllaries of Adverse Events and Deaths ............................................................................ 31 
7.1.7. 
Additional Analysis of Adverse Events ................................................................................ 33 
7.2. 
Laborato1y Evaluations ........................................................................................................................... 34 
7.2.1. 
SUllllllaries of Numeric Laborat01y Results .......................................................................... 35 
7.2.2. 
Graded Laborato1y Values .................................................................................................... 35 
7.2.3. 
Liver-related Laborat01y Evaluations .................................................................................... 36 
7.2.4. 
Shifts Relative to the Baseline Abnonnality Grade .............................................................. 36 
7 .3. 
Body Weight and Vital Signs .................................................................................................................. 36 
7.4. 
Prior and Concolllitant Medications ........................................................................................................ 37 
7.4.1. 
Prior Medications .................................................................................................................. 37 
7.4.2. 
Conco1nitant Medications ...................................................................................................... 38 
7 .5. 
Electrocru·diogra1n (ECG) Results ........................................................................................................... 38 
7.6. 
Other Safety Measures ............................................................................................................................ 39 
7 .7. 
Changes from Protocol-Specified Safety Analyses ................................................................................. 39 
8. 
PHARMA CO KINETIC (PK) ANALYSES ........................................................................................................ .40 
9. 
IMMUNOGENICITY ANALYSES ................................................................................................................... .41 
10. REFERENCES .................................................................................................................................................... .43 
11. SOFTWARE ......................................................................................................................................................... 44 
12. SAP REVISION .................................................................................................................................................. .45 
13. APPENDICES ..................................................................................................................................................... .46 
Appendix 1. 
Appendix 2. 
Appendix 3. 
Table 1. 
CONFIDENTIAL 
Response Criteria in MDS (IWG 2006 Criteria) .................................................................... .47 
Response Criteria in AML (ELN 2017 Recollllllendations) ................................................... .48 
Additional Response Definitions Used in This Trial (2003 IWG Criteria) ............................ .49 
LIST OF IN-TEXT TABLES 
Analysis Visit Windows for Lab ............................................................................................. 19 
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LIST OF IN-TEXT FIGURES
Figure 1.
Study Schema: Relapsed/Refractory and TN/U Cohorts...........................................................9
Figure 2.
Study Schema: Rollover AML and RBC Transfusion-dependent Low-risk MDS 
Cohorts.....................................................................................................................................10


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LIST OF ABBREVIATIONS
ADA
anti-drug antibody
AE
adverse event
ALT
alanine aminotransferase
AML
acute myeloid leukemia
AST
aspartate aminotransferase
BLQ
below the limit of quantitation
BMI
body mass index
BSA
body surface area
CI
confidence interval
CR
complete remission
CRF
case report form
CSR
clinical study report
CTCAE
Common Terminology Criteria for Adverse Events
DCR
duration of complete remission
DOR
duration of response
ECG
electrocardiogram
ECOG
Eastern Cooperative Oncology Group
EFS
event-free survival
FAS
Full Analysis Set
FAB
French-American-British
HLT
high-level term
IPSS-R
revised international prognostic scoring system
KM
Kaplan-Meier
LLT
lower-level term
LOQ
limit of quantitation
MDS
myelodysplastic syndrome
MedDRA
Medical Dictionary for Regulatory Activities
MRD
minimal residual disease
ORR
Objective response rate
PFS
progression-free survival
PK
pharmacokinetic
PT
preferred term
Q1, Q3
first quartile, third quartile
OS
overall survival
R/R
relapse/refractory
RO
receptor occupancy
SAE
serious adverse event
SAP
statistical analysis plan
SE
Standard error


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SCT
stem cell transplant
StD
standard deviation
SOC
system organ class
TEAE
treatment-emergent adverse event
TFLs
tables, figures, and listings
TN/U
treatment naïve/unfit
TTR
time to response
WHO
World Health Organization


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1.
INTRODUCTION
This statistical analysis plan (SAP) describes the statistical analysis methods and data 
presentations to be used in tables, figures, and listings (TFLs) in the clinical study report (CSR) 
for Study 5F9005. This SAP is updated based on 5F9005 SAP Version 2.0 and the study protocol 
amendment 9 dated 21 July 2022. Any changes made after the finalization of the SAP will be 
documented in the CSR. 
The pharmacodynamics analysis will be described in a separate document.
Analysis methods specified in this document take precedence over those described in protocol 
should there be any difference.  
1.1.
Study Objectives
The primary objectives of this study are as follows:

To confirm the safety and tolerability of magrolimab monotherapy in relapsed/refractory 
(R/R) acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) and of 
magrolimab in combination with azacitidine in previously untreated patients with AML or 
MDS and patients with R/R AML and MDS

To evaluate the safety, tolerability, and efficacy of magrolimab monotherapy in R/R 
AML/MDS, and of magrolimab in combination with azacitidine in previously untreated 
patients with AML/MDS or R/R AML/MDS as measured by complete remission (CR) rate 
for patients with AML and higher-risk MDS

To evaluate the safety, tolerability, and efficacy of magrolimab monotherapy or in 
combination with azacitidine in low-risk MDS patients as measured by RBC transfusion 
independence rate
The secondary objectives of this study are as follows:

To evaluate the pharmacokinetic (PK) profile of magrolimab alone and in combination with 
azacitidine

To evaluate the immunogenicity of magrolimab 

To evaluate the efficacy of magrolimab alone or in combination with azacitidine as measured 
by duration of CR (DCR); objective response rate (ORR); CR with partial hematologic 
recovery; duration of response (DOR) for patients with AML; DCR for higher-risk MDS; 
ORR and DOR for patients with MDS; RBC transfusion independence; mean hemoglobin 
increase on treatment; progression-free survival (PFS); relapse-free survival (RFS), event-
free survival (EFS); and overall survival (OS)

To assess the level of minimal residual disease (MRD) negativity


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1.2.
Study Design
This trial is an open label, multicenter Phase 1b trial investigating the following:

Magrolimab monotherapy or in combination with azacitidine in patients with R/R AML or 
MDS (including R/R low-risk RBC transfusion dependent MDS patients)

Magrolimab in combination with azacitidine in newly diagnosed intermediate/high/very 
high-risk MDS patients 

Magrolimab in combination with azacitidine in newly diagnosed AML patients ineligible for 
standard induction chemotherapy (including TP53 mutant AML) 

Magrolimab monotherapy or in combination with azacitidine for RBC transfusion-dependent 
low-risk MDS patients 
The study includes 4 groups of patients:  

R/R Cohorts:  R/R AML or MDS patients who have not previously received magrolimab, 
who will receive magrolimab monotherapy in the safety run-in cohort or magrolimab 
monotherapy in the R/R MDS Magrolimab Monotherapy Cohort, and who will receive 
magrolimab in combination with azacitidine in the R/R expansion cohort on this study.  The 
R/R MDS Magrolimab Monotherapy Expansion Cohort has been added to further define the 
activity of magrolimab alone in MDS.

Treatment-naïve/Unfit (TN/U) Cohorts:  AML patients ineligible for standard induction 
chemotherapy or previously untreated intermediate/high/very high-risk MDS patients by 
Revised International Prognostic Scoring System (IPSS-R) {Greenberg 2012}, who will 
receive magrolimab in combination with azacitidine on this study.  A subcohort of untreated 
AML patients ineligible for standard induction chemotherapy that have a TP53 gene 
mutation is included here.

RBC Transfusion-dependent Low risk MDS Cohort:  RBC transfusion-dependent very 
low- to low risk MDS patients by IPSS-R who are either of the following:
relapsed/refractory/intolerant to or ineligible for erythropoiesis-stimulating agents (ESA) 
therapy
have a deletion in chromosome 5q who are relapsed/refractory/intolerant to or ineligible 
for lenalidomide therapy

Rollover Cohort:  Patients who received magrolimab in the Phase 1 R/R AML study 
(SCI-CD47-002), who will continue magrolimab monotherapy on this study.
CCI


