Clinical trial NCT02953509
Conditions: Non Hodgkin Lymphoma
Sponsor: Gilead Sciences
Start date: 2016-11-21; Completion date: 2024-03-25
Enrollment: 178 participants; Allocation: NON_RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
The primary objectives of this study are:

* To investigate the safety and tolerability, and to define the recommended Phase 2 dose and schedule (RP2DS) for magrolimab in combination with rituximab and for magrolimab in combination with rituximab, gemcitabine, and oxaliplatin (R-GemOx).
* To evaluate the efficacy of magrolimab in combination with rituximab in participants with indolent lymphoma and diffuse large B-cell lymphoma (DLBCL) and to evaluate the efficacy of magrolimab in combination with R-GemOx in autologous stem cell transplant (ASCT) ineligible DLBCL participants.

Detailed description:

Arms: arm 1: Participants with B-cell non-hodgkin's lymphoma (NHL) will receive 1 mg/kg magrolimab intravenous (IV) infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 10 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab will be administered on Day 1 of every other cycle (on even cycles). Each cycle length of 28 days. arm 2: Participants with B-cell NHL will receive 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 20 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab will be administered on Day 1 of every other cycle (on even cycles). Each cycle length of 28 days. arm 3: Participants with B-cell NHL will receive 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 11,15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab will be administered on Day 1 of every other cycle (on even cycles). Each cycle length of 28 days. arm 4: Participants with B-cell NHL will receive 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 11, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab will be administered on Day 1 of every other cycle (on even cycles). Each cycle length of 28 days. arm 5: Autologous stem cell transplant ineligible diffuse large B-cell lymphoma (DLBCL) participants will receive 1 mg/kg magrolimab IV infusion priming dose(over 3 hours)on Day 1 of Cycle 1,followed by maintenance dose of 30 mg/kg on Days 8, 11, 15, 22, and 29 of Cycle 1;Days 1, 8, 15, and 22 of Cycle 2 followed by Days 1 and 15 of subsequent cycles.Cycle length will be 28 days.Rituximab 375 mg/m\^2 IV infusion will be given on Days 8, 15, 22, and 29 of Cycle 1,followed by 1 dose on Day 1 of Cycles 2 to 6.Thereafter from Cycle 8 and beyond,rituximab will be administered on Day 1 of every other cycle(on even cycles).Gemcitabine 1000 mg/m\^2 and oxaliplatin 100 mg/m\^2 IV infusion will be given as on Days 11 and 23 of Cycle 1 and Days 2 and 15 of Cycles 2 to 4.Granulocyte colony stimulating factor (G-CSF) prophylaxis will be given with gemcitabine and oxaliplatin treatment(Cycles 1-4).Allopurinol 300 mg orally daily will be administered for the first cycle only. arm 6: Autologous stem cell transplant ineligible DLBCL participants will receive 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by maintenance dose of 45 mg/kg on Days 8, 11, 15, 22, and 29 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 followed by Days 1 and 15 of subsequent cycles. The cycle length of 28 days. Rituximab 375 mg/m\^2 IV infusion will be administered on Days 8, 15, 22, and 29 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab will be administered on Day 1 of every other cycle (on even cycles). Gemcitabine 1000 mg/m\^2 and oxaliplatin 100 mg/m\^2 IV infusion will be administered as on Days 11 and 23 of Cycle 1 and Days 2 and 15 of Cycles 2 to 4. G-CSF prophylaxis will be administered with gemcitabine and oxaliplatin treatment (Cycles 1-4). Allopurinol 300 mg orally daily will be administered for the first cycle only. arm 7: Participants with B-cell indolent NHL (iNHL) (including follicular lymphoma \[FL\] and marginal zone lymphoma \[MZL\]) and DLBCL will receive 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab will be administered on Day 1 of every other cycle (on even cycles). Each cycle length of 28 days. arm 8: Participants with B-cell iNHL (including FL and MZL) and DLBCL will receive 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 11, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab will be administered on Day 1 of every other cycle (on even cycles). Each cycle length of 28 days. arm 9: Participants with B-cell iNHL (including FL and MZL) and DLBCL will receive 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 11, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab will be administered on Day 1 of every other cycle (on even cycles). Each cycle length of 28 days. arm 10: Participants with DLBCL will receive 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab will be administered on Day 1 of every other cycle (on even cycles). Each Cycle length of 28 days.
Interventions: intervention 1: Magrolimab intervention 2: Rituximab intervention 3: Gemcitabine intervention 4: Oxaliplatin intervention 5: Allopurinol
Intervention descriptions: intervention 1: Administered intravenously intervention 2: Administered intravenously on Days 8, 15, and 22 during Cycle 1, followed by 1 dose on Day 1 for Cycles 2 through 6, and Day 1 for every other cycle until Cycle 13 intervention 3: Administered intravenously on Days 11, 23 for Cycle 1 and Days 2 and 15 for Cycles 2 to 4 intervention 4: Administered intravenously on Days 11, 23 for Cycle 1 and Days 2 and 15 for Cycles 2 to 4 intervention 5: Administered orally during Cycle 1

Protocol documents:
Prot_000.pdf: 
Magrolimab
Protocol 5F9003
Final
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CLINICAL STUDY PROTOCOL
Protocol Title:
A Phase 1b/2 Trial of Hu5F9-G4 in Combination with
Rituximab or Rituximab + Chemotherapy in Patients with 
Relapsed/Refractory B-cell Non-Hodgkin’s Lymphoma
Protocol Number:
5F9003
Investigational Products: Hu5F9-G4 (magrolimab) in combination with rituximab and
magrolimab in combination with rituximab, gemcitabine, and 
oxaliplatin
Indication:
Non-Hodgkin’s Lymphoma
Development Phase:
1b/2
US IND Number:
118300
EudraCT Number:
2016-003408-29
Sponsor:
Gilead Sciences, Inc.
333 Lakeside Drive
Foster City, CA 94404 USA
Contact Information:
The medical monitor name and contact information will be 
provided on the Key Study Team Contact List 
Investigator(s):
Ranjana Advani, M.D.
Study Lead Principal Investigator
Professor of Lymphoma, Stanford University 
875 Blake Wilbur Drive Clinic C
Stanford, CA 94305, USA
Telephone: 
Graham Collins, M.D. D.Sc. FMedSci 
United Kingdom Lead Principal Investigator
Haemotology Consultant and Lymphoma Lead
Oxford University Hospital 
Churchill Hospital
Old Road, Headington, OX3 7LE 
United Kingdom
PPD


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Amendment History:
Amendment 12 Date:
02 November 2023
Amendment 11 Date:
19 June 2023
Amendment 10 Date:
31 March 2022
Amendment 9 Date:
22 November 2019
Amendment 8 Date:
01 October 2018
Amendment 7 Date:
27 July 2018
Amendment 6 Date:
09 July 2018
Amendment 5 Date:
18 May 2017
Amendment 4 Date:
10 February 2017
Amendment 3 Date:
28 November 2016
Amendment 2 Date:
24 August 2016
Amendment 1 Date:
23 August 2016
Original Protocol Date:
14 July 2016
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, Inc.
Compliance Statement:
This study will be conducted in accordance with Protocol 5F9003, the International 
Conference on Harmonisation (ICH), Guideline for Good Clinical Practice (GCP), 
and the applicable country and regional (local) regulatory requirements.


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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]
Senior Associate Director, Clinical Development
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), 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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SUMMARY OF CHANGES, PROTOCOL 5F9003 AMENDMENT 12
The primary reason for this amendment is to incorporate new safety management 
information from the current investigator’s brochure (IB). 
The major updates to the protocol and related rationale are as follows:
•
Section 1.6.1 was updated to clarify known hematological toxicities associated 
with magrolimab and rituximab and provides a link to the Section 6.2. In 
alignment with current safety data from magrolimab IB Edition 12, language 
was updated to replace language stating “no significant overlapping toxicities 
between magrolimab and rituximab have been observed in patients on this 
trial (data on file)” with language stating “to date, the safety profile of 
magrolimab in combination with rituximab has been shown tolerable”.
•
Section 1.6.3 was updated to remove the language related to “no overlapping 
myelosuppression toxicity” in alignment with the current safety data from 
magrolimab IB Edition 12.
•
Section 6.1.1.2 and was updated to incorporate dexamethasone into the 
premedication regimen guidance before the first 2 doses of magrolimab or in 
the case of reintroduction with repriming to align with magralimab IB 
Edition 12.
•
Section 6.2.1.3 was updated to incorporate dexamethasone into 
premedication guidance for safety management in case of Grade 3 or 
Grade 4 infusion related reaction (IRR) to align with magralimab IB Edition 12. 
•
Section 6.2.1.3 was updated to incorporate guidelines for safety management 
in case of severe neutropenia and serious infections. 
•
Section 6.2.1.3 toxicity management was clarified applying to Grade 1 and 
Grade 2 IRRs to include language that patients who experience IRRs with the 
first 2 doses of magrolimab should continue premedication with 
corticosteroids prior to subsequent doses at the investigator’s discretion.
•
Section 6.2.1.3 was updated to clarify that patients who receive premedication 
and still experience a recurrent Grade 3 IRR or who experience a Grade 4 
infusion reaction at any time will be permanently discontinued from study 
treatment.
•
Section 6.2.1.3 was updated to clarify that the premedication starting dose of 
oral acetaminophen to to be 650 mg in case of Grade 3 infusion reactions to 
align with safety management guidance in the IB.
•
Section 12.14 (Publication Policy) was removed as Gilead does not have a 
publication charter.
Additional change(s) to the protocol include the following:
•
Administrative, editorial, formatting updates, changes, corrections, and 
clarifications were made throughout, where appropriate. 


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PROTOCOL SYNOPSIS
Sponsor: Gilead Sciences, Inc.
Investigational Agents: Hu5F9-G4 (magrolimab) in combination with rituximab 
(magrolimab + rituximab, “antibody combination”) and magrolimab in combination with 
rituximab, gemcitabine, and oxaliplatin (magrolimab + R-GemOx, “chemotherapy 
combination”)
Protocol Number: 5F9003 Amendment 12
Study Title: A Phase 1b/2 Trial of Hu5F9-G4 in Combination with Rituximab or with 
Rituximab + Chemotherapy in Patients with Relapsed/Refractory B-cell Non-Hodgkin’s 
Lymphoma
Study Objectives and Endpoints
Synopsis Table 1
Study Objectives and Endpoints
PRIMARY
Objectives
Endpoints
•
To investigate the safety and tolerability, 
and to define the RP2DS for magrolimab 
in combination with rituximab and for 
magrolimab in combination with R-GemOx
•
To evaluate the efficacy of magrolimab in 
combination with rituximab in patients with 
indolent lymphoma and DLBCL and to 
evaluate the efficacy of magrolimab in 
combination with R-GemOx in ASCT 
ineligible DLBCL as measured by the ORR 
according to Lugano Classification for 
lymphomas (Cheson 2014; Table 10-1)
•
DLTs (Phase 1b only [in the antibody 
combination (magrolimab + rituximab) 
and the chemotherapy combination 
(magrolimab + R-GemOx) cohorts]) 
and AEs according to NCI CTCAE, 
Version 4.03
•
ORR as defined by the Investigator 
according to the Lugano Classification 
for lymphomas (Table 10-1)


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SECONDARY
Objectives
Endpoints
•
To evaluate the PK profiles of magrolimab 
in combination with rituximab and 
magrolimab in combination with R-GemOx
•
To evaluate the immunogenicity of 
magrolimab in combination with rituximab 
and magrolimab in combination with
R-GemOx
•
To evaluate the efficacy of magrolimab in 
combination with rituximab in indolent 
lymphoma and DLBCL and magrolimab in 
combination with R-GemOx in ASCT 
ineligible DLBCL as measured by the DOR, 
PFS, OS, and TTP
•
To evaluate the efficacy of magrolimab in 
combination with rituximab in patients with 
indolent lymphoma and DLBCL and 
magrolimab in combination with R-GemOx 
in ASCT ineligible DLBCL as measured by 
ORR according to LYRIC (Cheson 2016; 
Table 10-2)
•
Concentration versus time 
measurements for magrolimab in 
combination with rituximab and for 
magrolimab in combination with
R-GemOx and their PK parameters 
including Cmax and AUC
•
ADAs to magrolimab in 
combination with rituximab and 
magrolimab in combination with 
R-GemOx
•
DOR, PFS, OS, and TTP
•
ORR as defined by the Investigator 
according to the LYRIC criteria for 
lymphomas (Table 10-2)


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Overall Study Design
This trial is an open-label, multicenter, Phase 1b/2 trial investigating magrolimab + 
rituximab (antibody combination) in R/R B-cell non-Hodgkin’s lymphoma (NHL) and 
magrolimab + rituximab, gemcitabine, and oxaliplatin (R-GemOx; chemotherapy 
combination) in indolent lymphoma and diffuse large B-cell lymphoma (DLBCL) (refer 
to the Study Design Schema).
CCI


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Antibody Combination: Magrolimab + Rituximab
Phase 1b: Dose escalation and regimen exploration for patients with B-cell NHL 
Phase 2: Treatment cohorts evaluating RP2DS and alternate dose regimens 
(indolent lymphoma and DLBCL)
Chemotherapy Combination: Magrolimab + R-GemOx
Phase 1b: This cohort will be conducted in a safety dose-escalation phase followed 
by an expansion phase in high-dose chemotherapy and autologous stem cell 
transplant (ASCT) ineligible DLBCL.
Clinical Trial Steering Committee
The Clinical Trial Steering Committee (CTSC) will oversee the conduct of the clinical 
trial. The composition, structure, and function of the CTSC are defined in the CTSC 
Charter.
Duration of Treatment
Magrolimab + rituximab treatment may be continued until loss of clinical benefit or 
unacceptable toxicity for patients who do not have disease progression.
Gemcitabine and oxaliplatin dosing are intended to complete after Cycle 4; 
however, dosing may continue beyond Cycle 4, as needed, until a total of 8 doses 
have been received at the discretion of the Investigator. Patients who do not 
tolerate one of the study treatment drugs may continue the other study treatment 
drug(s) for the duration of the trial, if the Sponsor and Principal Investigator agree.
Overview of Assessments
Assessments will be conducted according to the schedules provided in Section 7.1.
Translational Studies
Samples will be collected according to the schedules provided in Section 7.1.
Correlative studies will be performed on peripheral blood samples to determine 
the biologic activity of magrolimab in combination with rituximab or R-GemOx on 
circulating immune cells and molecular subtypes of NHL. These studies may 
include, but are not limited to, investigations of plasma cytokine levels, 
characterization of circulating T cells, and characterization of circulating tumor or 
cell-free DNA.
Planned Number of Patients
Study Total: Up to 422 patients may be enrolled to ensure sufficient efficacy- 
evaluable patients across all cohorts.


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Phase 1b:
Antibody Combination: Magrolimab + Rituximab
25 to 38 patients (total planned)
Planned patients per dose level (potential for expansion in each cohort of up to 
16):
Level 1: 3 to 6
Level 2: 3 to 6
Level 3: 3 to 6
Level 4: 3 to 6
Chemotherapy Combination: Magrolimab + R-GemOx
29 to 68 patients (total planned)
Safety dose escalation: 9 to 48 (2 planned dose levels, 2 dose de-escalation 
levels)
Expansion: 20
Phase 2:
Up to 316 evaluable patients for efficacy (up to 108 patients with indolent 
lymphoma; up to 208 patients with DLBCL).
Inclusion Criteria
1.
Adults ≥ 18 years.
2.
Antibody combination (magrolimab + rituximab) Phase 1b cohort only: B- 
cell NHL expressing CD20 by immunohistochemistry (IHC) or flow 
cytometry, relapsed or refractory to at least 2 prior lines of therapy.
3.
DLBCL chemotherapy combination (magrolimab + R-GemOx) Phase 1b 
safety dose-escalation and expansion cohorts:
a. Histologically confirmed de novo or transformed DLBCL relapsed or 
refractory to 1 to 3 prior lines of therapy who are not candidates for high- 
dose chemotherapy and autologous stem cell transplantation (ASCT). 
Patients relapsed after ASCT are allowed.
b. At least 1 prior therapy must have included a CD20-targeted therapy.
c. Primary refractory patients are excluded as defined by failure to achieve a 
partial response (PR) or complete response (CR) to frontline therapy or 
progression within 3 months of completing treatment.
d. The 1 to 3 prior lines of therapy requirement is only applicable for 
treatment regimens for DLBCL and not for prior lymphomas in the case of 
transformed DLBCL.
4.
For the DLBCL antibody combination (magrolimab + rituximab) Phase 2 Cohort 
4, de novo or transformed DLBCL, not otherwise specified, according to the 
World Health Organization 2016 classification of lymphoid neoplasms 
(Swerdlow 2016) expressing CD20 by IHC or flow cytometry, that is relapsed or 
refractory to at least 2 prior lines of therapy containing and anti-CD20 therapy.
Prior autologous hematopoietic cell transplantation is permitted.


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5.
Indolent lymphoma Phase 2 Cohort: Histologically confirmed marginal zone 
or follicular lymphoma (Grade 1 to 3a) expressing CD20 by IHC or flow 
cytometry, relapsed or refractory to at least 2 prior lines of therapy.
6.
Eastern Cooperative Oncology Group (ECOG) score 0 to 2.
7.
Disease that is measurable or assessable for response per Lugano 
Classification for lymphomas (Cheson 2014; Table 10-1).
8.
Laboratory measurements, blood counts:
•
Hemoglobin must be ≥ 9 g/dL within 24 hours prior to the first 2 doses of 
magrolimab infusion. NOTE: Transfusions are allowed to meet hemoglobin 
eligibility (see Section 6.2.1.3 for anemia management).
•
Absolute neutrophil count (ANC) ≥ 1.0 × 109/mL
•
For the antibody combination (magrolimab + rituximab) Phase 1b 
and Phase 2 cohorts: Platelets ≥ 50 × 109/mL.
•
For the Phase 1b chemotherapy combination (magrolimab + R- 
GemOx) safety dose-escalation and expansion cohorts only, 
platelets ≥ 100 × 109/mL.
9.
Laboratory measurements, hepatic function:
•
Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) < 5 ×
upper limit of normal (ULN).
•
Bilirubin ≤ 1.5 × or 3.0 × ULN and primarily unconjugated if patient has a 
documented history of Gilbert’s syndrome or a genetic equivalent.
10.
Laboratory measurements, renal function:
•
Serum creatinine ≤ 1.5 × ULN or calculated glomerular filtration rate (GFR)
> 40 mL/min/1.73 m2.
11.
Women of childbearing potential (WOCBP) 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 magrolimab.
12.
WOCBP must be willing to use at least 1 highly effective method of 
contraception during the study and continue for 4 months after the last dose 
of magrolimab and 12 months after the last dose of rituximab.
13.
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 
and refrain from sperm donation during the study and for 4 months after 
the last dose of magrolimab and 12 months after the last dose of rituximab. 
If the partner is pregnant, male patients must use barrier method 
contraception (condom) during the study and for 4 months after the last 
dose of magrolimab and until there is a pregnancy outcome (whichever is 
applicable) to prevent fetal exposure to study drugs.
14.
Patient has provided informed consent.
15.
Must be willing and able to comply with clinic visits and procedures outlined in 
the study protocol.


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16.
DLBCL chemotherapy combination (magrolimab + R-GemOx) Phase 1b 
safety dose-escalation and expansion cohorts and Phase 2 antibody 
combination (magrolimab + rituximab) indolent lymphoma and DLBCL 
cohorts: Willing to consent to 1 mandatory pretreatment and 1 on-treatment 
tumor biopsy, unless determined to not be feasible by the Investigator 
(Reasons include, but are not limited to, lack of accessible tumor tissue to 
biopsy and patient safety issues.)
17.
CAR-T naïve or CAR-T ineligible patients and otherwise meet other 
inclusion/exclusion criteria may enroll. Patients who relapse following CAR-T 
therapy are not eligible.
Exclusion Criteria
1.
Patients with active brain metastases. (Patients with stable treated central 
nervous system [CNS] lesions who are off corticosteroid therapy for at least 
3 weeks are not considered active.)
2.
Prior allogeneic stem cell transplant.
3.
Prior anti-cancer therapy, including chemotherapy, hormonal therapy, 
and investigational agents within 3 weeks or within at least 4 half-lives 
prior to magrolimab dosing (up to a maximum of 4 weeks), whichever is 
longer.
NOTE: Low dose steroids (oral prednisone or equivalent ≤ 20 mg per day), 
localized 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.
4.
Known active or chronic hepatitis B or C infection or human 
immunodeficiency virus (HIV).
5.
Red blood cell (RBC) transfusion dependence, defined as requiring more than 
2 units of RBC transfusions during the 4-week period prior to screening. RBC 
transfusions are permitted during screening and prior to enrollment to meet 
the hemoglobin inclusion criteria.
6.
History of hemolytic anemia or Evans syndrome in the last 3 months.
7.
Positive IgG component of the direct antiglobulin test (DAT).
8.
Prior treatment with CD47 or signal regulatory protein alpha (SIRPα)- 
targeting agents.
9.
Second malignancy, except treated basal cell or localized squamous skin 
carcinomas, localized prostate cancer, or other malignancy for which patients 
are not on active anti-cancer therapy as defined in Exclusion Criterion 3.
10.
Hypersensitivity to the active substance, to murine proteins, or to any of the 
other excipients of rituximab listed in Appendix A.
11.
Significant medical diseases or conditions, as assessed by the Investigator.


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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, severely immunocompromised state, and 
congestive heart failure New York Heart Association (NYHA) Class II-IV.
12.
History of psychiatric illness or substance abuse likely to interfere with ability 
to comply with protocol requirements or give informed consent.
13.
Pregnancy or active breastfeeding.
14.
Additional exclusion criteria for DLBCL chemotherapy combination 
(magrolimab + R-GemOx) Phase 1b safety dose-escalation and 
expansion cohorts only:
a. Undergone ASCT within a period of  3 months before signing informed 
consent.
b. Prior treatment with gemcitabine and oxaliplatin. However, patients who 
relapse  12 months after treatment with a gemcitabine and oxaliplatin- 
containing regimen are allowed.
c. Known hypersensitivity to gemcitabine, oxaliplatin, or other 
platinum compounds.
d. Intolerance of gemcitabine, oxaliplatin, and/or rituximab as monotherapy 
or in combination due to unacceptable toxicities as determined by the 
treating Investigator.
Test Product, Dose, and Mode of Administration
Magrolimab is a humanized IgG4 monoclonal antibody (mAb) 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. Magrolimab is a humanized mAb 
against CD47.
Rituximab is a genetically engineered chimeric murine/human monoclonal IgG1 
kappa antibody directed against the CD20 antigen.
Gemcitabine is a nucleoside metabolic inhibitor that exhibits antitumor activity. 
Gemcitabine HCl is 2´-deoxy-2´,2´-difluorocytidine monohydrochloride (β-isomer).
Oxaliplatin is an antineoplastic agent. It is an organoplatinum complex in which the 
platinum atom is complexed with 1,2-diaminocyclohexane and with an oxalate ligand 
as a leaving group.
Dosing Regimens:
Antibody Combination: Magrolimab + Rituximab, Phase 1b
In Phase 1b, magrolimab was administered on Days 1, 8, 15, and 22 for all cycles 
(cycle length is 28 days). In Phase 1b, rituximab was administered on Days 8, 15, 
and 22 for the first cycle and then on Day 1 for Cycles 2 through 6. Rituximab 
dosing was extended beyond Cycle 6 in a protocol amendment letter.


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Amendment 12
CONFIDENTIAL
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Antibody Combination: Magrolimab + Rituximab, Phase 2 (Amendment 9) 
Synopsis Table 2
Dosing: Antibody Combination (Magrolimab + Rituximab) 
Phase 2 Cohort 4
Dose Schedule (Day per 28-day Cycle)
Drug/Dose (IV)
Cycle 1
Cycle 2
Cycles 3 to 6
Cycle 
7+
Magrolimab 1 mg/kg 
(prime)
Day 1
—
—
—
Magrolimab 30 mg/kg 
(maintenance)a
Day 8a, 
15, 22
Day 1, 8,
15, 22
Day 1,15
Day 1,
15
Rituximab 375 mg/m2 a
Day 8a, 
15, 22
Day 1
Day 1 of Cycle 6, then Day 1 every 
other Cycle starting Cycle 8
Abbreviations: IV = intravenous.
a. On Cycle 1 Day 8, magrolimab is to be given first followed by rituximab. For all other times when 
rituximab and magrolimab are given on the same visit, rituximab should be given first. There should be 
at least an hour interval between the end of infusion of the first drug and the beginning of the infusion of 
the second drug.
Chemotherapy Combination: Magrolimab + R-GemOx, Phase 1b
Synopsis Table 3
Chemotherapy Combination (Magrolimab + R-GemOx) Safety 
Dose-Escalation and Expansion Cohorts
Drug
Cycle 1
(5 weeks)
Cycle 2
(4 weeks)
Cycles 3 to 4
(4 weeks)
Cycles 5 to 6
(4 weeks)
Cycle 7+
(4 weeks)
DOSE- 
ESCALATION
Dose Level 1: 
Magrolimab (IV)a
1 mg/kg 
priming: Day 
1
30 mg/kg 
maintenance: 
Day 8, 11, 15,
22, 29
30 mg/kg 
maintenance: 
Day 1, 8, 15,
22
30 mg/kg 
maintenance: 
Day 1, 15
30 mg/kg 
maintenance: 
Day 1, 15
30 mg/kg 
maintenance: 
Day 1, 15
DOSE- 
ESCALATION
Dose Level 2: 
Magrolimab (IV)b
1 mg/kg 
priming: Day 
1
45 mg/kg 
maintenance: 
Day 8, 11, 15,
22, 29
45 mg/kg 
maintenance: 
Day 1, 8, 15,
22
45 mg/kg 
maintenance: 
Day 1, 15
45 mg/kg 
maintenance: 
Day 1, 15
45 mg/kg 
maintenance: 
Day 1, 15
DOSE- 
EXPANSION
Magrolimab 
(IV)c,d
1 mg/kg 
priming: Day 
1
30mg/kg 
maintenance: 
Day 8d, 15,
22, 29
30 mg/kg 
maintenance: 
Day 1, 8, 15,
22
30 mg/kg 
maintenance: 
Day 1, 15
30 mg/kg 
maintenance: 
Day 1, 15
30 mg/kg 
maintenance: 
Day 1, 15


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Protocol 5F9003
Final
Gilead Sciences, Inc
Amendment 12
CONFIDENTIAL
Page 15
02 November 2023
Drug
Cycle 1
(5 weeks)
Cycle 2
(4 weeks)
Cycles 3 to 4
(4 weeks)
Cycles 5 to 6
(4 weeks)
Cycle 7+
(4 weeks)
Rituximab (IV)d
375 mg/m2:
Day 8d, 15, 22,
29
375 mg/m2:
Day 1
375 mg/m2:
Day 1
375 mg/m2: 
Day 1 then Day 
1 every other 
cycle starting
Cycle 8
-
Gemcitabine (IV)
1000 mg/m2:
Day 11, 23
1000 mg/m2:
Day 2, 15
1000 mg/m2:
Day 2, 15
-
-
Oxaliplatin (IV)
100 mg/m2:
Day 11, 23
100 mg/m2:
Day 2, 15
100 mg/m2:
Day 2, 15
-
-
G-CSF
prophylaxise
Administer
Administer
Administer
-
-
Allopurinol (oral)f
Daily
-
-
-
-
Abbreviations: CTSC = Clinical Trial Steering Committee; G-CSF = granulocyte colony stimulating factor; 
IV = intravenous; R-GemOx = rituximab, gemcitabine, and oxaliplatin.
a.
Magrolimab maintenance dose maybe de-escalated to 20 mg/kg or 10 mg/kg with the identical dosing 
schedule of maintenance doses if the regimen is deemed too toxic by the CTSC.
b.
The CTSC may decide to explore higher doses of magrolimab in increments up to 50% higher than 
the prior dose level deemed to be safe in accordance with the modified 3 + 3 design.
c.
The magrolimab maintenance dose level utilized in the expansion phase will be the 
recommended dose selected by the CTSC from the safety dose-escalation phase.
d.
On Cycle 1 Day 8, magrolimab is to be given first followed by rituximab. For all other times 
when rituximab and magrolimab are given on the same visit, rituximab should be given first. 
There should be at least an hour interval between the end of infusion of the first drug and 
the beginning of the infusion of the second drug.
e.
G-CSF primary prophylaxis must be administered with gemcitabine and oxaliplatin treatment. Local 
standard of care or equivalent will be administered in accordance to local institutional guidelines or 
Investigator guidance. G-CSF prophylaxis should generally occur within several days after administration 
of each day gemcitabine and oxaliplatin is dosed. However, the timing of G-CSF prophylaxis may be 
given in accordance to local institutional guidelines.
f.
Allopurinol of 300 mg oral daily should be administered for the first cycle only to prevent tumor lysis 
syndrome associated with chemotherapy. Allopurinol may be given at 100 mg oral daily for the first 
cycle if significant renal impairment is present as determined by the Investigator.


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Protocol 5F9003
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Amendment 12
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Page 16
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STUDY DESIGN SCHEMA
Antibody Combination (Magrolimab + Rituximab)
Continued on the following page.
Patients with 
R 
histologically 
E 
confirmed 
G 
B-cell 
non-Hodgkin's 
I 
lymphoma (NHL) 
s 
> 
who have 
T 
relapsed or are 
E 
refractory to 
R 
at least 2 prior 
lines of therapy 
Phase lb 
All B Cell NHL 
(up to 25-38 patients) 
Level 1: 1,10 mg/kg 
Hu5F9-G4 weekly+ rituximab 375 mg/m2 
weekly du-ing Cyde 1 and Q4W 
thereafter 
,I 
Level 2: 1,20 mg/kg 
Hu5F9-G4 weekly+ rituximab 375 mg/m' 
weekly during Cycle 1 and Q4W 
,hereafter 
Level 3: 1 mg/kg prime, 
30 mg/kg load, 
30 mg/kg maintenance 
Hu5F9-G4 weekly+ rituximab 375 mg/m2 
weekly during Cyde 1 and Q4W thereafter 
Level 4 1 mg/kg prime, 
45 mg/kg load, 
45 mg/kg maintenance 
Hu5F9-G4 weekr/ through Cycle 2, then 45 
mg/kg Q2 weeks in Cycle 3 and beyond + 
rituximab 375 rrg/m2 weekly during Cycle 
1 and Q4W thereafter 
4-week DLT assessment 
Phase 1, Cohorts 1-4 
RP2D 
Phase 2* 
(up to 316 patients) 
Indolent Lymphoma 
DLBCL 
(up to 108 patients planned) 
(up to108 patients planned) 
RP2DS Hu5F9-G4 + 
rituximab 375 mg/m2 
weekly in Cycle 1; Q4W 
through Cycle 6; Q8W 
thereafter 
Weeks 1 to 8 
,j, 
CTSC efficacy analysis 1: 
after 14 evaluable 
patients: 
ORR~ 3/14 
Noi/ 
'\l Yes 
~ ----, 
Stop 
enrollment• 
Enroll 
additional 
CTSC efficacy analysis 2: 
after~ 24 evaluable 
patients: 
ORR 
30% or CR~ 20% 
Noi/ 
'\lYes 
Stop 
Complete 
enrollment* 
enrollment 
RP2DS Hu5F9-G4 + 
rituximab 375 mg/m' 
weekly in Cycle 1; Q4W 
through Cycle 6; Q8W 
thereafter 
Weeks 1 to 8 
,j, 
CTSC efficacy analysis 1: 
after 14 evaluable 
patients: 
ORR~ 3/14 
Noi/ 
Stop 
enrollment• 
CTSC efficacy analysis 2: 
after 40 evaluable 
patients: 
ORR~ 20% 
l\io"' 
Stop 
enrollment• 
Yes 
Complete 
enrollment 
Phase 2, Cohorts 1-3 
*An alternative dose regimen may be evaluated in additional patients as determined by the CTSC. 
Gray texts indicates completed or on-hold as of Amendment 9. 
DLBCL 
(up to 100 patients; 
Phase 2, Cohort 4) 
RP2DS Hu5F9-G4 + 
rituximab 375 mg/m2 
weekly in Cycle 1; Q4W 
through Cycle 6; Q8W 
thereafter 
Weeks 1 to 8 
CTSC efficacy analysis 1: 
after 20 evaluable 
patients: 
ORR~ 4/20 
'\l 
No 
Yes 
Stop 
Enroll 
enrollment 
additional 
'\l 
Complete 
enrollment 
to 100 


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Gilead Sciences, Inc
Amendment 12
CONFIDENTIAL
Page 17
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Chemotherapy Combination (Magrolimab +R GemOx)
Abbreviations: ASCT = autologous stem cell transplant; CR = complete response; CTSC = Clinical Trial Steering Committee; DLBCL = diffuse large B-cell 
lymphoma; DLT = dose-limiting toxicity; MTD = maximum tolerated dose; NHL = non-Hodgkin’s lymphoma; ORR = objective response rate; Q4W = every 
4 weeks; Q8W = every 8 weeks; RP2DS = recommended Phase 2 dose and schedule.
a. Refer to Table 6-3 for specific magrolimab dosing regimens.
b. Dose de-escalation to dose level -2 may further occur using a 1 mg/kg magrolimab priming dose and 10 mg/kg maintenance doses if the MTD is 
exceeded at dose level -1.
Histologically confirmed de 
novo or transformed DLBCL 
relapsed or refractory to at 
least one line of therapy 
who are ineligible for 
autologous transplantation 
or intensive chemotherapy. 
Patients relapsed after 
autologous transplantation 
are allowed. Primary 
refractory patients are 
excluded 
Phase lb 
High dose chemotherapy/ASCT ineligible DLBCL 
(29-68 patients) 
Safety dose escalation (N=9-48) 
Level 1: 1 r,11/kg prime, 30 
r,11/kg maintenance Hu5F9-
64 weekly"+ Rituximab, 
Gemcitabine, Oxaliplatin 
R 
• 
Yes 
E 
' 
G 
tNo 
-----3> 
s 
Dose de-escalation (if needed) 
Level -1: 1 111Vkg prime, 20 
maintenance Hu5F9-
64 weeklr" + Rituximab, 
Gemcitabine, Oxaliplatin 
T 
Level 2: 1 !1'1Vkg prime, 45 
• 
Yes 
.
-
Dose de-escalation (if needed) 
Level-2: 1 
prime, 10 
111Vkg maintenance Hu5F9-
G4 weeklr" + Rituximab, 
6emcitabine, Oxaliplatin 
E 
R 
111Vkg maintenance Hu5F9-
64 weekly'+ Rituximab, 
6emcitabine, Oxaliplatin 
No 
• 
Ye 
Stop Level 2 enrollment 
and expand Level 1 to up 
to6 patients 
--------.,. Select RP2D for expansion 
Expansion (N=20) 
Selected dose for Hu5F9-
G4" + Rituximab, 
Gemcitabine, Oxaliplatin 
-----3> Stop t 
tna I 
•
Yes 
he" 
/
~ 


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Protocol 5F9003
Final
Gilead Sciences, Inc
Amendment 12
CONFIDENTIAL
Page 18
02 November 2023
TABLE OF CONTENTS
CLINICAL STUDY PROTOCOL .......................................................................................1
PROTOCOL APPROVAL PAGE ......................................................................................3
PROTOCOL ACCEPTANCE PAGE .................................................................................4
SUMMARY OF CHANGES, PROTOCOL 5F9003 AMENDMENT 12 ..............................5
PROTOCOL SYNOPSIS ..................................................................................................6
STUDY DESIGN SCHEMA.............................................................................................16
TABLE OF CONTENTS..................................................................................................18
LIST OF FIGURES .........................................................................................................22
LIST OF TABLES............................................................................................................22
LIST OF APPENDICES ..................................................................................................23
ABBREVIATIONS AND DEFINITIONS...........................................................................24
1.
BACKGROUND........................................................................................................27
1.1.
Non-Hodgkin’s Lymphoma .............................................................................27
1.1.1.
Indolent Lymphoma...........................................................................27
1.1.2.
Diffuse Large B-cell Lymphoma ........................................................28
1.2.
Magrolimab.....................................................................................................29
1.2.1.
Nonclinical Background.....................................................................29
1.2.2.
Clinical Background...........................................................................32
1.3.
Rituximab........................................................................................................35
1.4.
Gemcitabine and Oxaliplatin Combination......................................................36
1.5.
Correlative Studies Background .....................................................................36
1.6.
Study Rationale and Risk-Benefit ...................................................................37
1.6.1.
Antibody Combination (Magrolimab + Rituximab).............................37
1.6.2.
Rationale for Change of Study Design ..............................................38
1.6.3.
Chemotherapy Combination (Magrolimab + R-GemOx) ...................39
1.7.
Dose Rationale ...............................................................................................41
1.7.1.
Antibody Combination (Magrolimab + Rituximab): Phase 1b 
Magrolimab .......................................................................................41
1.7.2.
Antibody Combination (Magrolimab + Rituximab): Phase 2 
Magrolimab .......................................................................................44
1.7.3.
Chemotherapy Combination (Magrolimab + R-GemOx) ...................45
2.
STUDY OBJECTIVES AND ENDPOINTS................................................................47
3.
STUDY DESIGN.......................................................................................................50
3.1.
Overall Study Design......................................................................................50
3.1.1.
Antibody Combination (Magrolimab + Rituximab).............................50
3.1.2.
Chemotherapy Combination (Magrolimab + R-GemOx) ...................55
3.2.
Clinical Trial Steering Committee....................................................................58


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3.3.
Data Monitoring Committee............................................................................59
3.4.
Number of Sites..............................................................................................59
3.5.
Estimated Study Duration and End of Study...................................................59
4.
PATIENT SELECTION AND ENROLLMENT............................................................59
4.1.
Study Entry Criteria.........................................................................................59
4.1.1.
Inclusion Criteria ...............................................................................59
4.1.2.
Exclusion Criteria ..............................................................................61
4.2.
Contraception Requirements..........................................................................62
4.3.
Patient Screening and Enrollment Procedures ...............................................64
4.4.
Informed Consent Process .............................................................................65
4.5.
Registration Process.......................................................................................65
5.
STUDY DRUG INFORMATION................................................................................65
5.1.
Study Drug: Antibody Combination (Magrolimab + Rituximab)......................65
5.1.1.
Physical Description of Study Drug ...................................................65
5.2.
Study Drug: Chemotherapy Combination (Magrolimab + R-GemOx)............67
5.1.2.
Physical Description of Study Drug ...................................................67
6.
TREATMENT PLAN .................................................................................................68
6.1.
Study Drug Administration..............................................................................68
6.1.1.
Antibody Combination (Magrolimab + Rituximab).............................68
6.1.2.
Chemotherapy Combination (Magrolimab + R-GemOx) ...................75
6.1.3.
Magrolimab Administration................................................................78
6.2.
Dose Delays, Dose Modifications, and Safety Management Guidelines........80
6.2.1.
Antibody Combination (Magrolimab + Rituximab).............................80
6.2.2.
Chemotherapy Combination (Magrolimab + R-GemOx) ...................91
6.3.
Prohibited Medication .....................................................................................97
6.3.1.
Magrolimab .......................................................................................97
6.3.2.
Rituximab ..........................................................................................97
6.3.3.
Gemcitabine and Oxaliplatin .............................................................97
6.4.
Duration of Treatment.....................................................................................98
6.5.
Patient Completion of the Study .....................................................................98
7.
STUDY EVALUATIONS ...........................................................................................99
7.1.
Schedules of Assessments ............................................................................99
7.1.1.
Antibody Combination (Magrolimab + Rituximab): 
Schedules of Assessments................................................................99
7.1.2.
Chemotherapy Combination (Magrolimab + R-GemOx): 
Schedules of Assessments................................................................99
7.1.3.
Historical Arms: Schedule of Assessments.....................................100
7.2.
Screening Assessments ...............................................................................111
7.3.
Description of Study Procedures ..................................................................112
7.3.1.
Physical Examination......................................................................112
7.3.2.
Vital Signs .......................................................................................112
7.3.3.
Electrocardiograms .........................................................................112


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7.3.4.
Type and Screen and Direct Antiglobulin Test ................................113
7.3.5.
Diagnostic Imaging..........................................................................113
7.3.6.
Pregnancy Test ...............................................................................113
7.3.7.
Peripheral Blood Smear Assessment..............................................114
7.3.8.
Adverse Events...............................................................................114
7.3.9.
Concomitant Medications................................................................114
7.4.
Safety Follow-up Visit ...................................................................................115
7.5.
Safety Assessments .....................................................................................116
7.6.
Efficacy Assessments...................................................................................118
7.6.1.
Immunogenicity...............................................................................118
7.7.
Pharmacodynamic and Biomarker Assessments .........................................118
7.7.1.
CD47 Receptor Occupancy ............................................................118
7.7.2.
Correlative Blood Samples..............................................................119
7.7.3.
Measurement of Plasma Cytokines.................................................120
7.7.4.
Characterization of Circulating T Cells............................................120
7.7.5.
Tumor and Bone Marrow Biopsies..................................................120
8.
STUDY DISCONTINUATION.................................................................................123
8.1.
Withdrawal of Patients from Study Drug Treatment......................................123
8.2.
Withdrawal of Patients from Study................................................................123
8.3.
Study Termination.........................................................................................124
9.
ASSESSMENT OF SAFETY..................................................................................124
9.1.
Safety Parameters and Definitions ...............................................................124
9.1.1.
Adverse Event.................................................................................125
9.1.2.
Serious Adverse Event....................................................................125
9.2.
Methods and Timing for Capturing and Assessing Safety Parameters.........126
9.2.1.
Adverse Event/Serious Adverse Event Reporting Period ...............126
9.2.2.
Eliciting Adverse Events..................................................................127
9.2.3.
Assessment of Severity and Causality of Adverse Events ..............127
9.3.
Procedures for Recording Adverse Events...................................................129
9.3.1.
Recording Adverse Events on the eCRF ........................................129
9.4.
Reporting Requirements for Serious Adverse Events ..................................133
9.4.1.
Reporting Requirements for All Serious Adverse Events................133
9.5.
Emergency Contacts ....................................................................................133
10. MEASUREMENT OF EFFECT ..............................................................................133
10.1. Anti-cancer Effect – Hematologic Tumors ....................................................133
10.2. Evaluation of Response................................................................................134
10.2.1.
Assessment of Evaluable Rather Than Measurable Disease..........144
11. STATISTICAL CONSIDERATIONS .......................................................................144
11.1. Analysis Sets ................................................................................................144
11.2. Sample Size Determination ..........................................................................145
11.2.1.
Antibody Combination (Magrolimab + Rituximab)...........................145
11.2.2.
Chemotherapy Combination (Magrolimab + R-GemOx) .................146


