A Phase 3, Randomized, Open-Label Study Evaluating the Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma (ZUMA-7)
Phase: PHASE3
Conditions: Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
Sponsor: Kite, A Gilead Company

CLINICAL STUDY PROTOCOL
Protocol Title: 
A Phase 3, Randomized, Open-Label Study Evaluating the Efficacy of 
Axicabtagene Ciloleucel versus Standard of Care Therapy in Subjects with 
Relapsed/Refractory Diffuse Large B Cell Lymphoma (ZUMA-7)
Protocol Number:
KTE-C19-107 (ZUMA-7)
USAN/INN:
Axicabtagene ciloleucel
Company Code:
KTE-C19
IND Number:
016278
EudraCT Number:
2017-002261-22 
Sponsor Name and Address:
Kite Pharma, Inc.
2400 Broadway
Santa Monica, CA 90404
United States of America
Contact Information:
The medical monitor name and contact information is provided on the Key Study 
Team Contact List
Protocol Version/Date:
Original: 22 May 2017
Amendment History:
Amendment 1: Version 2 27 September 2017
Amendment 2: 21 November 2017
Amendment 3: 16 January 2019
Amendment 4: 19 March 2019
Amendment 5: 25 June 2020
Amendment 5.1: 16 September 2020 – USA only
Amendment 6: 14 April 2023
Country-specific Requirements:
Country-specific requirements are listed in Appendix D
This study will be conducted in compliance with this protocol and in accordance with the ethical 
principles that have their origin in the Declaration of Helsinki, and that are consistent with 
International Council for Harmonisation (ICH) Good Clinical Practice (GCP) and applicable 
regulatory and local requirements.
CONFIDENTIALITY STATEMENT
This document contains confidential information of Kite Pharma, Inc., a wholly owned subsidiary of 
Gilead Sciences Inc. This document must not be disclosed to anyone other than the study site research 
staff, collaborators, and members of the Institutional Review Board/Independent Ethics Committee, a 
scientific review board, or an equivalent. The information in this document cannot be used for any 
purpose other than the conduct of the clinical investigation without the prior written consent of 
Kite Pharma, Inc. 
Kite 
A GILEAu Company 

Axicabtagene ciloleucel; KTE-C19
Kite Pharma, Inc.
Clinical Protocol: KTE-C19-107 (ZUMA-7)
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PROTOCOL SYNOPSIS
Title:
A Phase 3, Randomized, Open-Label Study Evaluating the Efficacy of 
Axicabtagene Ciloleucel versus Standard of Care Therapy in Subjects with 
Relapsed/Refractory Diffuse Large B Cell Lymphoma (ZUMA-7)
Indication:
Adult subjects with relapsed/refractory diffuse large B-cell lymphoma (r/r 
DLBCL).
Study Design:
This is a Phase 3 randomized, open-label, multicenter study evaluating the 
efficacy of axicabtagene ciloleucel versus standard of care therapy (SOC) 
in subjects with r/r DLBCL.  Adult subjects with r/r DLBCL after first-line 
rituximab and anthracycline-based chemotherapy will be randomized in a 
1:1 ratio to receive axicabtagene ciloleucel or SOC.  Randomization will be 
stratified by response to first-line therapy (primary refractory, vs relapse 
≤ 6 months of first-line therapy vs relapse > 6 and ≤ 12 months of  first-line 
therapy) and second-line age-adjusted International Prognostic Index (IPI) 
(0 to 1 vs 2 to 3) as assessed at the time of screening.
For subjects randomized to the control arm of the study, SOC will consist 
of a protocol-defined, platinum-based salvage combination chemotherapy 
regimen.  Subjects who respond to second-line chemotherapy (partial 
response [PR] or complete response [CR]) should proceed to high-dose 
therapy (HDT) and autologous stem cell transplant (ASCT).
An independent Data Safety Monitoring Board (DSMB) will meet every 
6 months after the first subject is randomized to review safety data and will 
review safety and efficacy data at the time of the planned interim futility 
analysis.  The DSMB will be chartered to make trial conduct 
recommendations based on an analysis of risk versus benefit.  The DSMB 
may meet more often as needed.  Refer to Section 9.9 for further details.
For study requirements assigned to each study arm, please refer to the 
schedule of assessments (SOA) and Section 7 for details.
A study schema is drawn out and described at the end of the protocol 
synopsis section.

Axicabtagene ciloleucel; KTE-C19 
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Clinical Protocol: KTE-Cl9-107 (ZUMA-7) 
Amendment6 
Study 
Objectives: 
Hypothesis: 
Primary 
Endpoint: 
CONFIDENTIAL 
Prirmuy Objective 
• 
To detennine if axicabtagene ciloleucel is superior to SOC as measured 
by event-free survival (EFS), as determined by blinded central review 
Seconda1y Objectives 
• 
To evaluate the effect of axicabtagene ciloleucel compared to SOC on 
objective response rate (ORR), as detennined by blinded centrnl review 
• 
To evaluate the effect of axicabtagene ciloleucel compared to SOC on 
overall survival (OS) 
• 
To evaluate the effect of axicabtagene ciloleucel compared to SOC on 
progression-free smvival (PFS) 
• 
To evaluate the effect of axicabtagene ciloleucel compared to SOC on 
duration of response (DOR) and duration of complete response among 
responding subjects, as detennined by blinded central review 
• 
To evaluate the safety of axicabtagene ciloleucel compared to SOC 
• 
To evaluate the effect of axicabtagene ciloleucel on patient reported 
outcomes (PROs) and quality of life (QoL) compared to SOC 
I 
I 
I 
I 
Axicabtagene ciloleucel will prolong EFS compared to SOC therapy in 
adult subjects with relapsed/refracto1y DLBCL. The hypothesized 
treatment effect coITesponds to a 50% improvement in EFS. 
Event-free Smvival (EFS): EFS is defined as the time from randomization 
to the earliest date of disease progression per the Lugano Classification 
{Cheson 2014}, commencement of new lymphoma therapy, or death from 
any cause. Subjects not meeting the criteria for these events by the analysis 
data cutoff date will be censored. For the primaiy analysis of EFS, disease 
progression events and censoring times will be detennined by blinded 
central review. Events of new therapy and death will be based on the 
clinical trial database. 
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Axicabtagene ciloleucel; KTE-C19
Kite Pharma, Inc.
Clinical Protocol: KTE-C19-107 (ZUMA-7)
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Secondary 
Endpoint(s):
Key secondary endpoints (in order of hierarchical testing)
•
Objective response rate
•
Overall survival
Secondary endpoints
•
EFS based on investigator disease assessments
•
Modified EFS based on blinded central review and on investigator 
disease assessments
•
Progression-free survival
•
Duration of response and complete response
•
Incidence of adverse events and clinically significant changes in safety 
lab values, including antibodies to axicabtagene ciloleucel
•
Changes from screening to post baseline in the global health status QoL 
scale and the physical functioning domain of the European 
Organisation for Research and Treatment of Cancer Quality of Life 
Questionnaire Cancer-30 (EORTC QLQ-C30)
•
Changes from screening to post baseline in the Euro-QOL, Five 
Dimensions, Five Levels (EQ-5D-5L) index and visual analog scale 
(VAS) scores
Sample Size:
Approximately 350 subjects
Study 
Eligibility:
Please refer to Section 5 for a complete and detailed list of inclusion and 
exclusion criteria. 
Treatment:
Axicabtagene ciloleucel arm
Subjects randomized to the axicabtagene ciloleucel arm of the study will 
receive a 3-day conditioning chemotherapy regimen consisting of 
fludarabine 30 mg/m2/day and cyclophosphamide 500 mg/m2/day on day -5 
to day -3 followed by 2 rest days (day -2 and day -1).
A single infusion of axicabtagene ciloleucel administered intravenously at a 
target dose of 2 x 106 anti-CD19 CAR T cells/kg on day 0.
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Axicabtagene ciloleucel; KTE-C19
Kite Pharma, Inc.
Clinical Protocol: KTE-C19-107 (ZUMA-7)
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Treatment:
Standard of Care arm
•
Subject will receive a second-line combination chemotherapy regimen 
(R-ICE, R-DHAP, R-ESHAP, or R-GDP) as selected by the treating 
investigator.
•
Subjects responding to second-line combination chemotherapy after 2 
or 3 cycles (PR or CR) should proceed to high-dose therapy (HDT) and 
autologous stem cell transplant (ASCT).
•
Peripheral stem cell collection, HDT, and ASCT infusion will be per 
institutional or regional guidelines.
Procedures:
As outlined in the SOAs, subjects will undergo the following procedures:  
collection of informed consent; medical history; physical exam; bone 
marrow biopsy; disease staging, including a baseline PET-CT scan; and 
blood draws for lactate dehydrogenase levels, complete blood count (CBC), 
and blood chemistries.  Subjects will also undergo baseline echocardiogram 
(ECHO) and electrocardiogram (ECG) assessments and Eastern 
Cooperative Oncology Group (ECOG) performance status. Women of 
childbearing potential will undergo a urine or serum pregnancy test.
Subjects randomized to the axicabtagene ciloleucel arm will undergo 
leukapheresis for the collection of peripheral blood mononuclear cells 
necessary for axicabtagene ciloleucel manufacturing.  Conditioning 
chemotherapy will be followed by 2 rest days and then infusion of 
axicabtagene ciloleucel.  Subjects will be under an observation period for at 
least 7 days after axicabtagene ciloleucel infusion to monitor for and 
manage any adverse events, unless otherwise required by country 
regulatory agencies (refer to Appendix D).  Blood draws for the analysis of 
anti-CD19 CAR T-cell levels will be performed.  Additional blood draws 
for cytokines, anti-axicabtagene ciloleucel antibodies, and 
replication-competent retrovirus (RCR) may be performed as clinically 
indicated.  Treatment with axicabtagene ciloleucel is intended to be 
definitive therapy and not a bridge to ASCT.
Subjects randomized to the SOC arm will receive investigator’s choice of 
second-line combination chemotherapy from the protocol-defined options. 
Up to 3 cycles (6 to 9 weeks) of combination chemotherapy will be 
administered every 2 to 3 weeks.  Subjects with a PR or CR to second-line 
therapy should proceed to HDT-ASCT.  Peripheral stem cell mobilization 
and leukapheresis will be performed according to institutional guidelines 
after the second or third cycle of second-line therapy to obtain a minimum 
target of 2 x 106 CD34+ hematopoietic stem cells per kilogram.  
HDT-ASCT will be performed per institutional guidelines.
Routinely throughout the conduct of the study, all subjects will be asked to 
report concomitant medications and adverse events, report subsequent 
lymphoma therapy, answer patient reported outcomes (PROs), and will 
have routine disease assessments as outlined in the SOAs.

