A Phase 1, Non-Randomized, Open-Label/Phase 2, Randomized, Blinded Study of ProTmune™ (ex Vivo Programmed Mobilized Peripheral Blood Cells) Versus Non-Programmed Mobilized Peripheral Blood Cells for Allogeneic Hematopoietic Cell Transplantation in Adult Subjects With Hematologic Malignancies
Phase: PHASE1
Conditions: Hematologic Malignancies, Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndromes, Chronic Myelogenous Leukemia, Acute Graft-versus-host Disease
Sponsor: Fate Therapeutics

 
 
CLINICAL STUDY PROTOCOL 
 
PROTECT: A Phase 1, Non-Randomized, Open-Label/Phase 2, 
Randomized, Blinded Study of ProTmune™ (ex vivo Programmed 
Mobilized Peripheral Blood Cells) Versus Non-Programmed 
Mobilized Peripheral Blood Cells for Allogeneic Hematopoietic Cell 
Transplantation in Adult Subjects with Hematologic Malignancies 
 
Investigational Product: ProTmune 
Protocol Number: PT-001 
 
 
Sponsor: 
Fate Therapeutics, Inc. 
3535 General Atomics Court, Suite 200  
San Diego, CA 92121 
Telephone: 858-875-1800 
Facsimile: 858-875-1843 
 
 
Version Number: 6.0 
Date: 29 March 2019 
 
 
 
Confidentiality Statement 
The information in this document is confidential and is not to be disclosed without the written 
consent of Fate Therapeutics, Inc. except to the extent that disclosure would be required by law 
and for the purpose of evaluating and/or conducting a clinical study for Fate Therapeutics, Inc. 
You are allowed to disclose the contents of this document only to your Institutional Review 
Board (IRB) or Independent Ethics Committee (IEC) and study personnel directly involved with 
conducting this protocol. Persons to whom the information is disclosed must be informed that the 
information is confidential and proprietary to Fate Therapeutics, Inc. and that it may not be 
further disclosed to third parties. 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
CLINICAL PROTOCOL APPROVAL FORM 
STUDY TITLE: 
A Phase 1, Non-Randomized, Open-Label/Phase 2, Randomized, Blinded Study of 
ProTmune™ (ex vivo Programmed Mobilized Peripheral Blood Cells) Versus 
Non-Programmed Mobilized Peripheral Blood Cells for Allogeneic Hematopoietic Cell 
Transplantation in Adult Subjects with Hematologic Malignancies 
This study protocol was subject to Sponsor review and approval. The information contained in 
this protocol is consistent with: 
• 
The current risk-benefit evaluation of the investigational medicinal product. 
• 
The moral, ethical and scientific principles governing clinical research as set out in the 
Declaration of Helsinki, and principles of GCP as described in 21 CFR parts 50, 54, 56,312 
and ICH E6(R) and according to applicable local requirements. 
The Investigator will be supplied with details of any significant or new findings related to 
treatment with the investigational medicinal product. 
Name and Title 
Peter Langecker, MD, PhD 
Executive Medical Director, 
Oncolo 
Confidential & Proprietary 
Version 6.0, 29 March 2019 
Date 
2 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
3 
INVESTIGATOR AGREEMENT 
By signing below I agree that: 
I have read this protocol. I approve this document and I agree that it contains all necessary details 
for carrying out the study as described. I will conduct this study in accordance with the design and 
specific provision of this protocol and will make a reasonable effort to complete the study within 
the time designated. I will provide copies of this protocol and access to all information furnished 
by Fate Therapeutics, Inc. (henceforth referred to as Fate) to study personnel under my supervision. 
I will discuss this material with them to ensure they are fully informed about the investigational 
product and study procedures. I will let them know that this information is confidential and 
proprietary to Fate and that it may not be further disclosed to third parties. I understand that the 
study may be terminated or enrollment suspended at any time by Fate, with or without cause, or 
by me if it becomes necessary to protect the best interests of the study subjects. 
I agree to conduct this study in full accordance with Food and Drug Administration Regulations, 
IRB/IEC Regulations and International Conference on Harmonisation Guidelines for Good 
Clinical Practices. 
 
 
 
 
 
 
______________________________________________  
____________________ 
Investigator’s Signature 
 
 
 
 
 
Date 
 
 
 
______________________________________________ 
Investigator’s Printed Name 
 
  
 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
4 
SYNOPSIS 
TITLE:  A Phase 1, Non-Randomized, Open-Label/Phase 2, Randomized, Blinded Study of 
ProTmune™ (ex vivo Programmed Mobilized Peripheral Blood Cells) Versus Non-Programmed 
Mobilized Peripheral Blood Cells for Allogeneic Hematopoietic Cell Transplantation in Adult 
Subjects with Hematologic Malignancies 
PROTOCOL NUMBER:  PT-001 
INVESTIGATIONAL PRODUCT:  ProTmune 
PHASE:  Phase 1/2 
INDICATION(S): Reduction of incidence and severity of acute graft-versus-host disease 
(aGvHD)  
OBJECTIVES: 
Phase 1 Part of the Study: 
Primary Objective: 
The primary objective of the Phase 1 part of the study is to evaluate the safety and tolerability of 
ProTmune ex vivo programmed mobilized peripheral blood (mPB) cells for hematopoietic cell 
transplantation (HCT) in adult subjects with hematologic malignancies.  
Secondary Objective: 
The secondary objective of the Phase 1 part of the study is to assess the efficacy of ProTmune 
ex vivo programmed mPB cells for HCT in adult subjects with hematologic malignancies. 
Phase 2 Part of the Study: 
Primary Objective: 
The primary objective of the Phase 2 part of the study is to assess the efficacy of ProTmune ex vivo 
programmed mPB cells for HCT in adult subjects with hematologic malignancies. 
Secondary Objective:  
The secondary objective of the Phase 2 part of the study is to further evaluate the safety and 
tolerability of ProTmune ex vivo programmed mPB cells for HCT in adult subjects with 
hematologic malignancies. 
Exploratory Objectives: 
The exploratory objectives for the Phase 2 part of the study may include the following: 
• To assess the incidence of neutrophil and platelet engraftment; 
• To assess the time to neutrophil and platelet engraftment;  
• To assess the cumulative incidence of aGvHD; 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
5 
• To assess the incidence of, and time to, CMV viremia, incidence and severity of CMV invasive 
disease, and incidence of CMV reactivation; 
• To assess time to first CMV-specific anti-viral therapy (AVT); 
• To assess the incidence of confirmed bacterial, fungal, viral, and parasitic infections; 
• To assess the time to first use of an agent to treat an infection other than CMV as clinically 
indicated; 
• To assess the time to first use of steroids to treat aGvHD;  
• To assess the time to escalation of treatment to first use of second line therapies for treatment 
of aGvHD; 
• To assess first episode, incidence, and duration of fever; 
• To assess biomarkers for aGvHD development; 
• To assess incidence and maximum severity of chronic graft-versus-host disease (cGvHD);  
• To assess cumulative incidence of primary and secondary graft failure;  
• To assess neutrophil and T-cell chimerism; 
• To determine relapse-free survival; 
• To determine the incidence of non-relapse mortality (NRM); 
• To determine survival at one-year and at two-years; and 
• To assess immune reconstitution (including B, T, dendritic, and natural killer [NK] cells). 
POPULATION: 
Inclusion Criteria for Phase 1 Part of the Study and Phase 2 Part of the Study: 
Subjects who meet all of the following criteria will be eligible to participate in the study: 
1. Male and female subjects aged 18 years and older;  
2. Subjects must have a hematologic malignancy for which allogeneic hematopoietic peripheral 
blood cell transplantation is deemed clinically appropriate. Eligible diseases and stages include 
and are limited to the following:  
• Acute myeloid leukemia in first complete remission (CR) (CR1) or second CR (CR2): 
o CR is defined as ≤5% bone marrow (BM) blasts with no morphological characteristics 
of acute leukemia (e.g., Auer Rods) in BM with ≥5% cellularity with normal peripheral 
blood counts; or 
o Morphologic CR (≤5% BM blasts) with incomplete blood count recovery; 
• Acute lymphoblastic leukemia (ALL), including T lymphoblastic lymphoma with a history 
of marrow involvement in CR1 or CR2: 
o CR is defined as ≤5% blasts with no morphological characteristics of acute leukemia 
in a BM with ≥5% cellularity; 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
6 
• Myelodysplastic syndrome (MDS); or 
• Chronic myelogenous leukemia (CML);   
3. Availability of a suitable 8/8 human leukocyte antigen (HLA)-A, -B, -C, and -DRB1-matched 
unrelated mPB donor; 
4. Subjects must have an mPB donor collection unit without using plerixafor (Mozobil™) that is 
≥5 × 106 CD34+ cells/kg in Phase 1 and ≥3 × 106 CD34+ cells/kg in Phase 2; 
5. Adequate performance status, defined as Karnofsky score ≥70%;  
6. For female subjects of childbearing potential, all of the following criteria must be met: 
• They are not pregnant (i.e., female subjects must have a negative serum pregnancy test at 
screening);  
• They are not breastfeeding;  
• They do not plan to become pregnant during the study; and 
• They are using an effective method of contraception from screening to the end of the study, 
unless their sexual partner is surgically sterile. Effective methods of preventing pregnancy 
are those contraceptive methods with a Pearl index of <1 used consistently and correctly 
(including, but not limited to, implantable contraceptives, injectable contraceptives, oral 
contraceptives, and transdermal contraceptives). 
Women are not considered to be of childbearing potential if they meet 1 of the following 
2 criteria, as documented by the Investigator: 
• They have had a hysterectomy, bilateral salpingectomy, or bilateral oophorectomy at 
minimum 1 menstrual cycle prior to signing the informed consent form (ICF); or 
• They are post-menopausal, defined as ≥1 year since their last menstrual period for women 
≥55 years of age or ≥1 year since their last menstrual period; 
7. For male subjects, agreement to use condoms with spermicide during sexual intercourse from 
screening to the end of study; and 
8. Willingness and ability to sign an Investigational Review Board/Ethics Committee-approved 
ICF before performance of any study specific procedures or tests and to comply with protocol 
visits, and study procedures. 
Exclusion Criteria for Phase 1 Part of the Study and Phase 2 Part of the Study: 
Subjects who meet any of the following criteria will be excluded from participation in the study:  
1. Phase 1 only: Known bone marrow fibrosis; Phase 2 only: Bone marrow fibrosis grade 3 
(severe) or greater; 
2. Positive serology for human immunodeficiency virus or human T-cell lymphotropic virus at 
any time prior to enrollment;  
3. Current uncontrolled bacterial, viral, or fungal infection (progression of clinical symptoms 
despite therapy);  
4. Prior autologous or allogeneic HCT; 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
7 
5. Active malignancy, other than the one for which the allogeneic mPB transplant is being 
performed, within 12 months of enrollment, excluding superficial basal cell and carcinoma in 
situ cervical cancer;  
6. Pulmonary disease such as symptomatic chronic obstructive lung disease, symptomatic 
restrictive lung disease, or FVC and FEV1 <50%, or hemoglobin corrected diffusing capacity 
of the lung of <50% of predicted value;  
7. Renal dysfunction defined as a calculated creatinine clearance <40 mL/min (Cockcroft-Gault 
equation);  
8. Hepatic disease defined as total serum bilirubin >2.0 mg/dL (except in the case of Gilbert’s 
syndrome or ongoing hemolytic anemia), or aspartate aminotransferase or alanine 
aminotransferase >2.0 × the upper limit of normal;  
9. Cardiac disease defined as symptomatic congestive heart failure (New York Heart Association 
[NYHA] Class III/IV) or evidence of left ventricular dysfunction (ejection fraction <45%) as 
measured by gated radionuclide ventriculogram or echocardiogram (ECHO); active angina 
pectoris or uncontrolled hypertension; or history of myocardial infarction with depressed 
ejection fraction;  
10. Neurologic disease, defined as symptomatic leukoencephalopathy, active central nervous 
system malignancy, or other neuropsychiatric abnormalities believed to preclude 
transplantation;  
11. Participation in another clinical trial involving an investigational product within 30 days prior 
to transplant; or 
12. Any condition or therapy, which, in the opinion of the Investigator, might pose a risk to the 
subject or make participation in the study not in the best interest of the subject (e.g., known 
allergy to human serum albumin [HSA]). 
STUDY DESIGN AND DURATION: 
This is a Phase 1, non-randomized, open-label/Phase 2, randomized, blinded, multi-center study 
of ProTmune ex vivo programmed mPB versus non-programmed mPB for allogeneic HCT in adult 
subjects with hematologic malignancies in the United States. All subjects in Phases 1 and 2 will 
receive a conditioning regimen comprising 1 of the following 5 preparative regimens: fludarabine 
and busulfan (FluBu4); busulfan (Bu) and cyclophosphamide (Cy); Cy and ≥12 Gy total body 
irradiation (TBI); TBI and etoposide; or fludarabine and melphalan (FluMel 140). 
The Phase 1 part of the study is a non-randomized, open-label, single-arm study that will treat 6 to 
10 subjects who have an available 8/8 HLA-A, -B, -C, and -DRB1-matched unrelated peripheral 
blood cell donor. All eligible subjects enrolled in the Phase 1 part of the study will receive 1 unit 
of ProTmune ex vivo programmed mPB cells as the cell source for the HCT.  
The Phase 2 part of the study is a randomized, blinded, 2-arm study that will treat approximately 
80 subjects who have an available 8/8 HLA-A, -B, -C, and -DRB1-matched unrelated peripheral 
blood cell donor. After meeting eligibility, approximately 90 subjects (assuming a dropout rate of 
approximately 15% prior to treatment) will be randomly assigned in a 1:1 ratio to receive either 
unmanipulated mPB cells (control arm) or ProTmune ex vivo programmed mPB cells 
(experimental arm) and stratified by the subjects' CMV status (+/-).  

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
8 
At initiation of the Phase 1 part of the study, 3 subjects will be enrolled and treated. At the time a 
subject engrafts (or fails to engraft by Day +28), a new subject may be treated. If 2 or more 
subjects fail to engraft by Day +28, or if 2 or more subjects experience secondary graft failure by 
Day +28, or if 2 of the first 3 or 4 of the first 6 subjects treated have died by ≤Day +28, subject 
treatment will be stopped until the Independent Data Monitoring Committee (IDMC) has assessed 
the cases and discussed with the Sponsor. The IDMC will be notified of all subject deaths 
occurring on study. If the investigational product does not meet release specifications to treat 2 of 
the first 3 subjects, 3 of the first 6 subjects, or 5 of the first 10 subjects in the Phase 1 part of the 
study, subject treatment will be stopped. 
If after 6 subjects have been dosed and evaluated for up to 28 days and ≤1 subject has not engrafted 
by Day +28, then enrollment in the Phase 2 portion of the study may proceed following IDMC 
review. 
Both the Phase 1 part of the study and Phase 2 part of the study will include a Screening Period 
(Day -53 through Day -11), Subject Conditioning Period (Day -10 through Day -1), Study 
Treatment Administration Day (Day 0; Day of HCT), Post-Transplant Follow-up Period (Day +1 
through Day +730, consisting of Post-Transplant Assessment Days and Post-Transplant Weekly 
Assessments, then intermittent assessments), and an Early Withdrawal Visit (if applicable). The 
total duration of subject participation will be up to 26 months for each subject in the Phase 1 part 
of the study and Phase 2 part of the study.  
The end of the study is considered as the completion through Day +365. All treated subjects will 
be followed for survival through Day +730 (i.e., 2 years).   
The study will utilize an Endpoint Adjudication Committee (EAC) blinded to treatment. The EAC 
will be responsible for adjudicating the aGvHD endpoint. Adjudication of the aGvHD endpoint 
will be in accordance with the EAC charter. 
During the Phase 1 part of the study, an IDMC will convene to assess safety data as outlined in 
the IDMC Charter. At that time, the Sponsor, in consultation with and based on recommendations 
from the IDMC, will decide whether the study should stop or whether the Phase 2 study can begin. 
During the Phase 2 part of the study, the IDMC will convene according to the guidelines outlined 
in the IDMC Charter. Additional safety monitoring based on NRM, secondary graft failure, and 
IDMC input will be applied during the study for the Phase 1 and Phase 2 parts of the study. 
With the exception of the stopping rules associated with the failure of ProTmune to meet release 
specifications, there are no formal stopping rules for the Phase 2 part of the study.  Stopping 
subject treatment may be triggered based on the continued review of subject safety data on study 
by the Sponsor and IDMC. If the investigational product does not meet release specifications for 
2 of the first 3 subjects, 3 of the first 6 subjects, or 5 of the first 10 subjects or 10 of the first 20 
subjects, subject treatment in the Phase 2 part of the study will be stopped, pending review by the 
IDMC. 
Screening Period (Day -53 to Day -11) for the Phase 1 and Phase 2 Parts of the Study: 
The Screening Period will occur between Day -53 and Day -11 (i.e., up to 6 weeks prior to the 
Subject Conditioning Period). At Screening, all subjects will review and sign an ICF and eligibility 
for study participation will be assessed. The Investigator will be required to verify that the subject 
completed HLA typing. Human leukocyte antigen typing can be completed prior to the Screening 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
9 
Period. Peripheral blood will be collected during the Screening Period to serve as a baseline 
sample for immune reconstitution analysis. 
The results of the bone marrow aspirate, spirometry, and ECHO or multiple gated acquisition 
(MUGA) performed prior to consent may be used for subject qualification as long as performed 
within 6 weeks prior to the Subject Conditioning Period, from Day -53 to Day -11.  
As a part of screening, all subjects will be tested for baseline CMV antibody titer and plasma CMV 
viremia. This baseline testing will be performed by a central laboratory and results will be 
provided to the clinical site and sponsor before initiation of randomization. 
Subject Conditioning Period (Day -10 to Day -1) for the Phase 1 and Phase 2 Parts of the Study: 
The Subject Conditioning Period will occur between Day -10 and Day -1. Day 0 is the day of mPB 
HCT transplant. Conditioning will include one of the following 5 preparative regimens: 
• CyTBI, with ≥12 Gy fractionated TBI; 
• BuCy where Bu = 16 mg/kg orally (PO) or 12.8 mg/kg intravenous (IV) infusion 
(alternatively, pharmacokinetic assessment and dose adjustment of busulfan can be based on 
a test dose or the first dose and will be conducted according to institutional practices); 
• FluBu4 with Bu as above;  
• TBI and etoposide; or 
• FluMel 140 
Filgrastim (granulocyte-colony stimulating factor) can be administered at 5 µg/kg/day beginning 
on Day +12, if ANC<500 cells/µL, until the ANC is >500 cells/µL. At Investigator discretion, 
filgrastim can be administered longer to support the white blood cells. Similarly, per Investigator 
discretion, filgrastim may be started before Day +12 if subsequent doses of methotrexate will not 
be administered due to severe mucositis, other toxicity, or severe infection. 
Graft-versus-host disease prophylaxis will be administered to all subjects. 
The GvHD prophylaxis regimen: 
• Methotrexate (15 mg/m2 IV infusion on Day +1 after hematopoietic cell infusion and 
10 mg/m2 on Days +3, +6, and +11), and 
• Tacrolimus (0.02 mg/kg every 24 hours as an IV infusion or 0.03 mg/kg PO beginning on Day 
-2, adjusted to target dose level of 5 to 15 ng/mL. Taper starting at Day +100).  
The GvHD prophylaxis dose may be reduced based on clinical judgment associated with toxicity. 
All chemotherapy administered to subjects will be dosed based on the subject’s actual body 
weight. However, for subjects weighing more than 125% of their ideal body weight, chemotherapy 
will be dosed based on the adjusted ideal body weight, or by Institutional Standards. 
Anti-thymocyte globulin is not permitted during the study.  
FDA-approved prophylactic therapies for CMV prevention (e.g., letermovir) will be permitted. 
Pre-emptive CMV therapy may be provided based upon institutional methodologies, Standard 
Operating Procedures, and clinical context. An additional blood sample for CMV testing will be 
collected prior to starting the preemptive therapy and sent for central laboratory testing.  