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11.3. Statistical Analyses Methods ........................................................................147
11.3.1.
Efficacy Analyses ............................................................................147
11.3.2.
Pharmacokinetics/Pharmacodynamics Analyses............................148
11.3.3.
Safety Analyses ..............................................................................150
11.4. Clinical Trial Steering Committee Meetings..................................................151
11.4.1.
Clinical Trial Steering Committee Meetings in Phase 2 for 
Antibody Combination (Magrolimab + Rituximab)............................151
11.4.2.
Clinical Trial Steering Committee Meetings in Phase 1b for 
Chemotherapy Combination (Magrolimab + R-GemOx) .................153
11.4.3.
Treatment-Related Toxicity Monitoring ...........................................153
11.5. Clinical Trial Steering Committee .................................................................154
12. ETHICAL AND ADMINISTRATIVE CONSIDERATIONS.......................................154
12.1. Compliance Statement .................................................................................154
12.2. Investigator Responsibilities .........................................................................155
12.3. Institutional Review Board or Independent Ethics Committee......................156
12.4. Informed Consent and Human Subject Protection........................................156
12.5. Confidentiality ...............................................................................................157
12.6. Urgent Safety Measures ...............................................................................158
12.7. Serious Breaches and Fraud........................................................................159
12.8. Study Monitoring...........................................................................................159
12.9. Audits and Inspections..................................................................................160
12.10.Data Collection and Handling .......................................................................160
12.11.Maintenance of Source Documents and Record Retention..........................161
12.12.Long-term Retention of Samples for Additional Future Research.................162
12.13.Financing and Insurance ..............................................................................164
13. REFERENCES.......................................................................................................165
14. APPENDICES ........................................................................................................169


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Protocol 5F9003
Final
Gilead Sciences, Inc
Amendment 12
CONFIDENTIAL
Page 22
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LIST OF FIGURES
Figure 1-1
Combination Treatment of AML Cells with AZA and Magrolimab Enhanced 
Phagocytic Elimination by Human Macrophages In Vitro..............................40
LIST OF TABLES
Synopsis Table 1
Study Objectives and Endpoints ..............................................................6
Synopsis Table 2
Dosing: Antibody Combination (Magrolimab + Rituximab) Phase 2 
Cohort 4 ........................................................................................................14
Synopsis Table 3
Chemotherapy Combination (Magrolimab + R-GemOx) Safety Dose-
Escalation and Expansion Cohorts ...............................................................14
Table 2-1
Study Objectives and Endpoints ...................................................................47
Table 6-1
Dosing: Antibody Combination (Magrolimab + Rituximab) Phase 1b...........70
Table 6-2
Dosing: Antibody Combination (Magrolimab + Rituximab) Phase 2 Cohort 4
71
Table 6-3
Dosing: Chemotherapy Combination (Magrolimab + R-GemOx) Safety Dose-
Escalation and Expansion Cohorts ...............................................................76
Table 6-4
Magrolimab Dose Modifications ....................................................................81
Table 6-5
Dose Reductions for Gemcitabine and Oxaliplatin for Hematologic Toxicities
93
Table 7-1
Antibody Combination (Magrolimab + Rituximab): RP2DS Phase 2 Schedule 
of Assessments (Including Phase 2 Cohort 4)............................................101
Table 7-2
Post-treatment Assessments: All Cohorts – Antibody Combination 
(Magrolimab + Rituximab) Phase 1b and Phase 2 and Chemotherapy 
Combination (Magrolimab + R-GemOx) Phase 1b .....................................104
Table 7-3
Pharmacokinetic Assessments: Chemotherapy Combination (Magrolimab + 
R-GemOx) Phase 1b and Antibody Combination (Magrolimab + Rituximab) 
Phase 2 .......................................................................................................105
Table 7-4
Correlative Studies: All Cohorts – Antibody Combination (Magrolimab + 
Rituximab) Phase 1b and Phase 2 and Chemotherapy Combination 
(Magrolimab + R-GemOx) Phase 1b...........................................................105
Table 7-5
Chemotherapy Combination (Magrolimab + R-GemOx): Phase 1b Schedule 
of Assessments, Safety Dose- Escalation and Expansion Cohorts............106
Table 7-6
Laboratory Analyte Listing for Safety and Other Assessments...................117
Table 9-1
Adverse Event Grade (Severity) Scale .......................................................128
Table 9-2
Causal Attribution Guidance .......................................................................128
Table 10-1
Lugano Classification of Response in Non-Hodgkin’s Lymphoma..............135
Table 10-2
Comparison of Lugano Classification and LYRIC Criteria ..........................142
Table 11-1
Noncompartmental Pharmacokinetic Parameters.......................................149
Table 11-2
Stopping Boundary Due to Toxicity for Each Phase 2 Cohort ....................154
Table H- 1
Antibody Combination (Magrolimab + Rituximab): Phase 1b Schedule of 
Assessments...............................................................................................176
Table H- 2
Antibody Combination (Magrolimab + Rituximab): Alternate RP2DS 
Schedule of Assessments...........................................................................180


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Amendment 12
CONFIDENTIAL
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Table H- 3
Pharmacokinetic Assessments: Antibody Combination (Magrolimab + 
Rituximab) Phase 1b...................................................................................183
Table H- 4
CD47 Receptor Occupancy Sample Time Points: Antibody Combination 
(Magrolimab + Rituximab) Phase 1b Only ..................................................184
LIST OF APPENDICES
APPENDIX A. RITUXAN®/MABTHERA (RITUXIMAB) PRESCRIBING INFORMATION..169
APPENDIX B NATIONAL CANCER INSTITUTE COMMON TERMINOLOGY CRITERIA 
FOR ADVERSE EVENTS ...........................................................................170
APPENDIX C THE LUGANO CLASSIFICATION AND LYRIC CRITERIA FOR LYMPHOMAS
171
APPENDIX D ECOG PERFORMANCE STATUS ..............................................................172
APPENDIX E PERIPHERAL SMEAR ASSESSMENT ......................................................173
APPENDIX F GEMZAR® (GEMCITABINE) PRESCRIBING INFORMATION...................174
APPENDIX G ELOXATIN® (OXALIPLATIN) PRESCRIBING INFORMATION ..................175
APPENDIX H HISTORY OF PATIENT ENROLLMENT AND ASSESSMENTS ................176
APPENDIX I
LYMPHOMA IMMUNOPHENOTYPING......................................................185


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Protocol 5F9003
Final
Gilead Sciences, Inc
Amendment 12
CONFIDENTIAL
Page 24
02 November 2023
ABBREVIATIONS AND DEFINITIONS
Term
Definition
5PS
5-point scale
ADA
anti-drug antibody
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
ASCT
autologous stem cell transplant (or transplantation)
AST
aspartate aminotransferase
AUC
area under the concentration-time curve
AUClast
AUC from time zero to the last measurable
concentration sampling time (tlast) (mass × time × volume ˗ 1)
AUCtau
AUC calculated to the end of a dosing interval (tau) at
steady state (amount × time × volume ˗ 1)
AZA
azacitidine
BLQ
below the limit of quantitation
BUN
blood urea nitrogen
CAR-T
chimeric antigen receptor
CBC
complete blood count
CFR
Code of Federal Regulations
CHOP
cyclophosphamide, doxorubicin, vincristine, and 
prednisone
CI
confidence interval
Cmax
maximum concentration observed
CMV
cytomegalovirus
CNS
central nervous system
CR
complete response
CRC
colorectal cancer
CRF
case report form (paper)
CT
computed tomography
CTCAE
Common Terminology Criteria for Adverse Events
CTSC
Clinical Trial Steering Committee
CV
coefficient of variation
CyTOF
mass cytometry
DAT
direct antiglobulin test
DLBCL
diffuse large B-cell lymphoma
DLT
dose-limiting toxicity
DNA
deoxyribonucleic acid
DOR
duration of response
EAS
Efficacy Analysis Set
ECG
electrocardiogram
ECOG
Eastern Cooperative Oncology Group
eCRF
electronic case report form
EDC
electronic data capture


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Term
Definition
EGA
4-bromobenzaldehyde N-(2,6-dimethylphenyl) 
semicarbazone
EOT
end-of-treatment
Fc
fragment, crystallizable
FDA
Food and Drug Administration
FDG
fluorodeoxyglucose
FL
follicular lymphoma
G-CSF
granulocyte colony stimulating factor
GCP
Good Clinical Practice
GFR
glomerular filtration rate
HIV
human immunodeficiency virus
IB
Investigator’s Brochure
ICF
informed consent form
ICH
International Conference on Harmonisation
IEC
Independent Ethics Committee
Ig
immunoglobulin
IHC
immunohistochemistry
INR
international normalized ratio
IR
indeterminate response
IRB
Institutional Review Board
IRR
infusion-related reaction
IV
intravenous
IWRS
interactive web response technology
KM
Kaplan-Meier
LDH
lactate dehydrogenase
LDi
longest diameter of a lesion
LHRH
luteinizing hormone-releasing hormone
LISS
low-ionic-strength solution
LYRIC
LYmphoma Response to Immunomodulatory Therapy 
Criteria
M1
macrophages that suppress tumor progression
M2
macrophages that promote tumor progression
mAb
monoclonal antibody
MDS
myelodysplastic syndrome
MedDRA
Medical Dictionary of Regulatory Activities
mg
milligram
MHRA
Medicines and Healthcare products Regulatory Agency 
(UK)
Min
minutes
MNS
a human blood group system based on 2 genes 
(glycophorin A and glycophorin B) on chromosome 4
MOA
mechanism of action
MRI
magnetic resonance imaging
MTD
maximum tolerated dose
No.
number
NCI
National Cancer Institute
NHL
non-Hodgkin’s lymphoma


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Term
Definition
NYHA
New York Heart Association
ORR
objective response rate
OS
overall survival
PD
pharmacodynamic
PE
physical examination
PeG
polyethylene glycol
PET
positron emission tomography
PFS
progression-free survival
PK
pharmacokinetic(s)
PKPD
Pharmacokinetic and pharmacodynamic
PPD
cross product of the LDi and perpendicular diameter
PR
partial response
PT
prothrombin time
Q2C
every 2 cycles
Q2W
every 2 weeks
Q4W
every 4 weeks
Q8W
every 8 weeks
RANKL
receptor activator of nuclear factor kappa-B ligand
RBC
red blood cell(s)
REC
Research Ethics Committee
R-GemOx
rituximab, gemcitabine, and oxaliplatin
Rh
Rhesus factor
RNA
ribonucleic acid
RP2DS
recommended Phase 2 dose and schedule
R/R
relapsed/refractory
RO
receptor occupancy
SAE
serious adverse event
SAP
Statistical Analysis Plan
SAF
Safety Analysis Set
SD
standard deviation
SDi
shortest axis perpendicular to the LDi
SGOT
serum glutamic oxaloacetic transaminase
SGPT
serum glutamic pyruvic transaminase
SIRPα
signal regulatory protein alpha
SOA
Schedule of Assessments
SPD
sum of the product of diameters
t1/2
terminal half-life
TEAE
treatment-emergent adverse event
TRAE
treatment-related adverse event
TTP
time to progression
ULN
upper limit of normal
UK
United Kingdom
US
United States
USP
United States Pharmacopeia
WBC
white blood cell
WOCBP
women of childbearing potential


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1. BACKGROUND
1.1.
Non-Hodgkin’s Lymphoma
Non-Hodgkin’s lymphoma (NHL) is among the most common cancers in the United 
States (US) and Europe with more than 70,000 and 93,000 new cases diagnosed 
every year, respectively (Ferlay 2015). NHL is a heterogeneous group of 
malignancies with varying clinical characteristics that are optimally managed 
through a range of different treatment modalities. The spectrum of NHL includes 
more indolent variants such as follicular and marginal zone lymphomas, to more 
aggressive subtypes such as diffuse large B-cell lymphoma (DLBCL). While 
systemic chemotherapy is a mainstay of treatment for most NHL variants, antitumor 
directed monoclonal antibodies (mAb) have an important role in the treatment of this 
disease (Oflazoglu 2010). Antibodies such as rituximab, which targets the B-cell 
antigen CD20, are now part of the standard treatment regimens for many B-cell 
NHLs (Keating 2010). However, once NHL becomes refractory to standard 
chemotherapy and antibody-based therapies, the overall prognosis is poor, with 
limited long-term survival. Thus, novel and effective therapies are needed to 
address this high unmet medical need.
1.1.1. Indolent Lymphoma
Indolent lymphomas represent 40% of all NHL subtypes, with follicular lymphoma 
(FL) occurring with the greatest frequency (Harris 1999). Indolent lymphomas 
present with a broad spectrum of disease characteristics. Patients often 
experience a chronic relapsing and remitting disease course and are exposed to 
several successive treatment regimens, resulting eventually in death due to 
disease progression. In general, treatment is reserved for patients who develop 
significant symptoms or who are sufficiently high risk to merit early therapy 
(Gribben 2007).
The most common frontline therapies include a combination of alkylators 
(including cyclophosphamide, doxorubicin, vincristine, and prednisone [CHOP] or 
bendamustine) in combination with the anti-CD20 mAb rituximab. In addition, 


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single agent rituximab is also often administered as frontline therapy, particularly 
in patients with lower disease burden or who may not tolerate combination 
chemo- immunotherapy (Sousou 2010). Rituximab was originally approved for 
use in patients with relapsed and refractory FL and low grade lymphoma. For 
patients with indolent NHL who initially respond (complete response [CR] or 
partial response [PR] with a time to progression [TTP] of at least 6 months) and 
then experience relapse after single-agent rituximab, retreatment with either 
rituximab alone or in combination with chemotherapy is frequently given 
(Kahl 2014; Gribben 2007; NCCN Guidelines Version 3 2016). Patients who 
become refractory to rituximab alone or in combination with chemotherapy have 
limited options for effective treatment.
One approach to enhancing the efficacy of rituximab is the addition of other biologic 
agents that could potentiate its activity. There is strong nonclinical evidence 
demonstrating that Hu5F9-G4 (magrolimab), an anti-CD47 antibody, can synergize 
with rituximab to eliminate both the indolent and aggressive lymphoma subtypes 
(Chao 2010a).
After exploring clinical proof of concept of the combination of magrolimab with 
rituximab to treat indolent and aggressive NHL, this trial may be expanded to explore 
efficacy.
1.1.2. Diffuse Large B-cell Lymphoma
DLBCL is an aggressive subtype of NHL that accounts for approximately 30% of all 
NHL (Non-Hodgkin’s Lymphoma Classification Project 1997). Combination 
chemotherapy with the addition of rituximab is standard of care for patients with 
newly diagnosed DLBCL. However, approximately 40% of patients with DLBCL 
relapse following initial immunochemotherapy (Vaidya 2014).
For patients who are eligible, salvage chemotherapy regimens followed by 
autologous stem cell transplantation (ASCT) is standard of care; although, many 
patients are not eligible for transplantation due to age and other medical co- 
morbidities. While multiple salvage regimens comprising combination


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chemotherapy are available for relapsed/refractory (R/R) disease, no standard 
salvage regimen exists currently. The development of more effective therapies 
for R/R DLBCL represents a high unmet medical need. In addition to indolent 
lymphoma, this study will investigate the use of an anti-CD47 antibody, 
magrolimab, in combination with rituximab for patients with DLBCL.
In DLBCL patients who relapsed or did not respond to frontline rituximab- 
chemotherapy combination, treatment with high-dose salvage chemotherapy with 
rituximab with subsequent ASCT is typically standard of care. Patients who relapse 
or are refractory after at least 2 lines of therapy are eligible for CAR-T cell therapy. 
However, a significant percentage of patients are not eligible for high-dose 
chemotherapy, ASCT, or CAR-T cell therapy due to a combination of age, co- 
morbidities, or failure to achieve a response to rituximab + salvage chemotherapy. 
These transplant-ineligible DLBCL patients have a poor prognosis (Mounier 2013) 
and treatment options are limited. When treatment is indicated, lower intensity 
salvage chemotherapies in combination with rituximab are generally administered 
that include rituximab, gemcitabine, and oxaliplatin (R-GemOx) or rituximab + 
bendamustine (Merchionne 2014). In transplant-ineligible DLBCL patients,
R-GemOx is often used as a lower intensity treatment option compared with 
rituximab + bendamustine, given its lower myelosuppression rates, better tolerability, 
and similar ability to induce clinical responses (Mounier 2013; Merchionne 2014).
However, significant clinical benefit with R-GemOx and other rituximab/salvage 
chemotherapies is limited due lack of durable responses. More effective treatment 
options that build on R-GemOx and other rituximab salvage chemotherapy regimens 
are needed.
1.2.
Magrolimab
1.2.1. Nonclinical Background
The Stanford researchers in the laboratories of Weissman and Majeti have identified 
CD47 as 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


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prophagocytic, “eat me,” signals (Jaiswal 2009; Majeti 2009). The Weissman 
laboratory have found that CD47 expression is increased on the surface of cancer 
cells from a large number of diverse human tumor types. Additional background 
information can be found in the most recent Investigator’s Brochure (IB).
A mAb targeting CD47 enables selective phagocytosis and elimination of tumor 
cells, but not normal cells, and is a potentially beneficial therapy for NHL.
CD47-blocking antibodies have been shown to exhibit potent synergy with tumor- 
specific mAbs, such as the anti-CD20 antibody rituximab in NHL. In nonclinical 
models of NHL (including both indolent lymphoma and DLBCL), anti-CD47 
antibody synergized with rituximab to yield dramatic levels of tumor phagocytosis in 
vitro compared to either monotherapy. This mechanism of synergy was due to the 
engaging of 2 mechanisms of phagocytosis: anti-CD47 antibody-mediated 
phagocytosis through inhibition of CD47-signal regulatory protein alpha (SIRPα) 
signaling and rituximab-mediated phagocytosis through delivery of a
pro-phagocytic signal through the fragment, crystallizable (Fc) receptor leading to 
antibody-dependent cellular phagocytosis (Chao 2010a). These nonclinical 
experiments provide the rationale for the use of anti-CD47 antibody in combination 
with rituximab for the treatment of patients with B-cell NHL.
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 immunoglobulin (Ig)G4 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.


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Most normal cells lack expression of pro-phagocytic signals and are unaffected by 
magrolimab. Red blood cells (RBCs) are a notable exception because CD47 
expression protects RBCs from elimination by splenic macrophages, as well as 
sinusoidal macrophages, in liver and bone marrow. As RBCs age, they lose CD47 
expression and reorganize membrane phospholipids in a manner that enhances 
pro-phagocytic signaling, leading to their elimination. 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 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 cells. 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.
The combination of magrolimab and rituximab represents a novel treatment 
modality that can induce synergistic antitumor responses in B-cell NHL nonclinical 
models. These data serve as the basis for the evaluation of this combination in B- 
cell NHL patients. The addition of chemotherapy to magrolimab can lead to 
enhanced tumor phagocytosis through induction of pro-phagocytic signals. These 
observations support the rationale for an additional combination of R-GemOx with 
magrolimab in patients with NHL.


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1.2.2. Clinical Background
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 IB, including data from Studies SCI-CD47-001 (solid tumor),
SCI-CD47-002 (acute myeloid leukemia [AML]), 5F9003 (this study in NHL), 5F9004 
(colorectal cancer [CRC]), and 5F9006 (ovarian cancer). Magrolimab has been 
administered as monotherapy and in combination with other antitumor compounds 
in clinical trials. Refer to the IB for additional information.
1.2.2.1.
Summary of Magrolimab Clinical Safety
As of 24 July 2019, more than 400 patients have been treated with magrolimab as 
monotherapy or in combination. The most common treatment-related adverse 
events (TRAEs) were anemia, fatigue, headache, infusion-related reaction (IRR), 
pyrexia, chills, nausea, RBC agglutination, and vomiting.
Generally, magrolimab has an acceptable safety profile across all clinical studies 
with no maximum tolerated dose (MTD) reached with up to 45 mg/kg of weekly 
dosing as monotherapy and in combination (Study SCI-CD47-001 data on file). 
The majority of magrolimab-associated toxicities observed to date have been 
transient and manageable.
Anemia is an on-target toxicity and typically characterized as a 1–2 g/dL fall in 
hemoglobin during the first 1 to 2 weeks of treatment. Use of a low dose priming 
and maintenance dose mitigates this hematological effects of magrolimab. Affected 
patients develop a compensatory reticulocytosis in the ensuing weeks. The 
mechanism of anemia is described in Section 1.2.1. Similar treatment-related 
effects on neutrophils and platelets have not been observed. Even in patients with 
R/R AML or NHL patients with limited bone marrow reserves, magrolimab has 
demonstrated an acceptable benefit-risk ratio. Supportive care with RBC and 
platelet transfusions, when required, have successfully been administered in


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patients without complications.
The IRRs have been observed, most commonly during the initial 2 study treatments. 
The most frequently reported signs and symptoms of IRR associated with 
magrolimab included chills, pyrexia, back pain, nausea, headache, vomiting, and 
dyspnea.
Hemagglutination or clumping of RBCs on the peripheral blood smear has also been 
observed, typically after the initial priming or first maintenance dose of drug.
Although common, it is generally transient and it not been consistently correlated 
with clinical symptoms or sequelae.
As of 24 July 2019, approximately 124 patients have received at least 1 dose of 
magrolimab in this NHL 5F9003 study. The most frequent adverse events (AEs) 
related to any study intervention (magrolimab and/or rituximab and/or gemcitabine 
and/or oxaliplatin) were IRR, chills, anemia, fatigue, headache, pyrexia, nausea, 
vomiting, dyspnea, thrombocytopenia, and neutropenia, events that are consistent 
with the safety profile of each study drug component.
For the most up-to-date information, refer to the magrolimab IB.
1.2.2.2.
Summary of Magrolimab Clinical Pharmacology
A summary of the clinical pharmacokinetic (PK) data from human clinical trials with 
magrolimab is presented in the most recent magrolimab IB.
Overall, the data indicated nonlinearity in the PK profiles over the dose range 0.3 to 
30 mg/kg – the apparent terminal half-life (t1/2) was higher at the higher doses of 10 
to 30 mg/kg compared to the lower doses indicating potential target mediated drug 
disposition. Drug exposures were dose proportional at doses ≥10 mg/kg, and a 
typical antibody-like profile with extended half-life was seen at these doses.
PK analysis showed a large difference in maximum serum concentration (Cmax)


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between the first and second doses at the dose of 1 mg/kg, indicating possible 
time-varying PK at this dose. After the first dose of 1 mg/kg, the Cmax was 
approximately 0.575 mcg/mL, whereas the Cmax after the second dose of 1 mg/kg 
was 10.6 mcg/mL (approximately 15-fold higher). On subsequent dosing, there 
were no further changes in the PK at this dose level. Furthermore, at higher 
doses (3, 10, 20, and 30 mg/kg), the PK profile was similar after the second and 
fifth doses, suggesting that the time variant PK only occurred at 1 mg/kg between 
the first and second weekly doses. All pre-first-dose concentrations were below 
the limit of quantitation (BLQ), indicating that the assay was specific to 
magrolimab. The mean Cmax after the 1-mg/kg priming dose was 0.7 mcg/mL. 
This concentration was associated with near-maximal receptor occupancy (RO) 
on RBCs (see magrolimab IB v7.0), indicating that this was an appropriate 
priming dose (Sikic 2016). Consistent with this profile, minimal accumulation in 
PK (< 2-fold) after multiple maintenance doses was seen at all doses between 
Weeks 2 and 5.
Binding of magrolimab to the CD47 receptor at various time points after the start 
of the dosing regimen was measured on circulating red and white blood cells 
(WBCs) using two RO assays. The RO assay data indicated that at a priming 
dose of 1 mg/kg, full RO was achieved before the end of first week on RBCs, 
indicating that this is an appropriate priming dose.
Anti-drug antibody (ADA) data have been evaluated. When ADA values were 
positive, titer values indicated that these ADAs were low in strength. A visual 
comparison of the PK of ADA+ and ADA- patients indicated lack of impact of 
ADA on the PK profile. Additional information can be found in the magrolimab 
IB.


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1.2.2.3.
Summary of Magrolimab Clinical Efficacy
Magrolimab as monotherapy at ascending dose levels (Study SCI-CD47-001) in 
patients with solid tumor showed two patients with objective responses. Study SCI- 
CD47-002 demonstrated limited efficacy of magrolimab as single agent in patients 
with AML.
Studies 5F9004 (solid tumor/CRC Phase 1b in combination with cetuximab) and 
5F9006 (solid tumor/ovarian cancer Phase 1b in combination with avelumab) are 
ongoing and have demonstrated limited signs of activity.
Studies 5F9003 (current study) and 5F9005 (AML/MDS [myelodysplastic syndrome]) 
Phase 1b/2 in combination with azacitidine [AZA]) have demonstrated signs of clinical 
activity and are ongoing.
For additional information, refer to the magrolimab IB.
1.3.
Rituximab
Rituxan®/MabThera® (rituximab), manufactured by Roche/Genentech, is a chimeric 
murine/human IgG1 kappa mAb that targets CD20. Its MOAs are thought to be 
antibody-dependent cellular cytotoxicity, complement-dependent cytotoxicity, and 
induction of apoptosis after binding to the CD20 antigen on the cell surface. The 
biological effect is manifested by B-cell depletion in peripheral blood, lymph nodes, 
and bone marrow. Rituximab is the first commercially available mAb for the 
treatment of lymphoma and is currently approved for several NHL indications 
including low-grade indolent lymphoma, chronic lymphocytic leukemia, and DLBCL. 
Rituximab is widely used in frontline and salvage regimens in B-cell NHL, either 
alone or in combination with chemotherapy. The estimated median terminal 
elimination half-life is 22 days (range 6.1 to 52 days), based on a population PK 
analysis of data from 298 NHL patients who received rituximab once weekly or once 
every 3 weeks (Appendix A).


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1.4.
Gemcitabine and Oxaliplatin Combination
GEMZAR (gemcitabine HCl) is a nucleoside metabolic inhibitor that exhibits 
antitumor activity (Appendix F). Gemcitabine HCl is 2´-deoxy-2´, 2´-difluorocytidine 
monohydrochloride (β-isomer). The half-life of gemcitabine ranges from 1.7 to 
19.4 hours. ELOXATIN® (oxaliplatin for injection and oxaliplatin injection) is an 
antineoplastic agent with the molecular formula C8H14N2O4Pt and the chemical name 
of cis-[(1 R,2 R)-1,2 cyclohexanediamine-N,N’] [oxalato(2-)- O,O’] platinum
(Appendix G). Oxaliplatin is an organoplatinum complex in which the platinum atom is 
complexed with 1,2-diaminocyclohexane and with an oxalate ligand as a leaving 
group. Combination therapy of gemcitabine and oxaliplatin (chemotherapy) with 
rituximab is a standard treatment for second-line and salvage therapy in DLBCL. The 
half-life of oxaliplatin is reported to have multiple phases, characterized by 2 relatively 
short distribution phases (t1/2α; 0.43 hours; and t1/2β; 16.8 hours) and a long terminal 
elimination phase (t1/2γ; 391 hours).
1.5.
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. In nonclinical studies, anti-CD47 antibody- 
mediated tumor cell phagocytosis has been demonstrated to occur through both 
antitumorigenic M1 and protumorigenic M2 macrophages (Zhang 2016). In addition, 
in vivo treatment of human xenograft tumors with an anti-CD47 antibody 
demonstrated increased M1 intratumoral macrophages (Zhang 2016), suggesting 
that an anti-CD47 antibody can also shift the phenotype of macrophages from the 
M2 toward the M1 phenotype. Since the recruitment of macrophage effectors is a 
key mechanism for antitumor 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 antitumor efficacy.


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In addition to modulating the innate immune system, anti-CD47 antibody therapy 
also activates the adaptive immune system towards an antitumor response.
Phagocytosis of tumor cells by macrophages and/or dendritic cells lead to cross- 
presentation of tumor antigens to T cells, enabling a T-cell antitumor response 
(Tseng 2013; Liu 2015a). In one nonclinical study, anti-CD47 antibody mediated a 
specific CD8 T-cell antitumor 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. Given the role of anti-CD47 antibody in mediating an antitumor 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.
1.6.
Study Rationale and Risk-Benefit
1.6.1. Antibody Combination (Magrolimab + Rituximab)
B-cell NHL patients with both indolent lymphomas and DLBCL who have relapsed or 
are refractory to treatment regimens containing rituximab have limited options for 
effective treatment. Specific indolent lymphomas, particularly FL, are deemed 
incurable, as described by frequent patterns of relapse during several lines of 
therapy. While overall survival (OS) for FL can be more than 10 years, 
approximately 15% to 20% of patients with newly diagnosed FL have rapidly 
evolving, progressive disease that results in death within 2 to 3 years
(Swenson 2005). Patients suffering from indolent lymphoma with high-risk disease 
features who have early disease recurrence after treatment with rituximab, are 
refractory to rituximab containing therapies, or are ineligible for more aggressive 
therapies represent an unmet medical need. Of patients with DLBCL, 30% to 40% 
relapse after first-line therapy and 10% experience refractory disease (Vaidya 2014; 
Morrison 2015). For patients with chemosensitive disease, the standard treatment


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for R/R DLBCL is salvage chemotherapy followed by autologous hematopoietic cell 
transplantation (Philip 1995). Patients with DLBCL who are refractory to frontline 
therapy, relapse, or are refractory to second line salvage regimens or autologous 
hematopoietic cell transplantation have an extremely poor prognosis
(Gisselbrecht 2010; Crump 2014; Van Den Neste 2016). In these settings, there is 
no standard treatment. Thus, R/R DLBCL represents a significant unmet need.
Magrolimab in combination with rituximab has been shown to have synergistic 
antitumor activity in nonclinical B-cell NHL models and provided a rationale for the 
clinical investigation of this combination in B-cell NHL patients. To date, the safety 
profile of magrolimab in combination with rituximab has been shown tolerable. 
Anemia, neutropenia, febrile neutropenia, leucopenia, and thrombocytopenia are 
adverse drug reactions associated with magrolimab and rituximab. Monitoring and 
management guideline for these potentially overlapping toxicities are provided in 
Section 6.2. 
Given the nonclinical and initial clinical evidence of activity for combination therapy 
with an anti-CD47 antibody and rituximab in both indolent lymphomas and DLBCL, 
the individual safety profiles of both magrolimab and rituximab to date showing 
tolerability, and the significant unmet medical need for these patient populations, the 
clinical combination therapy proposed for investigation in this trial has an acceptable 
risk-benefit profile for the patients proposed for enrollment.
For reference safety information and guidance for the Investigator, refer to the 
current magrolimab IB.
1.6.2. Rationale for Change of Study Design
The Clinical Trial Steering Committee (CTSC) elected to evaluate an additional 
Phase 2 dose level (DLBCL Phase 2 Cohort 4; Amendment 9) based on emerging 
clinical data as well as the aggregate safety, efficacy, PK, and pharmacodynamic 
(PD) data obtained in the completed Phase 1b/2 portions of this study. The 
principal aim of Amendment 9 is to broaden the therapeutic option to individuals with


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R/R DLBCL following multiple lines of therapy. The tumor types eligible for 
enrollment have been narrowed to R/R de novo or transformed DLBCL, not 
otherwise specified, to limit the heterogeneity of the study population. Magrolimab 
dosing schedule has been modified to align with other magrolimab trials (e.g., 
removal of Cycle 1 Day 11) and for patient convenience (e.g., extend dosing to 
every 4 weeks (Q4W) for a subset of patients). The order of drug administration has 
also been changed on Cycle 1 Day 8 (e.g., magrolimab first followed by rituximab) 
to potentially augment antitumor activity. Laboratory, PK, PD, and tumor response 
assessments have been reduced based on the aggregate of safety, PK, and PD 
data generated during the study to date and to improve patient convenience.
Peripheral blood and tumor immunophenotyping studies have been added as 
research assessments to help better understand the MOA of magrolimab 
combinations.
1.6.3. Chemotherapy Combination (Magrolimab + R-GemOx)
1.6.3.1.
Rationale for Study Design and Risk-Benefit
The DLBCL patients who are ineligible for high-dose chemotherapy salvage 
regimens and ASCT have a poor prognosis (Mounier 2013) and treatment options 
are limited. No true standard of care exists in this population, with patients often 
receiving rituximab-chemotherapy regimens such as R-GemOx or palliative care 
(Mounier 2013, Merchionne 2014). However, significant clinical benefit with R- 
GemOx and other rituximab/salvage chemotherapies is limited due lack of durable 
responses. The addition of magrolimab may augment antitumor activity of R- 
GemOx based on the previously described clinical data and the nonclinical rationale 
described below.
Chemotherapy combinations have the potential to augment efficacy of anti-CD47 
antibodies through induction of pro-phagocytic signals leading to synergistic tumor 
cell phagocytosis by anti-CD47 antibodies. Certain chemotherapies have been 
shown to upregulate calreticulin, a major pro-phagocytic signal expressed on tumors 
(Obeid 2007). For example, AZA, an anti-cancer agent nucleoside analog, has been 
shown to upregulate calreticulin (Boasman 2017) leading to an enhanced


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therapeutic response when combined with magrolimab. Magrolimab, when 
combined with AZA, led to significantly increased phagocytosis of cancer cells in 
vitro compared with either agent alone (Figure 1-1).
Figure 1-1
Combination Treatment of AML Cells with AZA and Magrolimab 
Enhanced Phagocytic Elimination by Human Macrophages In Vitro
Source: Study FSI-2017-001.
Abbreviations: AML = acute myeloid leukemia; AZA = azacitidine; Ig = immunoglobulin.
These combined data from another nucleoside analog + magrolimab combination 
study support the mechanistic rationale of combination of magrolimab with other 
agents including R-GemOx. In addition, the initial DLBCL efficacy signals observed 
with magrolimab + rituximab in the current study provide expectation for enhanced 
activity with the addition of gemcitabine and oxaliplatin. From a safety perspective, 
the addition of magrolimab to R-GemOx is not anticipated to lead to additional 
significant toxicities based on the observation that magrolimab has been 
well-tolerated with rituximab in Phase 1b study. 
In the current clinical study, magrolimab has been shown to be well-tolerated in the 
Phase 1b experience with encouraging preliminary efficacy signals observed in 
heavily pretreated DLBCL patients, and an acceptable safety profile. Importantly, a 
30 mg/kg magrolimab dose was well-tolerated in combination with rituximab without 
an MTD being reached. This data justifies the use of 30 mg/kg of magrolimab as a 
Phagocytosis of HL60 AML Cells by Human Macrophages 
<0.001 
<0.001 
<0.01 
<0.0001 
fl) 
100 
fl) 
0 
n.s. 
>-
0 0 
0) 
(IJ 
..c 
n.. 
50 
:'.2: 
0 
0 
Macrophage Donor 301 
Macrophage Donor 192 
-
+1 0ug/nt.. lgG4 -
+10ug/nt.. Hu5F9-G4 -
+3uMAza 
-
+3uMAza +10ug/rn... Hu5F9-G4 


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starting dose for the combination with R-GemOx. The addition of magrolimab to
R-GemOx therapy may enhance clinical efficacy while maintaining an acceptable 
risk:benefit profile. In summary, the combination of magrolimab and R-GemOx may 
be more efficacious in high-dose chemotherapy/ASCT ineligible DLBCL patients 
who have a high unmet medical need. The addition of magrolimab to R-GemOx is 
expected to be relatively well- tolerated. Thus, the potential efficacy:safety profile 
justifies a risk:benefit ratio for the investigation of magrolimab in combination with 
R-GemOx in ASCT ineligible DLBCL.
1.7.
Dose Rationale
1.7.1. Antibody Combination (Magrolimab + Rituximab): Phase 1b Magrolimab
Because CD47 is widely expressed on normal tissues, effective tumor penetration 
by magrolimab requires a dose regimen that ensures adequate saturation of the 
internal CD47 receptor sink and achieves effective circulating drug levels. In the 
Phase 1 trial of magrolimab in solid tumors, maintenance dose concentrations 
between 10 and 30 mg/kg weekly were associated with circulating magrolimab drug 
levels that correlated with nonclinical anti-cancer efficacy. The Phase 1b portion of 
this trial was designed to investigate a 1-mg/kg priming dose followed by weekly 
maintenance doses of 10, 20, 30, or 45 mg/kg.
Escalating doses of magrolimab were evaluated in combination with 375 mg/m2 of 
rituximab (Table 6-1). Based on the aggregate safety, efficacy, PK, and PD data 
obtained in the Phase 1b portion of the study of patients with NHL, the CTSC 
determined a recommended Phase 2 dose and schedule (RP2DS) for magrolimab. 
In summary, the magrolimab RP2DS is as follows: a priming dose of 1 mg/kg 
followed by maintenance doses of 30 mg/kg; administration will be intravenous (IV) 
weekly during Cycle 1, and then every 2 weeks (Q2W) starting at Cycle 2. (Refer to 
Section 3.1.1.1 for additional details on RP2DS selection.)
Patients enrolled in Phase 1b and continuing in study may be transitioned to the 
RP2DS for magrolimab and the schedule for rituximab administration for Phase 2, 
as described in Section 6.1.1.2.


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Dose Rationale
The following dosing regimen is proposed for further testing in this study: priming 
(1 mg/kg) on Day 1, followed by doses of 30 mg/kg on Day 8 and every week 
thereafter for the first 2 cycles, followed by 30 mg/kg Q2W from Cycle 3 Day 1 
onwards. Rationale for the proposed dose comes from safety, efficacy, and 
pharmacokinetic/pharmacodynamic (PKPD) modeling and simulation data 
obtained from all ongoing and completed clinical trials with magrolimab in patients 
with solid tumors, NHL, and AML/MDS.
In the first-in-human study of magrolimab SCI-CD47-001 in patients with solid 
tumors and hematological malignancies, after an initial priming dose of 1 mg/kg 
on the first day, magrolimab was tested as a monotherapy at weekly doses of up 
to 45 mg/kg. No significant dose-dependent toxicities were observed across the 
dose range tested. In studies SCI-CD47-002 and 5F9005, in patients with 
myeloid malignancies, magrolimab was administered as a monotherapy at doses 
of up to 30 mg/kg twice weekly and in combination with AZA and at doses of up to 
30 mg/kg weekly, respectively. In these studies, no significant dose-dependent 
toxicity was observed and magrolimab was well-tolerated over the tested dose 
range. In studies 5F9003 and 5F9004, magrolimab, in combination with rituximab 
and cetuximab, respectively, was found to be safe and well-tolerated at doses of 
45 mg/kg every other week. All doses were found to be safe and well-tolerated, 
and no MTD was identified in any of the trials (see IB Section 5.3.1). Based on 
the integrated safety data in multiple oncology populations including the proposed 
study population, both as a monotherapy and in combination with other
tumor-targeted antibodies and chemotherapeutics, the proposed dosing regimen 
of magrolimab is expected to be safe and well-tolerated in NHL patients.
Exposure-response analysis from available dose-ranging data in NHL patients 
also supports the proposed dosing regimen. After a priming dose of 1 mg/kg in 
the first week, maintenance doses in the range of 10–45 mg/kg every week and 


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30–45 mg/kg Q2W were tested in the Phase 2 portion of the ongoing Phase 1b/2 
trial of magrolimab in combination with rituximab in R/R NHL patients (Study 
5F9003). Based on data obtained from this study so far, there was no significant 
difference in efficacy across the dose range tested. For instance, in R/R DLBCL, 
the objective response rate (ORR) of patients in the combined 30 mg/kg dose arm 
(N=35) and at 45 mg/kg (n=17) was 34% and 38%, respectively (Advani 2019). 
The PKPD modeling also indicated lack of relationship between exposure and 
ORR across the entire dose/concentration range tested in Phase 1 and Phase 2 
studies. Also, no relationship was observed between concentrations and duration 
of response (DOR) in responders across the tested dose range. Put together, 
these results indicated maximal efficacy at 30 mg/kg with no further efficacy 
benefit at higher doses. In addition, in study 5F9003, maximal CD47 RO was 
observed at the maintenance dose of 30 mg/kg twice weekly.
In summary, the proposed dose regimen has been shown to be safe and well- 
tolerated in multiple oncology patient populations, including NHL patients. Based 
on PKPD modeling, the proposed dose is predicted to result in optimal efficacy in 
this population. Further increases in dose beyond 30 mg/kg are not predicted to 
result in increased efficacy.
Please refer to Section 5.3.1 of the most recent version of the magrolimab IB for 
further information on safety analyses and the magrolimab IND Module 5 and 
PKPD modeling and simulation report (FSI-2019-014) for the population PKPD 
analysis that supports this dosing justification.
Rituximab
Rituximab will be administered at the clinically approved dose concentration of 
375 mg/m2 IV. In Phase 1b, rituximab was given in a loading/maintenance dose 
regimen that included weekly doses of 375 mg/m2 on Days 8, 15, and 22 during 
the first cycle, followed by 1 dose of 375 mg/m2 per cycle for up to 6 total 
cycles. The dose regimen was selected based on the PK profile of rituximab, 
as well as evidence that a loading/maintenance regimen enhances efficacy in 
pretreated NHL patients (Ghielmini 2004).


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The rituximab dosing will be changed to Day 1 of Cycles 2 through 6, and Day 1 of 
every other cycle starting with Cycle 8 and beyond, as outlined in Table 6-1 and 
Table 6-2. The MOA of magrolimab synergy with rituximab relies on a constant 
supply of pro-phagocytic signal generated by rituximab’s Fc receptor.
1.7.2. Antibody Combination (Magrolimab + Rituximab): Phase 2 Magrolimab
Magrolimab will be administered at a 1 mg/kg priming IV dose on Day 1, followed by 
weekly maintenance doses of 30 mg/kg during Cycle 1, followed by 30 mg/kg dosing 
Q2W for Cycle 2+ until disease progression. Refer to Section 3.1.1.3.
Based on emerging clinical data as well as the aggregate safety, efficacy, PK, and 
PD data obtained in the completed Phase 1b/2 portions of this study, the dosing of 
the new DLBCL Phase 2 Cohort 4 arm (Amendment 9), is being implemented as 
follows:
A priming dose of 1 mg/kg followed by maintenance doses of 30 mg/kg; 
administration will be IV weekly during Cycles 1 and 2, and then Q2W starting at 
Cycle 3. The order of dose administration on Cycle 1, Day 8 will consist of 
magrolimab followed by rituximab. Cycle length is 28 days; refer to Section 6.1.1.1 
for additional details on magrolimab administration; refer to Section 1.7 for the 
starting dose rationale.
Please refer to Section 5.3.1 of the most recent version of the magrolimab IB for 
further information on safety analyses and the magrolimab IND Module 5 and 
PKPD modeling and simulation report (FSI-2019-014) for the population PKPD 
analysis that supports this dosing justification.
Rituximab
Rituximab will be administered at the clinically approved dose concentration of 
375 mg/m2 IV weekly starting Day 8 through Cycle 1. Rituximab will then begiven 
monthly on Day 1 from Cycles 2 through 6, then every other month of Day 1 
starting Cycles 6 and beyond until loss of clinical benefit or unacceptable toxicity.