Axicabtagene ciloleucel; KTE-C19
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Clinical Protocol: KTE-C19-107 (ZUMA-7)
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Independent of the randomized treatment arm, study procedures and 
disease assessments will occur at the same protocol-defined time points.
For details for all study requirements, refer to Section 7 and the SOAs. 
Duration of 
Study 
Participation
The duration of participation for individual subjects will vary depending on 
a subject’s screening requirements, response to treatment, potential for 
re-treatment, survival, and timing of the transition to a separate Kite 
Long-term Follow-up (LTFU) study.
For a subject who completes the entire protocol from the date of informed 
consent through the completion of the long-term follow-up period, the 
study will take approximately 5 years to complete for those randomized to 
the SOC arm and approximately 15 years to complete for those randomized 
to the axicabtagene ciloleucel arm.
Data Safety 
Monitoring 
Board 
(DSMB):
An independent DSMB will meet every 6 months after the first subject is 
randomized to review safety data and will review safety and efficacy data 
at the time of the planned interim futility analysis.  The DSMB will be 
chartered to make trial conduct recommendations based on an analysis of 
risk versus benefit.  The DSMB may meet more often as needed. Refer to 
Section 9.9 for further details.
Statistical 
Considerations:
The primary goal of the statistical analysis is to determine if there is a 
statistically significant improvement in event-free survival (EFS) between 
the treatment groups.  Approximately 350 subjects (175 per arm) will be 
randomized to attain 250 EFS events.  Randomization will be stratified by 
response to first-line therapy and second-line age-adjusted IPI assessed at 
the time of screening.  Efficacy analyses will be conducted on all 
randomized subjects analyzed according to randomized treatment arm.  
Safety analyses will be conducted on all subjects who receive 
protocol-specified therapy analyzed according to treatment actually 
received.  The study will have an overall alpha of 2.5% with 1-sided 
testing.  To preserve the overall significance level, statistical testing of the 
primary and key secondary efficacy endpoints will follow a hierarchical 
scheme.  EFS will be tested first at the primary EFS analysis.  Conditional 
on a statistically significant improvement in EFS, ORR will be tested at the 
2.5% level at the time of the primary EFS analysis.  Conditional on a 
statistically significant improvement in EFS and ORR, OS will be tested up 
to 3 times at an overall alpha level of 2.5%.  The primary analysis of OS 
will occur when approximately 210 deaths have been observed or no later 
than 5 years after the first subject is randomized. A first interim analysis of 
OS will occur at the time of the primary EFS analysis and a second interim 
analysis when approximately 160 deaths have been observed or no later 
than 4 years after the first subject is randomized.  A spending function of 
the Rho family will be used to allocate the alpha between the 2 interim 
analyses of OS and the primary analysis of OS.  Additionally, one interim 
futility analysis of EFS will be conducted after 135 EFS events have been 
observed.  Stratified (randomization factors) log-rank tests will be used to 

Axicabtagene ciloleucel; KTE-C19
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Clinical Protocol: KTE-C19-107 (ZUMA-7)
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test the null hypothesis of no difference in EFS and OS using an overall 
1-sided alpha level of 2.5%.  A stratified (randomization factors) 
Cochran-Mantel-Haenszel test will be used to test ORR at an overall 
1-sided alpha level of 2.5%.
For a full description of statistical analysis methods, refer to Section 10.

Axicabtagene ciloleucel; KTE-C19
Kite Pharma, Inc.
Clinical Protocol: KTE-C19-107 (ZUMA-7)
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STUDY SCHEMA
Screening
Randomization
Day 50 (from randomization) Disease Assessmentb 
Day 150 (from randomization) Disease Assessmentb 
Treatment Period: Standard of Care Therapy Treatment Arm
Subjects randomized to the SOC arm will receive a second-line 
combination chemotherapy regimen (R-ICE, R-DHAP, R-ESHAP, 
or R-GDP) as selected by the treating investigator.
Subjects will receive 2 or 3 cycles of chemotherapy administered 
every 2-3 weeks.
Subjects responding to second-line combination chemotherapy after 
2 or 3 cycles should proceed with HDT and ASCT. Subjects who do 
not respond to second-line chemotherapy can receive additional 
treatment off protocol.
Treatment Period: Axicabtagene Ciloleucel Treatment Arma
Subjects randomized to treatment with axicabtagene ciloleucel will 
receive a 3 day conditioning chemotherapy regimen consisting of 
fludarabine 30 mg/m2/day and cyclophosphamide 500 mg/m2/day 
(day -5 to day -3) followed by 2 rest days (day -2 & day -1).
Subjects will receive a single infusion of axicabtagene ciloleucel 
administered intravenously at a target dose of 2 x 106 anti-CD19 
CAR T cells/kg on treatment day 0.
Subjects will receive axicabtagene ciloleucel in a health care facility 
followed by a minimum 7day observation period.
Long Term Follow-up Period,b,c 
Day 100 (from randomization) Disease Assessmentb 
a
Bridging therapy: At the discretion of the investigator, corticosteroid bridging therapy may be considered for subjects with high disease 
burden at screening. Refer to Section 6.2.4.2 for details.
b
Disease Assessments: Calculated from the day of randomization and not the date of dosing with axicabtagene ciloleucel or SOC therapy.  
Independent of the randomized treatment arm, study procedures and disease assessments will occur at the same protocol defined time points.  
c
After completing at least 60 months of assessments in Study KTE-C19-107, subjects who received at least one dose of axicabtagene ciloleucel 
as protocol therapy will complete the remainder of the 15-year follow-up assessments in a separate LTFU study after providing informed 
consent. Refer to Section 3.5 
 Minimum observation period: 7 days unless otherwise required by country regulatory agencies (refer to Appendix D).
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Axicabtagene ciloleucel; KTE-C19
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Clinical Protocol: KTE-C19-107 (ZUMA-7)
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TABLE OF CONTENTS
PROTOCOL SYNOPSIS................................................................................................................................................2
STUDY SCHEMA..........................................................................................................................................................8
TABLE OF CONTENTS................................................................................................................................................9
LIST OF IN-TEXT TABLES .......................................................................................................................................11
LIST OF IN-TEXT FIGURES......................................................................................................................................11
LIST OF ABBREVIATIONS.......................................................................................................................................12
1.
OBJECTIVES.......................................................................................................................................................15
1.1.
Primary Objective....................................................................................................................................15
1.2.
Secondary Objectives ..............................................................................................................................15
2.
DISEASE BACKGROUND AND RATIONALE...............................................................................................16
2.1.
Standard First-line Therapy.....................................................................................................................16
2.2.
Standard Second-line Therapy ................................................................................................................16
2.3.
Study Rationale .......................................................................................................................................18
2.4.
Anti-CD19 Chimeric Antigen Receptor T Cells .....................................................................................19
2.4.1.
CD19 and Expression............................................................................................................19
2.4.2.
Anti-CD19 CAR T-cell Product (Axicabtagene Ciloleucel).................................................19
2.5.
Prior Anti-CD19 CAR T-cell Study Designs and Results.......................................................................20
2.5.1.
ZUMA-1................................................................................................................................20
2.5.2.
CAR T-cell Receptor Immunotherapy for Patients with B-cell Lymphoma 
(Protocol 09-C-0082, NCT00924326) ..................................................................................23
3.
STUDY DESIGN.................................................................................................................................................24
3.1.
General Study Design: ZUMA-7.............................................................................................................24
3.2.
Participating Sites....................................................................................................................................24
3.3.
Number of Subjects .................................................................................................................................24
3.4.
Replacement of Subjects .........................................................................................................................24
3.5.
Duration of Study and Subject Participation...........................................................................................25
3.5.1.
Study Duration for Individual Subjects.................................................................................25
3.5.2.
End-of-study Definition.........................................................................................................25
3.5.3.
Long-term Follow-up ............................................................................................................25
4.
SUBJECT SCREENING AND ENROLLMENT................................................................................................26
5.
SUBJECT ELIGIBILITY.....................................................................................................................................27
5.1.
Inclusion Criteria.....................................................................................................................................27
5.2.
Exclusion Criteria....................................................................................................................................28
6.
PROTOCOL TREATMENT................................................................................................................................31
6.1.
Treatment Terminology...........................................................................................................................31
6.2.
Axicabtagene Ciloleucel Study Treatment Arm......................................................................................32
6.2.1.
Leukapheresis........................................................................................................................32
6.2.2.
Conditioning Chemotherapy .................................................................................................32
6.2.3.
Axicabtagene Ciloleucel........................................................................................................33
6.2.4.
Cell Collection and Axicabtagene Ciloleucel Study Treatment Schedule 
and Administration................................................................................................................34
6.2.5.
Excluded Medications (Axicabtagene Ciloleucel Arm)........................................................42
6.2.6.
Subsequent Therapy (Axicabtagene Ciloleucel Arm)...........................................................42
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6.2.7.
Toxicity Management (Axicabtagene Ciloleucel Arm) ........................................................42
6.3.
Standard of Care Therapy Arm ...............................................................................................................43
6.3.1.
Standard of Care Chemotherapy Dosing and Administration...............................................43
6.3.2.
Concomitant Therapy (Standard of Care Arm).....................................................................44
6.3.3.
Excluded Medications (Standard of Care Arm) ....................................................................45
6.3.4.
Subsequent Therapy (Standard of Care Arm) .......................................................................45
6.3.5.
Toxicity Management (Standard of Care Arm).....................................................................45
7.
STUDY PROCEDURES......................................................................................................................................46
7.1.
Informed Consent ....................................................................................................................................46
7.2.
Screening .................................................................................................................................................46
7.3.
Randomization.........................................................................................................................................47
7.4.
Demographic Data...................................................................................................................................47
7.5.
Medical and Treatment History...............................................................................................................47
7.6.
Physical Exam, Vital Signs, and Performance Status .............................................................................48
7.7.
Neurological Examination.......................................................................................................................48
7.8.
Cardiac Function .....................................................................................................................................48
7.9.
Toxicity Evaluation .................................................................................................................................49
7.10.
Disease Response Assessment ................................................................................................................49
7.10.1.
Imaging..................................................................................................................................49
7.10.2.
Bone Marrow Biopsy and Aspirate .......................................................................................50
7.11.
Laboratory ...............................................................................................................................................50
7.11.1.
Local Lab Analysis................................................................................................................50
7.11.2.
Central Lab Analysis .............................................................................................................51
7.12.
Patient Reported Outcomes .....................................................................................................................52
7.12.1.
European Organisation for Research and Treatment of Cancer (EORTC) 
QLQ-C30 Version 3.0...........................................................................................................52
7.12.2.
EuroQol Five Dimensions Questionnaire (EQ-5D-5L).........................................................53
7.12.3.
Work Productivity and Activity Impairment Questionnaire (WPAI) ...................................53
7.13.
Biomarkers ..............................................................................................................................................54
7.14.
Post-treatment Follow-up ........................................................................................................................55
7.15.
Long-term Follow-up (Axicabtagene Ciloleucel and Standard of Care Arms) ......................................61
8.
SUBJECT WITHDRAWAL ................................................................................................................................65
8.1.
Reasons for Removal from Treatment ....................................................................................................66
8.2.
Reasons for Removal from Study............................................................................................................66
9.
SAFETY REPORTING........................................................................................................................................67
9.1.
Adverse Events........................................................................................................................................67
9.2.
Reporting of Adverse Events...................................................................................................................67
9.2.1.
Reporting Abnormal Laboratory Findings ............................................................................68
9.3.
Definition of Serious Adverse Events .....................................................................................................69
9.4.
Reporting of Serious Adverse Events......................................................................................................69
9.4.1.
Reporting Deaths...................................................................................................................70
9.5.
Diagnosis Versus Signs and Symptoms ..................................................................................................71
9.6.
Pregnancy and Lactation .........................................................................................................................71
9.7.
Hospitalization and Prolonged Hospitalization.......................................................................................72
9.8.
Abnormal Vital Sign Values ...................................................................................................................72
9.9.
Data Safety Monitoring Board ................................................................................................................73
10.
STATISTICAL CONSIDERATIONS.................................................................................................................74
10.1.
Hypothesis ...............................................................................................................................................74
10.2.
Study Endpoints.......................................................................................................................................74
10.2.1.
Primary ..................................................................................................................................74
10.2.2.
Key Secondary.......................................................................................................................75