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
10 
Other procedures for transplant preparation will also be performed at the Subject Conditioning 
Visit and per Institutional Standard. 
Hospital Admission (as per Institution Policy) for the Phase 1 and Phase 2 Parts of the Study: 
Subjects will be admitted to the hospital based on institutional policy.  
Study Treatment Administration (Day 0; Day of Hematopoietic Cell Transplantation) for the 
Phase 1 and Phase 2 Parts of the Study: 
A 12-lead triplicate electrocardiogram (ECG) (sequential, within 15 minutes total), complete 
blood count (CBC), and blood chemistry will be obtained on Day 0 prior to HCT. All eligible 
subjects will receive study treatment on the day of HCT (Day 0). For the Phase 1 part of the study, 
study treatment will consist of a single unit of ProTmune ex vivo programmed mPB cells. For the 
Phase 2 part of the study, study treatment will consist of either a single unit of ProTmune ex vivo 
programmed mPB cells or a single unit of unmanipulated mPB cells, based upon the subject’s 
randomized treatment allocation. The ProTmune graft will be prepared the same day as 
administration.  
Karnofsky Performance Status will be assessed at Day 0, following transplantation. 
Post-Transplant Assessment Days for the Phase 1 and Phase 2 Parts of the Study: 
Post-transplant visit windows are as follows: ±3 days for Day +7 through Day +100; ±14 days for 
Day +180; and ±28 days for Days +270, +365, and +730. Standard post-transplant testing will be 
performed per institutional guidelines and good clinical practice. 
The Day +730 visit will occur by conducting a telephone contact report for capture of survival 
status and adverse event reporting.  
Post-Transplant Weekly Visits for the Phase 1 and Phase 2 Parts of the Study: 
Clinical and laboratory assessments of aGvHD will be performed weekly from Day +1 through 
Day +100, and on Day +180. Acute GvHD assessments (incidence and maximum severity) of 
Grades I through IV of the skin, liver, and gut as per the CIBMTR aGvHD Grading Scale will be 
performed. 
Chronic GvHD assessments (incidence and maximum severity) of mild, moderate, or severe 
cGvHD as per National Institutes of Health (NIH) Consensus Criteria for cGvHD must be 
performed on Days +180, +270, and +365. 
Peripheral blood samples will be collected for CMV assessments of deoxyribonucleic acid by 
quantitative polymerase chain reaction (PCR) weekly from Day +7 through Day +100, and on 
Days +180, +270, and +365. Assessment of infection will be performed based on the NCI CTCAE 
and the Blood and Marrow Transplant Clinical Trials Network (BMT CTN) definitions. 
Peripheral blood will be collected for safety laboratory panels (hematology and serum chemistry), 
viral monitoring, immune reconstitution, chimerism, serum immunoglobulins, and GvHD 
exploratory biomarkers at the pre-specified time points. 
A 12-lead triplicate ECG (sequential, within 15 minutes total) will be obtained at Day +100. 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
11 
Bone marrow aspirate will be sent to pathology and to cytogenetics on Day +21 (only if absolute 
neutrophil count [ANC] <500/µL), and as clinically indicated (flow cytometry is required on BM 
aspirate). 
Karnofsky Performance Status will be assessed at all subsequent study visits after HCT up through 
Day +365 (which should include weekly assessments from Day +1 through Day +91, then on 
Days +100, +180, +270, and +365).  
The Day +730 visit will occur by conducting a telephone contact report for capture of survival 
status and adverse event reporting.  
Unscheduled visits 
An unscheduled visit is a visit that occurs in addition to the predefined protocol specific visit 
calendar. If an unscheduled visit occurs for a given subject, the visit must be documented on the 
Unscheduled Visit electronic case report form. 
Early Withdrawal Visit for the Phase 1 and Phase 2 Parts of the Study: 
If a subject is withdrawn from participation in the study prior to Day 0, the subject’s mPB will not 
be processed to a unit of ProTmune ex vivo programmed mPB cells, the subject will not be 
considered evaluable for any study-related endpoint analyses, and a new subject will be added for 
the Phase 1 portion of the study. If this occurs in the Phase 2 portion of the study, the subject will 
be replaced and a new subject will be randomized in order to have approximately 80 treated 
subjects.  
If a subject withdraws from the study after transplantation, information regarding secondary graft 
failure, disease relapse, serious adverse events involving GvHD and infections, and survival 
outcomes will be collected by phone on Days +180, +365, and +730. If a subject withdraws 
consent, survival outcomes will be assessed via public record search. 
If the subject relapses and/or receives a protocol-prohibited therapy, the subject will be withdrawn. 
However, survival will still be collected at Day +730 by telephone contact unless the subject 
withdraws consent, in which case survival outcomes will be assessed via public record search. 
A peripheral blood sample for safety laboratory panels (hematology and serum chemistry) will be 
collected.  
Karnofsky Performance Status should be assessed, and GvHD assessments must be performed, as 
applicable. 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
12 
Adverse Events 
Adverse events will be collected during Phase 1 and 2 as per the Common Terminology Criteria 
for Adverse Events (CTCAE) version 4.0, AE of infections will use both the CTCAE and the 
Blood and Marrow Transplant Clinical Trials Network (BMT CTN, Appendix G) criteria, as 
follows: 
• All serious adverse events (SAEs) will be recorded from Day -10 through Day +365, and only 
SAEs related to infused cells (ProTmune ex vivo programmed mPB cells or Control mPB cells) 
from Day +366 through Day +730; 
• Start of conditioning regimen (Day -10) through Day +100: Adverse events associated with 
infusion reactions, GvHD, infections, or engraftment failure (Grades 1 through 5). All other 
adverse events (Grades 2 through 5). Laboratory abnormalities will only be recorded as 
adverse events if deemed clinically significant by the Investigator; 
• From Day +100 through Day +365: Only adverse events associated with GvHD, infections, or 
secondary engraftment failure (Grades 1 through 5); 
Concomitant Medications 
All concomitant medications will be recorded starting at Day -30 through Day +100. From 
Day +100 through Day +730, only concomitant medications given as TKI maintenance, or that 
were ongoing at the time of, and for the treatment of, an AE of GvHD, infection or secondary 
engraftment failure or any SAE, will be recorded. 
DOSAGE FORMS AND ROUTE OF ADMINISTRATION: 
ProTmune is a donor-sourced, patient-specific, allogeneic cell therapy product consisting of the 
cells contained within a human mobilized peripheral blood (mPB) collection that have been 
programmed through an ex vivo programming process using a combination of 2 small molecules, 
16,16-dimethyl prostaglandin E2 (FT1050) and dexamethasone (FT4145). The cell populations 
include hematopoietic cells and other cell types. The final ProTmune product is formulated in 
Plasmalyte-A (or equivalent) and human serum albumin (HSA). 
Mobilized peripheral blood cells will be obtained from a matched-unrelated donor for a given 
subject. An 8/8 high resolution allelic HLA-match of HLA-A, -B, -C, and -DRB1 with recipient 
is required. Sites will request that consenting donors be mobilized with filgrastim to achieve a 
target collected CD34+ dose of ≥7 × 106 CD34+ cells/kg in Phase 1 and ≥5 × 106 CD34+ cells/kg 
in Phase 2. However, if the donor mPB unit collected for a subject in Phase 1 is not 
≥5 × 106 CD34+ cells/kg recipient weight, and in Phase 2 is not ≥3 × 106 CD34+ cells/kg recipient 
weight, the mPB unit will not be processed for ProTmune manufacturing and the subject will be 
considered a screen failure. 
For subjects enrolled in the Phase 1 part of the study, a reserve dose of 2 × 106 CD34+ cells/kg 
recipient weight will be maintained during ProTmune manufacturing to serve as a reserve in the 
event ProTmune manufacturing produces a ProTmune unit that does not meet ProTmune release 
specifications (e.g., <2 × 106 CD34+ cells/kg recipient weight, <70% viable). In this case, the 
ProTmune unit will be considered “unavailable” and count towards the Phase 1 stopping rules. 
The reserve unit must be administered; however, the Principal Investigator should follow their 
Institution’s standard operating procedure to determine whether the ProTmune unit should also be 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
13 
given to the recipient based on the risk-benefit assessment of administering the product with regard 
to the specification not being met. If the ProTmune unit is not administered, the subject will be 
withdrawn from study and replaced. If the ProTmune unit is administered, the subject will remain 
in study but will not be considered in the following assessment - "If after 6 subjects have been 
dosed and evaluated for up to 28 days and ≤1 subject has not engrafted by Day +28, then 
enrollment in the Phase 2 portion of the study may proceed following IDMC review". If the reserve 
unit is not used on Day 0, it will be cryopreserved at the site and can be used in the event of 
non-engraftment, or delayed engraftment. 
For subjects enrolled in the Phase 2 part of the study in the event ProTmune manufacturing 
produces a ProTmune unit that does not meet ProTmune release specifications (e.g., 
<2 × 106 CD34+ cells/kg recipient weight, <70% viable), the ProTmune unit will be considered 
“unavailable” and count towards the Phase 2 stopping rules. The Principal Investigator should 
follow their Institution’s standard operating procedure to determine whether the unit should be 
given to the recipient based on the risk-benefit assessment of administering the product with regard 
to the specification not being met.  If the ProTmune unit is not administered, or a subject is 
withdrawn from participation in the study prior to Day 0 and the subject’s mPB is not processed 
to a unit of ProTmune, the subject will be replaced and a new subject will be randomized in order 
to have approximately 80 treated subjects. If the ProTmune unit is administered, the subject will 
remain in study. 
Fate has established specific criteria that will be used to assess the quality of all mPB units 
collected for ex vivo programming. 
The Cell Processing Facility (CPF) at each participating site will be qualified and trained by Fate 
technical staff to manufacture the investigational product on site via the performance of a single 
ProTmune qualification run. Additionally, Fate technical representative(s) will be on site for the 
manufacture of each CPF’s first or second subject treatments and subsequent subject treatments 
as necessary by the CPF or Fate. 
ProTmune or Control cells will be released immediately by the CPF staff after final processing, 
including filtration, final packaging, rapid release testing, and labeling. 
SAFETY ENDPOINTS: 
The safety endpoints for both the Phase 1 and Phase 2 parts of the study include the assessment of 
adverse events as defined in the NCI CTCAE version 4.0, vital signs, physical examination 
findings, engraftment, graft failure, chimerism, clinical laboratory assessments, and 
electrocardiographic data through a 12-lead ECG. 
EFFICACY ENDPOINTS:  
The primary efficacy endpoint for both the Phase 1 and Phase 2 parts of the study is the following: 
• Cumulative incidence of CIBMTR Grades II-IV aGvHD through Visit Day +100 based on 
investigator results. Death and relapse without CIBMTR Grades II-IV aGvHD will be 
considered competing risks.  
o Each study site will determine the presence or absence of aGvHD by assigning the clinical 
stage for the target organs of the skin, liver, and gut along with assigning an overall grade 
according to the CIBMTR aGvHD Grading Scale (Appendix E). 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
14 
The key secondary efficacy endpoint for both the Phase 1 and Phase 2 parts of the study is the 
following: 
• Proportion of subjects alive without relapse and without moderate or severe cGvHD per NIH 
Consensus Criteria at Visit Day +365. 
All summaries for acute and chronic GvHD will be based on the investigator assessment unless 
noted otherwise.  
The exploratory efficacy endpoints for both the Phase 1 and Phase 2 parts of the study are the 
following: 
• Cumulative incidence through Visit Day +100 and through Visit Day +180 of: 
o CIBMTR Grades III-IV aGvHD; 
o CIBMTR Grades I-II aGvHD;  
o CIBMTR Grades I-IV aGvHD;  
o Maximum CIBMTR Grades II-IV aGvHD;   
o Maximum CIBMTR Grades III-IV aGvHD; 
o Maximum CIBMTR Grades II-IV aGvHD based on EAC adjudicated results;  
o Maximum CIBMTR Grades III-IV aGvHD based on EAC adjudicated results;  
• Duration of the Maximum CIBMTR Grade aGvHD through Visit Day +100; 
• Duration of CIBMTR Grades II-IV aGvHD through Visit Day +100; 
• Duration of CIBMTR Grades III-IV aGvHD through Visit Day +100; 
• One-Year GvHD-Free, Relapse-Free Survival (GRFS), a composite endpoint in which events 
include Grade III-IV aGvHD, cGvHD-requiring systemic immunosuppressive therapy, 
relapse, or death from any cause (Holtan et al. 2015); 
• Time to individual event components for GRFS:  
o Time to CIBMTR Grades III-IV aGvHD; 
o Time to first use of cGvHD-requiring systemic immunosuppressive therapy; 
o Time to relapse; 
o Time to death; 
• One-Year cGvHD-Free, Relapse-Free Survival (CRFS), a composite endpoint in which events 
include any cGvHD-requiring systemic immunosuppressive therapy, relapse, or death from 
any cause (Pasquini et al. 2018); 
• Cumulative incidence of Non-relapse mortality (NRM).  All deaths in the absence of relapse 
of the primary malignancy will be considered NRM, where relapse will be considered a 
competing risk; 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
15 
• Moderate or severe cGvHD per NIH Consensus Criteria for the global severity score cGvHD 
through Visit Day +365.  Death and relapse without moderate or severe cGvHD will be 
considered competing risks; 
• Proportion of subjects with systemic steroid use for aGvHD; 
• Time to first use of systemic steroids for aGvHD;  
• Total number of days of systemic steroid use for aGvHD; 
• Proportion of subjects with second-line therapies for treatment of aGvHD; 
• Time to first use of second-line therapies for treatment of aGvHD;  
• Proportion of subjects who are CMV positive at baseline with subsequent CMV reactivation. 
CMV reactivation is defined as subjects who have initiated anti-viral therapy for CMV; 
• Time to first treatment for CMV reactivation;  
• Relapse-free survival (RFS); 
• One-year survival; 
• Two-year survival. 
Additional exploratory analyses may be performed as necessary. 
STATISTICAL ANALYSES: 
All reporting and analyses will be conducted at the end of the study, which is defined as the date 
when the last subject last visit occurs or the date at which the last data point is collected for the 
completion of 1-year on study (Day +365), whichever occurs later. Analysis of the 2-year survival 
follow-up will be conducted upon completion of the Day +730 follow-up. The initial clinical study 
report will be completed following final analysis of the 1-year data and will be appended to include 
the 2-year survival data upon completion. 
Continuous variables will be summarized by using the number of non-missing observations, 
arithmetic mean, standard deviation, median, minimum, and maximum values as descriptive 
statistics. Categorical variables will be summarized by using the frequency count and the 
percentage of subjects in each category as descriptive statistics. Time-to-event variables will be 
summarized using Kaplan-Meier methods; competing risk methods will be used in the presence 
of competing risk factors (e.g., death or relapse without aGvHD for evaluating aGvHD).  
Efficacy analyses will be performed based on the mITT Population. Additional sensitivity 
analyses will be performed based on the PP Population for the primary and key secondary efficacy 
endpoint for Phase 2. Efficacy data from the Phase 1 part of the study and Phase 2 part of the study 
will be summarized separately. Summary tables will present results for each phase by treatment 
group. The safety profile will be based on adverse events, vital signs, physical examinations, 
clinical laboratory assessments, engraftment, graft failure, chimerism, and ECGs. All safety 
analysis will be based on the Safety Population. 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
16 
SAMPLE SIZE DETERMINATION: 
The background cumulative incidence rate of International Bone Marrow Transplant Registry 
(IBMTR) Grades B-D aGvHD in this population is assumed to be between 40% and 60% as 
reported in the literature (Jagasia et al. 2012).   
Phase 1: Allowing for a dropout rate of approximately 15%, approximately 8-12 subjects will be 
enrolled to include 6-10 evaluable.  
Phase 2: When accounting for competing risk factors (death or relapse without aGvHD), a sample 
size of 80 subjects (40 subjects in each treatment group) allows for approximately 85% power to 
detect a reduction in the cumulative incidence rate of CIBMTR Grades II-IV aGvHD through Day 
+100 from 55% to 25% (i.e., a hazard ratio of 0.3464) in the Control versus ProTmune treatment 
arms using a two-sided log-rank test at a 0.05 significance level. This calculation assumes the 
cumulative incidence rate for competing risk factors is 10% through Visit Day +100. Allowing 
for a dropout rate of approximately 15%, approximately 90 subjects will be randomized to include 
approximately 80 treated subjects in the mITT Population. The sample size was calculated using 
PASS Sample Size Software (PASS 16 Power Analysis and Sample Size Software, 2018). 
SITES: Approximately 5 to 10 sites in the United States for the Phase 1 part of the study, and 
approximately 14 to 20 sites in the United States for the Phase 2 part of the study. 
SPONSOR: 
Fate Therapeutics, Inc. 
3535 General Atomics Court, Suite 200 
San Diego, CA 92121 
Telephone: 858-875-1800 
Facsimile: 858-875-1843 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
17 
TABLE OF CONTENTS 
INVESTIGATOR AGREEMENT.................................................................................................. 3 
SYNOPSIS ...................................................................................................................................... 4 
TABLE OF CONTENTS .............................................................................................................. 17 
LIST OF ABBREVIATIONS AND DEFINITION OF TERMS ................................................. 23 
1 
INTRODUCTION AND BACKGROUND INFORMATION ........................................ 26 
1.1 
Background ................................................................................................................. 26 
1.2 
Hematopoietic Stem Cell Transplants and Potential Complications .......................... 26 
1.2.1 Graft-Versus-Host Disease ................................................................................... 27 
1.2.2 Current Strategies to Prevent and/or Treat Graft-versus-Host Disease ................ 28 
1.2.3 Infections in the Hematopoietic Cell Transplant Setting ...................................... 28 
1.3 
ProTmune .................................................................................................................... 30 
1.3.1 Effects of FT1050 and FT4145 on T-cells ............................................................ 30 
1.3.2 Effects of F1050 and FT4145 on Hematopoietic Stem Cells ............................... 30 
1.3.3 Role of FT1050 and FT4145 in Hematopoietic Stem Cell Biology ..................... 31 
1.4 
Risk/Benefit ................................................................................................................ 31 
1.4.1 Summary of Nonclinical Studies .......................................................................... 31 
1.4.1.1 
In vitro characterization studies of hematopoietic stem cells .......................... 31 
1.4.1.2 
In vivo repopulating ability (engraftment) ....................................................... 32 
1.4.1.3 
T-cell characterization studies ......................................................................... 32 
1.4.1.4 
Summary of nonclinical findings .................................................................... 33 
1.4.2 Summary of Clinical Studies ................................................................................ 33 
1.5 
Rationale ..................................................................................................................... 33 
1.5.1 Proof-of-Concept Clinical Data ............................................................................ 33 
1.5.2 Nonclinical Data Supporting ProTmune’s Ability to Reduce Viral Infections .... 34 
1.6 
Rationale for ProTmune Clinical Study in Matched Unrelated Donors ..................... 34 
2 
STUDY OBJECTIVES ..................................................................................................... 36 
2.1 
Primary Objective(s) ................................................................................................... 36 
2.1.1 Primary Objective for the Phase 1 Part of the Study ............................................ 36 
2.1.2 Primary Objective for the Phase 2 Part of the Study ............................................ 36 
2.2 
Secondary Objectives.................................................................................................. 36 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
18 
2.2.1 Secondary Objective for the Phase 1 Study .......................................................... 36 
2.2.2 Secondary Objective for the Phase 2 Study .......................................................... 36 
2.3 
Exploratory Objectives ............................................................................................... 36 
2.3.1 Exploratory Objectives for the Phase 2 Part of the Study .................................... 36 
3 
STUDY DESCRIPTION .................................................................................................. 38 
3.1 
Summary of Study Design .......................................................................................... 38 
3.1.1 Study Design for the Phase 1 Part of the Study .................................................... 38 
3.1.2 Study Design for the Phase 2 Part of the Study .................................................... 42 
3.1.3 Early Stopping Rules for the Study ...................................................................... 45 
3.1.3.1 
Early stopping rules for the Phase 1 part of the study ..................................... 45 
3.1.3.2 
Early stopping rules for the Phase 2 part of the study ..................................... 45 
3.2 
Independent Data Monitoring Committee .................................................................. 46 
3.2.1 Endpoint Adjudication Committee ....................................................................... 46 
3.3 
Study Indication(s) ...................................................................................................... 46 
3.4 
Conditioning and Graft-versus-Host Disease Prophylaxis Regimens ........................ 46 
3.5 
Prophylactic and Pre-emptive Therapy for CMV Infection ....................................... 47 
3.6 
Reserve Hematopoietic Stem Cells ............................................................................. 47 
3.7 
Transfusion and Support Guidelines ........................................................................... 48 
4 
SELECTION AND WITHDRAWAL OF SUBJECTS .................................................... 49 
4.1 
Inclusion Criteria for the Phase 1 Part of the Study and the Phase 2 Part of the Study
..................................................................................................................................... 49 
4.2 
Exclusion Criteria for the Phase 1 Part of the Study and the Phase 2 Part of the Study
..................................................................................................................................... 50 
4.3 
Withdrawal Criteria .................................................................................................... 51 
4.4 
Screen Failures and Subject Replacement .................................................................. 52 
5 
STUDY TREATMENTS .................................................................................................. 53 
5.1 
Treatment Groups ....................................................................................................... 53 
5.1.1 Study Treatment Groups for the Phase 1 Part of the Study .................................. 53 
5.1.2 Study Treatment Groups for the Phase 2 Part of the Study .................................. 53 
5.2 
Rationale for Dosing ................................................................................................... 53 
5.3 
Randomization and Blinding ...................................................................................... 53 
5.3.1 Randomization and Blinding for the Phase 1 Part of the Study ........................... 53 
5.3.2 Randomization and Blinding for the Phase 2 Part of the Study ........................... 53 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
19 
5.4 
Breaking the Blind ...................................................................................................... 54 
5.5 
Drug Supplies.............................................................................................................. 54 
5.5.1 Formulation and Packaging .................................................................................. 54 
5.5.2 Study Drug Preparation and Dispensing ............................................................... 55 
5.5.3 Study Drug Administration ................................................................................... 56 
5.5.4 Treatment Compliance .......................................................................................... 56 
5.5.5 Storage and Accountability ................................................................................... 56 
5.6 
Prior and Concomitant Medications and/or Procedures ............................................. 57 
5.6.1 Prohibited Medications and/or Procedures for the Phase 1 Part of the Study and 
Phase 2 Part of the Study ...................................................................................... 57 
5.6.2 Documentation of Prior and Concomitant Medication Use for the Phase 1 Part of 
the Study and Phase 2 Part of the Study ............................................................... 57 
6 
STUDY PROCEDURES .................................................................................................. 59 
6.1 
Informed Consent........................................................................................................ 59 
6.1.1 Informed Consent for the Phase 1 Part of the Study and Phase 2 Part of the Study
............................................................................................................................... 59 
6.2 
Screening Period (Day -53 to Day -11) ...................................................................... 59 
6.2.1 Screening Period (Day -53 to Day -11) for the Phase 1 Part of the Study and 
Phase 2 Part of the Study ...................................................................................... 59 
6.3 
Subject Conditioning (Day -10 to Day -1) .................................................................. 60 
6.3.1 Subject Conditioning (Day -10 to Day -1) for the Phase 1 Part of the Study and 
Phase 2 Part of the Study ...................................................................................... 60 
6.4 
Hospital Admission (Institution Policy) ..................................................................... 61 
6.4.1 Hospital Admission (Institution Policy) for the Phase 1 Part of the Study and 
Phase 2 Part of the Study ...................................................................................... 61 
6.5 
Study Treatment Administration: Day of Hematopoietic Stem Cell Transplant (Day 0)
..................................................................................................................................... 62 
6.5.1 Study Treatment Administration: Day of Hematopoietic Stem Cell Transplant 
(Day 0) for the Phase 1 Part of the Study and Phase 2 Part of the Study ............. 62 
6.6 
Post-Transplant Assessment Days .............................................................................. 62 
6.6.1 Post-Transplant Assessment Days for the Phase 1 Part of the Study and Phase 2 
Part of the Study.................................................................................................... 62 
6.7 
Post-Transplant Weekly Assessments ........................................................................ 63 
6.7.1 Post-Transplant Weekly Visits for the Phase 1 Part of the Study and Phase 2 Part 
of the Study ........................................................................................................... 63 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
20 
6.8 
Unscheduled visits ...................................................................................................... 65 
6.9 
Early Withdrawal Visit and Study Withdrawal Procedures ....................................... 65 
7 
EFFICACY ASSESSMENTS .......................................................................................... 67 
7.1 
Acute Graft-versus-Host Disease Assessment ............................................................ 68 
7.2 
Chronic Graft-versus-Host Disease Assessment ........................................................ 68 
7.3 
Viral Monitoring ......................................................................................................... 69 
7.4 
Infectious Disease Titers ............................................................................................. 69 
7.5 
Karnofsky Performance Status ................................................................................... 69 
7.6 
Relapse of Malignancy ............................................................................................... 69 
7.7 
Immune Reconstitution ............................................................................................... 69 
7.8 
Serum Immunoglobulin .............................................................................................. 69 
7.9 
Bone Marrow Aspirate ................................................................................................ 69 
7.10 
GvHD Biomarkers ...................................................................................................... 70 
7.11 
Radiologic Tumor Staging .......................................................................................... 70 
8 
SAFETY ASSESSMENTS ............................................................................................... 71 
8.1 
Adverse Events ........................................................................................................... 71 
8.1.1 Adverse (Drug) Reaction ...................................................................................... 72 
8.1.2 Unexpected Adverse Drug Reaction ..................................................................... 73 
8.1.3 An Unexpected Adverse Drug Reaction is defined as an adverse reaction, the 
nature or severity of which is not consistent with the applicable product 
information. Assessment of Adverse Events by the Investigator ......................... 73 
8.2 
Serious Adverse Events .............................................................................................. 74 
8.3 
Serious Adverse Event Reporting − Procedures for Investigators.............................. 75 
8.4 
Pregnancy Reporting ................................................................................................... 75 
8.5 
Expedited Reporting ................................................................................................... 76 
8.6 
Engraftment, Graft Failure, and Chimerism ............................................................... 76 
8.6.1 Neutrophil and platelet engraftment per CIBMTR ............................................... 76 
8.6.2 Primary and secondary graft failure ...................................................................... 76 
8.6.3 Chimerism ............................................................................................................. 77 
8.7 
Clinical Laboratory Evaluations ................................................................................. 77 
8.8 
Serum Pregnancy Tests ............................................................................................... 78 
8.9 
Vital Signs ................................................................................................................... 78 
8.10 
Electrocardiograms ..................................................................................................... 78 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
21 
8.11 
Physical Examinations ................................................................................................ 78 
8.12 
Donor History ............................................................................................................. 78 
8.13 
Medical History and Concomitant Medications ......................................................... 78 
8.14 
Cardiac Function ......................................................................................................... 79 
8.15 
Pulmonary Function Tests .......................................................................................... 79 
9 
STATISTICS .................................................................................................................... 80 
9.1 
Analysis Populations ................................................................................................... 80 
9.1.1 Intent-to-Treat Population ..................................................................................... 80 
9.1.2 Modified Intent-to-Treat Population ..................................................................... 80 
9.1.3 Per-Protocol Population ........................................................................................ 80 
9.1.4 Safety Population .................................................................................................. 80 
9.2 
Statistical Methods ...................................................................................................... 80 
9.2.1 Analysis of Efficacy .............................................................................................. 81 
9.2.2 Analysis of Safety ................................................................................................. 82 
9.2.3 Interim Analysis .................................................................................................... 83 
9.2.4 Hypotheses ............................................................................................................ 83 
9.2.5 Sample Size Determination................................................................................... 84 
10 
DATA MANAGEMENT AND RECORD KEEPING..................................................... 85 
10.1 
Data Management ....................................................................................................... 85 
10.1.1 Data Handling ....................................................................................................... 85 
10.1.2 Computer Systems ................................................................................................ 85 
10.1.3 Data Entry ............................................................................................................. 85 
10.1.4 Medical Information Coding................................................................................. 85 
10.1.5 Data Validation ..................................................................................................... 85 
10.2 
Record Keeping .......................................................................................................... 85 
11 
INVESTIGATOR REQUIREMENTS AND QUALITY CONTROL ............................. 86 
11.1 
Ethical Conduct of the Study ...................................................................................... 86 
11.2 
Institutional Review Board/Independent Ethics Committee....................................... 86 
11.3 
Informed Consent........................................................................................................ 86 
11.4 
Subject Card ................................................................................................................ 87 
11.5 
Study Monitoring Requirements ................................................................................. 87 
11.6 
Disclosure of Data....................................................................................................... 87 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
22 
11.7 
Retention of Records................................................................................................... 87 
11.8 
Publication Policy ....................................................................................................... 88 
11.9 
Financial Disclosure.................................................................................................... 88 
11.10 Insurance and Indemnity ............................................................................................. 88 
11.11 Legal Aspects .............................................................................................................. 88 
12 
STUDY ADMINISTRATIVE INFORMATION ............................................................. 89 
12.1 
Protocol Amendments ................................................................................................. 89 
12.2 
Address List ................................................................................................................ 89 
12.2.1 Sponsor ................................................................................................................. 89 
12.2.2 Contract Research Organization ........................................................................... 89 
12.2.3 Drug Safety ........................................................................................................... 89 
12.2.4 Biological Specimens............................................................................................ 89 
13 
REFERENCES ................................................................................................................. 90 
APPENDIX A: SCHEDULE OF PROCEDURES FOR THE PHASE 1 AND PHASE 2 
PARTS OF THE STUDY ............................................................................................... 94 
APPENDIX B: STUDY DESIGN SCHEMATIC FOR THE PHASE 1 PART OF THE 
STUDY ............................................................................................................................. 98 
APPENDIX C: FLOW SCHEMATIC FOR THE PHASE 1 PART OF THE STUDY ....... 99 
APPENDIX D: KARNOFSKY PERFORMANCE STATUS SCALE ................................. 100 
APPENDIX E: ACUTE GVHD SCORING SYSTEM FOR INDIVIDUAL ORGANS: 
CIBMTR SCALE .......................................................................................................... 101 
APPENDIX F: NIH CONSENSUS CRITERIA FOR CHRONIC GVHD .......................... 102 
APPENDIX G: BMT CTN SEVERITY GRADING AND RECURRENCE INTERVAL 
DEFINITION ................................................................................................................ 105 
APPENDIX H: STUDY DESIGN SCHEMATIC FOR THE PHASE 2 PART OF THE 
STUDY ........................................................................................................................... 108 
APPENDIX I: FLOW SCHEMATIC FOR THE PHASE 2 PART OF THE STUDY ...... 109 
APPENDIX J: CLINICAL LABORATORY ANALYTES .................................................. 110 
 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
23 
LIST OF ABBREVIATIONS AND DEFINITION OF TERMS 
Abbreviation 
Definition 
aGvHD 
Acute graft-versus-host disease 
AIBW 
Adjusted ideal body weight 
ALL 
Acute lymphoblastic leukemia 
ALT 
Alanine aminotransferase 
AML 
Acute myeloid leukemia 
ANC 
Absolute neutrophil count 
 
AST 
Aspartate aminotransferase 
AVT 
Anti-viral therapy 
BM 
Bone marrow 
BMT CTN 
Blood and Marrow Transplant Clinical Trials Network 
Bu 
Busulfan 
cAMP 
Cyclic adenosine monophosphate 
CBC 
Complete blood count 
cGvHD 
Chronic graft-versus-host disease 
CIBMTR 
Center for International Blood and Marrow Transplant Research 
CML 
Chronic myelogenous leukemia 
CMV 
Cytomegalovirus 
CPF 
Cell Processing Facility 
CR 
Complete remission 
CRA 
Clinical research associate 
CRFS 
Chronic graft-versus-host disease-free, relapse-free survival 
CRO 
Contract research organization 
CTA 
Clinical trial authorization 
CTCAE 
Common Terminology Criteria for Adverse Events 
CXCR4 
C-X-C chemokine receptor type 4 
Cy 
Cyclophosphamide 
DNA 
Deoxyribonucleic acid 
EAC 
Endpoint Adjudication Committee 
EBV 
Epstein Barr Virus 
ECG 
Electrocardiogram 
ECHO 
Echocardiogram 
eCRF 
Electronic case report form 
EDC 
Electronic data capture 
FDA 
Food and Drug Administration 
FluBu4 
Fludarabine and busulfan 
GvHD 
Graft-versus-host disease 
GRFS 
Graft-versus-host disease-free, relapse-free survival 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
24 
Abbreviation 
Definition 
GvL 
Graft-versus-leukemia 
HCT 
Hematopoietic stem cells 
HHV-6 
Human herpes virus 6 
HIV 
Human immunodeficiency virus 
HLA 
Human leukocyte antigen 
HSA 
Human serum albumin 
HSC 
Hematopoietic stem cells 
HSV 
Herpes simplex virus 
HTLV 
Human T-cell lymphotropic virus 
IB 
Investigator’s Brochure 
IBW 
Ideal body weight 
ICF 
Informed consent form 
ICH  
International Conference on Harmonisation 
IDMC 
Independent Data Monitoring Committee 
IEC 
Independent Ethics Committee 
IFN 
Interferon 
Ig 
Immunoglobulin  
IL 
Interleukin 
IRB 
Institutional Review Board 
IV 
Intravenous 
IWRS 
Interactive Web Response Services 
MAC 
Myeloablative conditioning 
MDS 
Myelodysplastic syndrome 
mPB 
Mobilized peripheral blood 
MUGA 
Multiple gated acquisition 
NCI 
National Cancer Institute 
NIH 
National Institutes of Health 
NK 
Natural killer 
NMDP 
National Marrow Donor Program 
NRM 
Non-relapse mortality 
NYHA 
New York Heart Association 
PCR 
Polymerase chain reaction 
PO 
Orally 
RBC 
Red blood cell 
RFS 
Relapse-free survival 
SAE 
Serious adverse event 
SAP 
Statistical Analysis Plan 
SDF-1 
Stromal derived factor-1 
SUSAR 
Serious and unexpected suspected adverse reaction 
TBI 
Total body irradiation 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
25 
Abbreviation 
Definition 
TEAE 
Treatment-emergent adverse event 
VZV 
Varicella zoster virus 
 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
26 
1 
INTRODUCTION AND BACKGROUND INFORMATION 
1.1 
Background 
Hematologic malignancies encompass a wide range of cancers that involve the bone marrow (BM) 
and lymph nodes. Rich in growth factors and cytokines, the BM provides an ideal 
microenvironment for hematologic malignancies that lends itself to progression of leukemogenesis 
and cancer progression (Raimondo et al. 2015). Malignancies of the BM, such as acute myeloid 
leukemia (AML) and acute lymphoblastic leukemia (ALL), affect all ages (Smith et al. 2011).  
Recent advances in survival and treatment options using chemotherapy, transplantation, and 
radiation have resulted in survival rates around 90% for some hematologic malignancies 
(McLaughlin 2015). However, patients still incur numerous adverse reactions and systemic 
toxicities due to such therapies. For patients who do not obtain remission or who relapse, 
allogeneic hematopoietic cell transplantation (HCT) may be the only remaining treatment option 
(McLaughlin 2015). 
Before receiving allogeneic HCT, a patient must undergo 1 of 2 types of preparative treatment 
regimens: myeloablative conditioning (MAC) or non-MAC, such as reduced intensity 
conditioning. The goal of such conditioning regimens is to suppress the recipient’s immune system 
sufficiently to allow adequate engraftment of the donor cells, to reduce the presence of neoplastic 
cells.  
1.2 
Hematopoietic Stem Cell Transplants and Potential Complications 
For patients with advanced stages of hematologic malignancies, allogeneic HCT is often the only 
therapeutic option that offers the potential to prolong lifespan or even a curative outcome. While 
BM has historically been the principal source of hematopoietic stem cells (HSC) in allogeneic 
HCT, the majority of recent procedures have been conducted with mobilized peripheral blood 
(mPB) as a cell source, including mPB collected from matched related donors or matched unrelated 
donors (National Marrow Donor Program [NMDP] 2015). In the United States, approximately 
20,000 patients receive autologous or allogeneic HCT each year (Majhail et al. 2015). Only 
one-third of all patients eligible for allogeneic HCT have a human leukocyte antigen 
(HLA)-matched related donor in their family and in those cases, transplant from a matched related 
donor becomes the optimal treatment.  
Patients who do not have an HLA-matched relative rely on alternative stem cell sources, which 
include: matched unrelated donors, haploidentical donors, and umbilical cord blood (Ballen et al. 
2012). Approximately 50% to 60% of allogeneic HCTs reported to the Center for International 
Blood and Marrow Transplant Research (CIBMTR) use unrelated donors (Majhail et al. 2015). 
Additionally, over the past decade, the number of peripheral blood cell grafts facilitated by the 
NMDP has grown substantially, such that currently around 75% of unrelated grafts are peripheral 
blood cells (Woolfrey et al. 2011).  
This shift toward the use of mPB over BM was enabled by the relative ease of collection, obviating 
the need to harvest T-cells from a donor through surgical aspiration of the BM. In addition, mPB 
results in quicker engraftment kinetics and potentially decreased early morbidity relative to BM 
(Schmitz et al. 2006; Nagler et al. 2012; Eapen et al. 2007). Specifically, several large, multicenter, 
randomized studies have collectively demonstrated that time to engraftment/reconstitution is faster 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
27 
and more robust with mPB than with BM, which may be associated with decreased rates of relapse 
and infections (Pidala et al. 2009). 
Numerous complications may arise from HCT, whether using BM, mPB, or umbilical cord blood. 
The primary complication that may arise from HCT is graft-versus-host disease (GvHD). The use 
of mPB is associated with higher rates of GvHD compared to BM, which has limited the universal 
adoption of this otherwise convenient and highly effective cell source for HCT. 
Infections are a second important contributor of morbidity and mortality for patients undergoing 
HCT. Transplant-related infections are a universal issue that span across the HCT spectrum of 
stem cell sources, donor graft types and conditioning regimens (Wingard et al. 2010).  
For patients undergoing HCT, there is a clear need for new approaches to reduce rates of GvHD 
without compromising the anti-leukemia and anti-infective properties of the T-cells in the graft. 
1.2.1 
Graft-Versus-Host Disease 
Graft-versus-host disease is the result of an intricate immune response following allogeneic 
stimuli, when T-cells of the donor recognize the presence of histocompatibility antigens in the host 
that differ from those of the donor cells. This initial antigen recognition results in T-cell activation 
and proliferation, which leads to the production and secretion of a variety of cytokines, which are 
responsible for the inflammatory effects and tissue damage associated with GvHD (Ferrara and 
Deeg 1991). 
Conventionally, GvHD was divided into acute and chronic variants based upon the time of onset, 
using an arbitrary cutoff of 100 days for acute GvHD (aGvHD). Risk factors for the development 
of GvHD include degree of HLA disparity (HLA mismatch), donor-recipient gender disparity, 
increasing age of the host, CMV status of donor and host, intensity of the transplant conditioning 
regimen, GvHD prophylactic regimen used, source of cell graft, greater pre-transplant 
comorbidities, and specific HLA haplotypes (Sorror et al. 2014; Hahn et al. 2008).  
Between 35% and 60% of patients who undergo allogenic HCT are likely to develop aGvHD 
(Jacobson and Vogelsang 2007, Choi and Reddy 2014). In 1974, Glucksberg published the first 
aGVHD classification (Glucksberg et al. 1974), modified by Thomas in 1975. The Glucksberg 
system remains the most commonly used system. Although this classification has prognostic value, 
it is complex. In fact, there are 125 possible combinations of organ involvement and severity, 
where each of 3 organs is staged from 0 to 4, which are then combined to calculate an overall 
grade. However, in the overall grading system, 62 of the possible 125 combinations are not defined 
(Cahn et al. 2005). In recognition of the systems limitations, a consensus workshop was held in 
1995 and a modified Glucksberg grading system was proposed (Przepiorka et al. 1995) and a 
severity index published a year later (Rowlings et al. 1997). This modified grading scale is referred 
to as the CIBMTR grading scale. A revised CIBMTR scale was published in 2012 (CIBMTR 
Forms Manual 2012) and will be the scale by which aGvHD will be graded in this study. 
Acute GvHD is classified based on the degree of severity of the affected organs, skin, liver, and 
gastrointestinal tract, with involvement of each organ ranging from mild to severe based on the 
International Blood and Marrow Transplant Research Index (Majhail et al. 2015; Rowlings et al. 
1997). Acute GvHD is then given an overall grade based a 4-grade scale, with Grade A (I) 
considered mild, Grade B (II) moderate, Grade C (III) severe, and Grade D (IV) life-threatening. 
The survival of patients at Day +100 post-transplant is reduced with increasingly severe aGvHD, 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
28 
with survival in less than 45% of patients with severe aGvHD (Weisdorf et al. 1990; Nash et al. 
1992). 
Despite the accepted role of allogeneic T-cells in GvHD, the overall pathophysiology is still poorly 
understood. The development of predictive biomarkers to better assess the balance between GvHD 
and graft-versus-leukemia (GvL), as well as response to therapy, may provide better insights into 
disease prognosis and treatment optimization. A number of biomarkers have been previously 
proposed and summarized (Rozmus and Shultz 2011). Human leukocyte antigen disparity between 
donor and recipient has been linked to incidence and severity of chronic GvHD (cGvHD), however 
while HLA-A/-B disparity increases risk of cGvHD, HLA-DR or -DQ does not. The role of minor 
histocompatibility antigens in promoting GvHD has been debated as has the role of non-HLA 
polymorphisms. Non-HLA polymorphisms associated with susceptibility or severity of GvHD 
include heparinase, poly-ADP-ribose polymerase 1, madCAM-1, haptoglobin, HMGB-1 CCR9, 
and a range of classical Th1 and Th2 cytokines, including interleukin (IL)-10, tumor necrosis 
factor-α, IL-6, IL-1α, and interferon (IFN)-ɣ. Increased numbers of CD8/CD4 T-cells, TH-17 
T-cells, and monocytes can be observed in tissues affected by GvHD. Where practical, 
investigating the expression and distribution of putative biomarkers may provide additional 
insights into the safety and efficacy of novel approaches to treat or prevent GvHD. 
1.2.2 
Current Strategies to Prevent and/or Treat Graft-versus-Host Disease 
In the mid-1980s, calcineurin-inhibitor-based regimens were first used for GvHD prevention and 
treatment (Choi and Reddy 2014). While there have been several new insights regarding the 
pathophysiology of GvHD, there has been little progress in GvHD prevention and treatment. 
Despite better HLA-matching between donor and recipient and GvHD prophylaxis methods, 
aGvHD. Graft-versus-host disease still develops in approximately 40% to 60% of recipients 
(Choi and Reddy 2014). Additional preventative and therapeutic measures used for GvHD include 
non-specific immunosuppressive drugs, such as corticosteroids and methotrexate, as well as more 
specific T-cell immunosuppressive drugs, such as cyclosporine and tacrolimus (FK506). 
Corticosteroids remain the most widely used "front-line" therapy for the treatment of clinical 
GvHD, commonly administered in combination with therapeutic doses of cyclosporine or 
tacrolimus. Long-term use of corticosteroids may result in numerous adverse reactions, including 
Cushingoid features, hyperglycemia, psychosis, dyslipidemia, myopathy, osteoporosis, cataract 
formation, osteonecrosis, and immunosuppression (Liu et al. 2013). In addition, corticosteroids 
have been linked with a variety of drug-drug interactions, including those that share critical 
metabolic steps mediated by cytochrome P450 enzymes, resulting in clearance of concomitantly 
administered corticosteroids (Feldweg and Leddy 1999). Given the number and severity of the 
side effects associated with existing treatment options, there is a clear need for new approaches to 
treat GvHD. 
1.2.3 
Infections in the Hematopoietic Cell Transplant Setting 
Despite significant improvements in the supportive care of HCT patients and modifications to the 
guidelines for infection prevention, infections remain the primary cause of death for 17% to 20% 
of patients who undergo allogeneic HCT (Tomblyn et al. 2009). As such, there remains an unmet 
medical need for the prevention and pre-emptive therapy of infections in the HCT setting. 
Cytomegalovirus is an important pathogen in patients who undergo an allogeneic HCT, since 
CMV can affect almost any organ, and can result in pneumonia, gastrointestinal ulcers, and 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
29 
retinitis. Without prophylaxis, CMV infection after allogeneic HCT affects approximately 80% of 
CMV-seropositive patients (Ljungman et al. 2011). Although current strategies have resulted in 
the decreased incidence of CMV disease, CMV prophylaxis and pre-emptive therapy are not 
without risk. Ganciclovir, a synthetic guanine derivative active against CMV, is one of several 
drugs utilized for both prophylaxis and pre-emptive therapy in patients receiving allogeneic HCT 
(Tomblyn et al. 2009). Those patients who do not tolerate standard doses of ganciclovir typically 
receive foscarnet, with lower doses in those with renal impairment (Tomblyn et al. 2009).  
The use of ganciclovir has an important toxicity profile as noted by its current black box warning 
for granulocytopenia, anemia, and thrombocytopenia diaphoresis (Ganciclovir [Systemic]: Drug 
Information 2015). In animal studies, ganciclovir was found to be carcinogenic, teratogenic, and 
caused aspermatogenesis (Ganciclovir [Systemic]: Drug Information 2015). Significant adverse 
reactions (>10%) of fever, diarrhea, anorexia, vomiting, cytopenias, retinal detachment, increased 
serum creatinine, sepsis, and diaphoresis are associated with ganciclovir (Ganciclovir [Systemic]: 
Drug Information 2015). When given at engraftment, ganciclovir can be deleterious to the graft 
due to prolonged neutropenia, and can result in more invasive bacterial and fungal infections 
(Boeckh et al. 1996; Goodrich et al. 1993; Salzberger et al. 1997).  
As use of pre-emptive anti-CMV therapy has increased, late CMV infection and disease (after 
Day +100) has become more significant following allogeneic HCT and is associated with 
non-relapse mortality (NRM) (Ozdemir et al. 2007). To minimize the toxicity from antiviral 
agents, most prefer a pre-emptive approach for CMV in HCT recipients rather than prophylaxis. 
The drawback of pre-emptive therapy, in addition to drug toxicity, is that the outcome is limited 
by the frequency and duration of monitoring (Tomblyn et al. 2009). The outcome of pre-emptive 
therapy is largely dependent on timely detection of CMV in the blood before the onset of disease 
and the early detection of CMV. Disease may occur due to missed surveillance tests or tests that 
are spaced too far apart. If a patient progresses to disease, treatment is not always effective; CMV 
pneumonia is the most detrimental complication of CMV in HCT recipients due to its high 
mortality rate, despite treatment (Reed et al. 1988). 
The opportunistic bacterial, viral, fungal, and parasitic pathogens that occur in allogeneic HCT 
recipients result in numerous clinical syndromes, including, but not limited to CNS and ocular 
manifestations, sinusitis and mucositis, pneumonia, esophagitis, diarrhea and colitis, hepatitis, 
hemorrhagic cystitis, nephritis, skin lesions, bone marrow suppression, blood stream infection, 
shock (including septic shock) and fever (Tomblyn et al. 2009). Among the current strategies for 
prophylaxis or pre-emptive therapy are fluoroquinolones (e.g., levofloxacin) and immune globulin 
intravenous (IV) for bacterial infections; acyclovir for HSV infections; fluconazole for fungal 
diseases; and trimethoprim sulfamethoxazole for parasitic infections (Tomblyn et al. 2009). The 
adverse reactions and toxicities from such drugs include, but are not limited to, anaphylaxis, 
QT prolongation; hepatoxicity and hematologic toxicity; central nervous system and dermatologic 
adverse reactions; pulmonary edema (e.g., transfusion-related acute lung injury); tendinitis and 
tendon rupture; exacerbation of muscle weakness; fatal reactions to agranulocytosis, aplastic 
anemia, and other blood dyscrasias; fatal renal failure; and fatal reactions to Stevens-Johnson 
syndrome and toxic epidermal necrolysis (Acyclovir [Systemic]: Drug Information 2015; 
Fluconazole: Drug Information. Lexicomp. 2015; Immune Globulin: Drug Information 2015; 
Levofloxacin 
[Systemic]: 
Drug 
Information 
2015; 
Trimethoprim-Sulfamethoxazole 
[co-trimoxazole]: Drug Information 2015).  