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1.7.3. Chemotherapy Combination (Magrolimab + R-GemOx)
R-GemOx is an established treatment regimen for DLBCL with a known toxicity 
profile when given together in the similar regimen as investigated in this study 
(Lopez 2008; Mounier 2013).
Magrolimab
In the chemotherapy combination cohort, magrolimab will be first evaluated in dose 
escalation with R-GemOx. The magrolimab dosing in the dose-escalation cohort 
will be administered at a 1 mg/kg priming IV dose on Day 1, with a higher 
maintenance IV dose on Day 8, 11, 15, 22, and 29 in Cycle 1 and weekly 
maintenance doses through Cycle 2. After Cycle 2, maintenance doses will be 
Q2W until disease progression. Refer to Table 6-3 for specific dosing regimens for 
magrolimab in the safety dose-escalation and expansion cohort. The Cycle 1 
Day 11 magrolimab loading dose has been eliminated for the Dose-Expansion 
cohort as of Amendment 9.
Rituximab
Rituximab will be utilized similarly to the dosing schedule determined in the Phase 1b 
magrolimab + rituximab dose escalation portion of this study. Rituximab will be 
administered at the approved dose concentration of 375 mg/m2 IV weekly starting Day 
8 through Cycle 1. Rituximab will then be given monthly on Day 1 of each cycle from 
Cycles 2 through 6 and then Day 1 every other cycle starting at Cycle 8 and continue 
until disease progression or unacceptable toxicity.
Gemcitabine
Gemcitabine will be administered at 1000 mg/m2 on Days 11 and 23 of Cycle 1, and 
subsequently on Day 2 and 15 of Cycles 2 through 4. This dosing regimen is based 
on a widely utilized dose of 1000 mg/m2 on a Q2 week schedule for up to 4 months 
in combination with rituximab and oxaliplatin in ASCT ineligible DLBCL
(Mounier 2013). Patients may receive gemcitabine for longer than 4 cycles to 
receive the total 8 doses if dose delays occur. Gemcitabine is a dministered on days 


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separate from rituximab to avoid potential infusion reaction and other toxicities 
(Lopez 2008).
Oxaliplatin
Oxaliplatin will be administered at 100 mg/m2 on Days 11 and 23 of Cycle 1, and 
subsequently on Day 2 and 15 of Cycles 2 through 4. This dosing regimen is based 
on a widely utilized dose of 100 mg/m2 on a Q2 week schedule for up to 4 months in 
combination with rituximab and oxaliplatin in ASCT ineligible DLBCL (Mounier 2013). 
Patients may receive oxaliplatin for longer than 4 cycles to receive the total 8 doses 
if dose delays occur. Oxaliplatin is administered on days separate from rituximab to 
avoid potential infusion reaction and other toxicities.


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2.
STUDY OBJECTIVES AND ENDPOINTS
Objectives and endpoints for the study are outlined below in Table 2-1.
Table 2-1
Study Objectives and Endpoints
PRIMARY
Objectives
Endpoints
•
To investigate the safety and 
tolerability, and to define the RP2DS 
for magrolimab in combination with 
rituximab and for magrolimab in 
combination with R-GemOx
•
To evaluate the efficacy of magrolimab 
in combination with rituximab in patients 
with indolent lymphoma and DLBCL 
and to evaluate the efficacy of 
magrolimab in combination with R- 
GemOx in ASCT ineligible DLBCL as 
measured by the ORR according to 
Lugano Classification for lymphomas 
(Cheson 2014; Table 10-1)
•
DLTs (Phase 1b only [in the antibody 
combination (magrolimab + 
rituximab) and the chemotherapy 
combination (magrolimab +
R-GemOx) cohorts]) and AEs 
according to NCI CTCAE, Version 
4.03
•
ORR as defined by the Investigator 
according to the Lugano Classification 
for lymphomas (Table 10-1)
SECONDARY
Objectives
Endpoints
•
To evaluate the PK profiles of 
magrolimab in combination with 
rituximab and magrolimab in 
combination with R-GemOx
•
To evaluate the immunogenicity of 
magrolimab in combination with 
rituximab and magrolimab in 
combination with R-GemOx
•
To evaluate the efficacy of magrolimab in
combination with rituximab in indolent 
lymphoma and DLBCL and magrolimab 
in combination with R-GemOx in ASCT 
ineligible DLBCL as measured by the 
DOR, PFS, OS, and TTP
•
To evaluate the efficacy of magrolimab 
in combination with rituximab in 
patients with indolent lymphoma and 
DLBCL and magrolimab in combination 
with R-GemOx in ASCT ineligible 
DLBCL as measured by ORR 
according to LYRIC (Cheson 2016; 
Table 10-2)
•
Concentration versus time 
measurements for magrolimab in 
combination with rituximab and for 
magrolimab in combination with
R-GemOx and their PK parameters 
including Cmax and AUC
•
ADA to magrolimab in combination 
with rituximab and magrolimab in 
combination with R-GemOx
•
DOR, PFS, OS, and TTP
•
ORR as defined by the Investigator 
according to the LYRIC Criteria for 
lymphomas (Table 10-2)


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CCI


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3.
STUDY DESIGN
3.1.
Overall Study Design
This trial is an open-label, multicenter, Phase 1b/2 trial investigating the combination 
of magrolimab + rituximab (antibody combination; Section 3.1.1) and magrolimab + 
R-GemOx (chemotherapy combination; Section 3.1.2) in R/R B-cell NHL.
3.1.1. Antibody Combination (Magrolimab + Rituximab)
3.1.1.1.
Phase 1b Study Design (Magrolimab + Rituximab)
The dose escalation portion of the Phase 1b cohort followed a standard 3 + 3 study 
design in patients with B-cell NHL received magrolimab and rituximab to investigate 
a 1-mg/kg magrolimab priming dose followed by weekly maintenance doses of 10, 
20, 30, or 45 mg/kg to determine the MTD and to identify the recommended Phase 2 
dose and schedule (RP2DS) for magrolimab in combination with rituximab.
Rituximab was administered by IV infusion at the clinically approved dose of 375 
mg/m2. Rituximab was given in a regimen that includes weekly doses on Days 8, 
15, and 22 during Cycle 1, followed by 1 dose on Day 1 of Cycles 2 through 6, and 
Day 1 of every other cycle thereafter. During Cycle 1, Weeks 2 through 4, and for 
Cycles 2 through 6, magrolimab and rituximab were administered on the same day. 
On days on which both rituximab and magrolimab were given for Cycle 1 Day 8 and 
beyond, rituximab was given first. Magrolimab was given at least 1 hour after the 
rituximab infusion was completed.
Dose escalation of magrolimab proceeded through the designated dose levels, as 
shown in Table 6-1. Decisions related to dose escalation were 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. Dose Level 3 
exploration was based on ongoing PK evaluation and clinical data review, and as 
decided by the CTSC. Ten patients were added to Dose Level 3 (that was


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previously demonstrated to be safe) for the purpose of confirming the tolerability of 
magrolimab and to provide additional PK data to assist in the selection of an 
RP2DS. The CTSC subsequently recommended to open-dose Level 4 to evaluate 
magrolimab at 45 mg/kg in Phase 1b.
Phase 1b for magrolimab + rituximab has enrolled 29 total patients (3 in Level 
1, 6 in Level 2, 13 in Level 3, 7 in Level 4) (data on file).
Dose escalation and cohort expansion decisions were reviewed and approved 
by the CTSC.
The rationales for the study and for the dose(s) are provided in Section 1.6 and 
Section 1.7, respectively. Based on review of safety, efficacy, and PK data available 
from Phase 1b (as outlined in Section 1.6.2), the CTSC determined that the Phase 1b 
dose-escalation phase of the trial reached sufficient evidence to determine a 
magrolimab RP2DS of a 1 mg/kg priming dose, followed by 30 mg/kg IV weekly 
during Cycle 1, and then Q2W (cycle length is 28 days).
Dose-Limiting Toxicity Evaluation (Magrolimab + Rituximab)
Dose escalation decisions were 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 dose cohort completed at least 1-week 
of treatment before additional patients were enrolled in the cohort. The third patient 
in a cohort completed the DLT Assessment Period prior to escalating to the next 
dose level.
DLT-evaluable Patients (Magrolimab + Rituximab)
Patients assigned to a particular dose cohort in Phase 1b were considered evaluable 
for assessment of DLT if EITHER of the following criteria were met during the DLT 
assessment period:
•
The patient experienced a DLT.
•
The patient completed at least 3 infusions of magrolimab and 2 infusions 
of rituximab.


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For the Phase 1b part of the study, patients who withdrew before completing the 
4-week DLT assessment period for reasons other than a DLT, or who do not fulfill 
either of the criteria above, were not evaluable for assessment of DLT for dose 
review decisions and were replaced in the cohort.
Definition of DLT (Magrolimab + Rituximab)
Toxicities were graded according to the National Cancer Institute Common 
Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.03 (Appendix B). 
A DLT was defined as any Grade 3 or greater AE that is assessed as related to 
study drug (magrolimab and/or rituximab) that occurs during the 4-week DLT 
observation period. DLTs applied only to patients in the Phase 1b part of the study 
for the magrolimab + rituximab cohort.
The following events were exceptions to the DLT definition and were NOT 
considered a DLT:
•
Grade 3 anemia, however, Grade 3 hemolytic anemia that is medically 
significant, requires hospitalization or prolongation of existing hospitalization, 
is disabling, or limits self-care activities of daily life (ADL) is considered a 
DLT.
•
Grade 3 indirect/unconjugated hyperbilirubinemia that resolves to ≤ Grade 2 
with supportive care within 1 week and is not associated with other clinically 
significant consequences.
•
Isolated Grade 3 electrolyte abnormalities that resolve to ≤ Grade 2 with 
supportive care within 1 week and are not associated with other clinically 
significant consequences.
•
Grade 3 elevation in alanine aminotransferase (ALT), aspartate 
aminotransferase (AST), or alkaline phosphatase that resolves to ≤ Grade 2 
with supportive care within 1 week and is not associated with other clinically 
significant consequences.
•
Transient Grade 3 nausea, vomiting, diarrhea, local reactions, influenza-like 
symptoms, myalgias, fever, headache, or acute pain that resolves to 


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≤ Grade 2 within ≤ 72 hours with supportive care.
•
Grade 3 fatigue that resolves to ≤ Grade 2 within 2 weeks on study
•
Grade 3 magrolimab or rituximab-related infusion 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.
•
Grade 3 tumor lysis syndrome or related electrolyte disturbances 
(hyperkalemia, hypophosphatemia, hyperuricemia) that resolve to ≤ Grade 2 
within 7 days
•
Grade 3 or 4 lymphopenia
•
Grade 3 infusion reactions attributed to rituximab; an infusion reaction can 
only be attributed to rituximab alone if the infusion reaction occurs after the 
start of rituximab infusion, but prior to magrolimab infusion, on days where 
rituximab and magrolimab are both dosed
3.1.1.2.
Recommended Phase 2 Dose and Schedule (Magrolimab + Rituximab)
As noted in Section 1.6.2 and Section 3.1.1 the CTSC determined a RP2DS for 
magrolimab based on data obtained in the Phase 1b portion of this study. Based on 
emerging data, the CTSC may select additional Phase 2 doses and schedules for 
evaluation.
3.1.1.3.
Phase 2 Study Design (Magrolimab + Rituximab)
The Phase 2 part of the study will explore the combination of magrolimab + 
rituximab at the RP2DS determined from Phase 1b antibody combination 
(magrolimab + rituximab) in 2 separate cohorts: 1) patients with indolent lymphoma 
(to include FL and marginal zone lymphoma), and 2) patients with DLBCL. For the 
Phase 2 part of the study, dosing will be as described in Section 6.1.1.1 and 
Section 6.1.1.2. Treatment for patients in the 2 cohorts will be conducted according 
to an initial two-stage design. After 14 patients in each arm have been enrolled, an 
efficacy futility analysis will be performed. Patients who do not complete at least
8 weeks on study may be replaced. If  3 patients out of 14 achieve an ORR in
-


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either cohort, enrollment may continue in the respective cohort. For any interim 
analysis point, accrual in either arm may be opened earlier by the CTSC at any point 
at which sufficient anti-cancer activity is observed.
For the DLBCL cohort (Phase 2 Cohorts 1 to 3), if the initial stage of clinical 
activity is met (in the first evaluable 14 patients), the CTSC will convene to review 
and approve proceeding with subsequent accrual of 40 efficacy-evaluable 
patients of either or both DLBCL and indolent lymphoma cohorts or to terminate 
the study according to the pre-specified stopping rules described in 
Section 11.4.1.
Per Amendment 9, the inclusion criteria were modified for DLBCL patients, and 
as such, this DLBCL cohort under the new inclusion criteria may be expanded to 
100 total patients for potential registrational approval. After the first 20 efficacy- 
evaluable patients, an efficacy analysis will be conducted by the CTSC, with 
subsequent determination to enroll the full 100 patients or to stop enrollment.
Enrollment may proceed if an ORR of 20% (4/20 patients) or higher is achieved 
with the 20 efficacy-evaluable patient analysis.
For the indolent lymphoma cohort, if the initial stage of clinical activity is met (in the 
first evaluable 20 patients), the CTSC will convene to review and approve 
proceeding with subsequent accrual of at least 24 efficacy-evaluable patients. After 
this interim analysis in at least 24 patients, the CTSC will review and may proceed 
with subsequent enrollment up to approximately 94 evaluable patients in the 
indolent lymphoma cohort.
The CTSC may also approve further enrollment and exploration of additional 
alternate Phase 2 doses to evaluate 14 additional patients given the heterogeneity of 
DLBCL and indolent lymphoma patients or to explore alternative dose regimens that 
may enhance efficacy. If alternative dosing regimens in Phase 2 are explored, then 
this futility analysis in an additional 14 patients will also be applied and further 
enrollment in either DLBCL or indolent lymphoma will occur as described above.
As noted in Section 3.1.1, the CTSC has determined the RP2DS for


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magrolimab based on data obtained in the Phase 1b antibody combination 
(magrolimab + rituximab) portion of the study. Refer to Section 6.1 for details 
of study drug administration.
3.1.2. Chemotherapy Combination (Magrolimab + R-GemOx)
The combination of magrolimab + R-GemOx will be explored in a Phase 1b 
design with an initial safety dose-escalation phase (with dose de-escalation if 
necessary) followed by an expansion phase in high-dose chemotherapy/ASCT 
ineligible patients.
Table 7-2 outlines post-treatment assessments for the safety dose-escalation and 
expansion phases of the magrolimab + R-GemOx cohort. PK assessments are 
outlined in Table 7-3 and correlative studies time points are outlined in Table 7-4. 
The Schedule of Assessments (SOA) for the chemotherapy combination 
(magrolimab + R-GemOx) is provided in Table 7-5.
3.1.2.1.
Phase 1b Safety Dose-Escalation Phase (Magrolimab + R-GemOx)
In the Phase 1b safety dose-escalation phase, a dose escalation of magrolimab in 
combination with R-GemOx will be investigated to determine the MTD, if one exists, 
and to identify a recommended magrolimab + R-GemOx dose for use in the 
expansion cohort.
Three to 6 patients will be enrolled in each dose cohort. If none of the first
3 patients experienced a DLT, dose escalation can proceed to the next higher dose 
cohort or the cohort can be expanded. If 1 of the first 3 patients experience a DLT, 
the cohort will be expanded to 6 patients. If  34% of patients in a dose level 
experience a DLT at any time, the MTD dose level will be exceeded in that cohort, 
and dose escalation is to be halted. Additional patients can be treated at a lower 
dose level. The selected dose for the expansion phase must not exceed a 34% 
DLT rate in at least 6 patients treated.
Patients will receive magrolimab + R-GemOx according to the dose schedule


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outlined in Section 6.1.2, Table 6-3. The Phase 1b dosing will start at dose level 1, 
using a 1 mg/kg magrolimab priming and 30 mg/kg maintenance doses in 
combination with standard dose R-GemOx. If this cohort is deemed to be safe, 
dosing will proceed to dose level 2 using a 45 mg/kg magrolimab maintenance dose. 
If the MTD is exceeded in cohort 1, then dose de-escalation will occur and the dose 
level -1 will be enrolled using a 1 mg/kg magrolimab priming and 20 mg/kg 
maintenance dose in combination with standard dose R-GemOx. Dose de- 
escalation of magrolimab to a 10 mg/kg maintenance dose may be further explored 
in another 6 patients if the 20 mg/kg maintenance dose level exceeds the MTD. The 
CTSC can decide to explore higher doses of magrolimab (beyond dose level 2) up to 
a 50% higher dose than the prior dose level in accordance with the modified 3+3 
design and if the lower dose level is deemed to be safe.
The first patient in each dose level is required to complete at least 9 days of 
treatment before additional patients are enrolled in the cohort. Subsequent patients 
may be simultaneously enrolled. The third patient in a cohort must complete the 
DLT Assessment Period before escalating to the next dose level. The Sponsor 
may decide whether a fourth patient can be enrolled to the same cohort before the 
first three patients complete the DLT Assessment Period, to have an extra patient in 
case one of the three earlier patients are not evaluable for DLT or if there is a DLT 
within the cohort requiring cohort expansion.
The magrolimab dose in combination with R-GemOx used in the expansion phase 
will be determined by the CTSC based on safety and clinical data. The CTSC may 
decide to expand any safety dose-escalation cohort to 10 additional patients to any 
magrolimab dose level combination that is deemed to be safe to collect additional 
safety, PK, or clinical data. Selection of the recommended dose of magrolimab + 
R-GemOx for the expansion phase may or may not include the Day 11 magrolimab 
dose, as determined by the CTSC.
Dose-Limiting Toxicity Evaluation (Magrolimab + R-GemOx)
Safety, tolerability, and dose de-escalation decisions will be made by the CTSC


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based on the first 5 weeks of treatment for each patient in the safety dose escalation 
magrolimab + R-GemOx cohort. Six patients will be initially enrolled, with dose de- 
escalation cohorts of magrolimab possible based on safety data. The DLT 
evaluation period will begin starting Week 2 through Week 5. AEs after initiation of 
the 1 mg/kg magrolimab priming dose on Day 1 and before initiation of gemcitabine 
and oxaliplatin on Day 11 will not be evaluable as DLTs. The safety dose-escalation 
cohort is designed to investigate the safety and tolerability of magrolimab and 
rituximab in combination with gemcitabine and oxaliplatin; therefore, DLTs are 
evaluated in patients that receive gemcitabine and/or oxaliplatin in addition to 
magrolimab and rituximab.
DLT-evaluable Patients (Magrolimab + R-GemOx)
Patients enrolled in the safety dose-escalation part of the Phase 1b magrolimab + R- 
GemOx 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 
of magrolimab, rituximab, and gemcitabine or oxaliplatin.
•
The patient completed at least 3 infusions of magrolimab, 2 infusions 
of rituximab, and 1 infusion of gemcitabine and oxaliplatin.
For the safety dose-escalation cohort, patients who withdraw before completing the 
5-week DLT assessment period for reasons other than a DLT or who do not fulfill 
either of the criteria above are not evaluable for assessment of DLT for safety review 
decisions and will be replaced in the cohort.
Definition of DLT (Magrolimab + R-GemOx)
Toxicities are graded according to the NCI CTCAE, Version 4.03 (Appendix B).
A DLT in this magrolimab + R-GemOx cohort is defined by the criteria listed above 
in Section 3.1.1.1 with the additional definitions listed below:
•
≥ Grade 4 hematologic toxicity that does not resolve to ≤ Grade 2 and delays 
initiation of cycle 2 by more than 14 days.
•
≥ Grade 4 febrile neutropenia or associated infections


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•
≥ Grade 4 non-hematologic toxicity that does not resolve or decrease to ≤
Grade 2 within 1 week.
•
≥ Grade 4 IRR
•
Recurrent ≥ Grade 3 magrolimab, rituximab, gemcitabine, or oxaliplatin 
IRR despite optimal pretreatment regimen, which is defined as 
acetaminophen or a comparable non-steroid anti-inflammatory agent, 
plus an antihistamine and corticosteroids. In addition to the above, 
optimal pretreatment regimen includes antiemetic pretreatment for 
gemcitabine and/or oxaliplatin IRRs.
3.1.2.2.
Phase 1b Expansion Phase (Magrolimab + R-GemOx)
After the safety dose-escalation phase is completed, the dose regimen of magrolimab
+ R-GemOx that is well-tolerated and recommended by the CTSC will be utilized in 
treating 20 patients in an expansion phase to evaluate efficacy of the combination. 
Table 6-3 (provided in Section 6.1.2) outlines the expansion phase dosing regimen 
and schedule. For the expansion phase, patients may be enrolled simultaneously 
without an observation time between patients.
3.2.
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, expansion of cohorts, using higher or lower dose levels, 
defining any new dose cohorts, identification of the RP2DS, and interim efficacy 
analysis decisions. The CTSC will meet at a minimum at the completion of each 
dosing cohort during dose-escalation phase of the trial, at any protocol-specified 
formal interim analyses, and when emergent critical safety data are reported.
The composition, structure, and function of the CTSC are defined in the CTSC 
Charter.


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3.3.
Data Monitoring Committee
Data Monitoring Committee functions for this trial will be performed by the CTSC, as 
defined and described in Section 3.2.
3.4.
Number of Sites
Approximately 20 sites located in the US, United Kingdom (UK), and Australia will 
be included  in this trial. Additional sites may be included based on enrollment and 
study timelines.
3.5.
Estimated Study Duration and End of Study
Individual patient participation will include screening/enrollment, treatment, and 
follow-up. It is anticipated that this study will take approximately 42 months for 
screening/enrollment and treatment of all patients. 
4.
PATIENT SELECTION AND ENROLLMENT
4.1.
Study Entry Criteria
4.1.1. Inclusion Criteria
1.
Adults ≥ 18 years
2.
Antibody combination (magrolimab + rituximab) Phase 1b cohort only: 
B-cell NHL expressing CD20 by immunohistochemistry (IHC) or flow 
cytometry, relapsed or refractory to at least 2 prior lines of therapy.
3.
DLBCL chemotherapy combination (magrolimab + R-GemOx) Phase 1b 
safety dose-escalation and expansion cohorts:
a. Histologically confirmed de novo or transformed DLBCL relapsed or 
refractory to 1 to 3 prior lines of therapy who are not candidates for 
high-dose chemotherapy and ASCT. Patients relapsed after ASCT are 
allowed.
b. At least 1 prior therapy must have included a CD20-targeted therapy.
c. Primary refractory patients are excluded as defined by failure to achieve a 
PR or CR to frontline therapy or progression within 3 months of 
completing treatment.
d. The 1 to 3 prior lines of therapy requirement is only applicable for 
treatment regimens for DLBCL and not for prior lymphomas in the case of 
transformed DLBCL.


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4.
For the DLBCL antibody combination (magrolimab + rituximab) Phase 2 Cohort 
4, de novo or transformed DLBCL, not otherwise specified, according to the 
World Health Organization 2016 classification of lymphoid neoplasms 
(Swerdlow 2016) expressing CD20 by IHC or flow cytometry, that is relapsed 
or refractory to at least 2 prior lines of therapy containing and anti-CD20 
therapy. Prior autologous hematopoietic cell transplantation is permitted.
5.
Indolent lymphoma Phase 2 Cohort: Histologically confirmed marginal 
zone or FL (Grade 1 to 3a) expressing CD20 by IHC or flow cytometry, 
relapsed or refractory to at least 2 prior lines of therapy.
6.
Eastern Cooperative Oncology Group (ECOG) score 0 to 2
7.
Disease that is measurable or assessable for response per Lugano 
Classification for lymphomas (Cheson 2014; Table 10-1)
8.
Laboratory measurements, blood counts:
•
Hemoglobin must be ≥ 9 g/dL within 24 hours prior to the first 2 doses of 
magrolimab infusion. NOTE: Transfusions are allowed to meet hemoglobin 
eligibility (see Section 6.2.1.3 for anemia management)
•
Absolute neutrophil count (ANC) ≥ 1.0 × 109/mL
•
For the antibody combination (magrolimab + rituximab) Phase 1b 
and Phase 2 cohorts: Platelets ≥ 50 × 109/mL
•
For the Phase 1b chemotherapy combination (magrolimab +
R-GemOx) safety dose-escalation and expansion cohorts only,
platelets ≥ 100 × 109/mL
9.
Laboratory measurements, hepatic function:
•
AST/ALT < 5 × upper limit of normal (ULN)
•
Bilirubin ≤ 1.5 × or 3.0 × ULN and primarily unconjugated if patient has a
documented history of Gilbert’s syndrome or a genetic equivalent
10.
Laboratory measurements, renal function:
•
Serum creatinine ≤ 1.5 × ULN or calculated GFR > 40 mL/min/1.73 m2
11.
Women of childbearing potential (WOCBP) 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 magrolimab.
12.
WOCBP must be willing to use at least 1 highly effective method of 
contraception during the study and continue for 4 months after the last dose 
of magrolimab and 12 months after the last dose of rituximab
13.
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 
and refrain from sperm donation during the study and for 4 months after 
the last dose of magrolimab and 12 months after the last dose of rituximab. 
If the partner is pregnant, male patients must use barrier method 
contraception (condom) during the study and for 4 months after the last 
dose of magrolimab and until there is a pregnancy outcome (whichever is 
applicable) to prevent fetal exposure to study drugs.
14.
Patient has provided informed consent


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15.
Must be willing and able to comply with clinic visits and procedures outlined in 
the study protocol
16.
DLBCL chemotherapy combination (magrolimab + R-GemOx) Phase 1b 
safety dose-escalation and expansion cohorts and Phase 2 antibody 
combination (magrolimab + rituximab) indolent lymphoma and DLBCL 
cohorts: Willing to consent to 1 mandatory pretreatment and 1 on-treatment 
tumor biopsy, unless determined to not be feasible by the Investigator 
(Reasons include, but are not limited to, lack of accessible tumor tissue to 
biopsy and patient safety issues.)
17.
CAR-T naïve or CAR-T ineligible patients and otherwise meet other 
inclusion/exclusion criteria may enroll. Patients who relapse following CAR-T 
therapy are not eligible.
4.1.2. Exclusion Criteria
1.
Patients with active brain metastases (patients with stable treated central 
nervous system [CNS] lesions who are off corticosteroid therapy for at least  
3 weeks are not considered active)
2.
Prior allogeneic stem cell transplant
3.
Prior anti-cancer therapy including chemotherapy, hormonal therapy, and 
investigational agents within 3 weeks or within at least 4 half-lives prior to 
magrolimab dosing (up to a maximum of 4 weeks), whichever is longer. 
NOTE: Low dose steroids (oral prednisone or equivalent ≤ 20 mg per day),  
localized non-CNS radiotherapy, previous hormonal therapy with LHRH 
agonists for prostate cancer, and treatment with bisphosphonates and 
RANKL inhibitors are not criteria for exclusion.
4.
Known active or chronic hepatitis B or C infection or HIV.
5.
RBC transfusion dependence, defined as requiring more than 2 units of 
RBC transfusions during the 4-week period prior to screening. RBC 
transfusions are permitted during screening and prior to enrollment to meet 
the hemoglobin inclusion criteria.
6.
History of hemolytic anemia or Evans syndrome in the last 3 months.
7.
Positive IgG component of the direct antiglobulin test (DAT).
8.
Prior treatment with CD47 or SIRPα-targeting agents.
9.
Second malignancy, except treated basal cell or localized squamous skin 
carcinomas, localized prostate cancer, or other malignancy for which patients 
are not on active anti-cancer therapy, as defined in Exclusion Criterion 3.
10.
Hypersensitivity to the active substance or to murine proteins, or to any of the 
other excipients of rituximab listed in Appendix A.
11.
Significant medical diseases or conditions, as assessed by the Investigator 
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, severely immunocompromised state, and 
congestive heart failure NYHA Class II-IV.


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12.
History of psychiatric illness or substance abuse likely to interfere with ability 
to comply with protocol requirements or give informed consent
13.
Pregnancy or active breastfeeding
14.
Additional exclusion criteria for DLBCL chemotherapy combination 
(magrolimab + R-GemOx) Phase 1b safety dose-escalation and 
expansion cohorts only:
a. Undergone ASCT within a period of ≤ 3 months before signing 
informed consent
b. Prior treatment with gemcitabine and oxaliplatin. However, patients 
who relapse ≥ 12 months after treatment with a gemcitabine and 
oxaliplatin-containing regimen are allowed.
c. Known hypersensitivity to gemcitabine, oxaliplatin, or other platinum 
compounds
d.
Intolerance of gemcitabine, oxaliplatin, and/or rituximab as 
monotherapy or in combination due to unacceptable toxicities as 
determined by the treating Investigator
4.2.
Contraception Requirements
Magrolimab is contraindicated in pregnancy as a higher incidence of total 
pregnancy loss has been observed in an embryo-fetal development toxicity study 
in cynomolgus monkeys and there is a strong suspicion of human fetotoxicity in 
early pregnancy based on the non-clinical data. For magrolimab, there is no 
anticipated PK interaction with progestin or other steroids based on the distinct 
clearance pathways. 
Female patients of childbearing potential who have a negative serum or urine 
pregnancy test before enrollment must agree to use one 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
•
Intra-uterine device
•
Intra-uterine hormone-releasing system
•
Oral combined hormonal contraception (estrogen and progestogen 
containing) associated with inhibition of ovulation (oral, intravaginal, 
transdermal)


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•
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, or post-ovulation methods), and neither 
are 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 magrolimab, 
throughout the trial and for 12 months after the last dose of rituximab, 6 months 
after the last dose of gemcitabine or oxaliplatin, or 4 months after the last dose of 
magrolimab, whichever occurs later.
Male patients with partners of childbearing potential must agree to take measures 
not to father children by using one of the following forms of effective contraception:
•
Methods Considered Highly Effective
(defined as methods that can achieve a failure rate of less than 1% per year 
when used consistently and correctly)
o
Vasectomy
o
Partner with bilateral tubal occlusion
o
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). 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.
•
Method Not Considered Highly Effective
(defined as methods that result in a failure rate of more than 1% per year)
o
Condom plus spermicide


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Contraception must be effective at the first administration of magrolimab, 
throughout the trial, and for 12 months after the last dose of rituximab, 6 months 
after the last dose of gemcitabine or oxaliplatin, or 4 months after the last dose of 
magrolimab, whichever occurs 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 plus spermicidal gel) to prevent the unborn fetus or the baby being 
exposed to investigational product.
Male patients must also refrain from sperm donation from the first administration of 
magrolimab throughout the trial and for 12 months after the last dose of rituximab, 
6 months after the last dose of gemcitabine or oxaliplatin, or 4 months after the last 
dose of magrolimab, whichever occurs later.
4.3.
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 within 2 days of consent (refer to Section 4.5). 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 patient has been registered in the interactive web response 
technology (IWRS) system. After signing the ICF, eligible patients are expected to 
receive the first dose of magrolimab (Study Day 1) within 30 days.


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4.4.
Informed Consent Process
All participants must be provided a consent form 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 standard of care 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 the consent documents must be 
retained in the medical record or research file.
4.5.
Registration Process
The site will register the patient via IWRS within 2 days of consent. IWRS will 
assign each patient a unique patient identification number.
Prior to being assigned a dose cohort or treatment arm, patients must have signed 
the informed consent and satisfied all of the eligibility criteria. Once a patient has 
been assigned to a dose cohort, and receives the first (priming) dose, they will be 
considered enrolled.
5.
STUDY DRUG INFORMATION
Detailed instructions for magrolimab + R-GemOx preparation and handling 
are provided in the Pharmacy Manual.
5.1.
Study Drug: Antibody Combination (Magrolimab + Rituximab)
5.1.1. Physical Description of Study Drug
5.1.1.1.
Magrolimab
The active pharmaceutical ingredient (API) is magrolimab, a humanized IgG4 mAb 
of the IgG4 kappa isotype containing a Ser-Pro 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 two identical 444 amino acid


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heavy gamma chains and two 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. 
Additional details about magrolimab are provided in the Pharmacy Manual.
5.1.1.2.
Rituximab
Rituximab is a genetically engineered chimeric murine/human monoclonal IgG1 
kappa antibody directed against the CD20 antigen (Appendix A). Rituximab is a 
sterile, clear, colorless, preservative-free liquid concentrate for IV administration.
Rituximab is supplied at a concentration of 10 mg/mL in either 100 mg/10 mL or 
500 mg/50 mL single-use vials. The product is formulated in polysorbate
80 (0.7 mg/mL), sodium chloride (9 mg/mL), sodium citrate dihydrate (7.35 
mg/mL), and Water for Injection. The pH is 6.5. Diluted solutions should be 
stored refrigerated (2 to 8°C).
Rituximab vials (100 mg/10 mL single-use vials and 500 mg/50 mL single-use vials) 
are stable at 2 to 8°C (36°F to 46°F). Rituximab vials should be protected from 
direct sunlight.
Diluted rituximab solution should be stored at 2 to 8°C because there is no 
preservative. The diluted solution is stable for 24 hours at 2 to 8°C.


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5.2.
Study Drug: Chemotherapy Combination (Magrolimab + R-GemOx)
5.1.2. Physical Description of Study Drug
Refer to Section 5.1.1.1 and Section 5.1.1.2 for descriptions of magrolimab 
and rituximab, respectively.
5.1.2.1.
Gemcitabine
Gemcitabine HCl (GEMZAR) is a nucleoside metabolic inhibitor that exhibits 
antitumor activity. Gemcitabine HCl is 2´-deoxy-2´,2´-difluorocytidine 
monohydrochloride (β-isomer). The empirical formula for gemcitabine HCl is 
C9H11F2N3O4 • HCl. It has a molecular weight of 299.66. It is soluble in water, 
slightly soluble in methanol, and practically insoluble in ethanol and polar organic 
solvents. The clinical formulation is supplied in a sterile form for IV use only. Vials 
of GEMZAR contain either 200 mg or 1 g of gemcitabine HCl (expressed as free 
base) formulated with mannitol (200 mg or 1 g, respectively) and sodium acetate 
(12.5 mg or 62.5 mg, respectively) as a sterile lyophilized powder.
Hydrochloric acid and/or sodium hydroxide may have been added for pH 
adjustment. GEMZAR (gemcitabine for injection United States 
Pharmacopeia [USP]) is a white to off-white lyophilized powder available in 
sterile single-use vials containing 200 mg or 1 g of gemcitabine.
Additional details will be provided in a separate Pharmacy Manual.
5.1.2.2.
Oxaliplatin
ELOXATIN® (oxaliplatin for injection and oxaliplatin injection) is an antineoplastic 
agent with the molecular formula C8H14N2O4Pt and the chemical name of
cis-[(1 R,2 R)-1,2 cyclohexanediamine-N,N’] [oxalato(2-)- O,O’] platinum. Oxaliplatin 
is an organoplatinum complex in which the platinum atom is complexed with
1,2-diaminocyclohexane and with an oxalate ligand as a leaving group.
The molecular weight is 397.3. Oxaliplatin is slightly soluble in water at 6 mg/mL, 
very slightly soluble in methanol, and practically insoluble in ethanol and acetone.


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Powder for solution for infusion: ELOXATIN is supplied in vials containing 50 mg or 
100 mg of oxaliplatin as a sterile, preservative-free lyophilized powder for 
reconstitution. Lactose monohydrate is present as an inactive ingredient at 450 mg 
and 900 mg in the 50 mg and 100 mg dosage strengths, respectively.
Concentrate for solution for infusion: ELOXATIN is supplied in vials containing 
50 mg, 100 mg, or 200 mg of oxaliplatin as a sterile, preservative-free, aqueous 
solution at a concentration of 5 mg/mL. Water for Injection, USP is present as an 
inactive ingredient.
Additional details will be provided in a separate Pharmacy Manual.
6.
TREATMENT PLAN
6.1.
Study Drug Administration
6.1.1. Antibody Combination (Magrolimab + Rituximab)
Planned Phase 1b dose levels for the antibody combination (magrolimab + 
rituximab) are outlined below in Table 6-1 and the current Phase 2 dose for the 
antibody combination (magrolimab + rituximab) is outlined in Table 6-2. The initial 
CTSC RP2DS and alternative dose regimens evaluated can be found in
Appendix H. Patients enrolled under alternate schedules will have transitioned to 
the SOA described in Table 7-1. Details of magrolimab administration are provided 
in Section 6.1.1.1 and details of rituximab administration are provided in
Section 6.1.1.2.
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 
(Appendix A). Dose modifications for changes in body weight < 10% may be made 
according to local institutional guidelines.


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In addition, a 90-minute rituximab infusion may be given as an alternative to 
standard rituximab infusion times for the Cycle 2 rituximab dose and beyond, if in 
accordance with local clinical guidelines.
For Phase 2, patients may be enrolled simultaneously without a dosing observation 
time between patients.
Magrolimab + rituximab treatment may be extended to ‘until loss of clinical benefit 
or unacceptable toxicity’ for patients who do not have disease progression.
Patients who develop a known adverse reaction to rituximab may continue treatment 
with magrolimab and will not be required to discontinue the study.


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Table 6-1
Dosing: Antibody Combination (Magrolimab + Rituximab) Phase 1b
Dose Schedule (Day per 28-day Cycle)a
Dose Level
Drug/Dose 
(IV)
Cycle 1
Cycle 2
Cycle 3+
Phase 1b: Level 1 Priming
Magrolimab 
1 mg/kg
Day 1
—
—
Maintenance
Magrolimab 
10 mg/kga
Day 8, 15, 22
Day 1, 8, 15,
22
Day 1, 8, 15,
22
Rituximab 
375 mg/m2
Day 8, 15, 22
Day 1
C3-C6, Day 1
Phase 1b: Level 2 Priming
Magrolimab 
1 mg/kg
Day 1
—
—
Maintenance
Magrolimab 
20 mg/kga
Day 8, 15, 22
Day 1, 8, 15,
22
Day 1, 8, 15,
22
Rituximab 
375 mg/m2
Day 8, 15, 22
Day 1
C3-C6, Day 1
Phase 1b: Level 3 Priming
Magrolimab 
1 mg/kg
Day 1
—
—
Maintenance
Magrolimab 
30 mg/kga
Day 8, 11, 15,
22
Day 1, 8, 15,
22
Day 1, 8, 15,
22
Rituximab 
375 mg/m2
Day 8, 15, 22
Day 1
C3-C6, Day 1
Phase 1b: Level 4 Priming
Magrolimab 
1 mg/kg
Day 1
—
—
Maintenance
Magrolimab 
45 mg/kga
Day 8, 11, 15,
22
Day 1, 8, 15,
22
Day 1, 15
Rituximab 
375 mg/m2
Day 8, 15, 22
Day 1
C3-C6, Day 1
Abbreviations: C = cycle number; IV = intravenous; RP2DS = recommended Phase 2 dose and schedule.
a. Phase 1b patients who continue treatment in Phase 2 may follow the Phase 2 dosing schedule (i.e., at the 
RP2DS). In Amendment 6, rituximab dosing was added to Day 1 of every other cycle starting with Cycle 8 and 
beyond.


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Table 6-2
Dosing: Antibody Combination (Magrolimab + Rituximab) Phase 2 
Cohort 4
Dose Schedule (Day per 28-day Cycle)
Drug/Dose (IV)
Cycle 1
Cycle 2
Cycles 3 to 6
Cycle 7+
Magrolimab 1 mg/kg (prime)
Day 1
—
—
—
Magrolimab 30 mg/kg 
(maintenance)a
Day 8a, 15,
22
Day 1, 8, 15,
22
Day 1,15
Day 1, 15
Rituximab 375 mg/m2 a
Day 8a, 15,
22
Day 1
Day 1 of
Cycle 6,
then Day 1 
every other 
Cycle 
starting
Cycle 8
Abbreviations: IV = intravenous.
a. On Cycle 1 Day 8 magrolimab is to be given first, followed by rituximab. For all other times when rituximab 
and magrolimab are given on the same visit, rituximab should be given first. There should be at least an 
hour interval between the end of infusion of the first drug and the beginning of the infusion of the second 
drug.
6.1.1.1.
Magrolimab Administration
The magrolimab dosing regimen is provided in Table 6-1 (Phase 1b) and 
Table 6-2 (Phase 2).
Patients will receive a priming dose of 1 mg/kg magrolimab on Day 1 of Cycle 1, 
and then maintenance doses:
•
Cycle 1 Day 1: Administration of 1 mg/kg IV priming dose only; the duration of 
the infusion of the priming dose will be 3 hours (± 30 minutes). Repriming doses 
are required for patients who experience a treatment delay of longer than 2 
weeks after a priming dose or longer than 4 weeks after at least 1 maintenance 
dose. Details are provided in Section 6.1.1.4.
•
Loading/maintenance dosing: IV administration; the duration of the infusion 
of the maintenance dose will be 2 hours (± 30 minutes) except in cases 
outlined in the pharmacy manual.
The order of administration has been changed in Amendment 9 when both 
magrolimab and rituximab Phase 2 Cohort 4 and R-Gem-Ox Expansion cohort are 
given on Cycle 1, Day 8, magrolimab will be given first, and then, rituximab will be 
administered at least 1 hour after the completion of magrolimab administration. At 


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subsequent visits when both magrolimab and rituximab are given on the same day, 
rituximab will be given first followed by magrolimab at least 1 hour after the 
completion of rituximab infusion. If patients have unacceptable toxicity due to 
rituximab as determined by the treating Investigator and Sponsor, then patients 
may continue on study with magrolimab monotherapy. This continuation requires 
consultation with the Sponsor. Volume restriction may be considered for patients 
with cardiac, pulmonary, or other medical condition which render the patient 
sensitive to fluid overload. Refer to Pharmacy Manual for more information.
Patients enrolled in the Phase 1b part of the study who have been on study for at 
least 8 weeks may have their magrolimab dose revised to the RP2DS, at the 
discretion of the Investigator and the Sponsor.
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 during the first week of treatment in patients with 
symptoms of anemia or at increased risk for complications of anemia.
6.1.1.2.
Premedication (for Magrolimab)
The optimal pretreatment regimen is defined as acetaminophen/paracetamol plus 
an antihistamine (i.e., oral acetaminophen 650 to 1000 mg [4 g/day maximum 
dose], oral or IV diphenhydramine 25 to 50 mg or comparable regimen) plus IV 
dexamethasone 4 to 20 mg, or comparable regimen.
•
Premedication is required before administration of the first 2 doses of 
magrolimab.
•
Premedication is also required for the repriming dose and the first 
maintenance dose.
•
Premedication for subsequent magrolimab treatments may be continued 


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based on the treating physician’s clinical judgement and the 
presence/severity of prior infusion reactions where allowed (Guidance is 
provided under Management of Infusion Reactions in Section 6.2.1.3).
6.1.1.3.
Post-infusion Monitoring (for Magrolimab)
All patients should be monitored for 1 hour post-infusion during Cycle 1 and after 
any “reprime” infusion at later cycles. Post-infusion monitoring should begin after 
the last study drug is given. Post-infusion monitoring is not required for doses after 
Cycle 1 Day 22, unless the patient is “reprimed”. Patients who experience any 
TRAEs during the observation period should be further monitored, as clinically 
appropriate. Patients who experience a Grade 2 infusion 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.
6.1.1.4.
Repriming (for Magrolimab)
The following list describes the requirements for magrolimab repriming.
•
Patients who experience an interruption of >2 weeks after receiving only the 
priming dose (1 mg/kg) must be “reprimed” by receiving the magrolimab 
priming dose of 1 mg/kg IV over 3 hours (±30 minutes) and 3 subsequent 
weekly maintenance doses prior to starting a Q2W dosing schedule.
•
Patients who experience an interruption of > 4 weeks after receiving at least 
1 maintenance dose (i.e., 30 mg/kg) must be “reprimed” by receiving the 
magrolimab priming dose of 1 mg/kg IV over 3 hours (±30 minutes) and 
3 weekly maintenance doses prior to starting the Q2W dosing schedule.
•
For long-term patients (≥ 18 months therapy) who are receiving maintenance 
magrolimab Q4W and experience an interruption of > 6 weeks after receiving 
the last dose must be “reprimed” by receiving the magrolimab priming dose of 
1 mg/kg over 3 hours then weekly maintenance doses prior to starting a Q4W 
dosing schedule.
•
Rituximab must be administered as regularly scheduled (e.g., magrolimab 
repriming doses may be administered on the same day as rituximab is given and 
schedule of rituximab administration should be maintained.)