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Figure 1.
Study Schema: Relapsed/Refractory and TN/U Cohorts
Abbreviations:  AML = acute myeloid leukemia; CTSC = Clinical Trial Steering Committee; D = day; IPSS-R = Revised 
International Prognostic Scoring System; MDS = myelodysplastic syndrome; Q2W = every 2 weeks; Q8 week = every 8 weeks; 
R/R = relapsed/refractory; TN/U = treatment-naïve/unfit; WHO = World Health Organization 
a
Dosing will be 1 mg/kg twice weekly for 1 week (Cycle 1 Days 1 and 4) followed by 15 mg/kg on Cycle 1 Day 8; then 30 
mg/kg twice weekly from Cycle 1 Day11 and thereafter for R/R Safety Cohort or 30 mg/kg on Cycle 1 Days 11, 15, and 22; 
then 30 mg/kg QW in Cycle 2 (Days 1, 8, 15, and 22); then Q2W (Days 1, 15) starting Cycle 3 and thereafter, as per dosing 
schedule for other cohorts..
b
There will be approximately 92 MDS patients in total, inclusive of those 16 MDS patients treated in the original 30-patient 
TN/U Expansion Cohort.
As of Amendment 3 dated as 06 March 2018, the recommended Phase 2 dose and regimen 
(RP2DS) and the recommended dose for the cohort was determined to be magrolimab dosing at 
1 mg/kg on Days 1 and 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and 22; and 30 mg/kg 
QW Cycle 2 and beyond.  As of Amendment 6, the RP2DS, as selected by the CTSC in 
November 2019, was determined to be magrolimab dosing at 1 mg/kg on Days 1 and 4; 
15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and 22; 30 mg/kg QW for Cycle 2; and 30 mg/kg 
Q2W starting Cycle 3 and thereafter.  
Pathologically 
confirmed 
relapsed or 
refractory 
(primary 
refractory and 
relapsed 
refractory) AML, 
or intermediate/ 
high risk MDS as 
defined by WHO 
criteria 
Previously untreated 
AML patients who 
are ineligible for 
standard cytarabine 
+ anthracycline 
induction 
chemotherapy due 
to co-morbidity, age 
or other factors, or 
previously untreated 
intermediate to very 
high risk MDS 
patients by IPSS-R 
R 
Relapsed/Refractory AML/MDS Cohorts 
Magrolimab monotherapy or in combination with azacitidine 
R/R Safety Cohort• 
(10 patients) 
Week4 
R/R Expansion Cohort 
36 
tients 
E -------:> 
1, 15, 30" mg/kg twice 
weekly magrolimab 
CTSC 
Decision 
to Proceed 
Yes -------:> 
1, 15, 30" mg/kg 02W 
magrolimab + 75 mg/m2 
azacitidine 01-7 
G 
s 
T 
E 
R 
R 
E 
G 
I 
s 
T 
E 
R 
*R/R Safety Cohort dosed to enrolment asof 
Amendment 3 
\ 
week response assessments 
\
Treatment until progression 
R/R MDS Magrolimab Monotherapy Cohort 
Simon Stage 1 
(11 patients) 
1, 15, 30" mg/kg 
Q2W magrolimab 
Treatment-na'ive Unfit (TN/U) Cohorts 
Magrolimab + azacitidine 
1111/U Dose Evaluation 
1111/U Expansion 
1P53 mutant 1111/U 
AML Expansion 
(up to 18 patients)• 
(30 patients) 
Level 1: 1, 15, 30" 
mg/kg twice 
RP2D 
----'> weekly magrolimab 
----'> 
+75mg/m2 
azacitidine 01-7 
28--0ay cycles 
Q8 week response assessments 
Treatment until progression 
S'fN/U Evaluation Cohort dosed to 
Enrolment asof Amendment 5 
1, 15,30" mg/kg 
(62 patients) 
magrolimab weekly+ 
1, 15, 30" mg/kg 
75 mg/m2 azacitidine 
D1-7 
magrolimabQ2W + 
75 mg/m2 
t 
azacitidine D1-7 
1111/U Expansion: 
MDS registrational cohort 
(92 total patientsb) 
(36 patients) 
(56 patients) 
CR 
1, 15,30" mg/kg 
> 35.5% 
magrolimabweekly + 
-----:;> 
1, 15, 30"mg/kg 
magrolimabQ2W + 
(23 patients) 
lf>l/11 
No further 
enrollment 
75 mg/m2 azacitidine D1-7 
75 mg/m2 azacitidine D1-7 
Simon Stage 2 
(12 patients) 
1, 15, 30" mg/kg 
Q2W magrolimab 


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Figure 2.
Study Schema: Rollover AML and RBC Transfusion-dependent 
Low-risk MDS Cohorts
Abbreviations:  AML = acute myeloid leukemia; CTSC = Clinical Trial Steering Committee; D =day; del5q = deletion in 
chromosome 5q; ESA = erythropoiesis-stimulating agent; MDS = myelodysplastic syndrome; Q4W = every 4 weeks; 
R/R = relapsed/refractory; TN/U = treatment-naïve/unfit; RBC = red blood cell
a
Dosing will be 1 mg/kg on Cycle 1 Day 1; 30 mg/kg on Cycle 1 Days 8, 15, and 22; and 60 mg/kg Q4W starting Cycle 2 
and thereafter.
b
The safety cohort will be treated with magrolimab monotherapy.  For patients who do not respond after Cycle 2, azacitidine 
may be added on subsequent cycles.
c
The expansion cohort will be treated with magrolimab or magrolimab+azacitidine based on CTSC evaluation of the safety 
cohort.
1.3.
Sample Size and Power
The number of patients planned for inclusion in this trial is up to a total of approximately 
287 patients evaluable for efficacy, as follows:  

R/R Safety Cohort: 10 patients

R/R Expansion Cohort: Up to 36 patients

R/R MDS Magrolimab Monotherapy Cohort: 23 patients

TN/U Dose Evaluation Cohort: Up to 18 patients 
RBC transfusion 
dependent low risk 
MDS patients R/R 
to ESAs or R/R to 
lenalidomide for 
patients with del5q 
Rollover Cohort* 
Magrolimab monotherapy 
Patients on 
*Rollover Cohort Closed to Enrollment as of 
AML Phase 1 Rollover Amendments 
Trial 
(SCI-CD47-002) 
with clinical 
benefit on 
magrolimab 
(Up to 8 patients) 
Continued magrolimab 
treatment until progression 
RBC Transfusion Dependent 
Low Risk MDS Cohort 
R 
E 
G -----3'> 
I 
s 
T 
E 
R 
Magrolimab + azacitidine 
Safety Cohort 
(6 patients) 
1, 30, Go• mg/kg 
Q4W magrolimab 
+ 
75 mg/m2 
azacitidine D1-5b 
Week G 
CTSC 
Decision 
to Proceed 
Expansion Cohort 
(14 patients) 
--------3> 
Yes 
1, 30, Go• mg/kg 
Q4W magrolimab 
+ 
75 mg/m2 
azacitidine D1-5c 


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
TN/U Expansion Cohort: Up to 172 patients, including
Original 30 TN/U Expansion (enrolled 18 AML and 16 MDS patients, including 
4 replacement patients)
At least 92 MDS patients (including the original 16 MDS patients enrolled in the original 
TN/U Expansion), of whom at least 56 patients will be on Q2W dosing.  The overall 
MDS expansion to 92 patients will be considered for TN/U MDS.  
Up to 62 TP53 mutant AML patients (i.e., 12 original TP53 mutation AML patients, plus 
20 additional TP53 mutant AML patients added per CTSC decision in September 2019, 
plus 30 additional TP53 mutant AML patients per CTSC decision July 2020)

RBC Transfusion-dependent Low-risk MDS Cohort:  Up to 20 patients

Rollover Cohort:  Up to 8 patients
For the R/R Safety Cohort and Expansion Cohort, approximately 46 patients may be enrolled, 
including 10 patients treated in the safety run-in cohort and 36 patients treated in the expansion 
cohort.  For the R/R Safety Cohort, 10 patients were enrolled, and this cohort was closed to 
further enrollment as of Amendment 3.  Based on safety and efficacy data, the CTSC may decide 
to expand the R/R Expansion Cohort to include additional patients.  An ORR of 17% has been 
reported in patients with R/R AML who have been treated with azacitidine {Itzykson 2015}.  For 
an estimated response rate of 33% or higher, 36 patients would provide a 95% confidence 
interval, with the lower bound to exclude 18.6%, the azacitidine monotherapy efficacy rate.
Per FDA feedback, a magrolimab monotherapy cohort in R/R MDS will be evaluated to further 
define the activity of magrolimab to the contribution of magrolimab+azacitidine in MDS to 
support a potential single-arm approval of magrolimab+azacitidine in MDS.  Patients will be 
enrolled in a Simon’s 2-stage design.  With a 1-sided significance level of 0.05 and 80% power, 
the null hypothesis that the magrolimab monotherapy ORR is 9% will be tested against the 
alternative of 30%.  In the first stage, 11 patients will be enrolled.  If there are 1 or fewer 
responses observed in these 11 patients, the cohort will be stopped.  Otherwise, 12 additional 
patients will be accrued, for a total of 23.  This cohort was stopped after 11 patients enrolled per 
CTSC decision in October 2020.  The null hypothesis will be rejected if 5 or more responses are 
observed in 23 patients. 
For the TN/U Dose Evaluation Cohort, up to 18 patients can be enrolled based on a 3+3 dose 
de-escalation design assuming 3 potential dose cohorts with a maximum of 6 patients treated per 
cohort.  For the TN/U Dose Evaluation Cohort, 8 patients were enrolled, and this cohort was 
closed to further enrollment as of Amendment 5.  
For the TN/U Expansion Cohort, a total of up to 172 patients may be enrolled. An initial sample 
size of 30 patients was proposed so that the 95% confidence interval of the desired 35% or 
higher CR rate would exclude a known CR rate of 17.85% for azacitidine alone.  This sample 
size calculation was based on inclusion of both TN/U AML and higher-risk MDS patients.  For 
the higher-risk, untreated, MDS-only Expansion Cohort added in Amendment 5 (16 originally 


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enrolled MDS patients + 76 additional patients for n = 92), an evaluation will occur after 
36 patients have reached the first response assessment (Cycle 3 Day 1); however, enrollment will 
continue and will not be paused in the interim.  A sample size of 36 patients provides 80% power 
to reject the null hypothesis that the CR rate is 16.5% or lower at 2-sided 0.05 significant level, 
assuming the true magrolimab+azacitidine CR rate is at least 35.5% (19% improvement).  The 
null CR rate of 16.5% is based on the pivotal randomized trial leading to azacitidine approval in 
MDS reanalyzed by IWG 2000 criteria ({Silverman 2006}, where the upper bound of the 1-sided 
95% confidence interval for azacitidine CR rate is 16.5%, with a point estimate of 10%.  Based 
on Amendment 6, per discussion with the FDA in November 2019, the primary endpoint for this 
untreated, higher-risk MDS cohort was changed from CR+PR to CR rate to support a potential 
single-arm approval.  In accordance with this CR endpoint and a transition to a Q2W 
magrolimab dosing regimen, a cohort of 56 patients at Q2W magrolimab dosing was added.  A 
sample size of 56 patients provides 80% power to reject the null hypothesis that the CR rate is 
16.5% or lower at a 2-sided 0.05 significant level, assuming the true CR rate is at least 31.5% 
(i.e., a 15% improvement).  A combined planned sample size of 92 patients for the MDS 
Registrational Cohort will provide an 80% power to reject the updated null CR rate of 23.5% at a 
2-sided 0.05 significant level, assuming the true magrolimab+azacitidine CR rate is 36.5%.
Per the CTSC decision in September 2019 and Amendment 6, a subcohort of TP53 mutant TN/U 
AML patients was added.  Initially, 12 patients and then an additional 20  patients will be 
enrolled.  Analysis of these patients will include all TP53 mutant patients meeting subcohort 
eligibility criteria enrolled prior to the Amendment/CTSC decision.  A sample size of 32 patients 
was selected to evaluate the initial efficacy of magrolimab+azacitidine as compared to available 
therapies (most notably venetoclax+hypomethylating agents) in TP53 mutant AML.  While 
venetoclax in combination with hypomethylating agents (azacitidine or decitabine) is approved 
in newly diagnosed AML patients who are ineligible for intensive chemotherapy, its efficacy in 
TP53 mutant AML patients is limited.  Per a recent report, the CR+ complete remission with 
incomplete blood count recovery (CRi) rate of venetoclax+hypomethylating agent in TP53 
mutant AML was 47% with a median duration of CR of 5.6 months and a median overall 
survival of 7.2 months {DiNardo 2019}.  In contrast, in all-comer AML patients, the CR+CRi 
rate was 67% with a median duration of CR of 11.3 months and a median overall survival of 
17.5 months.  Assuming an observed magrolimab+azacitidine ORR of 59% for a sample size of 
32 patients, the 1-sided 90% confidence interval will have a lower bound of 46.5%, which 
excludes a control ORR of 46%.  Based on emerging data, the CTSC may decide to enroll 
additional patients for further safety, efficacy, or dosing information.  Per CTSC decision in 
July 2020 and captured in Amendment 7, an additional 30 TP53 mutant AML patients were 
enrolled for the TN/U Expansion TP53 AML Cohort (n = 62).
For the RBC Transfusion-dependent Low-risk MDS Cohort, approximately 20 patients will be 
enrolled.  Initially, 6 patients will be enrolled with a safety evaluation after all 6 patients 
complete at least Cycle 2 Day 15 treatment.  This safety evaluation is being conducted given that 
a 60 mg/kg dose of magrolimab will be administered starting in Cycle 2, of which this highest 
dose has not yet been tested in patients.  However, an equivalent dose of 60 mg/kg given in 
1 week (30 mg/kg twice weekly) has already been administered to MDS and AML patients in 
this trial and has been well tolerated.  The CTSC will then evaluate based on the aggregate safety 
profile in these 6 patients and determine whether enrollment should proceed to the remaining 