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10.2.3.
Secondary ..............................................................................................................................75
10.2.5.
Analysis Subsets....................................................................................................................77
10.2.6.
Covariates..............................................................................................................................77
10.3.
Sample Size Considerations ....................................................................................................................78
10.4.
Access to Individual Subject Treatment Assignments ............................................................................80
10.5.
Interim Analysis and Early Stopping Guidelines ....................................................................................80
10.5.1.
Safety Interim Analysis .........................................................................................................80
10.5.2.
Efficacy Interim Analysis......................................................................................................80
10.6.
Planned Method of Analysis ...................................................................................................................80
10.6.1.
Event-free Survival................................................................................................................81
10.6.2.
ORR.......................................................................................................................................82
10.6.3.
OS..........................................................................................................................................82
10.6.4.
Progression-free Survival, Duration of Response, and Time to Next 
Therapy..................................................................................................................................83
10.6.5.
Safety.....................................................................................................................................83
10.6.6.
Pharmacokinetic Analyses.....................................................................................................83
10.6.7.
Immunogenicity Analyses.....................................................................................................83
10.6.8.
Health-related Quality of Life ...............................................................................................83
10.6.9.
Cytokines, Product Characteristics, and Molecular and Histological 
Characteristics .......................................................................................................................83
10.6.10.
Long-term Data Analysis ......................................................................................................84
11.
REGULATORY OBLIGATIONS.......................................................................................................................85
11.1.
Independent Review Board/Independent Ethics Committee...................................................................85
11.2.
Subject Confidentiality............................................................................................................................85
11.3.
Investigator Signatory Obligations..........................................................................................................86
12.
PROTOCOL AMENDMENTS AND TERMINATION .....................................................................................87
13.
STUDY DOCUMENTATION AND ARCHIVE ................................................................................................88
14.
STUDY MONITORING AND DATA COLLECTION......................................................................................90
15.
PUBLICATION ...................................................................................................................................................91
16.
COMPENSATION...............................................................................................................................................92
17.
REFERENCES.....................................................................................................................................................93
18.
APPENDICES......................................................................................................................................................98
LIST OF IN-TEXT TABLES
Table 1.
Baseline Characteristics and Results from ZUMA-1 Primary Analysis .................................22
Table 2.
Schedule of Assessments Axicabtagene Ciloleucel Arm........................................................56
Table 3.
Schedule of Assessments SOC Chemotherapy Arm ...............................................................59
Table 4.
Schedule of Assessments Long-term Follow-up Period..........................................................63
LIST OF IN-TEXT FIGURES
Figure 1.
Anti-CD19 CAR Construct and Mechanism of Action...........................................................20
Figure 2.
Study Testing Scheme .............................................................................................................79
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LIST OF ABBREVIATIONS
Abbreviation
Definition
AE
Adverse event
ALL
Acute lymphoblastic leukemia
ALT
Alanine aminotransferase
ANC
Absolute neutrophil count
ASCT
Autologous stem cell transplant
AST 
Aspartate aminotransferase
AUC
Area under the curve
Axicabtagene ciloleucel 
Autologous T cells transduced with retroviral vector containing anti-CD19 
CD28/CD3ζ chimeric antigen receptor
CAR
Chimeric antigen receptor 
CBC
Complete blood count
CLL
Chronic lymphocytic leukemia
CMR
Complete metabolic response
CNS
Central nervous system
CR
Complete response
CRF
Case Report Form
CRP
C-reactive protein 
CRO
Contract Research Organization
CRR
Complete radiologic response
CRS
Cytokine release syndrome
CSF
Cerebrospinal fluid
CSR
Clinical Study Report
CT
Computed tomography
CTCAE
Common Terminology Criteria for Adverse Events
DLBCL
Diffuse large B-cell lymphoma
DOR
Duration of response
DSMB
Data Safety Monitoring Board
eCRF
Electronic Case Report Form
ECG
Electrocardiogram
ECHO
Echocardiogram
ECOG
Eastern Cooperative Oncology Group
EEG
Electroencephalogram 
EFS
Event-free survival
End of study (primary 
completion)
Defined as when the last subject has undergone an assessment for the purpose of the 
event driven primary analysis
EORTC QLQ-C30
European Organisation for Research and Treatment of Cancer Quality of Life 
Questionnaire Cancer-30 (QLQ-C30)
EQ-5D-5L
Euro-QOL, Five Dimensions, Five Levels
FAS
Full analysis set

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Abbreviation
Definition
FL
Follicular lymphoma 
GCP
Good Clinical Practice
GP
General practitioner
HCP
Healthcare provider
HDT
High-dose therapy 
HEENT
Head, ears, eyes, nose, throat
HIV
Human immunodeficiency virus
HLH
Hemophagocytic lymphohistiocytosis
HRQoL
Health-related quality of life
IB
Investigator’s Brochure
ICF
Informed Consent Form
ICH
International Conference on Harmonisation
ID
Identification
IHC
Immunohistochemistry 
IL
Interleukin
IP
Investigational product
IPI
International Prognostic Index  
IPM
Investigational Product Manual
IRB/IEC
Institutional Review Board/Independent Ethics Committee
IV
Intravenous
IXRS 
Interactive Voice/Web (X) Response System
LDH
Lactate dehydrogenase
LTFU
Long-term follow up
LVEF
Left ventricular ejection fraction 
MCL
Mantle cell lymphoma
MedDRA
Medical Dictionary for Regulatory Activities
mEFS
Modified EFS; defined the same way as EFS, except that failure to attain CR or PR 
by Day 150 assessment is not considered as an event
MMSE
Mini-Mental Status Exam
MRI
Magnetic resonance imaging
MSGV1
Murine stem cell virus-based vector
NCI
National Cancer Institute
NE
Neurologic event
NHL
Non-Hodgkin lymphoma
NMR
No metabolic response
NPT
Nasopharyngeal-throat
ORR
Objective response rate
OS
Overall survival
PBMC
Peripheral blood mononuclear cell
PCR
Polymerase chain reaction

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Abbreviation
Definition
PD
Progressive disease
PET-CT
Positron emission tomography-computed tomography
PFS
Progression-free survival
PK
Pharmacokinetic
PMBCL
Primary mediastinal B-cell lymphoma 
PMD
Progressive metabolic disease
PMR
Partial metabolic response
PR
Partial response
PRD
Progressive radiologic disease
PRO
Patient reported outcome
PRR
Partial radiologic response
QoL
Quality of life
qPCR
Quantitative polymerase chain reaction
RCR
Replication-competent retrovirus
r/r
Relapsed/refractory
SAE
Serious adverse event
scFv
Single-chain variable fragment
SCT
Stem cell transplant
SD
Stable disease
SOA
Schedule of assessment
SOC
Standard of care
SRD
Stable radiologic disease
Study Day 0
Day of randomization
SUSAR
Suspected unexpected serious adverse reaction
TBI
Total body irradiation
TEAE
Treatment-emergent adverse event
TFL
Transformed follicular lymphoma
TNF
Tumor necrosis factor
Treatment day 0
Defined as the first day that axicabtagene ciloleucel or CD34+ stem cells for ASCT 
are administered to the subject
ULN
Upper limit of normal
UTI
Urinary tract infection
VAS
Visual analog scale
WBC
White blood cell
WPAI:GH
Work productivity and activity impairment questionnaire: general health

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1.
OBJECTIVES
1.1.
Primary Objective
•
To determine if axicabtagene ciloleucel is superior to standard of care (SOC) as measured by 
event-free survival (EFS), as determined by blinded central review
1.2.
Secondary Objectives
•
To evaluate the effect of axicabtagene ciloleucel compared to SOC on objective response rate 
(ORR), as determined by blinded central review
•
To evaluate the effect of axicabtagene ciloleucel compared to SOC on overall survival (OS)
•
To evaluate the effect of axicabtagene ciloleucel compared to SOC on progression-free 
survival (PFS)
•
To evaluate the effect of axicabtagene ciloleucel compared to SOC on duration of response 
(DOR) and duration of complete response among responding subjects, as determined by 
blinded central review
•
To evaluate the safety of axicabtagene ciloleucel compared to SOC
•
To evaluate the effect of axicabtagene ciloleucel on patient reported outcomes (PROs) and 
quality of life (QoL) compared to SOC
CCI
I 
I 
I 
I 
I 

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2.
DISEASE BACKGROUND AND RATIONALE
Non-Hodgkin lymphoma (NHL) comprises a heterogeneous group of cancers originating 
primarily in B lymphocytes and, to a lesser extent, in T lymphocytes and natural killer cells.  
NHL is the most prevalent hematological malignancy and is the seventh most common new 
cancer among men and women, accounting for 4% of all new cancer cases and 3% of cancer-
related deaths {Howlader 2015}.
Diffuse large B-cell lymphoma (DLBCL) is the most common subtype of NHL, accounting for 
approximately 30% to 40% of all cases {Chaganti 2016, Morton 2006, Sehn 2015}.  DLBCL 
comprises a group of lymphoid malignancies composed of large cells with vesicular nuclei, 
prominent nucleoli, basophilic cytoplasm, and a high proliferation rate {Martelli 2013}.  Patients 
often present with single or multiple rapidly enlarging symptomatic masses, with up to 40% 
occurring at extranodal sites, particularly the gastrointestinal tract (stomach and ileocecal 
region).  Centroblast- and immunoblast-like cells are the predominant morphology, and these 
cells typically express the B-cell markers CD19, CD20, CD22, as well as surface 
immunoglobulin.
2.1.
Standard First-line Therapy
Since the 1970s, the CHOP chemotherapy regimen (cyclophosphamide, doxorubicin, vincristine, 
and prednisone) had been standard of care first-line therapy.  More intensive combinations failed 
to show additional survival benefit.  The current standard of care for first-line treatment is CHOP 
in combination with an anti-CD20 monoclonal antibody rituximab (R-CHOP, rituximab-based 
chemoimmunotherapy) {Flowers 2010}.  In the seminal study by the Groupe d’Etude des 
Lymphomes de l’Adulte, first-line R-CHOP was superior to CHOP {Feugier 2005}, with 
10-year OS and PFS of 43.5% versus 27.6% and 36.5% versus 20%, respectively {Feugier 
2005}.  Thus, while more effective than chemotherapy alone, first-line R-CHOP still only results 
in long-term disease remission in < 40% of subjects.  Recently a Phase 3 trial of first-line 
R-CHOP versus dose-adjusted R-EPOCH demonstrated no difference in EFS or OS between the 
regimens {Wilson 2016}.
The International Prognostic Index (IPI), which includes age, performance status, lactate 
dehydrogenase (LDH) level, stage, and extranodal involvement, correlates with outcomes to 
standard first-line therapy.  More recently, prognostic molecular features have been identified.  
Gene expression profiling has been used to categorize DLBCL into the germinal center B-cell 
type, and activated B-cell type is associated with worse outcomes.  Additionally, double- and 
triple-hit lymphomas with translocations of MYC and either BCL2 and/or BCL6 have been 
shown to have a poor prognosis with R-CHOP chemotherapy {Green 2012}.
2.2.
Standard Second-line Therapy
Patients with DLBCL who relapse after or are refractory to first-line therapy (relapsed/refractory 
[r/r] DLBCL) have poor prognosis.  In the LNH-98.5 trial, approximately 40% of patients 
relapse after R-CHOP, and 70% of these patients die within the first 2 years after progression 
despite salvage therapy, with a median OS of 0.7 years after progression {Coiffier 2010}.