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•
Premedication is required for the repriming dose and the following/subsequent 
maintenance dose.
On the day that patients receive their repriming dose, a predose ADA sample is to 
be collected.
For patients who are reprimed, the following assessments are to be performed at the 
supplemental weekly visits (e.g., Day 8, Day 22):
o
Complete blood count (CBC) with differential, platelets, reticulocytes
o
Peripheral blood smear
o
Serum chemistry
o
Haptoglobin, D-dimer, thrombin, fibrinogen (Day 8 only)
o
Prothrombin time (PT)/international normalized ratio (INR), activated partial 
thromboplastin time (aPTT) (Day 8 only)
o
Vital signs
o
Physical examination (Day 8 only)
o
AEs
o
Concomitant medications
The visit window for the weekly repriming visits is ± 3 days.
6.1.1.5.
Rituximab Administration
Patients will receive rituximab at a dose of 375 mg/m2 given IV starting on Day 8, 
followed by Days 15 and 22. Starting at Cycle 2, rituximab will be given on Day 1 of 
each cycle up to Cycle 6. Thereafter (i.e., Cycles 8 and beyond): administration of 
375 mg/m2 rituximab IV infusion on Day 1 of every-other-cycle (on even cycles).
In addition, a 90-minute rituximab infusion may be given as an alternative to standard 
rituximab infusion time for Cycle 2 dose and beyond, if in accordance with local 
clinical guidelines.
Rituximab will be administered until loss of clinical benefit or unacceptable toxicity. If 
patients have unacceptable toxicity due to rituximab as determined by the treating 
Investigator and Sponsor, then patients may continue on study with magrolimab 
monotherapy. This continuation requires consultation with the Sponsor.


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6.1.2. Chemotherapy Combination (Magrolimab + R-GemOx)
Study drug administration of the combination of magrolimab + R-GemOx will be 
according to Table 6-3 for the safety dose-escalation and expansion phases.
Combination therapy with gemcitabine and oxaliplatin is standard of care at most 
centers and will not be supplied by the Sponsor. Sites that require the Sponsor to 
provide this combination will not be able to enroll patients in this cohort.


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Table 6-3
Dosing: Chemotherapy Combination (Magrolimab + R-GemOx) Safety 
Dose-Escalation and Expansion Cohorts
Drug
Cycle 1
(5 weeks)
Cycle 2
(4 weeks)
Cycles 3–4
(4 weeks)
Cycles 5–6
(4 weeks)
Cycle 7+
(4 weeks)
DOSE- 
ESCALATION
Dose Level 1: 
Magrolimab (IV)a
1 mg/kg priming:
Day 1
30 mg/kg 
maintenance:
Day 8, 11, 15, 22,
29
30 mg/kg 
maintenance: 
Day 1, 8, 15, 22
30 mg/kg 
maintenance: 
Day 1, 15
30 mg/kg 
maintenance: 
Day 1, 15
30 mg/kg 
maintenance: 
Day 1, 15
DOSE- 
ESCALATION
Dose Level 2: 
Magrolimab (IV)b
1 mg/kg priming:
Day 1
45 mg/kg 
maintenance:
Day 8d, 11, 15, 22,
29
45 mg/kg 
maintenance: 
Day 1, 8, 15, 22
45 mg/kg 
maintenance: 
Day 1, 15
45 mg/kg 
maintenance: 
Day 1, 15
45 mg/kg 
maintenance: 
Day 1, 15
DOSE- 
EXPANSION
Magrolimab 
(IV)c, d
1 mg/kg priming:
Day 1
30 mg/kg 
maintenance:
Day 8, 15, 22,
29
30 mg/kg 
maintenance: 
Day 1, 8, 15, 22
30 mg/kg 
maintenance: 
Day 1, 15
30 mg/kg 
maintenance: 
Day 1, 15
30 mg/kg 
maintenance: 
Day 1, 15
Rituximab (IV)
375 mg/m2:
Day 8d, 15, 22, 29
375 mg/m2:
Day 1
375 mg/m2:
Day 1
375 mg/m2:
Day 1 then
Day 1 every
other cycle
starting Cycle 8
Gemcitabine (IV)
1000 mg/m2:
Day 11, 23
1000 mg/m2:
Day 2, 15
1000 mg/m2:
Day 2, 15
-
-
Oxaliplatin (IV)
100 mg/m2:
Day 11, 23
100 mg/m2:
Day 2, 15
100 mg/m2:
Day 2, 15
-
-
G-CSF
prophylaxise
Administer
Administer
Administer
-
-
Allopurinol (oral)f
Daily
-
-
-
-
Abbreviations: CTSC = Clinical Trial Steering Committee; G-CSF = granulocyte colony stimulating factor; 
IV = intravenous; R-GemOx = rituximab, gemcitabine, and oxaliplatin.
a.
Magrolimab maintenance dose maybe de-escalated to 20 mg/kg or 10 mg/kg with the identical dosing 
schedule of maintenance doses if the regimen is deemed too toxic by the CTSC.
b.
The CTSC may decide to explore higher doses of magrolimab in increments up to 50% higher than the 
prior dose level deemed to be safe in accordance with the modified 3 + 3 design.
c.
The magrolimab maintenance dose level utilized in the expansion phase will be the 
recommended dose selected by the CTSC from the safety dose-escalation phase.
d.
On Cycle 1 Day 8 magrolimab is to be given first, followed by rituximab. For all other times 
when rituximab and magrolimab are given on the same visit, rituximab should be given 
first. There should be at least an hour interval between the end of infusion of the first drug 
and the beginning of the infusion of the second drug.
e.
G-CSF primary prophylaxis must be administered with gemcitabine and oxaliplatin treatment. Local 
standard of care or equivalent will be administered in accordance to local institutional guidelines or 
Investigator guidance. G-CSF prophylaxis should generally occur within several days after administration 
of each day gemcitabine and oxaliplatin is dosed. However, the timing of G-CSF prophylaxis may be given 
in accordance to local institutional guidelines.
f.
Allopurinol of 300 mg oral daily should be administered for the first cycle only to prevent tumor lysis 
syndrome associated with chemotherapy. Allopurinol may be given at 100 mg oral daily for the first cycle if 
significant renal impairment is present as determined by the Investigator


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The dose of each study drug (magrolimab and R-GemOx) 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 (rituximab Appendix A, gemcitabine Appendix F, and 
oxaliplatin Appendix G). Dose modifications for changes in body weight < 10% may 
be made according to local institutional guidelines.
Magrolimab and rituximab treatment may extend throughout the trial for patients 
who do not have disease progression or who continue to have clinical benefit.
Gemcitabine and oxaliplatin dosing will complete after Cycle 4; however, dosing 
may continue beyond Cycle 4, as needed, until a total of 8 doses have been 
received at the discretion of the Investigator.
Patients who develop a significant known adverse reaction to rituximab, 
gemcitabine, and/or oxaliplatin may discontinue that drug(s), will not be required to 
discontinue the study, and may continue treatment with magrolimab, rituximab, 
and other chemotherapy component.
Granulocyte colony stimulating factor (G-CSF) prophylaxis is required for 
gemcitabine and oxaliplatin dosing to mitigate myelosuppression and dose delays 
observed with this chemotherapy combination. G-CSF primary prophylaxis must be 
administered with gemcitabine and oxaliplatin treatment (Cycles 1–4, or later if dose 
delays). Neupogen, Neulasta, or other equivalent will be administered in accordance 
to local institutional guidelines or Investigator guidance. G-CSF prophylaxis should 
generally occur within several days after administration of each day gemcitabine and 
oxaliplatin is dosed. However, the timing of G-CSF prophylaxis may be given in 
accordance to local institutional guidelines.


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6.1.3. Magrolimab Administration
The magrolimab dosing regimen for the safety dose-escalation and expansion 
phases of the magrolimab + R-GemOx cohort will be the same as outlined in 
Section 6.1.1.1.
When both magrolimab and rituximab are given on the same visit day, magrolimab 
will be administered at least 1 hour after the completion of the rituximab 
administration. When magrolimab and gemcitabine and oxaliplatin are given on the 
same visit day, magrolimab will be administered at least 30 minutes after the 
completion of gemcitabine and oxaliplatin administration.
6.1.3.1.
Premedication
Premedication for magrolimab must be administered as described in  
Section 6.1.1.2.
6.1.3.2.
Post-infusion Monitoring
Post-infusion monitoring for magrolimab should be performed as described in 
Section 6.1.1.3.
6.1.3.3.
Repriming
Magrolimab repriming instructions are outlined in Section 6.1.1.4.
6.1.3.4.
Gemcitabine Administration
In both the safety dose-escalation and expansion phases, patients will receive 
gemcitabine at a dose of 1000 mg/m2 given IV. Dosing is outlined in Table 6-3. For all 
doses, gemcitabine will be administered over 30 minutes. Dosing administration is 
outlined below:
•
Cycle 1: Administration of 1000 mg/m2 IV on Days 11 and 23
•
Cycles 2 through 4: Administration of 1000 mg/m2 IV on Day 2 and 15 of 
each cycle


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For visit days where gemcitabine and oxaliplatin are administered together (Cycle 1: 
Day 11 and 23) and Cycles 2 through 4: Day 2 and 15), gemcitabine should be 
administered first, followed by oxaliplatin infusion. On visit days where gemcitabine 
and oxaliplatin are administered together with magrolimab (Cycle 1 Day 11 [if 
applicable] and Cycles 2 through 4: Day 15), sequential gemcitabine and oxaliplatin 
infusions should be completed 30 minutes before the start of magrolimab 
administration.
6.1.3.5.
Oxaliplatin Administration
In both the safety dose-escalation and expansion phases, patients will receive 
oxaliplatin at a dose of 100 mg/m2 given IV. Dosing is outlined in Table 6-3. For 
all doses, oxaliplatin will be administered over 2 hours. Dosing administration is 
outlined below:
•
Cycle 1: Administration of 100 mg/m2 IV on Days 11 and 23
•
Cycles 2 through 4: Administration of 100 mg/m2 IV on Day 2 and 15 of each 
cycle
For visit days where gemcitabine and oxaliplatin are administered together (Cycle 1: 
Day 11 and 23 and Cycles 2 through 4: Day 2 and 15), gemcitabine should be 
administered first, followed by oxaliplatin infusion. On visit days where gemcitabine 
and oxaliplatin are administered together with magrolimab (Cycle 1 Day 11 [if 
applicable] and Cycles 2 through 4: Day 15), sequential gemcitabine and oxaliplatin 
infusions should be completed 30 minutes before the start of magrolimab 
administration.
6.1.3.6.
Premedication and Required Medications
Hydration, anti-emetics, anti-microbial prophylaxis and other prophylactic supportive 
treatment should be administered for gemcitabine and oxaliplatin according to local 
institutional guidelines and drug prescribing information where appropriate.
For both the safety dose-escalation and expansion phases, allopurinol of 300 mg 
oral daily should be administered during the first cycle only to prevent tumor lysis 


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syndrome associated with chemotherapy. Allopurinol may be given at 100 mg oral 
daily for the first cycle if significant renal impairment is presence as determined by 
the Investigator.
G-CSF prophylaxis is required for gemcitabine and oxaliplatin dosing to mitigate 
myelosuppression and dose delays observed with this chemotherapy combination. 
G-CSF primary prophylaxis must be administered with gemcitabine and oxaliplatin 
treatment (Cycles 1–4, or later if dose delays). Neupogen, Neulasta, or other 
equivalent will be administered in accordance to local institutional guidelines or 
Investigator guidance. G-CSF prophylaxis should generally occur within several 
days after administration of each day gemcitabine and oxaliplatin is dosed.
However, the timing of G-CSF prophylaxis may be given in accordance to local 
institutional guidelines.
6.2.
Dose Delays, Dose Modifications, and Safety Management Guidelines
6.2.1. Antibody Combination (Magrolimab + Rituximab)
6.2.1.1.
Dose Delays
Treatment delays of more than 4 weeks (such as for an unrelated medical condition 
with expected recovery) require notification to the Sponsor.
6.2.1.2.
Dose Modifications
Magrolimab may be withheld if treatment-emergent magrolimab-related AEs occur, 
which include all AEs that constitute a DLT, as defined in Section 3.1.1.1. If the 
severity has recovered to Grade 0 to 2 within 4 weeks and in the absence of disease 
progression, magrolimab may be re-introduced at a dose of 10, 20, or 30 mg/kg (i.e., 
the appropriate next lower dose level deemed safe by the CTSC). With 2 
exceptions, 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 
either hemolytic anemia or Grade ≥ 4 non-hematological toxicity will not restart 
magrolimab and will be withdrawn from study drug. Data from patients who restart 


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dosing after the recovery period will not contribute to the MTD evaluation at the 
lower dose level. Patients who have dose reductions in magrolimab can re-escalate 
back up to the RP2DS magrolimab dose level based on Investigator’s discretion with 
notification to the Sponsor.
An interruption is defined as a non-protocol-specified interruption from treatment, 
assessments, and procedures. Patients with an interruption of longer than 4 weeks 
or a treatment delay of longer than 4 weeks or more must be “reprimed” by receiving 
the priming dose of 1 mg/kg IV over 3 hours (± 30 minutes) again prior to resuming 
the assigned maintenance treatment dose (refer to Section 6.1.1.1).
For patients who have achieved a CR and who have been receiving study 
medication(s) for ≥ 18 months, the magrolimab dosing will be extended to Q4W at  
the discretion of the Investigator after discussion with the Medical Monitor. In this 
situation, the repriming requirement is extended to 6 weeks (e.g., 6 weeks exactly 
between doses, repriming is not required and 6 weeks + 1 day or more between 
doses, repriming is required).
Table 6-4
Magrolimab Dose Modifications
CTCAE Grade of Anemia
Management
Follow-Up
Grade 2
Mild-to-moderate new 
symptoms
Continue magrolimab and monitor 
signs and symptoms closely, 
transfuse per institutional 
guidelines
Monitor per institutional guidelines
If worsening, follow Grade 3 or 4 
guidelines
Grade 3 or 4
Severe new symptoms; 
new/worsening anemia; 
life-threatening
Contact the medical monitor for 
Grade 3 or 4 if a drug hold is 
required. Transfuse as needed 
and monitor until recovery
Monitor per institutional guidelines 
until recovery
CTCAE Grade of 
Thromboembolic event
Management
Follow-Up
Grade 1
Continue magrolimab and monitor 
signs and symptoms
Consider imaging as clinically 
indicated
Grade 2
Mild-to-moderate new 
symptoms
Continue magrolimab, monitor 
signs and symptoms
Intervene as clinically indicated
If worsening, follow Grade 3 or 4 
guidelines
Grade 3 or 4
Severe new symptoms; 
new/worsening; 
life-threatening
Contact the medical monitor for 
Grade 3 or 4 if a drug hold is 
required
Monitor signs and symptoms, 
intervene as clinically indicated
If improving to baseline 
magrolimab may resume
If no clinical improvement after 8 
weeks or worsening, consider 
permanent discontinuation of 
magrolimab


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CTCAE Grade of 
Pneumonitis
Management
Follow-Up
Grade 1
Radiographic changes (chest 
x-ray or CT) only
Monitor for signs and symptoms 
weekly and consider monitoring 
with chest x-ray
Consider pulmonary and 
infectious disease consults
Consider reimaging with CT in 3 
to 4 weeks as clinically indicated
May resume magrolimab with 
radiographic evidence of 
improvement or resolution
If no clinical improvement or 
worsening, treat as Grade 2
Grade 2
Mild-to-moderate new 
symptoms
Interrupt magrolimab therapy per 
protocol
Pulmonary and infectious disease 
consults
Consider empirical antibiotics
Monitor signs and symptoms 
every 2 to 3 days; consider 
hospitalization
1 mg/kg/day oral prednisone or IV 
equivalent
Consider bronchoscopy, lung 
biopsy
Reimage every 1 to 3 days
If improving to baseline, taper 
corticosteroids over 4 to 6 weeks 
and resume magrolimab therapy 
per protocol
If no clinical improvement after 48 
to 72 hours or worsening, treat as 
Grade 3 to 4
Grade 3 or 4
Severe new symptoms; 
new/worsening hypoxia; 
life-threatening
Discontinue magrolimab therapy
Hospitalize
Pulmonary and infectious disease 
consults
1 to 2 mg/kg/day 
methylprednisolone IV or IV 
equivalent
Add empirical antibiotics and 
consider prophylactic antibiotics 
for opportunistic infections
Consider bronchoscopy, lung 
biopsy
If improving to baseline, taper 
corticosteroids over 4 to 6 weeks
If no clinical improvement after 48 
hours or worsening, consider 
additional immunosuppression 
(eg, infliximab, 
cyclophosphamide, IV 
immunoglobulin, mycophenolate 
mofetil)


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Intra-patient Dose Escalation
When an RP2DS has been determined, patients enrolled in the Phase 1b part of the 
study who have been on study for at least 8 weeks may have their maintenance 
dose escalated to the dose level that has been previously determined to be safe in 
this study, at the discretion of the Investigator and the Sponsor.
Rituximab
Dose modifications for rituximab should be in accordance with the prescribing 
information (Appendix A).
6.2.1.3.
Safety Management Magrolimab
For additional information regarding safety, refer to the current version of the 
magrolimab IB.
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 clinical thromboembolic events and magrolimab use. Patients 
should be closely monitored for the symptoms of thromboembolic events and 
treated accordingly.
Severe Neutropenia
Severe neutropenia and febrile neutropenia have been reported in patients treated 
with magrolimab. Close monitoring of hematologic parameters (refer to Table 7-1, 
Table 7-2, and Table 7-5) including neutrophils is required for all patients treated 
with magrolimab. Prophylactic antibiotics and/or antimycotics should be considered. 
Administer G-CSF if clinically indicated.  
Recommendations for magrolimab dose delay in case of severe neutropenia: 
•
For Grade 3 neutropenia (ANC <1000 to 500/μL) without fever or 
infection, delay of magrolimab dosing is not recommended.


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•
For Grade 4 neutropenia (ANC < 500/μL) without fever or infection, or 
Grade 3 or higher neutropenia with fever or infection, magrolimab dose 
delay should be considered. Upon resolution to Grade ≤ 2, resuming 
magrolimab at the same dose should be considered.
•
For persistent severe neutropenia or febrile neutropenia (> 2 
occurrences), discontinuation of magrolimab can be considered.
Serious Infections
For serious infections, hold magrolimab until the infection has resolved clinically. For 
serious infections that remain active for ≥ 14 days, consider discontinuation of 
magrolimab. Patients (with or without neutropenia) should be regularly monitored for 
signs and symptoms of infection. For patients with prolonged neutropenia or patients at 
risk, consider infection prophylaxis including antibiotics (eg, fluoroquinolone) or 
antifungal agents (eg, oral triazoles or parenteral echinocandin) in accordance with 
current guidelines.
Anemia, Blood Cross-Matching, and Packed Red Blood Cell Transfusion 
Procedures
Magrolimab binds to RBCs and leads to erythrophagocytosis. CD47 is a member of 
the Rh complex in the RBC 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, treatment‑related anemia 
could be life‑threatening or fatal. Significant drops (up to 3 g/dL) have been 
observed in early doses. 
Patients with a low baseline hemoglobin level, especially those with cardiac history 


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or risk factors, must be monitored closely after initial administrations of magrolimab 
as preexisting anemia could be exacerbated (Section 6.1.1.1). Red blood cell 
transfusions are permitted prior to study treatment to ensure adequate hemoglobin 
level per the investigator’s clinical judgment. The need for RBC transfusions and 
anemia from other causes in patients with cancer means that care has to be taken 
with RBC cross‑matching and packed RBC transfusions.
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 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.
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, the institution may use 
historical blood group or O type, as per the institutional guidelines.
For emergency transfusions, the transfusion centers may consider using emergency 
Group O red cells 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 cross-match 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).
Blood Components for Transfusion
For all elective red cell transfusions, leukocyte-reduced units matched for the 
phenotype of the patients (as described above) will be used. Where exact matching 
for all the specified blood groups proves impractical (e.g., for MNS blood group), 
local sites will decide on the best matched donor units to be used. Cytomegalovirus 
(CMV) matching (i.e., CMV seronegative units for CMV-seronegative patients) will 
not be required for this study because it will limit the inventory for antigen matching.
If the cross match is incompatible, the RBC units that are Coombs cross- 
match incompatible will be selected (e.g., phenotype-matched or least 
incompatible) for issue at the discretion of the local site’s Transfusion Service 
Medical Director or equivalent person, where available.
For emergency transfusions, the transfusion laboratory may consider using 
emergency Group O Rhesus negative units if phenotyped units are not available.
Blood plasma therapy will be blood type specific. Platelets will be blood type 
compatible whenever possible, and if not, will have been tested and found not to 
have high titer anti-A or anti-B.
Management of Infusion 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 B). For the purposes of this study, the time frame for infusion reaction 
assessment is the 24-hour period beginning from the start of the infusion.
Recommendations for the management of IRRs are provided below.
•
For Grade 1 IRRs, described as mild transient reaction, infusion interruption 
is not indicated and intervention is not indicated:


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o
Remain at bedside and monitor patient until recovery from symptoms.
o
Patients who experience IRRs with the first 2 doses of magrolimab should 
continue premedication with corticosteroids prior to subsequent doses at the 
investigator’s discretion.
•
For Grade 2 IRRs, infusion interruption is indicated, but patient responds 
promptly to symptomatic treatment (e.g., antihistamines, 
acetaminophen, 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 25 to 50 mg IV 
(or equivalent) and/or 500 to 1000 mg oral acetaminophen (4 g/day 
maximum dose).
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
Patients who experience IRRs with the first 2 doses of magrolimab 
should continue premedication with corticosteroids prior to subsequent 
doses at the investigator’s discretion.
o
The amount of magrolimab infused must be recorded on the 
electronic case report form (eCRF).
o
Patients who experience a Grade 2 infusion reaction during the post- 
infusion observation period that does not resolve during that time should 
be observed until the AE resolves or stabilizes to ≤ Grade 1, with vital sign 
measurements as medically indicated for the management of the AE.
•
For Grade 3 or Grade 4 IRRs, where:
Grade 3 is described as prolonged IRRs (e.g., not rapidly responsive to 


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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.
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 subcutaneous 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 plus ranitidine 50 mg IV with 
methylprednisolone 100 mg IV (or equivalent), as needed.
•
The patient should be monitored until the Investigator is 
comfortable that the symptoms will not recur.
•
Patients who experience Grade 3 infusion reactions must be given 
premedication prior to all subsequent doses. In this setting, 
premedication with oral acetaminophen (650 to 1000 mg, 4 g/day 
maximum dose), oral or IV diphenhydramine (25 to 50 mg [or 
equivalent] with or without ranitidine), and IV dexamethasone 4 to 
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.
•
Patients who receive premedication and still experience 
a recurrent Grade 3 or patients who experience a Grade 
4 infusion reaction at any time will be permanently 
discontinued from study treatment.
•
For anaphylaxis, Investigators should follow their institutional 
guidelines for treatment.
•
All patients who experience Grade 3 or greater IRRs will be 
observed until the AE resolves or stabilizes, with vital sign 


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measurements and additional evaluations as medically indicated 
for the management of the AE(s).
Post-infusion Observation Period
All patients should be monitored for 1 hour post-infusion during Cycle 1 and after 
any “reprime” infusion at later cycles.
Patients who experience a Grade 2 infusion 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.
Tumor Lysis Syndrome
In the case of evidence for tumor lysis syndrome associated with magrolimab, 
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. Study treatment should be held until the patient’s condition resolves or 
stabilizes.
Rituximab
Administration, Hypersensitivity, and Infusion Reactions
Available at the bedside prior to rituximab administration should be epinephrine for 
subcutaneous injection, diphenhydramine hydrochloride for IV injection, and 
resuscitation equipment for the emergency management of anaphylactoid reactions. 
Premedication with an antihistamine and acetaminophen/paracetamol is required 
prior to rituximab dosing, in accordance with local best practices. Rituximab should 
be administered IV through a dedicated line at an initial rate of 50 mg/hour.
If hypersensitivity or infusion-related events do not occur, infusion rate may be 
escalated in 50 mg/hour increments every 30 minutes, to a maximum of
400 mg/hour. If hypersensitivity or infusion-related events develop, the 
infusion should be temporarily slowed or interrupted. The patient should be 
treated according to the appropriate standard of care. The infusion can be 


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continued at one-half the previous rate when symptoms resolve. Subsequent 
rituximab infusions can be administered at an initial rate of 100 mg/hour and 
increased at 30-minute intervals by 100-mg/hour increments to a maximum of 
400 mg/hour. If, in accordance with local clinical guidelines, a 90-minute 
rituximab infusion is given and the patient experiences an infusion reaction, 
refer to local prescribing information for infusion adjustments (Appendix A).
During the rituximab infusion, the patient should be monitored until the infusion is 
discontinued according to standard practice guidelines for rituximab. Following the 
antibody infusion, the IV line should be maintained for medications as needed. If 
there are no complications after 1 hour of observation, the IV line may be 
discontinued. Additional details about rituximab infusion are provided in Appendix A.
Presence of Circulating Lymphoma Cells
In patients with evidence of circulating lymphoma cells in the peripheral blood, it is 
recommended that the initial infusion rate be reduced to 25 mg/hour as these 
patients may have increased propensity to infusion reactions and tumor lysis 
syndrome.
Cardiovascular
Infusions should be discontinued in the event of serious or life-threatening cardiac 
arrhythmias. Patients who develop clinically significant arrhythmias should undergo 
cardiac monitoring during and after subsequent infusions of rituximab. Patients with 
preexisting cardiac conditions, including arrhythmias and angina, and who have had 
recurrences of these events during rituximab therapy, should be monitored 
throughout the infusion and immediate post-infusion period.
Tumor Lysis Syndrome
Rituximab rapidly decreases the number of benign and malignant CD20 positive 
cells. Tumor lysis syndrome has been reported to occur within 12 to 24 hours after 
the first rituximab infusion in patients with high numbers of circulating malignant 
lymphocytes. Patients with high tumor burden (bulky lesions) may also be at risk. 
Patients at risk of developing tumor lysis syndrome should be followed closely and 
appropriate laboratory monitoring performed. Appropriate medical therapy should 


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be provided for patients who develop tumor lysis syndrome. Following treatment 
for and resolution of tumor lysis syndrome, subsequent rituximab therapy was 
administered in conjunction with prophylactic therapy for this syndrome in a limited 
number of cases.
6.2.2. Chemotherapy Combination (Magrolimab + R-GemOx)
6.2.2.1.
Dose Delays
This section provides information related to dose delays for the chemotherapy 
combination (magrolimab + R-GemOx) cohort only. Dose delay information for the 
antibody combination (magrolimab + rituximab) cohort is provided in
Section 6.2.1.1. Treatment delays of more than 4 weeks or 5 weeks for CR 
patients who have received study drugs ≥18 months and are on a 4 weekly cycle of 
magrolimab (such as for an unrelated medical condition with expected recovery) 
require notification to the Sponsor.
Magrolimab and/or Rituximab Dose Delays
No specific dose delays for magrolimab and rituximab are required. Treatment 
interruption for magrolimab and rituximab is allowed after the start of Cycle 3 at the 
discretion of the Investigator and with Sponsor approval. An interruption is defined 
as a non-protocol-specified interruption from treatment, assessments, and 
procedures. Patients with an interruption of longer than 4 weeks (2 weeks is 
maximum allowed for an elective drug treatment interruption), or a treatment delay 
of  longer than 4 weeks or more, must be “reprimed” by receiving the priming dose of
1 mg/kg IV over 3 hours (± 30 minutes) again before resuming the assigned
maintenance treatment dose (refer to Section 6.1.1.4). For patients who are in CR 
and have been on study treatment for ≥ 18 months and are receiving magrolimab 
Q4W, the repriming window has been extended to 6 weeks (i.e., repriming is 
necessary if the dose interruption is longer than 6 weeks). For patients on a 
priming/maintenance/loading dose cohort who have an interruption, the 
maintenance dose will be resumed after repriming.


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Gemcitabine and/or Oxaliplatin Dose Delays
Patients should receive a total of 8 gemcitabine and oxaliplatin doses; however, 
fewer than 8 doses may be administered at the discretion of the Investigator.
Patients should be returned to their Q2W gemcitabine and oxaliplatin schedule as 
soon as possible after missed, held, or delayed doses at the discretion of the 
Investigator. Gemcitabine and oxaliplatin dosing may continue beyond Cycle 4, as 
needed, until a total of 8 doses have been received at the discretion of the 
Investigator.
If gemcitabine and oxaliplatin dosing is delayed and doses are given at 
supplemental visits (e.g., Day 8 or Day 22), the following assessments (laboratory 
tests or other) are required:
•
CBC with differential, platelets, reticulocytes
•
Serum chemistry
•
Vital signs
•
Physical examination
•
AEs
•
Concomitant medications
Gemcitabine and oxaliplatin dosing should be delayed for either or both of the 
following hematologic toxicities:
•
Platelets <50 × 109/mL
•
ANC <1 × 109/mL
Patients can resume gemcitabine and oxaliplatin dosing when the platelets are
> 50 × 109/mL and the ANC is > 1 × 109/mL. Magrolimab and rituximab doses do not
need to be delayed for recovery of platelets and ANC as above. This dose delay 
guidance applies for gemcitabine and oxaliplatin only. If gemcitabine and oxaliplatin 
are delayed, magrolimab and rituximab should generally continue to be administered 
on schedule.
Additional growth factor support (G-CSF), in addition to the mandated G-CSF 
prophylaxis, may be given in any cycle at the discretion of the Investigator. In 
general, if gemcitabine and oxaliplatin dosing is delayed, magrolimab and 
rituximab will continue to be administered on schedule. Possible exceptions 


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should be discussed with the Sponsor. Dose reductions in gemcitabine and/or 
oxaliplatin doses are to be considered according to the guidelines provided in 
Table 6-5.
Table 6-5
Dose Reductions for Gemcitabine and Oxaliplatin for Hematologic 
Toxicities
Druga
Guidance
Dose Reduction
Dose delay of >2 weeks occurs 
for the first time
No dose reduction is required, 
consider additional G-CSF 
support in addition to prophylaxis
Dose delay of >2 weeks occurs 
for the second time
20% total dose reduction to 
800 mg/m2
After 20% dose reduction, if 
subsequent dose is delayed for
>2 weeks
50% total dose reduction to 
500 mg/m2
Gemcitabine (IV) 1000 mg/m2
After 50% dose reduction, if 
subsequent dose is delayed for
>2 weeks
Discontinue gemcitabine
Dose delay of >2 weeks occurs 
for the first time
No dose reduction is required, 
consider additional G-CSF 
support in addition to prophylaxis
Dose delay of >2 weeks occurs 
for the second time
20% total dose reduction to 
80 mg/m2
After 20% dose reduction, if 
subsequent dose is delayed for
>2 weeks
50% total dose reduction to 
50 mg/mg2
Oxaliplatin (IV) 100 mg/m2
After 50% dose reduction, if 
subsequent dose is delayed for
>2 weeks
Discontinue oxaliplatin
Abbreviations: G-CSF = granulocyte colony stimulating factor; IV = intravenous.
a.
For dose delays as above for hematologic toxicities, both gemcitabine and oxaliplatin should in 
general be dose reduced. Exceptions may occur where dose reduction for hematologic toxicity 
would occur for either gemcitabine or oxaliplatin and should be discussed with the Sponsor. For 
other (non-hematologic) toxicities specific to gemcitabine and/or oxaliplatin, dose reductions can 
follow the above when deemed appropriate by the treating physician. Dose reductions different 
from Table 6-5 should be discussed and approved by the Sponsor.


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6.2.2.2.
Dose Modifications
Dose modifications for rituximab, gemcitabine, or oxaliplatin should be in accordance 
with the respective prescribing information. However, specific dose reductions for 
hematologic toxicities due to gemcitabine and oxaliplatin should be followed as 
according to Table 6-5.
For patients with renal impairment, no dose reductions are required for 
creatinine clearance > 30 mL/min. For creatinine clearance  30 mL/min, dose 
reductions for gemcitabine and/or oxaliplatin may be considered by the treating 
Investigator with approval from the Sponsor.
Dose modifications or discontinuations of gemcitabine and/or oxaliplatin for other 
toxicities related to study drug may be instituted based on local institutional 
guidelines and the discretion of the Investigator.
For patients who have achieved a CR and who have been receiving study 
medication(s) for 18 months or longer, the magrolimab dosing will be extended to 
Q4W at the discretion of the Investigator after discussion with the Medical 
Monitor. In this situation, the repriming requirement is extended to 6 weeks (e.g., 
6 weeks exactly between doses, repriming is not required and 6 weeks + 1 day 
or more between doses, repriming is required).
6.2.2.3.
Safety Management
If unacceptable toxicities occur, gemcitabine, oxaliplatin, and/or rituximab may be 
discontinued while continuing magrolimab treatment, according to Investigator’s 
discretion with approval from the Sponsor. If unacceptable toxicities occur with 
gemcitabine and/or oxaliplatin, treatment with magrolimab and rituximab may be 
continued according to Investigator discretion with approval from the Sponsor.
Magrolimab
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Rituximab
Safety management guidelines for rituximab are provided in Section 6.2.1.3.
Gemcitabine
Treatment precautions for gemcitabine should be taken in accordance with the 
gemcitabine US prescribing information (Appendix F) and local institutional 
guidelines. Several specific precautions are outlined below.
If capillary leak syndrome, posterior reversible encephalopathy syndrome, or 
hemolytic-uremic syndrome is observed, discontinue treatment with gemcitabine. 
Consider discontinuing gemcitabine treatment for severe renal impairment or severe 
hepatic toxicity.
Exacerbation of Radiation Toxicity
Gemcitabine may cause severe and life-threatening toxicity when administered 
concurrently or within 7 days of radiation therapy. Local radiation therapy is not to 
be administered in the magrolimab + R-GemOx cohort within 7 days of 
gemcitabine administration.
Tumor Lysis Syndrome
Tumor lysis syndrome may occur with cytotoxic chemotherapy agents. Allopurinol is 
administered for the first cycle in the magrolimab + R-GemOx cohort as prophylaxis. 
Standard management will include vigorous IV hydration; correction of acidosis, if 
present; hypouricemic agents; and close monitoring of serum uric acid, phosphorus, 
and electrolytes. Patients will be admitted to the hospital as clinically indicated. Study 
treatment should be held until the patient’s condition resolves or stabilizes.
Oxaliplatin
Treatment precautions for oxaliplatin should be taken in accordance with the 
oxaliplatin US prescribing information (Appendix G) local institutional guidelines. 
Several specific precautions are outlined below.


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Hypersensitivity
If significant hypersensitivity to oxaliplatin is observed, treatment should be 
administered with antihistamine and corticosteroid. At the physician’s discretion, the 
patient may be re-challenged with oxaliplatin on the next dose with the following 
premedication prescribed or per local institutional guidelines: Dexamethasone 4 mg 
oral every 6 hours x 3 doses starting 24 hours pretreatment, plus 8 mg IV 30 minutes 
predose.
Peripheral Neuropathy
Oxaliplatin dose should be reduced by 20% for Grade 2 or higher neuropathies that 
are persistent (>14 days). Oxaliplatin should be discontinued if there is persistent 
symptomatic paresthesia or other severe neurotoxicity despite a 20% oxaliplatin 
dose attenuation.
Acute Laryngopharyngeal Dysesthesia
Some patients experience laryngopharyngeal dysesthesia (unpleasant sensations in 
the throat) with oxaliplatin. Onset is typically during or within hours of infusion and 
resolves within minutes to a few days. Symptoms are exacerbated by cold, so 
patients should be well advised on precautions. If this finding occurs, subsequent 
infusions of oxaliplatin should be given over an extended time of 6 hours. These 
findings do not require treatment or dose reduction. Treatment may be given at 
clinician’s discretion and can include anxiolytics and/or observation.
Tumor Lysis Syndrome
Tumor lysis syndrome may occur with cytotoxic chemotherapy agents. Allopurinol is 
administered for the first cycle in the magrolimab + R-GemOx cohort as prophylaxis. 
Standard management will include vigorous IV hydration; correction of acidosis, if 
present; hypouricemic agents; and close monitoring of serum uric acid, phosphorus, 
and electrolytes. Patients will be admitted to the hospital as clinically indicated.
Study treatment should be held until the patient’s condition resolves or stabilizes.


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6.3.
Prohibited Medication
6.3.1. Magrolimab
Anti-cancer therapies (including chemotherapy, hormonal therapy, and 
investigational agents) are prohibited within 4 weeks or within at least 4 half-lives (up 
to a maximum of 4 weeks), whichever is longer, before magrolimab administration 
and during the study. However, low dose steroids (oral prednisone or equivalent 
≤ 20 mg per day), localized non-CNS radiotherapy, previous hormonal therapy with 
LHRH agonists for prostate cancer, and treatment with bisphosphonates and 
RANKL inhibitors are not criteria for exclusion of patients from the study and are 
permitted during the study. Steroid doses higher than 20 mg prednisone equivalent 
per day may be administered for management of clinical conditions for a temporary 
period if deemed clinically necessary by the Investigator with approval from the 
Sponsor.
6.3.2. Rituximab
Because the safety of immunization with live viral vaccines following rituximab 
therapy has not been studied, vaccination with live virus vaccines is not 
recommended while the patient is being treated with rituximab or while peripherally 
B cell depleted (Appendix A).
6.3.3. Gemcitabine and Oxaliplatin
There are no prohibited medications specific for gemcitabine and oxaliplatin in 
addition to what is already defined in this section.
Gemcitabine and warfarin precaution: Gemcitabine may increase anticoagulant 
effect/increased bleeding risk with gemcitabine due to decreased hepatic 
metabolism of warfarin. Monitor INR regularly and adjust warfarin dosage as 
appropriate.


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For gemcitabine, radiation therapy that is allowed on study should not be 
administered within 7 days of gemcitabine dosing. Clinical studies have shown that 
concurrent administration of radiation therapy with gemcitabine can lead to 
increased toxicities (Appendix F). If radiation therapy within 7 days of gemcitabine 
dosing is needed for clinical care based on the overall risk:benefit profile, approval 
must be given by the Sponsor.
Oxaliplatin and nephrotoxic drugs precaution: Nephrotoxic drugs
(e.g., aminoglycosides, amphotericin, furosemide, non-steroidal anti-inflammatory
drugs, and others) may lead to additive nephrotoxicity with oxaliplatin. Avoid 
combination if possible or monitor renal function closely.
6.4.
Duration of Treatment
Patients may continue to receive combination magrolimab and rituximab treatment 
for as long as they tolerate it, for the duration of the trial. Gemcitabine and 
oxaliplatin dosing are intended to complete after Cycle 4; however, dosing may 
continue beyond Cycle 4, as needed, until a total of 8 doses have been received at 
the discretion of the Investigator. Patients who do not tolerate one of the study 
treatment drugs may continue the other study treatment drug for the duration of the 
trial, if the Sponsor and Principal Investigator agree.
6.5.
Patient Completion of the Study
Patients who have not demonstrated disease progression may continue to receive 
magrolimab and/or rituximab treatment. All patients will be followed through 
completion of all study treatment. Patients with ongoing serious adverse events 
(SAEs) and drug-related AEs will be followed for safety as outlined in Section 9.2.1.
Patients are considered to have completed study participation when they finish the 
Safety Follow-up Visit, as outlined in Section 7.4.


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7.
STUDY EVALUATIONS
7.1.
Schedules of Assessments
7.1.1. Antibody Combination (Magrolimab + Rituximab): Schedules of 
Assessments
The SOAs for both Phase 1b and Phase 2 of the antibody combination (magrolimab + 
rituximab) are presented in the following tables:
Table 7-1.
Antibody Combination (Magrolimab + Rituximab): RP2DS 
Phase 2 Schedule of Assessments (Including Phase 2 Cohort 4)
Table 7-2.
Post-treatment Assessments: All Cohorts – Antibody Combination 
(Magrolimab + Rituximab) Phase 1b and Phase 2 and Chemotherapy 
Combination (Magrolimab + R-GemOx) Phase 1b
Table 7-3.
Pharmacokinetic Assessments: Chemotherapy Combination 
(Magrolimab + R-GemOx) Phase 1b and Antibody Combination 
(Magrolimab + Rituximab) Phase 2
Table 7-4.
Correlative Studies: All Cohorts – Antibody Combination 
(Magrolimab + Rituximab) Phase 1b and Phase 2 and Chemotherapy Combination 
(Magrolimab + R-GemOx) Phase 1b
Unless otherwise noted, procedures are to be completed prior to any study drug 
infusion.
7.1.2. Chemotherapy Combination (Magrolimab + R-GemOx): Schedules of 
Assessments
The SOAs for the chemotherapy combination (magrolimab + R-GemOx) are presented 
in the following tables:
Table 7-2.
Post-treatment Assessments: All Cohorts – Antibody Combination 
(Magrolimab + Rituximab) Phase 1b and Phase 2 and Chemotherapy 
Combination (Magrolimab + R-GemOx) Phase 1b
Table 7-3.
Pharmacokinetic Assessments: Chemotherapy Combination 
(Magrolimab + R-GemOx) Phase 1b and Antibody Combination 
(Magrolimab + Rituximab) Phase 2
Table 7-4.
Correlative Studies: All Cohorts – Antibody Combination 
(Magrolimab + Rituximab) Phase 1b and Phase 2 and Chemotherapy Combination 
(Magrolimab + R-GemOx) Phase 1b
Table 7-5. Chemotherapy Combination (Magrolimab + R-GemOx): Phase 1b 
Schedule of Assessments, Safety Dose-Escalation and Expansion Cohorts


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7.1.3. Historical Arms: Schedule of Assessments
A listing of SOA from Phase 1b studies that are no longer enrolling and with 
patients in long-term follow up can be found in Appendix H.


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Table 7-1
Antibody Combination (Magrolimab + Rituximab): RP2DS Phase 2 Schedule of Assessments (Including 
Phase 2 Cohort 4)
Examination
Cycle (28-day Cycles)
1
2
3
4
5+
Cycle Day
SC
1
2
8
15
22
1
8
15
22
1
15
1
15
1
15a
Visit Window (Days)
-30
None
±1
±2
±1
± 2
Assessments
Informed consentb
X
Demographics
X
Medical and cancer 
history
X
Inclusion/exclusion 
criteria
X
Enrollment cohort 
assignmentb
X
Pregnancy testc
X
X
d
X
X
X
X
CBC with differential, 
platelets, reticulocytesc
X
Xs
X
Xt
X
X
X
X
X
X
X
X
X
X
X
X
Pre-infusion peripheral 
blood smeare
Xc
X
X
Serum or plasma 
chemistryc
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Serum uric acid, 
phosphorousc
X
X
X
X
X
Haptoglobin, D-dimer, 
thrombin time and 
plasma fibrinogenc
X
X
X
X
X
PT/INR, aPTTc
X
X
Type and screen 
(ABO/Rh), DAT, 
phenotyping/ 
genotypingu
X
Lymphocyte subset 
analysisf
X
X
X
X
X
Peripheral blood CD20+ 
enumerationg
X
X
X
X
X
Urinalysisc
X
X
Correlative studiesh
X
X
X
X


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Final
Gilead Sciences, Inc
Amendment 12
CONFIDENTIAL
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02 November 2023
Examination
Cycle (28-day Cycles)
1
2
3
4
5+
Cycle Day
SC
1
2
8
15
22
1
8
15
22
1
15
1
15
1
15
a
Visit Window (Days)
-30
None
±1
±2
±1
± 2
Assessments
Pharmacokineticsi
X
X
X
X
X
X
X
Xj
Antidrug antibodies
X
X
X
Xj
ECOG performance 
statusk
X
X
X
X
X
X
X
X
X
Vital signsl
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Physical examinationm
X
Xc
X
X
X
X
X
X
X
X
X
X
X
ECGn
X
Tumor/lymph node 
biopsyo
X
X
Diagnostic imaging and 
response assessment
X
Xp
Xp
Bone marrow biopsyq
X
Xr
Adverse events
Concomitant medications
Study Drug Administration
Rituximab
Xs
X
X
X
X
X
C5
and 
C6,
then 
Q2C
Magrolimab
X
Xs
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; aPTT = activated partial thromboplastin time; C = cycle number; CBC = complete 
blood count; CR = complete response; DAT = direct antiglobulin test; DLT = dose-limiting toxicity; ECG = electrocardiogram; ECOG = Eastern 
Cooperative Oncology group; PT/INR = prothrombin time/international normalized ratio; PE = physical exam; PI = Principal Investigator; 
PK = pharmacokinetics; PR = partial response; Q2C = every 2 cycles; RBC = red blood cell; Rh = Rhesus factor; RP2DS = recommended Phase 2 dose 
and schedule; SC = screening.
NOTE: Patients who will be transitioned from Phase 1b to Phase 2 dosing may have rituximab extended dosing that occurs on odd cycles rather than 
even (i.e., dosing on odd cycles will not be considered a protocol deviation); refer to Section 6.2.1.2.
a.
No assessment should be performed at C18+ D15 when magrolimab is dosed at D1 only.
b.
First dose of magrolimab must be given within 30 days of signing informed consent.
c.
Pre-infusion assessments may be performed up to 72 hours before study drug administration during the initial dose, however with subsequent doses, 
pre-infusion assessments may be performed up to 24 hours before study drug administration.
.... 