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14 patients.  If so, these 14 patients can be simultaneously enrolled.  The sample size of 
20 patients is to be enrolled to evaluate an initial efficacy signal in this population, with further 
enrollment based on this signal.  Based on emerging data, the CTSC may decide to enroll 
additional patients for further safety, efficacy, or dosing information.  These may be enrolled as 
either magrolimab monotherapy or in combination with azacitidine.  Patients may have their 
magrolimab dose interval changed (i.e., to more frequent [Q2W] or less frequent [> Q4W]) at 
any time on therapy based on CTSC recommendations or Sponsor requirement.
For the Rollover Cohort, 1 eligible patient from the Phase 1 study (SCI-CD47-002) is now 
enrolled in this study, and this cohort was closed to further enrollment as of Amendment 3.  


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2.
TYPE OF PLANNED ANALYSIS
2.1.
Primary Analysis
When all the subjects of the TN/U MDS have at least 12 months of efficacy follow-up from their 
first response assessments at the beginning of Cycle 3, or have discontinued from the study, 
outstanding data queries have been resolved or adjudicated as unresolvable, and the data have 
been cleaned and finalized, the primary analysis of the data will be performed.
2.2.
Follow-up Analysis
After the primary analysis, additional supplemental analyses of efficacy and safety may be 
performed to satisfy regulatory requirements or to perform long-term efficacy (eg, overall 
survival) and follow-up safety assessments. P-values for the updated analyses of efficacy are for 
display purposes only, no formal hypothesis testing will be conducted.
2.3.
Final Analysis
After all subjects have completed the study, outstanding data queries have been resolved or 
adjudicated as unresolvable, and the data have been cleaned and finalized, the final analysis of 
the data will be performed.


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3.
GENERAL CONSIDERATIONS FOR DATA ANALYSES
Analysis results will be presented using descriptive statistics. For categorical variables, the 
number and percentage of subjects in each category will be presented; for continuous variables, 
the number of subjects (n), mean, standard deviation (StD) or standard error (SE), median, first 
quartile (Q1), third quartile (Q3), minimum, and maximum will be presented.
All statistical tests will be 2-sided and performed at the 5% significance level unless otherwise 
specified.
By-subject listings will be presented for all subjects in the All Enrolled Analysis Set and sorted 
by subject ID number, visit date, and time (if applicable). Data collected on log forms, such as 
AEs, will be presented in chronological order within the subject. The treatment group to which 
subjects were initially assigned will be used in the listings. Age, sex at birth, race, and ethnicity 
will be included in the listings, as space permits.
3.1.
Analysis Sets
Analysis sets define the subjects to be included in an analysis. Analysis sets and their definitions 
are provided in this section. The analysis set will be identified and included as a subtitle of each 
table, figure, and listing.
For each analysis set, the number and percentage of subjects eligible for inclusion will be 
summarized.
A listing of reasons for exclusion from analysis sets will be provided by subject.
3.1.1.
All Enrolled Analysis Set
All Enrolled Analysis Set includes all subjects who are enrolled into the cohorts specified in 
Section 1.2 based on the enrollment CRF.
3.1.2.
Full Analysis Set
The Full Analysis Set (FAS) includes subjects in All Enrolled Analysis Set, who took at least 
1 dose of magrolimab. For TN/U MDS, subjects who were assessed as higher MDS risk (defined 
as intermediate/high/very high-risk) by IPSS-R at baseline are eligible to be included in FAS. 
This is the primary analysis set for efficacy analyses.
3.1.3.
Efficacy Evaluable Analysis Set
The Efficacy Evaluable Analysis Set includes subjects in the FAS set, who have at least 
1 disease response assessment or who died before the first disease response assessment.
The Efficacy Evaluable Analysis Set is the secondary analysis set for efficacy analyses.


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3.1.4.
Safety Analysis Set
The Safety Analysis Set includes subjects in All Enrolled Analysis Set, who took at least 1 dose 
of magrolimab. This is the primary analysis set for safety analyses.
3.1.5.
Pharmacokinetic Analysis Set
The Pharmacokinetic (PK) Analysis Set will include subjects in All Enrolled Analysis Set, who 
took at least 1 dose of magrolimab and have at least 1 detectable postdose magrolimab 
concentration value reported by the PK laboratory. This is the primary analysis set for all PK 
analyses.
3.1.6.
Immunogenicity Analysis Set
The Immunogenicity Analysis Set includes subjects in All Enrolled Analysis Set, who took at 
least 1 dose of magrolimab and have at least 1 anti-drug antibody (ADA) sample result reported.
3.2.
Subject Grouping
For TN/U MDS cohort, the analyses will be presented by total and then split by dose schedule 
(i.e. QW and Q2W) unless otherwise specified. Subjects with Q2W dosing schedule are defined 
as patients who start to receive 1 magrolimab dose every 2 weeks starting at Cycle 3. Subjects 
with QW dosing schedule are defined as patients who do not start 1 magrolimab dose every 
2 weeks at the beginning of Cycle 3. For patients who discontinued from treatment before 
Cycle 3, the patients will be counted under the planned dose schedule. 
PK and immunogenicity analyses might follow different grouping structure.  
3.3.
Strata and Covariates
This study does not use a stratified randomization schedule when enrolling subjects. 
No covariates will be included in efficacy and safety analyses.
3.4.
Examination of Subject Subgroups
Subgroup analyses based on baseline characteristics will be explored for TN/U MDS cohort. The 
presumed prognostic baseline characteristics include the following:

Age (< 65 years and  65 years)

Sex (male and female)

Race (white and all other races)

IPSS-R for MDS Risk Category (intermediate, high, and very high)

Baseline bone marrow blast (<=5% and >5%)


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
TP53 status (mutant and wild type)

Cytogenetics status (complex and not complex) 

Cytogenetics risk category (favorable, intermediate, and poor)

MDS status (therapy related and non-therapy related)  

ECOG status (0, 1, and 2)
If the number of subjects in one or more subgroups is too small to conduct the analysis, some 
subgroups will be pooled for the analysis. 
3.5.
Missing Data and Outliers
3.5.1.
Missing Data
In general, missing data will not be imputed unless methods for handling missing data are 
specified. Exceptions are presented in this document.
For missing last dosing date of study drug, imputation rules are described in Section 4.2.1. The 
handling of missing or incomplete dates for disease diagnosis is described in Section 5.3, for date 
of death and the start date of new anti-cancer therapy in Section 6.2.2, for AE onset in 
Section 7.1.5.2, and for prior and concomitant medications in Section 7.4.
3.5.2.
Outliers
Outliers will be identified during the data management and data analysis process, but no 
sensitivity analyses will be conducted. All data will be included in the data analysis.
3.6.
Data Handling Conventions and Transformations
The following conventions will be used for the imputation of date of birth when it is partially 
missing or not collected:

If only month and year of birth is collected, then “15” will be imputed as the day of birth

If only year of birth is collected, then “01 July” will be imputed as the day and month of birth

If year of birth is missing, then date of birth will not be imputed
In general, age will be derived based on date of birth and the date of the first dose of study drug 
administration. If complete date of birth is not available, the reported age will be used instead. If 
an enrolled subject was not dosed with any study drug, the enrollment date will be used instead 
of the Day 1 visit date. For screening failures, the date the informed consent was signed will be 
used for the age derivation. Age required for longitudinal and temporal calculations and analyses 
(eg, estimates of creatinine clearance, age at date of AE) will be based on age derived from date 
of birth and the date of the measurement or event, unless otherwise specified.


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Non-PK data that are continuous in nature but are less than the lower limit of quantitation (LOQ) 
or above the upper LOQ will be imputed as follows:

A value that is 1 unit less than the LOQ will be used to calculate descriptive statistics if the 
datum is reported in the form of “ x” (where x is considered the LOQ). For example, if the 
values are reported as < 50 and < 5.0, values of 49 and 4.9, respectively, will be used to 
calculate summary statistics. An exception to this rule is any value reported as < 1 or < 0.1, 
etc. For values reported as < 1 or < 0.1, a value of 0.9 or 0.09, respectively, will be used to 
calculate summary statistics.

A value that is 1 unit above the LOQ will be used to calculate descriptive statistics if the 
datum is reported in the form of “> x” (where x is considered the LOQ). Values with decimal 
points will follow the same logic as above.