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
30 
In summary, infectious diseases are still a common cause of morbidity and mortality in patients 
undergoing HCT. Even in the setting of enhanced infectious disease surveillance, the therapies 
used in the prophylaxis and pre-emptive settings have limitations due to potentially severe or 
life-threatening toxicities, as well as possibly being deleterious to the graft. Therefore, there 
continues to be an unmet medical need for the prevention or treatment of infectious complications 
in patients who undergo an HCT transplant. 
1.3 
ProTmune 
ProTmune is a donor-sourced, patient-specific, allogeneic cell therapy product consisting of the 
cells contained within a human mobilized peripheral blood (mPB) collection that have been 
programmed through an ex vivo programming process using a combination of 2 small molecules, 
16,16-dimethyl prostaglandin E2 (FT1050) and dexamethasone (FT4145). The cell populations 
include hematopoietic cells and other cell types.  
The objective of ProTmune is to prevent aGvHD and CMV infection. ProTmune products are 
manufactured by ex vivo programming of cells in donor mPB units with a combination of 
16, 16-dimethyl prostaglandin E2 (dmPGE2, also referred to as FT1050) and a glucocorticoid 
(dexamethasone, also referred to as FT4145). ProTmune is intended for adults who will undergo 
HCT with cells contained in donor mPB units. Based on nonclinical data, ProTmune has the 
potential to reduce aGvHD while retaining GvL activity through programming a number of key 
biological pathways in both HSC and T-cells contained in mPB. Three processes are thought to be 
responsible for the development of aGvHD: cytokine storm following tissue injury caused by the 
conditioning regimen given prior to HCT, alloactivation of donor T-cells (activation, proliferation, 
and differentiation), and organ damage caused by direct cytotoxic activity or through the 
production of inflammatory cytokines (Hill and Ferrara 2000; Bouchlaka et al. 2010).  
1.3.1 
Effects of FT1050 and FT4145 on T-cells 
In the nonclinical setting, ProTmune was found to have a significantly reduced allogeneic response 
in a mixed lymphocyte reaction. The reduced proliferation in response to an allogeneic target was 
accompanied by a significant reduction in IFN-ɣ cytokine response and concomitant induction of 
an immunomodulatory IL-4 response, suggesting that these cells have been programmed into a 
less responsive state. Consistent with this finding, ex vivo programming also served to upregulate 
expression of IL-10 by T-cells, a well-known potent and anti-inflammatory cytokine. This reduced 
proliferation response was also accompanied by decreased expression levels of the T-cell 
activation markers ICOS and 41BB. This phenotype may improve patient outcomes by preventing 
the unwanted cytokine-driven expansion of alloreactive T-cells in the first days and weeks 
following HCT. In addition, in vivo experiments demonstrated that programmed donor T-cells led 
to reduced rates of aGvHD without compromising the GvL response. Nonclinical studies are 
further summarized in Section 1.4.1. 
1.3.2 
Effects of F1050 and FT4145 on Hematopoietic Stem Cells 
FT1050 specifically interacts with HSC by binding the G protein-coupled prostaglandin receptors, 
EP2 and EP4, which activates adenylate cyclase and increases the intracellular levels of the 
secondary messenger molecule, cyclic adenosine monophosphate (cAMP). This increase in 
intracellular cAMP initiates a signaling cascade that activates cAMP response element-binding 
protein and other transcription factors in the nucleus inducing a number of gene expression 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
31 
changes in human CD34+ cells involved in cell cycle, anti-apoptosis and survival, and improved 
HSC function (North et al. 2007 and Hoggatt et al. 2009). Glucocorticoids were identified in a 
combinatorial small molecule screen performed at Fate. Dexamethasone (FT4145) was found to 
synergize with FT1050 to further enhance the homing and engraftment properties of HSC.  
1.3.3 
Role of FT1050 and FT4145 in Hematopoietic Stem Cell Biology 
Approximately 30% of patients receive a suboptimal dose of HSC due to poor mobilization and 
collection, which can result in delayed neutrophil recovery and increased susceptibility to 
life-threatening infections (To et al. 2011). Approaches to improve HSC engraftment have 
previously focused on increasing numbers of donor HSCs using multi-week expansion strategies 
(Wagner et al. 2015); however, more recent approaches involve simple ex vivo programming 
strategies designed to enhance the homing efficiencies of HSCs to the BM niche (Hogatt et al. 
2009; Greim et al. 2014).  
Several factors play a role in the engraftment of HSC into BM. Bone marrow niche sites represent 
specific microenvironments that promote the proliferation and differentiation of HSC into mature 
blood cells. An important phase of engraftment of HSC involves the homing of these cells to the 
appropriate sites within the BM. A key component of this homing mechanism is the interaction 
between stromal derived factor-1 (SDF-1), which is displayed on cells within the BM niche, and 
C-X-C chemokine receptor type 4 (CXCR4), which is expressed on the cell surface of HSC. The 
ligand-receptor interaction between SDF-1 and CXCR4 promotes the localization and retention of 
HSC in the BM niche. Ex vivo programming of mPB derived HSCs with FT1050 and FT4145 
leads to significant upregulation of CXCR4 and enhanced migration in vitro to gradients of SDF-1 
in transwell assays; see ProTmune Investigator’s Brochure (IB). The mechanism of action for the 
2 modulators, FT1050 and FT4145 is derived by a “cross-talk” that occurs via downstream 
intracellular signaling events which directly leads to the synergistic increase in CXCR4 gene and 
protein expression. 
1.4 
Risk/Benefit 
1.4.1 
Summary of Nonclinical Studies 
1.4.1.1 
In vitro characterization studies of hematopoietic stem cells 
Homing is an important first step in the engraftment process in which circulating HSC actively 
cross the blood/BM endothelium barrier and lodge in BM niches. These niche sites represent 
specific microenvironments that promote the expansion and differentiation of HSC into 
progenitors and mature lineages. The receptor CXCR4 is one of the key surface receptors involved 
in stem cell homing, activation of this receptor by ligand binding promotes the migration of these 
stem cells towards the high levels of SDF-1α. Additionally, SDF-1α is the natural ligand for 
CXCR4 found in high levels in post-cytoablated BM (Hogatt et al. 2009). FT1050 and 
FT4145-programmed HSC exhibited dramatic upregulation of CXCR4 at both the messenger 
ribonucleic acid level (~60-fold, p≤0.0001; paired t-test; see ProTmune IB) and the surface protein 
level (p≤0.0005; paired t-test; see ProTmune IB). Hematopoietic stem cells programmed with 
FT1050 and FT4145 also displayed increased migration rates to a gradient of SDF-1 in an in vitro 
transwell migration assay relative to vehicle controls (p=0.0001; paired t-test). This increased 
directional migration demonstrates an increased SDF-1α homing ability in the programmed cells. 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
32 
1.4.1.2 
In vivo repopulating ability (engraftment) 
Increased CXCR4 levels on HSC may lead to an increased ability of these cells to migrate in vivo 
into BM stem cell niches and accelerate engraftment, thereby improving immune reconstitution. 
Using an immunodeficient mouse model, Fate evaluated the ability of ex vivo programming of 
mPB CD34+ cells with FT1050 and FT4145 to improve engraftment. Compared to untreated 
control cells, significantly enhanced engraftment (engraftment defined >0.5% human CD45 in the 
marrow, p=0.01; unpaired t-test) of human CD34+ treated with FT1050 and FT4145 was observed 
in several independent experiments with 3 different donors, with an average overall human 
hematopoietic cell engraftment of 8% at 8 weeks post infusion compared to 2.9% in the control 
group; see ProTmune IB. 
Human chimerism was tracked in the peripheral blood of human mPB CD34+ treated with vehicle, 
FT1050, or FT1050 and FT4145 for all 3 donors over time. This study demonstrated that ex vivo 
programming significantly improved long-term engraftment outcomes of human mPB CD34+ 
cells. 
Using ex vivo programming to enhance immune reconstitution minimizes the risks of infections 
and relapse. In multiple in vitro assays and in vivo models, HSC modulated with FT1050 and 
FT4145 demonstrated improved homing, migration and enhanced long-term engraftment. 
1.4.1.3 
T-cell characterization studies 
As highlighted earlier, one of the major complications associated with allogenic HCT is aGvHD 
mediated by allogenic activated donor T-cells. Fate has conducted several nonclinical studies to 
characterize how the T-cell compartment of mPB is affected by ex vivo programming with FT1050 
and FT4145. T-cells programmed with FT1050 and FT4145 were characterized using both in vitro 
assays (e.g., mixed lymphocyte reactions) and in vivo models (e.g., GvHD and GvL). Programmed 
T-cells (both CD4 and CD8) had lower proliferation rates relative to vehicle-treated cells in a 5-day 
co-culture with mismatched peripheral blood mononuclear cells from a different donor. In the 
mouse GvHD model, T-cells programmed with FT1050 and FT4145 had reduced levels of 
inflammatory cytokines, reduced GvHD scores and enhanced survival relative to the vehicle 
treated cells; see ProTmune IB. Lastly, in mouse GvL models, T-cells programmed with FT1050 
and FT4145 retained GvL activity against the A20 lymphoma cells; see ProTmune IB. 
ProTmune utilizes a small molecular modulator, referred to as FT4145, which synergizes with 
FT1050 to promote the supra-physiologic activation of genes implicated in the cell cycle, immune 
tolerance, and anti-viral properties of T-cells. Nonclinical in vitro and animal studies have 
demonstrated that mPB treated with FT1050 and FT4145 result in reduced allogeneic GvHD while 
maintaining GvL response, suggesting that ProTmune may provide a clinical benefit in terms of 
GvHD reduction. These data also suggest that programmed cell populations in mPB treated with 
FT1050 and FT4145 have further potential to prevent viral (CMV) reactivation though the same 
modulation of T-cells. 
Combined, these studies demonstrated that pharmacologic programming mPB cells with FT1050 
+ FT4145 prior to allogenic HCT may offer an innovative therapeutic approach to reduce rates of 
GvHD without compromising the GvL response. 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
33 
1.4.1.4 
Summary of nonclinical findings 
Predictive in vitro assays and in vivo models have demonstrated the potential safety and efficacy 
of ProTmune. Results of the currently available in vitro and in vivo nonclinical studies have 
demonstrated that ex vivo programming of mPB cells with FT1050 and FT4145 can enhance 
engraftment of HSC and reduce GvHD through programming a number of key biological pathways 
in mPB T-cells. Reduced expression levels of phenotypic markers of activation is suggestive of a 
reduced activation capacity in the programmed T-cells that could, in concert with the cytokine 
data, lead to a lower potential for transplanted cells to promote GvHD in patients. Furthermore, 
mouse models demonstrated that treatment with FT1050 and FT4145 led to reduced GvHD scores, 
enhanced survival, reduced levels of pro-inflammatory cytokines without compromising the GvL 
activity of the T-cells. Taken together, these nonclinical studies demonstrate the safety and 
potential efficacy of ProTmune. 
1.4.2 
Summary of Clinical Studies 
This study is the first time ProTmune programmed mPB will be administered to humans. Based 
on current nonclinical data, ProTmune programming of mPB is anticipated to be safe and well 
tolerated. In conjunction with continual safety monitoring for all subjects enrolled in the study, 
various clinical and biomarker endpoints will be monitored in this first-in-human trial. 
Refer to the ProTmune Investigator Brochure for additional information on the safety of 
ProTmune. 
1.5 
Rationale  
1.5.1 
Proof-of-Concept Clinical Data 
Recent results from Fate’s Phase 2 PUMA clinical trial of ProHema (FT1050-programmed 
umbilical cord blood) provide compelling proof-of-concept data that ex vivo programming of 
donor grafts can enhance the therapeutic properties of donor-derived T-cells in the setting of HCT. 
Interim data from the PUMA study showed that subjects administered ProHema experienced a 
46% reduction in severe viral infection-related adverse events following HCT. Specifically, 9 of 
28 subjects administered ProHema, or 32%, experienced 1 or more severe viral infection-related 
adverse events (Grades 3 through 5) following HCT, as compared to 9 of 15 control subjects, or 
60%. Immunophenotyping analysis of subject blood samples from the PUMA study taken at 
different time points post-HCT (30, 60, 100, and 180 days) showed that, in subjects administered 
ProHema, T-cells had improved persistence compared to T-cells of control subjects. These 
observations are consistent with a 2014 publication by Fate’s collaborators that investigated the 
T-cell compartment of subjects administered ProHema in Fate’s Phase 1b clinical trial of ProHema 
(Li et al. 2014). The collaborator’s immunophenotyping analysis showed that the T-cell 
compartment of subjects administered ProHema exhibited a higher percentage of T-cells with a 
stem/memory phenotype compared to samples from historical control subjects (N = 53). The data 
from the PUMA study, including both the reduction in severe viral infection-related adverse events 
and the phenotypic changes to the T-cell compartment, provides supporting evidence for the ability 
to efficiently program donor immune cells.  
Infections are a major cause of morbidity and mortality for patients undergoing HCT procedures. 
During the first 100 days following HCT, graft-derived T lymphocytes provide the first wave of 
the immune protection against viral infections. The second wave of T-cells comes from de novo 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
34 
thymopoiesis, which typically requires 6 to 12 months to fully restore the T-cell compartment. 
Viral infections, including those from CMV, are particularly prevalent in the immediate 
post-transplant period, where it has been reported that over 90% of CMV infections occur within 
the first 100 days following HCT (Jain et al. 2014).  
The protection afforded by the graft-derived T-cells is limited during the initial period following 
HCT for several reasons. One of the factors that limits the effectiveness of the donor-derived 
T-cells in fighting viral infections results directly from the HCT conditioning regimen. In the days 
following HCT, high levels of inflammatory cytokines are present in patients’ blood, which can 
drive the rapid expansion and exhaustion of the adoptively-transferred CD4+ and CD8+ T-cells. 
This response results in a depleted and functionally-impaired T-cell compartment, limiting the 
ability of these cells to provide immune protection. 
1.5.2 
Nonclinical Data Supporting ProTmune’s Ability to Reduce Viral Infections 
Fate has been advancing the nonclinical development of ProTmune, an mPB unit programmed 
with 2 small molecules, FT1050, which is the small molecule Fate uses for the production of 
ProHema, and FT4145. This development effort has been driven by Fate’s specific intent of 
enhancing the therapeutic properties of donor T-cells in in the setting of HCT. Nonclinical studies 
demonstrate that ex vivo programming mPB with the combination of FT1050 and FT4145 renders 
the immune cells in mPB less responsive to the high levels of activating cytokines, which reduces 
the expansion and exhaustion of donor T-cells. In vitro assays designed to mimic the high levels 
of inflammatory cytokines found in patients following HCT show that programmed T-cells have 
reduced proliferation rates and reduced expression levels of key T-cell activation markers 
compared to vehicle treated cells; see ProTmune IB. Importantly, these assays show that the 
viability of the programmed T-cells is not negatively impacted; see ProTmune IB. Preliminary 
data suggests that preventing the rapid expansion and exhaustion of T-cells during the first week 
post-HCT has the potential to preserve a diverse T-cell repertoire over the first critical weeks and 
months following HCT, and that the programming of donor-derived T-cells has the potential to 
reduce the incidence of life-threatening viral infections. 
1.6 
Rationale for ProTmune Clinical Study in Matched Unrelated Donors 
Many patients with hematologic malignancies advance to a stage where allogeneic HCT becomes 
the only remaining therapeutic option that offers the potential to prolong lifespan or even a curative 
outcome. Approximately 50% to 60% of allogeneic HCTs reported to the CIBMTR use unrelated 
donors (Majhail et al. 2015). Over the past decade, the number of peripheral blood cell grafts 
facilitated by the NMDP has grown substantially, such that currently around 75% of HCT 
procedures that utilize unrelated grafts employ peripheral blood cells (Woolfrey et al. 2011). 
Several large, multicenter, randomized studies have collectively demonstrated that time to 
engraftment/reconstitution is faster and more robust with mPB than with BM (Pidala et al. 2009). 
However, mPB is also associated with higher rates of both acute and cGvHD (as compared to the 
use of BM or umbilical cord blood), which has limited the universal adoption of this otherwise 
convenient and highly effective cell source for HCT. This is attributed in part to the large number 
of T-cells infused with mPB as compared to other cell sources (Anasetti et al. 2012). Since no 
therapy has yet been approved for the prevention of GvHD, current treatments for GvHD include 
drugs prescribed off-label and can thus be ineffective. For patients undergoing HCT, there is a 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
35 
clear need for new approaches to reduce rates of GvHD without compromising the anti-leukemia 
and anti-infective properties of the T-cells in the graft. 
ProTmune has the potential to reduce aGvHD while retaining GvL activity through programming 
a number of key biological pathways in both HSC and T-cells in mPB. Additionally, previous 
clinical experience with one of the ProTmune programming agents (FT1050) suggests the potential 
of ProTmune to reduce viral infections following HCT. The nonclinical studies summarized 
previously demonstrate the safety and potential efficacy of ProTmune. 
Taken together, patients undergoing HCT who receive mPB that has been programmed using 
FT1050 and FT4145 are expected to have improved outcomes. The primary goal of this Phase 1/2 
study is to assess the safety, tolerability, and potential efficacy of ProTmune for reduction of 
incidence and severity of aGvHD in adult subjects who have undergone a matched, unrelated HCT 
for hematologic malignancies. 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
36 
2 
STUDY OBJECTIVES 
2.1 
Primary Objective(s) 
2.1.1 
Primary Objective for the Phase 1 Part of the Study  
The primary objective of the Phase 1 part of the study is to evaluate the safety and tolerability of 
ProTmune ex vivo programmed mPB cells for HCT in adult subjects with hematologic 
malignancies. 
2.1.2 
Primary Objective for the Phase 2 Part of the Study  
The primary objective of the Phase 2 part of the study is to assess the efficacy of ProTmune ex vivo 
programmed mPB cells for HCT in adult subjects with hematologic malignancies. 
2.2 
Secondary Objectives 
2.2.1 
Secondary Objective for the Phase 1 Study 
The secondary objective of the Phase 1 part of the study is to assess the efficacy of ProTmune ex 
vivo programmed mPB cells for HCT in adult subjects with hematologic malignancies. 
2.2.2 
 Secondary Objective for the Phase 2 Study 
The secondary objective of the Phase 2 part of the study is to further evaluate the safety and 
tolerability of ProTmune ex vivo programmed mPB cells for HCT in adult subjects with 
hematologic malignancies. 
2.3 
Exploratory Objectives 
2.3.1 
Exploratory Objectives for the Phase 2 Part of the Study  
The exploratory objectives for the Phase 2 part of the study may include the following: 
• To assess the incidence of neutrophil and platelet engraftment; 
• To assess the time to neutrophil and platelet engraftment;  
• To assess the cumulative incidence of aGvHD; 
• To assess the incidence of, and time to, CMV viremia, incidence and severity of CMV invasive 
disease, and incidence of CMV reactivation; 
• To assess time to first CMV-specific anti-viral therapy (AVT); 
• To assess the incidence of confirmed bacterial, fungal, viral, and parasitic infections; 
• To assess the time to first use of an agent to treat an infection other than CMV as clinically 
indicated; 
• To assess the time to first use of steroids to treat aGvHD;  
• To assess the time to escalation of treatment to first use of second line therapies for treatment 
of aGvHD; 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
37 
• To assess first episode, incidence, and duration of fever; 
• To assess biomarkers for aGvHD development; 
• To assess incidence and maximum severity of cGvHD;  
• To assess cumulative incidence of primary and secondary graft failure;  
• To assess neutrophil and T-cell chimerism; 
• To determine relapse-free survival; 
• To determine the incidence of NRM; 
• To determine the survival at one-year and at two-years; and 
• To assess immune reconstitution (including B, T, dendritic, and natural killer [NK] cells). 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
38 
3 
STUDY DESCRIPTION 
3.1 
Summary of Study Design 
This is a Phase 1, non-randomized, open-label/Phase 2, randomized, blinded, multi-center study 
of ProTmune ex vivo programmed mPB versus non-programmed mPB cells for allogeneic HCT in 
adult subjects with hematologic malignancies in the United States. All subjects in Phases 1 and 2 
will receive a conditioning regimen comprising 1 of the following 5 preparative regimens: 
fludarabine and busulfan (FluBu4); busulfan (Bu) and cyclophosphamide (Cy); Cy and ≥12 Gy 
total body irraditiation (TBI); TBI and etoposide; or fludarabine and melphalan (FluMel 140). 
Refer to Section 3.4 for a detailed description of the regimens required per the protocol. 
It is anticipated that the majority of subjects will be recruited from referrals for transplantation at 
the study sites. Potential study subjects can be pre-screened for study eligibility (evaluation of 
inclusion and exclusion criteria) based on the standard of care assessments that were completed 
prior to obtaining an informed consent, only with previously obtained Institutional Review Board 
(IRB) or Independent Ethics Committee (IEC) approval of such pre-screening procedures. Data 
will be requested from study centers in order to track screening and recruitment activity. 
Both the Phase 1 part of the study and Phase 2 part of the study will include a Screening Period 
(Day -53 through Day -11), Subject Conditioning Period (Day -10 through Day -1), Study 
Treatment Administration Day (Day 0; Day of HCT), Post-Transplant Follow-up Period (Day +1 
through Day +730, consisting of Post-Transplant Assessment Days and Post-Transplant Weekly 
Assessments, then intermittent assessments), and an Early Withdrawal Visit (if applicable). Refer 
to Appendix A for a summary of the Study Procedures for the Phase 1 and 2 parts of the study. 
The total duration of subject participation will be up to 26 months for each subject in the Phase 1 
part of the study and Phase 2 part of the study.  
The end of the study is considered as the completion through Day +365. All treated subjects will 
be followed for survival through Day +730 (i.e., 2 years).   
The study will utilize an Endpoint Adjudication Committee (EAC) blinded to treatment. The EAC 
will be responsible for adjudicating the aGvHD endpoint in accordance with the EAC charter. 
3.1.1 
Study Design for the Phase 1 Part of the Study 
The Phase 1 part of the study is a non-randomized, open-label, single-arm study that will enroll 
6 to 10 subjects who have an available 8/8 HLA-A, -B, -C, and -DRB1-matched unrelated 
peripheral blood cell donor. All eligible subjects enrolled in the Phase 1 part of the study will 
receive 1 unit of ProTmune ex vivo programmed mPB cells as the cell source for the HCT 
procedure. For a study design schematic for the Phase 1 part of the study, refer to Appendix B. 
At initiation of the Phase 1 part of the study, 3 subjects will be enrolled and treated. At the time a 
subject engrafts (or fails to engraft by Day +28), a new subject may be treated.   
The study will utilize an EAC blinded to treatment who will be responsible for adjudicating the 
aGvHD endpoint in accordance with the EAC charter. 
Early stopping rules for the Phase 1 part of the study will be in place from the start of the study 
throughout the duration of the study and, if applicable, triggered prior to assessments by the 
Independent Data Monitoring Committee (IDMC). Refer to Section 3.1.3.1 for a description of the 
early stopping rules for the Phase 1 part of the study.  

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
39 
An IDMC will convene to assess safety data as outlined in the IDMC Charter. At that time, the 
Sponsor, in consultation with and based on recommendations from the IDMC, will decide whether 
the study should stop or whether the Phase 2 study can begin.  
The Phase 1 part of the study will consist of approximately 5 to 10 sites in the United States. 
For a flow schematic for the Phase 1 part of the study, refer to Appendix C. 
A summary of the study visits for the Phase 1 part of the study are described below. For further 
detail regarding study procedures at each study visit, refer to Appendix A. 
Screening Period for the Phase 1 Part of the Study (Day -53 to Day -11)  
The Screening Period will occur between Day -53 and Day -11 (i.e., up to 6 weeks prior to the 
Subject Conditioning Period). At Screening, all subjects will review and sign an informed consent 
form (ICF) and eligibility for study participation will be assessed. The Investigator will be required 
to verify that the subject completed HLA typing, which can be completed prior to the Screening 
Period. Peripheral blood will be collected during the Screening Period to serve as a baseline sample 
for immune reconstitution analysis. 
The results of the bone marrow aspirate, spirometry, and ECHO or multiple gated acquisition 
(MUGA) performed prior to consent may be used for subject qualification as long as performed 
within 6 weeks prior to the Subject Conditioning Period, from Day -53 to Day -11. 
As a part of screening, all subjects will be tested for baseline CMV antibody titer and plasma CMV 
viremia. This baseline testing will be performed by a central laboratory and results will be provided 
to the clinical site and sponsor before initiation of randomization.  
All concomitant medications will be recorded starting at Day -30 through Day +100. From 
Day +100 through Day +730, only concomitant medications given as TKI maintenance, or that 
were ongoing at the time of, and for the treatment of, an AE of GvHD, infection or secondary 
engraftment failure or any SAE, will be recorded. 
Subject Conditioning Period for the Phase 1 Part of the Study (Day -10 to Day -1) 
The Subject Conditioning Period will occur between Day -10 and Day -1. Day 0 is the day of mPB 
HCT transplant. Subject conditioning will be administered as the conditioning regimen per the 
protocol (refer to Section 3.4). Graft-versus-host disease prophylaxis will be administered to 
subjects. 
Anti-thymocyte globulin is not permitted during the study.  
FDA-approved prophylactic therapies for CMV prevention (e.g., letermovir) will be permitted. 
Refer to Section 3.5 for a description of pre-emptive therapy for infection. Pre-emptive CMV 
therapy will be provided based upon institutional methodologies, Standard Operating Procedures, 
and clinical context. An additional blood sample for CMV testing will be taken for central 
laboratory testing prior to starting the preemptive therapy.  
Other procedures for transplant preparation will also be performed at the Subject Conditioning 
Visit and per Institutional Standard. 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
40 
Adverse events will be collected during Phase 1 and 2 as per the Common Terminology Criteria 
for Adverse Events (CTCAE) version 4.0, AE of infections will use both the CTCAE and the 
Blood and Marrow Transplant Clinical Trials Network (BMT CTN, Appendix G) criteria, as 
follows: 
• All serious adverse events (SAEs) will be recorded from Day -10 through Day +365, and only 
SAEs related to infused cells (ProTmune ex vivo programmed mPB cells or Control mPB cells) 
from Day +366 through Day +730; 
• Start of conditioning regimen (Day -10) through Day +100: Adverse events associated with 
infusion reactions, GvHD, infections, or engraftment failure (Grades 1 through 5). All other 
adverse events (Grades 2 through 5). Laboratory abnormalities will only be recorded as adverse 
events if deemed clinically significant by the Investigator; 
• From Day +100 through Day +365: Only adverse events associated with GvHD, infections, or 
secondary engraftment failure (Grades 1 through 5); 
Hospital Admission for the Phase 1 Part of the Study  
Subjects will be admitted to the hospital based on institutional policy. 
Study Treatment Administration for the Phase 1 Part of the Study (Day 0; Day of Hematopoietic 
Cell Transplant) 
A 12-lead triplicate electrocardiogram (ECG) (sequential, within 15 minutes total), complete blood 
count (CBC), and blood chemistry will be obtained on Day 0 prior to HCT. All eligible subjects 
will receive study treatment on the day of HCT (Day 0). For the Phase 1 part of the study, study 
treatment will consist of a single unit of ProTmune ex vivo programmed mPB cells. The ProTmune 
graft will be prepared the same day as administration. Refer to the ProTmune IB for a description 
of release testing criteria. Refer to Section 3.6 for a description of the algorithm for reserve HSC.  
Karnofsky Performance Status will be assessed at Day 0, following transplantation (refer to 
Appendix D for a description of Karnofsky Performance Status). For a description of transfusion 
and support guidelines, refer to Section 3.7. 
Post-Transplant Assessment Days for the Phase 1 Part of the Study 
Post-transplant visit windows are as follows: ±3 days for Day +7 through Day +100; ±14 days for 
Day +180; and ±28 days for Days +270, +365, and +730. Standard post-transplant testing will be 
performed per institutional guidelines and good clinical practice. 
The Day +730 visit will occur by conducting a telephone contact report for capture of survival 
status and adverse event reporting.  
Post-Transplant Weekly Visits for the Phase 1 Part of the Study 
Clinical and laboratory assessments of aGvHD will be performed weekly from Day +1 through 
Day +100, and on Day +180. Acute GvHD assessments (incidence and maximum severity) of 
Grades I through IV of the skin, liver, and gut as per the CIBMTR aGvHD Grading Scale will be 
performed. For a description of the CIBMTR aGvHD Grading Scale, refer to Appendix E. 
Chronic GvHD assessments (incidence and maximum severity) of mild, moderate, or severe 
cGvHD as per National Institutes of Health (NIH) Consensus Criteria for cGvHD will be 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
41 
performed on Days +180, +270, and +365. For a description of the NIH Consensus Criteria for 
cGvHD, refer to Appendix F. 
Peripheral blood samples will be collected for CMV assessments of deoxyribonucleic acid (DNA) 
by quantitative polymerase chain reaction (PCR) weekly from Days +7 through Day +100, and on 
Days +180, +270 and +365. Assessment of infection will be performed based on the NCI CTCAE 
and the Blood and Marrow Transplant Clinical Trials Network (BMT CTN) definitions. Study 
sites will monitor CMV viremia using local assays and frequencies as determined by local 
practices for in-patient and out-patient care. Therefore, if a blood sample is being drawn for a CMV 
PCR at a local virology laboratory, a sample must also be drawn at the same time and sent to the 
central virology laboratory for a CMV PCR result. See Appendix G.  
Peripheral blood will be collected for safety laboratory panels (hematology and serum chemistry), 
viral monitoring, immune reconstitution, chimerism, serum immunoglobulins, and GvHD 
exploratory biomarkers at the time points specified in Appendix A. 
A 12-lead triplicate ECG (sequential, within 15 minutes total) will be obtained at Day +100. 
Bone marrow aspirate will be sent to pathology and to cytogenetics on Day +21 (only if absolute 
neutrophil count [ANC] <500/µL), and as clinically indicated (flow cytometry is required on BM 
aspirate). 
Karnofsky Performance Status (Appendix D) will be assessed at all subsequent study visits after 
HCT up through Day +365 (which should include weekly assessments from Day +1 through 
Day +91, then on Days +100, +180, +270, and +365).  
The Day +730 visit will occur by conducting a telephone contact report for capture of survival 
status and adverse event reporting.  
Unscheduled visits 
An unscheduled visit is a visit that occurs in addition to the predefined protocol specific visit 
calendar. If an unscheduled visit occurs for a given subject, the visit must be documented on the 
Unscheduled Visit CRF. 
Early Withdrawal Visit for the Phase 1 Part of the Study 
If a subject is withdrawn from participation in the study prior to Day 0, the subject’s mPB will not 
be processed to a unit of ProTmune ex vivo programmed mPB cells, the subject will not be 
considered evaluable for any study-related endpoint analyses, and the subject will be replaced. 
If a subject withdraws from the study after transplantation, information regarding secondary graft 
failure, disease relapse, serious adverse events involving GvHD and infections, and survival 
outcomes will be collected by phone on Days +180, +365, and +730. If a subject withdraws 
consent, survival outcomes will be assessed via public record search.  
If the subject relapses and/or receives a protocol-prohibited therapy, the subject will be withdrawn 
from the study. However, survival will still be collected at Day +730 by telephone contact unless 
the subject withdraws consent, in which case survival outcomes will be assessed via public record 
search.  
A peripheral blood sample for safety laboratory panels (hematology and serum chemistry) will be 
collected.  

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
42 
Karnofsky Performance Status should be assessed (Appendix D), and GvHD assessments 
(incidence and maximum severity) (Appendix E and Appendix F) must be performed. 
In instances where donors require plerixafor for mobilization of peripheral blood, the subject will 
be off-study and replaced. 
3.1.2 
Study Design for the Phase 2 Part of the Study 
The Phase 2 part of the study may begin after 6-10 subjects have completed Phase 1 and the safety 
data has been reviewed by the IDMC. If after 6 subjects have been dosed and evaluated in Phase 
1 for up to 28 days and ≤1 subject has not engrafted by Day +28, then enrollment in the Phase 2 
portion of the study may proceed following IDMC review. 
The Phase 2 part of the study is a randomized, blinded, 2-arm study that will treat approximately 
80 subjects who have an available 8/8 HLA-A, -B, -C, and -DRB1-matched unrelated peripheral 
blood cell donor. After meeting eligibility, approximately 90 subjects (assuming a dropout rate of 
approximately 15% prior to treatment) will be randomly assigned in a 1:1 ratio to receive either 
unmanipulated mPB cells (control arm) or ProTmune ex vivo programmed mPB cells 
(experimental arm) and stratified by the subjects' CMV status). For a study design schematic of 
the Phase 2 part of the study, refer to Appendix H. 
The study will utilize an Endpoint Adjudication Committee (EAC) blinded to treatment. The EAC 
will be responsible for adjudicating the aGvHD endpoint in accordance with the EAC charter. 
Early stopping rules for the Phase 2 part of the study will be in place from the start of the study 
throughout the duration of the study and, if applicable, triggered prior to assessments by the IDMC. 
With the exception of the stopping rules associated with the failure of ProTmune to meet release 
specifications, there are no formal stopping rules for the Phase 2 part of the study. Stopping subject 
treatment may be triggered based on the continued review of subject safety data on study by the 
Sponsor and IDMC. If the investigational product does not meet release specifications to treat 2 
of the first 3 subjects, 3 of the first 6 subjects, or 5 of the first 10 subjects or 10 of the first 20 
subjects, subject treatment in the Phase 2 part of the study will be stopped. Refer to Section 3.1.3.2 
for a description of the early stopping rules for the Phase 2 part of the study. 
During the Phase 2 part of the study, the IDMC will convene according to the guidelines outlined 
in the IDMC Charter. Additional safety monitoring based on NRM, secondary graft failure, and 
IDMC input will be applied during the study for the Phase 1 and Phase 2 parts of the study. 
The Phase 2 part of the study will comprise approximately 14 to 20 sites in the United States. 
For a flow schematic for the Phase 2 part of the study, refer to Appendix I.  
A summary of the study visits for the Phase 2 part of the study are described below. For further 
detail regarding study procedures at each study visit, refer to Appendix A. 
Screening Period for the Phase 2 Part of the Study (Day -53 to Day -11)  
The Screening Period will occur between Day -53 and Day -11 (i.e., up to 6 weeks prior to the 
Subject Conditioning Period). At Screening, all subjects will review and sign an ICF and eligibility 
for study participation will be assessed. The Investigator will be required to verify that the subject 
completed HLA typing. HLA typing can be completed prior to the Screening Period. Peripheral 
blood will be collected during the Screening Period for baseline immune reconstitution analysis. 
After meeting eligibility, subjects will be randomly assigned in a 1:1 ratio to receive either 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
43 
unmanipulated mPB cells (control arm) or ProTmune ex vivo programmed mPB cells 
(experimental arm) and stratified by the subjects' CMV status. 
The results of the bone marrow aspirate, spirometry, and ECHO or multiple gated acquisition 
(MUGA) performed prior to consent may be used for subject qualification as long as performed 
within 6 weeks prior to the Subject Conditioning, from Day -53 to Day -11. 
As a part of screening, all subjects will be tested for baseline CMV antibody titer and plasma CMV 
viremia. This baseline testing will be performed by a central laboratory and results will be provided 
to the clinical site and sponsor before initiation of randomization. 
All concomitant medications will be recorded starting at Day -30 through Day +100. From 
Day +100 through Day +730, only concomitant medications given as TKI maintenance, or that 
were ongoing at the time of, and for the treatment of, an AE of GvHD, infection or secondary 
engraftment failure or any SAE, will be recorded. 
Subject Conditioning Period for the Phase 2 Part of the Study (Day -10 to Day -1) 
The Subject Conditioning Period will occur between Days -10 and Day -1 (i.e., up to 9 days prior 
to Hospital Admission). Subject conditioning will be administered as the conditioning regimen, as 
required per the protocol (refer to Section 3.4). Graft-versus-host disease prophylaxis will be 
administered. 
Anti-thymocyte globulin is not permitted during the study.  
FDA-approved prophylactic therapies for CMV prevention (e.g., letermovir) will be permitted. 
Refer to Section 3.5 for a description of pre-emptive therapy for infection. Pre-emptive CMV 
therapy may be provided based upon institutional methodologies, Standard Operating Procedures, 
and clinical context. An additional blood sample for CMV testing will be taken for central 
laboratory testing prior to starting the preemptive therapy.  
Other procedures for transplant preparation will also be performed at the Subject Conditioning 
Visit and per Institutional Standard. 
Adverse events will be collected during Phase 1 and 2 as per the CTCAE version 4.0, AE of 
infections will use both the CTCAE and the Blood and Marrow Transplant Clinical Trials Network 
(BMT CTN, Appendix G) criteria, as follows: 
• All SAEs will be recorded from Day -10 through Day +365, and only SAEs related to infused 
cells (ProTmune mPB cells or Control mPB cells) from Day +366 through Day +730; 
• Start of conditioning regimen (Day -10) through Day +100: Adverse events associated with 
infusion reactions, GvHD, infections, or engraftment failure (Grades 1 through 5). All other 
adverse events (Grades 2 through 5). Laboratory abnormalities will only be recorded as adverse 
events if deemed clinically significant by the Investigator; 
• From Day +100 through Day +365: Only adverse events associated with GvHD, infections, or 
secondary engraftment failure (Grades 1 through 5). 
Hospital Admission for the Phase 2 Part of the Study 
Subjects will be admitted to the hospital based on institutional policy. 
Study Treatment Administration for the Phase 2 Part of the Study (Day 0; Day of Hematopoietic 
Cell Transplant) 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
44 
A 12-lead triplicate ECG (sequential, within 15 minutes total), CBC, and blood chemistry will be 
obtained on Day 0 prior to HCT. All eligible subjects will receive study treatment on the day of 
HCT (Day 0). For the Phase 2 part of the study, study treatment will consist of either a single unit 
of ProTmune ex vivo programmed mPB cells or a single unit of unmanipulated mPB cells, based 
upon the subject’s randomized treatment allocation. The ProTmune graft will be prepared the same 
day as administration. Refer to the ProTmune IB for a description of release testing criteria.  
Karnofsky Performance Status (Appendix D) will be assessed at Day 0, following transplantation. 
For a description of transfusion and support guidelines, refer to Section 3.7. 
Post-Transplant Assessment Days for the Phase 2 Part of the Study  
Post-transplant visit windows are as follows: ±3 days for Day +7 through Day +100; ±14 days for 
Day +180; and ±28 days for Days +270, +365, and +730. Standard post-transplant testing will be 
performed per institutional guidelines and good clinical practice. 
The Day +730 visit will occur by conducting a telephone contact report for capture of survival 
status and adverse event reporting.  
Post-Transplant Weekly Visits for the Phase 2 Part of the Study 
Clinical and laboratory assessments of aGvHD will be performed weekly from Day +1 through 
Day +100, and at Day +180. Acute GvHD assessments (incidence and maximum severity) of 
Grades I through IV aGvHD of the skin, liver, and gut as per the CIBMTR aGvHD Grading Scale. 
For a description of the CIBMTR cGvHD Grading Scale, refer to Appendix E. 
Chronic GvHD assessments (incidence and maximum severity) of mild, moderate, or severe 
cGvHD as per NIH Consensus Criteria for cGvHD must be performed on Days +180, +270 and 
+365. For a description of the NIH Consensus Criteria for cGvHD, refer to Appendix F. 
Peripheral blood samples will be collected for CMV assessments of DNA by quantitative PCR 
weekly from Days +7 through Day +100, and at Days +180, +270 and +365. Assessment of 
infection will be performed based on the NCI CTCAE and the BMT CTN Definitions. Study sites 
will monitor CMV viremia using local assays and frequencies as determined by local practices for 
in-patient and out-patient care. Therefore, if a blood sample is being drawn for a CMV PCR at a 
local virology laboratory, a sample must also be drawn at the same time and sent to the central 
virology laboratory for a CMV PCR result. See Appendix G.  
Peripheral blood will be collected for safety laboratory panels (hematology and serum chemistry), 
viral monitoring, immune reconstitution, chimerism, serum immunoglobulins, and GvHD 
exploratory biomarkers at the time points specified in Appendix A. 
A 12-lead triplicate ECG (sequential, within 15 minutes total) will be obtained at Day +100. 
Bone marrow aspirate will be sent to pathology and to cytogenetics on Day +21 (only if ANC 
<500/µL), and as clinically indicated (flow cytometry is required on BM aspirate). 
Karnofsky Performance Status (Appendix D) will be assessed at all subsequent study visits after 
HCT up through Day +365 (which should include weekly assessments from Day +1 through 
Day +91, then on Days +100, +180, +270, and +365).  
The Day +730 visit will occur by conducting a telephone contact report for capture of survival 
status and adverse event reporting.  