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Patients with r/r DLBCL have heterogeneous outcomes to second-line therapy.  The goal of 
salvage chemotherapy is to determine chemo-sensitivity prior to proceeding to high-dose 
therapy-autologous stem cell transplant (HDT-ASCT).  The second-line age-adjusted IPI 
(sAAIPI: LDH, stage, and performance status) can further predict outcome for r/r DLBCL for 
both chemotherapy-sensitive and all patients {Hamlin 2003}.
Results of the PARMA trial {Philip 1995} demonstrated superior outcome for salvage therapy 
plus ASCT compared with salvage therapy alone for patients with r/r DLBCL (5-year EFS of 
46% vs 12%, and OS of 53% and 32%, respectively), leading to the adoption of second-line 
chemotherapy plus ASCT as the standard of care.  Patients who are unable to undergo ASCT due 
to comorbidities or chemotherapy insensitive disease have poor long-term outcomes.
Second-line chemotherapy regimens generally consist of non-cross-resistant drugs to first-line 
R-CHOP.  Common regimens include R-GDP, R-DHAP, R-ICE, and R-ESHAP.  Institutional 
preference and adverse event (AE) profile often dictate which treatment regimen is used.  No 
regimen has demonstrated superiority in a randomized trial.  The Phase 3 LY12 trial compared 
GDP to DHAP followed by HDT and ASCT in patients with r/r DLBCL.  ORRs (45% vs 44%), 
EFS (HR = 0.99), and OS (HR = 1.03) were similar between arms although hematologic toxicity 
was more severe in the DHAP arm {Crump 2014}.  In the Phase 3 CORAL trial, patients with r/r 
DLBCL were randomized to R-ICE versus R-DHAP followed by HDT and ASCT, followed by a 
second randomization to rituximab maintenance or no maintenance.  ORRs (64% vs 63%) and 
3 year OS (47% vs 51%) were similar between the two regimens; however, more hematologic 
toxicity was associated with R-DHAP.  Maintenance with rituximab was not shown to be 
beneficial after ASCT.
Those with chemo-sensitive disease that responds to second-line chemotherapy proceed to HDT 
and ASCT.  HDT-ASCT involves peripheral stem cell collection, myeloablative high-dose 
chemotherapy with or without total body irradiation (TBI), and stem cell rescue.  Although 
treatment procedures may vary between different regions and institutions, the general process 
remains consistent.  Stem cells are mobilized from the bone marrow to the periphery with G-CSF 
and then collected by leukapheresis.  HDT utilizes a myeloablative conditioning regimen 
consisting of combination chemotherapy with or without TBI.  The choice of regimens varies 
because no single regimen has demonstrated superiority in a randomized trial; however, 
chemotherapy-only regimens may have lower rates of secondary myelodysplastic syndrome and 
acute myeloid leukemia {Barrington 2010, Darrington 1994, Stone 1994}.  A common regimen 
is carmustine (BCNU), etoposide, ara-C, and melphalan (BEAM), which typically is initiated a 
week prior to stem cell infusion.  G-CSF is administered the day following stem cell infusion to 
support engraftment and reconstitution of the bone marrow, effectively rescuing hematopoiesis 
and reducing the period of profound neutropenia during which life-threatening infections can 
occur.  The routine use of G-CSF has led to reduction of early transplant-related mortality, but it 
remains as high as 5% even in experienced institutions.
In the CORAL trial, patients treated with rituximab-based first-line therapy who relapse within 
1 year of diagnosis have poor outcomes.  The 1-year EFS in this group (approximately 60% of 
the patients) was below 20% in those who relapse before 1 year compared to 50% in those with 
relapse after 1 year {Gisselbrecht 2010}.  Also, half of the patients did not reach ASCT, 

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predominantly due to inadequate response to second-line chemotherapy; approximately 84% due 
to treatment failure and 9.4% due to toxicity.  Inadequate response to second-line chemotherapy 
implies chemo-resistance, and ASCT would not be indicated because of probable inadequate 
response to high-dose chemotherapy.  Their prognosis is poor, with a median OS of about 
4.4 months {Van Den Neste 2016}.
The Phase 3 ORCHARRD trial, the largest second-line study in DLBCL with positron emission 
tomography (PET)-based assessments, demonstrated that patients with primary refractory or 
early-relapsed disease have poor outcomes {van Imhoff 2017}.  Patients were treated with 
rituximab- or ofatumumab-based salvage DHAP therapy followed by HDT-ASCT in responders 
based on PET-CT assessment.  Those with primary refractory disease or who relapse 
≤ 12 months after completion of first-line treatment, representing 70% of patients in the trial, 
have lower PFS and OS compared to those who relapse > 12 months, with a highly significant 
hazard ratio of 0.32 (95% confidence interval [CI] 0.24 to 0.44) and 0.4 (95% CI 0.29 to 0.55), 
respectively.  This, along with results from other ASCT studies {Guglielmi 1998} {Vellenga 
2008}, highlights that primary refractory or early relapsed disease, regardless as defined as 
≤ 12 months from diagnosis, from CR, or from end of first-line treatment, are poor prognostic 
factors.
Thus, treatment of patients with r/r DLBCL remains challenging.  There is a significant unmet 
need for better therapies in these patients.
2.3.
Study Rationale
Patients with r/r DLBCL especially primary refractory and early relapse within 1 year after first-
line rituximab-based chemoimmunotherapy have poor prognosis even with HDT-ASCT.  
Because these patients are resistant to chemotherapy, they may benefit from therapies with 
different mechanisms of action.  Immunotherapy, which is based on the enhancement of an 
immune response against the tumor, is a promising approach to treating many cancer types.  
T cells play an important role in destroying diseased cells throughout the body.  Studies with 
immune checkpoint inhibitors and bi-specific T-cell engagers have demonstrated the potential of 
T cells to treat cancer.  T cells need to possess the appropriate specificity for a tumor, be present 
in sufficient numbers, and overcome any local immunosuppressive factors to be effective.  
Chimeric antigen receptor (CAR) engineered T cells may address these issues and are a 
promising approach for cancer therapy.
Axicabtagene ciloleucel is an engineered autologous T-cell immunotherapy by which a patient’s 
own T cells are collected and subsequently genetically altered to recognize CD19.  CD19 is 
expressed on the cell surface of B-cell malignancies.  In ZUMA-1, which investigated the safety 
and efficacy of axicabtagene ciloleucel in subjects with refractory aggressive NHL, axicabtagene 
ciloleucel significantly improved ORR (P < 0.0001).  The ORR was 82% with a complete 
response (CR) rate of 54%.  At the primary analysis, 44% of subjects had ongoing responses 
(39% in CR) (shown in Table 1).  Axicabtagene ciloleucel may have an improved efficacy and 
tolerability in patients with less chemo-refractory disease and lower disease burden.  Therefore, 
axicabtagene ciloleucel will be compared to SOC in patients with r/r DLBCL.

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2.4.
Anti-CD19 Chimeric Antigen Receptor T Cells
2.4.1.
CD19 and Expression
CD19 is a 95 kD transmembrane protein expressed only in the B-cell lineage.  It is expressed in 
all normal B cells starting at the pro-B-cell stage until the final differentiation stage and is not 
expressed in pluripotent hematopoietic stem cells or most plasma cells.  The pattern of CD19 
expression is maintained in B-cell malignancies, including subtypes of B-cell NHL, DLBCL, 
primary mediastinal B-cell lymphoma (PMBCL), transformed follicular lymphoma (TFL), 
mantle cell lymphoma (MCL), acute lymphocytic leukemia (ALL), chronic lymphocytic 
leukemia (CLL), and non T-cell acute lymphoblastic leukemia {Blanc 2011} with the exception 
of multiple myeloma.
2.4.2.
Anti-CD19 CAR T-cell Product (Axicabtagene Ciloleucel)
Anti-CD19 CAR T cells are autologous human T cells that have been engineered to express an 
extracellular single-chain variable fragment (scFv) with specificity for CD19 linked to an 
intracellular signaling part comprised of signaling domains from CD28 and CD3ζ molecules 
arranged in tandem.
An anti-CD19 CAR vector construct has been designed, optimized, and initially tested at the 
Surgery Branch of the National Cancer Institute (NCI) (refer to Figure 1); {Kochenderfer 2009, 
Kochenderfer 2010}.  The scFv is derived from the variable region of the anti-CD19 monoclonal 
antibody FMC63 {Nicholson 1997}.  A portion of the CD28 costimulatory molecule is added, as 
murine models suggest this is important for the anti-tumor effect and expansion of anti‑CD19 
CAR T cells {Kowolik 2006}.  The signaling domain of the CD3ζ chain is essential for T-cell 
activation.  These fragments were cloned into the murine stem cell virus-based vector (MSGV1), 
utilized to genetically engineer the autologous T cells.  The safety and efficacy of anti-CD19 
CAR T cells has been evaluated in subjects with CD19+ B-cell malignancies at the NCI 
{Kochenderfer 2012, Kochenderfer 2015, Kochenderfer 2017}.  The same anti‑CD19 CAR 
vector construct used in the NCI protocol and ZUMA-1 will be used in this study.
The CAR construct is inserted into the T cells’ genome by retroviral vector transduction.  
Briefly, peripheral blood mononuclear cells (PBMCs) are obtained by leukapheresis and Ficoll 
separation.  PBMCs are activated by culturing with an anti-CD3 antibody in the presence of 
recombinant human interleukin-2 (IL-2).  Stimulated cells are transduced with a retroviral vector 
containing an anti-CD19 CAR gene and propagated in culture to generate sufficient engineered 
T cells for administration.

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Figure 1.
Anti-CD19 CAR Construct and Mechanism of Action
Abbreviations:  CD, cluster of differentiation; LTR, long terminal repeat; scFv, single-chain variable fragment; CAR, chimeric 
antigen receptor.
2.5.
Prior Anti-CD19 CAR T-cell Study Designs and Results
2.5.1.
ZUMA-1
Kite Pharma, Inc. (hereafter referred to as Kite or Kite Pharma) is developing axicabtagene 
ciloleucel, which targets CD19 expressing B-cell malignancies.  The CAR vector construct is 
identical to the one used in NCI protocols {Kochenderfer 2017}.  Kite Pharma, in conjunction 
with the NCI Surgery Branch, has developed a streamlined process for the generation of the anti-
CD19 CAR T cells.  The ZUMA-1 study design and results from the most current interim 
analysis at the time of protocol development is summarized below.
To review the latest data from the ZUMA-1 study, please refer to the Investigator’s Brochure 
(IB).
2.5.1.1.
ZUMA-1 Study Design
ZUMA-1 is phase 1/2 multicenter, open-label study evaluating the safety and efficacy of 
axicabtagene ciloleucel in subjects with refractory aggressive NHL.
CD28 
S' LTR 
scFv 
CD3~ 
3' LTR 
CAR vector construct 
Viral vector 
Target binding domain: 
antibody derived (scFv} 
CAR-engineered 
Tcell 
CAR-engineered 
Tcell 
Tumor cell 

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The primary objective of Phase 1 was to evaluate the safety of axicabtagene ciloleucel regimens.  
The primary objective of Phase 2 was to evaluate the efficacy of axicabtagene ciloleucel, as 
measured by objective response rate in subjects with DLBCL, PMBCL, and TFL.  Secondary 
objectives included assessing the safety and tolerability of axicabtagene ciloleucel and additional 
efficacy endpoints.  Phase 2 subjects enrolled into 2 separate cohorts designated as Cohort 1 and 
Cohort 2.  Cohort 1 would enroll approximately 72 adult subjects with refractory DLBCL, and 
Cohort 2 intended to enroll up to 40 adult subjects with refractory PMBCL and TFL.
Subjects were treated with conditioning chemotherapy consisting of fludarabine 30 mg/m2/day 
and cyclophosphamide 500 mg/m2/day, administered for 3 days followed by 2 rest days before 
receiving axicabtagene ciloleucel.  Axicabtagene ciloleucel was administered as a single infusion 
of CAR transduced autologous T cells administered intravenously at a target dose of 2 x 106 
anti-CD19 CAR T cells/kg.  After investigational product (IP) was dosed, subjects were assessed 
for post-treatment response followed by a long-term follow-up period for duration of response 
and overall survival.
2.5.1.2.
ZUMA-1 Primary Analysis
As of 27 Jan 2017, the time of the primary analysis data cutoff, 77 subjects in Cohort 1 and 
24 subjects in Cohort 2 were evaluable (Table 1).  Axicabtagene ciloleucel was successfully 
manufactured in 99% of subjects enrolled.  Average turnaround time from apheresis to receipt of 
axicabtagene ciloleucel at clinical sites was 17 days.
With an ORR of 82% in Cohort 1+2, the study met the primary endpoint (P < 0.0001; exact 
binomial test comparing observed ORR to historical control of 20%), with 49% CRs.  In all 
101 subjects, ORR was 82%, with CR in 54% and a median time to CR of 1 month (Table 1); 
44% had ongoing responses (CR in 39%) at the time of the primary analysis.  ORR was 
consistent across a broad range of covariates, including refractory subgroup, stage, IPI, and age.
With a median follow-up time of 8.7 months, the median DOR was 8.1 months.  The median 
DOR in subjects achieving CR was not reached.  The median PFS was 5.9 months, and the 
median OS was not reached.  Kaplan–Meier estimates of OS at 6, 9, and 12 months were 79.8%, 
68.4% and 54.5%.
The most common Grade 3 or higher treatment-emergent AEs (TEAEs) are also shown in 
Table 1.  There were two Grade 5 axicabtagene ciloleucel related events, including 
hemophagocytic lymphohistiocytosis (HLH) and cardiac arrest in the setting of cytokine release 
syndrome (CRS).
Peak CAR T-cell expansion was associated with ongoing response at 3 months (P = 0.004) and 
Grade ≥ 3 neurological events (NEs; P = 0.02).  Subjects with Grade ≥ 3 CRS and NEs had 
increased levels of IL-15 (P = 0.04 and P = 0.006, respectively) and IL-6 (P = 0.001 and 
P = 0.0003, respectively).