The LOQ will be used to calculate descriptive statistics if the datum is reported in the form of 
“≤ x” or “≥ x” (where x is considered the LOQ).
If methods based on the assumption that the data are normally distributed are not adequate, 
analyses may be performed on transformed data or nonparametric analysis methods may be used, 
as appropriate.
3.7.
Analysis Visit Windows
3.7.1.
Definition of Study Day
Study day will be calculated from the first dosing date of study drug and derived as follows:

For postdose study days: Assessment Date – First Dosing Date + 1

For days prior to the first dose: Assessment Date – First Dosing Date 
Therefore, study day 1 is the day of first dose of study drug administration.
3.7.2.
Analysis Visit Windows
Subject visits might not occur on protocol-specified days. Therefore, for the purpose of analysis, 
observations will be assigned to analysis windows. The analysis windows for lab are provided in 
Table 1:


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Table 1.
Analysis Visit Windows for Lab
Visit Window Study Day
Analysis Visit
Nominal Study Day
Lower Limit
Upper Limit
Baseline  
1a
Week 1
8
1b
11
Week 2
15
12
18
Week 3
22
19
25
Week 4
29
26
32
Week 5
36
33
39
Week 6
43
40
46
Week 7
50
47
53
Week 8
57
54
63
Week 10
71
64
77
Week xx
xx*7+1
(xx-1)*7+1
(xx+1)*7
a
Prior to first dose date time.
b
Post first dose date time.
The nominal visit as recorded on the CRF will be used when data are summarized by visit. 
However, the following exceptions will be made:

An unscheduled visit prior to the first dosing of study drug will be included in the calculation 
of the baseline value, if applicable.

Unscheduled visits after the first dosing of study drug will be included in determining the 
maximum postbaseline toxicity grade.
3.7.3.
Selection of Data in the Event of Multiple Records in an Analysis Visit 
Window
For baseline, the last nonmissing value on or prior to the first dosing date of study drug will be 
selected, unless specified differently. If there are multiple records with the same time or no time 
recorded on the same day, the baseline value will be the average of the measurements for 
continuous data, or the measurement with the lowest severity (eg, normal will be selected over 
abnormal for safety findings) for categorical data.
For postbaseline values:

The record closest to the nominal day for that visit will be selected.

If there are 2 records that are equidistant from the nominal day, the later record will be 
selected.

If there is more than 1 record on the selected day, the average will be taken for continuous 
data and the worse severity will be taken for categorical data, unless otherwise specified.


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4.
SUBJECT DISPOSITION
4.1.
Subject Enrollment and Disposition
A summary of subject enrollment will be provided for each country, investigator and overall. 
The summary will present the number and percentage of subjects enrolled. For each column, the 
denominator for the percentage calculation will be the total number of subjects analyzed for that 
column.
A summary of subject disposition will be provided. This summary will present the number of 
subjects screened, the number of subjects enrolled, and the number of subjects in each of the 
categories listed below:

Safety Analysis Set 

Full Analysis Set

Efficacy Evaluable Analysis Set

Continuing Magrolimab 

Continuing Azacitidine

Magrolimab discontinuation and reasons 

Azacitidine discontinuation and reasons

Survival follow-up status

Study discontinuation and reasons
For the status of study drug and study completion and reasons for discontinuation, the number 
and percentage of subjects in each category will be provided. The denominator for the 
percentage calculation will be the total number of subjects in the All Enrolled Analysis Set 
corresponding to that column. 
The by-subject listing will be provided by subject identification (ID) number in ascending order 
to support the above summary tables. 
4.2.
Extent of Study Drug Exposure and Adherence
Extent of exposure to study drug will be examined by assessing the total duration of exposure to 
study drug and the level of adherence relative to the study drug regimen specified in the protocol. 
The analyses will be done for magrolimab and azacitidine separately. 


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4.2.1.
Duration of Exposure to Study Drug
Total duration of exposure to study drug will be defined as last dosing date minus first dosing 
date plus 1, regardless of any temporary interruptions in study drug administration, and will be 
expressed in months. If the last study drug dosing date is missing,

If the study drug is permanently withdrawn, the latest date among the study drug end date, 
start date of AE leading to study treatment discontinuation, clinical visit date, laboratory 
sample collection date, and vital signs assessment date that occurred during the on-treatment 
period will be used for subjects included in the final analyses or the last available date in the 
database snapshot for subjects who were still on treatment at the time of an interim analysis.

If the study drug completion status is unknown, the earlier of the date of death or data cutoff 
date for analysis will be used.
The total duration of exposure to study drug will be summarized using descriptive statistics. 
Summaries will be provided for the Safety Analysis Set.
The number of cycles subjects were exposed to each study drug will be summarized using 
descriptive statistics, as well as the number and percentage of subjects exposed to a given cycle 
category (eg, ≥1, ≥2, ≥3, etc).
The number and percentage of subjects with infusion interruptions and discontinuation will be 
summarized.
4.2.2.
Adherence to Study Drug
4.2.2.1.
Average Actual Dosage
The level of adherence of each drug will be calculated based on the following formulas and 
summarized respectively using descriptive statistics:

Adherence per Specified Dose Level (%) =  
Total Amount of Study Drug Administered
Study Drug Prescribed to be Administered  x 100

Adherence of Specified Cycle (%) 
=
Doses (mg) Administered within Actual Cycle
Doses (mg) Specified by Protocol within Specified Cycle   x 100, 
averaged across all cycles treated

Adherence of Average Daily Dose (%) 
= Doses (mg) Administered within Actual Cycle/Actual Cycle Length
Doses (mg) Specified by Protocol within Specified Cycle/28 Days  x 100, 
averaged across all cycles treated
No formal statistical testing is planned.
(-----) 


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A by-subject listing of each study drug administration will be provided by subject ID number 
(in ascending order) and visit (in chronological order).
4.3.
Protocol Deviations 
Subjects who did not meet the eligibility criteria for study entry, but enrolled in the study will be 
summarized. The summary will present the number and percentage of subjects who did not meet 
at least 1 eligibility criterion and the number of subjects who did not meet specific criteria based 
on the All Enrolled Analysis Set. A by-subject listing will be provided for those subjects who did 
not meet at least 1 eligibility (inclusion or exclusion) criterion. The listing will present the 
eligibility criterion (or criteria if more than 1 deviation) that subjects did not meet and related 
comments, if collected.
Protocol deviations occurring after subjects entered the study are documented during routine 
monitoring. The number and percentage of subjects with important protocol deviations by 
deviation reason (eg, nonadherence to study drug, violation of select inclusion/exclusion criteria) 
will be summarized for the All Enrolled Analysis Set. A by-subject listing will be provided for 
those subjects with important protocol deviation.


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5.
BASELINE CHARACTERISTICS  
5.1.
Demographics and Baseline Characteristics
Subject demographic variables (ie, age, sex, race, and ethnicity) and baseline characteristics 
(body weight [in kg], height [in cm], body mass index [BMI; in kg/m2], Body Surface Area 
[BSA; in m2]) will be summarized using descriptive statistics for continuous variables and using 
number and percentage of subjects for categorical variables. The summary of demographic data 
will be provided for the Safety Analysis Set.
A by-subject demographic listing, including the informed consent date, will be provided by 
subject ID number in ascending order.
5.2.
Other Baseline Characteristics
ECOG performance status will be summarized for the Safety Analysis Set and will be listed. 
5.3.
Medical History
Medical history will be collected at screening for disease-specific and general conditions 
(ie, conditions not specific to the disease being studied).
The following disease-specific medical history will be summarized for the Safety Analysis Set. 
No formal statistical testing is planned. 

Time since initial AML/MDS diagnosis (months)

Time since the most recent AML/MDS assessment (months)

Revised International Prognostic Scoring System (IPSS-R) for MDS risk category

AML Cytogenetic and Molecular Risk Group by European Leukemia Net (ELN) Criteria

World Health Organization (WHO) Classification of AML/MDS

French-American-British (FAB) Classification of AML

Therapy-related MDS (Yes/No)

AML/MDS status at enrollment

RBC-transfusion Independence at Enrollment (Yes/No)

Cytogenetic risk assessment

TP53 mutation status


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Time since initial AML/MDS diagnosis (months) will be calculated by (date of first dosing date 
of study drug (or enrollment date if patient is not treated with any study drug) – date of initial 
AML/MDS diagnosis) / 30.4375. Time since date of most recent AML/MDS assessment 
(months) will be calculated by (date of first dosing date of study drug (or enrollment date if 
patient is not treated with any study drug) – date of most recent AML/MDS diagnosis) /30.4375. 
In deriving the time since AML/MDS diagnosis, the partial dates will be imputed as follows:

If day and month are missing but year is available, then the imputed day and month will be 
01 Jan.

If day is missing but the month and year are available, then the imputed day will be the 
first day of the month.

Partial date will not be imputed if the year is missing.
A by-subject listing of general medical history will be provided by subject ID number in 
ascending order.
5.4.
Prior Anti-cancer Therapy
Number of prior regimens, time since the completion of last regimen, and time since progression 
in the last regiment will be using descriptive statistics based on the Safety Analysis Set. A partial 
completion date will be imputed using the algorithm defined in Section 5.3.
The regimens and prior therapies that the subjects received will be summarized and listed. The 
last regimen subjects received prior to study entry and the best response and PD to the last 
regimen will be summarized.
Number of subjects who received prior radiation therapy, prior cancer-related surgery, and prior 
transfusions within 8 weeks prior to enrollment will be summarized and listed.