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Protocol 5F9003
Final
Gilead Sciences, Inc
Amendment 12
CONFIDENTIAL
Page 103
02 November 2023
d.
May use screening pregnancy test performed within 72 hours of first dose. 
e.
Peripheral blood smear slides will be read locally for results and retained. Details are provided in Section 7.3.7.
f.
Lymphocyte subset analysis every cycle for Cycle 1 to Cycle 6, prior to administration of study drug; following Cycle 6, analyses are at the 
discretion of the PI.
g.
For sites that have the capability of local CD20+ testing, CD20+ B lymphocyte cell enumeration in the peripheral blood every cycle for Cycle 1 to 
Cycle 6, prior to administration of study drug; following Cycle 6, analyses are at the discretion of the PI. Following Cycle 18, analyses are not 
required. CD20+ B-cell enumeration at safety follow-up visit. Both absolute and % of lymphocytes are preferred.
h.
Time point details for correlative studies are provided in Table 7-4.
i.
Time point details for PK time points are provided in Table 7-3.
j.
Starting with Cycle 5, samples to be collected Cycle 5 Day 1, Cycle 9 Day 1, Cycle 13 Day 1, then discontinue until safety follow-up visit. For patients 
who are in CR and have been on study treatment for ≥ 18 months and are receiving magrolimab Q4W, an additional ADA sample is to be collected at 
the third cycle Day 1 since 4-week dosing was started. 
k.
ECOG performance status is not required for patients who have completed more than 18 cycles.
l
Prior to infusion of study drug. Details are provided in Section 7.3.2.
m.
Full PE at screening, symptom-directed PE thereafter.
n.
Single ECG at screening.
o.
Two tumor/lymph node biopsies are mandatory during the study, one within the screening period and a second on-treatment (Cycle 2 Day 8, 
-1 to +3 weeks) unless determined to not be feasible by the Investigator. For patients who achieve a PR or CR, 
 
 For core biopsies, in addition to a specimen that is sent to the central laboratory, 
local lymphoma immunophenotyping panel is requested (see Appendix I). For large excisional biopsy, a portion of the specimen is to be sent for 
local lymphoma immunophenotyping panel, and the remainder of the tissue is to be processed and sent to central laboratory per tissue collection 
guidance.
p. 
Response assessments at Cycle 3 Day 1 (± 7 days) then Q2C (± 7 days). Assessments may be adjusted by ± 4 weeks to coordinate with treatment 
cycle timing. Note that patients may be on odd or even cycles based on whether rituximab is being added back on even or odd cycles (post Cycle 6) 
for some patients. For patients who continue on study medications for ≥18 months, response assessment may be extended to every 3 to 4 cycles at 
the discretion of the Investigator. Details are provided in Section 7.3.5.
q.    Bone marrow biopsy will be performed for response assessment in those patients with known bone marrow disease involvement and also performed 
to confirm CR at any response assessment, where clinically appropriate, and at disease progression.
r.     To be performed with diagnostic imaging (± 7 days from Cycle 3, Day 1).
s.
On Cycle 1 Day 8 only, magrolimab should be given prior to rituximab. All other times when magrolimab and rituximab are given on the same visit, 
rituximab should be given before magrolimab. There should be at least an hour interval between the end of infusion of the first drug and the 
beginning of infusion of the second drug.
t
Within 24 hours prior to each of the first 2 doses of magrolimab infusion during initial treatment (Days 1 and 8), all patients must have a documented 
hemoglobin ≥ 9.0 g/dL (Section 6.1.1.1). Patients who do not meet these criteria must be transfused and have their hemoglobin rechecked to meet 
9.0 g/dL prior to each of the first 2 doses of magrolimab. An additional hemoglobin must be checked 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 during the first week of treatment in patients with symptoms of anemia or at increased risk for complications of anemia.
u.   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. RBC genotyping instead of extended RBC phenotyping is acceptable for any patient. A RBC 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).
CCI


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Protocol 5F9003
Final
Gilead Sciences, Inc
Amendment 12
CONFIDENTIAL
Page 104
02 November 2023
Table 7-2
Post-treatment Assessments: All Cohorts – Antibody Combination 
(Magrolimab + Rituximab) Phase 1b and Phase 2 and Chemotherapy Combination 
(Magrolimab + R-GemOx) Phase 1b
Examination
Post-treatment Assessments: All Cohorts – 
Antibody Combination (Magrolimab + Rituximab) 
Phase 1b and Phase 2 and Chemotherapy 
Combination (Magrolimab + R-GemOx) Phase 1b
Safety Follow-upa
Cycle (28-day Cycles)
30 Days After Last Dose of the Last Study Druga
Visit Window
± 7 Days
Assessments
Serum or urine pregnancy test
X
CBC with differential, platelets, retics
X
Serum or plasma chemistry
X
Pharmacokinetics
X
Antidrug antibodies
X
ECOG performance status
X
Vital signs
X
Physical examination 
(symptom-directed)
X
Diagnostic imaging
Xb
Response assessment
Xb
Adverse events
X
Concomitant medications
X
Abbreviations: CBC = complete blood count; ECOG = Eastern Cooperative Oncology Group; 
R-GemOx = rituximab, gemcitabine, and oxaliplatin.
a.
Safety Follow-up should occur at 30 ± 7 days; however, the follow-up may occur at an earlier time point if the 
patient is starting a new therapy.
b.
Required only if not completed within the last 4 weeks.


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Protocol 5F9003
Final
Gilead Sciences, Inc
Amendment 12
CONFIDENTIAL
Page 105
02 November 2023
Table 7-3 Pharmacokinetic Assessments: Chemotherapy Combination (Magrolimab + 
R-GemOx) Phase 1b and Antibody Combination (Magrolimab + Rituximab) Phase 2
Cycle 1
Cycle 2
Cycle 3 to
Cycle 6
Cycles 9
and 13
Cycle X, 
X+1, and 
X+2 c
Day
1
8
15
1
15
1
1
1
Before rituximab infusion 
(within 12 hours)
X
X
X
Xb
Before magrolimab infusion 
(within 12 hours)
X
X a
X a
X a
X
X a,b
X b
X
Abbreviations: PK = pharmacokinetic(s); R-GemOx = rituximab, gemcitabine, and oxaliplatin.
a.
Sample to be collected before rituximab infusion when applicable. On days when both rituximab 
and magrolimab are administered, PK samples for rituximab and magrolimab can be combined in a 
single blood draw taken prior to administration of either drug.
b.
Starting with Cycle 5, samples to be collected Cycle 5 Day 1, Cycle 9 Day 1, Cycle 13 Day 
1, then discontinue until safety follow-up.
c.
For patients who are in CR  and have been on study treatment for ≥ 18 months and are 
receiving magrolimab Q4W, additional PK samples are to be collected. Since some 
patients are ongoing longer than 18 months, the table refers to the cycle that 4-week 
dosing starts as referred to as Cycle X. The PK samples should only be collected for 3 
cycles.
Table 7-4 Correlative Studies: All Cohorts – Antibody Combination (Magrolimab + 
Rituximab) Phase 1b and Phase 2 and Chemotherapy Combination (Magrolimab + R-
GemOx) Phase 1b
Time Points
Cycle 1
Cycle 2
Cycle 3
Cycle X, X+1, 
and X+2 c
Day
1
15
1
1
1
Phase 1b
Pre-study drug infusiona
X
X
X
X b
X
Phase 2
Pre-study drug infusiona
X
X
X
Xb
X
Abbreviations: R-GemOx = rituximab, gemcitabine, and oxaliplatin; RO = receptor occupancy.
a.
Cycle 1 Day 1 pre-infusion laboratory tests may be collected up to 72 hours before study drug 
treatment.
b.
To be performed with diagnostic imaging (± 7 days from Cycle 3, Day 1).
c.
For patients who are in CR  and have been on study treatment for ≥ 18 months and are receiving 
magrolimab Q4W, additional RO samples are to be collected. Since some patients are ongoing longer 
than 18 months, the table refers to the cycle that 4-week dosing starts as referred to as Cycle X. The RO 
samples should only be collected for 3 cycles.


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Protocol 5F9003
Final
Gilead Sciences, Inc
Amendment 12
CONFIDENTIAL
Page 106
02 November 2023
Table 7-5
Chemotherapy Combination (Magrolimab + R-GemOx): Phase 1b Schedule of Assessments, Safety Dose- 
Escalation and Expansion Cohorts
Examination
Chemotherapy Combination (Magrolimab + R-GemOx):
Phase 1b Schedule of Assessments, Safety Dose-Escalation and Expansion Cohorts
Cycle (28-day 
cycles) except for 
Cycle 1 (35 days)
1
2
3
4
5
6+
Cycle day
SC
1
2
8
11
15
22
23
29
1
2
8
15
22
1
2
15
1
2
15
1
15
1
15
Visit window (days)
-30
None
±1
±2
±1
±2
Assessments
Informed consenta
X
Demographics
X
Medical and cancer 
history
X
Inclusion/exclusion 
criteria
X
Enrollment cohort 
assignmenta
X
Pregnancy testb
X
Xc
X
X
X
X
X
CBC with differential, 
platelets, 
reticulocytesb, u
X
Xu
X
Xu
X
X
X
X
X
X
X
X
X
X
X
X
X
Peripheral blood 
smeard
Xb
X
X
Serum or plasma 
chemistryb
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X


Magrolimab
Protocol 5F9003
Final
Gilead Sciences, Inc
Amendment 12
CONFIDENTIAL
Page 107
02 November 2023
Examination
Chemotherapy Combination (Magrolimab + R-GemOx):
Phase 1b Schedule of Assessments, Safety Dose-Escalation and Expansion Cohorts
Cycle (28-day 
cycles) except for 
Cycle 1 (35 days)
1
2
3
4
5
6+
Cycle day
SC
1
2
8
11
15
22
23
29
1
2
8
15
22
1
2
15
1
2
15
1
15
1
15
Visit window (days)
-30
None
±1
±2
±1
±2
Assessments
Serum uric acid, 
phosphorousb
X
X
X
X
X
X
X
Haptoglobin,
D-dimer, thrombin
time and plasma 
fibrinogenb
X
X
X
X
X
X
PT/INR, aPTTb
X
X
Type and screen 
(ABO/Rh), DAT, 
phenotyping/ 
genotypingv
X
Lymphocyte subsete
X
X
X
X
X
X
Peripheral blood 
CD20+ enumerationf
X
X
X
X
X
X
Urinalysisb
X
Correlative studiesg
X
X
X
X
Pharmacokineticsh
X
X
X
X
X
X
X
Xi
X
Anti-drug antibodies
X
X
X
Xi
X
ECOG performance 
status
X
X
X
X
X
X
X
X
X
X


Magrolimab 
Protocol 5F9003 
Gilead Sciences, Inc 
Examination 
Cycle (28-day 
cycles) except for 
Cycle 1 (35 days) 
Cycle day 
Visit window (days) 
Assessments 
Vital signsi 
Physical examinationk 
ECG1 
Tumor/lymph node 
biopsy, mandatorym 
Diagnostic imaging 
and response 
assessment 
Bone marrow biopsy<> 
Adverse eventsP 
Concomitant 
medicationsP 
Allopurinol 300 mg 
oral dailyq 
G-CSF prophylaxis' 
CONFIDENTIAL 
SC 
1 
2 
-30 
None ±1 
X 
X 
X 
X 
x c 
X 
X 
X 
X 
X 
Chemotherapy Combination (Magrolimab + R-GemOx): 
Final 
Amendment 12 
Phase 1 b Schedule of Assessments, Safety Dose-Escalation and Expansion Cohorts 
1 
2 
3 
4 
5 
6+ 
8 
11 15 
22 23 
29 
1 
2 
8 
15 
22 
1 
2 
15 
1 
2 
15 
1 
15 
1 
15 
±2 
±1 
±2 
X 
X 
X 
X X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Xn 
Q2C 
X 
-
Page 108 
02 November 2023 


Magrolimab
Protocol 5F9003
Final
Gilead Sciences, Inc
Amendment 12
CONFIDENTIAL
Page 109
02 November 2023
Examination
Chemotherapy Combination (Magrolimab + R-GemOx):
Phase 1b Schedule of Assessments, Safety Dose-Escalation and Expansion Cohorts
Cycle (28-day 
cycles) except for 
Cycle 1 (35 days)
1
2
3
4
5
6+
Cycle day
SC
1
2
8
11
15
22
23
29
1
2
8
15
22
1
2
15
1
2
15
1
15
1
15
Visit window (days)
-30
None ±1
±2
±1
±2
Assessments
Study drug 
administration
Rituximabs
Xs
X
X
X
X
X
X
X
C6,
then 
Q2C
Magrolimabs,t
X
Xs
Xt
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Gemcitabine
X
X
X
X
X
X
X
X
Oxaliplatin
X
X
X
X
X
X
X
X
Abbreviations: ABO = any of the four blood groups A, B, AB, and O; ADA = anti-drug antibody; aPTT = activated partial thromboplastin time; 
C = cycle number; CBC = complete blood count; CR = complete response; DAT = direct antiglobulin test; ECG = electrocardiogram; ECOG = 
Eastern Cooperative Oncology Group; G-CSF = granulocyte colony stimulating factor; PT/INR = prothrombin time/international normalized 
ratio; PE = physical examination; PI = Principal Investigator; PK = pharmacokinetics; PR = partial response; Q2C = every 2 cycles; RBC = red 
blood cell; R-GemOx = rituximab, gemcitabine, and oxaliplatin; Rh = Rhesus factor; SC = screening.
a.
First dose of magrolimab must be given within 30 days of signing informed consent.
b.
Pre-infusion assessments tests may be collected up to 72 hours before study drug administration during the initial dose; however, with 
subsequent doses, pre-infusion assessments may be collected up to 24 hours before study drug administration.
c.
May use screening pregnancy test performed within 72 hours of first dose.
d.
Peripheral blood smear slides will be read locally for results and retained. Details are provided in Section 7.3.7.
e.
Lymphocyte subset analysis every cycle for Cycle 1 to Cycle 6, prior to administration of study drug; following Cycle 6, analyses are at the 
discretion of the PI. 
f.
For sites that have the capability of local CD20+ testing, CD20+ B lymphocyte cell enumeration in the peripheral blood every cycle for Cycle 1 to 
Cycle 6, prior to administration of study drug; following Cycle 6, analyses are at the discretion of the PI. CD20+ B-cell enumeration at safety 
follow-up visit. Both absolute and % of lymphocytes are preferred.


Magrolimab
Protocol 5F9003
Final
Gilead Sciences, Inc
Amendment 12
CONFIDENTIAL
Page 110
02 November 2023
g.
Time point details for correlative studies are provided in Table 7-4.
h.
Time point details for PK time points are provided in Table 7-3.
i.
Starting with Cycle 5, samples to be collected Cycle 5 Day 1, Cycle 9 Day 1, Cycle 13 Day 1, then discontinue until safety follow-up.
j.
Prior to infusion of study drug. Details are provided in Section 7.3.2.
k.
Full PE at screening, symptom-directed PE thereafter. A neurologic examination should be done at minimum of Day 1 of each cycle as part of 
the physical examination.
l.
Single at screening. For Phase 1b Dose Escalation cohort, triplicate ECGs will be performed within 2 hours prior to the first drug infusion and within 
30 minutes  after the last drug infusion (Section 7.3.3). This includes Cycle 1 Day 1 when only magrolimab is administered and continues through 
Cycle 2 Day 2. For patients enrolled in the 20-patient expansion cohort, only a single ECG at screening will be performed.
m.
Two tumor/lymph node biopsies are mandatory during the study, one within the screening period and a second on-treatment (Cycle 2 Day 
8, -1 to +3 weeks) unless determined to not be feasible by the Investigator. For patients who achieve a PR or CR, 
 
. For core biopsies, in addition to a specimen that is sent 
to the central laboratory, local lymphoma immunophenotyping panel is requested (see Appendix I). For large excisional biopsy, a portion 
of the specimen is to be sent for local lymphoma immunophenotyping panel, and the remainder of the tissue is to be processed and sent 
to central laboratory per tissue collection guidance.
n.
Response assessments at Cycle 3 Day 1 (± 7 days) and then Q2C (± 7 days). Assessments may be adjusted by ± 4 weeks to coordinate with 
treatment cycle timing. For patients who continue on study medications for ≥18 months, response assessment may be extended to every 3 to 4 
cycles at the discretion of the Investigator. Details are provided in Section 7.3.5.
o.
Bone marrow biopsy will be performed for response assessment in those patients with known bone marrow disease involvement and also 
performed to confirm CR at any response assessment, where clinically appropriate, and at disease progression.
p.
To be assessed at each physician visit.
q.
Allopurinol is administered for Cycle 1 only to prevent tumor lysis syndrome. For renal impairment, 100 mg oral may be given.
r.
G-CSF primary prophylaxis must be administered with gemcitabine and oxaliplatin treatment. Local standard of care or equivalent will be 
administered in accordance to local institutional guidelines or Investigator guidance. G-CSF prophylaxis should generally occur within several days 
after administration of each day gemcitabine and oxaliplatin is dosed. However, the timing of G-CSF prophylaxis may be given in accordance to 
local institutional guidelines.
s.
On Cycle 1 Day 8 only, magrolimab should be given prior to rituximab. All other times when magrolimab and rituximab are given on the same 
visit, rituximab should be given before magrolimab. There should be at least an hour interval between the end of infusion of the first drug and the 
beginning of infusion of the second drug.
t.
Cycle 1 Day 11 magrolimab Dose Escalation cohort only. Cycle 1 Day 11 magrolimab is not given to Dose Expansion cohort as of Amendment 9.
u
Within 24 hours prior to each of the first 2 doses of magrolimab infusion during initial treatment (Days 1 and 8), all patients must have a documented 
hemoglobin ≥ 9.0 g/dL. Patients who do not meet these criteria must be transfused and have their hemoglobin rechecked to meet 9.0 g/dL prior to each 
of the first 2 doses of magrolimab. An additional hemoglobin must be checked 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 during the first week of treatment in patients with symptoms of anemia or at increased risk for complications of anemia.
v
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. RBC genotyping instead of extended RBC phenotyping is acceptable for any patient. A RBC 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).
CCI


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Protocol 5F9003
Final
Gilead Sciences, Inc
Amendment 12
CONFIDENTIAL
Page 111
02 November 2023
7.2.
Screening Assessments
The following procedures are to be completed during the screening period:
•
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.
•
Vital signs: blood pressure, heart rate, respiration, temperature, height and 
weight.
•
Physical examination (complete) and ECOG (Appendix D).
•
Single electrocardiogram (ECG).
•
Evaluation for presence of B cells for DLBCL Phase 2 Cohort 4.
•
Relevant medical and cancer history will be completed through consent (all 
findings recorded on the medical history eCRF.
•
Documentation of concomitant and prior medications.
•
AEs related to Screening procedures and any SAE reporting.
•
Reporting of AEs caused by a protocol-mandated intervention (e.g., AEs 
related to invasive procedures such as biopsies)
•
Urine or serum pregnancy test (in WOCBP).
•
Local laboratory values, including hematology, serum or plasma 
chemistry, and urinalysis (Table 7-6).
•
Local laboratory type and screen (ABO/Rh) and DAT (details are provided in 
Section 6.2.1.3 and Section 7.3.4).
•
Local laboratory Peripheral Blood Smears (details are provided in 
Section 7.3.7).
•
Tumor/lymph node biopsy: mandatory for the chemotherapy 
combination (magrolimab + R-GemOx) Phase 1b cohort and antibody 
combination (magrolimab + rituximab) Phase 2 cohort.
•
Bone marrow biopsy for patients with known disease involvement of the bone 
marrow, prior to treatment: mandatory for all cohorts.
•
Diagnostic imaging (Historic imaging may be used for screening if performed


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Final
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Amendment 12
CONFIDENTIAL
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within 30 days of the first dose of magrolimab. Details are provided in 
Section 7.3.5).
Screening assessments will be completed within a 30-day screening period prior to 
the enrollment. Patients may qualify for enrollment at any time during the 30-day 
screening period. Assessments performed as part of standard of care 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, Schedules of Assessments.
7.3.1. Physical Examination
A complete physical examination should be performed at Screening. Thereafter, 
symptom-directed physical examinations are acceptable and should also include 
routine examination of the skin (including fingers, toes, and ears) and CNS.
7.3.2. Vital Signs
Vital signs should include heart rate, respiratory rate, blood pressure, and 
temperature. Height should be recorded during Screening. Weight should be 
recorded during Screening and on Day 1 of each cycle. Vital signs should be 
obtained prior to infusion of each study drug and as needed, at the investigator’s 
discretion.
7.3.3. Electrocardiograms
One ECG will be performed at screening for all cohorts. Triplicate ECGs will be 
performed before the rituximab dose (within 2 hours of infusion) and within 
30 minutes after the end of magrolimab infusion for the antibody combination 
(magrolimab + rituximab) Phase 1b cohorts only and chemotherapy combination 
(magrolimab + R-GemOx) for Phase 1b Dose-Escalation cohort only at designated 
study days.


Magrolimab
Protocol 5F9003
Final
Gilead Sciences, Inc
Amendment 12
CONFIDENTIAL
Page 113
02 November 2023
7.3.4. Type and Screen and Direct Antiglobulin Test
Magrolimab may interfere with RBC phenotyping due to expected coating of 
the RBC 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 6.2.1.3. 
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. Diagnostic Imaging
Appropriate cancer staging assessments should be performed (e.g., 
fluorodeoxyglucose [FDG] positron emission tomography/computed tomography 
[PET/CT] for patients with lymphoma). Imaging assessments should be conducted 
according to Lugano Classification and LYmphoma Response to Immunomodulatory 
Therapy Criteria (LYRIC Criteria for lymphomas) (Table 10-1 and Table 10-2), when 
appropriate. The same imaging modality used at screening should be used 
throughout the study whenever possible. It is understood that some circumstances 
may require a different imaging modality. An alternate imaging modality is 
acceptable and may be performed at the Investigator’s discretion. All scans for 
tumor assessments performed during the study will be sent to the imaging central 
laboratory designated by the Sponsor for archival.
7.3.6. Pregnancy Test
Pregnancy tests are required only for WOCBP (excluding patients who are 
post-menopausal with absence of menses for at least 1 year and/or surgically 
sterilized). A urine or serum pregnancy test is required at screening and within
72 hours before administration of magrolimab 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 administration of magrolimab. Pregnancy tests will be performed 
Q4W.


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7.3.7. Peripheral Blood Smear Assessment
Peripheral smears will be collected prior to selected study drug infusions and 
assessed for the presence or absence of RBC fragments/schistocytes and RBC 
agglutination, in addition to standard cell morphology assessment. These samples 
should be collected from the arm contralateral to the arm being used for study drug 
infusion/injection, if possible. All other observed findings should be reported 
according to local laboratory hematopathology standard procedures. Peripheral 
smears will be assessed locally per the guidelines provided in Appendix E.
7.3.8. Adverse Events
After signing of informed consent, but prior to initiation of study medications, only 
events deemed by the Investigator to have been caused by a protocol-mandated 
intervention (e.g., invasive procedures such as biopsies) will be collected as AEs or 
SAEs, if applicable (Section 9.2.1).
After the first dose of study drug, all AEs observed by the Investigator or reported 
by the patient after the first dose of any of the study drugs through 30 days after the 
discontinuation of study treatment, are to be reported using the applicable eCRF 
(Section 9).
Following 30 days after the last dose of investigational product, Investigators should 
only report any SAEs that are considered to be related to study treatment 
(magrolimab, rituximab, gemcitabine, and/or oxaliplatin).
7.3.9. Concomitant Medications
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 events 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.


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7.4.
Safety Follow-up Visit
The Safety Follow-up visit is to be completed 30 days ± 7 days after the last 
dose of magrolimab, rituximab, gemcitabine, and/or oxaliplatin or prior to 
beginning a new anti-cancer therapy, whichever is earlier. Reason for 
discontinuation of study treatment will be recorded.
•
Local laboratory
o
CBC (with differential, platelets, retics)
o
Serum or plasma chemistry
•
Serum or urine pregnancy test (in WOCBP)
•
PK sample collection. Separate PK samples will be collected for magrolimab 
and rituximab.
•
ADA testing
•
ECOG performance status (Appendix D)
•
Vital signs
o
blood pressure
o
heart rate
o
respiration
o
temperature
o
weight
•
Physical examination (symptom-directed)
•
Diagnostic imaging (± 7 days), if not performed within the last 4 weeks 
(Section 7.3.4)
•
Response assessment (± 7 days), if not performed within the last 4 weeks 
(refer to Section 10.2)
•
AEs
•
Concomitant medications


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•
Refer to the schedule provided in Table 7-2 for specific Safety Follow-up Visit 
procedures.
•
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 (or return to baseline) or stabilization of 
these events, unless the patient starts a new anti-cancer treatment or until the 
medical monitor deems it necessary after the end of the study. Follow-up will 
stop when a patient begins a new anti-cancer treatment.
7.5.
Safety Assessments
Analytes to be assessed by the local laboratory or specialty laboratories are 
presented in Table 7-6.


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Table 7-6
Laboratory Analyte Listing for Safety and Other Assessments
Chemistry
Hematology
Urinalysis
Type and Screen (ABO/Rh), 
Direct Antiglobulin Test
Other Laboratory 
Measurements
Sodium 
Potassium 
Chloride 
Bicarbonate 
Total protein 
Albumin
Calcium 
Magnesium 
Phosphorus 
Glucose
BUN or Urea 
Creatinine
Uric acid 
Phosphorus 
Total bilirubin 
Direct bilirubin 
LDH
AST (SGOT) 
ALT (SGPT)
Alkaline 
phosphatase
RBC
Hemoglobin 
Hematocrit 
Platelets
WBC Differential
•
Neutrophils
•
Eosinophils
•
Basophils
•
Lymphocytes
•
Monocytes 
Reticulocytes 
Haptoglobin
D-Dimer 
Thrombin
Plasma fibrinogen PT, 
aPTT, and INR 
Peripheral Blood Smear
•
Spherocytes
•
RBC Fragments/Schistocytes
•
RBC Agglutination
•
Nucleated RBCs
•
RBC abnormalities
•
Platelet Aggregation 
Lymphocyte subset analysis
•
CD20+ B lymphocyte cell 
enumeration in the peripheral blood
RBC
Glucose 
Protein 
Urine pH 
Ketones 
Bilirubin 
Urine
Specific gravity 
Blood
ABO
Rh Blood Group System
•
Rh D Factor
•
Rh C Factor
•
Rh E Factor
•
Rh c Factor
•
Rh e Factor
Phenotyping/genotyping (including 
minor antigen such as CcDEe, Cw, 
MNSs, Kk, FyaFyb, JkaJkb)
Antigen MNS Blood Group
•
M +/-
•
N +/-
•
S +/-
•
s +/- 
DAT
Serum or Urine 
Pregnancy 
Correlative studies 
Pharmacokinetics 
ADAs
Notes: Full phenotyping should be performed if the patient has not been transfused in last 3 months. These assays may be performed at a specialty laboratory. Refer to 
Section 7.1 for Schedule of Assessment tables for collection time points. Refer to Section 7.7.5 for biopsy guidelines.
Abbreviations: ABO = any of the four blood groups A, B, AB, and O; ADA = anti-drug antibody; 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.


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7.6.
Efficacy Assessments
Patients will be assessed for response using the Lugano Classification and LYRIC 
Criteria for lymphomas (Table 10-1 and Table 10-2). The first response 
assessment will occur at Cycle 3 Day 1 (± 7 days). Subsequent response 
assessments will occur Q8W and may be adjusted by ± 4 weeks to coordinate with 
treatment cycle timing. For patients who continue on study medication(s) for 
≥18 months, response assessment may be extended to every 3 to 4 cycles at the 
discretion of the Investigator. Response assessment will be obtained at treatment 
termination, unless a prior radiographic assessment has been performed within the 
last 7 days or at a prior response assessment that documented progressive 
disease.
For patients with disease involvement in the bone marrow prior to treatment, a 
bone marrow aspirate and biopsy will be performed at first response assessment 
on Cycle 3 Day 1. In addition, a bone marrow assessment will be conducted to 
confirm CR, which may occur at any response assessment time point. If a patient 
achieves a CR, subsequent bone marrow aspirate and biopsies are not required to 
be performed, but may be performed at the Investigator’s discretion.
7.6.1. Immunogenicity
Peripheral blood for immunogenicity assessments for ADAs against magrolimab 
will be collected on Day 1 before infusion and then according to the SOA. When 
collected on the day of study drug dosing, the blood sample must be collected pre- 
dose. A validated assay will be used to measure antibodies to magrolimab in 
serum samples. Neutralizing antibodies to magrolimab may also be assessed for 
patients who test positive for ADA. ADAs to rituximab may be assessed if the 
CTSC or Sponsor determines such testing is needed.
7.7.
Pharmacodynamic and Biomarker Assessments
7.7.1. CD47 Receptor Occupancy
Testing for CD47 RO on select target cells enables PD testing of magrolimab to


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inform both safety and efficacy parameters. First, the degree of saturation of CD47 
receptors on RBCs serves as a PD assessment for degree of anemia. Second, 
CD47 RO on WBCs and circulating or bone marrow-resident lymphoma cells 
provides information on the level of CD47 saturation of the internal CD47 tissue sink 
and drug exposures on tumor cells, respectively.
In settings in which there is disease involvement of the bone marrow, a bone 
marrow aspirate sample will be obtained on Cycle 3 Day 1 (± 7 days) for response 
assessment, and will be used to assess CD47 RO in the bone marrow, additional 
correlative study assessments, and biobanking.
The RO sample collection in peripheral blood was discontinued in Protocol 
Amendment 6. At the discretion of the Sponsor, CD47 RO studies may not be 
performed at clinical sites where sample shipments cannot be delivered within stability 
time parameters (due to transit times). At the discretion of the CTSC, CD47 RO 
studies may be discontinued if sufficient data have been collected.
CD47 RO is not currently being conducted in the chemotherapy combination 
(magrolimab + R-GemOx) cohort but may be added in at the discretion of the CTSC 
based on emerging data.
7.7.2. Correlative Blood Samples
Correlative studies will be performed on peripheral blood samples to determine the 
biologic activity of magrolimab in combination with rituximab or R-GemOx on 
circulating immune cells and molecular subtypes of NHL. These studies may 
include, but are not limited to, investigations of plasma cytokine levels, 
characterization of circulating T cells, characterization of circulating tumor or cell- 
free deoxyribonucleic acid (DNA) and other studies. Where applicable, blood 
samples will be collected according to the schedule presented in Table 7-4. If at 
any point in the study the CTSC determines that sufficient correlative data have 
been generated, it may halt the collection and analysis of these samples.


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7.7.3. 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 magrolimab to engage these immune cells.
7.7.4. 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.
Additional peripheral blood mononuclear cells, serum, and plasma at the 
specified time points will also be cryopreserved and biobanked for future 
analyses.
7.7.5. Tumor and Bone Marrow Biopsies
Tumor and bone marrow biopsies will be collected to investigate lymphoma


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immunophenotyping, study drug modulation of the tumor environment, penetration 
into the tumor, and correlation of anti-cancer response to molecular subtypes of 
NHL. Analysis of immune cell composition within these tumor samples will be 
performed by IHC, immunofluorescence, or other similar assay to include 
macrophage, lymphocyte, and other immune cell subsets. Markers of immune cell 
activation may also be investigated by flow cytometric analysis or other similar 
method, in addition to frequency of immune cell infiltrates within the tumors. It is 
hypothesized that higher levels of macrophage and/or T-cell infiltration in the 
tumor either pretreatment or post-treatment will correlate with a clinical response 
to therapy.
From the tumor biopsies obtained according to Section 7.1, detection of the 
presence of study drug (magrolimab and/or rituximab) saturation in tumors will be 
determined. Saturation of tumor cells with magrolimab and/or rituximab will be 
determined by measuring levels of magrolimab, human IgG4, and/or anti-rituximab 
antibodies. Analysis of magrolimab penetration into tumor tissue will be analyzed in 
paired treatment biopsies obtained from study patients. The proportion of patients 
with magrolimab presence in tumor tissues as measured by IHC (1+ or greater) will 
be calculated for each expansion cohort independently, and the 95% confidence 
intervals (CI) for each will be determined.
From the same tumor biopsies, DNA/ ribonucleic acid (RNA) sequencing may be 
performed to assess for genomic mutations, gene expression changes, cell-of-origin 
status, and presence of neoantigens pre and post initiation of therapy. Paired 
peripheral blood samples may also be used for sequencing to aid in determining 
germline status. Remaining tumor samples at the specified time points may be 
cryopreserved and biobanked for future analyses.
 
 
 Likewise, tumor biopsies are mandatory for the antibody combination
CCI
-


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(magrolimab + rituximab) Phase 2 cohort, unless the Investigator determines that it 
is not feasible. Reasons for biopsy not being feasible could include, but are not 
limited to, lack of accessible tumor tissue to biopsy and patient safety issues. A 
tumor (lymph node) biopsy will be obtained during the screening period and on Cycle 
2 Day 8 (-1 week to +3 weeks). Core biopsies will be collected at these time points. 
Where possible, excisional biopsies are preferred over core biopsies. Archival tumor 
tissue block may be collected by the Sponsor for correlative studies. The tissue 
block is preferred, but if not available, upon Sponsor’s request, at least 10 unstained 
slides may be sent to central laboratory.
In cases in which there is known disease involvement of the bone marrow, a bone 
marrow aspirate and biopsy are mandatory for all cohorts and will be conducted prior 
to treatment and on Cycle 3 Day 1 (± 7 days) for response assessment 
 
. A separate aspirate sample is also to be collected at the same 
time to assess CD47 RO in the bone marrow, additional correlative study 
assessments, and biobanking. The bone marrow core biopsy will be sent to the 
.
Refer to the laboratory manual for specific instruction. It may be necessary to collect 
a separate core biopsy from the one collected for clinical diagnosis.
In addition, for patients who achieve a PR or CR while on study, a repeat tumor 
biopsy and bone marrow aspirate/biopsy (where applicable) will be collected at the 
time of disease progression or relapse whenever possible. 
 
 
 
 
. At the discretion of the Sponsor, the separate bone 
marrow aspirate may not be performed at clinical sites where sample shipments 
cannot be delivered within stability time parameters (due to transit times).
CCI
CCI
CCI


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8. STUDY DISCONTINUATION
8.1.
Withdrawal of Patients from Study Drug Treatment
Patients (or a legally acceptable representative) may decline to continue receiving 
study drug at any time during the study. The patient’s health and welfare is the 
primary consideration in any determination to discontinue study drug treatment.
It is strongly encouraged that patients to return for their Safety Follow-up Visit 30 
days (± 7 days) after their last dose of study drug as outlined in Section 7.1, 
Schedules of Assessments. All patients who withdraw from study drug treatment 
will be followed for disease response and survival.
Patients who develop a known adverse reaction to rituximab, gemcitabine, and/or 
oxaliplatin may continue treatment with magrolimab and will not be required to 
discontinue the study. This continuation requires consultation with the Sponsor. 
Reasons for patient withdrawal from study drug treatment may include, but are not 
limited to, the following:
•
Patient’s request, with or without a stated reason
•
Evidence of tumor progression
•
Clinically significant deterioration of the patient’s -condition including 
clinically significant study drug-related AEs
•
AE
•
Noncompliance
•
Pregnancy
8.2.
Withdrawal of Patients from Study
Patients have the right to withdraw from the study 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. Patient data up to 
withdrawal of consent will be included in the analysis of the study, and where 
permitted, publicly available data may be included after withdrawal of consent.


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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 discontinuation may include, but are not limited to, the following:
•
Patient’s request, with or without a stated reason
•
Protocol-specified reason
•
Clinically significant deterioration of the patient’s condition
•
Noncompliance
•
Sponsor’s discretion
•
Lost to follow-up
8.3.
Study Termination
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.
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, ECGs, and physical exams; 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 International Conference on Harmonisation 
(ICH) guidelines, Food and Drug Administration (FDA) regulations, European 
Clinical Trials Directive, and/or local regulatory requirements.


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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 (refer to Section 9.2.1)
•
Complications that occur as a result of protocol-mandated interventions 
(e.g., invasive procedures such as biopsies)
•
Events that occur prior to administration of study treatment that are related to 
a protocol-mandated intervention (e.g., invasive procedures such as 
biopsies)
•
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 at any dose:
•
Is fatal (i.e., the AE is the actual cause of death)
•
Is Life threatening (i.e., the AE in which the patient was at immediate risk of 
death at the time of the event; it does not refer to an event which 
hypothetically might have caused death if it were 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 study drug(s)
•
Considered a significant medical event by the Investigator based on sound 
medical and scientific judgment (i.e., may jeopardize the patient or may


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require medical/surgical intervention to prevent one of the outcomes listed 
above)
All AEs that do not meet any of the criteria for serious should be regarded as non- 
SAEs.
The terms “severe” and “serious” are not synonymous. Severity refers to the 
intensity of an AE (as in Grade 1 [mild], Grade 2 [moderate], Grade 3 [severe], 
Grade 4 [life-threatening] or Grade 5 [death] per CTCAE v. 4.03). 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. SAEs are reported 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/Serious Adverse Event Reporting Period
After signing of informed consent, but prior to initiation of any of the study drugs, all 
events deemed by the Investigator to have been 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 drug, 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 is later) unless the patient begins an alternative 
anti-cancer therapy prior to the said period. After 30 days post-last dose of study


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drug or the Safety Follow-up Contact (whichever is later), Investigators are to report 
only new study drug-related AEs or SAEs.
The Investigator must report any follow-up information regarding SAEs and study 
drug-related AEs until resolution (or return to baseline) or stabilization, unless the 
patient starts a new anti-cancer therapy or until the medical monitor deems it 
necessary after the end of the study. At any time, Investigators are to report 
SAEs that they assess to be related to any of the study drugs (magrolimab, 
rituximab, gemcitabine, and/or oxaliplatin received as part of this study).
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 
(refer to Section 9.1.2 for seriousness criteria), severity (Table 9-1), and causality. 
A causality assessment will be made for each of the study drugs (i.e., magrolimab 
and R-GemOx). Table 9-2 provides guidance for assessing the causal 
relationship to the study drug(s).


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The AE grading (severity) scale NCI CTCAE v4.03 (Appendix B) will be used for AE 
reporting.
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.
Abbreviations: ADL = activities of daily life; AE = adverse event.
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 any 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
(Related)
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
(Not 
Related)
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 study drug (i.e., magrolimab and R-GemOx) 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 
separate log lines of the eCRF and SAE report form (if the event is serious). 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.


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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 increases. If a persistent AE becomes more severe, it should 
be recorded again on a new log line on the Adverse Event eCRF indicating the 
change in severity.
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.
9.3.1.4.
Abnormal Laboratory Values
Only clinically significant laboratory abnormalities and ECG results 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 laboratory abnormality is not a sign of a disease or syndrome, the 
abnormality itself should be recorded as an AE on the eCRF only if it is deemed 
clinically significant. 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.


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9.3.1.5.
Deaths
All events leading to death 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.
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, if known.
9.3.1.6.
Worsening of Disease
Worsening of and/or progression of disease should not be routinely recorded as 
an AE or SAE if not resulting in death. These data will be captured as efficacy 
assessment data. However, worsening and/or progression of lymphoma should 
be recorded as an SAE if the outcome is fatal in the absence of other signs and 
symptoms (Section 9.3.1.5), or 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 care, waiting for insurance 
authorization)
--


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9.3.1.8.
Other Reportable Information
Certain information, although not considered an AE or SAE, must be 
recorded, reported, and followed up as indicated below. This includes the 
following:
Pregnancy
Female patients who become pregnant during the study must discuss with the 
Investigator their treatment options and must discontinue receiving any of the 
study drugs immediately. Male patients whose partners become pregnant may 
continue receiving study treatment; however, they must use a barrier method 
(condom) to prevent the unborn fetus from being exposed to any of the study 
drug.
Any pregnancy occurring in a patient or a patient’s partner during treatment with 
any study drug or within 6 months of last study drug administration must be 
reported within 24 hours of becoming aware of it, using a Pregnancy Notification 
Form (provided in the Investigator Trial File). If the pregnancy occurs in a patient’s 
partner, the Investigator must obtain consent from the patient’s partner before 
collecting any pregnancy-related information. All pregnancies must be followed up 
until there is a pregnancy outcome. The Investigator must report the pregnancy 
outcome using a pregnancy outcome form. In the event that the neonate/s 
has/have abnormalities at birth, additional data will be collected regarding the 
abnormalities.
Any congenital anomaly/birth defect in an offspring born to a 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.
Stillbirth or spontaneous or therapeutic abortion must be reported as an SAE 
(medically significant event) and recorded on an SAE Report Form, and forwarded 
to the Sponsor as described in Section 9.4.1.


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Overdose
An overdose is a dose higher than that indicated in the protocol, with or without 
an AE.
Abuse or Misuse
Abuse or misuse of a study drug is use for nonclinical reasons, with or 
without experiencing an AE.
9.4.
Reporting Requirements for Serious Adverse Events
9.4.1. Reporting Requirements for All 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.
9.5.
Emergency Contacts
Medical Monitor Contact Information for Sites in Case of an Emergency:
email:  #5f9003mm@gilead.com 
10. MEASUREMENT OF EFFECT
10.1.
Anti-cancer Effect – Hematologic Tumors
Both Lugano Classification and LYRIC Criteria will be used for evaluation of 
response. The first response assessment will occur at Cycle 3 Day 1 (± 1 week). 
Subsequent response assessments will occur Q8W (± 1 week). For patients who 
continue on study medication(s) for ≥18 months, response assessment may be 
decreased to every 3 or 4 cycles at the discretion of the Investigator. Response 
assessment will be obtained at treatment termination, unless a prior radiographic 
assessment has been performed within the last 7 days or at a prior response 
assessment that documented progressive disease. Definitions of response 
parameters are provided below. For patients with disease involvement in the bone 
marrow prior to treatment, a bone marrow aspirate and biopsy will be performed at 
the first response assessment at the beginning of Cycle 3. In addition, a bone 


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marrow assessment will be conducted to confirm CR, which may occur at any 
response assessment time point. If a patient achieves a CR, subsequent bone 
marrow aspirate and biopsies are not required to be performed, but may be 
performed at the Investigator’s discretion.
10.2.
Evaluation of Response
Hematologic tumor response will be evaluated using Lugano Classification, 
reproduced from Cheson 2014, outlined in Table 10-1 below. Immune response will 
be evaluated using the LYRIC criteria reproduced from Cheson 2016, outlined in 
Table 10-2.