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
45 
Unscheduled visits 
An unscheduled visit is a visit that occurs in addition to the predefined protocol specific visit 
calendar. If an unscheduled visit occurs for a given subject, the visit must be documented on the 
Unscheduled Visit CRF. 
Early Withdrawal Visit for the Phase 2 Part of the Study 
If a subject is withdrawn from participation in the study prior to Day 0, the subject’s mPB will not 
be processed to a unit of ProTmune ex vivo programmed mPB cells, the subject will not be 
considered evaluable for any study-related endpoint analyses, and the subject will be replaced. If 
this occurs in the Phase 2 portion of the study and the subject was already randomized, the subject 
will be replaced and a new subject will be randomized in order to have approximately 80 treated 
subjects. 
If a subject withdraws from the study after transplantation, information regarding secondary graft 
failure, disease relapse, serious adverse events involving GvHD and infections, and survival 
outcomes will be collected by phone on Days +180, +365, and +730. If a subject withdraws 
consent, survival outcomes will be assessed via public record search.  
If the subject relapses and/or receives a protocol-prohibited therapy, the subject will be withdrawn. 
However, survival will still be collected unless the subject withdraws consent, in which case 
survival outcomes will be assessed via public record search. A peripheral blood sample for safety 
laboratory panels (hematology and serum chemistry) will be collected.  
Karnofsky Performance Status should be assessed (Appendix D), and GvHD assessments must be 
performed, as applicable. 
In instances where donors require plerixafor for mobilization of peripheral blood, the subject will 
be off-study and replaced. 
3.1.3 
Early Stopping Rules for the Study 
3.1.3.1 
Early stopping rules for the Phase 1 part of the study 
At initiation of the Phase 1 part of the study, 3 subjects will be enrolled and treated. At the time a 
subject engrafts (or fails to engraft by Day +28), a new subject may be treated. If 2 or more subjects 
fail to engraft by Day +28, or if 2 or more subjects experience secondary graft failure by Day +28, 
or if 2 of the first 3 or 4 of the first 6 subjects treated have died by ≤Day +28, subject treatment 
will be stopped until the IDMC has assessed the cases and discussed with the Sponsor. The IDMC 
will be notified of all subject deaths occurring on study. If the investigational product does not 
meet release specifications to treat 2 of the first 3 subjects, 3 of the first 6 subjects, or 5 of the first 
10 subjects, subject treatment will be stopped pending review by the IDMC.  
3.1.3.2 
Early stopping rules for the Phase 2 part of the study 
With the exception of the stopping rules associated with the failure of ProTmune to meet release 
specifications, there are no formal stopping rules for the Phase 2 part of the study. Stopping subject 
treatment may be triggered based on the continued review of subject safety data on study by the 
Sponsor and IDMC. If the investigational product does not meet release specifications to treat 2 
of the first 3 subjects, 3 of the first 6 subjects, or 5 of the first 10 subjects or 10 of the first 20 
subjects, subject treatment in the Phase 2 part of the study will be stopped, pending review by the 
IDMC.  

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
46 
3.2 
Independent Data Monitoring Committee 
During the Phase 1 part of the study, an IDMC will convene to assess safety data as outlined in the 
IDMC Charter. At that time, the Sponsor, in consultation with and based on recommendations 
from the IDMC, will decide whether the study should stop or whether the Phase 2 study can begin. 
If the IDMC and Sponsor determine that there are no safety concerns based on Phase 1 safety data, 
Phase 2 study enrollment will begin. During the Phase 2 part of the study, the IDMC will convene 
according to the guidelines outlined in the IDMC Charter. Additional safety monitoring based on 
NRM, secondary graft failure, and IDMC input will be applied during the study for the Phase 1 
and Phase 2 parts of the study. 
3.2.1 
Endpoint Adjudication Committee 
The study will utilize an Endpoint Adjudication Committee (EAC) blinded to treatment 
assignment. The EAC will be responsible for adjudicating the aGvHD endpoint in accordance with 
the EAC charter. 
3.3 
Study Indication(s) 
For the Phase 1 and Phase 2 part of the study, ProTmune will be evaluated for the reduction of 
incidence and severity of acute GvHD in adult subjects with hematologic malignancies. 
3.4 
Conditioning and Graft-versus-Host Disease Prophylaxis Regimens 
All eligible subjects in the Phase 1 part of the study and Phase 2 part of the study will receive 1 of 
the following 5 preparative regimens:  
• CyTBI, with ≥12 Gy fractionated TBI; 
• BuCy where Bu = 16 mg/kg orally (PO) or 12.8 mg/kg IV infusion (alternatively, 
pharmacokinetic assessment and dose adjustment of Bu can be based on a test dose or the first 
dose and will be conducted according to institutional practices);  
• FluBu4 with Bu as above;  
• TBI and etoposide; or 
• FluMel 140 
Graft-versus host disease prophylaxis will be administered to all subjects. 
The GvHD prophylaxis regimen: 
• Methotrexate (15 mg/m2 IV infusion on Day +1 after hematopoietic cell infusion and 10 mg/m2 
on Days +3, +6, and +11), and 
• Tacrolimus (0.02 mg/kg every 24 hours as an IV infusion or 0.03 mg/kg PO beginning on Day 
-2, adjusted to target dose level of 5 to 15 ng/mL. Taper starting at Day +100). 
The GvHD prophylaxis may be dose reduced based on clinical judgment and associated with 
toxicity. 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
47 
All chemotherapy administered to subjects will be dosed based on the subject’s actual body weight. 
However, for subjects weighing more than 125% of their ideal body weight (IBW), chemotherapy 
will be dosed based on the adjusted ideal body weight (AIBW), or by Institutional Standards 
(Hicks et al. 2012). 
Ideal Body Weight Formula: 
Males IBW = 50 kg + 2.3 kg/inch over 5 feet 
Females IBW = 45.5 kg + 2.3 kg/inch over 5 feet 
 
Adjusted Ideal Body Weight Formula: 
AIBW = IBW + [(0.25) × (Actual Body Weight - IBW)] 
3.5 
Prophylactic and Pre-emptive Therapy for CMV Infection 
For the study, prophylactic and pre-emptive therapy for viral infection for the Phase 1 part of the 
study and Phase 2 part of the study comprise the following: 
• FDA-approved prophylactic therapies for CMV prevention (e.g., letermovir) will be permitted; 
• Two peripheral blood samples at each testing time point (1 blood sample to be utilized locally 
at the site for subject management and 1 blood sample for central laboratory testing) will be 
collected for viral assessments of DNA by quantitative PCR for Epstein Barr Virus (EBV), 
CMV, human herpes virus 6 (HHV-6), and BK virus weekly from Days +7 through Day +100, 
and at Days +180, +270 and +365; 
• Pre-emptive CMV therapy may be initiated based upon institutional policies and procedures, 
Standard Operating Procedures, and clinical context. An additional blood sample for CMV 
testing will be obtained for central laboratory testing and prior to starting the preemptive 
therapy. and 
• If clinical site viral testing is positive, subjects will receive pre-emptive therapy with an 
anti-viral therapy (i.e., ganciclovir, foscarnet, etc.) per Institutional Standard. 
3.6 
Reserve Hematopoietic Stem Cells 
For subjects enrolled in the Phase 1 part of the study, a reserve dose of 2 × 106 CD34+ cells/kg 
recipient weight will be maintained during ProTmune manufacturing to serve as a reserve in the 
event ProTmune manufacturing produces a ProTmune unit that does not meet ProTmune release 
specifications (e.g., <2 × 106 CD34+ cells/kg recipient weight, <70% viable). In this case, the 
ProTmune unit will be considered “unavailable” and count towards the Phase 1 stopping rules. 
The reserve unit must be administered; however, the Principal Investigator should follow their 
Institution’s standard operating procedure to determine whether the ProTmune unit should also be 
given to the recipient based on the risk-benefit assessment of administering the product with regard 
to the specification not being met. If the ProTmune unit is not administered, the subject will be 
withdrawn from study and replaced. If the ProTmune unit is administered, the subject will remain 
in study but will not be considered in the following assessment- "If after 6 subjects have been 
dosed and evaluated for up to 28 days and ≤1 subject has not engrafted by Day +28, then 
enrollment in the Phase 2 portion of the study may proceed following IDMC review". If the reserve 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
48 
unit is not used on Day 0, it will be cryopreserved at the site and can be used in the event of 
non-engraftment, or delayed engraftment. If unused, the reserve dose may be disposed of in 
accordance with institutional practices. 
3.7 
Transfusion and Support Guidelines 
The following guidelines for platelet and red blood cell (RBC) transfusions will be followed 
starting on Day 0: 
• Platelet and RBC transfusion technical support will be dictated by Institutional guidelines 
including product irradiation and CMV status of transfused product;  
• Platelet threshold transfusion guidelines:  
o A threshold of 10 ×109/L for prophylactic platelet transfusion; 
o A threshold of 20 ×109/L for fever, sepsis, splenomegaly, and other well-established causes 
of increased platelet consumption; 
o A threshold of >50 ×109/L if an invasive procedure is planned; 
o Single donor platelets should be used in preference to random donor platelets, if feasible; 
and 
o HLA-matched platelets should be used in subjects with allo-immunization; 
• Red blood cell transfusion guidelines:  
o An attempt should be made to maintain the hematocrit ≥24% and hemoglobin >8 g/dL, or 
higher in cases of symptomatic management of anemia or other medically indicated 
indications; and 
• Filgrastim (granulocyte-colony stimulating factor) can be administered at 5 µg/kg/day 
beginning on Day +12, if engraftment has not occurred, until the ANC is >500 cells/µL. At 
Investigator discretion, filgrastim can be administered longer to support the white blood cells. 
Similarly, per Investigator discretion, filgrastim may be started before Day +12 if subsequent 
doses of methotrexate will not be administered due to severe mucositis, other toxicity, or severe 
infection. 
 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
49 
4 
SELECTION AND WITHDRAWAL OF SUBJECTS 
4.1 
Inclusion Criteria for the Phase 1 Part of the Study and the Phase 2 Part of the 
Study 
Subjects who meet all of the following criteria will be eligible to participate in the study: 
1. Male and female subjects aged 18 years and older;  
2. Subjects must have a hematologic malignancy for which allogeneic hematopoietic peripheral 
blood cell transplantation is deemed clinically appropriate. Eligible diseases and stages include 
and are limited to the following:  
• Acute myeloid leukemia in first complete remission (CR) (CR1) or second CR (CR2): 
o CR is defined as ≤5% BM blasts with no morphological characteristics of acute 
leukemia (e.g., Auer Rods) in BM with ≥5% cellularity with normal peripheral blood 
counts; or 
o Morphologic CR (≤5% BM blasts) with incomplete blood count recovery; 
• Acute lymphoblastic leukemia (ALL), including T lymphoblastic lymphoma with a history 
of marrow involvement in CR1 or CR2: 
o CR is defined as ≤5% blasts with no morphological characteristics of acute leukemia 
in a BM with ≥5% cellularity;  
• Myelodysplastic syndrome (MDS); or 
• Chronic myelogenous leukemia (CML); 
3. Availability of a suitable 8/8 HLA-A, -B, -C, and -DRB1-matched unrelated mPB donor; 
4. Subjects must have an mPB donor collection unit without using plerixafor (Mozobil™) that is 
≥5 × 106 CD34+ cells/kg in Phase 1 and ≥3 × 106 CD34+ cells/kg in Phase 2;  
5. Adequate performance status, defined as Karnofsky score ≥70%;  
6. For female subjects of childbearing potential, all of the following criteria must be met: 
• They are not pregnant (i.e., female subjects must have a negative serum pregnancy test at 
screening);  
• They are not breastfeeding;  
• They do not plan to become pregnant during the study; and 
• They are using an effective method of contraception from screening to the end of the study, 
unless their sexual partner is surgically sterile. Effective methods of preventing pregnancy 
are those contraceptive methods with a Pearl index of <1 used consistently and correctly 
(including, but not limited to, implantable contraceptives, injectable contraceptives, oral 
contraceptives, and transdermal contraceptives); 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
50 
Women are not considered to be of childbearing potential if they meet 1 of the following 
2 criteria, as documented by the Investigator: 
• They have had a hysterectomy, bilateral salpingectomy, or bilateral oophorectomy at 
minimum 1 menstrual cycle prior to signing the ICF; or 
• They are post-menopausal, defined as ≥1 year since their last menstrual period for women 
≥55 years of age or ≥1 year since their last menstrual period; and 
7. For male subjects, agreement to use condoms with spermicide during sexual intercourse from 
screening to the end of study; and 
8. Willingness and ability to sign an IRB/IEC-approved ICF before performance of any study 
specific procedures or tests and to comply with protocol visits, and study procedures. 
4.2 
Exclusion Criteria for the Phase 1 Part of the Study and the Phase 2 Part of the 
Study 
Subjects who meet any of the following criteria will be excluded from participation in the study:  
1. Phase 1 only: Known bone marrow fibrosis; Phase 2 only: Bone marrow fibrosis grade 3 
(severe) or greater; 
2. Positive serology for human immunodeficiency virus (HIV) or human T-cell lymphotropic 
virus (HTLV) at any time prior to enrollment;  
3. Current uncontrolled bacterial, viral, or fungal infection (progression of clinical symptoms 
despite therapy);  
4. Prior autologous or allogeneic HCT;  
5. Active malignancy, other than the one for which the allogeneic mPB transplant is being 
performed, within 12 months of enrollment, excluding superficial basal cell and carcinoma 
in situ cervical cancer;  
6. Pulmonary disease such as symptomatic chronic obstructive lung disease, symptomatic 
restrictive lung disease, or FVC and FEV1 <50%, or hemoglobin corrected diffusing capacity 
of the lung of <50% of predicted value;  
7. Renal dysfunction defined as a calculated creatinine clearance <40 mL/min (Cockroft-Gault 
equation);  
8. Hepatic disease defined as total serum bilirubin >2.0 mg/dL (except in the case of Gilbert’s 
syndrome or ongoing hemolytic anemia), or aspartate aminotransferase (AST) or alanine 
aminotransferase (ALT) >2.0 × the upper limit of normal;  
9. Cardiac disease defined as symptomatic congestive heart failure (New York Heart Association 
[NYHA] Class III/IV) or evidence of left ventricular dysfunction (ejection fraction <45%) as 
measured by gated radionuclide ventriculogram or echocardiogram (ECHO); active angina 
pectoris or uncontrolled hypertension; or history of myocardial infarction with depressed 
ejection fraction;  
10. Neurologic disease, defined as symptomatic leukoencephalopathy, active central nervous 
system malignancy, or other neuropsychiatric abnormalities believed to preclude 
transplantation;  

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
51 
11. Participation in another clinical trial involving an investigational product within 30 days prior 
to transplant; or 
12. Any condition or therapy, which, in the opinion of the Investigator, might pose a risk to the 
subject or make participation in the study not in the best interest of the subject (e.g., known 
allergy to human serum albumin [HSA]). 
4.3 
Withdrawal Criteria 
A subject may voluntarily withdraw from the study at any time and without prejudice to his or her 
future medical care by the Investigator or at the institution. The Investigator, at his or her 
discretion, may withdraw a subject from participating in the study. 
Participation of a subject in this clinical study can be discontinued for any of the following reasons: 
1. The subject withdraws consent or requests discontinuation from the study for any reason;  
2. Occurrence of any medical condition or circumstance that exposes the subject to substantial 
risk and/or does not allow the subject to adhere to the requirements of the protocol;  
3. Any serious adverse event (SAE), clinically significant adverse event, severe laboratory 
abnormality, intercurrent illness, or other medical condition which indicates to the Investigator 
that continued participation is not in the best interest of the subject;  
4. Pregnancy; 
5. Requirement of prohibited concomitant medication;  
6. Subject failure to comply with protocol requirements or study-related procedures, including 
lost to follow-up; 
7. Other safety or ethical reasons; or 
8. Discontinuation of the study by the Sponsor or the regulatory authority. 
If a subject withdraws prematurely from the study due to the above criteria or any other reason, 
study staff should make every effort to complete the full panel of assessments scheduled for the 
Early Withdrawal Visit. The date and reason for subject withdrawal from the study must be 
documented in the electronic Case Report Form (eCRF). 
In the case of subjects lost to follow-up, attempts to contact the subject must be made and 
documented in the subject’s medical records. 
If a subject withdraws from the study after transplantation, information regarding secondary graft 
failure, disease relapse, serious adverse events involving GvHD and infections, and survival 
outcomes will be collected on Days +180, +365, and +730 by phone. 
If the subject relapses and/or receives non-protocol therapy, the subject will be withdrawn. 
However, survival will still be collected unless the subject withdraws consent, in which case 
survival outcomes will be obtained via public record search. 
If the Sponsor discontinues the study, the Investigator should notify the IRB/IEC in writing of the 
study’s completion or discontinuation and send a copy of the notification to the Sponsor. 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
52 
4.4 
Screen Failures and Subject Replacement 
A screen failure is any subject who signs consent but fails to meet at least one of the eligibility 
requirements during screening and whose donor cells are not processed as ProTmune or Control. 
This may occur for many reasons, such as:  
• The donor unit does not meet requirements for ProTmune (or Control) processing, such as 
CD34+ count of the mPB unit is lower than specified in the protocol or cannot be processed 
prior to the expiration of the unit,  
• The donor requires plerixafor for mobilization of peripheral blood. 
In all cases, the subject will be considered a screen-failure, will not continue in study and will be 
replaced.  If this occurs after randomization in the Phase 2 portion of the study, a new subject will 
be randomized. 
In the event ProTmune/Control manufacturing produces a ProTmune/Control unit that does not 
meet release specifications (e.g. for ProTmune, <2 × 106 CD34+ cells/kg recipient weight, <70% 
viable) and the ProTmune/Control unit is not administered, the subject will be withdrawn from the 
study and a new subject will be added for the Phase 1 portion of the study. If this occurs in the 
Phase 2 portion of the study, the subject will be replaced and a new subject will be randomized in 
order to have approximately 80 treated subjects. 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
53 
5 
STUDY TREATMENTS 
5.1 
Treatment Groups 
5.1.1 
Study Treatment Groups for the Phase 1 Part of the Study 
For the Phase 1 part of the study, 6 to 10 subjects will receive a single unit of ProTmune ex vivo 
programmed mPB cells as the cell source for the HCT procedure at Day 0. 
5.1.2 
Study Treatment Groups for the Phase 2 Part of the Study 
For the Phase 2 part of the study of the study, all eligible subjects will receive either a single unit 
of ProTmune ex vivo programmed mPB cells or a single unit of unmanipulated mPB cells, based 
upon the subject’s randomized treatment allocation.  
5.2 
Rationale for Dosing 
According to the American Society of Blood & Marrow Transplant, the absolute cell threshold to 
guarantee engraftment is not specifically known. The minimally accepted cells dose is 
2 × 106 CD34+ cells/kg. The literature reports successful engraftment can occur at doses as low as 
0.75 × 106 CD34+ cells/kg. However, higher doses are associated with faster engraftment, reduced 
rates of infection, and NRM. Therefore, the Sponsor has selected a target minimum treatment dose 
of ≥2 × 106 CD34+ cells/kg.  
5.3 
Randomization and Blinding 
5.3.1 
Randomization and Blinding for the Phase 1 Part of the Study 
Randomization and blinding for the Phase 1 part of the study are not applicable. The Phase 1 part 
of the study is nonrandomized and open-label. 
5.3.2 
Randomization and Blinding for the Phase 2 Part of the Study 
For the Phase 2 part of the study, approximately 90 subjects who have an available 8/8 HLA-A, -B, 
-C, and -DRB1-matched unrelated peripheral blood cell donor will be randomly assigned in a 
1:1 ratio to result in approximately 80 treated subjects (40 subjects per treatment group) to receive 
either unmanipulated mPB cells (control arm) or ProTmune ex vivo programmed mPB cells 
(experimental arm) and stratified by the subjects' CMV status. Randomization will be performed 
during the Subject Conditioning Period once the central lab CMV results are known and must 
occur no later than Day -7.  
Treatment assignment in Phase 2 will be blinded to Investigator, subject and Sponsor, but not Cell 
Processing Facility (CPF) staff. To blind the Investigator and subject, ProTmune and control mPB 
units will be prepared by the CPF as described in the cell processing batch records and then sent 
to the treatment area in the afternoon for administration to the subject. Infusion of the control unit 
will be held until the afternoon of the subject’s Day 0 to mimic the processing time of ProTmune. 
The ProTmune unit and Control unit will look similar. Both ProTmune and Control will be placed 
in 400 mL blood transfer bags. The volume of each unit may be reduced or increased to achieve a 
final volume of 250 mL; volume increases will be achieved by addition of PlasmaLyte-A (or 
equivalent) with 4.2% - 5% HSA according to the Batch Production record and site protocol.  The 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
54 
blood transfer bags will be labeled with a Fate-provided product label that will maintain the blind 
to investigator and subject. 
5.4 
Breaking the Blind 
The Phase 1 part of the study is not blinded, and although the Phase 2 part of the study is blinded, 
it is likely not necessary to break the blind to the Investigator or subject as knowledge of the single-
dose treatment assignment would not impact any aspects of subject management. Should the 
Investigator require the treatment assignment, the following unblinding procedure must be 
followed: 
1. Locate the sealed envelope that contains the 6-digit unblinding authorization code provided 
to your site, 
2. Log into the ClinTrak interactive response technology (IRT) database and select the 
“Unblind a Patient (Emergency Only)” action, 
3. Select the subject number from the drop-down menu and enter the 6-digit code, 
4. The treatment assignment will be provided by the system and a notification of unblinding 
will be sent to the study Sponsor and CRO.  
Note: The Investigator must print and file the unblinding notification within the subject’s source 
documentation along with a written rationale for the necessity to unblind the subject. A new sealed 
envelope with a 6-digit unblinding authorization code will be sent to the site for use with future 
subjects. 
5.5 
Drug Supplies 
5.5.1 
Formulation and Packaging 
ProTmune is a donor-sourced, patient-specific, allogeneic cell therapy product consisting of the 
cells contained within a human mobilized peripheral blood (mPB) collection that have been 
programmed through an ex vivo programming process using a combination of 2 small molecules, 
16,16-dimethyl prostaglandin E2 (FT1050) and dexamethasone (FT4145). The cell populations 
include hematopoietic cells and other cell types. The final ProTmune product is formulated in 
Plasmalyte-A (or equivalent) and HSA. Refer to the ProTmune IB for specific details regarding 
the manufacture and release testing of the investigational product. 
Control cells will be comprised of an unmanipulated mPB unit that is visually indistinguishable 
from ProTmune.  Both ProTmune and Control will be placed in 400 mL blood transfer bags. The 
volume of each unit may be reduced or increased to achieve a final volume of 250 mL; volume 
increases will be achieved by addition of PlasmaLyte-A (or equivalent) with 4.2% - 5% HSA 
according to the Batch Production record and the site protocol. The blood transfer bags will be 
labeled with a Fate-provided product label that will maintain the blind to investigator and subject. 
Fate has established specific criteria that will be used to assess the suitability of all mPB units 
collected for ex vivo programming or Control. 
The CPF at each participating site will be qualified and trained by Fate technical staff to 
manufacture the investigational product on site via the performance of a single ProTmune 
qualification run. Additionally, Fate technical representative(s) will be on site for the manufacture 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
55 
of each CPF’s first or second subject treatments and subsequent subject treatments as necessary 
by the CPF or Fate. 
ProTmune ex vivo programmed mPB cells (or Control) will be released immediately by the CPF 
staff after final processing, including filtration, final packaging, and rapid release testing, and 
labeling. If the product does not meet Fate’s pre-defined rapid release acceptance criteria, the CPF 
will immediately contact Fate Manufacturing and the Investigator to make a prompt decision on 
use of the investigational product. Exceptional use of investigational product when specification 
is not met will be documented by the CPF with signature approval documented by the Investigator. 
Refer to the ProTmune IB for a description of release testing criteria. 
The final container of the investigational product will be labeled by the CPF using a Fate-approved 
label. A photocopy of the investigational product label will be retained by the CPF. If additional 
labeling is required by the clinical site or CPF, this labeling must be distinct from the Fate product 
label. 
5.5.2 
Study Drug Preparation and Dispensing 
Mobilized peripheral blood cells will be obtained from a matched-unrelated donor for a given 
subject. An 8/8 high resolution allelic HLA-match of HLA-A, -B, -C, and -DRB1 with recipient 
is required. Sites will request that consenting donors be mobilized with filgrastim to achieve a 
target collected CD34+ dose of ≥7 × 106 CD34+ cells/kg in Phase 1 and ≥5 × 106 CD34+ cells/kg 
in Phase 2. However, if the donor mPB unit collected for a subject in Phase 1 is not 
≥5 × 106 CD34+ cells/kg recipient weight, and in Phase 2 is not ≥3 × 106 CD34+ cells/kg recipient 
weight, the mPB unit will not be processed for ProTmune manufacturing and the subject will be 
considered a screen failure. 
For subjects enrolled in the Phase 1 part of the study, a reserve dose of 2 × 106 CD34+ cells/kg 
recipient weight will be maintained during ProTmune manufacturing to serve as a reserve in the 
event ProTmune manufacturing produces a ProTmune unit that does not meet ProTmune release 
specifications (e.g., <2 × 106 CD34+ cells/kg recipient weight, <70% viable). In this case, the 
ProTmune unit will be considered “unavailable” and count towards the Phase 1 stopping rules. 
The reserve unit must be administered; however, the Principal Investigator should follow their 
Institution’s standard operating procedure to determine whether the ProTmune unit should also be 
given to the recipient based on the risk-benefit assessment of administering the product with regard 
to the specification not being met. If the ProTmune unit is not administered, the subject will be 
withdrawn from study and replaced. If the ProTmune unit is administered, the subject will remain 
in study but will not be considered in the following assessment. If after 6 subjects have been dosed 
and evaluated for up to 28 days and ≤1 subject has not engrafted by Day +28, then enrollment in 
the Phase 2 portion of the study may proceed following IDMC review. If the reserve unit is not 
used on Day 0, it will be cryopreserved at the site and can be used in the event of non-engraftment, 
or delayed engraftment. 
For subjects enrolled in the Phase 2 part of the study in the event ProTmune manufacturing 
produces a ProTmune unit that does not meet ProTmune release specifications (e.g., 
<2 × 106 CD34+ cells/kg recipient weight, <70% viable), the ProTmune unit will be considered 
“unavailable” and count towards the Phase 2 stopping rules. The Principal Investigator should 
follow their Institution’s standard operating procedure to determine whether the unit should be 
given to the recipient based on the risk-benefit assessment of administering the product with regard 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
56 
to the specification not being met. If the ProTmune or Control unit is not administered, or a subject 
is withdrawn from participation in the study prior to Day 0, the subject will be replaced and a new 
subject will be randomized in order to have approximately 60 treated subjects.  If the ProTmune 
or Control unit is administered, the subject will remain in study. 
5.5.3 
Study Drug Administration 
Prior to infusion of ProTmune or Control, the subject will be pre-medicated 30 to 60 minutes 
before the administration of ProTmune or Control based upon institutional standards (e.g., 
acetaminophen, diphenhydramine, or H2 blockers).  
Upon receipt of the infusion of ProTmune or Control, the chain of custody documentation should 
be completed to confirm that the specified unit of ProTmune is the correct product for the subject 
by checking both the product label and the subject’s identity, and the product should be inspected 
for any irregularities such as visible particulates or leakage from the container. Any irregularities 
noted should be immediately discussed with the CPF and with the Sponsor that issued the product 
for infusion to determine whether the product is safe for infusion. 
ProTmune cells have already been filtered by the CPF and therefore should NOT be filtered during 
administration. If the investigational product meets release criteria, it should be administered by 
IV infusion via gravity. The investigational product should not be administered in the same tubing 
concurrently with products or solutions other than 0.9% Sodium Chloride, Injection (USP). The 
ProTmune investigational product should be infused at approximately 5 mL to 15 mL per minute, 
for a total infusion time of approximately 15 to 50 minutes. If the infusion of investigational 
product is not complete by 30 minutes, the contents of the bag should be mixed by gently 
massaging the bag once 30 minutes after start of infusion. The infusion rate should be reduced if 
the fluid load is not tolerated. Diuretics may be used to prevent volume overload. The infusion 
should be held if the subject develops a clinically significant infusion reaction that requires 
intervention. The infusion can be restarted if the reaction resolves, based upon the Investigator’s 
medical judgment. 
5.5.4 
Treatment Compliance 
Only qualified members of the study team should administer the study treatment to eligible 
subjects.  
The conditioning 
regimen, 
GvHD 
prophylaxis, 
GvHD 
treatments 
and 
any 
other 
immunosuppression should be documented in the eCRF for each subject. The start and stop dates 
and start and stop times of the conditioning regimen (including dosages of chemotherapy and TBI), 
GvHD prophylaxis and GvHD treatments should be documented in the eCRF for each subject.  
The CD34+ cell dose administered will be documented in the eCRF. 
If the reserve cell dose was used, this must be documented in the eCRF. 
The start and stop date and start and stop times of the HCT, including whether the HCT was 
completed, should be documented in the eCRF for each subject. 
5.5.5 
Storage and Accountability 
The Sponsor will supply all reagents and manufacturing supplies that are necessary for ProTmune 
preparation to all study sites.  

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
57 
It is the responsibility of the Investigator to supervise accurate monitoring of the receipt, storage, 
dispensing, and accounting of all supplies. Sites must retain accurate, original site records of study 
supplies, inventory, and copies of all invoices of study supplies, shipments, and records of 
investigational product disposition.  
Supplies accountability forms will be provided for tracking study supplies such as FT1050 and 
FT4145. 
Each site must keep all unused study supplies until the Site Monitor either arranges return to the 
Sponsor or gives instructions pertaining to its disposition. 
During Phase 1 each site will label, cryopreserve and store the frozen reserve unit for each subject, 
if unused the reserve dose may be disposed in accordance with institutional practices. 
5.6 
Prior and Concomitant Medications and/or Procedures 
5.6.1 
Prohibited Medications and/or Procedures for the Phase 1 Part of the Study and 
Phase 2 Part of the Study 
Subjects may not receive the following concurrent medications or procedures unless otherwise 
noted: 
• Treatment with non-protocol mandated cytotoxic/myelosuppressive or investigational therapy 
from Day -30 onwards,  
EXCEPTIONS:  
o The use of tyrosine kinase inhibitors (TKIs) against Bcr-Abl & FLT3, for maintenance 
therapy in eligible subjects are permitted prior to Day -14 and then again after neutrophil 
engraftment.  
o Following transplant, enrollment into acute GvHD-treatment studies will be allowed for 
subjects with steroid-refractory GvHD. 
• Non-protocol induction radiation therapy, 
o  EXCEPTION: palliative radiation therapy is allowed. 
• Anti-thymocyte globulin, 
•  GvHD prophylaxis not specified per the protocol, or  
• mPB units from donors that required plerixafor for mobilization. 
5.6.2 
Documentation of Prior and Concomitant Medication Use for the Phase 1 Part of the 
Study and Phase 2 Part of the Study 
All concomitant medications will be recorded starting at Day -30 through Day +100. From 
Day +100 through Day +730, only concomitant medications given as TKI maintenance, or that 
were ongoing at the time of, and for the treatment of, an AE of GvHD, infection or secondary 
engraftment failure or any SAE, will be recorded.  
All medications taken up to 30 days prior to Day 0 and throughout the study will be captured in 
the eCRFs. Examples include the following: 
• Conditioning and immunosuppressive agents and medications,  

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
58 
• Premedications for ProTmune or Control unit infusion,  
• Transfusions,  
• GvHD prophylaxis and treatment, and  
• Medications taken for a reportable adverse event. 
Pre-emptive CMV therapy may be provided based upon institutional methodologies, Standard 
Operating Procedures, and clinical context. An additional blood sample for CMV testing will be 
collected prior to starting the preemptive therapy and sent for central laboratory testing and prior 
to starting the preemptive therapy.  
Filgrastim can be administered at 5 µg/kg/day beginning on Day +12, if ANC <500 cells/µL, until 
the ANC is >500 cells/µL. At Investigator discretion, filgrastim can be administered longer to 
support the white blood cells. Similarly, per Investigator discretion, filgrastim can be started before 
Day +12 if subsequent doses of methotrexate will not be administered due to severe mucositis, 
other toxicity, or severe infection. 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
59 
6 
STUDY PROCEDURES 
For a study visit schedule in tabular format for the Phase 1 part of the study and Phase 2 part of 
the study, refer to Appendix A. 
 