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Table 1.
Baseline Characteristics and Results from ZUMA-1 Primary Analysis
Cohort 1
DLBCL
(N = 77)
Cohort 2
PMBCL/TFL
(N = 24)
Total
(N = 101)
Baseline Characteristics
 
 
 
Median Age (range), years
58 (25-76)
57 (23-76)
58 (23-76)
Age ≥ 65 years, n (%)
17 (22)
7 (29)
24 (24)
Male, n (%)
50 (65)
18 (75)
68 (67)
ECOG performance status 1, n (%)
49 (64)
10 (42)
59 (58)
Received ≥ 3 lines of prior therapy
49 (64)
21 (88)
70 (70)
Refractory ≥ 2 lines of prior therapy
59 (77)
19 (79)
78 (77)
Relapse post ASCT
16 (21)
5 (21)
21 (21)
Response
 
 
 
Objective response rate, n (%)
63 (82)
20 (83)
83 (82)
95% CI
P-valuea
(71, 90)
(63, 95)
(73, 89)
P<0.0001
Best response, n (%)
 
 
 
CR
38 (49)
17 (71)
55 (54)
PR
25 (32)
3 (13)
28 (28)
Safety
Total (N=101)
Common Grade 3 or higher AEs, n (%)b
 
Neutropenia/neutrophil count decreased
66 (66)
Leukopenia/WBC count decreased
44 (44)
Anemia
43 (43)
Febrile neutropenia
31 (31)
Thrombocytopenia
24 (24)
Encephalopathy
21 (21)
Grade 3 or higher AEs of clinical interest, n (%)
 
Cytokine release syndromec
13 (13)
Neurological eventsc
28 (28)
Abbreviations:  DLBCL, diffuse large B-cell lymphoma; PMBCL, primary mediastinal B-cell lymphoma; TFL, transformed 
follicular lymphoma;  ECOG, Eastern Cooperative Oncology Group; ASCT, autologous stem cell transplant; CI, confidence 
interval; CR, complete response; PR, partial response; AE, adverse event; WBC, white blood count.
Notes:  All AEs are treatment emergent.
a
Exact binomial test comparing observed ORR in DLBCL to a historical control assumption of 20%.
b
Occurring in > 20% of patients.
c
 Combined terms.

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2.5.2.
CAR T-cell Receptor Immunotherapy for Patients with B-cell Lymphoma 
(Protocol 09-C-0082, NCT00924326)
The NCI clinical study (Protocol 09-C-0082) of anti-CD19 CAR T-cell therapy has demonstrated 
durable objective responses in patients with advanced B-cell malignancies, including NHL. This 
study enrolled adults age 18 to 68 with B-cell lymphomas or leukemias expressing CD19 as 
cohorts to determine the safety and feasibility of the administration of anti-CD19-CAR 
engineered peripheral blood lymphocytes with a nonmyeloablative conditioning regimen. The 
CAR construct is identical to the one used in ZUMA-1.  In the NCI cohort of 43 subjects with 
relapsed/refractory B-cell malignancies, the ORR was 74%, with a CR rate of 54% and a partial 
response (PR) rate of 21% (as of 10 Nov 2016, data on file at Kite Pharma).  Twenty-one of the 
43 subjects (49%) were still in response, with a median follow-up of 36 months (range 13 to 
78 months). Median DOR was 35 months (range 23 to 77 months).  Nineteen subjects (44%) had 
ongoing responses for more than 1 year.  Median PFS and OS have not been reached.
In the most recent report focusing on 22 subjects treated with low dose conditioning 
chemotherapy, 19 had DLBCL, 2 had follicular lymphoma (FL), and one had MCL 
{Kochenderfer 2017}.  The CR rate was 55% and PR rate was 18%.  In particular, among a 
subset of 19 subjects with DLBCL, the ORR was 68% with a CR in 47% and a PR in 21%.  Of 
the 12 subjects who achieved CR, 11 remain in CR, with a median duration of 12.5 months and 
longest of 24 months ongoing at the time of analysis.  PFS was 63.6% at 12 months.  Remissions 
were associated with high serum IL-15 levels and high peak blood CAR T-cell expansion.  
Reversible Grade 3 or 4 neurologic toxicities were observed in 55% of subjects, with no Grade 5 
events.  Complete resolution was observed within the majority of subjects with supportive 
treatment; only 1 subject received dexamethasone and 2 received tocilizumab.  Neurologic 
toxicity was associated with high peak blood CAR T-cell levels and high serum granzyme B, 
IL-10, and IL-15 levels.

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3.
STUDY DESIGN
3.1.
General Study Design: ZUMA-7
ZUMA-7 is a Phase 3 randomized, open-label, multicenter study evaluating the efficacy of 
axicabtagene ciloleucel versus SOC in adult subjects with r/r DLBCL.  Adult subjects with r/r 
DLBCL after first-line rituximab and anthracycline-based chemotherapy will be randomized in a 
1:1 ratio to receive axicabtagene ciloleucel or SOC.  Randomization will be stratified by 
response to first-line therapy (primary refractory, vs relapse ≤ 6 months of first-line therapy vs 
relapse > 6 and ≤ 12 months of first-line therapy) and second-line age-adjusted IPI (0 to 1 vs 2 to 
3) as assessed at the time of screening.
For subjects randomized to the control arm of the study, SOC will consist of a protocol-defined, 
platinum-based salvage combination chemotherapy regimen.  Subjects who respond to 
second-line chemotherapy should proceed to HDT and ASCT.
An independent Data Safety Monitoring Board (DSMB) will meet every 6 months after the first 
subject is randomized to review safety data and will review safety and efficacy data at the time 
of the planned interim futility analysis.  The DSMB will be chartered to make trial conduct 
recommendations based on an analysis of risk versus benefit.  The DSMB may meet more often 
as needed.  Refer to Section 9.9 for further details.
For study requirements assigned to each study arm, please refer to the schedule of assessments 
(SOAs) and Section 7 for details.
A study schema is drawn out and described at the end of the protocol synopsis section.
3.2.
Participating Sites
Approximately 80 centers located in North America, Europe, and Israel will participate in this 
study.  During the conduct of the study, additional sites, regions, or countries may be added as 
necessary.
3.3.
Number of Subjects
Participants in this trial will be referred to as “subjects.”  It is anticipated that approximately 
350 subjects will be randomized into this study.
3.4.
Replacement of Subjects
Subjects will not be replaced, and all subjects randomized will be included in the intent-to-treat 
analysis.

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3.5.
Duration of Study and Subject Participation
3.5.1.
Study Duration for Individual Subjects
The duration of the study for individual subjects will vary.  For a subject who completes the 
entire protocol from the date of informed consent through the completion of the long-term 
follow-up period, the study will take approximately 5 years to complete for those randomized to 
the SOC arm and approximately 15 years to complete for those randomized to the axicabtagene 
ciloleucel arm. Individual study duration may vary depending on a subject’s screening 
requirements, response to treatment, potential for re-treatment, survival and timing of transition 
to a separate Kite Long-term Follow-up (LTFU) study (discussed in Section 3.5.3 and 
Section 7.15).
The need for prolonged follow-up is based on the potential presence of replication-competent 
retrovirus (RCR) in treated subjects and the need to understand and mitigate the potential risks of 
delayed onset AEs that could be the potential consequence of treatment with this emerging 
technology.
3.5.2.
End-of-study Definition
The end of study is defined as when the last remaining subject completes their last visit on this 
study and transitions to a separate LTFU study (Section 3.5.3), or, when the last remaining 
subject, while still a participant in this study, is considered lost to follow-up, withdraws full 
consent, or dies.
3.5.3.
Long-term Follow-up
After completing at least 60 months of assessments in this study, all subjects who received at 
least one dose of axicabtagene ciloleucel as protocol therapy will be transitioned to a separate 
LTFU study after providing informed consent, where they will be monitored for the possible 
occurrence of late-onset targeted AEs/serious AEs (SAEs) including secondary malignancies, 
and the presence of RCR suspected to be related to axicabtagene ciloleucel for up to 15 years 
(refer also to Section 7.15). In the LTFU study, subjects will continue assessments at timepoints 
contiguous with their timepoint in this study.

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4.
SUBJECT SCREENING AND ENROLLMENT
All subjects must sign and date the Institutional Review Board/Independent Ethics Committee 
(IRB/IEC) approved consent form before initiating any study-specific procedures or activities 
that are not part of a subject’s routine care.  Refer to Section 7 for details.
Kite Pharma will assign a unique 9-digit screening subject identification (ID) number before any 
study procedures are performed for all subjects who enter into the screening period for the study 
(entry is defined as the point at which the subject signs the informed consent) as described in the 
Investigational Product Manual (IPM).  This screening subject identification number will be used 
to identify the subject throughout the study and must be used on all study documentation related 
to the subject.  Furthermore, the screening subject identification number will remain constant 
throughout the entire clinical study; it will not be changed after enrollment or if the subject is 
rescreened or retreated.
Following all screening activities, the subject will be registered in the Interactive Voice/Web 
Response System (IXRS) for randomization upon the investigator confirming eligibility of the 
subject.  For further details on the consent, screening, and enrollment process, refer to Section 7, 
the IPM, and the IXRS manual.

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5.
SUBJECT ELIGIBILITY
5.1.
Inclusion Criteria
101)
Histologically proven large B-cell lymphoma including the following types defined by 
WHO 2016 {Swerdlow 2016}:
DLBCL not otherwise specified (including ABC/GCB)
HGBL with or without MYC and BCL2 and/or BCL6 rearrangement
DLBCL arising from FL
T-cell/histiocyte rich large B-cell lymphoma
DLBCL associated with chronic inflammation
Primary cutaneous DLBCL, leg type
Epstein-Barr virus (EBV) + DLBCL
102)
Relapsed or refractory disease after first-line chemoimmunotherapy
Refractory disease defined as no complete remission to first-line therapy; subjects who 
are intolerant to first-line therapy are excluded
■
Progressive disease (PD) as best response to first-line therapy
■
Stable disease (SD) as best response after at least 4 cycles of first-line therapy (eg, 
4 cycles of R-CHOP)
■
PR as best response after at least 6 cycles and biopsy-proven residual disease or 
disease progression ≤ 12 months of therapy
Relapsed disease defined as complete remission to first-line therapy followed by biopsy-
proven disease relapse ≤ 12 months of first-line therapy
103)
Subjects must have received adequate first-line therapy including at a minimum:
Anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20 
negative, and
An anthracycline containing chemotherapy regimen
104)
Intent to proceed to HDT and ASCT if response to second-line therapy
105)
Subjects must have radiographically documented disease

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106)
No known history or suspicion of central nervous system (CNS) involvement by 
lymphoma
107)
At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed since any prior 
systemic cancer therapy at the time the subject provides consent
108)
Age 18 years or older at the time of informed consent
109)
ECOG performance status of 0 or 1
110)
Adequate bone marrow, renal, hepatic, pulmonary and cardiac function defined as:
Absolute neutrophil count (ANC) ≥1000/µL
Platelet count ≥ 75,000/µL
Absolute lymphocyte count ≥ 100/µL
Creatinine clearance (as estimated by Cockcroft Gault) ≥ 60 mL/min
Serum alanine aminotransferase/aspartate aminotransferase (ALT/AST) ≤ 2.5 upper limit 
of normal (ULN)
Total bilirubin ≤ 1.5 mg/dl, except in subjects with Gilbert’s syndrome
Cardiac ejection fraction ≥ 50%, no evidence of pericardial effusion as determined by an 
echocardiogram (ECHO), and no clinically significant electrocardiogram (ECG) findings
No clinically significant pleural effusion
Baseline oxygen saturation > 92% on room air
111)
Females of childbearing potential must have a negative serum or urine pregnancy test 
(females who have undergone surgical sterilization or who have been postmenopausal for 
at least 2 years are not considered to be of childbearing potential)
5.2.
Exclusion Criteria
201)
History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg, 
cervix, bladder, breast) unless disease free for at least 3 years
202)
History of Richter’s transformation of CLL or PMBCL
203)
History of autologous or allogeneic stem cell transplant
204)
Received more than one line of therapy for DLBCL
205)
Prior CD19 targeted therapy