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6.
EFFICACY ANALYSES
Response will be assessed in MDS subjects using the criteria in Appendix 1, which are based on 
the 2006 IWG criteria {Cheson 2006}. For AML subjects, response assessment criteria are in 
Appendix 2 (which are based on ELN AML recommendation {Dohner 2017}) and IWG criteria 
{Cheson 2003} in Appendix 3.
6.1.
Primary Efficacy Endpoint
6.1.1.
Definition of the Primary Efficacy Endpoint
The primary efficacy endpoint of this study for MDS registrational cohort is: 
CR Rate for MDS:  The CR rate is the proportion of subjects who achieve complete remission 
per IWG 2006 criteria {Cheson 2006} per investigator’s evaluation prior to initiation of any 
other new anti-cancer therapy including stem cell transplant (SCT).
CR Rate for AML: The CR rate is the proportion of subjects who achieved complete remission 
without minimal residual disease and complete remission per ELN 2017 Recommendation 
{Dohner 2017} and IWG criteria {Cheson 2003} per investigator’s evaluation prior to initiation 
of any other new anti-cancer therapy including SCT.
6.1.2.
Statistical Hypothesis for the Primary Efficacy Endpoint 
The primary efficacy hypothesis to be tested for TN/U MDS is:
𝐻0: CR rate = 23.5%
𝐻1: CR rate ≠ 23.5%
6.1.3.
Analyses of the Primary Efficacy Endpoint
The analyses of primary efficacy endpoint will be based on the FAS. 
CR rate and 95% confidence interval will be estimated using Clopper-Pearson method. The 
hypothesis will be tested at 2-sided 0.05 significance level based on exact method and p value 
will be presented. 
6.1.4.
Sensitivity Analyses of the Primary Efficacy Endpoint
To assess the robustness of the primary efficacy results, CR rate will be analyzed based on the 
Efficacy Evaluable Analysis Set.
EFS will be analyzed without considering any other new anti-cancer therapy as a censoring 
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I 
I 
I 
I 
6.2. 
6.2.1. 
Secondary Efficacy Endpoints 
Definition of Secondary Efficacy Endpoints 
The secondaiy efficacy endpoints include: 
Version 3.0 
DCR: The DCR is defined as the time from the date of the first CR (prior to initiation of any 
other new anti-cancer therapy including SCT) until the date of documented relapse disease or 
death from any cause, whichever occurs first. Subjects who ai·e not observed to have relapse 
disease or death will be censored at their last response assessment date. 
Objective Response Rate (ORR): For AML, the ORR is the propo1tion of subjects who 
achieve Complete Response (CR), CR with incomplete hematologic (count) recove1y (CRi), CR 
with paitial hematologic (count) recove1y (CRh), Paitial Response (PR), Mmphologic 
Leukeinia-Free State (MLFS) prior to initiation of a new anti-cancer therapy including SCT per 
European Leukeinia Net (ELN) AML 2017 recommendations {Dohner 2017} per investigator's 
evaluation. 
For MDS, the ORR is the propo1tion of subjects who achieve Complete Reinission (CR), Pa1tial 
Reinission (PR), maiTow CR or hematological improvement (HI) prior to initiation of a new anti-
cancer therapy including SCT per IWG 2006 criteria {Cheson 2006} per investigator's 
evaluation. 
Duration of Response (DOR): The DOR is measured from the time assessment criteria are first 
met for objective response (prior to initiation of any other new anti-cancer therapy including 
SCT) until the first date of documented relapse, disease progression or death. Those who ai·e not 
observed to have one of these events will be censored at their last response assessment date 
without evidence of progression/relapse. 
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Ma gr oli ma b
5 F 9 0 0 5 Statistical A nal ysis Pla n
Versi o n 3. 0
C O N FI D E N TI A L
Pa ge 2 7
0 6 Fe br uar y 2 0 2 3
O ver all S ur vi v al ( O S) :  O S is meas ure d fr o m t he date of st u d y treat me nt i nitiati o n u ntil t he date 
of deat h fr o m a n y ca use.  T h ose w h o are n ot o bser ve d t o die d uri n g t he st u d y will be ce ns ore d at 
t heir last k n o w n ali ve date.
Pr o gressi o n-free S ur vi v al ( P F S) :  P F S is defi ne d as t he ti me fr o m t he date of st u d y treat me nt 
i nitiati o n u ntil t he date of d oc u me nte d rela pse, disease pr o gressi o n or deat h fr o m a n y ca use, 
w hic he ver occ urs first. T h ose w h o are n ot o bser ve d t o ha ve o ne of t hese e ve nts will be ce ns ore d 
at t heir last res p o nse assess me nts date wit h e vi de nce of n o disease pr o gressi o n/rela pse.
E ve nt-free S ur vi v al ( E F S) :  F or A M L, E F S is defi ne d as t he ti me fr o m t he date of st u d y 
treat me nt i nitiati o n u ntil t he date of d oc u me nte d disease pr o gressi o n, deat h fr o m a n y ca use, or 
treat me nt fail ure ( defi ne d as fail ure t o ac hie ve C R/ C Ri/ C R h b y C ycle 5 Da y 1), w hic he ver 
occ urs first.  
F or M D S, E F S is defi ne d as t he ti me fr o m t he date of st u d y treat me nt i nitiati o n t o tra nsf or mati o n 
t o A M L or deat h fr o m a n y ca use, w hic he ver occ urs first.  Patie nts w h o are n ot o bser ve d t o ha ve 
o ne of t hese e ve nts d uri n g t he st u d y will be ce ns ore d at t heir last res p o nse assess me nt date wit h 
e vi de nce of n o tra nsf or mati o n t o A M L. 
R B C Tr a nsf usi o n I n de pe n de nce R ate : T he R B C tra nsf usi o n i n de pe n de nce rate is t he 
pr o p orti o n of patie nts w h o ha ve a 5 6- da y or l o n ger peri o d wit h n o R B C tra nsf usi o ns at a n y ti me 
bet wee n t he date of st u d y treat me nt i nitiati o n a n d treat me nt disc o nti n uati o n a m o n g all patie nts 
w h o are R B C tra nsf usi o n- de pe n de nt at baseli ne.
M R D Ne g ati ve Res p o nse R ate : T he M R D- ne gati ve res p o nse rate is defi ne d as t he pr o p orti o n of 
patie nts w h o reac h M R D- ne gati ve disease stat us pri or t o i nitiati o n of ot her ne w a nti-ca ncer 
t hera p y i ncl u di n g S C T a n d  ac hie ve a m or p h ol o gic C R or marr o w C R f or M D S patie nts a n d 
ac hie ve C R/ C Ri/ C R h/ M L F S f or A M L patie nts. M R D- ne gati ve disease stat us will be assesse d 
usi n g a m ulti para meter fl o w c yt o metr y base d assa y perf or me d b y a ce ntral la b orat or y.
6. 2. 2.  
A n al ysis Met h o ds f or Sec o n d ar y Effic ac y E n d p oi nts
O R R a n d t he best res p o nse will be s u m marize d b y t he n u m ber of s u bjects a n d t he fre q ue nc y. 
9 5 % CI base d o n Cl o p per- Pears o n met h o d will be prese nte d f or O R R. A n y res p o nse assess me nts 
after ot her a nti-ca ncer t hera p y i ncl u di n g S C T will e xcl u de d fr o m t he a nal yses.
D C R, D O R, P F S, E F S, a n d O S will be a nal yze d usi n g t he Ka pla n- Meier met h o d. A nal ysis of 
D C R will be a nal yze d o n patie nts w h o ac hie ve d C R pri or t o i nitiati o n of a n y ot her ne w a nti-
ca ncer t hera p y i ncl u di n g S C T, a n d D O R will be a nal yze d o n patie nts w h o ac hie ve d o bjecti ve 
res p o nses pri or t o i nitiati o n of a n y ot her ne w a nti-ca ncer t hera p y i ncl u di n g S C T. P F S, E F S, a n d 
O S will be c o n d ucte d o n F A S. T he K M esti mate of me dia n, 9 5 % CI of me dia n, Q 1, a n d Q 3 will 
be prese nte d. Ka pla n- Meier pl ot will be pr o vi de d w he n a p pr o priate. T he f oll o wi n g ce ns ori n g 
r ules will be i m ple me nte d:
F or O S: if s u bjects are n ot k n o w n t o be dea d at t he ti me of a nal ysis, t he s u bjects will be ce ns ore d 
at t he last k n o w n ali ve date. 
F or D C R, D O R, P F S, E F S, a n d Ti me t o Tra nsf or mati o n t o A M L (secti o n ):


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• 
For DCR and DOR, if subjects have only one CR or ORR prior to any other new anti-cancer 
therapy (if there is) without any subsequent response assessments or events, the subjects will 
be censored on the CR/ORR date (i.e. duration of 1 day). 
• 
For PFS, EFS and Time to Transfonnation to AML, if subjects do not have any response 
assessment or conesponding events prior to any other new anti-cancer therapy (ifthere is), 
the subjects will be censored on Study Day 1 (i.e. duration of 1 day). 
• 
If subjects do not have any events, the subjects will be censored at the last response 
assessment on or before any other new anti-cancer therapy (if there is) excluding SCT. 
• 
If subjects are observed to have events occmTed after any other new anti-cancer therapy (if 
there is) excluding SCT, the subjects will be censored at their last response assessment date 
on or before any other new anti-cancer therapy excluding SCT. 
Eve1y attempt will be made to ensure that complete death dates are recorded. In those rare 
instances where complete death dates are not recorded, the following algorithm will be used: 
• 
If day is missing but the month and year are available, then the imputed date will be the first 
day of the month or the last known alive date + 1, whichever is later. 
• 
If day and month are missing but year is available, then the imputed date will be 0lJan of 
that year or the last known alive date + 1, whichever is later. 
When the date of initiation of any other new anti-cancer therapy is incomplete or missing, the 
following algorithm will be followed: 
• 
If the day is missing but the month and year are available, then the imputed day will be the 
first day of the month or the day of last dose + 1 if the month and year of new anti-cancer 
therapy and the month and year of last dose are the same. 
• 
If day and month are missing but year is available, then the imputed day and month will be 
0lJan or the date oflast dose+ 1 if the year of new anti-cancer therapy and the year oflast 
dose are the same. 
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Time to Response (TTR): Time to response is defined as the time for the date of study 
treatment initiation to the date of first OR prior to any other new anti-cancer therapy including 
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6.4. 
Changes from Protocol-Specified Efficacy Analyses 
As secondaiy efficacy endpoints, RFS will not be analyzed since the cunent definition of DCR is 
same RFS. And 12-week RBC transfusion independence rates won't be provided due to clinical 
conce1ns. 
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7.
SAFETY ANALYSES
7.1.
Adverse Events and Deaths
7.1.1.
Adverse Event Dictionary
Clinical and laboratory adverse events (AEs) will be coded using the current version of 
MedDRA. System organ class (SOC), high-level group term (HLGT), high-level term (HLT), 
preferred term (PT), and lower-level term (LLT) will be provided in the AE dataset.
7.1.2.
Adverse Event Severity
Adverse events are graded by the investigator as Grade 1, 2, 3, 4, or 5 according to CTCAE 
Version 4.03 or customized AE severity grading as defined in the protocol Appendix B (for 
hemagglutination and microangiopathy AEs). The severity grade of events for which the 
investigator did not record severity will be categorized as “missing” for tabular summaries and 
data listings. The missing category will be listed last in summary presentation.
7.1.3.
Relationship of Adverse Events to Study Drug
Related AEs are those for which the investigator selected “Related” on the AE CRF to the 
question of “Relationship to magrolimab” or “Relationship to azacitidine”.  Relatedness will 
always default to the investigator’s choice, not that of the medical monitor. Events for which the 
investigator did not record relationship to study drug will be considered related to study drug for 
summary purposes. However, by-subject data listings will show the relationship as missing.
7.1.4.
Serious Adverse Events
Serious adverse events (SAEs) will be identified and reported as SAEs if the AEs met the 
definitions of SAEs that were specified in the study protocol. SAEs captured and stored in the 
clinical database will be reconciled with the SAE database from the Gilead Global Patient Safety 
Department before data finalization.
7.1.5.
Treatment-Emergent Adverse Events 
7.1.5.1.
Definition of Treatment-Emergent Adverse Events
Treatment-emergent adverse events (TEAEs) are defined as 1 or both of the following:

Any AEs with an onset date on or after the study drug start date and no later than 30 days 
after permanent discontinuation of study drug and before the first date of new anti-cancer 
therapy including SCT

Any AEs leading to discontinuation of study drug.


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7.1.5.2.
Incomplete Dates
If the onset date of the AE is incomplete and the AE stop date is not prior to the first dosing date 
of study drug, then the month and year (or year alone if month is not recorded) of onset 
determine whether an AE is treatment emergent. The event is considered treatment emergent if 
both of the following 2 criteria are met:

The AE onset is the same as or after the month and year (or year) of the first dosing date of 
study drug, and

The AE onset date is the same as or before the month and year (or year) of the date 
corresponding to 30 days after the date of the last dose of study drug 
An AE with completely missing onset and stop dates, or with the onset date missing and a stop 
date later than the first dosing date of study drug, will be considered to be treatment emergent. In 
addition, an AE with the onset date missing and incomplete stop date with the same or later 
month and year (or year alone if month is not recorded) as the first dosing date of study drug will 
be considered treatment emergent.
In case when the AE onset date is incomplete and needs to be imputed, the following algorithm 
will be followed:

If the day is missing but the month and year are available, then the imputed day will be the 
first day of the month or the first dosing date if they have the same month and year, 
whichever is later.

If the day and month are missing but year is available, then the imputed day and month will 
be 01Jan or the first dosing date if they have the same year, whichever is later.
7.1.6.
Summaries of Adverse Events and Deaths
Treatment-emergent AEs will be summarized based on the Safety Analysis Set.
7.1.6.1.
Summaries of AE Incidence by Severity 
The number and percentage of subjects who experienced at least 1 TEAE will be provided and 
summarized by SOC, and PT. For the AE categorizes described below, summaries will be 
provided by SOC, PT and maximum severity:

TEAEs

TEAEs with Grade 3 or higher

TE magrolimab-related AEs

TE azacitidine-related AEs 


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
TE magrolimab-related AEs with Grade 3 or higher

TE azacitidine-related AEs with Grade 3 or higher

TE SAEs

TE magrolimab-related SAEs

TE azacitidine-related SAEs

TEAEs leading to discontinuation of azacitidine

TEAEs leading to discontinuation of magrolimab

TE AEs leading to death (ie, outcome of death)

TEAEs leading to dose delay or interruption of azacitidine

TEAEs leading to dose reduction of azacitidine

TEAEs leading to dose delay or interruption of magrolimab

TEAEs leading to dose reduction of magrolimab
A brief, high-level summary of AEs described above will be provided by the number and 
percentage of subjects who experienced the above AEs.
Multiple events will be counted only once per subject in each summary. Adverse events will be 
summarized and listed first in alphabetic order of SOC and then by PT in descending order of 
total frequency within each SOC. For summaries by severity, the most severe severity will be 
used for those AEs that occurred more than once for a given subject during the study.
In addition to the above summary tables, all TEAEs, TEAEs of Grade 3 or higher, TE SAEs and 
TE treatment-related AEs will be summarized by PT only in descending order of total frequency.
In addition, data listings will be provided for the following:

All AEs, indicating whether the event is treatment emergent

All AEs with Grade 3 or higher

All SAEs

All Deaths

All AEs leading to death (ie, outcome of death)


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
All AEs leading to discontinuation of any study drug

TEAEs leading to dose delay or temporary interruption of any study drug

TEAEs leading to dose reduction of any study drug
7.1.6.2.
Summary of Deaths
A summary (number and percentage of subjects) of deaths will be provided. The summary will 
include the following categories:

All deaths

Deaths within 30 days of the first or the last dosing of study drug

Deaths within 60 days of the first dosing of study drug

Deaths beyond 30 days of the last dosing of study drug
7.1.7.
Additional Analysis of Adverse Events
The incidence of infusion reaction AEs and Treatment-Emergent AEs will be examined. 
7.1.7.1.
Infusion Reaction Adverse Events (IRAE)
The incidence of infusion reaction AEs will be examined. Infusion reaction AEs are defined by 
the NCI CTCAE (under the category “General disorders and administration site conditions”) as 
“a disorder characterized by adverse reaction to the infusion of pharmacological or biological 
substances”. For the purpose of this study, they are defined as AEs described in Amendment 7 
that occur within the 24-hour period beginning from the start of the infusion.  
The number and percentage of subjects who experienced any of the infusion reaction AEs events 
assessed by investigators will be summarized by PT. 
7.1.7.2.
Treatment-Emergent Adverse Events (TEAE) of Special Interest
The following AEs of special interest (may not limit to) will be summarized: 

Anaemia (MST Anemia_Extravascular Transient Hemolysis)

Infusion Related Reaction (IRR) (Hypersensitivity (SMQ <narrow>) – within one day of 
magrolimab infusion) 

Transfusion Reactions due to Magrolimab Interference with RBC typing (Gilead’s MST)

Thromboembolic Events (Embolic and Thrombotic Events (SMQ))

Pneumonitis (Interstitial Lung Disease (SMQ))


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
AE onset time within 2 weeks, >2weeks - 2 months, >2-6 months, >6-12 months, and 
>12 months of first dosing of any study drug
Anaemia/Hemolytic Anemia 
IRR
Interference with Blood Cross Match or Packed RBC Transfusion Outcomes
Thromboembolic Events
Pneumonitis
Immune-Mediated Events 
Number and percentage of subjects with AEs of Clinical significance will be summarized by PT. 
7.1.7.3.
Other Important Safety Topics

Infections and Infestations (SOC)

Immune-Mediated Events (Immune-mediate/autoimmune disorder (SMQ) - Narrow)
Number and percentage of subjects with AEs of other important safety topics (may not limit to 
the above list) will be summarized by PT. 
7.2.
Laboratory Evaluations
Laboratory data collected during the study will be analyzed and summarized using both 
quantitative and qualitative methods. Summaries of laboratory data will be provided for the 
Safety Analysis Set and will include data collected up to the last dose of study drug plus 30 days 
for subjects who have permanently discontinued study drug and before new anti-cancer therapy 
including SCT. The analysis will be based on values reported in conventional units. When values 
are below the LOQ, they will be listed as such, and the closest imputed value will be used for the 
purpose of calculating summary statistics as specified in Section 3.7. 
A by-subject listing for laboratory test results will be provided for hematology, serum chemistry, 
and coagulation separately. Values falling outside of the relevant reference range and/or having a 
severity grade of 1 or higher on CTCAE severity grade will be flagged in the data listings, as 
appropriate.
Scatter plots of lab parameters will include (but not limit to) hemoglobin, platelet, and absolute 
neutrophil counts across time will be provided. 


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7.2.1.
Summaries of Numeric Laboratory Results
Descriptive statistics will be provided for chemistry, hematology, and coagulation as follows:

Baseline values 

Postbaseline maximum value

Postbaseline minimum value

Change and percentage change from baseline to postbaseline maximum value

Change and percentage change from baseline to postbaseline minimum value
A baseline laboratory value will be defined as the last measurement obtained on or prior to the 
date/time of first dose of study drug. Change from baseline to a postbaseline visit will be defined 
as the visit value minus the baseline value. The mean, median, Q1, Q3, minimum, and maximum 
values will be displayed to the reported number of digits; StD values will be displayed to the 
reported number of digits plus 1.
In the case of multiple values in an analysis window, data will be selected for analysis as 
described in Section 3.7.3. 
7.2.2.
Graded Laboratory Values
CTCAE Version 4.03 will be used to assign toxicity grades (0 to 4) to laboratory results for 
analysis. Grade 0 includes all values that do not meet the criteria for an abnormality of at least 
Grade 1. For laboratory tests with criteria for both increased and decreased levels, analyses for 
each direction (ie, increased, decreased) will be presented separately.
7.2.2.1.
Treatment-Emergent Laboratory Abnormalities
Treatment-emergent laboratory abnormalities are defined as values that increase at least 
1 toxicity grade from baseline at any postbaseline time point, up to and including the date of last 
dose of study drug plus 30 days for subjects who permanently discontinued study drug and 
before new anti-cancer therapy including SCT, or the last available date in the database snapshot 
for subjects who were still on treatment at the time of an interim analysis. If the relevant baseline 
laboratory value is missing, any abnormality of at least Grade 1 observed within the time frame 
specified above will be considered treatment emergent.
7.2.2.2.
Summaries of Laboratory Abnormalities
The following summaries (number and percentage of subjects) for laboratory abnormalities will 
be provided by lab test:

Baseline grade (Grade 0 to 4 separately, Grade 3 or 4, Grade 1 to 4, and Missing)

Worst treatment-emergent laboratory abnormalities postbaseline grade (Grade 1 to 4 
separately, Grade 3 or 4, and Grade 1 to 4)


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The summary of the baseline abnormalities will use the number of subjects in the Safety 
Analysis Set as the denominator. The summary of the worst treatment-emergent laboratory 
abnormalities postbaseline is the number of subjects with nonmissing postbaseline values up to 
30 days after the last dosing date. 
A by-subject listing of treatment-emergent Grade 3 or 4 laboratory abnormalities will be 
provided by subject ID number and time point in chronological order. This listing will include all 
test results that were collected throughout the study for the lab test of interest, with all applicable 
severity grades displayed.
7.2.3.
Liver-related Laboratory Evaluations
Liver-related abnormalities after initial study drug dosing will be examined and summarized 
using the number and percentage of subjects who were reported to have the following laboratory 
test values for postbaseline measurements:

Aspartate aminotransferase (AST):  > 3 times of the upper limit of reference range (ULN)

Alanine aminotransferase (ALT):  > 3 x ULN

AST or ALT:  > 3 x ULN

Total bilirubin: > 2 x ULN

AST or ALT > 3 x ULN and total bilirubin: > 2 x ULN
The summary will include data from all postbaseline visits up to 30 days after the last dose of 
study drug. For individual laboratory tests, subjects will be counted once based on the most 
severe postbaseline values. For both the composite endpoint of AST or ALT and total bilirubin, 
subjects will be counted once when the criteria are met at the same postbaseline visit date. The 
denominator is the number of subjects in the Safety Analysis Set who have nonmissing 
postbaseline values of all relevant tests at the same postbaseline visit date. A listing of subjects 
who met at least 1 of the above criteria will be provided.
7.2.4.
Shifts Relative to the Baseline Abnormality Grade
Shift tables will be presented by showing change in abnormality grade from baseline to the worst 
postbaseline abnormality grade for chemistry, hematology, and coagulation. 
7.3.
Body Weight and Vital Signs
Descriptive statistics will be provided for body weight and vital signs as follows:

Baseline value

Postbaseline maximum value


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
Postbaseline minimum value

Change and percentage change from baseline to postbaseline maximum value

Change and percentage change from baseline to postbaseline minimum value
A baseline value will be defined as the last available value collected on or prior to the date/time 
of first dose of study drug. Change from baseline to a postbaseline visit will be defined as the 
postbaseline value minus the baseline value. Body weight and vital signs measured at 
unscheduled visits will be included for the baseline value selection. 
In the case of multiple values in an analysis window, data will be selected for analysis as 
described in Section 3.7.3. No formal statistical testing is planned.
A by-subject listing of vital signs will be provided by subject ID number and visit in 
chronological order. Body weight, height and BMI will be included in the vital signs listing, if 
space permits. If not, they will be provided separately.
7.4.
Prior and Concomitant Medications
Medications collected at screening and during the study will be coded using the current version 
of World Health Organization (WHO) Drug dictionary.
7.4.1.
Prior Medications
Prior medications are defined as any medications taken before a subject takes the first study 
drug.
Prior medications will be summarized by Anatomical Therapeutic Chemical (ATC) drug class 
Level 2 and preferred name using the number and percentage of subjects. A subject reporting the 
same medication more than once will be counted only once when calculating the number and 
percentage of subjects who received that medication. The summary will be ordered 
alphabetically by ATC medical class and then by preferred term in order of descending overall 
frequency within each ATC medical class. For drugs with the same frequency, sorting will be 
done alphabetically.
For the purposes of analysis, any medication with a start date prior to the first dosing date of 
study drug will be included in the prior medication summary regardless of when the stop date is. 
If a partial start date is entered the medication will be considered prior unless the month and year 
(if day is missing) or year (if day and month are missing) of the start date are after the first 
dosing date. Medications with a completely missing start date will be included in the prior 
medication summary, unless otherwise specified.
Summaries will be based on the Safety Analysis Set. No formal statistical testing is planned.


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7.4.2.
Concomitant Medications
Concomitant medications are defined as medications taken while a subject took study drug. Use 
of concomitant medications will be summarized by ATC drug class Level 2 and preferred name 
using the number and percentage of subjects. A subject reporting the same medication more than 
once will be counted only once when calculating the number and percentage of subjects who 
received that medication. The summary will be ordered alphabetically by ATC medical class and 
then by preferred term in descending overall frequency. For drugs with the same frequency, 
sorting will be done alphabetically.
For the purposes of analysis, any medications with a start date prior to or on the first dosing date 
of study drug and continued to be taken after the first dosing date, or started after the first dosing 
date but prior to or on the last dosing date of study drug will be considered concomitant 
medications. Medications started and stopped on the same day as the first dosing date or the last 
dosing date of study drug will also be considered concomitant. Medications with a stop date prior 
to the date of first dosing date of study drug or a start date after the last dosing date of study drug 
will be excluded from the concomitant medication summary. If a partial stop date is entered, any 
medication with the month and year (if day is missing) or year (if day and month are missing) 
prior to the date of first study drug administration will be excluded from the concomitant 
medication summary. If a partial start date is entered, any medication with the month and year (if 
day is missing) or year (if day and month are missing) after the study drug stop date will be 
excluded from the concomitant medication summary. Medications with completely missing start 
and stop dates will be included in the concomitant medication summary, unless otherwise 
specified. Summaries will be based on the Safety Analysis Set. No formal statistical testing is 
planned.
All prior and concomitant medications (other than per-protocol study drugs) will be provided in a 
by-subject listing sorted by subject ID number and administration date in chronological order.
7.5.
Electrocardiogram (ECG) Results
The QT interval (measured in millisecond [msec]) is a measure of the time between the start of 
the Q wave and the end of the T wave in the heart’s electrical cycle. The QT interval represents 
electrical depolarization and repolarization of the ventricles. The QT interval is affected by heart 
rate, and a number of methods have been proposed to correct QT for heart rate. 
Corrected QT (QTc) intervals will be derived using Fridericia’s correction (QTcF) as follows: 
𝑄𝑇𝑐𝐹= 𝑄𝑇
3 𝑅𝑅
where QT is measured in msec; RR = 60/Heart Rate (beats per min [bpm]) and RR is 
measured in seconds
11 


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The maximum post-baseline QTcF interval values obtained during the study will be summarized 
within the following categories: 

> 450 msec

> 480 msec

> 500 msec
The maximum post-baseline change from baseline in QTcF interval values obtained during the 
study will also be summarized within the following categories:

> 30 msec

> 60 msec
The maximum post-infusion change from prior-infusion in QTcF interval values obtained during 
the study will also be summarized using descriptive statistics.
For the summaries of maximum post-baseline QTcF interval, maximum post-baseline change 
from baseline in QTcF interval, and maximum post-infusion change from pre-infusion in QTcF 
interval, both triplicate and one-time measurements will be included. 
QTcF and uncorrected QT values at each visit and change from baseline at each visit will be 
summarized for the Safety Analysis Set using descriptive statistics. For baseline, as long as 
triplicate measurements are available prior to the first study treatment, the average of triplicate 
results will be defined as baseline. Otherwise, the last non-missing value of one-time 
measurement prior to the first study treatment is defined as baseline.  At each post-treatment 
visit, the average of triplicate measurements takes precedence over one-time measurement value 
as well. 
7.6.
Other Safety Measures
Post treatment anti-cancer therapies (other than those allowed per-protocol) will be provided in a 
by-subject listing sorted by subject ID number and administration date in chronological order. 
7.7.
Changes from Protocol-Specified Safety Analyses
There are no deviations from the protocol-specified safety analyses.


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8. 
PHARMACOKINETIC (PK) ANALYSES 
Individual patient's concentrntion data for magrolimab will be listed based on the sampling time 
point. Summaiy statistics (n, mean, median, SD, coefficient of vai·iation [%CV], min, max, QI, 
Q3, and geometric mean) will be presented for magrolimab senun concentrntions at each 
scheduled time point, split by dosing groups in each coho1t. Descriptive graphical plots of 
individual and mean (SD) concentration-versus-time profiles split by dosing groups in each 
coho1t will be generated. 
Missing concentration values will be repo1ted as is in data listings. Concentration values below 
lower limit of quantitation will be set to zero in summa1y statistics, and repo1ted as-is in data 
listings. 
PK data from this study will be combined with data from other 
• 
. 
. 
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9.
IMMUNOGENICITY ANALYSES
The immunogenicity analyses will use the Immunogenicity Analyses Set. The following 
measures of anti magrolimab antibody positivity will be reported: ADA prevalence, ADA 
incidence (i.e. sum of Treatment-Induced and Treatment-Boosted ADA rate), ADA 
transience/persistence rate, and neutralizing anti-body (nAb) incidence. 
ADA Prevalence: the proportion of subjects who had at least one positive ADA sample 
(baseline or post-baseline) based on the Immunogenicity Analysis Set.
ADA Incidence (treatment-emergent ADA): the proportion of subjects who had treatment-
induced or treatment-boosted ADA based on subjects who had non-missing baseline ADA 
sample and at least one post-treatment ADA result reported in Immunogenicity Analysis Set.
Treatment-Induced ADA Rate: the proportion of subjects who had negative baseline ADA 
sample and at least one positive post-treatment ADA sample based on subjects who had both 
non-missing baseline and at least one post-treatment ADA result reported (i.e. ADA Incidence 
Analysis Set).
Treatment-Boosted ADA Rate: the proportion of subjects who had positive baseline ADA 
sample and at least one positive post-treatment ADA sample and the (max titer of the post-
treatment ADA) / (titer of baseline ADA) >= 4 based on the ADA Incidence Analysis Set
Persistent ADA is defined as 
a) Treatment-Induced ADA detected at two or more sampling time points during the 
treatment (including follow-up period if any), where the first and last ADA-positive 
sample (irrespective of any negative samples in between) are separated by a period of 
16 weeks or longer. 
or
b) Treatment-Induced ADA detected in the last sampling time point of the treatment study 
period.
ADA Persistence Rate: the proportion of subjects who had persistent ADA based on the ADA 
Incidence Analysis Set.
Transient ADA is defined as: Treatment-Induced ADA that does not meet the definition of 
persistent ADA. The proportion of subjects who had transient ADA is based on the subjects 
evaluable for ADA incidence.
Neutralizing antibody (NAb) Incidence: the proportion of subjects who had at least one 
positive neutralizing antibody result reported based on the treatment-emergent ADA (treatment-
induced or treatment-boosted ADA) among the subjects evaluable for ADA incidence.