6.1 
Informed Consent 
6.1.1 
Informed Consent for the Phase 1 Part of the Study and Phase 2 Part of the Study 
Prior to any study-related activities that are not standard of care (e.g., before administration of the 
study treatment) the subject or subject’s legal representative must review, sign, and date an 
IRB/IEC-approved ICF. The format and content of the subject ICF must be agreed upon by the 
Investigators, the appropriate IRB/IEC, and the Sponsor. 
The original signed ICFs (together with any subsequent IRB/IEC-approved amended versions) 
must be retained by the Investigator in the subject’s study file. A copy of the original signed and 
dated ICF must be given to the subject. 
6.2 
Screening Period (Day -53 to Day -11) 
6.2.1 
Screening Period (Day -53 to Day -11) for the Phase 1 Part of the Study and Phase 2 
Part of the Study 
For the Phase 1 part of the study and Phase 2 part of the study, all subjects will undergo screening 
procedures once they have given their written, informed consent to participate in the study. 
Screening procedures must be completed within 6 weeks prior to initiation of conditioning 
regimen. 
Upon completion of all screening procedures and determination of eligibility, subjects will be 
scheduled for administration of conditioning regimen and admission for transplant, per 
institutional procedures. A screening log will be maintained to record the reasons for exclusion 
from study for all subjects who sign the informed consent and undergo screening. 
There may be situations in which a subject is not able to begin the conditioning within 6 weeks of 
the study screening. In these instances, the subject may need to be re-screened. This will involve 
repeating select or all screening procedures, as advised by the Medical Monitor. 
The following procedures and assessments will be performed during the Screening Period (Day -53 
to Day -11) for the Phase 1 part of the study and Phase 2 part of the study (refer to Appendix A 
for details): 
• Informed Consent will be obtained from all subjects prior to the initiation of any study 
procedures or tests;  
• Inclusion and Exclusion Criteria will be reviewed and completed for subject registration; 
• Investigator is required to verify that the subject completed HLA typing (HLA typing can be 
completed prior to the Screening Period); 
• ECHO or multiple gated acquisition (MUGA) scan (to assess left ventricular ejection fraction 
or shortening fraction) will be obtained if not completed within 6 weeks prior to the Subject 
Conditioning Period, from Day -53 to Day -11; 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
60 
• Demographics and medical history, including prior treatment history information for 
hematological malignancy, will be reviewed and recorded; 
• Qualification of mPB unit by Fate representative;  
• Karnofsky Performance Status (Appendix D) will be assessed;  
• Bone marrow aspirate will be performed and sent to pathology and cytogenetics; 
• All subjects will be tested for baseline CMV antibody titer (immunoglobulin [Ig]G/IgM) and 
plasma CMV viremia. This baseline testing will be performed by a central laboratory and 
results will be provided to the clinical site prior to the initiation of randomization; 
• A complete physical examination will be performed;  
• Vital signs (systolic and diastolic blood pressure, pulse rate, respiratory rate, and temperature) 
will be obtained;  
• 12-lead triplicate ECG will be obtained;  
• All concomitant medications will be recorded starting at Day -30 (through Day +100); 
• Pulmonary function tests will be performed; and 
• Peripheral blood sample(s) will be collected for the following:  
o Blood typing and RBC antibody screen, 
o Safety laboratory tests (hematology [CBC and when possible per Institutional practice to 
include a differential (automated or manual)] and serum chemistry panels), 
o Infectious disease titers, 
o Immune reconstitution assays, and 
o Serum pregnancy testing for females of child-bearing potential. 
For the Phase 2 part of the study only: after meeting eligibility and results of the central lab 
CMV antibody titer are available, subjects will be randomized to either the control arm or 
ProTmune arm no later than Day -7. 
6.3 
Subject Conditioning (Day -10 to Day -1) 
6.3.1 
Subject Conditioning (Day -10 to Day -1) for the Phase 1 Part of the Study and 
Phase 2 Part of the Study 
For the Phase 1 part of the study and Phase 2 part of the study, the following procedures will be 
performed for subjects who are enrolled, meet the eligibility criteria, and randomized, in 
preparation for the subject’s transplant: 
• Medical history will be updated prior to start of conditioning regimen; 
• All SAEs will be recorded; 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
61 
• Starting on Day -10, adverse events will be collected as per CTCAE 4.0, AE of infections will 
use both the CTCAE and the BMTN CT criteria as follows: Adverse events associated with 
infusion reactions, GvHD, infections, or engraftment failure (Grades 1 through 5). All other 
adverse events (Grades 2 through 5). Laboratory abnormalities will only be recorded as adverse 
events if deemed clinically significant by the Investigator; 
• A complete physical examination will be performed;  
• Vital signs will be collected and recorded;  
• Concomitant medications will be reviewed and recorded; 
• For pre-emptive CMV therapy, 2 peripheral blood samples (1 blood sample to be utilized 
locally at the site for subject management and 1 blood sample for central laboratory testing) 
will be collected for CMV assessments of DNA by quantitative PCR prior to starting the 
preemptive therapy;  
• Subject conditioning will include 1 of the following 5 preparative regimens: 
o CyTBI, with ≥12 Gy fractionated TBI; 
o BuCy where Bu = 16 mg/kg PO or 12.8 mg/kg IV infusion (Pharmacokinetic assessment 
and dose adjustment of Bu can be based on a test dose or the first dose and will be 
conducted according to institutional practices); 
o FluBu4 with Bu as above; 
o TBI with etoposide; or 
o FluMel 140; and 
• GvHD prophylaxis will be initiated (see Section 3.4); and 
• Randomization of subject within Interactive Web Response Services (IWRS) will be 
performed once the central lab screening CMV results are known and must occur no later than 
Day -7. 
6.4 
Hospital Admission (Institution Policy) 
6.4.1 
Hospital Admission (Institution Policy) for the Phase 1 Part of the Study and Phase 2 
Part of the Study 
The following procedures will be performed at the time of Hospital Admission:  
• Subject will be admitted to the hospital unit; 
• Medical history will be updated;  
• All SAEs will be recorded; 
• Adverse events will be collected as per CTCAE 4.0, AE of infections will use both the CTCAE 
and the BMTN CT criteria as follows: Adverse events associated with infusion reactions, 
GvHD, infections, or engraftment failure (Grades 1 through 5). All other adverse events 
(Grades 2 through 5). Laboratory abnormalities will only be recorded as adverse events if 
deemed clinically significant by the Investigator; 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
62 
• A complete physical examination will be performed;  
• Vital signs will be collected and recorded;  
• All concomitant medications will be reviewed and recorded; and 
• Peripheral blood samples will be collected for safety laboratory tests (hematology [CBC and 
when possible per Institutional practice to include a differential (automated or manual)] and 
serum chemistry panels). 
6.5 
Study Treatment Administration: Day of Hematopoietic Stem Cell Transplant 
(Day 0) 
6.5.1 
Study Treatment Administration: Day of Hematopoietic Stem Cell Transplant (Day 0) 
for the Phase 1 Part of the Study and Phase 2 Part of the Study 
The following assessments and procedures will be performed on Day 0: 
• A subset of follow-up physical examination assessments will be performed prior to HCT; 
• Vital signs will be obtained prior to infusion of investigational product, and at 15, 30, 45, and 
60 minutes after the start of infusion of investigational product (Note: these are targeted 
collection times; protocol deviations will only be documented when a collection is missed); 
• A 12-lead triplicate ECG will be obtained prior to HCT; 
• All concomitant medications will be reviewed and recorded; 
• Peripheral blood samples will be collected for safety laboratory tests (hematology [CBC and 
when possible per Institutional practice to include a differential (automated or manual)] and 
serum chemistry panels) prior to HCT; 
• Investigational product will be prepared; 
• Subject will receive transplant; 
• Karnofsky Performance Status (Appendix D) will be assessed after HCT; and 
• All SAEs will be recorded; 
• Adverse events will be collected as per CTCAE 4.0, AE of infections will use both the CTCAE 
and BMTN CT criteria as follows: Adverse events associated with infusion reactions, GvHD, 
infections, or engraftment failure (Grades 1 through 5). All other adverse events (Grades 2 
through 5). Laboratory abnormalities will only be recorded as adverse events if deemed 
clinically significant by the Investigator. 
6.6 
Post-Transplant Assessment Days 
6.6.1 
Post-Transplant Assessment Days for the Phase 1 Part of the Study and Phase 2 
Part of the Study 
Post-transplant visit windows are as follows: ±3 days for Day +7 through Day +100; ±14 days for 
Day +180; and ±28 days for Days +270, +365, and +730. 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
63 
The Day +730 visit will occur by conducting a telephone contact report for capture of survival 
status and adverse event reporting. 
The following procedures will be performed at the time points as described in Appendix A:  
• A subset of follow-up physical examination assessments (with the exception of height) will be 
performed weekly from Day +1 through Day +28; 
• Vital signs will be obtained weekly from Day +1 through Day +28; 
• All concomitant medications will be recorded (starting at Day -30) through Day +100. From 
Day +100 through Day +730, only concomitant medications given as TKI maintenance, or that 
were ongoing at the time of, and for the treatment of, an AE of GvHD, infection or secondary 
engraftment failure or any SAE, will be recorded; 
• Karnofsky Performance Status (Appendix D) will be assessed at all subsequent study visits 
after HCT up through Day +365 (which should include weekly assessments from Day +1 
through Day +28); 
• A peripheral blood sample for hematology (CBC and when possible per Institutional practice 
to include a differential (automated or manual)) will be collected daily from Day +1 through 
Day +28 (or until the subject achieves neutrophil engraftment, whichever event occurs first; 
following engraftment, blood for hematology is to be collected per institutional policy);  
• A 12-lead triplicate ECG will be obtained at Day +100; 
• All SAEs will be recorded; 
• Through Day +100, adverse events will be collected as per CTCAE 4.0, AE of infections will 
use both CTCAE and BMTN CT criteria as follows: Adverse events associated with infusion 
reactions, GvHD, infections, or engraftment failure (Grades 1 through 5). All other adverse 
events (Grades 2 through 5). Laboratory abnormalities will only be recorded as adverse events 
if deemed clinically significant by the Investigator; and 
• From Day +100 through Day +365: Only adverse events associated with GvHD, infections, or 
secondary engraftment failure (Grades 1 through 5).  
6.7 
Post-Transplant Weekly Assessments 
6.7.1 
Post-Transplant Weekly Visits for the Phase 1 Part of the Study and Phase 2 Part of 
the Study 
Post-transplant visit windows are as follows: ±3 days for Day +7 through Day +100; ±14 days for 
Day +180; and ±28 days for Days +270, +365, and +730. 
Standard post-transplant testing will be performed per institutional guidelines and good clinical 
practice. 
The following assessments will be performed at the time points as described in Appendix A: 
• A subset of follow-up physical examination assessments (with the exception of height) will be 
performed weekly from Day +35 through Day +91, then on Days +100, +180, +270, and +365; 
• The Day +730 visit will occur by conducting a telephone contact report for capture of survival 
status and adverse event reporting; 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
64 
• Vital signs will be obtained weekly from Day +35 through Day +91, then on Days +100, +180, 
+270, and +365; 
• All concomitant medications will be recorded (starting at Day -30) through Day +100. From 
Day +100 through Day +730, only concomitant medications given as TKI maintenance, or that 
were ongoing at the time of, and for the treatment of, an AE of GvHD, infection or secondary 
engraftment failure or any SAE, will be recorded; 
• Bone marrow aspirate will be sent to pathology and to cytogenetics on Day +21 (only if ANC 
<500/µL), and as clinically indicated (flow cytometry is required on BM aspirate);  
• Karnofsky Performance Status (Appendix D) will be assessed at all subsequent study visits 
after HCT up through Day +365 (which should include weekly assessments from Day +1 
through Day +91, then on Days +100, +180, +270, and +365); 
• A peripheral blood sample for hematology (CBC and when possible per Institutional practice 
to include a differential (automated or manual)) will be collected on Days +35, +42, +49, +56, 
+63, +70, +77, +84, +100, +180, and +365;  
• A peripheral blood sample for serum chemistry panels will be collected weekly from Day +1 
through Day +100, then at Day +180; 
• Two peripheral blood samples at each testing time point (1 blood sample to be utilized locally, 
per institutional policy as required, at the site for subject management and 1 blood sample for 
central laboratory testing) will be collected for viral assessments of DNA by quantitative PCR 
for EBV, CMV, HHV-6, and BK virus weekly from Day +7 through Day +100, and at Days 
+180, +270, and +365; 
• Peripheral blood samples for immune reconstitution assays will be collected at Days +7, +14, 
+28, +56, +91, +180, +270, and +365. The peripheral blood sample will be sent to a central 
laboratory for analysis; 
• All SAEs will be recorded; 
• Through Day +100, adverse events will be collected as per CTCAE 4.0, AE of infections will 
use both the CTCAE and BMTN CT criteria as follows: Adverse events associated with 
infusion reactions, GvHD, infections, or engraftment failure (Grades 1 through 5). All other 
adverse events (Grades 2 through 5). Laboratory abnormalities will only be recorded as adverse 
events if deemed clinically significant by the Investigator;  
• From Day +100 through Day +365: Only adverse events associated with GvHD, infections, or 
secondary engraftment failure (Grades 1 through 5); 
• Clinical and laboratory assessments of aGvHD will be performed weekly from Day +1 through 
Day +100, and on Day +180. Acute GvHD assessments (incidence and maximum severity) of 
Grades I through IV of the skin, liver, and gut as per the CIBMTR aGvHD Grading Scale 
(Appendix E) will be performed; 
• Chronic GvHD assessments (incidence and maximum severity) of mild, moderate, or severe 
cGvHD as per NIH Consensus Criteria for cGvHD (Appendix F) will be performed on 
Days +180, +270, and +365;  

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
65 
• Peripheral blood samples will be collected for CMV assessments of DNA by quantitative PCR 
weekly from Days +7 through Day +100, and at Days +180, +270, and +365. Assessment of 
infection will be performed based on the NCI CTCAE and the BMT CTN Definitions;  
• Neutrophil and T-cell chimerism will be assessed on the third consecutive day of ANC 
>500 cells/µL (neutrophil only) and on Days +28, +100, +180, and +365 (both neutrophil and 
T-cell): 
o When feasible, fractional chimerism (total, myeloid, lymphoid) will be performed from 
peripheral blood samples; 
o If there is no evidence for donor engraftment by Day +21, then the subject will undergo 
BM and peripheral blood chimerism studies; and 
o If donor engraftment is not present by Day +28 BM examination, and the subject’s disease 
is not present, the subject should be considered a primary graft failure (in the absence of 
relapsed disease); 
• Serum IgG, IgM, and IgA will be collected by a peripheral blood sample at Days +100, +180, 
and +365; and 
• Peripheral blood samples for GvHD exploratory biomarkers will be obtained once weekly from 
Days +7 through Day +42, then on Day +100. Samples will be banked. 
6.8 
Unscheduled visits 
An unscheduled visit is a visit that occurs in addition to the predefined protocol specific visit 
calendar. If an unscheduled visit occurs for a given subject, the visit must be documented on the 
Unscheduled Visit CRF.  
6.9 
Early Withdrawal Visit and Study Withdrawal Procedures 
If a subject withdraws or is withdrawn from the study prior to Day 0, the subject’s mPB will not 
be processed to a unit of ProTmune or Control cells, and the subject will not be considered 
evaluable for any study-related endpoint analyses. If this occurs in the Phase 2 portion of the study 
and the subject was already randomized, the subject will be replaced and a new subject will be 
randomized in order to have approximately 80 treated subjects. 
If a subject withdraws from the study after transplantation, information regarding secondary graft 
failure, disease relapse, serious adverse events involving GvHD and infections, and survival 
outcomes will be collected on Days +180, +365, and +730 by phone. 
If the subject relapses and/or receives a protocol-prohibited therapy, the subject will be withdrawn. 
However, survival will still be collected unless the subject withdraws consent, in which case 
survival outcomes will be assessed via public record search. 
A subject will have completed the study when he or she completes the Day +365 study visit. For 
subjects who are withdrawn from the study prior to completion, all assessments as described in 
Appendix A for the Early Withdrawal Visit should be completed. Procedures include the 
following:  
• Applicable concomitant medications will be reviewed and recorded as per Section 8.12; 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
66 
• A subset of follow-up physical examination assessments (with the exception of height) will be 
performed; 
• Vital signs will be obtained; 
• Karnofsky Performance Status (Appendix D) will be assessed; 
• Peripheral blood samples will be collected for the following: 
o Safety laboratory tests (hematology [CBC and when possible per Institutional practice to 
include a differential (automated or manual)] and serum chemistry panels), 
o Viral assessments, and 
o CMV assessments of DNA by quantitative PCR. Assessment of infection will be performed 
based on the NCI CTCAE and the BMT CTN Definitions; and 
• Acute GvHD or cGvHD assessments (Appendix E and Appendix F) must be performed, as 
applicable.  
If a subject withdraws or is withdrawn from the study at any time following the study treatment 
administration, the Investigator should make every effort to follow the subject and collect the 
information as specified for the Early Withdrawal Visit in Appendix A. If a subject is withdrawn 
for safety reasons, additional safety assessments and follow-up could be required. Refer to 
Section 8.1 and Section 8.3 for a description of the follow-up of adverse events and SAEs. 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
67 
7 
EFFICACY ASSESSMENTS 
The primary efficacy endpoint for both the Phase 1 and Phase 2 parts of the study is the following: 
• Cumulative incidence of CIBMTR Grades II-IV aGvHD through Visit Day +100 based on 
investigator results. Death and relapse without CIBMTR Grades II-IV aGvHD will be 
considered competing risks. 
o Each study site will determine the presence or absence of aGvHD by assigning the clinical 
stage for the target organs of the skin, liver, and gut along with assigning an overall grade 
according to the CIBMTR aGvHD Grading Scale (Appendix E). 
The key secondary efficacy endpoint for both the Phase 1 and Phase 2 parts of the study is the 
following: 
• Proportion of subjects alive without relapse and without moderate or severe cGvHD per NIH 
Consensus Criteria at Visit Day +365. 
All summaries for acute and chronic GvHD will be based on the investigator assessment unless 
noted otherwise.  
The exploratory efficacy endpoints for both the Phase 1 and Phase 2 parts of the study are the 
following: 
• Cumulative incidence through Visit Day +100 and through Visit Day +180 of: 
o CIBMTR Grades III-IV aGvHD  
o CIBMTR Grades I-II aGvHD;  
o CIBMTR Grades I-IV aGvHD;  
o Maximum CIBMTR Grades II-IV aGvHD;   
o Maximum CIBMTR Grades III-IV aGvHD; 
o Maximum CIBMTR Grades II-IV aGvHD based on EAC adjudicated results;  
o Maximum CIBMTR Grades III-IV aGvHD based on EAC adjudicated results;  
• Duration of the Maximum CIBMTR Grade aGvHD through Visit Day +100; 
• Duration of CIBMTR Grades II-IV aGvHD through Visit Day +100; 
• Duration of CIBMTR Grades III-IV aGvHD through Visit Day +100; 
• One-Year GvHD-Free, Relapse-Free Survival (GRFS), a composite endpoint in which events 
include Grade III-IV aGvHD, cGvHD-requiring systemic immunosuppressive therapy, 
relapse, or death from any cause (Holtan et al. 2015); 
• Time to individual event components for GRFS:  
o Time to CIBMTR Grades III-IV aGvHD; 
o Time to first use of cGvHD-requiring systemic immunosuppressive therapy; 
o Time to relapse; 
o Time to death; 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
68 
• One-Year cGvHD-Free, Relapse-Free Survival (CRFS), a composite endpoint in which events 
include any cGvHD-requiring systemic immunosuppressive therapy, relapse, or death from 
any cause (Pasquini et al. 2018); 
• Cumulative incidence of Non-relapse mortality (NRM). All deaths in the absence of relapse of 
the primary malignancy will be considered NRM, where relapse will be considered a 
competing risk; 
• Moderate or severe cGvHD per NIH Consensus Criteria for the global severity score cGvHD 
through Visit Day +365. Death and relapse without moderate or severe cGvHD will be 
considered competing risks; 
• Proportion of subjects with systemic steroid use for aGvHD; 
• Time to first use of systemic steroids for aGvHD;  
• Total number of days of systemic steroid use for aGvHD; 
• Proportion of subjects with second-line therapies for treatment of aGvHD 
• Time to first use of second-line therapies for treatment of aGvHD;  
• Proportion of subjects who are CMV positive at baseline with subsequent CMV reactivation. 
CMV reactivation is defined as subjects who have initiated anti-viral therapy for CMV; 
• Time to first treatment for CMV reactivation; 
• Relapse-free survival (RFS); 
• One-year survival; 
• Two-year survival. 
Additional exploratory analyses may be performed as necessary. 
7.1 
Acute Graft-versus-Host Disease Assessment 
Acute GvHD assessments of the overall Grades I through IV aGvHD of the skin, liver, and gut as 
per the CIBMTR aGvHD Grading Scale must be performed weekly from Day +1 through Day 
+100 and on Day +180. Assessments must be made consistently for each subject by the 
Investigator. For a detailed description of the CIBMTR aGvHD Grading Scale, refer to Appendix 
E.  
The data for the GvHD target organs should be recorded on the GvHD eCRF, and must include 
the percentage of skin rash involvement, volume of stool output, and level of weekly maximum 
reported bilirubin level. Differential diagnoses should be recorded (e.g., investigational product 
reaction, conditioning regimen, total parenteral nutrition, infection, or veno-occlusive disease) 
each week for the specified organ involved. 
7.2 
Chronic Graft-versus-Host Disease Assessment 
Chronic GvHD assessments of mild, moderate, or severe cGvHD as per NIH Consensus Criteria 
for cGvHD must be performed on Days +180, +270, and +365. Assessments must be made 
consistently for each subject by the Investigator. For a detailed description of the NIH Consensus 
Criteria for cGvHD, refer to Appendix F. 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
69 
The data for the GvHD target organs should be recorded on the GvHD eCRF. 
7.3 
Viral Monitoring 
Two peripheral blood samples at each testing time point (1 blood sample to be utilized locally at 
the site for subject management and 1 blood sample for central laboratory testing) will be collected 
for viral assessments of DNA by quantitative PCR for EBV, CMV, HHV-6, and BK virus weekly 
from Days +7 through Day +100 and at Days +180, +270, and +365. 
7.4 
Infectious Disease Titers  
Infectious diseases screen during the Screening Period by peripheral blood sample will include 
titers for EBV, CMV, hepatitis panel (hepatitis A antibody, hepatitis B surface antibody, 
hepatitis B surface antigen, hepatitis B core antibody, and hepatitis C antibody), BK virus, herpes 
simplex virus (HSV), HHV-6, HIV, HTLV types I/II antibody, syphilis, and varicella zoster virus 
(VZV). Additionally, testing for CMV viremia via PCR will be performed. Titer and CMV viremia 
testing will be done by central laboratory testing during the Screening Period. 
7.5 
Karnofsky Performance Status 
The Karnofsky Performance Status (Appendix D) will be assessed as part of the study eligibility 
assessment, and will be assessed during the Screening Period, at Day 0 after HCT, all subsequent 
study visits up through Day +365 (which should include, but are not limited to, weekly from 
Day +1 through Day +91, then on Days +100, +180, +270, and +365), and the Early Withdrawal 
Visit, if applicable. 
7.6 
Relapse of Malignancy 
The definition of relapse is based on the disease under study and should be sourced from the 
National Comprehensive Cancer Network guidelines. For AML and ALL, relapse following CR 
is defined as reappearance of leukemic blasts in the peripheral blood or the finding of >5% blasts 
in the BM, not attributable to another cause or extramedullary relapse. 
Evidence of minimal residual disease will not be sufficient to meet the definition of disease 
recurrence in the context of this study. 
7.7 
Immune Reconstitution 
Peripheral blood samples for immune reconstitution assays will be collected at baseline (during 
the Screening Period), and at Days +7, +14, +28, +56, +91, +180, +270, and +365. The peripheral 
blood sample will be sent to a central laboratory for analysis. 
7.8 
Serum Immunoglobulin 
Serum IgG, IgM, and IgA will be collected by a peripheral blood sample at Days +100, +180, and 
+365. 
7.9 
Bone Marrow Aspirate 
Bone marrow aspirate will be sent to pathology and to cytogenetics during the Screening Period, 
on Day +21 in those subjects whose ANC is <500/µL, and as clinically indicated. Flow cytometry 
is required on BM aspirate. 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
70 
7.10 
GvHD Biomarkers 
Peripheral blood samples for GvHD exploratory biomarkers will be obtained once weekly from 
Days +7 through Day +42, then on Day +100. Samples will be banked.  
7.11 
Radiologic Tumor Staging 
If appropriate, radiologic tumor staging will be completed by the Investigator during the Screening 
Period. 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
71 
8 
SAFETY ASSESSMENTS 
The safety endpoints for both the Phase 1 and Phase 2 parts of the study include the assessment of 
adverse events, vital signs, physical examination findings, engraftment, graft failure, chimerism, 
clinical laboratory assessments, and electrocardiographic data through a 12-lead ECG. 
8.1 
Adverse Events 
Any adverse event experienced between signing the ICF and prior to administration of the study 
conditioning regimen will be recorded in the medical history. 
Adverse events will be collected during Phase 1 and 2, as follows: 
• All serious adverse events (SAEs) will be recorded from Day -10 through Day +365, and only 
SAEs related to the infused cells (ProTmune ex vivo programmed mPB cells or Control mPB 
cells) from Day +366 through Day +730; 
• Start of conditioning regimen (Day -10) through Day +100: Adverse events associated with 
infusion reactions, GvHD, infections, or engraftment failure (Grades 1 through 5). All other 
adverse events (Grades 2 through 5). Laboratory abnormalities will only be recorded as adverse 
events if deemed clinically significant by the Investigator; 
• From Day +100 through Day +365: Only adverse events associated with GvHD, infections, or 
secondary engraftment failure (Grades 1 through 5);  
The details of each event will be recorded in the appropriate eCRF.  
An adverse event is defined as any untoward medical occurrence in a clinical investigation subject 
administered a pharmaceutical product, which does not necessarily have a causal relationship with 
this treatment. An adverse event can therefore be any unfavorable and/or unintended sign 
(including an abnormal laboratory finding), symptom, or disease temporally associated with the 
use of an investigational medicinal product, whether or not related to the investigational medicinal 
product. All adverse events, including observed or volunteered problems, complaints, or 
symptoms, are to be recorded on the appropriate eCRF. 
Adverse events, which include clinically significant laboratory test results, will be monitored and 
documented. Subjects should be instructed to report any adverse event that they experience to the 
Investigator. Investigators should make an assessment for adverse events at each visit and record 
the event on the appropriate adverse event eCRF. 
The following information about each adverse event should be recorded in the source 
documentation and in the eCRF: 
• Onset and cessation dates of adverse events or SAEs, 
• Severity, 
• SAE (yes or no), 
• Relationship to the cell product, (ProTmune ex vivo programmed mPB cells or Control mPB 
cells). For SAEs only, relationship to conditioning regimen medications, and GvHD 
prophylaxis medications (tacrolimus and methotrexate) is also required. 
• Action taken in response to the event. 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
72 
The Investigator will make assessments of adverse event or SAE severity and of the possible 
relationship to study medication(s). 
Wherever possible, a specific disease or syndrome rather than individual associated signs and 
symptoms should be identified by the Investigator and recorded on the eCRF. However, if an 
observed or reported sign or symptom is not considered a component of a specific disease or 
syndrome by the Investigator, it should be recorded as a separate adverse event on the eCRF. 
Additionally, the condition that led to a medical or surgical procedure (e.g., surgery, endoscopy, 
tooth extraction, or transfusion) should be recorded as an adverse event, not the procedure.  
Any medical condition already present at screening or randomization should not be reported as an 
adverse event unless the medical condition or signs or symptoms present at baseline changes in 
severity or seriousness at any time during the study. In this case, it should be reported as an adverse 
event. 
Clinically significant abnormal laboratory or other examination (e.g., ECG) findings that are 
detected during the study or are present at screening or randomization and significantly worsen 
during the study should be reported as adverse events. The Investigator will exercise his or her 
medical and scientific judgment in deciding whether an abnormal laboratory finding or other 
abnormal assessment is clinically significant. Clinically significant abnormal laboratory values 
occurring during the clinical study will be followed until repeat tests return to normal, stabilize, or 
are no longer clinically significant. Any abnormal test that is determined to be an error does not 
require reporting as an adverse event. 
If a clinically significant abnormal laboratory finding meets the definition of an adverse event, a 
diagnosis or any clinical signs and symptoms rather than the abnormal laboratory finding should 
be recorded if possible.  
All adverse events must be followed until resolution, until the condition stabilizes, until the event 
is otherwise explained or is judged by the Investigator to be no longer clinically significant, or 
until the subject is lost to follow-up. The Investigator is responsible for ensuring that follow-up 
includes any supplemental investigations necessary to elucidate as completely as practical the 
nature and/or causality of the adverse event. This may include additional laboratory tests or 
investigations, histopathological examinations, or consultation with other health care 
professionals. 
The Sponsor may request that the Investigator perform or arrange for the conduct of supplemental 
measurements and/or evaluations of an adverse event. If a subject dies during participation in the 
study or during a recognized follow-up period, then Sponsor should be provided with a copy of 
any post-mortem findings, including histopathology, as required. 
8.1.1 
Adverse (Drug) Reaction 
All noxious and unintended responses to the study medication(s) should be considered an adverse 
drug reaction. “Responses” to the infused cells means that a causal relationship between the study 
medication(s) and an adverse event is at least a reasonable possibility, i.e. the relationship cannot 
be ruled out. 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
73 
8.1.2 
Unexpected Adverse Drug Reaction 
8.1.3 
An Unexpected Adverse Drug Reaction is defined as an adverse reaction, the nature 
or severity of which is not consistent with the applicable product information. 
Assessment of Adverse Events by the Investigator 
The Investigator will assess the severity (intensity) of each adverse event as mild, moderate, or 
severe, and will also categorize each adverse event as to its potential relationship to the infused 
cells using the categories of yes or no. 
The severity of all adverse events should be graded according to the NCI CTCAE version 4.0. 
These criteria can be found at http://ctep.cancer.gov/reporting/ctc.html. For those adverse events 
not listed in the NCI CTCAE, the following grading system should be used: 
• Mild (CTCAE Grade 1): Transient symptoms, awareness of sign/symptom, but easily tolerated 
and no interference with subject’s daily activities; 
• Moderate (CTCAE Grade 2): Marked signs/symptoms that interfere with subject’s usual 
activities, but still acceptable; 
• Severe (CTCAE Grade 3): Incapacitating signs/symptoms that cause considerable interference 
with the subject’s daily activities, unacceptable; 
• Life-threatening (CTCAE Grade 4): Life threatening or disabling adverse event; and 
• Death (CTCAE Grade 5): Death-related adverse event. 
AEs of infections will use both the CTCAE and the Blood and Marrow Transplant Clinical Trials 
Network (BMT CTN, Appendix G) criteria. 
Causality Assessment: 
For this study, the Investigator should evaluate the relatedness of all adverse events to 
investigational study medications (ProTmune ex vivo programmed mPB cells or Control mPB 
cells). Relatedness to non-investigational study medications (conditioning medications and GvHD 
prophylaxis medications) is only required for SAEs. Safety monitoring for adverse events for this 
study begins as of the start of the conditioning regimen and will be reported as per the requirements 
outlined in Section 8.1. 
The relationship of an adverse event to the study medication(s) is (are) to be assessed according to 
the following definitions: 
No (unrelated, not related, no relation) – The time course between the administration of the study 
medication(s) and the occurrence or worsening of the adverse event rules out a causal relationship 
and another cause (concomitant drugs, therapies, complications, etc.) is suspected. 
Yes (related) – The time course between the administration of the study medication(s) and the 
occurrence or worsening of the adverse event is consistent with a causal relationship and no other 
cause (concomitant drugs, therapies, complications, etc.) can be identified. 
The definition implies a reasonable possibility of a causal relationship between the event and the 
study medication(s). This means that there are facts (evidence) or arguments to suggest a causal 
relationship. 
The following factors should also be considered: 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
74 
• The temporal sequence from the study medication(s) administration:  
The event should occur during or after the study medication(s) is administered. The length of 
time from the administration of the study medication(s) to the event should be evaluated in the 
clinical context of the event. 
• Underlying, concomitant, intercurrent diseases: 
Each report should be evaluated in the context of the natural history and course of the disease 
being treated and any other disease the subject may have. 
• Concomitant drug: 
The other drugs the subject is taking or the treatment the subject receives should be examined 
to determine whether any of them might be recognized to cause the event in question. 
• Known response pattern for study medication(s) administration: 
Clinical and/or nonclinical data may indicate whether a particular response is likely to be a 
class effect. 
• Exposure to physical and/or mental stresses: 
The exposure to stress might induce adverse changes in the recipient and provide a logical and 
better explanation for the event. 
8.2 
Serious Adverse Events 
An adverse event or adverse reaction is considered serious if, in the view of either the Investigator 
or Sponsor, it results in any of the following outcomes: 
• Death; 
• A life-threatening adverse event; 
NOTE: An adverse event or adverse reaction is considered “life-threatening” if, in view of either 
the Investigator or Sponsor, its occurrence places the subject at immediate risk of death. It does 
not include an event that, had it occurred in a more severe form, might have caused death. 
• Requires hospitalization or prolongation of existing hospitalizations; 
NOTE: Any hospital admission with at least 1 overnight stay will be considered an in-patient 
hospitalization. An emergency room visit without hospital admission will not be recorded as a 
SAE under this criterion, nor will hospitalization for a procedure scheduled or planned before 
signing of informed consent. However, unexpected complications and/or prolongation of 
hospitalization that occur during elective surgery should be recorded as adverse events and 
assessed for seriousness. Admission to the hospital for social or situational reasons (i.e., no place 
to stay, live too far away to come for hospital visits) will not be considered in-patient 
hospitalizations.  
• A persistent or significant disability/incapacity or substantial disruption of the ability to 
conduct normal life functions; 
• A congenital anomaly/birth defect; or 
• An important medical event. 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
75 
NOTE: Important medical events that may not result in death, be life-threatening, or require 
hospitalization may be considered an SAE when, based upon appropriate medical judgment, they 
may jeopardize the subject and may require medical or surgical intervention to prevent one of the 
outcomes listed above. Examples of such medical events include allergic bronchospasm requiring 
intensive treatment in an emergency room or at home, blood dyscrasias or convulsions that do not 
result in inpatient hospitalizations, or the development of drug dependency. 
8.3 
Serious Adverse Event Reporting − Procedures for Investigators 
Initial Reports 
All SAEs occurring from the start of the conditioning regimen (Day -10) until Day +365, and only 
SAEs related to infused cells (ProTmune ex vivo programmed mPB cells or Control mPB cells) 
from Day +366 through Day +730, must be reported to Medpace Clinical Safety within 24 hours 
of the knowledge of the occurrence (this refers to any adverse event that meets any of the 
aforementioned serious criteria). SAE forms must list the subject identification number and a 
comprehensive narrative that includes a chronological description and assessment of the event.  
To report the SAE, complete the SAE form electronically in the electronic data capture (EDC) 
system for the study. When the form is completed, Medpace Safety personnel will be notified 
electronically and will retrieve the form. If the event meets serious criteria and it is not possible to 
access 
the 
EDC 
system, 
send 
an 
email 
to 
Medpace 
Safety 
at 
medpace-
safetynotification@medpace.com or call the Medpace SAE hotline (phone number listed below), 
and fax the completed paper SAE form to Medpace (fax number listed below) within 24 hours of 
awareness. When the EDC system becomes available, the SAE information must be entered within 
24 hours of the system becoming available. 
Safety Contact Information: Medpace Clinical Safety 
Medpace SAE hotline – USA: 
Telephone: +1-800-730-5779, ext. 2999 or +1-513-579-9911, ext. 2999 
Facsimile: +1-866-336-5320 or +1-513-579-0444 
e-mail: medpace-safetynotification@medpace.com 
Follow-Up Reports 
The Investigator must continue to follow the subject until the SAE has subsided or until the 
condition becomes chronic in nature, stabilizes (in the case of persistent impairment), or the subject 
dies. 
Within 24 hours of receipt of follow-up information, the Investigator must update the SAE form 
electronically in the EDC system for the study and submit any supporting documentation 
(e.g., subject discharge summary or autopsy reports) to Medpace Clinical Safety via fax or e-mail. 
If it is not possible to access the EDC system, refer to the procedures outlined above for initial 
reporting of SAEs.  
8.4 
Pregnancy Reporting 
If the subject or partner of a subject participating in the study becomes pregnant during the study, 
the Investigator should report the pregnancy to Medpace Clinical Safety within 24 hours of being 
notified. Medpace Clinical Safety will then forward the Exposure In Utero form to the Investigator 
for completion.  