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Table 10-1
Lugano Classification of Response in Non-Hodgkin’s Lymphoma
Response and Site
PET-CT–Based Response
CT-Based Response
Complete
Complete metabolic response
Complete radiologic response (all of the following)
Lymph nodes and
Score 1, 2, or 3* with or without a residual mass on
Target nodes/nodal masses must regress to 
extra lymphatic sites 5PS†
≤ 1.5 cm in LDi
It is recognized that in Waldeyer’s ring or extranodal
No extralymphatic sites of disease 
sites with high physiologic uptake or with activation
within spleen or marrow (e.g., with chemotherapy or 
myeloid colony-stimulating factors), uptake may be 
greater than normal mediastinum and/or liver. In 
this circumstance, complete metabolic response 
may be inferred if uptake at sites of initial 
involvement is no greater than surrounding normal 
tissue even if the tissue has high physiologic uptake
Nonmeasured
Not applicable
Absent 
lesion
Organ
Not applicable
Regress to normal 
enlargement
New lesions
None
None
Bone marrow
No evidence of FDG-avid disease in marrow
Normal by morphology; if indeterminate, IHC
negative
Partial
Partial metabolic response
Partial remission (all of the following): 
Lymph nodes and
Score 4 or 5† with reduced uptake compared with
≥ 50% decrease in SPD of up to 6 target
extralymphatic sites
baseline and residual mass(es) of any size
measurable nodes and extranodal sites
At interim, these findings suggest responding
When a lesion is too small to measure on CT, 
disease
assign 5 mm x 5 mm as the default value
At end of treatment, these findings indicate residual
When no longer visible, 0 x 0 mm
disease
For a node > 5 mm x 5 mm, but smaller than 
normal, use actual measurement for calculation
Nonmeasured
Not applicable
Absent/normal, regressed, but no increase 
lesions


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Response and Site
PET-CT–Based Response
CT-Based Response
Organ enlargement
Not applicable
Spleen must have regressed by > 50% in length 
beyond normal
New lesions
None
None
Bone marrow
Residual uptake higher than uptake in normal
Not applicable 
marrow but reduced compared with baseline (diffuse
uptake compatible with reactive changes from 
chemotherapy allowed). If there are persistent focal 
changes in the marrow in the context of a nodal 
response, consideration should be given to further 
evaluation with MRI or biopsy or an interval scan
No response or
No metabolic response
Stable disease 
stable disease
Target nodes/nodal Score 4 or 5 with no significant change in FDG
< 50% decrease from baseline in SPD of up to 
masses, extranodal uptake from baseline at interim or end of treatment 6 dominant, measurable nodes and extranodal 
lesions
sites; no criteria for progressive disease are met
Nonmeasured
Not applicable
No increase consistent with progression 
lesions
Organ enlargement
Not applicable
No increase consistent with progression
New lesions
None
None
Bone marrow
No change from
Not applicable 
baseline


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Response and Site
PET-CT–Based Response
CT-Based Response
Progressive disease
Progressive metabolic disease
Progressive disease requires at least 1 
of the following PPD progressions:
Individual target nodes/nodal masses
Score 4 or 5 with an increase in intensity 
of uptake from baseline and/or
An individual node/lesion must be 
abnormal with LDi > 1.5 cm and
Extranodal lesions
New FDG avid foci consistent with 
lymphoma at interim or end of treatment 
assessment.
Increase by ≥ 50% from PPD nadir and
An increase
in LDi or SDi from nadir
0.5 cm for lesions ≤ 2 cm
1.0 cm for lesions > 2 cm
In the setting of splenomegaly, the 
splenic length must increase by > 50% 
of the extent of its prior increase beyond 
baseline (e.g., a 15-cm spleen must 
increase to > 16 cm). If no prior 
splenomegaly, must increase by at least 
2 cm from baseline
New or recurrent splenomegaly
Nonmeasured lesions
None
New or clear progression of preexisting 
nonmeasured lesions
New lesions
New FDG-avid foci consistent with 
lymphoma rather than another etiology 
(e.g., infection, inflammation)
If uncertain regarding etiology of new 
lesions, biopsy or interval scan may be 
considered
Regrowth of previously resolved lesions 
A new node > 1.5 cm in any axis
A new extranodal site > 1.0 cm in any 
axis, if 1.0 cm in any axis, its presence 
must be unequivocal and must be 
attributable to lymphoma. Assessable 
disease of any size unequivocally 
attributable to lymphoma
Bone marrow
New or recurrent FDG-avid foci
New or recurrent involvement
Abbreviations: 5PS = 5-point scale; CT = computed tomography; FDG = fluorodeoxyglucose; GI = gastrointestinal; IHC = 
immunohistochemistry; LDi = longest transverse diameter of a lesion; MRI = magnetic resonance imaging; PET = positron emission 
tomography; PPD = cross product of the LDi and  perpendicular diameter; SDi = shortest axis perpendicular to the LDi; SPD = sum of the 
product of the perpendicular diameters for multiple lesions.


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Footnotes: *A score of 3 in many patients indicates a good prognosis with standard treatment, especially if at the time of an interim scan. However, in 
trials involving PET where de-escalation is investigated, it may be preferable to consider a score of 3 as inadequate response (to avoid 
undertreatment).
Measured dominant lesions: Up to six of the largest dominant nodes, nodal masses, and extranodal lesions selected to be clearly measurable in two 
diameters.
Nodes should preferably be from disparate regions of the body and should include, where applicable, mediastinal and retroperitoneal 
areas. Non-nodal lesions include those in solid organs (e.g., liver, spleen, kidneys, lungs), GI involvement, cutaneous lesions, or those 
noted on palpation.
Nonmeasured lesions: Any disease not selected as measured, dominant disease and truly assessable disease should be considered not 
measured. These sites include any nodes, nodal masses, and extranodal sites not selected as dominant or measurable or that do not meet 
the requirements for measurability but are still considered abnormal, as well as truly assessable disease, which is any site of suspected 
disease that would be difficult to follow quantitatively with measurement, including pleural effusions, ascites, bone lesions, leptomeningeal 
disease, abdominal masses, and other lesions that cannot be confirmed and followed by imaging.
In Waldeyer’s ring or in extranodal sites (e.g., GI tract, liver, bone marrow), FDG uptake may be greater than in the mediastinum with complete 
metabolic response but should be no higher than surrounding normal physiologic uptake (e.g., with marrow activation as a result of 
chemotherapy or myeloid growth factors).
†PET 5PS: 1, no uptake above background; 2, uptake ≤ mediastinum; 3, uptake > mediastinum but ≤ liver; 4, uptake moderately > liver; 5, 
uptake markedly higher than liver and/or new lesions; X, new areas of uptake unlikely to be related to lymphoma. Source: Cheson BD, Fisher 
RI, Barrington SF, et al. Recommendations for initial evaluation, staging, and response assessment of Hodgkin and non-Hodgkin’s 
lymphoma: the Lugano Classification. J Clin Oncol. 2014;32(27):3059-3068 (Cheson 2014); refer also to Appendix C.


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If a patient’s response is PD based on LUGANO Classification and has indeterminant 
response (IR) per LYRIC Criteria, then the patient may continue on the study 
treatment unless there is disease progression according to LYRIC Criteria.
For patients staged with PET/CT focal uptake in nodal and extranodal sites that 
is in keeping with lymphoma, according to the distribution and/or CT 
characteristics, is considered involvement with lymphoma, including spleen, liver, 
bone, thyroid, and so on. For patients staged with CT, up to 6 of the largest 
target nodes, nodal masses, or other lymphomatous lesions that are measurable 
in 2 diameters (longest diameter [LDi] and shortest diameter) should be identified 
from different body regions representative of the patient’s overall disease burden 
and include mediastinal and retroperitoneal disease, if involved. A measurable 
node must have an LDi greater than 1.5 cm. Measurable extranodal disease 
(e.g., hepatic nodules) may be included in the 6 representative, measured 
lesions. A measurable extranodal lesion should have an LDi greater than 
1.0 cm. All other lesions (including nodal, extranodal, and assessable disease) 
should be followed as non-target disease (e.g., cutaneous, gastrointestinal, 
bone, spleen, liver, kidneys, pleural or pericardial effusions, ascites). In patients 
in whom a discordant histology or malignant transformation is suspected, a 
PET/CT may identify the optimal site to biopsy for confirmation.
The following modifications to the Lugano Classification will be made for this study 
protocol:
Bone marrow assessment: For patients with disease involvement of the bone 
marrow prior to treatment, a bone marrow aspirate and biopsy will be performed at 
first response assessment at the beginning of Cycle 3. In addition, a bone marrow 
assessment will be conducted to confirm CR, which may occur at any response 
assessment time point. If a patient achieves a CR, subsequent bone marrow aspirate 
and biopsies are not required to be performed, but may be performed at the 
Investigator’s discretion.
Refinement of the Lugano Classification, LYRIC Criteria: Based on emerging


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data in immunomodulatory agents, of which magrolimab is one, it appears that these 
agents may be associated with clinical and imaging findings during treatment 
suggestive of progressive disease, despite evidence of clinical benefit.
Thus, according to the LYRIC Criteria, an indeterminate response (IR) criteria will be 
utilized for response assessment. A patient will be considered to have IR in 1 or more 
of the 3 following circumstances:
1. Increase in overall tumor burden (as assessed by sum of the product of the 
diameters [SPD]) of ≥ 50% of up to 6 measurable lesions in the first 12 weeks 
of therapy, without clinical deterioration [IR(1)]
2. Appearance of new lesions or growth of one or more existing lesion(s) ≥ 50% at 
any time during treatment; occurring in the context of lack of overall progression 
(< 50% increase) of overall tumor burden, as measured by SPD of up to 6 
lesions at any time during the treatment [IR(2)]
3. Increase in FDG uptake of 1 or more lesion(s) without a concomitant increase 
in lesion size or number [IR(3)]
For patients categorized as having any of the above types of IR, it is mandatory to 
obtain a repeat imaging after an additional 12 weeks (or earlier if clinically indicated). 
At that time, response should be re-evaluated, and the patient should be considered 
to have true progressive disease if the SPD of target lesion has increased further, with 
the considerations below:
•
In the case of IR(1), the comparison should be between the first IR(1) and the 
current SPD, with an increase of ≥ 10% constituting progressive disease. In 
addition, there should be an increase of ≥ 5 mm (in either dimension) of
≥ 1 lesion for lesions ≤ 2 cm and 10 mm for lesions > 2 cm, to be consistent 
with the Lugano classification. The 10% threshold is empiric, but designed to 
account for variability in measurement, particularly when taken along with the 
minimum increase. If the target SPD increase is < 10%, the response would 
still be categorized as IR(1), and the patient could continue treatment until a 
subsequent scan shows either true progressive disease [≥ 10% increase from


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first IR(1) time point and an increase of > 5 mm in either dimension of
≥ 1 lesion] or response (≥ 50% decrease from baseline). In this situation, it is 
reasonable to repeat imaging in 4 to 8 weeks of the original IR(1) time point to 
ensure absence of significant further increase.
•
In the case of IR(2), the new or growing lesion(s) (unless biopsy proven to be 
benign) should be added to the target lesion(s), up to a total of no more than 
6 total lesions. If the SPD of the newly defined set of target lesions has 
increased ≥ 50% from their nadir value (which may precede the IR time point), 
the patient should be considered to have progressive disease.
•
In the case of IR(3), because inflammatory responses may result in an 
increase in the standardized uptake value of a lesion, the patient will not be 
considered to have progressive disease unless there is evidence of 
progressive disease by an increase in lesion size or the development of new 
lesions, as noted above.
A comparison of Lugano Classification and LYRIC Criteria is provided in Table 10-2.


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Table 10-2
Comparison of Lugano Classification and LYRIC Criteria
Criteria
CR
PR
PD
PET-CT score 4 or 5 with an increase in 
intensity of uptake from baseline and/or 
new FDG-avid foci consistent with 
lymphoma at interim or end- of- 
treatment assessment. OR On CT, an 
individual node/lesion must be 
abnormal with: LDi >1.5 cm and 
increase by ≥50% from PPD nadir and 
an increase in LDi or SDi from nadir 0.5 
cm for lesions ≤2 cm 1.0 cm for lesions
>2 cm
In the setting of splenomegaly, the 
splenic length must increase by >50% 
of the extent of its prior increase beyond 
baseline (e.g., a 15-cm spleen must 
increase to >16 cm). If no prior 
splenomegaly, must increase by ≥2 cm
from baseline. New or recurrent 
splenomegaly
New or clear progression of preexisting 
nonmeasured lesions
Regrowth of previously resolved lesions 
A new node >1.5 cm in any axis or a 
new extranodal site >1.0 cm in any axis; 
if <1.0 cm in any axis, its presence must
be unequivocal and must be attributable 
to lymphoma
Lugano
PET-CT, score 1, 2, or 3* with or 
without a residual mass on 5PS† OR on 
CT, target nodes/nodal masses must 
regress to ≤1.5 cm in LDi
PET-CT score 4 or 5 with reduced 
uptake compared with baseline and 
residual mass(es) of any size. OR On 
CT ≥50% decrease in SPD of up to 6 
target measurable nodes and 
extranodal sites
AND/OR new or recurrent involvement 
of the bone marrow


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Criteria
CR
PR
PD
LYRIC
Same as Lugano
Same as Lugano
As with Lugano with the following 
exceptions: IR
IR(1): ≥50% increase in SPD in first 12 
weeks IR(2): <50% increase in SPD 
with:
a.
New lesion(s), or
b.
≥50% increase in PPD of a 
lesion or set of lesions at any 
time during treatment
IR (3): increase in FDG uptake without
a concomitant increase in lesion size 
meeting criteria for PD.
Abbreviations: 5PS = 5-point scale; CR = complete response; CT = computed tomography; FDG = fluorodeoxyglucose; IR = indeterminate response; LDi = longest 
diameter; LYRIC = LYmphoma Response to Immunomodulatory Therapy Criteria; PD = pharmacodynamics(s); PET = positron emission tomography; PPD = product of 
the perpendicular diameters; PR = partial response; SDi = short diameter; SPD = sum of the product of the perpendicular diameters for multiple lesions.
*A score of 3 in many patients indicates a good prognosis with standard treatment, especially if at the time of an interim scan. However, in trials involving PET where 
de-escalation is investigated, it may be preferable to consider a score of 3 as inadequate response (to avoid undertreatment).
†PET 5PS: 1, no uptake above background; 2, uptake ≤ mediastinum; 3, uptake > mediastinum but ≤ liver; 4, uptake greater than liver; 5, uptake markedly higher than 
liver (2-3 times SUVmax in normal liver) and/or new lesions; X, new areas of uptake unlikely to be related to lymphoma.
Source: This is an excerpt from: Cheson BD, Ansell S, Schwartz L, et al. Refinement of the Lugano Classification lymphoma response criteria in the era of 
immunomodulatory therapy. Blood. 2016;128(21):2489-2496. (Cheson 2016); refer also to Appendix C.


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10.2.1.Assessment of Evaluable Rather Than Measurable Disease
Patients with evaluable, but not measurable response, will be assessed with 
the study used to establish evaluable disease at least Q8W.
11.STATISTICAL CONSIDERATIONS
11.1.
Analysis Sets
Enrolled Analysis Set – includes all enrolled patients. Typically, summary tables 
of disposition and protocol deviations will be performed on the Enrolled Analysis 
Set.
DLT Analysis Set 1 (Antibody Combination [magrolimab + rituximab]) – 
includes all enrolled Phase 1b patients in the magrolimab + rituximab cohort who 
met EITHER of the following criteria:
•
The patient experienced a DLT
•
The patient completed at least 3 infusions of magrolimab and 2 infusions 
of rituximab.
DLT Analysis Set 2 (Chemotherapy Combination [magrolimab + R-GemOx]) – 
includes all enrolled Phase 1b patients in the magrolimab + R-GemOx cohort who 
met EITHER of the following criteria:
•
The patient experienced a DLT at any time after initiation of the first 
infusion of magrolimab, rituximab, and gemcitabine or oxaliplatin
•
The patient completed at least 3 infusions of magrolimab, 2 infusions 
of rituximab, and 1 infusion of gemcitabine and oxaliplatin
Efficacy Analysis Set (EAS) – includes all enrolled patients who received at 
least 1 dose of magrolimab.
The analyses of ORR, DOR, progression-free survival (PFS), OS, and TTP will 
be performed on the EAS.
Safety Analysis Set (SAF) – includes all enrolled patients who receive at 
least 1 dose of any study drug.


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Safety, demographics, and medical/cancer history, etc., will be performed on 
the SAF.
Pharmacokinetics Analysis Set – includes all patients who receive at least 
1 dose of study drug and have measurable concentrations of magrolimab from 
PK blood samples.
11.2.
Sample Size Determination
The overall sample size for both the antibody combination (magrolimab + 
rituximab) and chemotherapy combination (magrolimab + R-GemOx) cohorts can 
be up to 422 patients.
11.2.1.Antibody Combination (Magrolimab + Rituximab)
The overall sample size could be up to 354 for enrollment of the antibody 
combination (magrolimab + rituximab) cohort to ensure sufficient efficacy-evaluable 
patients for each indication. This sample size includes both the Phase 1b and 
Phase 2 parts of the antibody combination (magrolimab + rituximab). In the Phase 
1b antibody combination (magrolimab + rituximab) cohort of the study, a standard 
3+3 dose escalation design is employed to explore the MTD of the investigational 
combination. There were 4 dose cohort levels, with an estimated total of 25 to 
38 patients planned in the Phase 1b depending on the possible cohort expansion 
in a 3+3 design. In Phase 1b, patients who were not evaluable for DLT were to be 
replaced. The Phase 2 part of the study will enroll patients with indolent lymphoma 
or DLBCL. Pending decisions from CTSC, additional arms in Phase 2 may be 
opened to test dose levels different from the current RP2DS of 30 mg/kg.
Cohorts 1 to 3 of the antibody combination (magrolimab + rituximab) Phase 2 part 
of the study will comprise up to 216 patients evaluable for efficacy (up to 94 with 
indolent lymphoma and 94 with DLBCL) if both stages of each group are fully 
accrued. The additional 28 patients account for testing of additional dose regimens 
for indolent lymphoma and DLBCL. The sample size of 94 was determined to


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ensure the lower bound of the 95% CI will exclude 30% if the observed response 
rate is 40% or higher.
Cohort 4 of the antibody combination (magrolimab + rituximab) Phase 2 part of the 
study will comprise up to 100 DLBCL patients if both stages are fully accrued. The 
sample size of 100 was determined to ensure the lower bound of the 95% CI will 
exclude 20% if the ORR is 30% or higher. This desired ORR is based on a ORR 
that is higher than current standard of care and that provides significant clinical 
benefit for these DLBCL and indolent lymphoma heavily pretreated patient 
populations.
11.2.2.Chemotherapy Combination (Magrolimab + R-GemOx)
The total planned number of patients for the chemotherapy combination (magrolimab
+ R-GemOx) Phase 1b cohort is 29 to 68 efficacy-evaluable patients, including the 
safety dose-escalation cohort of approximately 9 to 48 patients (if dose de-escalation 
occurs an additional 6 patients may be enrolled for 2 dose levels) and the expansion 
of approximately 20 patients.
For the chemotherapy combination (magrolimab + R-GemOx) Phase 1b cohort, an 
initial safety dose escalation will be conducted. If the treatment combination is not 
tolerated, dose de-escalation of magrolimab may occur with another 6 patients 
across two dose levels treated in the safety phase. If the magrolimab + R-GemOx 
regimen is well-tolerated, an additional 20 patients will be treated in an expansion 
phase to determine efficacy. The sample size of 26 total efficacy-evaluable patients 
was calculated based on a desired ORR of 50% for the treatment combination.
With a sample size of 26 patients, the lower bound of the 95% CI would exclude an 
alternative ORR of 33%. A 33% ORR is what has been reported for R-GemOx in 
the indicated DLBCL population (Mounier 2013) with a desired ORR of 50% in the 
chemotherapy combination (magrolimab + R-GemOx) Phase 1b cohort is expected 
to provide a meaningful clinical improvement and benefit in this patient population.


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11.3.
Statistical Analyses Methods
All analyses will be conducted for the antibody combination (magrolimab + 
rituximab) cohorts, including Phase 1b, Phase 2, and combined, unless otherwise 
specified. All analyses will be conducted for the chemotherapy combination 
(magrolimab + R-GemOx) cohort, unless otherwise specified.
For continuous variables, the mean, standard deviation (SD), median, and ranges 
will be provided. For categorical variables, the frequency and percentage in each 
category will be provided, along with 95% CIs, when appropriate. For time-to-event 
variables, the Kaplan-Meier (KM) estimates (unit: month) and corresponding two- 
sided 95% CIs for the median and quartiles will be provided. The KM plot 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 
Statistical Analysis Plan (SAP).
11.3.1.Efficacy Analyses
Endpoints used in the efficacy analysis are ORR, DOR, PFS, OS, and TTP.
11.3.1.1.
Objective Response Rate
Objective response is defined as CR+PR determined by Lugano 
Classification (primary efficacy) and LYRIC criteria (secondary efficacy) for 
lymphomas (Table 10-1 and Table 10-2). ORR is defined as the proportion of 
patients with objective response in the EAS.
11.3.1.2.
Duration of Response
The DOR is measured from when the first (objective) response is met (i.e., CR or 
PR) until the first date of objectively documented progressive disease. Patients 
who do not have objectively documented progressive disease will be censored at 
the last response assessment date with evidence of no disease 
progression/relapse.


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11.3.1.3.
Progression-free Survival
The PFS is measured from dose initiation until the first date of objectively 
documented disease progression or death, whichever occurs earlier. Patients who 
do not have objectively documented disease progression AND not died will be 
censored at the last response assessment date with evidence of no disease 
progression/relapse.
11.3.1.4.
Overall Survival
The OS is measured from dose initiation until death. Patients who did not die 
will be censored at their last known alive date.
11.3.1.5.
Time to Progression
The TTP is measured from dose initiation until the first date of objectively 
documented progressive disease. Patients who do not have objectively 
documented progressive disease (in the response evaluation form of the eCRF) will 
be censored at the last response assessment date with evidence of no disease 
progression/relapse.
11.3.2. Pharmacokinetics/Pharmacodynamics Analyses
11.3.2.1.
Pharmacokinetic Analyses
The PK analysis will be conducted for magrolimab and possibly, rituximab on the PK 
Analysis Set. Based on the distinct MOAs of magrolimab and rituximab, 
overlapping drug PK interactions are not expected. For the chemotherapy 
combination (magrolimab + R-GemOx) cohort, overlapping drug PK interactions are 
not expected for magrolimab and R-GemOx. Thus, samples for PK analysis for 
rituximab for all cohorts will be banked and will be conducted based on CTSC 
recommendation. Thus, samples for PK analysis for magrolimab for all cohorts will 
be banked and will be conducted based on CTSC recommendation. 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.


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With the frequency of dosing and sampling in mind, the following parameters may be 
calculable after single and multiple doses (Table 11-1).
Table 11-1
Noncompartmental Pharmacokinetic Parameters
AUClast
The AUC from time zero to the last measurable concentration sampling time
(tlast) (mass × time × volume ˗ 1)
AUCtau
The AUC calculated to the end of a dosing interval (tau) at steady state
(amount × time × volume ˗ 1)
Cmax
The maximum (peak) observed plasma, blood, serum, or other body fluid drug
concentration after single dose administration (mass × volume ˗ 1)
The PK parameters listed in Table 11-1 will be determined using non- 
compartmental method(s) for magrolimab.
All concentrations that were BLQ or missing data will be reported as such in the 
concentration data listings. The BLQ concentrations will be treated as zero in 
summary statistics.
Descriptive statistics of all PK parameters will include arithmetic and 
geometric mean, median, SD, coefficient of variation (CV), geometric CV, 
minimum and maximum. Zero concentrations will not be included in the 
geometric mean calculation.
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 the 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.
11.3.2.2.
Immunogenicity Analyses
Development of ADAs will be analyzed using a validated immunoassay, using a 
tiered testing approach – screening, confirmatory, and titer. 


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Relationship between ADA formation on PK, PD, and safety/efficacy may also 
be explored, if relevant. Immunogenicity analysis may be performed for 
rituximab.
11.3.3.Safety Analyses
The statistical analysis of safety data will be conducted for patients in the SAF 
and will include patients with non-missing data for the particular safety endpoint 
being analyzed. Safety variables may include, but are not limited to: DLTs, 
treatment-emergent adverse events (TEAE; AEs satisfy one or both of the 
following: 1) 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 or the 
initiation of the subsequent line of anticancer therapy, whichever is earlier. 2) Any 
AEs leading to discontinuation of study drug.), TRAEs (TEAEs that are 
considered to be related to any study drugs), vital signs, physical examinations, 
laboratory tests, ECGs, RO, and ADA assessments.
Data will be presented by Phase 1b antibody combination (magrolimab + 
rituximab) by dose cohort, Phase 1b chemotherapy combination (magrolimab + 
R-GemOx) by dose cohort, and Phase 2 antibody combination (magrolimab + 
rituximab) by arm. Some safety data may be summarized over all Phase 1b 
dose cohorts and across both Phase 1b and Phase 2 parts. 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.
11.3.3.1.
Adverse Events
The AEs will be coded using Medical Dictionary for Regulatory Activities (MedDRA) 
version 24.1 or later and the NCI CTCAE v 4.03 (Appendix B) will be used to grade 
severity of AEs and laboratory toxicities. Patient incidence of 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


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dose cohort and for all dose cohorts combined. These events will also be 
summarized by Phase 2 antibody combination (magrolimab + rituximab) arm 
(indolent lymphoma and DLBCL) and across all Phase 2 patients. TEAEs resulting 
in withdrawal from study drug or further study participation will be tabulated and/or 
listed. DLTs will also be listed.
The AEs that occurred during screening, but before exposure to study drug, will 
be reported in the AE line listings and appropriately identified as non-TEAEs.
The AEs and SAEs occurring during screening will be reported separately for 
patients who were screened, but not entered into the study with line listings and/or 
summary tables, along with relevant demographic data collected.
11.3.3.2.
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 and ADA at any time will be summarized. ECGs, vital 
signs, and physical examination will be summarized at select time points.
Details will be provided in the SAP.
11.4.
Clinical Trial Steering Committee Meetings
11.4.1.Clinical Trial Steering Committee Meetings in Phase 2 for Antibody 
Combination (Magrolimab + Rituximab)
Serial analyses will be conducted in the Phase 2 antibody combination (magrolimab
+ rituximab) cohort for CTSC meetings to facilitate the decision making on go/no-go 
based on the safety and efficacy evaluation.
After 14 patients are enrolled at any RP2DS in the Phase 2 antibody combination 
(magrolimab + rituximab) DLBCL and/or 14 patients in the indolent lymphoma arm 
have completed a 4-week safety assessment, a safety analysis will be performed. 
If 33% of patients experience any Grade 3 or greater AE that is assessed as 
related to study drug (magrolimab and/or rituximab) and results in permanent


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discontinuation, withdrawal, or death, then that Phase 2 arm will be stopped. 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. The trial may 
otherwise proceed to accrue the second stage if the response criteria described 
above are met.
If results from the safety analysis described above are deemed safe for continuing 
the treatment with this regimen in either the DLBCL and/or indolent lymphoma arm 
and if  3 out of 14 patients have an objective response in either the DLBCL and/or 
indolent lymphoma arm, then further enrollment will continue in that arm.
Otherwise enrollment in that arm will stop. The CTSC may approve further 
enrollment and exploration of an additional Phase 2 dose or to explore alternative 
dose regimens that may enhance efficacy.
In the DLBCL cohort (Phase 2 Cohorts 1 to 3), if the CTSC approves further 
enrollment after assessment of 14 patients in Phase 2, an analysis for efficacy will 
be performed after 40 patients in the Phase 2 antibody combination (magrolimab + 
rituximab) DLBCL cohort. The CTSC will convene and provide recommendations 
to the Sponsor to proceed with full accrual of the DLBCL cohort, or terminate the 
study according to the pre-specified stopping rules. For the Phase 2 antibody 
combination (magrolimab + rituximab) DLBCL cohort, additional enrollment will 
proceed if the ORR is  20%. For the revised DLBCL cohort (DLBCL Phase 2 
Cohort 4), an interim evaluation will be conducted after 20 efficacy-evaluable 
patients and if the ORR is  20% (4/20 patients), then enrollment may proceed to 
100 patients total.
In the indolent lymphoma cohort, if the CTSC approves further enrollment after 
assessment of 14 patients in Phase 2, an analysis for efficacy will be performed 
after at least 24 patients in the Phase 2 antibody combination (magrolimab + 
rituximab) indolent lymphoma cohort. The CTSC will convene and provide 
recommendations to the Sponsor to proceed with full accrual of the indolent 
lymphoma cohort or terminate the study according to the pre-specified stopping


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rules. For the Phase 2 antibody combination (magrolimab + rituximab) indolent 
lymphoma cohort, additional enrollment will proceed if the ORR  30% or if the CR 
rate is  20%.
The response rates needed for further enrollment for both DLBCL and indolent 
lymphoma cohorts are based on a futility analysis in which response rates 
lower than specified would halt further enrollment.
11.4.2.Clinical Trial Steering Committee Meetings in Phase 1b for Chemotherapy 
Combination (Magrolimab + R-GemOx)
The chemotherapy combination (magrolimab + R-GemOx) safety dose-escalation 
phase will enroll 3 to 6 DLT-evaluable patients at each dose cohort in accordance 
with a modified 3+3 design. CTSC meetings will decide whether to escalate, de- 
escalate dose or expand another 10 patients at any dose level. Once a RP2DS is 
determined by CTSC meeting, 20 patients will be enrolled at this dose level in the 
chemotherapy combination (magrolimab + R-GemOx) dose-expansion cohort.
CTSC meeting may stop ASCT ineligible DLBCL arm for safety reasons relating 
to study drug (magrolimab and/or R-GemOx).
The CTSC may approve further enrollment and exploration of an additional dose or 
dosing schedule or to explore alternative dose regimens that may enhance 
efficacy.
11.4.3.Treatment-Related Toxicity Monitoring
The treatment-related toxicity monitoring is added after completion of study 
enrollment. It will be monitored at a preset frequency with the stopping 
boundary listed in Table 11-2 based on actual number of patients at the dose 
level for each Phase 2 cohort. The boundary will be reviewed retrospectively for 
all phase 2 cohorts first, then the frequency of review will be every 6 months 
after patients are treated at least 6 months. This is a Pocock-type boundary 
(Ivanova 2005) that yields the probability of crossing the boundary of at most 
80% when the rate of Grade 4 or higher treatment-related TEAEs is 33%, or the 


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rate of treatment-related deaths is 15%.
Table 11-2
Stopping Boundary Due to Toxicity for Each Phase 2 Cohort
Phase 2 
Cohort 1
Phase 2 
Cohort 2
Phase 2 
Cohort 3
Phase 2 
Cohort 4
Number of Subjects
N = 43
N = 14
N = 31
N = 28
Subjects with Grade 4/5 
Treatment-related TEAEs
≥ 16
≥ 5
≥ 11
≥ 10
Subjects with Treatment-related 
deaths
≥ 7
≥ 2
≥ 5
≥ 5
TEAE = treatment-emergent adverse event
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, 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 composition, structure, 
and function of the CTSC are defined in the CTSC Charter.
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 Good Clinical Practice (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, Code of Federal Regulations (CFR), ICH, GCP, and the like shall be 
interpreted as also referring to any corresponding requirements of local regulatory


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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.
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 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


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or interpretation of the study.
•
An Investigator contributing a high number of eligible patients.
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 into the study and 
shipment of magrolimab.
The Investigator must submit and, where necessary, obtain approval from the 
IRB/IEC for all subsequent protocol amendments and changes to the informed 
consent document. 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 informed 
consent document to be used at his or her site. Updates to the template are to 
be communicated formally in writing from Gilead Sciences Study Monitor to the 
Investigator. The written informed consent document 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 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


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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.
•
On the CRF demographics page, in addition to the unique 
patient identification number, include the age at time of 
enrollment


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•
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., 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.


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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.
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 SOA (as described in Section 7.1), the 
Investigator may search publicly 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 (or paper CRFs) and source 
documentation as part of the case histories. Gilead Sciences will supply the eCRF, 
which will be completed in English.


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The Investigator or designee must enter all results collected during the clinical 
study into eCRFs (or CRFs). Guidelines for completion of eCRFs will be reviewed 
with study site personnel at the site initiation visits. Investigators are responsible 
for approval of the entered/corrected data.
All entries made on the eCRF (or CRF), 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,


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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.
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.
12.12. Long-term Retention of Samples for Additional Future Research
Blood, tumor, or bone marrow specimens will be cryopreserved for additional 
analyses. These samples will be retained for long-term storage by the Sponsor and 
described in the informed consent.
Any blood, tissue, or biomarker sample collected according to the SOA
(Section 7.1) may be analyzed for any of the tests outlined in the protocol and for 
any tests necessary to minimize risks to study patients. This includes testing to 
ensure that analytical methods produce reliable and valid data throughout the 
course of the study. It may also include, but is not limited to, investigation of 
unexpected results, incurred sample reanalysis, and analyses for method transfer 
and comparability.
All samples and associated results will be coded prior to being shipped from the


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site for analysis or storage. Samples will be tracked using a unique identifier that is 
assigned to the samples for the study. Results are stored in a secure database to 
ensure data integrity and control.
If permitted by local law and if informed consent is provided by the patient, 
Gilead Sciences may do additional testing on remaining samples (i.e., residual 
and back-up) to investigate and better understand NHL and the dose response
and/or prediction of response to magrolimab; to characterize antibody response; 
and to characterize aspects of the molecule (e.g., MOA/target, metabolites).
Results from this analysis are to be documented and maintained but are not 
necessarily reported as part of this study. Samples may be retained for up to 
20 years.
 
 
 
 
The patient retains the right to request that the sample material be destroyed by 
contacting the Investigator. Following the request from the patient, the 
Investigator is to provide the Sponsor with the required study and patient number 
so that any remaining blood samples and any other components from the cells 
can be located and destroyed. Samples will be destroyed once all protocol- 
defined procedures have been completed.
Information collected from samples prior to the request for destruction will be 
retained by the Sponsor. The Sponsor is the exclusive owner of any data, 
discoveries, and derivative materials from the sample materials and is 
responsible for the destruction of the sample(s) at the request of the patient 
through the Investigator, at the end of the storage period or as appropriate (e.g., 
the scientific rationale for experimentation with a certain sample type no longer 
justifies keeping the sample). If a commercial product is developed from this
CCI


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research project, the Sponsor owns the commercial product. The patient has no 
commercial rights to such product and has no commercial rights to the data, 
information, discoveries, or derivative materials gained or produced from the 
sample.
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.


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13.
REFERENCES
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Boasman K, Bridle C, Simmonds M, et al. Role of pro-phagocytic calreticulin and 
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ruxolitinib. EHA 2017 abstract only. 
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Chao MP, Alizadeh AA, Tang C, et al. Anti-CD47 antibody synergizes with 
rituximab to promote phagocytosis and eradicate non-Hodgkin lymphoma. Cell. 
2010a;142(5):699-713.
Chao MP, Jaiswal S, Weissman-Tsukamoto R, et al. Calreticulin is the dominant 
pro-phagocytic signal on multiple human cancers and is counterbalanced by 
CD47. Sci Transl Med. 2010b;2(63):63ra94.
Chao MP, Alizadeh AA, Tang C, et al. Therapeutic antibody targeting of CD47 
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Chao MP, Tang C, Pachynski RK, et al. Extranodal dissemination of non- 
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Cheson BD, Fisher RI, Barrington SF, et al. Recommendations for initial evaluation, 
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Cheson BD, Ansell S, Schwartz L, et al. Refinement of the Lugano Classification 
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2016;128(21):2489-2496.
Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0, 
Published: May 28, 2009 (v4.03: June 14, 2010), U.S. Department of Health and 
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Crump M, Kuruvilla J, Couban S., et al. Randomized comparison of gemcitabine, 
dexamethasone, and cisplatin versus dexamethasone, cytarabine, and cisplatin 
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2014;32(31):3490-3496.
Edris B, Weiskopf K, Volkmer AK, et al. Antibody therapy targeting the CD47 protein 
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Ghielmini M, Schmitz SF, Cogliatti SB, et al. Prolonged treatment with rituximab in 
patients with follicular lymphoma significantly increases event-free survival and 
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Gisselbrecht C, Glass B, Mounier N, et al. Salvage regimens with autologous 
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Gribben JG. How I treat indolent lymphoma. Blood. 2007;109(11):4617-4626.
Harris NL, Jaffe ES, Diebold J, et al. World Health Organization classification of 
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treatment trial for low–tumor burden follicular lymphoma: Eastern Cooperative 
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Kim D, Wang J, Willingham SB, et al. Anti-CD47 antibodies promote phagocytosis 
and inhibit the growth of human myeloma cells. Leukemia. 2012;26(12):2538- 
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Liu X, Pu Y, Cron K, et al. CD47 blockade triggers T cell-mediated destruction of 
immunogenic tumors. Nat Med. 2015a;21(10):1209-1215.
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.
Lopez A, Gutierrez A, Palacios A, et al. GEMOX-R regimen is a highly effective 
salvage regimen in patients with refractory/relapsing diffuse large-cell lymphoma: a 
phase II study.  Eur J Haematol. 2008 Feb;80(2):127-132.
Majeti R, Chao MP, Alizadeh AA, et al. CD47 is an adverse prognostic factor and 
therapeutic antibody target on human acute myeloid leukemia stem cells. Cell.
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Merchionne F, Quintana G, Gaudio F, et al. Bendamustine plus rituximab for 
relapsed or refractory diffuse large B cell lymphoma: a retrospective analysis. 
Leuk Res. 2014 Dec;38(12):1446-1450.
Morrison VA, Hamlin P, Soubeyran P, et al. Approach to therapy of diffuse 
large B-cell lymphoma in the elderly: the International Society of Geriatric 
Oncology (SIOG) expert position commentary. Ann Oncol. 2015;26(6):1058- 
1068.
Mounier N, El Gnaoui T, Tilly H, et al. Rituximab plus gemcitabine and oxaliplatin in 
patients with refractory/relapsed diffuse large B-cell lymphoma who are not 
candidates for high-dose therapy. A phase II Lymphoma Study Association trial.
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oncology. MAbs. 2010;2(1):14-19.
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Sikic B, Narayanan S, Colevas AD, et al. A first-in-human, first-in-class phase I trial 
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Hematol. 2010;47(2):133-142.
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Organization classification of lymphoid neoplasms. Blood. 2016;127(20):2375-2390.
Tseng D, Volkmer JP, Willingham SB, et al. Anti-CD47 antibody-mediated 
phagocytosis of cancer by macrophages primes an effective antitumor T- 
cell response. Proc Natl Acad Sci USA. 2013;110(27):11103-11108.
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Troughton MC, Simmons LW, Langley C, Youssef M, Marques MB. A Novel Use 
of Human Platelet Concentrate to Resolve Interference of Anti-CD47 in Serologic 
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Willingham SB, Volkmer JP, Gentles AJ, et al. The CD47-signal regulatory protein 
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Zhang M, Hutter G, Kahn S, et al. Anti-CD47 treatment stimulates phagocytosis of 
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macrophages in vivo. PLoS One. 2016;11(4):e0153550.


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14.
APPENDICES
APPENDIX A.
RITUXAN®/MABTHERA (RITUXIMAB) PRESCRIBING 
INFORMATION
RITUXAN®(rituximab) prescribing information
Available online: http://www.gene.com/download/pdf/rituxan_prescribing.pdf 
Accessed 27 April 2017
MabThera®(rituximab) prescribing information 
Available online:
http://www.ema.europa.eu/docs/en_GB/document_library/ 
EPAR_-_Product_Information/human/000165/WC500025821.pdf
Accessed 27 April 2017


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APPENDIX B
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) 
https://evs.nci.nih.gov/ftp1/CTCAE/About.html
Accessed 27 April 2017


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APPENDIX C
THE LUGANO CLASSIFICATION AND LYRIC CRITERIA FOR 
LYMPHOMAS
Publications:
LUGANO CLASSIFICATION:
Cheson BD, Fisher RI, Barrington SF, et al. Recommendations for initial evaluation, 
staging, and response assessment of Hodgkin and non-Hodgkin lymphoma: the 
Lugano classification. J Clin Oncol. 2014;32(27):3059-3068.
LYRIC CRITERIA:
Cheson BD, Ansell S, Schwartz L, et al. Refinement of the Lugano Classification 
lymphoma response criteria in the era of immunomodulatory therapy. Blood. 2016 
Sep 20;128(21):2489-2496.
Available online: 
http://www.bloodjournal.org/content/bloodjournal/128/21/2489.full.pdf
Accessed 25 April 2017


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APPENDIX D
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.
Karnofsky Performance Status
Publication:
Karnofsky D, Burchenal J, The clinical evaluation of chemotherapeutic agents in 
cancer. In: MacLeod C, ed. Evaluation of Chemotherapeutic Agents. New York, 
NY: Columbia University Press; 1949:191–205.
Available online:
http://ecog-acrin.org/resources/ecog-performance-status 
Accessed 7 June 2016


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APPENDIX E
PERIPHERAL SMEAR ASSESSMENT
Peripheral smears will be assessed by the designated hematopathology 
service using the following guidelines:
RBC Agglutination
0–9%
Not reported/absent
10–19%
1+
20–50%
2+
51–75%
3+
> 75%
4+
Spherocytes
0–1 cells/100 RBCs
Not reported/absent
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/absent
1–2 cells/100 RBCs
1+
> 2–5 cells/100 RBCs
2+
> 5–10 cells/100 RBCs
3+
> 10 cells/100 RBCs
4+
Abbreviations: RBCs = red blood cells.
All other observed findings: report according to local laboratory hematopathology 
standard procedures.
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 F
GEMZAR® (GEMCITABINE) PRESCRIBING INFORMATION
GEMZAR®(gemcitabine) prescribing information 
Available online: https://pi.lilly.com/us/gemzar.pdf
Accessed 18 August 2018


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APPENDIX G
ELOXATIN® (OXALIPLATIN) PRESCRIBING INFORMATION
ELOXATIN®(oxaliplatin) prescribing information 
Available online:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021759s012lbl.pdf 
Accessed 18 August 2018


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APPENDIX H
HISTORY OF PATIENT ENROLLMENT AND ASSESSMENTS
Table H- 1
Antibody Combination (Magrolimab + Rituximab): Phase 1b Schedule of Assessments
Examination
Antibody Combination (Magrolimab + Rituximab): Phase 1b Schedule of Assessments
Cycle (28-day 
Cycles)
1
2 s
3 s
4 s
5+ s
Cycle Day
SC
1 2
8
9
11 15
22
1
2
4 8
15
22
1
8
15
22
1
8
15
22
1
8 15
22
Visit Window (Days)
- 
30
None
±1
± 
2
±1
±2
Assessments
Informed consent
X
Demographics
X
Medical and cancer 
history
X
Inclusion/exclusion 
criteria
X
Enrollment cohort 
assignment a
X
Pregnancy test b
X
Xc
X
X
X
X
CBC with 
differential, 
platelets, 
reticulocytes b
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Peripheral blood 
smear d
X
Xb X
X
X
X
X
X
Serum or plasma 
chemistry b
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Serum uric acid, 
phosphorous b
X
X
X
X
X
Haptoglobin,
D-dimer, thrombin 
time, and plasma
fibrinogen b
X
X
X
X
X
X
X
X
X
PT/INR, aPTT b
X
X
X
X
X
X


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Examination
Antibody Combination (Magrolimab + Rituximab): Phase 1b Schedule of Assessments
Cycle (28-day 
Cycles)
1
2 s
3 s
4 s
5+ s
Cycle Day
SC
1
2
8
9
11
1
5
22
1
2
4
8
15
22
1
8
15
22
1
8
15
22
1
8
15
22
Visit Window (Days)
- 
30
None
±1
± 
2
±1
±2
Assessments
Type and screen 
(ABO/Rh), DAT
X
Lymphocyte subset 
analysis
X
X
X
X
X
Urinalysis b
X
X
Correlative studies e
X
X
X
Xr
Pharmacokinetics f
X
X
X
X
X
X
X
X X
X
X
X
X
X
X p
Antidrug antibodies
X
X
X
X
X
CD47 receptor 
occupancy g
X
X
X
X
X
X
X
X
X
X p
ECOG performance 
status
X
X
X
X
X
X
X
X
X
Vital signs h
X
X
X
X
Xn
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Physical 
examination i
X
Xb
X
X
X
X
X
X
X
X
DLT assessment j
X
ECG k
X
X
X
X
Tumor/lymph node 
biopsy, 
 
(within the 
screening period 
and ± 1 week for 
later samples) u
X
X
CCI-


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Examination
Antibody Combination (Magrolimab + Rituximab): Phase 1b Schedule of Assessments
Cycle (28-day 
Cycles)
1
2 s
3 s
4 s
5+ s
Cycle Day
SC
1
2
8
9
11
1
5
22
1
2
4
8
15
22
1
8
15
22
1
8
15
22
1
8
15
22
Visit Window (Days)
-30
None
±1
± 
2
±1
±2
Assessments
Diagnostic imaging l
X
X
Q8Wq
Bone marrow 
biopsym
X
X
Response 
assessment
X
Q8W q
Adverse events
Concomitant 
medications
Study Drug 
Administration
Rituximab n
X
X
X
X
X
X
Xn
Magrolimab t
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X X
X
Magrolimab 
(Loading Dose 
Cohort only)
X
Xo
Xo
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; aPTT = activated partial thromboplastin time; CBC = complete blood 
count; CR = complete response; DAT = direct antiglobulin test; DLT = dose- limiting toxicity; ECG = electrocardiogram; ECOG = Eastern 
Cooperative Oncology Group; PT/INR = prothrombin time/international normalized ratio; PE = physical exam; PK = pharmacokinetics; 
Q8W = every 8 weeks; Rh = Rhesus factor; SC = Screening.
NOTE: Patients who will be transitioned from Phase 1b to Phase 2 dosing may have rituximab extended dosing that occurs on odd cycles 
rather than even (i.e., dosing on odd cycles will not be considered a protocol deviation); refer to Section 6.2.1.2.
a.
First dose of magrolimab must be given within 30 days of signing informed consent.
b.
Pre-infusion assessments tests may be collected up to 72 hours before study drug administration during the initial dose; 
however, with subsequent doses pre-infusion assessments maybe collected up to 24 hours before study drug administration.
c.
May use screening pregnancy test performed within 72 hours of first dose.