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206)
Treatment with systemic immunostimulatory agents (including, but not limited to, 
interferon and IL-2) within 6 weeks or 5 half-lives of the drug, whichever is shorter, prior 
to the first dose of axicabtagene ciloleucel or SOC
207)
Prior chimeric antigen receptor therapy or other genetically modified T-cell therapy or 
prior randomization into ZUMA-7
208)
History of severe, immediate hypersensitivity reaction attributed to aminoglycosides
209)
Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring 
intravenous (IV) antimicrobials for management.  Simple urinary tract infection (UTI) 
and uncomplicated bacterial pharyngitis are permitted if responding to active treatment.
210)
Known history of infection with human immunodeficiency virus (HIV) or hepatitis B 
(HBsAg positive) or hepatitis C virus (anti-HCV positive).  If there is a positive history 
of treated hepatitis B or hepatitis C, the viral load must be undetectable per quantitative 
polymerase chain reaction (PCR) and/or nucleic acid testing.
211)
Active tuberculosis
212)
Presence of any indwelling line or drain (eg, percutaneous nephrostomy tube, indwelling 
Foley catheter, biliary drain, or pleural/peritoneal/pericardial catheter). Dedicated central 
venous access catheters, such as a Port-a-Cath or Hickman catheter, are permitted.
213)
Subjects with detectable cerebrospinal fluid malignant cells or known brain metastases or 
with a history of cerebrospinal fluid malignant cells or brain metastases
214)
History or presence of non-malignant CNS disorder, such as seizure disorder, 
cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune 
disease with CNS involvement
215)
Subjects with cardiac atrial or cardiac ventricular lymphoma involvement
216)
History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, New 
York Heart Association Class II or greater congestive heart failure, or other clinically 
significant cardiac disease within 12 months of enrollment
217)
Requirement for urgent therapy due to tumor mass effects, such as bowel obstruction or 
blood vessel compression
218)
History of autoimmune disease requiring systemic immunosuppression and/or systemic 
disease modifying agents within the last 2 years
219)
History of idiopathic pulmonary fibrosis, organizing pneumonia (eg, bronchiolitis 
obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active 
pneumonitis per chest computed tomography (CT) scan at screening.  History of radiation 
pneumonitis in the radiation field (fibrosis) is allowed.

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220)
History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of 
enrollment
221)
Any medical condition likely to interfere with assessment of safety or efficacy of study 
treatment
222)
History of severe immediate hypersensitivity reaction to tocilizumab or any of the agents 
used in this study (for sites in Switzerland, refer to the additional country-specific 
exclusion criterion in Appendix D)
223)
Treatment with a live, attenuated vaccine within 6 weeks prior to initiation of study 
treatment or anticipation of need for such a vaccine during the course of the study
224)
Women of childbearing potential who are pregnant or breastfeeding because of the 
potentially dangerous effects of chemotherapy on the fetus or infant.  Subjects of either 
sex who are not willing to practice birth control from the time of consent and at least 
6 months after the last dose of axicabtagene ciloleucel or SOC chemotherapy
225)
In the investigator’s judgment, the subject is unlikely to complete all protocol-required 
study visits or procedures, including follow-up visits, or comply with the study 
requirements for participation

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6.
PROTOCOL TREATMENT
6.1.
Treatment Terminology
For subjects randomized to the axicabtagene ciloleucel arm of the study:
•
Bridging therapy refers to corticosteroids administered after leukapheresis through 5 days 
prior to administration of axicabtagene ciloleucel.
•
Conditioning chemotherapy refers to fludarabine and cyclophosphamide used for 
lymphodepletion prior to administration of axicabtagene ciloleucel.
•
The investigational product is named axicabtagene ciloleucel.
For subjects randomized to the SOC arm of the study:
•
The second-line combination chemotherapy regimen refers to the rituximab and platinum-
based chemotherapy regimen.
•
The second-line combination chemotherapy regimen will be selected by the treating 
investigator.  The allowed regimens are R-ICE, R-DHAP, R-ESHAP, or R-GDP.
•
Response to second-line combination chemotherapy refers to a PR or CR after 2 or 3 cycles.
•
Stem cell collection refers to CD34+ hematopoietic stem cells collected by leukapheresis 
from the peripheral blood after G-CSF stimulation.
HDT refers to the myeloablative regimen administered prior to autologous stem cell infusion.  
The HDT regimen will be selected by the treating investigator.
For subjects randomized to either the axicabtagene ciloleucel or the SOC arm of the study:
•
Leukapheresis refers to:
The procedure for collection of peripheral blood mononuclear cells used to manufacture 
the subject-specific axicabtagene ciloleucel treatment (axicabtagene ciloleucel arm) or
The procedure for peripheral CD34+ hematopoietic stem cell collection (SOC arm).  
Cells collected with the intent of ASCT will follow institutional guidelines and will not 
be shipped to Kite Pharma.
•
Concomitant medication refers to treatment that subjects can receive during the conduct of 
the study.
•
Excluded medications refer to treatment that is not to be administered, unless otherwise 
specified, during the conduct of the study.

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Subsequent new lymphoma therapy refers to treatment administered after axicabtagene ciloleucel 
or SOC necessary to treat a subject’s disease.
6.2.
Axicabtagene Ciloleucel Study Treatment Arm
6.2.1.
Leukapheresis
Subjects will undergo leukapheresis to obtain T cells for the manufacturing of axicabtagene 
ciloleucel.  Leukapheresed cells obtained at participating centers will be shipped to the Kite 
manufacturing facility as described in the IPM.
6.2.2.
Conditioning Chemotherapy
Conditioning chemotherapy for lymphodepletion will be supplied by the investigative site unless 
otherwise noted.  Treatment should be administered per institutional guidelines.  Refer to the 
current product label for guidance on packaging, storage, preparation, administration, and 
toxicity management associated with the administration of chemotherapy agents.
6.2.2.1.
Fludarabine
Fludarabine phosphate is a synthetic purine nucleoside that differs from physiologic nucleosides 
in that the sugar moiety is arabinose instead of ribose or deoxyribose.  Fludarabine is a purine 
antagonist antimetabolite.
6.2.2.2.
Cyclophosphamide
Cyclophosphamide is a nitrogen mustard-derivative alkylating agent.  Following conversion to 
active metabolites in the liver, cyclophosphamide functions as an alkylating agent; the drug also 
possesses potent immunosuppressive activity.  The serum half-life after IV administration ranges 
from 3 to 12 hours; the drug and/or its metabolites can be detected in the serum for up to 
72 hours after administration.
6.2.2.3.
Mesna
Mesna is a detoxifying agent used to prevent the hemorrhagic cystitis induced by chemotherapy.  
The active ingredient in mesna is a synthetic sulfhydryl compound designated as 
sodium-2-mercaptoethane sulfonate with a molecular formula of C2H5NaO3S2.
6.2.2.4.
Rationale for Conditioning Chemotherapy
Increasing levels of conditioning chemotherapy correlates with clinical responses to adoptive cell 
therapy {Dudley 2008}.  Specifically, there appears to be a link between adequate 
lymphodepletion and adoptively transferred T-cell expansion and function in pre-clinical models.  
The depth and duration of the lymphodepletion in preclinical models correlate with anti-tumor 
activity of the adoptively transferred tumor-specific CD8+ T cells {Gattinoni 2005}.  
Lymphodepletion may function by eradicating cytokine sinks for the transferred cells, 
eliminating T regulatory cells, or enhancing antigen presenting cell activation {Klebanoff 2005}.  
Cyclophosphamide and fludarabine combination is a potent lymphodepleting regimen.  
Cyclophosphamide (500 mg/m2/day) and fludarabine (30 mg/m2/day) both given for 

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3 consecutive days has been studied and tolerated in subjects with B-cell malignancies {O'Brien 
2001} and was used in the ZUMA-1 trial {Locke 2017}.
6.2.3.
Axicabtagene Ciloleucel
6.2.3.1.
Investigational Product Description
Axicabtagene ciloleucel is supplied cryopreserved in cryostorage bags.  The product in the bag is 
clear to opaque in clarity and white to red in color with no visible foreign particles. The 
cryostorage bag containing axicabtagene ciloleucel arrives frozen in a liquid nitrogen dry 
shipper.  The bag must be stored in vapor phase of liquid nitrogen, and the product must remain 
frozen until the subject is ready for treatment to assure viable live autologous cells are 
administered.  Several inactive ingredients are added to the product to assure viability and 
stability of the live cells through the freezing, thawing, and infusion process.
Axicabtagene ciloleucel is a subject-specific product, and the intended subject will be identified 
by a unique subject ID number.  Upon receipt, verification that the product and subject-specific 
labels match the subject’s information (eg, subject ID number) is essential.  Do not infuse the 
product if the information on the subject-specific label does not match the intended subject.  The 
volume of axicabtagene ciloleucel infused, the thaw start/stop time, and axicabtagene ciloleucel 
administration start/stop time will all be noted in the subject medical record.  Axicabtagene 
ciloleucel must not be thawed until the subject is ready for the infusion. Refer to the IPM for 
details and instruction on storage, thawing, and administration of axicabtagene ciloleucel.
There have been no instances of accidental overdose of subjects in this program to date.  In case 
of accidental overdose, treatment should be supportive.  Corticosteroid therapy may be 
considered if any dose is associated with severe toxicity.
If any problems related to the use of axicabtagene ciloleucel or any products that support the 
management of axicabtagene ciloleucel (eg, cryostorage bags, subject identification labels) are 
identified, research staff should report the problem per the instructions in the IPM.
6.2.3.2.
Rationale for Axicabtagene Ciloleucel Dose
The rationale for the axicabtagene ciloleucel dose in this study is based on the aggregate safety 
and efficacy data compiled from the ZUMA-1 study as outlined in Section 2.5.1.2 and the IB.  
Based on the favorable benefit/risk ratio seen in ZUMA-1, axicabtagene ciloleucel will be 
administered at a target dose of 2 x 106 anti-CD19 CAR T cells/kg, but may be dosed at a 
minimum of 1 x 106 anti-CD19 CAR T cells/kg.  For subjects weighing > 100 kg, a maximum 
flat dose of axicabtagene ciloleucel at 2 x 108 anti-CD19 CAR T cells will be administered.

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6.2.4.
Cell Collection and Axicabtagene Ciloleucel Study Treatment Schedule and 
Administration
6.2.4.1.
Leukapheresis (Within Approximately 5 Days of Randomization)
If any screening assessments or procedures are repeated between confirmation of eligibility and 
the start of leukapheresis and results are outside the eligibility criteria listed in Section 5, contact 
the sponsor’s medical monitor prior to proceeding with leukapheresis.
Before leukapheresis commences, the below criteria must be met:
•
No evidence or suspicion of an infection
•
Corticosteroid therapy at a pharmacologic dose (≥ 5 mg/day of prednisone or equivalent 
doses of other corticosteroids) and other immunosuppressive drugs must be avoided for 
7 days prior to leukapheresis.
If criteria are not met, leukapheresis must be delayed until the event resolves.  If leukapheresis is 
delayed more than 5 days after randomization, baseline complete blood count (CBC) with 
differential and chemistry panel must be repeated.  If results are outside the eligibility criteria 
listed in Section 5, contact the medical monitor prior to proceeding with leukapheresis.
The leukapheresis visit should occur within approximately 5 days of randomization.
After the above criteria are met, mononuclear cells will be obtained by leukapheresis (12 to 
15 liter apheresis with a goal to target approximately 5 to 10 x 109 mononuclear cells).  The 
leukapheresed cells are then packaged for expedited shipment to the manufacturing facility as 
described in the IPM.
Refer to the SOA Table 2 for a listing of study procedures to be completed during the 
leukapheresis visit.
6.2.4.2.
Bridging Therapy (administered after leukapheresis and completed at least 
5 days prior to initiating axicabtagene ciloleucel)
At the discretion of the investigator, bridging therapy may be considered for subjects with high 
disease burden at screening.
Bridging therapy with corticosteroids is allowed, such as dexamethasone at a dose of 20 to 
40 mg or equivalent, either PO or IV daily for 1 to 4 days.  Choice of corticosteroid and dosing 
can be adjusted for age/comorbidities or per clinical judgement.