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
76 
The subject or partner should be followed by the Investigator until completion of the pregnancy. 
If the pregnancy ends for any reason before the anticipated date, the Investigator should notify 
Medpace Clinical Safety. At the completion of the pregnancy, the Investigator will document the 
outcome of the pregnancy. If the outcome of the pregnancy meets the criteria for immediate 
classification as an SAE (i.e., postpartum complication, spontaneous abortion, stillbirth, neonatal 
death, or congenital anomaly), the Investigator should follow the procedures for reporting an SAE. 
8.5 
Expedited Reporting 
The Sponsor will report all relevant information about suspected unexpected serious adverse 
reactions that are fatal or life-threatening as soon as possible to the Food and Drug Administration 
(FDA), applicable competent authorities in all the Member States concerned, and to the Central 
Ethics Committee, and in any case no later than 7 days after knowledge by the Sponsor of such a 
case, and that relevant follow-up information will subsequently be communicated within an 
additional 8 days.  
All other suspected unexpected serious adverse reactions will be reported to the FDA, applicable 
competent authorities concerned and to the Central Ethics Committee concerned as soon as 
possible but within a maximum of 15 days of first knowledge by the Sponsor.  
The Sponsor will also inform all Investigators as required.  
Expedited reporting will only be conducted for SUSARs related to ProTmune. 
The current ProTmune IB will be used to assess for expectedness for the purposes of serious and 
unexpected suspected adverse reaction (SUSAR) reporting. The ProTmune IB will be reviewed 
yearly and the periodicity of the review will be harmonized with the reporting period of the 
Development Safety Update Report. 
8.6 
Engraftment, Graft Failure, and Chimerism  
8.6.1 
Neutrophil and platelet engraftment per CIBMTR 
ANC and platelets from the clinical laboratory assessments will be used to evaluate engraftment.  
• Neutrophil engraftment is defined as the first date of 3 consecutive laboratory values of an 
ANC ≥ 0.5 x 109/L obtained on different days. 
• Platelet engraftment is defined as the first date of 3 consecutive laboratory values of 
platelets ≥ 20 × 109/L obtained on different days without platelet transfusions within the 
preceding 7 days. 
8.6.2 
Primary and secondary graft failure 
Primary graft failure is defined as the subject not ever meeting the definition of neutrophil 
engraftment or any use of the reserve hematopoietic cell product (in Phase 1). If donor engraftment 
is not present through Visit Day +28 bone marrow examination and the subject’s disease is not 
present, the subject is also considered as a primary graft failure (in the absence of relapsed disease). 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
77 
Secondary graft failure is defined as graft failure occurring after initial engraftment (ANC 
≥500 cells/µL), including the presence of >95% recipient CD3+ or myeloid cells, re-infusion of 
donor cells because of permanent loss of neutrophils (<0.5 × 109/L) and/or platelets <30 × 109/L, 
or >50% recipient CD3+ cells and treatment with donor lymphocyte infusion. 
8.6.3 
Chimerism 
Neutrophil and T-cell chimerism will be assessed on the third consecutive day of ANC 
>500 cells/µL (neutrophil only) and on Days +28, +100, +180, and +365 (both neutrophil and 
T-cell). Chimerism will be measured by PCR amplification of recipient-and-donor-derived cells; 
which may include single nucleotide polymorphism and/or DNA microsatellites (short tandem 
repeats) analyses consistent with Institutional Standards. Chimerism will be measured by 
restriction fragment length polymorphism or microsatellite. Chimerism studies will be performed 
by short tandem repeats and/or flow cytometry according to local laboratory practices. When 
feasible, fractional chimerism (total, myeloid, lymphoid) will be performed from peripheral blood 
samples. If there is no evidence for donor engraftment by Day +21, then the subject will undergo 
BM and peripheral blood chimerism studies. If donor engraftment is not present by Day +28 BM 
examination, and the subject’s disease is not present, the subject should be considered a primary 
graft failure (in the absence of relapsed disease). 
8.7 
Clinical Laboratory Evaluations 
Safety laboratory tests will include hematology and serum chemistry panels. Peripheral blood 
samples will be collected and forwarded to either local laboratories or central laboratories for 
testing as described in Appendix A.  
The following clinical laboratory tests will be performed (the analyses of which are the minimum): 
• Hematology (CBC and when possible per Institutional practice to include a differential 
(automated or manual)): RBCs, hemoglobin, hematocrit, platelets, total white blood cell, 
neutrophils, bands, lymphocytes, eosinophils, and monocytes. Manual differential will include 
blasts if present and ANC calculation; and 
• Serum chemistry: includes creatinine, ALT, AST, alkaline phosphatase, blood urea nitrogen, 
lactate dehydrogenase, sodium, potassium, calcium, phosphorus, chloride, CO2, albumin, 
bilirubin (total and direct), and magnesium.  
Clinical laboratory test results should be within normal limits or for certain clinical laboratory 
tests, within an “acceptable” range based on disease characteristics. 
The results will be forwarded to the Investigator for review. Any abnormalities deemed clinically 
significant by the Investigator will be reported as adverse events and recorded in the subject’s 
eCRF if they meet adverse event reporting criteria (refer to Section 8.1). Any clinically significant 
abnormal laboratory values that persist should be followed by the Investigator. Such events should 
be followed until they have resolved (within normal limits or return to baseline) or the Investigator 
assesses them to be chronic or stable. 
The Investigator should file all copies of the laboratory reports in the subject’s study chart.  
Note: Clinical laboratory testing may be performed at any time during the study if clinically 
indicated. 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
78 
8.8 
Serum Pregnancy Tests 
Serum pregnancy tests will be performed during the Screening Period from all female subjects of 
child bearing potential. Pregnant females will be excluded from the study. 
8.9 
Vital Signs 
Vital signs will be recorded at study visits as described in Appendix A and will include systolic 
blood pressure, diastolic blood pressure, pulse rate, respiratory rate, and temperature. 
8.10 
Electrocardiograms 
Standard supine triplicate 12-lead ECG (sequential, within 15 minutes total) will be performed by 
qualified technicians during the Screening Period, at Day 0 prior to HCT, and at Day +100. 
Electrocardiograms will be reviewed at the site for treatment of any urgent issues. The clinical 
significance of any ECG change must be assessed by the Investigator in the context of the subject’s 
medical history, physical examination, and concomitant medications. The Investigator or 
delegated physician will review, sign, and date all ECGs. For the purposes of QTc interval 
calculation, QTcF is the preferred calculation. 
8.11 
Physical Examinations 
During the Screening Period, and at Subject Conditioning and Hospital Admission, a complete 
physical examination will be performed. The complete examination should include height, body 
weight, skin, head-neck, eyes-ears-nose-throat, lungs-chest, heart, abdomen, extremities, and 
appearance. 
A subset of follow-up physical examination assessments (with the exception of height) will be 
performed on the subject at Day 0 prior to HCT and weekly from Day +1 through Day +91, then 
on Days +100, +180, +270, and +365.  
All physical examination findings must be documented in the subject’s study chart and also 
recorded in the appropriate eCRF. 
8.12 
Donor History 
During the Screening Period, the following should be documented in the eCRF, including (but not 
limited to) donor age, sex, race or ethnicity, parity, CMV status, and blood type. 
8.13 
Medical History and Concomitant Medications 
Significant medical history will be collected from the subject at the Screening Visit and should 
include (but not be limited to) demographic information, current and past medical conditions, 
co-morbid diseases, prior treatment history information for hematological malignancy, and 
medications up to 30 days prior to the Screening Visit. The medical history must be documented 
in the subject’s study chart (the on-site source document) prior to study treatment administration 
and also recorded on the appropriate eCRF. 
Updated medical history information is to be collected at Subject Conditioning and the Hospital 
Admission Visit (to include any event that has occurred since the Screening Visit that could be 
considered clinically significant). Furthermore, any clinically significant that occurs after the ICF 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
79 
is signed but prior to administration of the study treatment is to be recorded as an update to the 
Medical History. 
All concomitant medication usage will be collected and recorded on the appropriate eCRF starting 
at Day -30 through Day +100. From Day +100 through Day +730, only concomitant medications 
given as TKI maintenance, or that were ongoing at the time of, and for the treatment of, an AE of 
GvHD, infection or secondary engraftment failure or any SAE, will be recorded. 
8.14 
Cardiac Function 
During the Screening Period, either an ECHO or MUGA scan will be obtained to assess for left 
ventricular ejection fraction or shortening fraction for eligibility criteria assessment by the 
Investigator, if not performed within 6 weeks prior to the Subject Conditioning Period, from Day 
-53 to Day -11. 
8.15 
Pulmonary Function Tests 
Pulmonary function tests will be assessed during the Screening Period, if not performed within 
6 weeks prior to the Subject Conditioning Period, from Day -53 to Day -11. 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
80 
9 
STATISTICS 
9.1 
Analysis Populations 
9.1.1 
Intent-to-Treat Population 
The Intent-to-Treat (ITT) Population for Phase 1 will include all subjects who received ProTmune. 
The ITT Population for Phase 2 will include all randomized subjects. The ITT population will 
include each subject in their randomized treatment group, regardless of actual treatment received.  
9.1.2 
Modified Intent-to-Treat Population 
The Modified Intent-to-Treat (mITT) Population will include all subjects in the ITT Population 
who receive IP (defined as either ProTmune or Control mBP units). Subjects who are randomized 
and do not receive IP because the incoming donor mPB unit did not meet criteria for 
manufacturing, or because their health status deteriorated and they no longer met eligibility 
criteria, will be considered screen failures and are not part of mITT. Despite the exclusion of these 
subjects, the ITT principle would be considered preserved since the decision of whether or not to 
receive treatment is not expected to be influenced by knowledge of the assigned treatment and 
would be expected to occur equally in either treatment group. Summaries and analyses utilizing 
the mITT Population will include each subject in their randomized treatment group, regardless of 
actual treatment received.   
9.1.3 
Per-Protocol Population  
The Per-Protocol (PP) Population will include all Phase 2 subjects in the mITT Population who do 
not have any major protocol violations deemed to impact the results as defined in the statistical 
analysis plan prior to locking the database.  
9.1.4 
Safety Population 
The Safety Population will include all subjects who receive IP. All safety analysis will be based 
on the Safety Population. Summaries and analyses utilizing the Safety Population will include each 
subject in the treatment group representing the actual treatment received, regardless of 
randomization. For example, if a single dose of ProTmune is received by a subject randomized to 
the control arm, the subject will be analyzed in the ProTmune arm. 
9.2 
Statistical Methods 
A Statistical Analysis Plan (SAP) will be finalized before database lock. Any changes to the 
methods described in the final SAP will be described and justified as needed in the clinical study 
report. 
All reporting and analyses will be conducted at the end of the study, which is defined as the date 
when the last subject last visit occurs or the date at which the last data point is collected for the 
completion of 1-year on study (Day +365), whichever occurs later. Analysis of the 2-year survival 
follow-up will be conducted upon completion of the Day +730 follow-up. The initial clinical study 
report will be completed following final analysis of the 1-year data and will be appended to include 
the 2-year survival data upon completion. 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
81 
Summary statistics will be presented by treatment group. Unless otherwise stated, continuous 
variables will be summarized by using the number of non-missing observations, arithmetic mean, 
standard deviation, median, minimum, and maximum values as descriptive statistics. Categorical 
variables will be summarized by using the frequency count and the percentage of subjects in each 
category as descriptive statistics.  
Statistical analyses will be performed using SAS® (Version 9.3, or higher). 
9.2.1 
Analysis of Efficacy 
Based on the timing from randomization to infusion of IP (defined as ProTmune or Control mPB 
units), a post-randomization screen failure may occur if the mPB donor collection unit fails to meet 
the requirements for ProTmune or Control processing (see Section 4.4). As such, the ITT 
population will only be used to summarize subject disposition.  
Efficacy analyses will be performed based on the mITT Population. Additional sensitivity analyses 
will be performed based on the PP Population for the primary and key secondary efficacy endpoint 
for Phase 2. Efficacy data from the Phase 1 part of the study and Phase 2 part of the study will be 
summarized separately. Summary tables will present results for each phase by treatment group.  
The primary efficacy endpoint is the cumulative incidence of CIBMTR Grades II through IV 
aGvHD through Visit Day +100 based on investigator results; death and relapse without Grades 
II-IV aGvHD will be considered competing risks. Subjects who are alive with no occurrence of 
Grade II-IV aGvHD through Visit Day +100 will be censored at their last assessment for aGvHD 
on or prior to Visit Day +100.  
Phase 1: Cumulative incidence curves will be constructed for the primary efficacy endpoint along 
with curves for death and relapse without CIBMTR Grades II-IV aGvHD as competing risks. The 
first day of Grades II-IV aGvHD will be used to calculate the cumulative incidence curve. The 
estimate of the cumulative incidence rate of Grades II-IV aGvHD by Day +100 and the associated 
2-sided 95% confidence intervals will be estimated based on the cumulative incidence function 
with variance estimated using the Delta method. 
Phase 2:  The cumulative incidence curves and estimates of the cumulative incidence rate along 
with the associated 2-sided 95% confidence intervals will be presented in the same manner 
described in Phase 1. The cumulative incidence functions for CIBMTR Grades II-IV aGvHD by 
Day +100 between the two treatment groups will be compared using Gray’s test (Gray 1988) at a 
two-sided 0.05 significance level. The corresponding hazard ratio of the treatment effect along 
with the 95% confidence interval will be calculated using the Fine and Gray’s sub-distribution 
hazard model (Fine and Gray 1999) with treatment and age as a covariate. Other covariates may 
be considered for model inclusion.   
The key secondary efficacy endpoint is the proportion of subjects alive without relapse and without 
moderate or severe cGvHD per NIH Consensus Criteria for the global severity score at Visit Day 
+365 using observed cases. Subjects meeting these criteria will be considered a responder.   
Phase 1: The number of subjects that are alive without relapse and without moderate or severe 
cGvHD at Visit Day +365 will be summarized using counts and percentages. Summaries will also 
include the number of subjects that are considered non-responders.   

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
82 
Phase 2: The same summaries described in Phase 1 will be presented by treatment group. 
Statistical comparisons between treatment groups will be performed using a logistic regression 
with treatment and age as a covariate. Other covariates may be considered for model inclusion.   
Sensitivity analyses of the primary efficacy and key secondary efficacy endpoints will be repeated 
using the PP population. For the responder/non-responder endpoint, analyses using non-responder 
imputation cases will also be performed; other methods may be explored to account for missing 
data such as multiple imputation methods.    
All exploratory efficacy endpoints will be summarized descriptively by phase and treatment 
groups using the mITT Population, unless otherwise noted. For Phase 2, nominal 2-sided p-values 
(without adjustment for multiple comparisons) will be reported as a measure of the strength of 
association between the endpoint and the treatment effect rather than formal tests of hypotheses.  
Exploratory time-to-event endpoints in the presence of competing risks (e.g., aGvHD and cGvHD) 
will be performed using the cumulative incidence function in the same manner as the primary 
efficacy endpoint.  
Exploratory time-to-event endpoints will be summarized using Kaplan-Meier estimates and a two-
sided log-rank test to compare treatment groups. In addition, the hazard ratio along with the 95% 
confidence intervals will be calculated using a Cox proportional hazards model with treatment and 
age as covariates. Other covariates may be considered for model inclusion. 
9.2.2 
Analysis of Safety 
The safety profile will be based on adverse events, vital signs, physical examinations, engraftment, 
graft failure, chimerism, clinical laboratory assessments, and ECGs. All safety analysis will be 
based on the Safety Population. 
Safety analyses in general will be descriptive and will be presented by phase and treatment group 
in tabular format. Categorical endpoints will be summarized using number and percentage of 
subjects within each category. Continuous endpoints will be summarized descriptively with 
summary statistics (n, mean, standard deviation, standard error, median, Q1, Q3, minimum, and 
maximum). 
A treatment-emergent adverse event (TEAE) is defined as an adverse event with a start date and 
time on or after the administration of investigational product. AEs that are designated as GvHD-
related events per the investigator as indicated on the eCRF are considered signs and symptoms of 
GvHD. GvHD-specific details are also collected on separate eCRFs to assess efficacy. As such, 
non-serious GvHD-related adverse events will not be included in the AE analyses and will be 
summarized separately; GvHD-related AEs that meet the criteria of SAEs will be included in the 
summaries of AEs and SAEs. The number and percentage of subjects with TEAEs will be tabulated 
by System Organ Class and Preferred Term for each treatment group and by severity and 
relationship to treatment. Adverse events leading to discontinuation of the study and serious 
adverse events will be summarized by treatment group. By-subject listings will also be provided 
for any deaths, SAEs, and adverse events leading to discontinuation of the study. 
Non-CMV infections are defined as bacterial, fungal, viral (excluding CMV), and parasitic 
infections. The number of subjects with non-CMV infections will be summarized using frequency 
counts and percentages overall and by System Organ Class and Preferred Term.  

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
83 
Febrile neutropenia, as collected on the eCRF and defined by the Infectious Disease Society of 
America Fever and Neutropenia Guidelines Panel (Freifeld et al. 2011): 
• Fever is defined as a single oral temperature measurement of ≥38.3°C (101°F) or a 
temperature of ≥38.0°C (100.4°F) sustained over a 1-hour period 
• Neutropenia is defined as an ANC of <0.5 × 109/L  
The number of subjects with febrile neutropenia will be summarized using frequency counts and 
percentages.  
The following safety endpoints will be summarized using descriptive statistics: 
• proportion of subjects with neutrophil engraftment per CIBMTR through Visit Day +28 
• proportion of subjects with platelet engraftment per CIBMTR through Visit Day +100 per 
CIBMTR will be summarized using  
• time to neutrophil engraftment  
• time to platelet engraftment  
• proportion of subjects with primary graft failure 
• proportion of subjects with secondary graft failure 
Descriptive statistics will be provided for clinical laboratory data and vital signs data, presented as 
both actual values and changes from baseline over time. Abnormal physical examination findings 
will be presented in a by-subject data listing. 
Descriptive statistics will be provided for ECG interval data and presented as both actual values 
and changes from baseline. Details of any abnormalities will be included in subject listings. 
9.2.3 
Interim Analysis 
During Phase 1, the IDMC will convene to assess safety data as outlined in the IDMC Charter. At 
that time, the Sponsor, in consultation with and based on recommendations from the IDMC, will 
decide whether the study should stop or whether the Phase 2 study can begin. If the IDMC and 
Sponsor determine that there are no safety concerns based on Phase 1 safety data, Phase 2 study 
enrollment will begin.  
During Phase 2, the IDMC will convene according to the guidelines outlined in the IDMC Charter. 
There are no formal interim analyses for efficacy planned.   
9.2.4 
Hypotheses  
The following hypothesis statements are given to provide some context to the comparisons being 
performed. 
Primary efficacy endpoint 
H0 (null hypothesis): There is no difference in the cumulative incidence of CIBMTR Grade II-IV 
aGvHD (with death or relapse without CIBMTR Grade II-IV aGvHD as competing events) 
through Visit Day +100 between the ProTmune and Control groups.    

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
84 
H1 (alternative hypothesis): There is a difference in the cumulative incidence of CIBMTR Grade 
II-IV aGvHD (with death or relapse without CIBMTR Grade II-IV aGvHD as competing events) 
through Visit Day +100 between the ProTmune and Control groups. 
Key secondary efficacy endpoint 
H0 (null hypothesis): There is no difference in the proportion of subjects alive without relapse and 
without moderate or severe cGvHD per NIH Consensus Criteria at Visit Day +365 between the 
ProTmune and Control groups.    
H1 (alternative hypothesis): There is a difference in the proportion of subjects alive without relapse 
and without moderate or severe cGvHD per NIH Consensus Criteria at Visit Day +365 between 
the ProTmune and Control groups.    
Hypothesis testing will be described in the statistical analysis plan. 
9.2.5 
Sample Size Determination 
The background cumulative incidence rate of International Bone Marrow Transplant Registry 
(IBMTR) Grades B-D aGvHD in this population is assumed to be between 40% and 60% as 
reported in the literature (Jagasia et al. 2012). 
Phase 1: Allowing for a dropout rate of approximately 15%, approximately 8-12 subjects will be 
enrolled to include 6-10 evaluable subjects.  
Phase 2: When accounting for competing risk factors (death or relapse without aGvHD), a sample 
size of 80 subjects (40 subjects in each treatment group) allows for approximately 85% power to 
detect a reduction in the cumulative incidence rate of CIBMTR Grades II-IV aGvHD through Visit 
Day +100 from 55% to 25% (i.e., a hazard ratio of 0.3464) in the Control versus ProTmune 
treatment arms using a two-sided log-rank test at a 0.05 significance level. This calculation 
assumes the cumulative incidence rate for competing risk factors is 10% through Visit Day +100. 
Allowing for a dropout rate of approximately 10%, approximately 90 subjects will be randomized 
to include approximately 80 treated subjects in the mITT Population. The sample size was 
calculated using PASS Sample Size Software (PASS 16 Power Analysis and Sample Size 
Software, 2018). 
 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
85 
10 
DATA MANAGEMENT AND RECORD KEEPING 
10.1 
Data Management 
10.1.1 
Data Handling 
Data will be recorded at the site on eCRFs and reviewed by the clinical research associate (CRA) 
during monitoring visits. The CRAs will verify data recorded in the EDC system with source 
documents. All corrections or changes made to any study data must be appropriately tracked in an 
audit trail in the EDC system. An eCRF will be considered complete when all missing, incorrect, 
and/or inconsistent data has been accounted for. 
10.1.2 
Computer Systems 
Data will be processed using a validated computer system conforming to regulatory requirements. 
10.1.3 
Data Entry 
Data must be recorded using the EDC system as the study is in progress. All site personnel must 
log into the system using their secure user name and password in order to enter, review, or correct 
study data. These procedures must comply with Title 21 of the Code of Federal Regulations 
(21 CFR Part 11) and other appropriate international regulations. All passwords will be strictly 
confidential. 
10.1.4 
Medical Information Coding 
For medical information, the following thesauri will be used: 
• Medical Dictionary for Regulatory Activities for medical history and adverse events, and 
• World Health Organization Drug Dictionary for prior and concomitant medications. 
10.1.5 
Data Validation 
Validation checks programmed within the EDC system, as well as supplemental validation 
performed via review of the downloaded data, will be applied to the data in order to ensure 
accurate, consistent, and reliable data. Data identified as erroneous, or data that are missing, will 
be referred to the investigative site for resolution through data queries. 
The eCRFs must be reviewed and electronically signed by the Investigator. 
10.2 
Record Keeping 
Records of subjects, source documents, monitoring visit logs, eCRFs, inventory of investigational 
product, regulatory documents, and other Sponsor correspondence pertaining to the study must be 
kept in the appropriate study files at the site. Source data is defined as all information in original 
records and certified copies of original records of clinical findings, observations, or other activities 
in a clinical study necessary for the evaluation and reconstruction of the clinical study. Source data 
are contained in source documents (original records or certified copies). These records will be 
retained in a secure file for the period as set forth in the Clinical Study Agreement. Prior to transfer 
or destruction of these records, the Sponsor must be notified in writing and be given the 
opportunity to further store such records.  

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
86 
11 
INVESTIGATOR REQUIREMENTS AND QUALITY CONTROL 
11.1 
Ethical Conduct of the Study 
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for 
designing, conducting, recording, and reporting studies that involve human subjects. Compliance 
with this standard provides public assurance that the rights, safety, and well-being of study subjects 
are protected, consistent with the principles that have their origin in the Declaration of Helsinki, 
and that the clinical study data are credible. 
11.2 
Institutional Review Board/Independent Ethics Committee 
The IRB/IEC will review all appropriate study documentation in order to safeguard the rights, 
safety, and well-being of subjects. The study will only be conducted at sites where IRB/IEC 
approval has been obtained. The protocol, ProTmune IB, ICF, advertisements (if applicable), 
written information given to the subjects, safety updates, annual progress reports, and any revisions 
to these documents will be provided to the IRB/IEC by the Investigator. 
Federal regulations and International Conference on Harmonisation (ICH) require that approval 
be obtained from an IRB/IEC prior to participation of subjects in research studies. Prior to study 
onset, the protocol, any protocol amendments, ICFs, advertisements to be used for subject 
recruitment, and any other written information regarding this study to be provided to a subject or 
subject’s legal guardian must be approved by the IRB/IEC. 
No investigational product will be released to the site for dosing until written IRB/IEC 
authorization has been received by the Sponsor. 
It is the responsibility of the Sponsor or their designee (i.e., Medpace) to obtain the approval of 
the responsible ethics committees according to the national regulations.  
The study will only start in the respective sites once the respective committee’s written approval 
has been given. 
11.3 
Informed Consent 
The ICF and any changes to the ICF made during the course of the study must be agreed to by the 
Sponsor or designee and the IRB/IEC prior to its use and must be in compliance with all ICH GCP, 
local regulatory requirements, and legal requirements.  
The Investigator must ensure that each study subject is fully informed about the nature and 
objectives of the study and possible risks associated with participation and must ensure that the 
subject has been informed of his/her rights to privacy. The Investigator will obtain written 
informed consent from each subject before any study-specific activity is performed and should 
document in the source documentation that consent was obtained prior to enrollment in the study. 
The original signed copy of the ICF must be maintained by the Investigator and is subject to 
inspection by a representative of the Sponsor, their representatives, auditors, the IRB/IEC and/or 
regulatory agencies. A copy of the signed ICF will be given to the subject. 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
87 
11.4 
Subject Card 
On enrollment in the study, the subject will receive a subject card to be carried at all times. The 
subject card will state that the subject is participating in a clinical research study, type of treatment, 
and contact details in case of an SAE. 
11.5 
Study Monitoring Requirements 
It is the responsibility of the Investigator to ensure that the study is conducted in accordance with 
the protocol, ICH GCP, applicable regulatory requirements, the Declaration of Helsinki (for United 
States sites), and that valid data are entered into the eCRFs. 
To achieve this objective, the monitor’s duties are to aid the Investigator and, at the same time, the 
Sponsor in the maintenance of complete, legible, well organized and easily retrievable data. Before 
the enrollment of any subject in this study, the Sponsor or their designee will review with the 
Investigator and site personnel the following documents: protocol, ProTmune IB, eCRFs and 
procedures for their completion, informed consent process, and the procedure for reporting SAEs. 
The Investigator will permit the Sponsor or their designee to monitor the study as frequently as 
deemed necessary to determine that data recording and protocol adherence are satisfactory. During 
the monitoring visits, information recorded on the eCRFs will be verified against source 
documents and requests for clarification or correction may be made. After the eCRF data is entered 
by the site, the CRA will review the data for safety information, completeness, accuracy, and 
logical consistency. Computer programs that identify data inconsistencies may be used to help 
monitor the clinical study. If necessary, requests for clarification or correction will be sent to 
Investigators. The Investigator and his/her staff will be expected to cooperate with the monitor and 
provide any missing information, whenever possible. 
All monitoring activities will be reported and archived. In addition, monitoring visits will be 
documented at the investigational site by signature and date on the study-specific monitoring log. 
11.6 
Disclosure of Data 
Data generated by this study must be available for inspection by the FDA, the Sponsor or their 
designee, applicable foreign health authorities, and the IRB/IEC as appropriate. Subjects or their 
legal representatives may request their medical information be given to their personal physician or 
other appropriate medical personnel responsible for their welfare. 
Subject medical information obtained during the study is confidential and disclosure to third 
parties other than those noted above is prohibited. 
11.7 
Retention of Records 
To enable evaluations and/or audits from regulatory authorities or the Sponsor, the Investigator 
will keep records, including the identity of all participating subjects (sufficient information to link 
records, e.g., CRFs and hospital records), all original signed ICFs, copies of all CRFs, SAE forms, 
source documents, and detailed records of treatment disposition. The records should be retained 
by the Investigator according to specifications in the ICH guidelines, local regulations, or as 
specified in the Clinical Study Agreement, whichever is longer. The Investigator must obtain 
written permission from the Sponsor before disposing of any records, even if retention 
requirements have been met. 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
88 
If the Investigator relocates, retires, or for any reason withdraws from the study, the Sponsor should 
be prospectively notified. The study records must be transferred to an acceptable designee, such 
as another Investigator, another institution, or to the Sponsor.  
11.8 
Publication Policy 
Following completion of the study, the data may be considered for publication in a scientific 
journal or for reporting at a scientific meeting. Each Investigator is obligated to keep data 
pertaining to the study confidential. The Investigator must consult with the Sponsor before any 
study data are submitted for publication. The Sponsor reserves the right to deny publication rights 
until mutual agreement on the content, format, interpretation of data in the manuscript, and journal 
selected for publication are achieved. 
11.9 
Financial Disclosure 
Investigators are required to provide financial disclosure information to the Sponsor to permit the 
Sponsor to fulfill its obligations under 21 CFR Part 54. In addition, Investigators must commit to 
promptly updating this information if any relevant changes occur during the study and for a period 
of 1 year after the completion of the study. 
11.10 
Insurance and Indemnity 
In accordance with the relevant national regulations, the Sponsor has taken out subject liability 
insurance for all subjects who have given their consent to the clinical study. This cover is designed 
for the event that a fatality, physical injury, or damage to health occurs during the clinical study’s 
execution. 
11.11 
Legal Aspects 
The clinical study is submitted to the relevant national competent authorities in all participating 
countries to achieve a clinical trial authorization (CTA). 
The study will commence (i.e., initiation of study centers) when the CTA and favorable Ethics 
opinion have been received.  