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d.
Peripheral blood smear slides will be read at the site, and sent to the Sponsor for storage. Details are provided in Section 7.3.7 and in 
the Laboratory Manual.
e.
Time point details for correlative studies are provided in Table 7-4.
f.
Time point details for PK studies are provided in Table 7-5.
g.
Time point details for receptor occupancy studies are provided in Table H-4. Receptor occupancy assessment is only required in Phase 
1b. Receptor occupancy sample collection in peripheral blood was discontinued in Protocol Amendment 6.
h.
Prior to infusion and within 1 hour after the end of each infusion. Details are provided in Section 7.3.2.
i.
Full PE at screening, symptom-directed PE thereafter.
j.
DLT will be assessed through the first 4 weeks of the study.
k.
Single at screening. For Phase 1b only, triplicate within 2 hours prior to rituximab infusion and within 30 minutes of the end of 
magrolimab infusion (Section 7.3.3).
l.
(± 1 week) Refer to Section 7.3.5 for details.
m.
Bone marrow biopsy will be performed for response assessment in patients with known bone marrow disease involvement and to confirm 
CR at any response assessment, where clinically appropriate, and at disease progression.
n.
Rituximab will be continued at even cycles in Cycles 6 and beyond until loss of clinical benefit or unacceptable toxicity.
o.
Loading Dose Cohort only: Loading doses of magrolimab administered on Days 8 and 11 may be shifted ± 1 day, provided that loading 
doses are not administered on consecutive days.
p.
Starting with Cycle 5, samples to be collected every other cycle (e.g., Cycle 5, 7, and so on).
q.
Response assessments may be adjusted by ± 4 weeks to coordinate with treatment cycle timing. After Cycle 3, window is ± 14 days.
r.
To be performed with diagnostic imaging (± 7 days from Cycle 3, Day 1).
s.
For a Q2W dosing schedule, visits on Days 8 and 22 are not required.
t.
For some dose levels, a Day 11 magrolimab loading dose is administered, as well as magrolimab being administered on Days 1 and 15 
starting in Cycle 3 (for Dose Level 4). See Table 6-1 for magrolimab dosing schedules according to dose level.
u.
Archival tumor tissue may be collected by the Sponsor for correlative studies. The tissue block is preferred, but if not available at least 
10 unstained slides are suggested.


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Table H- 2
Antibody Combination (Magrolimab + Rituximab): Alternate RP2DS Schedule of Assessments
Examination
Antibody Combination (Magrolimab + Rituximab): Alternate RP2DS Schedule of Assessments
Cycle (28-day Cycles)
1
2
q
3
q
4
q
5+ q
Cycle Day
SC
1
2
8
11
15
22
1
8
15
22
1
8
15
22
1
8 15
22
1
8 15
22
Visit Window (Days)
-30
None
±1
±2
±1
± 2
Assessments
Informed consent
X
Demographics
X
Medical and cancer 
history
X
Inclusion/exclusion 
criteria
X
Enrollment cohort 
assignment a
X
Pregnancy test b
X
Xc
X
X
X
X
CBC with differential, 
platelets, reticulocytes b
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Peripheral blood smear d
X
X b
X
X
X
X
X
X
Serum chemistry b
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Serum uric acid, 
phosphorous b
X
X
X
X
X
Haptoglobin, D-dimer, 
thrombin time and 
plasma fibrinogen b
X
X
X
X
X
X
X
X
X
PT/INR, aPTT b
X
X
X
X
X
X
Type and screen 
(ABO/Rh), DAT
X
Lymphocyte subset 
analysis
X
X
X
X
Urinalysis b
X
X
Correlative studies e
X
X
Xo
X


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Gilead Sciences, Inc
Amendment 12
CONFIDENTIAL
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02 November 2023
Examination
Antibody Combination (Magrolimab + Rituximab): Alternate RP2DS Schedule of Assessments
Cycle (28-day Cycles)
1
2
q
3
q
4
q
5+ q
Cycle Day
SC
1
2
8
11
15
22
1
8
15
22
1
8
15
22
1
8 15
22
1
8 15
22
Visit Window (Days)
-30
None
±1
±2
±1
± 2
Assessments
Pharmacokinetics f
X
X
X
X
X
X
X
Xm
Antidrug antibodies
X
X
X
X
Xm
ECOG performance 
status
X
X
X
X
X
X
X
X
X
Vital signs g
X
X
X
X
X p
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X X
X
Physical examination h
X
Xc
X
X
X
X
X
X
X
X
X
ECG i
X
Tumor/lymph node 
biopsy j
X
Xo
Diagnostic imagingk
X
X
Q2Cn
Bone marrow biopsy l
X
X
Response assessment
X
Q2Cn
Adverse events
Concomitant medications
Study Drug 
Administration
Rituximab
X
X
X
X
X
X
C5+C6,then 
Q2C
Magrolimab
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X X
X
Magrolimab
(Loading Dose Cohort only)
X
Xp
Xp
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; aPTT = activated partial thromboplastin time; C = cycle number; CBC = 
complete blood count; CR = complete response; DAT = direct antiglobulin test; DLT = dose-limiting toxicity; ECG = electrocardiogram; 
.. 


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Final
Gilead Sciences, Inc
Amendment 12
CONFIDENTIAL
Page 182
02 November 2023
ECOG = Eastern Cooperative Oncology Group; PT/INR = prothrombin time/international normalized ratio; PE = physical exam; PK = 
pharmacokinetics; Q2C = every 2 cycles; Rh = Rhesus factor; RP2DS = recommended Phase 2 dose and schedule; SC = screening.
a.
First dose of magrolimab must be given within 30 days of signing informed consent.
b.
Pre-infusion assessments tests may be collected up to 72 hours before study drug administration during the initial dose, however 
with subsequent doses pre-infusion assessments may be collected up to 24 hours before study drug administration.
c.
May use screening pregnancy test performed within 72 hours of first dose.
d.
Peripheral blood smear slides will be retained and sent to the Sponsor for storage. Details are provided in Section 7.3.7.
e.
Time point details for correlative studies are provided in Table 7-4.
f.
Time point details for PK time points are provided in Table 7-3.
g.
Prior to infusion and within 30 minutes after the end of each infusion. Details are provided in Section 7.3.2.
h.
Full PE at screening, symptom-directed PE thereafter.
i.
Single at screening.
j.
The tumor/lymph node biopsy is mandatory within the screening period and the window is ± 2 weeks for later samples. Archival tumor 
tissue may be collected by the Sponsor for correlative studies. The tissue block is preferred, but if not available at least 10 unstained 
slides are suggested.
k.
(± 1 week) Details are provided in Section 7.3.5.
l.
Bone marrow biopsy will be performed for response assessment in those patients with known bone marrow disease involvement and 
also performed to confirm CR at any response assessment, where clinically appropriate, and at disease progression.
m.
Starting with Cycle 5, samples to be collected every other cycle (e.g., Cycle 5, 7, and so on).
n.
Response assessments may be adjusted by ± 4 weeks to coordinate with treatment cycle timing.
o.
To be performed with diagnostic imaging (± 7 days from Cycle 3, Day 1).
p.
Loading Dose Cohort only: Loading doses of magrolimab administered on Days 8 and 11 may be shifted ± 1 day, provided that loading 
doses are not administered on consecutive days.
q.
For a Q2W dosing schedule, visits on days 8 and 22 are not required.


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Final
Gilead Sciences, Inc
Amendment 12
CONFIDENTIAL
Page 183
02 November 2023
Table H- 3
Pharmacokinetic Assessments: Antibody Combination (Magrolimab + Rituximab) Phase 1b
Cycle 1
Cycle 2
C3-C6
C7+
EOT
Day
1
8
9
11
15
22
1
2
4
8
15
22
1
1
—
Pre-rituximab infusion 
(within 12 hours)
X
X
X
X
Xa
X
Pre-magrolimab infusion 
(within 12 hours)
X
Xb
Xb
Xb
Xb
Xb
Xb
Xa,b
Xa
X
1 hour (± 15 min) after 
magrolimab infusion
X
X
X
X
X
X
Xa
Xa
24 hours (± 8 hours) after 
most recent magrolimab 
infusion (Cycle 1 Day 8 or
Cycle 2 Day 1)
X
X
72 hours (± 12 hours) 
after most recent 
magrolimab infusion 
(Cycle 1 Day 8 or Cycle 2
Day 1)
Xc
X
1 hour (± 15 min) after 
rituximab infusion
X
X
X
Abbreviations: C = cycle number; EOT = end-of-treatment; min = minute(s); PK = pharmacokinetic(s). 
Note: Separate PK samples will be collected for magrolimab and rituximab.
a.
Starting with Cycle 5, samples to be collected every other cycle (e.g., Cycle 5, 7, and so on).
b.
Sample to be collected before rituximab infusion when applicable.
c.
Sample to be collected before magrolimab dose when applicable to loading dose cohort.


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Gilead Sciences, Inc
Amendment 12
CONFIDENTIAL
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02 November 2023
Table H- 4
CD47 Receptor Occupancy Sample Time Points: Antibody Combination (Magrolimab + 
Rituximab) Phase 1b Only
Time Points
Cycle 1
Cycle 2
Cycle 3+
EOT
Day
1
2
8
11
15
22
1
8
1
—
Pre-study drug infusion a
X
X
Xc
X
X
X
X
Xb
X
1 hour (± 15 min) after 
magrolimab infusion
X
X
Xc
X
X
Xb
24 hours (± 8 hours) after 
magrolimab infusion on Day 1
X
72 hours
(± 12 hours) after 
magrolimab infusion on Day 
8
Xc
Abbreviations: EOT = end-of-treatment; min = minute(s).
Note: Receptor occupancy samples will be collected and evaluated for Phase 1b only. Receptor occupancy sample collection was 
discontinued in Protocol Amendment 6.
a.
Sample to be collected before rituximab infusion when applicable.
b.
Starting with Cycle 5, samples to be collected every other cycle (e.g., Cycle 5, 7, and so on).
c.
72 hour samples to be collected for non-loading dose cohort only. Predose and 1-hr samples to be collected for patients in the 
loading dose cohort only.


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Final
Gilead Sciences, Inc
Amendment 12
CONFIDENTIAL
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APPENDIX I
LYMPHOMA IMMUNOPHENOTYPING
In addition to tumor biopsy to be sent to the central laboratory where sufficient tumor 
sample is available, local lymphoma immunophenotyping panel is requested. The 
collected specimen will be divided into 2 portions (1) 1 portion  will be sent for local 
lymphoma immunophenotyping (lymphoma panel), and the results will be reported in the 
eCRF; and (2) the second portion to be processed locally or sent to the central laboratory 
as described in the laboratory manual.


Prot 5F9003 amd-12
ELECTRONIC SIGNATURES
Signed by
Meaning of Signature
Server Date
(dd-MMM-
yyyy hh:mm:ss)
Clinical Development
eSigned
02-Nov-2023
15:48:44
PPD

SAP_001.pdf: 
STATISTICAL ANALYSIS PLAN
Study Title:
A Phase 1b/2 Trial of Hu5F9-G4 in Combination with 
Rituximab or Rituximab + Chemotherapy in Patients with 
Relapsed/Refractory B-cell Non-Hodgkin’s Lymphoma 
Name of Test Drug:
Magrolimab (Hu5F9-G4)
Study Number:
5F9003
Protocol Version (Date):
Amendment 12 (02 November 2023)
Analysis Type:
Final Analysis
Analysis Plan Version:
1.0
Analysis Plan Date:
17 May 2024
Analysis Plan Author:
CONFIDENTIAL AND PROPRIETARY INFORMATION
PPD
[r) GILEAU 


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Version 1.0
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TABLE OF CONTENTS
STATISTICAL ANALYSIS PLAN ...............................................................................................................................1
TABLE OF CONTENTS................................................................................................................................................2
LIST OF TABLES..........................................................................................................................................................4
LIST OF ABBREVIATIONS.........................................................................................................................................5
1.
INTRODUCTION..................................................................................................................................................8
1.1.
Study Objectives........................................................................................................................................8
1.2.
Study Design ...........................................................................................................................................10
1.2.1.
Key Inclusion Criteria ...........................................................................................................11
1.2.2.
Key Exclusion Criteria ..........................................................................................................12
1.2.3.
Phase 1b Antibody (Magrolimab + Rituximab) Study Design .............................................12
1.2.4.
Phase 2 Antibody (Magrolimab + Rituximab) Study Design ...............................................13
1.2.5.
Phase 1b Chemotherapy (Magrolimab + R-GemOx) Study Design .....................................15
1.3.
Sample Size and Power ...........................................................................................................................17
1.3.1.
Phase 1b Antibody Combination (Magrolimab + Rituximab) Sample Size .........................17
1.3.2.
Phase 2 Antibody Combination (Magrolimab + Rituximab) Sample Size ...........................17
1.3.3.
Phase 1b Chemotherapy Combination (Magrolimab + R-GemOx) Sample 
Size........................................................................................................................................17
2.
TYPE OF PLANNED ANALYSIS......................................................................................................................19
2.1.
Interim Analyses......................................................................................................................................19
2.1.1.
Planned Interim Analyses for Phase 1b Dose Escalation Cohorts ........................................19
2.1.2.
Planned Interim Analyses for Phase 2 Cohorts .....................................................................20
2.1.3.
Unplanned Interim Analysis 1...............................................................................................20
2.1.4.
Unplanned Interim Analysis 2...............................................................................................20
2.2.
Final Analysis..........................................................................................................................................20
3.
GENERAL CONSIDERATIONS FOR DATA ANALYSES.............................................................................21
3.1.
Analysis Sets ...........................................................................................................................................21
3.1.1.
Enrolled Analysis Set ............................................................................................................21
3.1.2.
Safety Analysis Set................................................................................................................21
3.1.3.
Efficacy Analysis Set ............................................................................................................21
3.1.4.
Dose-Limiting Toxicity Analysis Set 1.................................................................................21
3.1.5.
Dose-Limiting Toxicity (DLT) Analysis Set 2 .....................................................................22
3.2.
Patient Grouping......................................................................................................................................22
3.3.
Strata and Covariates...............................................................................................................................24
3.4.
Examination of Patient Subgroups ..........................................................................................................24
3.5.
Multiple Comparisons .............................................................................................................................24
3.6.
Missing Data and Outliers.......................................................................................................................24
3.6.1.
Missing Data..........................................................................................................................24
3.6.2.
Outliers ..................................................................................................................................24
3.7.
Data Handling Conventions and Transformations ..................................................................................24
3.8.
Analysis Visit Windows..........................................................................................................................25
3.8.1.
Definition of Study Day ........................................................................................................25
3.8.2.
Analysis Visit Windows........................................................................................................25
3.8.3.
Selection of Data in the Event of Multiple Records in an Analysis Visit 
Window .................................................................................................................................26
4.
PATIENT DISPOSITION....................................................................................................................................27
4.1.
Patient Enrollment and Disposition.........................................................................................................27


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4.2.
Extent of Study Drug Exposure...............................................................................................................28
4.2.1.
Duration of Exposure to Study Drug.....................................................................................28
4.3.
Protocol Deviations .................................................................................................................................28
4.4.
Assessment of COVID-19 Impact...........................................................................................................29
4.4.1.
Study Drug or Study Discontinuation Due to COVID-19.....................................................29
4.4.2.
Protocol Deviations Due to COVID-19 ................................................................................29
4.4.3.
Missed and Virtual Visits due to COVID-19 ........................................................................29
5.
BASELINE CHARACTERISTICS .....................................................................................................................30
5.1.
Demographics and Baseline Characteristics ...........................................................................................30
5.2.
Medical History.......................................................................................................................................30
5.3.
Prior Anti-cancer Therapy.......................................................................................................................30
6.
EFFICACY ANALYSES.....................................................................................................................................31
6.1.
Primary Efficacy Endpoint......................................................................................................................31
6.1.1.
Definition of the primary Efficacy Endpoint.........................................................................31
6.1.2.
Analysis Method of the Primary Efficacy Endpoint .............................................................31
6.2.
Secondary Efficacy Endpoints ................................................................................................................31
6.2.1.
Definition of Secondary Efficacy Endpoints.........................................................................31
6.2.2.
Analysis Methods for Secondart Efficacy Endpoints............................................................32
7.
SAFETY ANALYSES.........................................................................................................................................33
7.1.
Primary Safety Endpoint in Phase 1b......................................................................................................33
7.1.1.
Definition of the primary Safety Endpoint in Phase 1b ........................................................33
7.1.2.
Analysis Method of the Primary Safety Endpoint in Phase 1b .............................................35
7.2.
Adverse Events and Deaths.....................................................................................................................35
7.2.1.
Adverse Event Dictionary .....................................................................................................35
7.2.2.
Adverse Event Severity .........................................................................................................35
7.2.3.
Relationship of Adverse Events to Study Drug.....................................................................35
7.2.4.
Serious Adverse Events.........................................................................................................35
7.2.5.
Treatment-Emergent Adverse Events....................................................................................36
7.2.6.
Summaries of Adverse Events and Deaths............................................................................36
7.2.7.
Additional Analysis of Adverse Events ................................................................................39
7.3.
Laboratory Evaluations ...........................................................................................................................40
7.3.1.
Graded Laboratory Values ....................................................................................................41
7.4.
Body Weight and Vital Signs..................................................................................................................41
7.5.
Pre, Prior, and Concomitant Medications................................................................................................41
7.5.1.
Pre Medications.....................................................................................................................42
7.5.2.
Prior Medications ..................................................................................................................42
7.5.3.
Concomitant Medications......................................................................................................42
7.6.
Electrocardiogram Results.......................................................................................................................43
7.7.
Other Safety Measures ............................................................................................................................43
7.8.
Changes From Protocol-Specified Safety Analyses................................................................................43
8.
PHARMACOKINETIC (PK) AND IMMUNOGENICITY ANALYSES..........................................................44
9.
BIOMARKER ANALYSIS .................................................................................................................................45
10.
REFERENCES.....................................................................................................................................................46
11.
SOFTWARE.........................................................................................................................................................47
12.
APPENDIX ..........................................................................................................................................................48
Appendix 1.
Determining Missing and Virtual Visits Due To Covid-19 ....................................................48


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LIST OF TABLES
Table 1.
5F9003: Antibody Combination (Magrolimab + Rituximab) Phase 1b Cohorts and 
Schedule...................................................................................................................................13
Table 2.
5F9003: Antibody Combination (Magrolimab + Rituximab) Phase 2 Cohorts and 
Schedule...................................................................................................................................14
Table 3.
5F9003: Chemotherapy Combination (Magrolimab + R-GemOx) Safety Dose-
Escalation and Expansion Phase Cohorts and Schedule..........................................................16


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Statistical Analysis Plan – Final Analysis
Version 1.0
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LIST OF ABBREVIATIONS
ADA
antidrug antibody
AE
adverse event
ALT
alanine aminotransferase
aPTT
activated partial thromboplastin time
ASCT
autologous stem cell transplant
AST
aspartate aminotransferase
AUC
area under the concentration-time curve
BLQ
below the limit of quantitation
BMI
body mass index
CFR
Code of Federal Regulations
CI
confidence interval
CK
creatine kinase
Cmax
maximum serum concentration
COVID-19
Coronavirus disease 2019
CR
complete response
CRF
case report form
CSR
clinical study report
CTCAE
Common Terminology Criteria for Adverse Events
CTSC
Clinical Trial Steering Committee
CyTOF
mass cytometry
DILI
drug-induced liver injury
DLBCL
diffuse large B-cell lymphoma
DLT
dose-limiting toxicity
DNA
deoxyribonucleic acidi
DOR
duration of response
DMC
data monitoring committee
EAS
Efficacy Analysis Set
ECG
electrocardiogram
ECOG
Eastern Cooperative Oncology Group
eCRF
electronic case report form
ET
early termination
Hb
hemoglobin
HLT
high-level term
ICH
International Conference on Harmonization (of Technical Requirements for Registration of 
Pharmaceuticals for Human Use)
IL
Indolent lymphoma
INR
international normalized ratio
ITT
intent to treat
KM
Kaplan-Meier


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LLT
lower-level term
LOQ
limit of quantitation
LYRIC
Lymphoma Response to Immunomodulatory therapy Criteria
MDS
myelodysplastic syndrome
MedDRA
Medical Dictionary for Regulatory Activities
MMDL
median maintenance dose level
MST
MedDRA Search Term 
MTD
maximum tolerable dose
NCI-CTCAE
National Cancer Institute Common-Terminology Criteria for Adverse Events
NHL
non-Hodgkin’s lymphoma
NLP
natural language processing
ORR
objective response rate
OS
overall survival
PP
per protocol
PFS
progression-free survival
PK
pharmacokinetic
PR
partial response
PT
preferred term
Q1, Q3
first quartile, third quartile
Q2W
every two weeks
QRS
electrocardiographic deflection between the beginning of the Q wave and termination of the 
S wave representing time for ventricular depolarization
QT
electrocardiographic interval between the beginning of the Q wave and termination of the 
T wave representing the time for both ventricular depolarization and repolarization to occur
QTc
QT interval corrected for heart rate
QTcF
QT interval corrected for heart rate using Fridericia’s formula
RBC
red blood cells
R-GemOx
rituximab, gemcitabine, and oxaliplatin
RO
receptor occupancy
RP2DS
recommended Phase 2 dose and schedule
RR
electrocardiographic interval representing the time measurement between the R wave of one 
heartbeat and the R wave of the preceding heartbeat
SAF
Safety Analysis Set
SAP
statistical analysis plan
SD
standard deviation
SI (units)
international system of units
SMQ
Standardised MedDRA Queries
SOC
system organ class
TEAE
treatment-emergent adverse event
TFLs
tables, figures, and listings
TTP
time to progression


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ULN
upper limit of normal
VR
ventricular rate
WBC
white blood cells
WHO
World Health Organization


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Version 1.0
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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) of the final analysis for Study 
5F9003. The purpose of this final analysis is to summarize the available safety and efficacy data 
from Study 5F9003 for the final synoptic CSR. 
The SAP is based on the 5F9003 Study Protocol Amendment 12 dated 02 November 2023 and 
the electronic case report form (eCRF). The SAP will be finalized prior to data finalization for 
the final analysis. Any changes made after the finalization of the SAP will be documented in the 
clinical study report (CSR).
1.1.
Study Objectives
PRIMARY
Objectives
Endpoints
•
To investigate the safety and tolerability, 
and to define the RP2DS for magrolimab in 
combination with rituximab and for 
magrolimab in combination with R-GemOx
•
To evaluate the efficacy of magrolimab in 
combination with rituximab in patients with 
indolent lymphoma and DLBCL and to 
evaluate the efficacy of magrolimab in 
combination with R-GemOx in autologous 
stem cell transplant (ASCT) ineligible 
DLBCL as measured by the ORR according 
to Lugano Classification for lymphomas 
{Cheson 2014}
•
Dose-limiting toxicities (DLTs) 
(Phase 1b only [in the antibody 
combination (magrolimab + rituximab) 
and the chemotherapy combination 
(magrolimab + R-GemOX) cohorts]) 
and adverse events (AEs) according to 
National Cancer Institute Common 
Terminology Criteria for Adverse 
Events (NCI CTCAE), Version 4.03
•
ORR as defined by the Investigator 
according to the Lugano Classification 
for lymphomas


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SECONDARY
Objectives
Endpoints
•
To evaluate the pharmacokinetic (PK) 
profiles of magrolimab in combination with 
rituximab and magrolimab in combination 
with R-GemOx
•
To evaluate the immunogenicity of 
magrolimab in combination with rituximab 
and magrolimab in combination with 
R-GemOx
•
To evaluate the efficacy of magrolimab in 
combination with rituximab in indolent 
lymphoma and DLBCL, and magrolimab in 
combination with R-GemOx in ASCT 
ineligible DLBCL as measured by the 
duration of response (DOR), progression-
free survival (PFS), overall survival (OS), 
and time to progression (TTP)
•
To evaluate the efficacy of magrolimab in 
combination with rituximab in patients with 
indolent lymphoma and DLBCL, and 
magrolimab in combination with R-GemOx 
in ASCT ineligible DLBCL as measured by 
ORR according to Lymphoma Response to 
Immunomodulatory therapy Criteria 
(LYRIC; {Cheson 2016})
•
Concentration versus time 
measurements for magrolimab in 
combination with rituximab and for 
magrolimab in combination with 
R-GemOx and their PK parameters 
including maximum serum 
concentration (Cmax), and area under the 
concentration time curve (AUC)
•
Anti-drug antibodies (ADA) to 
magrolimab in combination with 
rituximab and magrolimab in 
combination with R-GemOx
•
DOR, PFS, OS, and TTP
•
ORR as defined by the Investigator 
according to the LYRIC Criteria for 
lymphomas


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1.2.
Study Design
This is an open-label, multicenter, Phase 1b/2 trial investigating the combination of magrolimab 
+ rituximab (antibody combination) and R-GemOx (chemotherapy combination) in R/R B-cell 
NHL. Safety and tolerability will be investigated during the Phase 1b portion of the study to 
determine the MTD and define a recommended phase 2 dose schedule (RP2DS) for magrolimab 
+ rituximab and magrolimab + R-GemOx. The primary efficacy analysis will be evaluated using 
the R2PDS in the Phase 2 portion of the study on the objective response rate (ORR) as defined 
by the investigator in accordance with the Lugano Classification {Cheson 2014}. Additional 
analyses will be performed to better understand the PK, immunogenicity, duration of response, 
progression-free survival, overall survival, and time to progression. 
CCI


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Further details of the study, including the schedule of assessments, are described in 5F9003 
Study Protocol Amendment 12.
1.2.1.
Key Inclusion Criteria
1) Antibody combination (magrolimab + rituximab) Phase 1b cohort only: B-cell NHL 
expressing CD20 by immunohistochemistry (IHC) or flow cytometry, relapsed or refractory 
to at least 2 prior lines of therapy.
2) Diffuse large B-cell lymphoma (DLBCL) chemotherapy combination 
(magrolimab + R-GemOx) Phase 1b safety dose-escalation and expansion cohorts: 
a) Histologically confirmed de novo or transformed DLBCL relapsed or refractory to 1 to 
3 prior lines of therapy who are not candidates for high-dose chemotherapy and 
autologous stem cell transplantation (ASCT). Patients relapsed after ASCT are allowed.
b) At least 1 prior therapy must have included a CD20-targeted therapy. 
c) Primary refractory patients are excluded as defined by failure to achieve a partial 
response (PR) or complete response (CR) to frontline therapy or progression within 
3 months of completing treatment.
d) The 1 to 3 prior lines of therapy requirement is only applicable for treatment regimens for 
DLBCL and not for prior lymphomas in the case of transformed DLBCL.
3) For the DLBCL antibody combination (magrolimab + rituximab) Phase 2 Cohort 4, de novo 
or transformed DLBCL, not otherwise specified, according to the World Health Organization 
2016 classification of lymphoid neoplasms {Swerdlow 2016} expressing CD20 by IHC or 
flow cytometry, that is relapsed or refractory to at least 2 prior lines of therapy containing 
and anti-CD20 therapy. Prior autologous hematopoietic cell transplantation is permitted.
4) Indolent lymphoma Phase 2 Cohort: Histologically confirmed marginal zone or follicular 
lymphoma (Grade 1 to 3a) expressing CD20 by IHC or flow cytometry, relapsed or 
refractory to at least 2 prior lines of therapy. 
5) Eastern Cooperative Oncology Group (ECOG) score 0 to 2
6) Disease that is measurable or assessable for response per Lugano Classification for 
lymphomas {Cheson 2014}
7) CAR-T naïve or CAR-T ineligible patients and otherwise meet other inclusion/exclusion 
criteria may enroll. Patients who relapse following CAR-T therapy are not eligible.


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1.2.2.
Key Exclusion Criteria
1) Prior allogeneic stem cell transplant
2) Prior anticancer therapy, including chemotherapy, hormonal therapy, and investigational 
agents within 3 weeks or within at least 4 half-lives prior to magrolimab dosing (up to a 
maximum of 4 weeks), whichever is longer.
3) Red blood cell (RBC) transfusion dependence, defined as requiring more than 2 units of RBC 
transfusions during the 4-week period prior to screening. RBC transfusions are permitted 
during screening and prior to enrollment to meet the hemoglobin inclusion criteria.
4) Additional exclusion criteria for DLBCL chemotherapy combination (magrolimab + 
R-GemOx) Phase 1b safety dose-escalation and expansion cohorts only: 
a) Undergone ASCT within a period of ≤ 3 months before signing informed consent.
b) Prior treatment with gemcitabine and oxaliplatin. However, patients who relapse 
≥ 12 months after treatment with a gemcitabine and oxaliplatin containing regimen are 
allowed.
c) Known hypersensitivity to gemcitabine, oxaliplatin, or other platinum compounds.
d) Intolerance of gemcitabine, oxaliplatin, and/or rituximab as monotherapy or in 
combination due to unacceptable toxicities as determined by the treating Investigator.
1.2.3.
Phase 1b Antibody (Magrolimab + Rituximab) Study Design
Dose escalation for the Phase 1b antibody combination followed a standard 3 + 3 design in 
patients with B-cell NHL receiving magrolimab + rituximab to investigate a 1 mg/kg 
magrolimab priming dose followed by weekly maintenance doses of 10, 20, 30, or 45 mg/kg to 
determine the MTD and to identify the RP2DS for magrolimab in combination with rituximab. 
Rituximab was administered by IV infusion at the clinical approved dose of 375 mg/m2. 
Magrolimab + rituximab treatment could have continued until loss of clinical benefit or 
unacceptable toxicity for patients who do not have disease progression. The detailed dosing 
regimens implemented in the Phase 1b antibody combination are described in Table 1.


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Table 1.
5F9003: Antibody Combination (Magrolimab + Rituximab) Phase 1b 
Cohorts and Schedule
Dose Schedule (Day per 28-day Cycle)a
Cohort
Drug/Dose (Intravenous)
Cycle 1
Cycle 2
Cycle 3+
Priming
Magrolimab 1 mg/kg
Day 1
—
—
Magrolimab 10 mg/kga
Day 8, 15, 22
Day 1, 8, 15, 22
Day 1, 8, 15, 22
Phase 1b
1
Maintenance
Rituximab 375 mg/m2
Day 8, 15, 22
Day 1
C3-C6 Day 1
Priming
Magrolimab 1 mg/kg
Day 1
—
—
Magrolimab 20 mg/kga
Day 8, 15, 22
Day 1, 8, 15, 22
Day 1, 8, 15, 22
Phase 1b
2
Maintenance
Rituximab 375 mg/m2
Day 8, 15, 22
Day 1
C3-C6 Day 1
Priming
Magrolimab 1 mg/kg
Day 1
—
—
Magrolimab 30 mg/kga
Day 8, 11b, 15, 22
Day 1, 8, 15, 22
Day 1, 8, 15, 22
Phase 1b
3
Maintenance
Rituximab 375 mg/m2
Day 8, 15, 22
Day 1
C3-C6 Day 1
Priming
Magrolimab 1 mg/kg
Day 1
—
—
Magrolimab 45 mg/kga
Day 8, 11b, 15, 22
Day 1, 8, 15, 22
Day 1, 15
Phase 1b
4
Maintenance
Rituximab 375 mg/m2
Day 8, 15, 22
Day 1
C3-C6 Day 1
C = cycle number; RP2DS = recommended Phase 2 dose and schedule
a
Phase 1b patients who continued treatment in Phase 2 could have followed the Phase 2 dosing schedule (ie, at the RP2DS). 
In Protocol Amendment 6, rituximab dosing was added to Day 1 of every other cycle starting with Cycle 8 and continuing 
beyond.
b
A loading dose of magrolimab was administered on Cycle 1 Day 11 for the loading dose cohort.
Based on review of Phase 1b cohort data, the Clinical Trial Steering Committee (CTSC) 
determined the magrolimab RP2DS to be 1 mg/kg priming dose, followed by 30 mg/kg 
maintenance IV weekly dose during Cycle 1, and then every two weeks (Q2W) starting at 
Cycle 2 (cycle length is 28 days). 
1.2.4.
Phase 2 Antibody (Magrolimab + Rituximab) Study Design
The Phase 2 portion of the study initially explored the RP2DS determined from the Phase 1b 
antibody combination (magrolimab + rituximab) portion of the study. Additional dosing 
regimens were later explored resulting in a total of 4 Phase 2 cohorts as follows:


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Table 2.
5F9003: Antibody Combination (Magrolimab + Rituximab) Phase 2 
Cohorts and Schedule
Dose Schedule (Day per 28-day Cycle)
Cohort
Drug/Dose (Intravenous)
Cycle 1
Cycle 2
Cycles 3-6
Cycle 7+
Priming
Magrolimab 1 mg/kg
Day 1
—
—
Magrolimab 30 mg/kg
Day 8, 15, 22
Day 1, 15
Day 1, 15
Day 1, 15
Phase 2
1
Maintenance
Rituximab 375 mg/m2
Day 8, 15, 22
Day 1
Day 1
Day 1 every 
other cycle 
starting at 
Cycle 8
Priming
Magrolimab 1 mg/kg
Day 1
—
—
Magrolimab 30 mg/kg
Day 8, 11a 
15, 22
Day 1, 8,
15, 22
Day 1, 15
Day 1, 15
Phase 2
2
Maintenance
Rituximab 375 mg/m2
Day 8, 15, 22
Day 1
Day 1
Day 1 every 
other cycle 
starting at 
Cycle 8
Priming
Magrolimab 1 mg/kg
Day 1
—
—
Magrolimab 45 mg/kg
Day 8, 11a, 
15, 22
Day 1, 8,
15, 22
Day 1, 15
Day 1, 15
Phase 2
3
Maintenance
Rituximab 375 mg/m2
Day 8, 15, 22
Day 1
Day 1
Day 1 every 
other cycle 
starting at 
Cycle 8
Priming
Magrolimab 1 mg/kg
Day 1
—
—
—
Magrolimab 30 mg/kgb
Day 8b, 15, 
22
Day 1, 8,
15, 22
Day 1, 15
Day 1, 15
Phase 2
4
(DLBCL 
only)
Maintenance
Rituximab 375 mg/m2 b
Day 8b, 15, 
22
Day 1
C6 Day 1
Day 1 every 
other cycle 
starting at 
Cycle 8
C = cycle number; DLBCL = diffuse large B-cell lymphoma
a
A loading dose of magrolimab was administered on Cycle 1 Day 11.
b
On Cycle 1 Day 8, magrolimab was administered first, followed by rituximab at least 1 hour later. For all other times when 
rituximab and magrolimab were administered at the same visit, rituximab was administered first. There was at least an hour 
interval between the end of infusion of the first drug and the beginning of the infusion of the second drug.
•
Phase 2 Cohort 1 (RP2DS) : Magrolimab 1 mg/kg (prime), Magrolimab 30 mg/kg 
(maintenance) weekly during Cycle 1 then Q2W starting at Cycle 2 (cycle length is 28 days), 
and Rituximab 375 mg/m2
•
Phase 2 Cohort 2 : Magrolimab 1 mg/kg (prime), Magrolimab 30 mg/kg (loading dose on 
Cycle 1 Day 11), Magrolimab 30 mg/kg (maintenance) weekly through Cycle 2, then Q2W 
starting at Cycle 3, and Rituximab 375 mg/m2


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•
Phase 2 Cohort 3 : Magrolimab 1 mg/kg (prime), Magrolimab 45 mg/kg (loading dose on 
Cycle 1 Day 11), Magrolimab 45 mg/kg (maintenance) weekly in Cycle 1 and 2, then Q2W 
starting at Cycle 3, and Rituximab 375 mg/m2
•
Phase 2 Cohort 4 (DLBCL only) : Magrolimab 1 mg/kg (prime), Magrolimab 30 mg/kg 
(maintenance) weekly through Cycle 2, then Q2W starting at Cycle 3, and Rituximab 
375 mg/m2
Magrolimab + rituximab treatment could have continued until loss of clinical benefit or 
unacceptable toxicity for patients who do not have disease progression. Details of the dosing 
regimens for each of the 4 Phase 2 cohorts are described in Table 2.
Enrollment in the initial RP2DS Phase 2 cohort 1 was conducted according to a 2-stage design, 
separately by tumor type (DLBCL and IL): 
1) After 14 DLBCL or IL patients are enrolled in Phase 2 cohort 1 and have completed a 
4-week safety assessment, an initial interim safety and efficacy analysis will be performed 
for those patients. Enrollment will continue only if < 33% of patients experience any Grade 3 
or greater AE that is assessed as related to study drug (magrolimab and/or rituximab), and 
results in permanent discontinuation, withdrawal, or death, and only if ≥ 3 out of 14 patients 
achieve an objective response. 
2) A subsequent interim efficacy analysis will be peformed for the DLBCL patients, after 
40 efficacy-evaluable DLBCL patients have been enrolled. Enrollment will continue up to 
94 DLBCL patients only if the observed response rate is ≥ 20%. A subsequent interim 
efficacy analysis will be peformed for the IL patients, after 24 efficacy-evaluable IL patients 
have been enrolled. Enrollment will continue up to 94 IL patients only if the ORR is ≥ 30% 
or if the CR rate is ≥ 20%.
After initial interim analyses of Phase 2 Cohort 1, the CTSC decided to explore additional dose 
regimens different from the RP2DS and enrolled 3 additional Phase 2 cohorts (Phase 2 Cohorts 
2-4). Per 5F9003 Study Protocol Amendment 10, for Phase 2 Cohort 4, which enrolled only 
DLBCL patients, an interim safety and efficacy analysis was planned after 20 efficacy-evaluable 
patients have been enrolled, and further enrollment will continue only if the ORR is ≥ 20%.
1.2.5.
Phase 1b Chemotherapy (Magrolimab + R-GemOx) Study Design
The combination of magrolimab + R-GemOx was explored in a Phase 1b study following a 
standard 3+3 design with an initial safety dose-escalation phase (with dose de-escalation if 
necessary) followed by an expansion phase (up to 20 additional patients) in high-dose 
chemotherapy/ASCT ineligible patients. Gemcitabine and oxaliplatin dosing are intended to 
complete after Cycle 4; however, dosing may continue beyond Cycle 4, as needed, until a total of 
8 doses have been received at the discretion of the investigator. The detail dosing regimens are 
described in Table 3.