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6.2.4.3.
Conditioning Chemotherapy (day -5 through day -3 before infusion of 
axicabtagene ciloleucel)
Administration of CAR T cells to subjects with ongoing infection or inflammation, even if such 
processes are asymptomatic, increases the risk of high grade and fatal toxicity.  All efforts should 
be made to rule out such conditions prior to cell infusion.
Signs, symptoms, or abnormal laboratory results attributed to the malignancy (eg “tumor fever,” 
elevated C-reactive protein [CRP]) are diagnoses of exclusion that require a documented work-
up to establish.
Conditioning chemotherapy and axicabtagene ciloleucel infusion should be initiated only once it 
is reasonably assured that cell infusion can safely proceed.
Refer to Section 6.2.4.8 for Requirements to Work-up Potential Infectious and/or Inflammatory 
States.
6.2.4.3.1.
Requirements for Initiation of Conditioning Chemotherapy
If any of the following criteria are met prior to the initiation of conditioning chemotherapy, then 
the work-up listed in Section 6.2.4.8 must be performed to determine the potential cause if there 
is no identified source of infection.
•
Temperature > 38°C within 72 hours of conditioning chemotherapy
•
CRP > 100 mg/L anytime between enrollment to start of conditioning chemotherapy
•
White blood cell (WBC) count or WBC differential concerning for infectious process 
between enrollment to start of conditioning chemotherapy (eg, WBC > 20,000, rapidly 
increasing WBC, or differential with high percentage of segs/bands)
Additionally:
•
If any screening assessments or procedures are repeated between confirmation of eligibility 
and the start of conditioning chemotherapy and results are outside the eligibility criteria listed 
in Section 5, then the condition must resolve prior to proceeding with conditioning 
chemotherapy.
•
Complete history and physical exam, including head, ears, eyes, nose, throat (HEENT); 
cardiac, vascular, respiratory, gastrointestinal, integumentary, and neurological systems must 
not reveal evidence of infection/inflammation.
•
The subject must not have received systemic anti-microbials for the treatment of a known or 
suspected infection within 48 hours before conditioning chemotherapy (prophylactic use of 
anti-microbials is allowed).

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•
Treatment course of any antimicrobials given for known or suspected antecedent infection 
should be complete as per infectious disease consult (if applicable) recommendation before 
stopping or switching to prophylactic antimicrobials.
•
If a subject is confirmed to have an infectious process for which antimicrobials are not 
available (eg, viral pneumonia), the infection must be clinically resolved as determined by 
the investigator in consultation with infectious disease service (if applicable).
•
Most recently collected blood, urine, or other body fluid cultures must show no growth for at 
least 48 hours, and any other infectious work-up performed (eg, bacterial, viral serologies, 
PCR, stool studies, imaging studies) must be negative.  If clinical suspicion is for an infection 
for which cultures are unlikely to be positive within 48 hours (eg, fungal infection), adequate 
time must be allowed for cultures to become positive.
•
Once the above criteria are met, then the subject can proceed with conditioning 
chemotherapy.
6.2.4.3.2.
Conditioning Chemotherapy Administration (day -5 through day -3 Prior to 
Axicabtagene Ciloleucel Infusion)
Subjects will receive a conditioning chemotherapy regimen consisting of cyclophosphamide and 
fludarabine.  The first dose of conditioning chemotherapy will be designated as day -5. Subjects 
will initiate conditioning chemotherapy with cyclophosphamide and fludarabine beginning on 
day -5 through day -3 with 2 rest days before receiving axicabtagene ciloleucel.  The 3-day 
conditioning chemotherapy regimen will be administered in an outpatient setting.
The 3-day conditioning regimen of fludarabine and cyclophosphamide will be administered in 
accordance with the below daily dosing instructions.
•
IV hydration with a balanced crystalloid according to institutional guidelines prior to 
administration of cyclophosphamide on the day of infusion
•
Cyclophosphamide 500mg/m2 IV over approximately 60 minutes
•
Fludarabine 30mg/m2 IV over approximately 30 minutes
•
Additional IV hydration with a balanced crystalloid according to institutional guidelines to be 
administered upon completion of the cyclophosphamide infusion
•
Mesna to be administered per institutional guidelines
Subjects should be instructed to drink plenty of liquids during and for 24 hours following the 
chemotherapy (approximately 2 liters/24 hours).  In general, subjects should be kept 
well-hydrated but closely monitored to prevent fluid overload.
Refer to the SOA Table 2 for a listing of study procedures to be completed during the 
axicabtagene ciloleucel conditioning chemotherapy period.

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6.2.4.4.
Requirements for Initiating Axicabtagene Ciloleucel Infusion (Treatment 
day 0)
If any of the following criteria are met prior to the initiation of axicabtagene ciloleucel infusion, 
then the work-up listed in Section 6.2.4.8 must be performed to determine the potential cause if 
there is no identified source of infection.
•
Temperature > 38°C within 72 hours of axicabtagene ciloleucel infusion
•
CRP > 100 mg/L anytime between enrollment to start of axicabtagene ciloleucel infusion
•
WBC count or WBC differential concerning for infectious process between enrollment to 
start of axicabtagene ciloleucel infusion (eg, WBC > 20,000, rapidly increasing WBC, or 
differential with high percentage of neutrophils/bands)
Additionally:
•
If any screening assessments or procedures are repeated between confirmation of eligibility 
and the start of axicabtagene ciloleucel infusion and results are outside the eligibility criteria 
listed in Section 5, then the condition must resolve prior to proceeding with axicabtagene 
ciloleucel infusion (except for peripheral blood cell counts that have been impacted by 
conditioning chemotherapy).
•
Complete history and physical exam including HEENT; cardiac, vascular, respiratory, 
gastrointestinal, integumentary, and neurological systems must not reveal evidence of 
infection/inflammation.
•
The subject must not have received systemic anti-microbials for the treatment of a known or 
suspected infection within 48 hours before axicabtagene ciloleucel (prophylactic use of 
anti-microbials is allowed).
•
Treatment course of any antimicrobials given for known or suspected antecedent infection 
should be complete as per infectious disease consult (if applicable) recommendation before 
stopping or switching to prophylactic antimicrobials.
•
If a subject is confirmed to have an infectious process for which antimicrobials are not 
available (eg, viral pneumonia), the infection must be clinically resolved as determined by 
the investigator in consultation with infectious disease service (if applicable).
•
Most recently collected blood, urine, or other body fluid cultures must show no growth for at 
least 48 hours, and any other infectious work-up performed (eg, bacterial, viral serologies, 
PCR, stool studies, imaging studies) must be negative.  If clinical suspicion is for an infection 
for which cultures are unlikely to be positive within 48 hours (eg, fungal infection), adequate 
time must be allowed for cultures to become positive.
Once the above criteria are met, then the subject can proceed with administration of axicabtagene 
ciloleucel.

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If the axicabtagene ciloleucel infusion is delayed > 2 weeks, protocol guidelines should be 
followed regarding the need for repeat conditioning chemotherapy.
6.2.4.5.
Axicabtagene Ciloleucel Premedication Dosing
The following pre axicabtagene ciloleucel infusion medications should be administered 
approximately 1 hour prior to infusion.
•
Acetaminophen 650 mg PO or equivalent
•
Diphenhydramine 12.5 mg administered either orally or via IV or equivalent
6.2.4.6.
Axicabtagene Ciloleucel Administration day 0
All subjects will receive axicabtagene ciloleucel infusion at a healthcare facility, followed by 
daily monitoring at a healthcare facility for at least 7 days to monitor for signs and symptoms of 
CRS and neurologic events, unless otherwise required by country regulatory agencies (refer to 
Appendix D). Alternatively, subjects may be hospitalized to receive their axicabtagene ciloleucel 
infusion and be observed for CRS and neurologic events in the hospital setting, if deemed 
appropriate by the investigator.
If subjects are hospitalized, subjects should not be discharged from the hospital until all 
axicabtagene ciloleucel related non-hematological toxicities resolve to ≤ Grade 1 or return to 
baseline. Subjects may be discharged with non-critical and clinically stable or improving 
toxicities (eg, renal insufficiency) even if > Grade 1, if deemed appropriate by the 
investigator.  Subjects should remain in a hospital for ongoing axicabtagene ciloleucel related 
fever, hypotension, hypoxia, or ongoing neurologic events > Grade 1 or if deemed necessary by 
the investigator.
Subjects should be instructed to remain within proximity of the clinical study site for at least 
4 weeks following axicabtagene ciloleucel infusion. Subjects and their family 
members/caregivers should be educated on potential CRS and neurologic symptoms, such as 
fever, dyspnea, confusion, aphasia, dysphasia, somnolence, encephalopathy, ataxia, or tremor. 
Subjects or their family members/caregivers should be instructed to immediately contact the 
treating investigator or seek immediate medical attention if any of these symptoms develop.
Refer to the SOA for a listing of study procedures to be completed during the axicabtagene 
ciloleucel treatment period.
Central venous access, such as a port or a peripherally inserted central catheter, is required for 
the administration of axicabtagene ciloleucel.  Catheter care, per institutional guidelines, should 
be followed.  Materials and instructions for the thawing, timing, and administration of 
axicabtagene ciloleucel are outlined in the IPM.  Vital signs should be measured during and after 
axicabtagene ciloleucel treatment (see Section 7.6). The IPM must be reviewed prior to 
administration of axicabtagene ciloleucel.
Research sites should follow institutional guidelines for the infusion of cell products.

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6.2.4.7.
Axicabtagene Ciloleucel Retreatment
Subjects who achieved a PR or CR and subsequently experience disease progression may have 
an option to receive a second course of conditioning chemotherapy and axicabtagene ciloleucel.
In either case, the following criteria must be met in order to be considered for a repeat course of 
therapy:
•
Subject had a PR or CR at the first disease assessment at Day 50 but subsequently 
experienced progression of disease at a later time
•
Tumor that is not known to be CD19 negative
•
Subject continues to meet the original study eligibility criteria with the exception of prior 
axicabtagene ciloleucel use in this study; screening assessments and procedures should be 
repeated if clinically indicated (eg, magnetic resonance imaging [MRI], ECHO)
•
Subject has not received subsequent therapy for the treatment of lymphoma
•
Subject did not experience a life-threatening toxicity related to axicabtagene ciloleucel 
during the original course of treatment
•
Toxicities related to conditioning chemotherapy (fludarabine and cyclophosphamide), with 
the exception of alopecia, have resolved to ≤ Grade 1 or returned to baseline prior to 
re-treatment
•
Subject does not have known axicabtagene ciloleucel neutralizing antibodies (exception: if a 
non-neutralizing axicabtagene ciloleucel antibody develops, subjects may be retreated if they 
meet the original study eligibility criteria)
•
Sites are strongly encouraged to collect a biopsy confirming disease progression and CD19 
expression and to submit the biopsied tissue to the central laboratory before initiating 
re-treatment
•
Subject received the initial axicabtagene ciloleucel infusion ≤ 24 months ago
The decision to re-treat should be made in consultation with the Kite medical monitor.  In 
addition, before performing any study-related procedures or treatment, it is necessary to 
1) discuss the risks and benefits of retreatment with the subject, and 2) confirm with the subject 
how the second dose will be manufactured. The second dose could be manufactured at the same 
time that the first axicabtagene ciloleucel is made with existing cryopreserved PBMCs. 
Alternatively, the subject may need to undergo a second leukapheresis and should be informed of 
this possibility.  These conversations should also be recorded in the subject’s source document.
A maximum of 1 retreatment course may occur per subject.  Subjects who are retreated will 
follow the same treatment schedule and procedural requirements per the initial treatment.