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
89 
12 
STUDY ADMINISTRATIVE INFORMATION 
12.1 
Protocol Amendments 
Any amendments to the study protocol will be communicated to the Investigators by Medpace or 
the Sponsor. All protocol amendments will undergo the same review and approval process as the 
original protocol. A protocol amendment may be implemented after it has been approved by the 
IRB/IEC, unless immediate implementation of the change is necessary for subject safety. In this 
case, the situation must be documented and reported to the IRB/IEC within 5 working days. 
12.2 
Address List 
12.2.1 
Sponsor 
Fate Therapeutics, Inc. 
3535 General Atomics Court, Suite 200  
San Diego, CA 92121 
USA 
Telephone: 858-875-1800 
Facsimile: 858-875-1843 
12.2.2 
Contract Research Organization 
Medpace, Inc.  
5375 Medpace Way 
Cincinnati, OH 45227 
USA 
Telephone: +1-800-730-5779 
Facsimile: +1-513-579-0444 
12.2.3 
Drug Safety 
Medpace Clinical Safety 
5375 Medpace Way 
Cincinnati, OH 45227 
USA 
Telephone: +1-800-730-5779, ext. 2999 
Facsimile: +1-866-336-5320 
12.2.4 
Biological Specimens 
Refer to the current PT-001 Laboratory Manual for a complete list of testing facilities. 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
90 
13
REFERENCES 
1. Acyclovir (Systemic): Drug Information. Lexicomp. 2015. 
2. Anasetti C, Logan BR, Lee SJ, et al. Peripheral-blood stem cells versus bone marrow from 
unrelated donors. N Engl J Med. 2012;367:1487-1496. 
3. Ballen KK, Koreth J, Chen Y, Dey B, Spitzer T. Selection of optimal alternative graft source: 
mismatched unrelated donor, umbilical cord blood, or haploidentical transplant. Blood. 
2012;119:1972-1980. 
4. Boeckh M, Gooley TA, Myerson D, Cunningham T, Schoch G, Bowden RA. Cytomegalovirus 
pp65 antigenemia-guided early treatment with ganciclovir versus ganciclovir at engraftment 
after allogeneic marrow transplantation: a randomized double-blind study. Blood. 
1996;88:4063-4071. 
5. Bolwell BJ, Kalaycio M, Andresen S, et al. A multivariable analysis of factors influencing 
mucositis after autologous progenitor cell transplantation. Bone Marrow Transplant. 
2002;30(9):587-591. 
6. Bouchlaka MN, Redelman D, Murphy WJ. Immunotherapy following hematopoietic stem cell 
transplantation: potential for synergistic effects. Immunotherapy. 2010;2:399-418. 
7. Cahn JY, Klein JP, Lee SJ, Milpied N, Blaise D, et al. Prosepctive evaluation of 2 acute 
graft-versus-host (GVHD) grading systems: a joint Societe Francaise de Greffe de Moelle et 
Therapie Cellulaire (SFGM-TC), Dan Farber Cancer Instititue (DFCI), and International Bone 
Marrow Transplant Registry (IBMTR) prospective study. Blood. 2005;106(4):1495-1500. 
8. Choi SW, Reddy P. Current and emerging strategies for the prevention of graft versus host 
disease. Nat Rev Clin Oncol. 2014;11:536-547. 
9. CIBMTR Forms Manual: Post-TED (Form2450); A00425 version 2.0 (8/01/2012). 
10. Duong HK, Savani BN, Copelan E, et al. Peripheral blood progenitor cell mobilization for 
autologous and allogenic hematopoietic cell transplantation: guidelines from the American 
Society for Blood and Marrow Transplantation. Biol Blood Marrow Transplant. 
2014;20:1262-1273. 
11. Eapen M, Logan BR, Confer DL, et al. Peripheral blood grafts from unrelated donors are 
associated with increased acute and chronic graft-versus-host disease without improved 
survival. Biol Blood Marrow Transplant. 2007;13:1461-1468. 
12. Feldweg AM, Leddy JP. Drug interactions affecting the efficacy of corticosteroid therapy a 
brief review with an illustrative case. J Clin Rheumatol. 1999;5:143-150. 
13. Ferrara JL, Deeg HJ. Graft-versus-host disease. N Engl J Med. 1991;324:667. 
14. Filipovich AH, Weisdorf D, Pavletic S, et al. National Institutes of Health consensus 
development project on criteria for clinical trials in chronic graft-versus-host disease: I. 
Diagnosis and staging working group report. Biol Blood Marrow Transplant. 
2005;11(12):945-956. 
15. Fine JP, Gray RJ (1999). A proportional hazards model for the subdistribution of a competing 
risk. JASA 94 (446): 496-509. 
16. Fluconazole: Drug Information. Lexicomp. 2015. 
. Fine JP, Gray RJ (1999). A proportional hazards model for the subdistribution of a competing
risk. JASA 94 (446): 496-509.
Acyclovir (Systemic): Drug Information. Lexicomp. 2015. 
. Duong HK, Savani BN, Copelan E, et al. Peripheral blood progenitor cell mobilization for 
autologous and allogenic hematopoietic cell transplantation: guidelines from the American 
Society for Blood and Marrow Transplantation. Biol Blood Marrow Transplant. 
2014;20:1262-1273.
Fluconazole: Drug Information. Lexicomp. 2015.
Bouchlaka MN, Redelman D, Murphy WJ. Immunotherapy following hematopoietic stem cell 
transplantation: potential for synergistic effects. Immunotherapy. 2010;2:399-418. 
. Feldweg AM, Leddy JP. Drug interactions affecting the efficacy of corticosteroid therapy a 
brief review with an illustrative case. J Clin Rheumatol. 1999;5:143-150. 
Cahn JY, Klein JP, Lee SJ, Milpied N, Blaise D, et al. Prosepctive evaluation of 2 acute 
graft-versus-host (GVHD) grading systems: a joint Societe Francaise de Greffe de Moelle et 
Therapie Cellulaire (SFGM-TC), Dan Farber Cancer Instititue (DFCI), and International Bone 
Marrow Transplant Registry (IBMTR) prospective study. Blood. 2005;106(4):1495-1500. 
Choi SW, Reddy P. Current and emerging strategies for the prevention of graft versus host
disease. Nat Rev Clin Oncol. 2014;11:536-547.
Anasetti C, Logan BR, Lee SJ, et al. Peripheral-blood stem cells versus bone marrow from 
unrelated donors. N Engl J Med. 2012;367:1487-1496. 
CIBMTR Forms Manual: Post-TED (Form2450); A00425 version 2.0 (8/01/2012). 
Filipovich AH, Weisdorf D, Pavletic S, et al. National Institutes of Health consensus
development project on criteria for clinical trials in chronic graft-versus-host disease: I. 
Diagnosis and staging working group report. Biol Blood Marrow Transplant.
2005;11(12):945-956. 
Eapen M, Logan BR, Confer DL, et al. Peripheral blood grafts from unrelated donors are 
associated with increased acute and chronic graft-versus-host disease without improved 
survival. Biol Blood Marrow Transplant. 2007;13:1461-1468.
Bolwell BJ, Kalaycio M, Andresen S, et al. A multivariable analysis of factors influencing
mucositis after autologous progenitor cell transplantation. Bone Marrow Transplant. 
2002;30(9):587-591. 
Ballen KK, Koreth J, Chen Y, Dey B, Spitzer T. Selection of optimal alternative graft source: 
mismatched unrelated donor, umbilical cord blood, or haploidentical transplant. Blood. 
2012;119:1972-1980.
Ferrara JL, Deeg HJ. Graft-versus-host disease. N Engl J Med. 1991;324:667.
Boeckh M, Gooley TA, Myerson D, Cunningham T, Schoch G, Bowden RA. Cytomegalovirus 
pp65 antigenemia-guided early treatment with ganciclovir versus ganciclovir at engraftment 
after allogeneic marrow transplantation: a randomized double-blind study. Blood.
1996;88:4063-4071.

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
91 
17. Freifeld AG, Bow EJ, Sepkowitz KA, et al. Clinical Practice Guideline for the Use of 
Antimicrobial Agents in Neutropenic Patients with Cancer: 2010 Update by the Infectious 
Diseases Society of America, Clinical Infectious Diseases, Volume 52, Issue 4, 15 February 
2011, Pages e56–e93. 
18. Ganciclovir (Systemic): Drug Information. Lexicomp. 2015. 
19. Gray RJ (1988). “A Class of K-Sample Tests for Comparing the Cumulative Incidence of a 
Competing Risk.” Annals of Statistics 16:1141–1154. 
20. Glucksberg H, Storb R, Fefer A, et al. Clinical manifestations of graft-versus-host disease in 
human recipients of marrow from HLA-matched sibling donors. Transplantation. 
1974;18:295-304. 
21. Goodrich JM, Bowden RA, Fisher L, Keller C, Schoch G, Meyers JD. Ganciclovir prophylaxis 
to prevent cytomegalovirus disease after allogeneic marrow transplant. Ann Intern Med. 1993; 
118:173-178. 
22. Greim H, Kaden D, Larson RA, et al. The bone marrow niche, stem cells, and leukemia: impact 
of drugs, chemicals, and the environment. Ann N Y Acad Sci. 2014;1310:7-31. 
23. Hahn T, McCarthy PL Jr, Zhang MJ, et al. Risk factors for acute graft-versus-host disease after 
human leukocyte antigen-identical sibling transplants for adults with leukemia. J Clin Oncol. 
2008;26:5728. 
24. Hicks C, Trickett A, Kwan YL, Ramanathan S. The use of adjusted ideal body weight for 
overweight patients undergoing HPC mobilization for autologous transplantation. Ann 
Hematol. 2012;91:1795-1801. 
25. Hill GR, Ferrara JL. The primacy of the gastrointestinal tract as a target organ of acute 
graft-versus-host disease: rationale for the use of cytokine shields in allogeneic bone marrow 
transplantation. Blood. 2000;95:2754-2759. 
26. Hoggatt J, Singh P, Sampath J, Pelus LM. Prostaglandin E2 enhances hematopoietic stem cell 
homing, survival, and proliferation. Blood. 2009;113:5444-5455. 
27. Holtan, SG, DeFor TE, Lazaryan A, et al. Composite end point of graft-versus-host disease-
free, relapse-free survival after allogeneic hematopoietic cell transplantation. Blood. 
2015;125(8):1333–1338. 
28. Immune Globulin: Drug Information. Lexicomp. 2015. 
29. Jacobsohn D, Vogelsang G. Acute graft versus host disease. Orphanet J Rare Dis. 2007;2:35. 
30. Jagasia M, Arora M, Flowers MED, et al. Risk factors for acute GVHD and survival after 
hematopoietic cell transplantation. Blood. 2012;119(1):296-307. 
31. Jain N, Lu K, Ito, S, et al. The clinical and financial burden of pre-emptive management of 
cytomegalovirus disease after allogeneic stem cell transplantation—implications for 
preventative treatment approaches. Cytotherapy. 2014;16:927-933. 
32. Levofloxacin [Systemic]: Drug Information. Lexicomp. 2015. 
33. Li L, Kim HT, Nellore A, et al. Prostaglandin E2 promotes survival of naive UCB T cells via 
the Wnt/b-catenin pathway and alters immune reconstitution after UCBT. Blood Cancer 
Journal. 2014;4:e178. 
Holtan, SG, DeFor TE, Lazaryan A, et al. Composite end point of graft-versus-host disease-
free, relapse-free survival after allogeneic hematopoietic cell transplantation. Blood. 
2015;125(8):1333–1338.
Immune Globulin: Drug Information. Lexicomp. 2015.
. Greim H, Kaden D, Larson RA, et al. The bone marrow niche, stem cells, and leukemia: impact 
of drugs, chemicals, and the environment. Ann N Y Acad Sci. 2014;1310:7-31.
Goodrich JM, Bowden RA, Fisher L, Keller C, Schoch G, Meyers JD. Ganciclovir prophylaxis
to prevent cytomegalovirus disease after allogeneic marrow transplant. Ann Intern Med. 1993; 
118:173-178.
. Jagasia M, Arora M, Flowers MED, et al. Risk factors for acute GVHD and survival after 
hematopoietic cell transplantation. Blood. 2012;119(1):296-307.
Li L, Kim HT, Nellore A, et al. Prostaglandin E2 promotes survival of naive UCB T cells via
the Wnt/b-catenin pathway and alters immune reconstitution after UCBT. Blood Cancer 
Journal. 2014;4:e178.
Hahn T, McCarthy PL Jr, Zhang MJ, et al. Risk factors for acute graft-versus-host disease after 
human leukocyte antigen-identical sibling transplants for adults with leukemia. J Clin Oncol.
2008;26:5728.
Ganciclovir (Systemic): Drug Information. Lexicomp. 2015.
7. Freifeld AG, Bow EJ, Sepkowitz KA, et al. Clinical Practice Guideline for the Use of
Antimicrobial Agents in Neutropenic Patients with Cancer: 2010 Update by the Infectious
Diseases Society of America, Clinical Infectious Diseases, Volume 52, Issue 4, 15 February
2011, Pages e56–e93.
Jain N, Lu K, Ito, S, et al. The clinical and financial burden of pre-emptive management of 
cytomegalovirus disease after allogeneic stem cell transplantation—
n—
n
implications for 
preventative treatment approaches. Cytotherapy. 2014;16:927-933. 
yty
Jacobsohn D, Vogelsang G. Acute graft versus host disease. Orphanet J Rare Dis. 2007;2:35.
Hicks C, Trickett A, Kwan YL, Ramanathan S. The use of adjusted ideal body weight for 
overweight patients undergoing HPC mobilization for autologous transplantation. Ann 
Hematol. 2012;91:1795-1801.
. Hoggatt J, Singh P, Sampath J, Pelus LM. Prostaglandin E2 enhances hematopoietic stem cell
homing, survival, and proliferation. Blood. 2009;113:5444-5455.
. Hill GR, Ferrara JL. The primacy of the gastrointestinal tract as a target organ of acute 
graft-versus-host disease: rationale for the use of cytokine shields in allogeneic bone marrow 
transplantation. Blood. 2000;95:2754-2759.
Glucksberg H, Storb R, Fefer A, et al. Clinical manifestations of graft-versus-host disease in 
human recipients of marrow from HLA-matched sibling donors. Transplantation.
1974;18:295-304.
Gray RJ (1988). “A Class of K-Sample Tests for Comparing the Cumulative Incidence of a 
Competing Risk.” Annals of Statistics 16:1141–1154. 
. Levofloxacin [Systemic]: Drug Information. Lexicomp. 2015.

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
92 
34. Liu D, Ahmet A, Ward L, et al. A practical guide to the monitoring and management of the 
complications of systemic corticosteroid therapy. Allergy Asthma Clin Immunol. 2013;9:30. 
35. Ljungman P, Hakki M, Boeckh M. Cytomegalovirus in hematopoietic stem cell transplant 
recipients. Hematol Oncol Clin North Am. 2011;25:151-169. 
36. Majhail NS, Mau LW, Payton T, Denzen E. National survey of blood and marrow transplant 
center personnel, infrastructure and models of care delivery. 2015. Accessed 08 December 
2015. Available at: http://www.cibmtr.org/referencecenter/Pages/index.aspx 
37. McLaughlin L, Cruz R, Bollard CM. Adoptive T-cell therapies for refractory/relapsed 
leukemia and lymphoma: current strategies and recent advances. Ther Adv Hematol. 
2015;6(6):295-307. 
38. Mor V, Laliberte L, Morris JN, Wieman M. The Karnofsky Performance Status Scale. An 
examination of its reliability and validity in a research setting. Cancer. 1984;53(9):2002-2007. 
39. Nagler A, Labopin M, Shimoni A, et al. Mobilized peripheral blood stem cells compared with 
bone marrow as the stem cell source for unrelated donor allogeneic transplantation with 
reduced-intensity conditioning in patients with acute myeloid leukemia in complete remission: 
an analysis from the Acute Leukemia Working Party of the European Group for Blood and 
Marrow Transplantation. Biol Blood Marrow Transplant. 2012;18:1422-429. 
40. Nash RA, Pepe MS, Storb G, et al. Acute graft-versus-host disease: analysis of risk factors 
after allogeneic marrow transplantation and prophylaxis with cyclosporine and methotrexate. 
Blood. 1992;80:1838-1845. 
41. National Marrow Donor Program. Available online https://bethematchclinical.org/  
42. North T, Goessling W, Walkley C, et al. Prostaglandin E2 regulate vertebrate haematopoietic 
stem cell homeostasis. Nature. 2007;447;1007-1011. 
43. Olsson R, Remberger M, et al. Graft Failure in the Modern Era of Allogeneic Hematopoietic 
SCT. Bone Marrow Transplantation. 2013;48:537-543. 
44. Ozdemir E, Saliba RM, Champlin RE, et al. Risk factors associated with late cytomegalovirus 
reactivation after allogeneic stem cell transplantation for hematological malignancies. Bone 
Marrow Transplant. 2007;40:125-136. 
45. Pasquini MC, Loan B, Jones, RJ, et al. Blood and Marrow Transplant Clinical Trials Network 
Report on the Development of Novel Endpoints and Selection of Promising Approaches for 
Graft-versus-Host Disease Prevention Trials. Biol Blood Marrow Transplant, 2018 (ahead of 
print).  
46. PASS 16 Power Analysis and Sample Size Software (2018). NCSS, LLC. Kaysville, Utah, 
USA, ncss.com/software/pass). 
47. Pidala J, Anasetti C, Kharfan-Dabaja M.A, Cutler C, Sheldon A, Djulbegovic B. Decision 
analysis of peripheral blood versus bone marrow hematopoietic stem cells for allogeneic 
hematopoietic cell transplantation. Biol Blood Marrow Transplant. 2009;15:1415-1421. 
48. Przepiorka D, Weisdorf D, Martin P, et al. Consensus conference on acute GVHD grading. 
Bone Marrow Transplant. 1995;15: 825-828. 
. Nagler A, Labopin M, Shimoni A, et al. Mobilized peripheral blood stem cells compared with 
bone marrow as the stem cell source for unrelated donor allogeneic transplantation with
reduced-intensity conditioning in patients with acute myeloid leukemia in complete remission: 
an analysis from the Acute Leukemia Working Party of the European Group for Blood and 
Marrow Transplantation. Biol Blood Marrow Transplant. 2012;18:1422-429. 
. McLaughlin L, Cruz R, Bollard CM. Adoptive T-cell therapies for refractory/relapsed 
leukemia and lymphoma: current strategies and recent advances. Ther Adv Hematol. 
2015;6(6):295-307. 
. Pidala J, Anasetti C, Kharfan-Dabaja M.A, Cutler C, Sheldon A, Djulbegovic B. Decision 
analysis of peripheral blood versus bone marrow hematopoietic stem cells for allogeneic 
hematopoietic cell transplantation. Biol Blood Marrow Transplant. 2009;15:1415-1421. 
. Ljungman P, Hakki M, Boeckh M. Cytomegalovirus in hematopoietic stem cell transplant 
recipients. Hematol Oncol Clin North Am. 2011;25:151-169. 
. Przepiorka D, Weisdorf D, Martin P, et al. Consensus conference on acute GVHD grading. 
Bone Marrow Transplant. 1995;15: 825-828.
Majhail NS, Mau LW, Payton T, Denzen E. National survey of blood and marrow transplant 
center personnel, infrastructure and models of care delivery. 2015. Accessed 08 December
2015. Available at: http://www.cibmtr.org/referencecenter/Pages/index.aspx 
Mor V, Laliberte L, Morris JN, Wieman M. The Karnofsky Performance Status Scale. An 
examination of its reliability and validity in a research setting. Cancer. 1984;53(9):2002-2007.
. Pasquini MC, Loan B, Jones, RJ, et al. Blood and Marrow Transplant Clinical Trials Network 
Report on the Development of Novel Endpoints and Selection of Promising Approaches for 
Graft-versus-Host Disease Prevention Trials. Biol Blood Marrow Transplant, 2018 (ahead of 
print). 
. Nash RA, Pepe MS, Storb G, et al. Acute graft-versus-host disease: analysis of risk factors 
after allogeneic marrow transplantation and prophylaxis with cyclosporine and methotrexate. 
Blood. 1992;80:1838-1845.
Liu D, Ahmet A, Ward L, et al. A practical guide to the monitoring and management of the 
complications of systemic corticosteroid therapy. Allergy Asthma Clin Immunol. 2013;9:30. 
. Olsson R, Remberger M, et al. Graft Failure in the Modern Era of Allogeneic Hematopoietic 
SCT. Bone Marrow Transplantation. 2013;48:537-543.
. Ozdemir E, Saliba RM, Champlin RE, et al. Risk factors associated with late cytomegalovirus
reactivation after allogeneic stem cell transplantation for hematological malignancies. Bone 
Marrow Transplant. 2007;40:125-136. 
2. North T, Goessling W, Walkley C, et al. Prostaglandin E2 regulate vertebrate haematopoietic 
stem cell homeostasis. Nature. 2007;447;1007-1011. 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
93 
49. Raimondo S, Corrado C, Raimondi L, De Leo G, Alessandro R. Role of Extracellular Vesicles 
in Hematological Malignancies. Biomed Res Int. 2015; 2015: 821613. Published online 
2015 Oct 25. 
50. Reed EC, Bowden RA, Dandliker PS, Lilleby KE, Meyers JD. Treatment of cytomegalovirus 
pneumonia with ganciclovir and intravenous cytomegalovirus immunoglobulin in patients 
with bone marrow transplants. Ann Intern Med. 1988; 109:783-788. 
51. Rowlings PA, Przepiorka D, Klein JP, et al. IBMTR Severity Index for grading acute 
graft-versus-host disease: retrospective comparison with Glucksberg grade. Br J Haematol. 
1997;97(4):855-864. 
52. Rozmus J, Shulz K. Biomarkers in Chronic GvHD. Exper Rev Hematol, 2011;4:329-342. 
53. Salzberger B, Bowden RA, Hackman RC, Davis C, Boeckh M. Neutropenia in allogeneic 
marrow transplant recipients receiving ganciclovir for prevention of cytomegalovirus disease: 
risk factors and outcome. Blood. 1997;90:2502-2508. 
54. Schmitz N, Eapen M, Horowitz MM, et al. Long-term outcome of patients given transplants 
of mobilized blood or bone marrow: A report from the International Bone Marrow Transplant 
Registry and the European Group for Blood and Marrow Transplantation. Blood. 
2006;108:4288-4290. 
55. Smith A, Howell D, Patmore R, Jack A, Roman E. Incidence of haematological malignancy 
by sub-type: a report from the Haematological Malignancy Research Network. British Journal
of Cancer. 2011;105:1684-1692. 
56. Sorror ML, Martin PJ, Storb RF, et al. Pretransplant comorbidities predict severity of acute 
graft-versus-host disease and subsequent mortality. Blood. 2014;124:287-295. 
57. Thomas ED, Storb R, Clift RA, Fefer A, Johnson FL, et al. Bone Marrow Transplantation. 
NEJM. 1975;292:895-902. 
58. To LB, Levesque JP, Herbert KE. How I treat patients who mobilize hematopoietic stem cells 
poorly. Blood. 2011;118:4530-4540. 
59. Tomblyn M, Chiller T, Einsele H, et al. Guidelines for preventing infectious complications 
among hematopoietic cell transplantation recipients: a global perspective. Biol Blood Marrow 
Transplant. 2009;15:1143-1238. 
60. Trimethoprim-Sulfamethoxazole (co-trimoxazole): Drug Information. Lexicomp. 2015. 
61. Wagner JE, Eapen M, Kurtzberg J. One-unit versus two-unit cord-blood transplantation. 
N Engl J Med. 2015;372:288. 
62. Weisdorf D, Haake R, Blazar B, et al. Treatment of moderate/severe acute graft-versus-host 
disease after allogeneic bone marrow transplantation: an analysis of clinical risk features and 
outcome. Blood 1990 Feb 15;75(4):1024-30. 
63. Wingard JR, Hsu J, Hiemenz JW. Hematopoietic stem cell transplantation: an overview of 
infection risks and epidemiology. Infect Dis Clin North Am. 2010;24:257. 
64. Woolfrey A, Klein JP, Haagenson M, et al. HLA-C Antigen mismatches are associated with 
worse outcomes in unrelated donor peripheral blood stem cell transplantation. Biol Blood 
Marrow Transplant. 2011;17:885-892. 
To LB, Levesque JP, Herbert KE. How I treat patients who mobilize hematopoietic stem cells
poorly. Blood. 2011;118:4530-4540.
. Schmitz N, Eapen M, Horowitz MM, et al. Long-term outcome of patients given transplants 
of mobilized blood or bone marrow: A report from the International Bone Marrow Transplant
Registry and the European Group for Blood and Marrow Transplantation. Blood.
2006;108:4288-4290.
. Smith A, Howell D, Patmore R, Jack A, Roman E. Incidence of haematological malignancy 
by sub-type: a report from the Haematological Malignancy Research Network. British Journal
of Cancer. 2011;105:1684-1692.
Salzberger B, Bowden RA, Hackman RC, Davis C, Boeckh M. Neutropenia in allogeneic
marrow transplant recipients receiving ganciclovir for prevention of cytomegalovirus disease: 
risk factors and outcome. Blood. 1997;90:2502-2508. 
Rowlings PA, Przepiorka D, Klein JP, et al. IBMTR Severity Index for grading acute 
graft-versus-host disease: retrospective comparison with Glucksberg grade. Br J Haematol. 
1997;97(4):855-864. 
Reed EC, Bowden RA, Dandliker PS, Lilleby KE, Meyers JD. Treatment of cytomegalovirus
pneumonia with ganciclovir and intravenous cytomegalovirus immunoglobulin in patients
with bone marrow transplants. Ann Intern Med. 1988; 109:783-788. 
Thomas ED, Storb R, Clift RA, Fefer A, Johnson FL, et al. Bone Marrow Transplantation. 
NEJM. 1975;292:895-902.
4. Woolfrey A, Klein JP, Haagenson M, et al. HLA-C Antigen mismatches are associated with 
worse outcomes in unrelated donor peripheral blood stem cell transplantation. Biol Blood 
Marrow Transplant. 2011;17:885-892.
. Trimethoprim-Sulfamethoxazole (co-trimoxazole): Drug Information. Lexicomp. 2015. 
. Tomblyn M, Chiller T, Einsele H, et al. Guidelines for preventing infectious complications 
among hematopoietic cell transplantation recipients: a global perspective. Biol Blood Marrow
Transplant. 2009;15:1143-1238.
Raimondo S, Corrado C, Raimondi L, De Leo G, Alessandro R. Role of Extracellular Vesicles
in Hematological Malignancies. Biomed Res Int. 2015; 2015: 821613. Published online
2015 Oct 25.
Wagner JE, Eapen M, Kurtzberg J. One-unit versus two-unit cord-blood transplantation. 
N Engl J Med. 2015;372:288. 
Sorror ML, Martin PJ, Storb RF, et al. Pretransplant comorbidities predict severity of acute
graft-versus-host disease and subsequent mortality. Blood. 2014;124:287-295. 
Rozmus J, Shulz K. Biomarkers in Chronic GvHD. Exper Rev Hematol, 2011;4:329-342.
. Weisdorf D, Haake R, Blazar B, et al. Treatment of moderate/severe acute graft-versus-host
disease after allogeneic bone marrow transplantation: an analysis of clinical risk features and 
outcome. Blood 1990 Feb 15;75(4):1024-30. 
. Wingard JR, Hsu J, Hiemenz JW. Hematopoietic stem cell transplantation: an overview of 
infection risks and epidemiology. Infect Dis Clin North Am. 2010;24:257.

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
94 
APPENDIX A: SCHEDULE OF PROCEDURES FOR THE PHASE 1 AND PHASE 2 PARTS OF THE STUDY 
Study Period 
SCRN1 
Subject 
COND 
Hospital 
ADM 
Day 
of 
HCT 
Days Post-Transplant 
Early 
Withdrawal 
Visit3 
Study Day 
-53 to 
-11 
-10 to 
-1 
INST 
Policy 
0 
+1 
+7 
+14 
+21 
+28 
+35 
+42 
+49 
+56 
+63 
+70 
+77 
+84 
+91 
+100 
+180 
+270 
+365 
+7302 
Visit window 
(days) 
- 
- 
- 
- 
- 
±3 
±3 
±3 
±3 
±3 
±3 
±3 
±3 
±3 
±3 
±3 
±3 
±3 
±3 
±14 
±28 
±28 
±28 
- 
Study 
Procedures 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Informed consent 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Inclusion and 
exclusion 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
HLA typing4 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ECHO or 
MUGA scan5 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Medical history 
X 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Qualification of 
mPB6 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Karnofsky 
Performance 
Status7 
X 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
 
Bone marrow 
aspirate8 
X 
 
 
 
 
 
 
X 
  
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
Infectious 
disease titers and 
plasma CMV 
PCR viremia9,10 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Physical 
examination11 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
 
Vital signs12 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
 
ECG13 
X 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
Concomitant 
medications14 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
 
Adverse events15 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
Pulmonary 
function tests 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Blood typing and 
RBC antibody 
screen 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Hematology16 
X 
 
X 
X16 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
X 
 
X 
 
X 
 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
95 
 APPENDIX A: SCHEDULE OF PROCEDURES FOR THE PHASE 1 AND PHASE 2 PARTS OF THE STUDY (CONTINUED) 
Study Period 
SCRN1 
Subject 
COND 
Hospital 
ADM 
Day 
of 
HCT 
Days Post-Transplant 
Early 
Withdrawal 
Visit3 
Study Day 
-53 to 
-11 
-10 to 
-1 
INST 
Policy 
0 
+1 
+7 
+14 
+21 
+28 
+35 
+42 
+49 
+56 
+63 
+70 
+77 
+84 
+91 
+100 
+180 
+270 
+365 
+7302 
Visit window 
(days) 
- 
- 
- 
- 
- 
±3 
±3 
±3 
±3 
±3 
±3 
±3 
±3 
±3 
±3 
±3 
±3 
±3 
±3 
±14 
±28 
±28 
±28 
- 
Study Procedures 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Serum chemistry17 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
 
X 
Immune 
reconstitution 
assays18 
X 
 
 
 
 
X 
X 
 
X 
 
 
 
X 
 
 
 
 
X 
 
X 
X 
X 
 
 
Serum pregnancy 
test19 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Randomization 
(Phase 2 only)20 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
CMV assessment 
for pre-emptive 
therapy21  
 
X 
 
 
 
X (ad hoc if subject is seen at an unscheduled visit) 
 
 
 
 
 
Conditioning 
regimen22 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
GvHD 
prophylaxis23 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Admission to 
hospital unit 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Prepare 
investigational 
product 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Transplantation 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Viral assessment24  
 
 
 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
aGvHD 
assessment25 
 
 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
 
X 
cGvHD 
assessment26 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
X 
X 
 
X 
Chimerism 
testing27 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
 
X 
X 
 
X 
 
 
Serum 
immunoglobulin28 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
X 
 
X 
 
 
GvHD 
biomarkers29 
 
 
 
 
 
X 
X 
X 
X 
X 
X 
 
 
 
 
 
 
 
X 
 
 
 
 
 
Survival  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
96 
 
1. 
The study will consist of a Screening Period of up to 6 weeks prior to administration of conditioning regimen (subject conditioning will occur between Day -10 to Day -1). General donor history will be 
collected in the eCRF, including (but not limited to) donor age, sex, race or ethnicity, CMV status, and blood type. Upon completion of all screening procedures and determination of eligibility, subjects 
will be scheduled for administration of conditioning regimen and admission for transplant, per institutional procedures. Screening procedures must be completed within 6 weeks prior to initiation of 
conditioning regimen. There may be situations in which a subject is not able to begin the conditioning within 6 weeks of the study screening. In these instances, the subject may need to be re-screened. 
This will involve repeating select or all screening procedures, as advised by the Medical Monitor. 
2. 
The Day +730 visit will occur by conducting a telephone contact report for capture of survival status and adverse event reporting. 
3. 
If a subject withdraws or is withdrawn from the study prior to Day 0, the subject’s mPB will not be processed to a ProTmune unit, they will not be considered evaluable for any study-related endpoint 
analyses, and the subject will be replaced. If a subject withdraws from the study after transplantation, information regarding secondary graft failure, disease relapse, serious adverse events involving 
GvHD and infections, and survival outcomes will be collected on Days +180, +365, and +730 by phone. 
4. 
Investigator is required to verify that the subject completed HLA typing. HLA typing can be completed prior to the Screening Period. 
5. 
During the Screening Period, either an ECHO or MUGA scan will be obtained to assess for LVEF or shortening fraction for eligibility criteria assessment by the Investigator. The results of an 
ECHO/MUGA performed prior to consent may be used for subject qualification as long as performed within 6 weeks prior to the Subject Conditioning Period, from Day -53 to Day -11. 
6. 
Qualification of mPB unit must be conducted by a Fate representative. 
7. 
Karnofsky Performance Status will be assessed during the Screening Period, at Day 0 after HCT, and all subsequent study visits up through Day +365 (which should include, but are not limited to, 
weekly from Day +1 through Day +91, then on Days +100, +180, +270, and +365). If applicable, Karnofsky Performance Status will be assessed at the Early Withdrawal Visit. Refer to Appendix D for 
details and the grading scale. 
8. 
Bone marrow aspirate will be sent to pathology and to cytogenetics during the Screening Period, on Day +21 in those subjects whose ANC is <500/µL, and as clinically indicated. Flow cytometry is 
required on BM aspirate. The results of the bone marrow aspirate performed prior to consent may be used for subject qualification as long as performed within 6 weeks prior to the Subject Conditioning 
Period, from Day -53 to Day -11. 
9. 
All subjects will be tested for baseline CMV antibody titer (IgG/IgM) and plasma CMV viremia. This baseline testing will be performed by a central laboratory and results will be provided to the 
clinical site prior to the initiation of randomization. 
10. Infectious diseases screen during the Screening Period by peripheral blood sample will include titers for EBV, CMV, hepatitis panel (hepatitis A antibody, hepatitis B surface antibody, hepatitis B 
surface antigen, hepatitis B core antibody, and hepatitis C antibody), BK virus, HSV, HHV-6, HIV, HTLV types I/II antibody, syphilis, and VZV. Titer testing will be done by central laboratory testing 
during the Screening Period. 
11. During the Screening Period, Subject Conditioning Period, and Hospital Admission, a complete physical examination will be performed. The complete examination should include height, body weight, 
skin, head-neck, eyes-ears-nose-throat, lungs-chest, heart, abdomen, extremities and appearance. A subset of follow-up physical examination assessments (with the exception of height) will be 
performed on the subject at Day 0 prior to HCT and weekly from Day +1 through Day +91, then on Days +100, +180, +270, and +365. If applicable, a follow-up physical examination assessment will 
be performed at the Early Withdrawal Visit. All physical examination findings must be documented in the subject’s study chart and also recorded in the appropriate eCRF. 
12. Vital Signs will be obtained at the Screening Period, Subject Conditioning Period, Hospital Admission, and at the following intervals on Day 0: prior to infusion of the cells, and at 15, 30, 45, and 
60 minutes after the start of infusion of the cells (Note: these are targeted collection times; protocol deviations will only be documented when a collection is missed). Vital Signs will be obtained weekly 
from Day +1 through Day +91, then on Days +100, +180, +270, and +365. If applicable, vital signs will be obtained at the Early Withdrawal Visit. Vital signs will include systolic blood pressure, 
diastolic blood pressure, pulse rate, respiratory rate, and temperature. 
13. A 12-lead triplicate ECG (sequential, within 15 minutes total) will be obtained during the Screening Period, at Day 0 (prior to HCT), and at Day +100. 
14. All concomitant medications will be recorded starting at Day -30 through Day +100. From Day +100 through Day +730, only concomitant medications given as TKI maintenance, or that were ongoing 
at the time of, and for the treatment of, an AE of GvHD, infection or secondary engraftment failure or any SAE, will be recorded. 
15. All SAEs will be recorded from Day -10 through Day +365, and only SAEs related to the infused cells (ProTmune ex vivo programmed mPB cells or Control mPB cells) from Day +366 through Day 
+730. From Day -10 through Day +100: adverse events will be collected as per CTCAE 4.0 (as well as BMT CTN for infections) as follows: Adverse events associated with infusion reactions, GvHD, 
infections, or engraftment failure (Grades 1 through 5). All other adverse events (Grades 2 through 5). Laboratory abnormalities will only be recorded as adverse events if deemed clinically significant 
by the Investigator. From Day +100 through Day +365: Only adverse events associated with GvHD, infections or secondary engraftment failure (Grades 1 through 5). 
16. Peripheral blood testing for hematology (CBC and when possible per institutional practice to include a differential (automated or manual) including total white blood cells, red blood cells, hemoglobin, 
hematocrit, platelets, neutrophils, bands, lymphocytes, eosinophils, and monocytes; manual differential will include blasts if present and ANC calculation) will be performed once during the Screening 
Period, once at Hospital Admission, once at Day 0 (prior to HCT), and daily from Day +1 through Day +28 (or until the subject achieves neutrophil engraftment, whichever event occurs first), and on 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
97 
Day +35, +42, +49, +56, +63, +70, +77, +84, +100, +180, and +365. If applicable, peripheral blood testing for hematology will be performed at the Early Withdrawal Visit. Following engraftment, 
blood for hematology is to be collected per institutional policy. Blood samples will be collected and forwarded to the local laboratory for analysis. 
17. A peripheral blood sample for serum chemistry will be collected once during the Screening Period, once at Hospital Admission, once at Day 0 prior to HCT, and weekly from Day +1 through Day +100, 
then at Day +180. If applicable, a peripheral blood sample for serum chemistry will be obtained at the Early Withdrawal Visit. Serum chemistry assessment will include creatinine, blood urea nitrogen, 
albumin, ALT, AST, bilirubin (total and direct), alkaline phosphatase, lactate dehydrogenase, calcium, sodium, potassium, phosphorus, chloride, CO2, and magnesium. 
18. Peripheral blood samples for immune reconstitution assays will be collected at baseline (during the Screening Period), and at Days +7, +14, +28, +56, +91, +180, +270, and +365. The peripheral blood 
sample will be sent to a central laboratory for analysis. 
19. A serum pregnancy test will be performed for females of child-bearing potential. 
20. For the Phase 2 part of the study only, after meeting eligibility and no later than Day -7, subjects will be randomized using the IWRS to either the Control arm or ProTmune arm. 
21. If pre-emptive CMV therapy is being initiated per local Institutional policy at a timepoint that does not have a regularly scheduled viral assessment (e.g., at conditioning or at an unscheduled visit), 2 
peripheral blood samples (1 blood sample to be utilized locally, per institutional policy as required, at the site for subject management and 1 blood sample for central laboratory testing) will be collected 
for CMV assessments of DNA by quantitative PCR prior to starting the preemptive therapy. 
22. The conditioning regimen will be administered to subject per Section 3.4. 
23. GvHD prophylaxis will be initiated per Section 3.4. 
24. Two peripheral blood samples at each testing time point (1 blood sample to be utilized locally at the site for subject management and 1 blood sample for central laboratory testing) will be collected for 
viral assessments of DNA by quantitative PCR for EBV, CMV, HHV-6, and BK virus weekly from Days +7 through Day +100, and at Days +180, +270, and +365. For CMV assessment: Assessment of 
infection will be performed based on the NCI CTCAE and the BMT CTN Definitions. Study sites will monitor CMV viremia using local assays and frequencies as determined by local practices for in-
patient and out-patient care. Therefore, if a blood sample is being drawn for a CMV PCR at a local virology laboratory, a sample must also be drawn at the same time and sent to the central virology 
laboratory for a CMV PCR result. If applicable, a peripheral blood sample for CMV assessment will be obtained at the Early Withdrawal Visit. 
25. Clinical and laboratory assessments of aGvHD will be performed weekly from Day +1 through Day +100, and on Day +180. If applicable, aGvHD assessments will be performed at the Early 
Withdrawal Visit. Acute GvHD assessments (incidence and maximum severity) of Grades I through IV aGvHD of the skin, liver, and gut as per the CIBMTR aGvHD Grading Scale (Appendix E) will 
be performed. 
26. Chronic GvHD assessments of mild, moderate, or severe cGvHD as per NIH Consensus Criteria for cGvHD (Appendix F) will be performed on Days +180, +270, and +365. If applicable, cGvHD 
assessments will be performed at the Early Withdrawal Visit. 
27. Neutrophil and T-cell chimerism will be assessed on the third consecutive day of ANC >500 cells/µL (neutrophil only) and on Days +28, +100, +180, and +365 (both neutrophil and T-cell). Chimerism 
will be measured by PCR amplification of recipient-and-donor-derived cells; which may include single nucleotide polymorphism and/or DNA microsatellites (short tandem repeats) analyses consistent 
with Institutional Standards. Chimerism will be measured by restriction fragment length polymorphism or microsatellite. Chimerism studies will be performed by short tandem repeats and/or flow 
cytometry according to local laboratory practices. When feasible, fractional chimerism (total, myeloid, lymphoid) will be performed from peripheral blood samples. If there is no evidence for donor 
engraftment by Day +21, then the subject will undergo BM and peripheral blood chimerism studies. If donor engraftment is not present by Day +28 BM examination, and the subject’s disease is not 
present, the subject should be considered a primary graft failure (in the absence of relapsed disease). 
28. Serum IgG, IgM, and IgA will be collected by a peripheral blood sample at Days +100, +180, and +365. 
29. Peripheral blood samples for GvHD exploratory biomarkers will be obtained once weekly from Days +7 through Day +42, then on Day +100. Samples will be banked. 
 