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If relevant, 
 tabular or graphical analysis may be conducted to determine the 
relationship between immunogenicity assay positivity and 1 or more safety, PK, or efficacy 
parameters (for example, drug concentrations, AEs, CR rate, DOR). Mixed effects modeling may 
also be conducted to evaluate these relationships, but that will be reported separately. The rate of 
neutralizing antibody positive subjects will also be summarized. 
CCI-


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10.
REFERENCES
Cheson BD, Bennett JM, Kopecky KJ, Buchner T, Willman CL, Estey EH, et al. Revised 
recommendations of the International Working Group for Diagnosis, 
Standardization of Response Criteria, Treatment Outcomes, and Reporting 
Standards for Therapeutic Trials in Acute Myeloid Leukemia. J Clin Oncol 
2003;21 (24):4642-9.
Cheson BD, Greenberg PL, Bennett JM, Lowenberg B, Wijermans PW, Nimer SD, et al. Clinical 
application and proposal for modification of the International Working Group 
(IWG) response criteria in myelodysplasia. Blood 2006;108 (2):419-25.
DiNardo CD, Pratz K, Pullarkat V, Jonas BA, Arellano M, Becker PS, et al. Venetoclax 
combined with decitabine or azacitidine in treatment-naive, elderly patients with 
acute myeloid leukemia. Blood 2019;133 (1):7-17.
Dohner H, Estey E, Grimwade D, Amadori S, Appelbaum FR, Buchner T, et al. Diagnosis and 
management of AML in adults: 2017 ELN recommendations from an 
international expert panel. Blood 2017;129 (4):424-47.
Greenberg PL, Tuechler H, Schanz J, Sanz G, Garcia-Manero G, Sole F, et al. Revised 
International Prognostic Scoring System for Myelodysplastic Syndromes. Blood 
2012;120 (12):2454-65.
Itzykson R, Thepot S, Berthon C, Delaunay J, Bouscary D, Cluzeau T, et al. Azacitidine for the 
treatment of relapsed and refractory AML in older patients. Leuk Res 2015;39 
(2):124-30.
Silverman LR, McKenzie DR, Peterson BL, Holland JF, Backstrom JT, Beach CL, et al. Further 
analysis of trials with azacitidine in patients with myelodysplastic syndrome: 
studies 8421, 8921, and 9221 by the Cancer and Leukemia Group B. J Clin Oncol 
2006;24 (24):3895-903.


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11.
SOFTWARE
SAS® Software Version 9.4. SAS Institute Inc., Cary, NC, USA.


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12.
SAP REVISION
Revision Date
(DD MMM YYYY)
Section
Summary of Revision
Reason for Revision
06 FEB 2023
Global
Include AML efficacy analyses 
To serve primary and final CSR 
analyses
06 FEB 2023
Global
Include all cohorts 
To serve primary and final CSR 
analyses


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13.
APPENDICES
Appendix 1.
Response Criteria in MDS (IWG 2006 Criteria)
Appendix 2.
Response Criteria in AML (ELN 2017 Recommendations)
Appendix 3.
Additional Response Definitions Used in This Trial (2003 IWG Criteria)


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Appendix 1.
Response Criteria in MDS (IWG 2006 Criteria)
Category
Response Criteria (responses must last ≥ 4 weeks)
Complete 
Remission 
Bone marrow ≤ 5% myeloblasts with normal maturation of all cell linesa
Persistent dysplasia will be noteda,b
Peripheral bloodc

Hgb ≥ 11 g/dL

Platelets ≥ 100 × 109/L

Neutrophils ≥ 1.0 × 109/Lb

Blasts 0%
Partial Remission
All CR criteria if abnormal before treatment except:

Bone marrow blasts decreased by ≥ 50% over pretreatment but still > 5%

Cellularity and morphology not relevant
Marrow CRb

Bone marrow ≤ 5% myeloblasts and decrease by ≥ 50% over pretreatmentb

Peripheral blood:  if HI responses, they will be noted in addition to marrow CRb
Stable Disease

Failure to achieve at least PR, but no evidence of progression for > 8 weeks
Failure
Death during treatment or disease progression characterized by worsening cytopenias, 
increase in percentage of bone marrow blasts, or progression to a more advanced MDS 
FAB subtype than pretreatment
Relapse after CR 
or PR
At least 1 of the following:

Return to pretreatment bone marrow blast percentage

Decrement of ≥ 50% from maximum remission/response levels in granulocytes or 
platelets

Reduction in Hgb concentration by ≥ 1.5 g/dL or transfusion dependenced
Cytogenetic 
Response

Complete:  Disappearance of chromosomal abnormality without appearance of new 
ones

Partial:  At least 50% reduction of the chromosomal abnormality
Disease 
Progression
For patients with:

Less than 5% blasts:  ≥ 50 increase in blasts to > 5% blasts

5%-10% blasts:   ≥ 50% increase in blasts to > 10% blasts

10%-20% blasts:  ≥ 50% increase in blasts to > 20% blasts

20%-30% blasts:  ≥ 50% increase in blasts to > 30% blasts
Any of the following:

At least 50% decrement from maximum remission/response in granulocytes or 
platelets

Reduction in Hgb by ≥ 2 g/dLd

Transfusion dependenced
Source:  {Cheson 2006}
Abbreviations:  CR = complete remission; FAB = myelodysplastic syndrome French-American-British classification; 
Hgb = hemoglobin; IWG = International Working Group; MDS = myelodysplastic syndrome; PR = partial remission.
a.
Dysplastic changes should consider the normal range of dysplastic changes
b.
Modification to IWG response criteria
c.
In some circumstances, protocol therapy may require the initiation of further treatment (e.g., consolidation, maintenance) 
before the 4-week period.  Such patients can be included in the response category into which they fit at the time the therapy 
is started.  Transient cytopenias during repeated chemotherapy courses should not be considered as interrupting durability of 
response, as long as they recover to the improved counts of the previous course.
d.
Impact of anemia must be deemed disease-related and not due to study treatment.


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Appendix 2.
Response Criteria in AML (ELN 2017 Recommendations) 
Definitions
Response Criteria
Neutrophils
Platelets
Bone Marrow Blasts
Other
Complete Remission 
without minimal 
residual disease 
(CRMRD-)
≥ 1.0 × 109/L
≥ 100 × 109/L
< 5%
If studied pretreatment, CR with 
negativity for a genetic marker by 
real-time quantitative polymerase 
chain reaction (RT-qPCR) or similar 
modality or CR with negativity by 
multi-color flow cytometry
Complete Remission 
(CR)
≥ 1.0 × 109/L
≥ 100 × 109/L
< 5%
Absence of circulating blasts and 
blasts with Auer rods; absence of 
extramedullary disease; MRD 
positive or unknown
Complete Remission 
with Incomplete 
Hematologic 
Recovery (CRi)
Neutrophils ≥ 1.0 × 109/L or
Platelets ≥ 100 × 109/L
< 5%
Absence of circulating blasts and 
blasts with Auer rods; absence of 
extramedullary disease; MRD 
positive or unknown
(All CR criteria except residual 
neutropenia [< 1.0 × 109/L] or 
thrombocytopenia [< 100 × 109/L])
Morphologic 
Leukemia-Free State 
(MLFS)
< 5%
Absence of blasts with Auer rods; 
absence of extramedullary disease; 
no hematologic recovery required; 
marrow should not merely be 
“aplastic”; at least 200 cells should 
be enumerated or cellularity should 
be at least 10%
Partial Remission 
(PR)
≥ 1.0 × 109/L
≥ 100 × 109/L
Decrease of bone 
marrow blast 
percentage to 5% to 
25%; and decrease of 
pretreatment bone 
marrow blast 
percentage by at least 
50%
Blasts < 5% with Auer rods may 
also be considered a PR
Stable Disease (SD)
Absence of CRMRD-, CR, CRi, PR, MLFS; and criteria for progressive disease not met
Progressive Disease 
(PD)

Evidence for an increase in bone marrow blast percentage and/or increase of absolute 
blast counts in the blood:
o
50% increase in marrow blasts over baseline (a minimum 15% point increase is 
required in cases with < 30% blasts at baseline; or persistent marrow blast 
percentage of > 70% over at least 3 months; without at least a 100% improvement 
in ANC to an absolute level (> 0.5 × 109/L [500/μL]), and/or platelet count to 
> 50 × 109/L (50,000/μL) non-transfused]; or
o
50% increase in peripheral blasts (WBC × % blasts) to > 25 × 109/L (> 25,000/μL) 
(in the absence of differentiation syndrome); or

New extramedullary disease
Source: {Dohner 2017}
Abbreviations:  AML = acute myeloid leukemia; ANC = absolute neutrophil count; CR = complete remission; MRD = minimal 
residual disease; WBC = white blood cell count.


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Appendix 3.
Additional Response Definitions Used in This Trial (2003 IWG 
Criteria) 
Definitions
Response Criteria
Neutrophils
Platelets
Bone Marrow 
Blasts
Other
Cytogenetic CR (cCR)
≥ 1.0  × 109/L
≥ 100  × 109/L
< 5%
Cytogenetics normal and no 
evidence of extramedullary 
disease 
Molecular CR (mCR)
≥ 1.0  × 109/L
≥ 100  × 109/L
< 5%
Molecular investigations 
normal and no evidence of 
extramedullary disease 
Treatment Failurea
Lack of response/Progressive Disease + loss of clinical benefit
Source: {Cheson 2003}
Abbreviations:  IWG = International Working Group.
a.
Treatment failure defined for this protocol


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