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Table 3.
5F9003: Chemotherapy Combination (Magrolimab + R-GemOx) 
Safety Dose-Escalation and Expansion Phase Cohorts and Schedule
Cohort
Drug
Cycle 1
(5 weeks)
Cycle 2
(4 weeks)
Cycles 3–4
(4 weeks)
Cycles 5–6
(4 weeks)
Cycle 7+
(4 weeks)
Phase 1b
5
Dose escalation
Magrolimab (IV)a
1 mg/kg priming: 
Day 1
30 mg/kg 
maintenance: 
Day 8, 11b, 15, 22, 
29
30 mg/kg 
maintenance: 
Day 1, 8, 15, 
22
30 mg/kg 
maintenance: 
Day 1, 15
30 mg/kg 
maintenance: 
Day 1, 15
30 mg/kg 
maintenance: 
Day 1, 15
Phase 1b
6
Dose escalation
Magrolimab (IV)c
1 mg/kg priming: 
Day 1
45 mg/kg 
maintenance: 
Day 8i, 11b, 15, 
22, 29
45 mg/kg 
maintenance: 
Day 1, 8, 15, 
22
45 mg/kg 
maintenance: 
Day 1, 15
45 mg/kg 
maintenance: 
Day 1, 15
45 mg/kg 
maintenance: 
Day 1, 15
Phase 1b
5d
Dose expansion
Magrolimab (IV)e
1 mg/kg priming: 
Day 1
30 mg/kg 
maintenance: 
Day 8, 11b,f, 15, 
22, 29
30 mg/kg 
maintenance: 
Day 1, 8, 15, 
22
30 mg/kg 
maintenance: 
Day 1, 15
30 mg/kg 
maintenance: 
Day 1, 15
30 mg/kg 
maintenance: 
Day 1, 15
Rituximab (IV)
375 mg/m2:
Day 8i, 15, 22, 29
375 mg/m2:
Day 1
375 mg/m2:
Day 1
375 mg/m2:
Day 1 then 
Day 1 every 
other cycle 
starting Cycle 8
Gemcitabine (IV)
1000 mg/m2:
Day 11, 23
1000 mg/m2:
Day 2, 15
1000 mg/m2:
Day 2, 15
–
–
Oxaliplatin (IV)
100 mg/m2:
Day 11, 23
100 mg/m2:
Day 2, 15
100 mg/m2:
Day 2, 15
–
–
G-CSF 
prophylaxisg
Administer
Administer
Administer
–
–
Used for 
each 
cohort
Allopurinol (oral)h
Daily
–
–
–
–
CTSC = Clinical Trial Steering Committee; G-CSF = granulocyte colony stimulating factor; IV = intravenous; MTD = maximum 
tolerated dose; Q2 months = every 2 months; R-GemOx = rituximab, gemcitabine, and oxaliplatin
a
Magrolimab maintenance dose could have been de-escalated to 20 mg/kg or 10 mg/kg with the identical dosing schedule of 
maintenance doses if the regimen was deemed too toxic by the CTSC.
b
A loading dose of magrolimab was administered on Cycle 1 Day 11.
c
The CTSC could have decided to explore higher doses of magrolimab in increments up to 50% higher than the prior dose 
level deemed to be safe in accordance with the modified 3 + 3 design.
d
Patients were enrolled into the same cohort as the 30 mg/kg magrolimab dose-escalation cohort.
e
The magrolimab maintenance dose level utilized in the expansion phase was the recommended dose selected by the CTSC 
from the safety dose-escalation phase.
f
The requirement for a loading dose of magrolimab on Cycle 1 Day 11 was removed in Protocol Amendment 10.
g
G-CSF primary prophylaxis must be administered with gemcitabine and oxaliplatin treatment. Local standard of care or 
equivalent was to be administered in accordance with local institutional guidelines or investigator guidance. G-CSF 
prophylaxis should have generally occurred within several days after administration on each day that gemcitabine and 
oxaliplatin was dosed. However, the timing of G-CSF prophylaxis could have been given in accordance with local 
institutional guidelines.


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h
Allopurinol of 300 mg oral daily should have been administered for the first cycle only to prevent tumor lysis syndrome 
associated with chemotherapy. Allopurinol could have been given at 100 mg oral daily for the first cycle if significant renal 
impairment was present as determined by the investigator. 
i
On Cycle 1 Day 8 magrolimab is to be given first, followed by rituximab. For all other times when rituximab and 
magrolimab are given on the same visit, rituximab should be given first. There should be at least an hour interval between 
the end of infusion of the first drug and the beginning of the infusion of the second drug.
1.3.
Sample Size and Power
The overall sample size planned for both the antibody combination (magrolimab + rituximab) 
and chemotherapy combination (magrolimab + R-GemOx) cohorts is up to 422 patients.
1.3.1.
Phase 1b Antibody Combination (Magrolimab + Rituximab) Sample Size
For the antibody combination (magrolimab + rituximab), up to 354 patients were planned for 
enrollment in both the Phase 1b and Phase 2 parts. In the Phase 1b antibody combination 
(magrolimab + rituximab) cohort of the study, a standard 3 + 3 dose escalation design is 
employed to explore the MTD of the investigational combination. There were 4 dose cohort 
levels, with an estimated total of 25 to 38 patients planned in the Phase 1b depending on the 
possible cohort expansion in a 3 + 3 design.
1.3.2.
Phase 2 Antibody Combination (Magrolimab + Rituximab) Sample Size
The Phase 2 part of the study will enroll patients with indolent lymphoma or DLBCL. Pending 
decisions from CTSC, additional arms in Phase 2 may be opened to test dose levels different 
from the current RP2DS of 30 mg/kg. Cohorts 1 to 3 of the antibody combination (magrolimab 
+ rituximab) Phase 2 part of the study will comprise up to 216 patients evaluable for efficacy (up 
to 94 with indolent lymphoma and 94 with DLBCL) if both stages of each group are fully 
accrued. The additional 28 patients account for testing of additional dose regimens for indolent 
lymphoma and DLBCL. The sample size of 94 was determined to ensure the lower bound of the 
95% CI will exclude 30% if the observed response rate is 40% or higher. 
Cohort 4 of the antibody combination (magrolimab + rituximab) Phase 2 part of the study will 
comprise up to 100 DLBCL patients if both stages are fully accrued. The sample size of 100 was 
determined to ensure the lower bound of the 95% CI will exclude 20% if the ORR is 30% or 
higher. This desired ORR is based on a ORR that is higher than current standard of care and that 
provides significant clinical benefit for these DLBCL and indolent lymphoma heavily pretreated 
patient populations.
1.3.3.
Phase 1b Chemotherapy Combination (Magrolimab + R-GemOx) Sample 
Size
For the chemotherapy combination (magrolimab + R-GemOx), the total planned number of 
patients for Phase 1b cohort was 29 to 68 efficacy-evaluable patients, including a safety dose 
escalation cohort of approximately 9 to 48 patients (if dose de-escalation occurs an additional 
6 patients may be enrolled for 2 dose levels) and a dose expansion cohort of approximately 
20 patients. The sample size of 26 total efficacy-evaluable patients at the selected dose level was 
calculated based on a desired ORR of ≥ 50% for the treatment combination. With a sample size 


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of 26 patients, the lower bound of the 95% CI would exclude an alternative ORR of 33%. A 
33% ORR is what has been reported for R-GemOx in the indicated DLBCL population 
{Mounier 2013} with a desired ORR of ≥ 50% in the chemotherapy combination 
(magrolimab + R-GemOx) Phase 1b cohort is expected to provide a meaningful clinical 
improvement and benefit in this patient population.


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2.
TYPE OF PLANNED ANALYSIS
2.1.
Interim Analyses
Interim analyses of safety and efficacy data generated during the trial were reviewed by the 
CTSC to make decisions about patient recruitment, trial management, initiation of protocol 
specific amendments, expansion of cohorts, using higher or lower dose levels, defining any new 
dose cohorts, identification of the RP2DS, and interim efficacy analysis decisions. A 
representative from the Sponsor, usually the Study Medical Monitor or designee, will chair the 
CTSC. The CTSC will oversee the conduct of the clinical trial and have representation from each 
participating site in the study. The CTSC will meet at a minimum at the completion of each 
dosing cohort during dose-escalation phase of the trial, at any protocol-specified formal interim 
analyses, and when emergent critical safety data are reported. The composition, structure, and 
function of the CTSC are defined in the CTSC Charter.
2.1.1.
Planned Interim Analyses for Phase 1b Dose Escalation Cohorts
Interim analysis of on-going data for each Phase 1b cohort was reviewed by the CTSC based on 
the first 4 weeks of treatment in each 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. 
This includes analyses of the Phase 1b, Antibody combination cohorts: 
•
Phase 1b Cohort 1 : 5F9 10 mg/kg no load + Rituximab 375 mg/m2
•
Phase 1b Cohort 2 : 5F9 20 mg/kg no load + Rituximab 375 mg/m2
•
Phase 1b Cohort 3 : 5F9 30 mg/kg load + Rituximab 375 mg/m2
•
Phase 1b Cohort 4 : 5F9 45 mg/kg load + Rituximab 375 mg/m2
And analysis of the Phase 1b, Chemotherapy combination cohorts:
•
Phase 1b Cohort 5 : 5F9 30 mg/kg load + Rituximab 375 mg/m2 + Gemcitabine 1000 mg/m2 
+ Oxaliplatin 100 mg/m2
•
Phase 1b Cohort 6 : 5F9 45 mg/kg load + Rituximab 375 mg/m2 + Gemcitabine 1000 mg/m2 
+ Oxaliplatin 100 mg/m2
Dose escalation analyses for Phase 1b Cohorts 1, 2, 3, 4, 5 and 6 have been completed and 
reviewed by the CTSC. Dose expansion analyses for the chemotherapy combination will occur 
when 26 total patients (up to 6 patients from the dose escalation phase, and at least 20 patients 
for the dose expansion phase) are evaluable for efficacy.


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2.1.2.
Planned Interim Analyses for Phase 2 Cohorts
Interim safety and efficacy analyses will be performed separately for DLBCL and IL patients 
treated with the RP2DS antibody combination enrolled in Phase 2 Cohort 1, and will be reviewed 
by the CTSC to decide whether to continue or stop enrollment after 14 efficacy-evaluable 
patients are available, respectively. If enrollment is approved, a subsequent interim analysis will 
be performed on the DLBCL patients in Phase 2 Cohort 1 when 40 efficacy-evaluable DLBCL 
patients are available, and a subsequent interim analysis will be performed on the IL patients in 
Phase 2 Cohort 1 when 24 efficacy-evaluable IL patients are available to determine whether to 
proceed to full accrual of 94 patients each for DL and IL patients, respectively. The initial 
interim safety and efficacy analyses of 14 efficacy-evaluable DLBCL and IL patients were 
completed and reviewed by the CTSC and further enrollment was approved.
Per 5F9003 Study Protocol Amendment 10, a separate DLBCL Phase 2 Cohort 4 was opened 
using modified inclusion criteria and an interim efficacy analysis will be performed for this 
cohort after 20 efficacy-evaluable patients are available to determine whether further enrollment 
in the cohort will continue up to 100 patients.
2.1.3.
Unplanned Interim Analysis 1
An unplanned interim safety analysis 1 of available study data using a data cut date of 
01 April 2021 was performed to support potential regulatory submission of the use of 
magrolimab in MDS.
2.1.4.
Unplanned Interim Analysis 2
An unplanned interim safety analysis 2 of available study data using a data cut date of 
17 March 2023 was performed to support potential regulatory submission of the use of 
magrolimab in MDS.
2.2.
Final Analysis
After all patients have completed or discontinued 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 patients in each category will be presented; for continuous variables, 
the number of patients (n), mean, standard deviation (SD) or standard error (SE), median, first 
quartile (Q1), third quartile (Q3), minimum, and maximum will be presented.
By-patient listings will be presented for all patients in the All Enrolled Analysis Set and sorted 
by dose level assigned, patient ID number, visit date, and time (if applicable). Data collected on 
log forms, such as AEs, will be presented in chronological order by patient. The dose level to 
which patients were initially assigned will be used in the listings. Age, sex at birth, race, and 
ethnicity information will be included in the listings, as space permits.
3.1.
Analysis Sets
Analysis sets define the patients 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 patients eligible for inclusion will be 
summarized.
3.1.1.
Enrolled Analysis Set
The Enrolled Analysis Set includes all patients who received a study patient identification 
number in the study after screening. 
3.1.2.
Safety Analysis Set
The Safety Analysis Set (SAF) includes all patients who received at least 1 dose of any study 
treatment. This is the primary analysis set for safety, demographics, and medical/cancer history.
3.1.3.
Efficacy Analysis Set
The Efficacy Analysis Set (EAS) includes all enrolled patients who received at least 1 dose of 
magrolimab. 
3.1.4.
Dose-Limiting Toxicity Analysis Set 1
The DLT Analysis Set 1 includes all enrolled Phase 1b patients in the magrolimab + rituximab 
cohort who met EITHER of the following criteria:
•
The patient experienced a DLT
•
The patient completed at least 3 infusions of magrolimab and 2 infusions of rituximab


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3.1.5.
Dose-Limiting Toxicity (DLT) Analysis Set 2
The DLT Analysis Set 2 includes all enrolled Phase 1b patients in the magrolimab + R-GemOx 
cohort who met EITHER of the following criteria:
•
The patient experienced a DLT at any time after initiation of the first infusion of magrolimab, 
rituximab, and gemcitabine or oxaliplatin
•
The patient completed at least 3 infusions of magrolimab and 2 infusions of rituximab, and 
1 infusion of gemcitabine and oxaliplatin
3.2.
Patient Grouping
Analyses will be presented by phase and treatment combination, with patients further grouped by 
cohort, unless otherwise specified, as follows:
•
Phase 1b, Antibody Combination
Phase 1b Cohort 1 : Magro 10 mg/kg no load + Ritux
Phase 1b Cohort 2 : Magro 20 mg/kg no load + Ritux
Phase 1b Cohort 3 : Magro 30 mg/kg load + Ritux
Phase 1b Cohort 4 : Magro 45 mg/kg load + Ritux
•
Phase 2, Antibody Combination
Phase 2 Cohort 1 : Magro 30 mg/kg no load + Ritux (RP2DS)
Phase 2 Cohort 2 : Magro 30 mg/kg load + Ritux
Phase 2 Cohort 3 : Magro 45 mg/kg load + Ritux
Phase 2 Cohort 4 : DLBCL Magro 30 mg/kg no load + Ritux
•
Phase 1b, Chemotherapy Combination
Phase 1b Cohort 5 : Magro 30 mg/kg mix load + R-GemOx
Phase 1b Cohort 6: Magro 45 mg/kg load + R-GemOx
where Magro stands for magrolimab with dose level corresponding to the maintenance dose, load 
or no load corresponding to whether a loading dose of magrolimab was given, Ritux stands for 
Rituximab 375 mg/m2 and R-GemOx stands for Rituximab 375 mg/m2 + Gemcitabine 
1000 mg/m2 + Oxaliplatin 100 mg/m2. The details of each dosing regimen for are described in 
Table 1 to Table 3.


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Efficacy analyses will be presented by dose and disease type, and by disease, as follows:
•
Phase 1b and 2, Antibody Combination
Magro 10 mg/kg + Ritux diffuse large B-cell lymphoma (DLBCL)
Magro 10 mg/kg + Ritux indolent lymphoma (IL)
Magro 10 mg/kg + Ritux DLBCL + IL
Magro 20 mg/kg + Ritux DLBCL
Magro 20 mg/kg + Ritux IL
Magro 20 mg/kg + Ritux DLBCL + IL
Magro 30 mg/kg + Ritux DLBCL
Magro 30 mg/kg + Ritux IL
Magro 30 mg/kg + Ritux DLBCL + IL
Magro 45 mg/kg + Ritux DLBCL
Magro 45 mg/kg + Ritux IL
Magro 45 mg/kg + Ritux DLBCL + IL
•
Phase 1b, Chemotherapy Combination
Magro 30 mg/kg + Chemo DLBCL
Magro 45 mg/kg + Chemo DLBCL
Actual magrolimab maintenance dose levels (MDL) will be defined as the maximum 
non-priming dose during Cycle 1 and 2, categorized by:
•
10 mg/kg: if 8.5 mg/kg < MDL <= 15 mg/kg
•
20 mg/kg: if 15 mg/kg < MDL <= 25 mg/kg
•
30 mg/kg: if 25 mg/kg < MDL <= 35 mg/kg
•
45 mg/kg: if 35 mg/kg < MDL < 50 mg/kg
If a magrolimab infusion interruption due to AE occurred, the actual magrolimab maintenance 
dose level will default to the assigned dose upon enrollment. Priming doses will be defined as 
actual magrolimab doses below 2 mg/kg and priming doses beyond the first dose for a patient 
will be defined as a re-priming dose. 


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3.3.
Strata and Covariates
This study did not use a stratified randomization schedule when enrolling patients. No covariates 
will be included in efficacy and safety analyses.
3.4.
Examination of Patient Subgroups
No patient subgroup analyses will be performed.
3.5.
Multiple Comparisons
Adjustments for multiplicity will not be made because no formal statistical testing will be 
performed in this analysis.
3.6.
Missing Data and Outliers
3.6.1.
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 AE onset in Section 7.2.5.2, and for prior and 
concomitant medications in Section 7.5.
3.6.2.
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.
3.7.
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 (in years) on the date of the first dose of study drug will be used for analyses and 
presented in listings. If age at Day 1 is not available for a patient, then age derived based on date 
of birth and the Day 1 visit date will be used instead. If an enrolled patient was not dosed with 
any study drug, the enrollment date will be used instead of the Day 1 visit date. For screen 
failures, the date the first 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.
3.8.
Analysis Visit Windows
3.8.1.
Definition of Study Day
Study day will be calculated from the first dosing date of any study drug 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 the first dose of any study drug administration.
3.8.2.
Analysis Visit Windows
The nominal visit as recorded on the CRF will be used when data are summarized by visit. Any 
data relating to unscheduled visits will not be assigned to a particular visit or time point. 
However, the following exceptions will be made:
•
An unscheduled visit prior to the first dosing of study drug may 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.
•
Data collected on a follow-up visits will be summarized as a separate visits.


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3.8.3.
Selection of Data in the Event of Multiple Records in an Analysis Visit 
Window
Depending on the statistical analysis method, single values may be required for each analysis 
window. For example, change from baseline by visit usually requires a single value, whereas a 
time-to-event analysis would not require 1 value per analysis window.
If multiple valid, nonmissing measurements exist in an analysis window, records will be chosen 
based on the following rules if a single value is needed:
•
For baseline, the last nonmissing value on or prior to 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 electrocardiogram [ECG] 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.
PATIENT DISPOSITION
4.1.
Patient Enrollment and Disposition
A summary of site patient enrollment will be provided by phase and treatment combination 
across cohorts. The summary will present the number and percentage of patients enrolled at each 
country and site. For each column, the denominator for the percentage calculation will be the 
total number of patients analyzed for that column.
A summary of treatment disposition will be provided by phase and treatment combination across 
cohorts. This summary will present the number of patients and percentage of patients in each of 
the categories listed below:
•
Did not receive magrolimab 
•
Received magrolimab priming dose only
•
Primary reason for discontinuation of magrolimab without any maintenance dose
•
Received magrolimab maintenance dose
•
Primary reason for discontinuation of magrolimab
The above summaries of did not receive magrolimab, and primary reason for discontinuation of 
magrolimab, would similarly be repeated for rituximab, gemcitibine, and for oxticibine, as 
applicable.
A summary of study disposition will be provided by phase and treatment combination across 
cohorts. This summary will present the number of patients in each of the categories listed below:
•
Study status (on treatment, in follow-up, off study)
•
Primary reason for study exit (withdrawal of consent for follow-up, lost to follow-up, study 
terminated by sponsor, death, other)
•
Time on study treatment (months)
•
Time on study (months)
For study status and primary reason for study exit, the number and percentage of patients in each 
category will be provided. For time on study treatment and study, descriptive statistics will be 
provided.
The denominator for the percentage calculation will be the total number of patients in the 
Enrolled Analysis Set corresponding to that column.


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The following by-patient listings will be provided by patient identification (ID) number in 
ascending order to support the above summary tables:
•
Enrollment
•
Patients who discontinued treatment
•
Patients who discontinued from study
4.2.
Extent of Study Drug Exposure
Extent of exposure to study drug will be examined by assessing the total duration of exposure to 
study drug specified in the protocol. This will be summarized by phase and treatment 
combination across cohorts for each study drug: magrolimab, rituximab, gemcitabine, and 
oxaliplatin, as applicable.
4.2.1.
Duration of Exposure to Study Drug
Total duration of exposure to study drug will be defined as last dosing date of any study drug 
minus first dosing date plus 1, regardless of any temporary interruptions in study drug 
administration, and will be expressed in weeks using up to 1 decimal place (eg, 4.5 weeks). 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 patients included in the final analyses or the last available date.
•
If the study drug completion status is unknown, the earlier of the date of death or data 
snapshot date for analysis will be used.
The total treatment duration (in months), total number of infusions, and cumulative dose 
administratered (in grams) will be summarized using descriptive statistics. The number and 
percentage of patients with any re-priming dose (only applicable to magrolimab), missed or 
delayed doses, missed or delayed doses due to AE, dose reductions, and dose interruptions will 
be summarized. Dose interruptions will be further broken down by those due to AE and duration 
of interruptions due to AE (in minutes). Summaries will be provided by phase and treatment 
combination for each cohort for the Safety Analysis Set.
By-subject listings of study drug administration will be provided.
4.3.
Protocol Deviations 
Patients who did not meet the eligibility criteria for study entry, but enrolled in the study will be 
listed. A by-subject listing will be provided for those patients 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 patients did not meet and related comments, if collected.


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Protocol deviations occurring after patients entered the study are documented during routine 
monitoring. The number and percentage of patients with important protocol deviations by 
deviation reason (eg, nonadherence to study drug, violation of select inclusion/exclusion criteria) 
will be summarized by phase and treatment combination across cohorts for the Enrolled Analysis 
Set. A by-patient listing will be provided for those patients with important protocol deviation(s).
4.4.
Assessment of COVID-19 Impact
This study was ongoing during the novel coronavirus disease 2019 (COVID-19) pandemic, and 
the COVID-19 pandemic has caused a disruption in the regular visit schedules for this study. 
Some patients were unable to attend onsite visits due to shelter in place guidelines, site closures, 
or other reasons. This section provides how to handle special situations due to COVID-19 in the 
analysis.
AEs due to COVID-19 will be included in AE analyses if applicable. A by-patient listing of 
Adverse Events due to COVID-19 will be provided.
4.4.1.
Study Drug or Study Discontinuation Due to COVID-19
A by-patient listing of reasons for premature study drug or study discontinuation due to 
COVID-19 will be created.
4.4.2.
Protocol Deviations Due to COVID-19
A by-patient listing will be provided for patients with protocol deviations related to COVID-19.
4.4.3.
Missed and Virtual Visits due to COVID-19
A by-patient listing of patients with missed or virtual visits due to COVID-19 will be provided 
by patient ID number in ascending order.
Information regarding virtual or missed visits due to COVID-19 was collected as free text in the 
CRF comment fields. The determination of missing or virtual visits due to COVID-19 was done 
using Natural Language Processing (NLP) to search the CRF comment fields. A detailed 
explanation of the algorithm is given in Appendix 1.


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5.
BASELINE CHARACTERISTICS 
5.1.
Demographics and Baseline Characteristics
Patient 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 [in 
m2]) will be summarized by phase and treatment combination for each cohort and overall using 
descriptive statistics for continuous variables and using number and percentage of patients for 
categorical variables. 
Other baseline characteristics include: 
•
ECOG performance status (0, 1, 2, >2)
•
DLBCL subcategories (transformed DLBCL, de novo DLBCL)
•
Indolent lymphoma types (follicular lymphoma, marginal zone lymphoma)
•
Lugano stage at initial diagnosis (I-II, III-IV, unknown)
•
Cell of origin (activated B-cell, germinal center B-cell, unknown, not applicable)
Demographics and baseline characteristics will be summarized by phase and treatment 
combination for each cohort and overall using descriptive statistics for continuous variables and 
using number and percentage of patients for categorical variables. Summaries will be provided 
for the Enrolled Analysis Set.
By-patient demographics and baseline characteristics listings will be provided by patient ID 
number in ascending order.
5.2.
Medical History
Medical history data were collected at screening and will be listed only. 
5.3.
Prior Anti-cancer Therapy
A by-subject listing of prior anti-cancner therapies will be provided by subject ID in ascending 
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6.
EFFICACY ANALYSES
6.1.
Primary Efficacy Endpoint
6.1.1.
Definition of the primary Efficacy Endpoint
The primary efficacy endpoint of this study is the objective response rate (ORR) as defined by 
the investigator according to the Lugano Classification for lymphomas. The objective response 
rate is calculated as proportion of subjects who achieved either complete remission (CR) or 
partial remission (PR), which are based on disease assessment before any new anti-cancer 
therapy, if any. Subjects with no assessment available after start date of any study drug will be 
considered as non-responder. 
6.1.2.
Analysis Method of the Primary Efficacy Endpoint
The analyses will be based on the Efficacy Analysis Set. Summary tables with best response and 
objective response rate will be provided for the Efficacy Analysis Set. The point estimates for 
ORR and correspoindg 2-sided exact 95% CIs based on the Clopper-Pearson method will be 
provided. 
6.2.
Secondary Efficacy Endpoints
6.2.1.
Definition of Secondary Efficacy Endpoints
Objective Response Rate (ORR): Objective response rate is defined as the proportion of 
patients who achieved CR+PR as determined by Lymphoma Response to Immunomodulatory 
therapy Criteria (LYRIC; {Cheson 2016}) while on study prior to the initiation of the subsequent 
line of anti-cancer therapy. According to Table 10-2 of the protocol, the criteria for CR and PR 
under LYRIC is the same as the criteria under Lugano. Response assessments on/after the 
initiation of the subsequent line of anti-cancer therapy will be excluded from deriavation.
Duration of Response (DOR): The DOR is measured from when the first (objective) response 
is met (i.e., CR or PR) until the first date of objectively documented progressive disease while on 
study prior to the initiation of the subsequent line of anti-cancer therapy. Patients who do not 
have objectively documented progressive disease will be censored at the last response 
assessment date. Response assessments after the initiation of the subsequent line of anti-cancer 
therapy will be excluded from deriavation.
Progression-free Survival (PFS): The PFS is measured from dose initiation until the first date 
of objectively documented progressive disease or death while on study prior to the initiation of 
the subsequent line of anti-cancer therapy. Patients who do not have progressive disease AND 
not died will be censored at the last response assessment date. Response assessments after the 
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Overall Survival (OS): The OS is measured from dose initiation until death. Patients who did 
not die will be censored at their last known alive date.
Time to Progression (TTP): The TTP is measured from dose initiation until the first date of 
objectively documented progressive disease while on study prior to the initiation of the 
subsequent line of anti-cancer therapy. Patients who do not have objectively documented 
progressive disease will be censored at the last response assessment date. Response assessments 
after the initiation of the subsequent line of anti-cancer therapy will be excluded from 
deriavation.
6.2.2.
Analysis Methods for Secondart Efficacy Endpoints
Objective Response Rate (ORR) : The point estimates for ORR and correspoindg 2-sided exact 
95% CIs based on the Clopper-Pearson method will be provided. 
Duration of Response (DOR): Duration of reponses will be base on patients with best response 
of complete or partial response. The median, first quartile (Q1) and third quartile (Q3) of DOR 
and time to objective response distribution will be estimated using the Kaplan-Meier method and 
the 95% CI on median will be provided.
Progression-free Survival: Medians, Q1, Q3 of the progression-free survival distributions, and 
the proportion of patients who are progression-free at 4, 6, 8, 12 and 15 months from the first 
dose of any study treatment will be estimated along with the 95% CI on median using the 
Kaplan-Meier method. 
Overall Survival: Medians, Q1, Q3 of the overall survival distributions, and the proportion of 
patients with death at 4, 6, 8, 12, 15 and 24 months from the first dose of any study treatment 
will be estimated along with the 95% CI on median using the Kaplan-Meier method.
Time to Progression: Medians, Q1, Q3 of the time to progression, and the proportion of patients 
who with disease progression at 4, 6, 8, 12, 15 and 24 months from the first dose of any study 
treatment will be estimated along with the 95% CIs on median using the Kaplan-Meier method.


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7.
SAFETY ANALYSES
Safety analyses will be presented by phase and treatment combination, with patients further 
grouped by cohort, as specified in Section 3.2.
7.1.
Primary Safety Endpoint in Phase 1b
7.1.1.
Definition of the primary Safety Endpoint in Phase 1b
The primary safety endpoint in phase 1b of the study is dose-limiting toxicity evaluation (DLT) 
for DLT-evaluable patients. 
DLT adverse events are determined by investigators by checking “Check if event is a DLT” in 
the Adverse Event CRF. 
For patients in the magrolimab + rituximab cohort: 
DLTs applied only to patients in the phase 1b part of the study for the magrolimab + rituximab 
cohort if either of the following criteria were met during the assessment period:
•
The patient experienced a DLT.
•
The patient completed at least 3 infusions of magrolimab and 2 infusions of rituximab.
For the Phase 1b part of the study, patients who withdrew before completing the 4-week DLT 
assessment period for reasons other than a DLT, or who do not fulfill either of the criteria above, 
were not evaluable for assessment of DLT for dose review decisions and were replaced in the 
cohort.
A DLT was defined as any Grade 3 or greater AE that is assessed as related to study drug 
(magrolimab and/or rituximab) that occurred during the 4-week DLT observation period. 
The following events were exceptions to the DLT definition and were NOT considered a DLT:
•
Grade 3 anemia, however, Grade 3 hemolytic anemia that is medically significant, requires 
hospitalization or prolongation of existing hospitalization, is disabling, or limits self-care 
activities of daily life (ADL) is considered a DLT.
•
Grade 3 indirect/unconjugated hyperbilirubinemia that resolves to ≤ Grade 2 with supportive 
care within 1 week and is not associated with other clinically significant consequences.
•
Isolated Grade 3 electrolyte abnormalities that resolve to ≤ Grade 2 with supportive care 
within 1 week and are not associated with other clinically significant consequences.


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•
Grade 3 elevation in alanine aminotransferase (ALT), aspartate aminotransferase (AST), or 
alkaline phosphatase that resolves to ≤ Grade 2 with supportive care within 1 week and is not 
associated with other clinically significant consequences.
•
Transient Grade 3 nausea, vomiting, diarrhea, local reactions, influenza-like symptoms, 
myalgias, fever, headache, or acute pain that resolves to ≤ Grade 2 within ≤ 72 hours with 
supportive care.
•
Grade 3 fatigue that resolves to ≤ Grade 2 within 2 weeks on study
•
Grade 3 magrolimab or rituximab-related infusion 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.
•
Grade 3 tumor lysis syndrome or related electrolyte disturbances (hyperkalemia, 
hypophosphatemia, hyperuricemia) that resolve to ≤ Grade 2 within 7 days
•
Grade 3 or 4 lymphopenia
•
Grade 3 infusion reactions attributed to rituximab; an infusion reaction can only be attributed 
to rituximab alone if the infusion reaction occurs after the start of rituximab infusion, but 
prior to magrolimab infusion, on days where rituximab and magrolimab are both dosed
For patients in the magrolimab + R-GemOX cohort: 
Patients enrolled in the safety dose-escalation part of the Phase 1b magrolimab + R-GemOx 
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 of magrolimab, 
rituximab, and gemcitabine or oxaliplatin.
•
The patient completed at least 3 infusions of magrolimab, 2 infusions of rituximab, and 
1 infusion of gemcitabine and oxaliplatin.
A DLT in this magrolimab + R-GemOx cohort is defined by the criteria for 
magrolimab + rituximab cohort listed above, with the additional definitions listed below:
•
≥ Grade 4 hematologic toxicity that does not resolve to ≤ Grade 2 and delays initiation of 
cycle 2 by more than 14 days.
•
≥ Grade 4 febrile neutropenia or associated infections
•
≥ Grade 4 non-hematologic toxicity that does not resolve or decrease to ≤ Grade 2 within 
1 week.


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•
≥ Grade 4 IRR
•
Recurrent ≥ Grade 3 magrolimab, rituximab, gemcitabine, or oxaliplatin IRR despite optimal 
pretreatment regimen, which is defined as acetaminophen or a comparable non-steroid 
anti-inflammatory agent, plus an antihistamine and corticosteroids. In addition to the above, 
optimal pretreatment regimen includes antiemetic pretreatment for gemcitabine and/or 
oxaliplatin IRRs.
7.1.2.
Analysis Method of the Primary Safety Endpoint in Phase 1b
The number and percentage of patients who experienced at least 1 DTLs will be provided and 
summarized by treatment cohort. A listing of DLT will also be provided.
7.2.
Adverse Events and Deaths
7.2.1.
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.
7.2.2.
Adverse Event Severity
Adverse events are graded by the investigator as Grade 1, 2, 3, 4, or 5 according to CTCAE 
Version 4.03. 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. 
7.2.3.
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”, “Relationship to rituximab”, “Relationship to 
gemcitabine”, or “Relationship to oxaliplatin”. 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-patient data listings will show the relationship as missing.
7.2.4.
Serious Adverse Events
Serious adverse events (SAEs) will be identified and captured 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.


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7.2.5.
Treatment-Emergent Adverse Events 
7.2.5.1.
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 the last dose of any study drug or the initiation of the subsequent line of anti-cancer 
therapy, whichever is earlier
•
Any AEs leading to discontinuation of study drug.
7.2.5.2.
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 01 Jan or the first dosing date if they have the same year, whichever is later.
7.2.6.
Summaries of Adverse Events and Deaths
Treatment-emergent AEs will be summarized based on the Safety Analysis Set.


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7.2.6.1.
Summaries of TEAEs
A brief, high-level summary of AEs will be provided by treatment group and by the number and 
percentage of patients who experienced:
•
Any TEAE
•
Any Grade ≥ 3 TEAE 
•
Any Grade 5 TEAE
•
Serious TEAE
•
TEAE leading to discontinuation of any study treatment, by magrolimab, rituximab, 
gemcitabine, and oxaliplatin, as applicable, and any study drug
•
Any TEAE of special interest
•
Any TEAE of other important safety topics
•
Any Grade ≥ 3 TEAE related to any study treatment 
•
Any Grade 5 TEAE related to any study treatment
•
Any TEAE related to any study treatment leading to discontinuation of study by magrolimab, 
rituximab, gemcitabine, and oxaliplatin, as applicable, or any study drug 
The high-level summary will be repeated analyzing AEs by dose level as follows:
•
Phase 1b + 2, Antibody Combination
Magro 10 mg/kg + Ritux
Magro 20 mg/kg + Ritux
Magro 30 mg/kg + Ritux
Magro 45 mg/kg + Ritux
•
Phase 1b, Chemotherapy Combination
Magro 30 mg/kg + R-GemOx
Magro 45 mg/kg + R-GemOx


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The number and percentage of patients who experienced at least 1 TEAE will be provided and 
summarized by SOC, PT, and severity where applicable within each treatment combination for 
the AE categories below: 
•
TEAEs
•
TEAEs related to magrolimab
•
TEAEs leading to death 
•
Treatment-emergent SAEs 
•
Treatment-emergent SAEs related to magrolimab
•
TEAEs leading to magrolimab discontinuation 
•
TEAEs leading to magrolimab infusion interruption 
•
TEAEs leading to magrolimab dose delay or dose reduction 
•
Grade 3 or higher TEAEs by SOC, PT, and severity
The number and percentage of patients who experienced at least 1 TEAE will be provided and 
summarized by PT and severity in descending order of total frequency:
•
TEAEs by PT and severity
For the AE categories described below, summaries will be provided by PT in descending order 
of total frequency:
•
TEAEs 
•
Grade 3 or higher TEAEs 
•
TEAEs leading to death
•
Treatment-emergent SAEs 
Multiple events will be counted only once per patient 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. All AE summaries will be based on TEAEs. For summaries by 
severity, the most severe severity will be used for those AEs that occurred more than once in a 
given patient during the study.


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In addition, data listings will be provided for the following:
•
All AEs, indicating whether the event is treatment emergent
•
Treatment-emergent SAEs
•
Adverse events leading to death
7.2.6.2.
Summary of Deaths
A summary (number and percentage of patients) of deaths will be provided by treatment group. 
The summary will include the following categories:
•
All deaths
•
Deaths within 30 days of the last dosing of any study drug
•
Deaths beyond 30 days of the last dosing of any study drug
Every 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.
A listing for deaths will also be provided.
7.2.7.
Additional Analysis of Adverse Events
7.2.7.1.
Treatment-Emergent Adverse Events (TEAEs) of Special Interest
A brief, high-level summary of the number and percentage of patients who experienced at least 1 
TEAEs of special interest will be provided by treatment cohort and category. A similar summary 
will be provided for other important safety topics.
•
Any TEAE
•
Any Grade ≥ 3 TEAE 
•
Any Grade 5 TEAE
•
TEAEs related to any study treatment, and magrolimab
•
Any Grade ≥ 3 TEAE related to any study treatment, and magrolimab
•
Any Grade 5 TEAE related to any study treatment, and magrolimab
•
TEAE leading to discontinuation of any study treatment, and magrolimab


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Number and percentage of subjects with the following AEs of special interest will be 
summarized by category and PT: 
•
Anaemia (MST Anemia Extravascular Transient Hemolysis)
•
Infusion Related Reaction (IRR) (SMQ-Hypersensitivity Narrow Terms) + within one day of 
latest infusion
•
Severe Neutropenia (PT-Neutrophil Count Decreased, Neutropenia and Febrile Neutropenia 
with Grade 3 or Higher)
•
Serious Infection (SOC-Infections and infectations with Serious AE)
•
Transfusion reactions due to magrolimab interference with RBC typing (Gilead’s MST)
•
Thromboembolic Events (SMQ-Embolic and Thrombotic Events Broad Terms)
•
Pneumonitis (SMQ-Interstitial Lung Disease Broad Terms)
7.2.7.2.
Other Important Safety Topics
Number and percentage of subjects with the following AEs of important safety topics will be 
summarized by category PT: 
•
Immune-Mediated Events (SMQ-Immune-mediate and autoimmune disorder Narrow Terms)
•
Hemorrhages (SMQ-Haemorrhages Broad Terms)
7.2.7.3.
Regrouped AE Terms
For the regrouped AE preferred terms described below, a brief, high-level summary will be 
provided by treatment cohort: 
•
Regrouped Anaemia and Haemoglobin Decreased
•
Regrouped Neutropenia and Neutrophil Count Decreased
•
Regrouped Thrombocytopenia and Platelet Count Decreased
7.3.
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 patients who have permanently discontinued study drug or the initiation of the subsequent 
line of anticancer therapy, whichever is earlier, or all available data at the time of the database 
snapshot for patients who were ongoing at the time of an interim analysis. The analysis will be 


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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.
7.3.1.
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. Local labs will be graded 
based on the central lab normal ranges with in-house macro. In the event that both central and 
local lab results are collected in the clinical database, the worst toxicity grade will be used for the 
summary of lab toxicities.
7.3.1.1.
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 patients who permanently discontinued study drug or the 
initiation of the subsequent line of anticancer therapy, whichever is earlier, or the last available 
date in the database snapshot for patients who were still on treatment at the time of the final 
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.
7.3.1.2.
Summaries of Laboratory Abnormalities
All laboratory parameters for serum chemistry and hematology will be summarized. The number 
and percentage of patients for laboratory abnormalities will be provided by laboratory test and 
dose level within each phase and treatment combination for the worst treatment-emergent 
laboratory abnormalities postbaseline grade. Shift tables will also be provided to assess changes 
in severity grade from baseline to the worst treatment-emergent laboratory abnormalities 
postbaseline grade. The summaries will use the number of patients in the Safety Analysis Set as 
the denominator.
A listing of grade 3 or 4 treatment-emergent laboratory abnormalities for hematology and 
chemistry will be provided.
7.4.
Body Weight and Vital Signs
No summary or listing of vital signs will be provided for synoptic CSR. Body weight is 
summarized in baseline characteristics in Section 5.1.
7.5.
Pre, Prior, and Concomitant Medications
Medications collected at screening and during the study will be coded using the current version 
of the World Health Organization (WHO) Drug dictionary.


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7.5.1.
Pre Medications
Premedications are defined as any medications taken before a patient took the first two doses of 
magrolimab (including the priming dose), as record on the Pre-Medications eCRF form.
The optimal pretreatment regimen is defined as acetaminophen/paracetamol plus an 
antihistamine (i.e., oral acetaminophen 650 mg to 1000 mg (4 g/day maximum dose) and oral of 
IV diphenhydramine 25 to 50 mg or comparable regimen) plus IV dexamethasone 4 to 20 mg, or 
comparable regimen. 
Premedication is required before administration of the first two doses of magrolimab.
•
Premedication is also required for the repriming dose and the first maintenance dose.
•
Premedication for subsequent magrolimab treatments may be continued based on the treating 
physician’s clinical judgement and the presence/severity of prior infusion reactions where 
allowed 
No summary of premedications will be provided. All the premidications will be provided in a by-
subject listing sorted by subject ID number and start date in chronological order.
7.5.2.
Prior Medications
Prior medications are defined as any medications taken before a subject took the first study drug.
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 category 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.
No summary of prior medications will not be provided. 
7.5.3.
Concomitant Medications
Concomitant medications are defined as medications taken while a patient took study drug. 
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 concomitant medication. 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 category. 


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No summary of concomitant medications will be provided. All prior and concomitant 
medications (other than per-protocol study drugs) will be provided in a by-patient listing sorted 
by patient ID number and administration date in chronological order. A listing of transfusions 
will also be provided.
7.6.
Electrocardiogram Results
No rummary or listing of ECG assessment results will be provided.
7.7.
Other Safety Measures
A by-subject listing of pregnancy test will be provided.
7.8.
Changes From Protocol-Specified Safety Analyses
None.


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8.
PHARMACOKINETIC (PK) AND IMMUNOGENICITY 
ANALYSES
PK and immunogenicity analyses were performed separately and are not described in this SAP.


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9. 
BIOMARKER ANALYSIS 
. Additional details will be provided separately 
by the biomarker sciences group. 
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10.
REFERENCES
Cheson BD, Ansell S, Schwartz L, Gordon LI, Advani R, Jacene HA, et al. Refinement of the 
Lugano Classification lymphoma response criteria in the era of 
immunomodulatory therapy. Blood 2016;128 (21):2489-96.
Cheson BD, Fisher RI, Barrington SF, Cavalli F, Schwartz LH, Zucca E, et al. 
Recommendations For Initial Evaluation, Staging, and Response Assessment Of 
Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification. J Clin Oncol 
2014;32 (27):3059-68.
Mounier N, El Gnaoui T, Tilly H, Canioni D, Sebban C, Casasnovas RO, et al. Rituximab plus 
gemcitabine and oxaliplatin in patients with refractory/relapsed diffuse large 
B-cell lymphoma who are not candidates for high-dose therapy. A phase II 
Lymphoma Study Association trial. Haematologica 2013;98 (11):1726-31.
Swerdlow SH, Campo E, Pileri SA, Harris NL, Stein H, Siebert R, et al. The 2016 revision of the 
World Health Organization classification of lymphoid neoplasms. Blood 
2016;127 (20):2375-90.


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


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12.
APPENDIX
Appendix 1.
Determining Missing and Virtual Visits Due To Covid-19
This appendix describes the clinical trial site collection of COVID-19 data pertaining to 
missed/virtual visits and the data processing algorithm used to determine which visits were 
missing and which visits were virtual.
Data collection
A COVID-19 supplement to the eCRF Completion Guidelines (CCG) was provided by data 
management to instruct clinical trial sites with respect to data entry expectations pertaining to 
scenarios related to the COVID-19 pandemic. If a visit was missed, sites should enter “Visit 
missed due to COVID-19.” If an in-person visit was conducted virtually, sites should enter 
“Virtual visit due to COVID-19.” 
Determination of Missed and Virtual visits
Natural Language Processing (NLP) was used to search the CRF comment fields to identify 
instances of “COVID-19” (or synonyms, see Appendix Table 1) and “Virtual” (or synonyms, see 
Appendix Table 1). The search terms are maintained in a global lookup table and can be 
modified to tune the NLP model. For any comments with COVID-19 search terms, assign 
“Missed visit” or “Virtual visit as follows:
1) If COVID-19 terms are identified through NLP and the visit date is missing, then result is 
”Missed Visit”
2) If COVID-19 and Virtual terms are identified through NLP for a visit, then result is “Virtual 
Visit”. When there are multiple records for the same subject and the same visit, NLP will be 
based on multiple records to ensure 1 unique category per subject per visit
3) Otherwise result is missing
Appendix Table 1.
Examples of search terms for “COVID-19” and “Virtual” used to 
identify missed and virtual visits.
Search terms for “COVID-19”
Search terms for “Virtual”
COVID19
CORONA
CORONAVIRUS
PANDEMIC
OUTBREAK
CRISIS
LOCKDOWN
QUARANTINE
SHELTER
VIRTUAL
TELEMED
TELEHEALTH
TELEPHONE
REMOTE
TELEMEDICINE 
TELECONSULTATION
TELEPHONICALLY
PHONE
HOME VISIT
ZOOM
SKYPE


5F9003-Final-SAP-v1.0
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Server Date
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PPD
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