ADM = Admission; aGvHD = Acute graft-versus-host disease; ALT = alanine aminotransferase; ANC = absolute neutrophil count; AST = aspartate aminotransferase; BM = Bone marrow; 
BMT CTN = Blood and Marrow Transplant Clinical Trials Network; CBC = Complete blood count; cGvHD = Chronic graft-versus-host disease; CMV = Cytomegalovirus; CO2 = Carbon dioxide; 
COND = Conditioning; CTCAE = Common Terminology Criteria for Adverse Events; DNA = Deoxyribonucleic acid; EBV = Epstein-Barr Virus; ECG = Electrocardiogram; ECHO = Echocardiogram; 
eCRF = Electronic case report form; GvHD = Graft-versus-host disease; HCT = Hematopoietic cell transplantation; HSV = Herpes simplex virus; HHV-6 = Human herpes virus 6; HIV = Human 
immunodeficiency virus; HLA = Human leukocyte antigen; HTLV = Human T-cell lymphotropic virus; Ig = Immunoglobulin; INST = Institutional; LVEF = Left ventricular ejection fraction; mPB = 
Mobilized peripheral blood; MUGA = Multiple gated acquisition; NCI = National Cancer Institute; NIH = National Institutes of Health; SAE = serious adverse event; SCRN = Screening; PCR = Polymerase 
chain reaction; VZV = Varicella zoster virus. 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
98 
APPENDIX B: STUDY DESIGN SCHEMATIC FOR THE PHASE 1 PART OF THE 
STUDY 
 
CIBMTR = Center for International Blood and Marrow Transplant Research; GvHD = Graft-versus-host disease; HLA = Human 
Leukocyte Antigen; HCT = Hematopoietic cell transplant; IV = intravenous; mPB = Mobilized peripheral blood; TBI = Total 
body irradiation. 
 
Non-Randomized Subjects 
N = approximately 6 to 10 treated subjects 
Subjects must have an available 8/8 HLA-A, -B, -C, 
and -DRB1-matched unrelated mPB donor. 
Screening and Subject Conditioning 
Screening Period: Day -53 to Day -11 (up to 6 weeks prior to the Subject Conditioning Period) 
Subject Conditioning Period: Day -10 to Day -1 
 
The conditioning regimen will be administered as required per the protocol. 
 
Conditioning Regimens: 
•
The conditioning regimen will include preparative regimens of fludarabine and busulfan 
(FluBu4); busulfan and cyclophosphamide; cyclophosphamide and TBI; TBI and etoposide; or 
fludarabine and melphalan (FluMel 140). 
GvHD Prophylaxis Regimen: 
•
Methotrexate (15 mg/m
2 on Day +1 after hematopoietic stem cell infusion and 10 mg/m
2 
on Days +3, +6, and +11), and 
•
Tacrolimus (0.02 mg/kg every 24 hours as an IV infusion or 0.03 mg/kg orally beginning 
on Day -2, adjusted to target dose level of 5 to 15 ng/mL. Taper starting at Day +100).  
Study Treatment Administration: Day 0 (Day of HCT) 
One unit of ProTmune ex vivo programmed mPB cells as the cell source for the HCT procedure. 
Hospital Admission: Per Institutional Policy 
Post-Transplant Follow-Up: After HCT up through Day +730 
Comprised of post-transplant assessments and post-transplant weekly visits through Day +100, 
intermittent visits through Day +365 and a telephone call on Day +730. 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
99 
APPENDIX C: FLOW SCHEMATIC FOR THE PHASE 1 PART OF THE STUDY 
*Comprised of post-transplant assessments and post-transplant weekly visits through Day +100, intermittent visits through Day +365 and a telephone call on Day +730. 
aGvHD = Acute graft-versus-host disease; CMV = Cytomegalovirus; EAC = Endpoint Adjudication Committee; ECG = Electrocardiogram; GvHD = Graft-versus-host disease; HLA = Human Leukocyte 
Antigen; HCT = Hematopoietic cell transplant; IDMC = Independent Data Monitoring Committee; mPB = Mobilized peripheral blood. 
 
2-Year Follow- up 
Screening  
Period  
(Day -53 to 
Day -11; up to 6 weeks 
prior to the 
Conditioning Period) 
Conditioning Regimen per 
protocol. 
GvHD Prophylaxis Regimen per 
protocol. 
Day -53 
Day -10 
Day 0 
Conditioning Period 
 (Day -10 to 
Day -1; up to 9 days 
prior to Hospital 
Admission) 
One unit of 
ProTmune  
ex vivo 
programmed 
mPB cells as 
the cell 
source for the 
HCT 
procedure. 
Day of 
HCT 
Post-Transplant 
Assessments* 
Post-Transplant 
Follow-up 
Study Completion 
An IDMC will convene to assess preliminary safety data 
as outlined in the IDMC Charter. At that time, the 
Sponsor, in consultation with and based on 
recommendations from the IDMC, will decide whether the 
study should stop or whether the Phase 2 study can begin. 
Key Assessments: 
•
Investigator is required to verify that the 
subject completed HLA typing. 
•
Infectious disease titers and CMV 
viremia.  
•
Peripheral blood baseline sample for 
immune reconstitution assays. 
Hospital 
Admission 
(Institutional 
Policy) 
Key Assessments: 
•
Adverse event monitoring. 
•
Karnofsky Performance Status. 
•
Acute GvHD assessments. 
•
Chronic GvHD assessments. 
•
Peripheral blood monitoring for safety panels, viral 
monitoring, immune reconstitution, chimerism, 
serum immunoglobulins, and GvHD exploratory 
biomarkers. 
•
Bone marrow aspirate. 
•
ECG. 
Key Assessments: 
•
ECG and safety panels 
on Day 0 prior to HCT. 
•
Adverse event 
monitoring (starting at 
Conditioning).  
•
Karnofsky Performance 
Status. 
The study will utilize an EAC to adjudicate the aGvHD 
endpoint at Day +100 and Day +180 in accordance with 
the EAC charter. 
Day +730* 
Day +365 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
100 
APPENDIX D: KARNOFSKY PERFORMANCE STATUS SCALE 
General Category 
Index 
Specific Criteria 
Able to carry on normal activity; no 
special care needed. 
100 
Normal; no complaints; no evidence of 
disease. 
90 
Able to carry on normal activity; minor 
signs or symptoms of disease. 
80 
Normal activity with effort; some signs 
or symptoms of disease. 
Unable to work; able to live at home 
and care for most personal needs; 
varying amount of assistance needed. 
70 
Cares for self; unable to carry on 
normal activity or to do work. 
60 
Requires occasional assistance from 
others but is able to care for most 
needs. 
50 
Requires considerable assistance from 
others and frequent medical care. 
Unable to care for self; requires 
institutional or hospital care or 
equivalent; diseases may be rapidly 
progressing.  
40 
Disabled; requires special care and 
assistance. 
30 
Severely disabled; hospitalization 
indicated; death not imminent. 
20 
Very sick; hospitalization necessary; 
active supportive treatment necessary. 
10 
Moribund. 
0 
Dead 
Source: Mor V, Laliberte L, Morris JN, Wieman M. The Karnofsky Performance Status Scale. An examination of its reliability and validity in 
a research setting. Cancer. 1984;53(9):2002-2007. 
 
 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
101 
APPENDIX E: ACUTE GVHD SCORING SYSTEM FOR INDIVIDUAL ORGANS: 
CIBMTR SCALE  
 
Stage 
Skin 
Liver 
Gut 
1 
Rash on <25% of skina 
Bilirubin 2-3 mg/dlb 
 
Diarrhea > 500 ml/dayc or 
persistent nausead 
2 
Rash on 25-50% of skin 
Bilirubin 3-6 mg/dl 
 
Diarrhea >1000 ml/day 
3 
Rash on >50% of skin 
Bilirubin 6-15 mg/dl 
Diarrhea >1500 ml/day 
 
 
4 
Generalized erythroderma 
with bullous formation 
Bilirubin >15 mg/dl 
Severe abdominal pain with or 
without ileus 
Grade e 
I 
Stage 1-2 
None 
None 
II 
Stage 3 or 
Stage 1 or 
Stage 1 
III 
-- 
Stage 2-3 or 
Stages 2-4 
IV f 
Stage 4 
Stage 4 
-- 
a Use “Rule of Nines” or burn chart to determine extent of rash. 
b Range given as total bilirubin. Downgrade one stage if an additional cause of elevated bilirubin has been documented. 
c Volume of diarrhea applies to adults. For pediatric subjects, the volume of diarrhea should be based on body surface area. Downgrade one 
stage if an additional cause of diarrhea has been documented. 
d Persistent nausea with histologic evidence of GvHD in the stomach or duodenum. 
e Criteria for grading given as minimum degree of organ involvement required to confer that grade. 
f Grade IV may also include lesser organ involvement with an extreme decrease in performance status. 
Source: CIBMTR Forms Manual: Post-TED (Form2450); A00425 version 2.0 (8/01/2012) 
 
 
 
 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
102 
APPENDIX F: NIH CONSENSUS CRITERIA FOR CHRONIC GVHD 
Performance Score: 
SCORE 0 
SCORE 1 
SCORE 2 
SCORE 3 
KPS, ECOG LPS 
Asymptomatic 
and fully active 
(ECOG 0; KPS 
or LPS 100%). 
Symptomatic, fully 
ambulatory, restricted 
only in physically 
strenuous activity 
(ECOG 1, KPS or LPS 
80-90%). 
Symptomatic, 
ambulatory, capable of 
selfcare, >50% of 
waking hours out of bed 
(ECOG 2, KPS or LPS  
60-70%). 
 
Symptomatic, limited 
self-care, >50% of 
waking hours in bed 
(ECOG 3-4, KPS or 
LPS <60%). 
Skin 
Clinical features: 
• Maculopapular rash 
• Lichen planus-like 
features 
• Papulosquamous 
lesions or ichthyosis 
• Hyperpigmentation 
• Hypopigmentation 
• Keratosis pilaris 
• Erythema 
• Erythroderma 
• Poikiloderma 
• Sclerotic features 
• Pruritus 
• Hair involvement 
• Nail involvement 
 
No symptoms. 
<18% BSA with disease 
signs but NO sclerotic 
features. 
19-50% BSA OR 
involvement with 
superficial sclerotic 
features “not 
hidebound” (able to 
pitch). 
>50% BSA OR deep 
sclerotic features 
“hidebound” (unable to 
pinch) OR impaired 
mobility, ulceration or 
severe pruritus. 
Mouth 
No symptoms. 
Mild symptoms with 
disease signs but not 
limiting oral intake 
significantly. 
Moderate symptoms 
with disease signs with 
partial limitation of oral 
intake. 
Severe symptoms with 
disease signs on 
examination with major 
limitation of oral intake. 
Eyes 
Mean tear test (mm): 
• >10 
• 6-10 
• ≤5 
• Not done 
No symptoms. 
Mild dry eye symptoms 
not affecting ADL 
(requiring eyedrops 
≤3 × per day) OR 
asymptomatic signs of 
keratoconjunctivits 
sicca. 
Moderate dry eye 
symptoms partially 
affecting ADL 
(requiring drops 
>3 × per day or punctal 
plugs), WITHOUT 
vision impairment. 
Severe dry eye 
symptoms significantly 
affecting ADL (special 
eyeware to relieve pain) 
OR unable to work 
because of ocular 
symptoms OR loss of 
vision caused by 
keratoconjunctivitis 
sicca. 
GI Tract  
No symptoms. 
Symptoms such as 
dysphagia, anorexia, 
nausea, vomiting, 
abdominal pain or 
diarrhea without 
significant weight loss 
(<5%). 
Symptoms associated 
with mild to moderate 
weight loss  
(5-15%). 
Symptoms associated 
with significant weight 
loss >15%, requires 
nutritional supplement 
for most calorie needs 
OR esophageal dilation. 
*AP may be elevated in growing children, and not reflective of liver dysfunction.  
†Pulmonary scoring should be performed using both the symptom and pulmonary function testing (PFT) scale whenever possible. When 
discrepancy exists between pulmonary symptom or PFT scores the higher value should be used for final scoring. Scoring using the Lung 
Function Score (LFS) is preferred, but if DLCO is not available, grading using FEV1 should be used. The LFS is a global assessment of lung 
function after the diagnosis of bronchiolitis obliterans has already been established [29]. The percent predicted FEV1 and DLCO (adjusted for 
hematocrit but not alveolar volume) should be converted to a numeric score as follows: >80% = 1; 70-79% = 2; 60-69% = 3; 50-59% = 4; 
40-49% = 5; =40% = 6.  
The LFS = FEV1 score = DLCO score, with a possible range of 2-12.  
ADL = activities of daily living; ALT = alanine aminotransferase; AP = alkaline phosphatase; AST = aspartate aminotransferase; BSA = body 
surface area; DLCO = diffusing capacity of the lung; ECOG = Eastern Cooperative Oncology Group; GvHD = graft-versus-host disease; 
KPS = Karnofsky Performance Status;LPS = Lansky Performance Status; LFTs = liver function tests; ULN = upper limit of normal. 
Source: Filipovich AH, Weisdorf D, Pavletic S, et al. National Institutes of Health consensus development project on criteria for clinical trials in 
chronic graft-versus-host disease: I. Diagnosis and staging working group report. Biol Blood Marrow Transplant. 2005;11(12):945-956. 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
103 
APPENDIX F: NIH CONSENSUS CRITERIA FOR CHRONIC GVHD (CONTINUED) 
Performance Score: 
SCORE 0 
SCORE 1 
SCORE 2 
SCORE 3 
Liver 
Normal LFT. 
Elevated Bilirubin, 
AP*, AST or ALT. 
Bilirubin  
>3 mg/dl or Bilirubin, 
enzymes 2-5 × ULN. 
Bilirubin or enzymes  
>5 × ULN. 
Lungs† 
 
 
FEVI 
 
 
 
DLCO 
No symptoms. 
 
 
 
 
• FEV1  
>80% OR 
LFS=2 
Mild symptoms 
(shortness of breath 
after climbing 1 flight 
of steps). 
 
• FEV1 60-79% OR 
LFS 3-5 
Moderate symptoms 
(shortness of breath 
after walking on flat 
ground). 
 
• FEV1 40-59% 
    OR LFS 6-9  
 
Severe symptoms 
(shortness of breath at 
rest; requiring 02). 
 
 
• FEVI ≤39% OR 
LFS 10-12 
Joints and Fascia 
No symptoms. 
Mild tightness of arms 
or legs, normal or mild 
decreased range of 
motion (ROM) AND 
not affecting ADL. 
Tightness of arms or 
legs OR joint 
contractures, erythema 
thought due to fasciitis, 
moderate decrease 
ROM AND mild to 
moderate limitation of 
ADL. 
Contractures WITH 
significant decrease of 
ROM AND significant 
limitation of ADL 
(unable to tie shoes, 
button shirts, dress self, 
etc.) 
 
Genital Tract 
No symptoms. 
Symptomatic with mild 
signs on examination 
AND no effect on 
coitus and minimal 
discomfort with 
gynecologic exam. 
Symptomatic with 
moderate signs on 
examination AND with 
mild dyspareunia or 
discomfort with 
gynecologic exam. 
Symptomatic WITH 
advanced signs 
(stricture, labial 
agglutination or severe 
ulceration) AND severe 
pain with coitus or 
inability to insert 
vaginal speculum. 
 
Other indicators, clinical manifestations or complications related to chronic GvHD (check all that apply and assign a 
score to its severity (0-3) based on its functional impact where applicable (none – 0, mild – 1, moderate – 2, severe – 3): 
• 
Esophageal stricture or web  
• 
Ascites (serositis) 
• 
Myasthenia Gravis 
• 
Polymyositis 
• 
Platelets >100,000/µl 
• 
Pericardial Effusion 
• 
Nephrotic syndrome 
• 
Cardiomyopathy 
• 
Cardiac conduction defects 
• 
Progressive onset 
• 
Pleural Effusion(s) 
• 
Peripheral Neuropathy 
• 
Eosinophilia >500µl 
• 
Coronary artery involvement 
  
*AP may be elevated in growing children, and not reflective of liver dysfunction.  
†Pulmonary scoring should be performed using both the symptom and pulmonary function testing (PFT) scale whenever possible. When 
discrepancy exists between pulmonary symptom or PFT scores the higher value should be used for final scoring. Scoring using the Lung 
Function Score (LFS) is preferred, but if DLCO is not available, grading using FEV1 should be used. The LFS is a global assessment of lung 
function after the diagnosis of bronchiolitis obliterans has already been established [29]. The percent predicted FEV1 and DLCO (adjusted for 
hematocrit but not alveolar volume) should be converted to a numeric score as follows: >80% = 1; 70-79% = 2; 60-69% = 3; 50-59% = 4; 40-
49% = 5; =40% = 6.  
The LFS = FEV1 score = DLCO score, with a possible range of 2-12.  
ADL = activities of daily living; ALT = alanine aminotransferase; AP = alkaline phosphatase; AST = aspartate aminotransferase; BSA = body 
surface area; DLCO = diffusing capacity of the lung; ECOG = Eastern Cooperative Oncology Group; GvHD = graft-versus-host disease; 
KPS = Karnofsky Performance Status; LPS = Lansky Performance Status; LFTs = liver function tests; ULN = upper limit of normal. 
Source: Filipovich AH, Weisdorf D, Pavletic S, et al. National Institutes of Health consensus development project on criteria for clinical trials in 
chronic graft-versus-host disease: I. Diagnosis and staging working group report. Biol Blood Marrow Transplant. 2005;11(12):945-956. 
 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
104 
APPENDIX F: NIH CONSENSUS CRITERIA FOR CHRONIC GVHD (CONTINUED) 
Global Severity Scoring of Chronic GvHD   
Elements included in the proposed global scoring system include both the number of organs or 
sites involved and the severity within each affected organ (note that performance status scoring is 
not incorporated into the global scoring system). The global descriptions of mild, moderate, and 
severe were chosen to reflect the degree of organ impact and functional impairment due to 
chronic GVHD. Although scoring is often used at the time of initial diagnosis, evaluating the 
clinical score periodically during the course of chronic GVHD may revise prognostic 
expectations and better describe the current severity of chronic GVHD.  
Note that the global scoring system can be applied only after the diagnosis of chronic GVHD is 
confirmed by either (1) the presence of a diagnostic feature or, if a diagnostic feature is not 
present, (2) at least 1 distinctive manifestation of chronic GVHD with the diagnosis supported by 
histologic, radiologic, or laboratory evidence of GVHD from any site. 
Mild chronic GVHD involves only 1 or 2 organs or sites (except the lung: see below), with no 
clinically significant functional impairment (maximum of score 1 in all affected organs or sites).  
Moderate chronic GVHD involves (1) at least 1 organ or site with clinically significant but no 
major disability (maximum score of 2 in any affected organ or site) or (2) 3 or more organs or 
sites with no clinically significant functional impairment (maximum score of 1 in all affected 
organs or sites). A lung score of 1 will also be considered moderate chronic GVHD.  
Severe chronic GVHD indicates major disability caused by chronic GVHD (score of 3 in any 
organ or site). A lung score of 2 or greater will also be considered severe chronic GVHD.  
Source: Filipovich AH, Weisdorf D, Pavletic S, et al. National Institutes of Health consensus development project 
on criteria for clinical trials in chronic graft-versus-host disease: I. Diagnosis and staging working group report. Biol 
Blood Marrow Transplant. 2005;11(12):945-956. 
 
 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
105 
APPENDIX G: BMT CTN SEVERITY GRADING AND RECURRENCE INTERVAL 
DEFINITION 
Type of 
Infection/Severity Grade 
Grade 1 
Grade 2 
Grade 3 
Bacterial infections 
Bacterial focus NOS 
requiring no more than 
14 days of therapy for 
treatment (e.g., urinary 
tract infection). 
Bacteremia (except CoNS) 
without severe sepsis.* 
Bacteremia with deep 
organ involvement (e.g., 
with new or worsening 
pulmonary infiltrates; 
endocarditis). 
Coag Neg Staph (S. epi), 
Corynebacterium, or 
Proprioniobacterium 
bacteremia. 
Bacterial focus with 
persistent signs, symptoms, 
or persistent positive 
cultures requiring greater 
than 14 days of therapy. 
Severe sepsis with 
bacteremia.  
Cellulitis responding to 
initial therapy within 
14 days. 
Cellulitis requiring a 
change in therapy due to 
progression. 
Localized or diffuse 
infections requiring 
incision with or without 
drain placement. 
Any pneumonia 
documented or presumed 
to be bacterial. 
Fasciitis requiring 
debridement. 
 
 
 
 
 
Pneumonia requiring 
intubation. 
C. Difficile toxin 
positive stool with 
diarrhea <1 L without 
abdominal pain (child 
<20 mL/kg). 
C. Difficile toxin positive 
stool with diarrhea ≥1 L 
(child ≥20 ml/kg) or with 
abdominal pain 
C. Difficile toxin positive 
stool with toxic dilation 
or renal insufficiency 
with/without diarrhea 
Fungal infections 
Superficial candida 
infection (e.g., oral 
thrush, vaginal 
candidiasis). 
Candida esophagitis 
(biopsy proven). 
Fungemia including 
Candidemia. 
- 
Proven or probable fungal 
sinusitis confirmed 
radiologically without 
orbital, brain, or bone 
involvement. 
Proven or probable 
invasive fungal infections 
(e.g., Aspergillus, Mucor, 
Fusarium, Scedosporium). 
- 
- 
Disseminated infections 
(defined as multifocal 
pneumonia, presence of 
urinary or blood antigen, 
and/or CNS involvement) 
with Histoplasmosis, 
Blastomycosis, 
Coccidiomycosis, or 
Cryptococcus. 
Pneumonocystis jiroveci 
pneumonia (regardless of 
PaO2 level). 
* For definition of sepsis, see source document. 
CMV = Cytomegalovirus; CNS = Central nervous system; EBV = Epstein-Barr virus; HHV-6 = Human herpesvirus 6; PTLD 
= Posttransplant Lymphoproliferative Disease; VZV = Varicella zoster virus. 
Source: Blood and Marrow Transplant Clinical Trials Network Technical Manual of Procedures, Appendix 4-A. Version 3.0, 
dated March 19, 2013. 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
106 
APPENDIX G: BMT CTN SEVERITY GRADING AND RECURRENCE INTERVAL 
DEFINITION (CONTINUED) 
Type of 
Infection/Severity Grade 
Grade 1 
Grade 2 
Grade 3 
Viral Infections 
Mucous HSV infection 
- 
- 
Dermatomal Zoster 
VZV infection with 3 or 
more dermatomes. 
Severe VZV infection 
(coagulopathy or organ 
involvement). 
Asymptomatic CMV 
viremia untreated or a 
CMV viremia with viral 
load decline by at least 
2/3 of the baseline value 
after 2 weeks therapy. 
Clinically active CMV 
infection (e.g., symptoms, 
cytopenias) or CMV 
viremia not decreasing by 
at least 2/3 of the baseline 
value after 2 weeks of 
therapy. 
CMV end-organ 
involvement 
(pneumonitis, enteritis, 
retinitis). 
EBV reactivation not 
treated with rituximab. 
EBV reactivation 
requiring institution of 
therapy with rituximab. 
EBV PTLD 
Adenoviral conjunctivitis 
asymptomatic viruria, 
asymptomatic stool 
shedding, and viermia not 
requiring treatment. 
Adenoviral upper 
respiratory infection, 
viremia, or symptomatic 
viruria requiring 
treatment. 
Adenovirus with 
end-organ involvement 
(except conjunctivitis and 
upper respiratory tract). 
Asymptomatic HHV-6 
viremia untreated or an 
HHV-6 viremia with a 
viral load decline by at 
least 0.5 log after 2 weeks 
of therapy. 
Clinically active HHV-6 
infection (e.g., symptoms, 
cytopenias) or HHV-6 
viremia without viral load 
decline 0.5 log after 2 
weeks of therapy. 
- 
BK viremia or viruria 
with cystis not requiring 
intervention. 
BK viermia or viruria 
with clinical consequence 
requiring prolonged 
therapy and/or surgical 
intervention. 
- 
Viremia (virus not 
otherwise specified) not 
requiring therapy. 
Any viremia (virus not 
otherwise specified) 
requiring therapy. 
- 
- 
Enterocolitis with enteric 
viruses. 
 
- 
- 
Symptomatic upper tract 
respiratory viruses. 
Lower tract respiratory 
viruses. 
- 
- 
Any viral encephalitis or 
meningitis. 
Parasitic infections 
- 
- 
CNS or other organ 
toxoplasmosis 
Strongyloides 
hyperinfection. 
* For definition of sepsis, see source document. 
CMV = Cytomegalovirus; CNS = Central nervous system; EBV = Epstein-Barr virus; HHV-6 = Human herpesvirus 6; 
PTLD = Posttransplant Lymphoproliferative Disease; VZV = Varicella zoster virus. 
Source: Blood and Marrow Transplant Clinical Trials Network Technical Manual of Procedures, Appendix 4-A. Version 3.0, 
dated March 19, 2013. 
 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
107 
APPENDIX G: BMT CTN SEVERITY GRADING AND RECURRENCE INTERVAL 
DEFINITION (CONTINUED) 
Type of 
Infection/Severity Grade 
Grade 1 
Grade 2 
Grade 3 
Nonmicrobiologically 
defined infections 
Uncomplicated fever with 
negative cultures 
responding within 14 days 
- 
- 
Clinically documented 
infection not requiring 
inpatient management 
Pneumonia or 
bronchopneumonia not 
requiring mechanical 
ventilation 
Any acute pneumonia 
requiring mechanical 
ventillation 
- 
Typhlitis 
- 
- 
- 
Severe sepsis* without an 
identified organism 
Recurrence Intervals to Determine Whether an Infection is the Same or New: 
1. CMV, HSV, EBV, HHV-6: 2 months (<60 days) 
2. VZV, HZV: 2 weeks (<14 days) 
3. Bacterial, non-C. difficile: 1 week (<7 days) 
4. Bacterial, C. difficile: 1 month (<30 days) 
5. Yeast: 2 weeks (<14 days) 
6. Molds: 3 months (<90 days) 
7. Helicobacter: 1 year (<365 days) 
8. Adenovirus, Enterovirus, Influenza, RSV, Parainfluenza, Rhinovirus: 2 weeks (<14 days) 
9. Polyomavirus (BK virus): 2 months (<60 days) 
* For definition of sepsis, see source document. 
CMV = Cytomegalovirus; CNS = Central nervous system; EBV = Epstein-Barr virus; HHV-6 = Human herpesvirus 6; PTLD 
= Posttransplant Lymphoproliferative Disease; VZV = Varicella zoster virus. 
Source: Blood and Marrow Transplant Clinical Trials Network Technical Manual of Procedures, Appendix 4-A. Version 3.0, 
dated March 19, 2013. 
 
 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
108 
APPENDIX H: STUDY DESIGN SCHEMATIC FOR THE PHASE 2 PART OF THE 
STUDY 
CIBMTR = Center for International Blood and Marrow Transplant Research; GvHD = Graft-versus-host disease; HLA = Human 
Leukocyte Antigen; HCT = Hematopoietic cell transplant; IV = Intravenous; mPB = Mobilized peripheral blood; TBI = Total 
body irradiation 
Randomized Subjects 
N = approximately 90 subjects randomized to achieve 80 treated 
Subjects must have an available 8/8 HLA-A, -B, -C, and -DRB1-matched 
unrelated mPB donor. 
 
Eligible subjects will be randomly assigned in a 1:1 ratio to receive either 
unmanipulated mPB cells (control arm) or ProTmune ex vivo programmed 
mPB cells (experimental arm) and will be stratified by CMV status. 
Screening and Subject Conditioning 
Screening Period: Day -53 to Day -11 (up to 6 weeks prior to the Subject Conditioning Period) 
Subject Conditioning Period: Day -10 to Day -1 
The conditioning regimen will be administered as required per the protocol. 
Conditioning Regimen: 
•
The conditioning regimen will include preparative regimens of fludarabine and busulfan (FluBu4); 
busulfan and cyclophosphamide; cyclophosphamide and TBI; TBI and etoposide; fludarabine and 
melphalan (FluMel 140) 
Randomization should occur no later than Day -7  
GvHD Prophylaxis Regimen: 
•
Methotrexate (15 mg/m
2 on Day +1 after hematopoietic cell infusion and 10 mg/m
2 on Days +3, 
+6, and +11), and 
•
Tacrolimus (0.02 mg/kg every 24 hours as an IV infusion or 0.03 mg/kg orally beginning on Day 
-2, adjusted to target dose level of 5 to 15 ng/mL. Taper starting at Day +100).  
Study Treatment Administration: Day 0 (Day of HCT) 
One unit of ProTmune ex vivo programmed mPB cells as 
the cell source for the HCT procedure 
Hospital Admission: Per Institutional Policy 
Post-Transplant Follow-Up: after HCT up through  
Day +730 
Comprised of post-transplant assessments and 
post-transplant weekly visits through Day +100, 
intermittent visits through Day +365 and a 
telephone call on Day +730. 
Study Treatment Administration: Day 0 (Day of HCT) 
One unit of unmanipulated mPB cells as the cell source 
for the HCT procedure 
Post-Transplant Follow-Up: after HCT up through 
Day +730 
Comprised of post-transplant assessments and 
post-transplant weekly visits through Day +100, 
intermittent visits through Day +365 and a 
telephone call on Day +730. 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
109 
APPENDIX I: FLOW SCHEMATIC FOR THE PHASE 2 PART OF THE STUDY 
*Comprised of post-transplant assessments and post-transplant weekly visits through Day +100, intermittent visits through Day +365 and a telephone call on Day +730.aGvHD = Acute graft-versus-host 
disease; CMV = Cytomegalovirus; EAC = Endpoint Adjudication Committee; ECG = Electrocardiogram; GvHD = Graft-versus-host disease; HLA = Human Leukocyte Antigen; HCT = Hematopoietic 
cell transplant; IDMC = Independent Data Monitoring Committee; mPB = Mobilized peripheral blood. 
Screening  
Period  
(Day -53 to 
Day -11; up to 6 weeks 
prior to the 
Conditioning Period) 
Conditioning Regimen per 
protocol. 
GvHD Prophylaxis Regimen per 
protocol. 
Day -53 
Day -10 
Day 0 
Conditioning Period 
 (Day -10 to 
Day -1; up to 9 days 
prior to Hospital 
Admission) 
One unit of 
ProTmune  
ex vivo 
programmed 
mPB cells as 
the cell 
source for the 
HCT 
procedure. 
Day of 
HCT 
Post-Transplant 
Assessments* 
Post-Transplant 
Follow-up 
Study Completion 
An IDMC will convene to assess preliminary safety data 
as outlined in the IDMC Charter. At that time, the 
Sponsor, in consultation with and based on 
recommendations from the IDMC, will decide whether the 
study should stop or whether the Phase 2 study can begin. 
Key Assessments: 
•
Investigator is required to verify that the 
subject completed HLA typing. 
•
Infectious disease titers and CMV 
viremia.  
•
Peripheral blood baseline sample for 
immune reconstitution assays. 
Hospital 
Admission 
(Institutional 
Policy) 
Key Assessments: 
•
Adverse event monitoring. 
•
Karnofsky Performance Status. 
•
Acute GvHD assessments. 
•
Chronic GvHD assessments. 
•
Peripheral blood monitoring for safety panels, viral 
monitoring, immune reconstitution, chimerism, 
serum immunoglobulins, and GvHD exploratory 
biomarkers. 
•
Bone marrow aspirate. 
•
ECG. 
Key Assessments: 
•
ECG and safety panels 
on Day 0 prior to HCT. 
•
Adverse event 
monitoring (starting at 
Conditioning).  
•
Karnofsky Performance 
Status. 
The study will utilize an EAC to adjudicate the aGvHD 
endpoint at Day +100 and Day +180 in accordance with 
the EAC charter. 
Day +730* 
Day +365 
2-Year Follow- up 

Fate Therapeutics, Inc. 
Clinical Study Protocol PT-001 
Confidential & Proprietary 
 
Version 6.0, 29 March 2019 
110 
APPENDIX J: CLINICAL LABORATORY ANALYTES 
Hematology (CBC with differential): 
Red blood cells 
Hemoglobin 
Hematocrit 
Platelets 
White blood cells 
Neutrophils 
Bands 
Lymphocytes 
Monocytes 
Manual differential includes: 
Blasts 
ANC calculation 
Serum chemistry: 
Creatinine 
ALT  
AST 
Alkaline phosphatase  
Blood urea nitrogen 
Lactate dehydrogenase 
Sodium 
Potassium 
Chloride 
CO2  
Bilirubin (total and direct) 
Magnesium 
Calcium 
Phosphorus 
Serum pregnancy test