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Allowance for retreatment is based on clinical experience in ZUMA-1, where a total of 
10 subjects were retreated with axicabtagene ciloleucel (1 subject in Phase 1 and 9 subjects in 
Phase 2).  Overall, 6 of 10 retreated subjects had a PR or CR to the retreatment.  The subject in 
Phase 1 achieved a PR at Month 1 after retreatment.  Among the 9 subjects retreated in Phase 2, 
five subjects responded (2 CR and 3 PR) at Month 1.  Analysis of duration of retreatment 
response (DORR) among the retreated subjects in Phase 2 showed a median DORR of 
3.5 months as of the data cutoff date.
After a subject is deemed eligible for retreatment and the means by which the second dose of 
axicabtagene ciloleucel has been confirmed (which will include determining whether a second 
leukapheresis is required), the subject will follow the same study procedure requirements that 
were followed during his or her initial course of treatment.
Refer to the SOA Table 2 for a listing of study procedures to be completed during the 
axicabtagene ciloleucel treatment period.
6.2.4.8.
Requirements to Work-up Potential Infectious and/or Inflammatory States
In the absence of an identified source of infection (eg, line infection, pneumonia on CXR), the 
minimum work-up to be performed prior to administration of conditioning chemotherapy and/or 
axicabtagene ciloleucel consists of:
•
Call Kite medical monitor
•
Infectious disease service consult (if applicable)
•
CT imaging of the chest, abdomen, and pelvis with IV contrast.  If there is a medical 
contraindication to contrast, then non-contrast CT is allowed.
•
 The following must be performed (prior to the initiation of antimicrobials if clinically 
feasible):
Blood cultures (aerobic and anaerobic x2 bottles each) and UA and urine culture.   
Deep/induced sputum culture if clinically indicated.
All indwelling lines, such as central venous catheters, should be examined for any signs 
of infection, and additional cultures should be drawn from the line.
Nasopharyngeal-throat (NPT) swab or equivalent assay for viral infection, such as 
influenza A/B (including H1N1), parainfluenza 1/2/3, adenovirus, respiratory syncytial 
virus, coronavirus, metapneumovirus
Collection of fungal cultures and markers as appropriate (eg, galactomannan, fungitell)
Collection of appropriate serum viral studies (eg, cytomegalovirus [CMV])

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•
If a central nervous system process is suspected, appropriate brain imaging and subsequent 
lumbar puncture with cytology, culture, Gram stain, and viral PCR should be performed.
•
Any additional sign or symptom-directed investigation should be performed as clinically 
indicated.
Prior to proceeding with conditioning chemotherapy and/or axicabtagene ciloleucel infusion, the 
above work-up must not suggest the presence of an active infection, and all requirements for 
conditioning chemotherapy and/or axicabtagene ciloleucel infusion must be satisfied.
If the axicabtagene ciloleucel infusion is delayed > 2 weeks following conditioning 
chemotherapy, protocol guidelines should be followed regarding the need for repeat conditioning 
chemotherapy.
If the above work-up was triggered due to CRP > 100 mg/L, CRP should be repeated, and if 
CRP continues to increase significantly, evaluation should be performed for any other potential 
infectious or inflammatory condition not previously evaluated.
6.2.4.9.
Concomitant Therapy (Axicabtagene Ciloleucel Arm)
Investigators may prescribe any concomitant medications or treatment deemed necessary to 
provide adequate supportive care, including growth factor support (eg, G-CSF) and routine 
anti-emetic prophylaxis except those medications listed in the excluded medication Section 6.2.5.  
Concomitant therapy does not include therapy used for the treatment of the disease.
For subjects who are not randomized (eg, screen failure), only concurrent therapies related to any 
serious adverse event(s) (SAEs) will be recorded.
For subjects who are randomized but not dosed with axicabtagene ciloleucel, concomitant 
concurrent therapies and subsequent anticancer therapy will only be recorded from the date of 
the informed consent through 30 days after the last study-specific procedure (eg, leukapheresis, 
conditioning chemotherapy).
For subjects who are randomized to receive axicabtagene ciloleucel and receive the dose of 
axicabtagene ciloleucel, all concomitant therapies, including medications, intubation, dialysis, 
oxygen, and blood products, should be recorded from the date of the informed consent through 
the Day 150 post-randomization visit, and targeted concomitant therapies from this visit until 
Month 12, or until a change in lymphoma therapy, or disease progression, whichever occurs first.  
Targeted concomitant therapies include gammaglobulin, immunosuppressive drugs, 
anti-infective drugs, and vaccinations.  Refer to Section 6.2.6 for details surrounding subsequent 
cancer therapy.
Specific concomitant medication collection requirements and instructions are included in the 
Case Report Form (CRF) completion guidelines.

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6.2.5.
Excluded Medications (Axicabtagene Ciloleucel Arm)
Corticosteroid therapy at a pharmacologic dose (≥ 5 mg/day of prednisone or equivalent doses of 
other corticosteroids) and other immunosuppressive drugs must be avoided for 7 days prior to 
leukapheresis and 5 days prior to axicabtagene ciloleucel administration.
Systemic corticosteroids may not be administered as premedication to subjects for whom CT 
scans with contrast are contraindicated (ie, subjects with contrast allergy or impaired renal 
clearance).  Such subjects should undergo MRI with contrast and non-contrast CT scans instead.
Corticosteroids and other immunosuppressive drugs should also be avoided for 3 months after 
axicabtagene ciloleucel administration unless used to manage axicabtagene ciloleucel related 
toxicities.  Other medications that might interfere with the evaluation of axicabtagene ciloleucel, 
such as non-steroidal anti-inflammatory agents, should also be avoided for the same period 
unless medically necessary.
Treatment for lymphoma, such as chemotherapy, immunotherapy, targeted agents, radiation, and 
high-dose corticosteroid, other than defined/allowed in this protocol, and other investigational 
agents are prohibited, except as needed for treatment of disease progression after axicabtagene 
ciloleucel.
If permissibility of a specific medication/treatment is in question, please contact the Kite Pharma 
medical monitor.  Please refer to the IB for additional information about excluded medications.
6.2.6.
Subsequent Therapy (Axicabtagene Ciloleucel Arm)
Subsequent therapy administered after axicabtagene ciloleucel necessary to treat a subject’s 
disease, such as non-study-specified chemotherapy, immunotherapy, targeted agents, as well as 
stem cell transplant and radiation therapy, will be recorded for all subjects randomized until one 
of the following happens: the subject completes the long-term follow-up period, is considered 
lost to follow up, withdraws consent, or dies.  If a subject progresses, sites are strongly 
encouraged to collect a biopsy confirming disease progression and to submit the biopsied tissue 
to the central laboratory.  Treatment with axicabtagene ciloleucel is intended to be definitive 
therapy and not a bridge to ASCT.
6.2.7.
Toxicity Management (Axicabtagene Ciloleucel Arm)
To date, the following important risks have been identified with axicabtagene ciloleucel:  CRS, 
neurologic events, infections, cytopenias, and hypogammaglobulinemia.  Refer to Section 6 of 
the current IB for details regarding these events and management guidance.
As the safety experience with axicabtagene ciloleucel increases, the management guidance may 
be updated. Therefore, it is important to always refer to the most current version of the 
axicabtagene ciloleucel IB for guidance regarding managing axicabtagene ciloleucel related 
toxicities. Additional information and management recommendations can also be found in the IB 
regarding important potential risks associated with axicabtagene ciloleucel as well as possible 
complications associated with malignancy and cancer treatment.

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6.3.
Standard of Care Therapy Arm
SOC therapy will be supplied by the investigative site unless otherwise noted.  Refer to the 
current product label for guidance on packaging, storage, preparation, and administration of each 
chemotherapy regimen and individual component of the regimen.  G-CSF will be administered 
based on regional/institutional standards to prevent chemotherapy delays and infection and for 
leukapheresis.
Administration of SOC therapy will be performed in a setting with emergency medical facilities 
and staff who are trained to monitor for and respond to medical emergencies.  Any overdose or 
incorrect administration of SOC therapy should be noted on the Study Drug Administration 
electronic Case Report Form (eCRF).
After SOC therapy is administered to a subject, the subject must receive the same SOC therapy 
option for subsequent cycles of therapy.  Individual agents of the choice of treatment may be 
altered based on subject care and toxicity management.
6.3.1.
Standard of Care Chemotherapy Dosing and Administration
SOC chemotherapy is recommended to start within approximately 5 days after randomization.
Rituximab + ifosfamide, carboplatin, and etoposide (R-ICE) suggested dosing {Gisselbrecht 
2010}:
•
Rituximab 375 mg/m2 before chemotherapy
•
Ifosfamide 5 g/m2 24h-CI on day 2 with mesna
•
Carboplatin area under the curve (AUC) 5 on day 2, maximum dose 800 mg
•
Etoposide 100 mg/m2/d on days 1-3
Rituximab + etoposide, methylprednisolone, cytarabine, cisplatin (R-ESHAP) suggested dosing 
{Martin 2008}:
•
Rituximab 375 mg/m2 day 1
•
Etoposide 40 mg/m2/d IV on days 1-4
•
Methylprednisolone 500 mg/d IV on days 1-4 or 5
•
Cisplatin at 25 mg/m2/d CI days 1-4
•
Cytarabine 2 g/m2 on day 5

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Rituximab + gemcitabine, dexamethasone and cisplatin/carboplatin (R-GDP) suggested dosing 
{Crump 2004, Gopal 2010}
•
Rituximab 375 mg/m2 day 1 (or day 8)
•
Gemcitabine 1 g/m2 on days 1 and 8
•
Dexamethasone 40 mg on days 1-4
•
Cisplatin 75 mg/m2 on day 1 (or carboplatin AUC = 5) {Gopal 2010}
Rituximab + dexamethasone, high-dose cytarabine and cisplatin (R-DHAP) suggested dosing 
{Gisselbrecht 2010}:
•
Rituximab 375 mg/m2 before chemotherapy
•
Dexamethasone 40 mg/d on days 1-4
•
High-dose cytarabine 2 g/m2 every 12 h for 2 doses on day 2 following platinum
•
Cisplatin 100 mg/m2 24h-CI on day 1 (or oxaliplatin 100 mg/m2) {Lignon 2010}
6.3.1.1.
Rationale for Standard of Care Dose and Schedule
Second-line chemotherapy regimens generally consist of non-cross-resistant drugs to first-line 
R-CHOP and includes platinum.  Common regimens include R-GDP, R-DHAP, R-ICE, and 
R-ESHAP.  Institutional preference and toxicity profile often dictate which treatment regimen is 
used because no single salvage regimen has demonstrated superiority in a randomized trial.  If 
adequate disease response (CR or PR) is demonstrated after 2 or 3 cycles of chemotherapy, 
HDT-ASCT may be initiated.
Prior to high-dose therapy, which is myeloablative, peripheral blood progenitor cells are 
collected by leukapheresis to a minimum target of 2 x 106 CD34+ hematopoietic stem cells per 
kg body weight, which will be reinfused after HDT to rescue hematopoiesis.  The HDT 
conditioning regimen consists of combination high-dose chemotherapy with or without TBI.  
Commonly used high-dose regimens include BEAM (BCNU, etoposide, ara-C, and melphalan) 
or CBV (cyclophosphamide, BCNU, and VP-16).  There is no standard high-dose regimen due to 
lack of randomized studies; therefore, HDT and ASCT procedures are per regional and 
institutional standards.
6.3.2.
Concomitant Therapy (Standard of Care Arm)
Investigators may prescribe any concomitant medications or treatment deemed necessary to 
provide adequate supportive care, including growth factor support (eg, G-CSF) and routine 
anti-emetic prophylaxis, except those medications listed in the excluded medication 
Section 6.3.3.  Concomitant therapy does not include therapy used for the treatment of the 
disease.

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For subjects who are not randomized (eg, screen failure), only concurrent therapies related to any 
SAEs will be recorded.
For subjects who are randomized but not dosed with SOC, concurrent therapies will only be 
recorded from the date of the informed consent through 30 days after the last study-specific 
procedure.
For subjects who are randomized and receive SOC therapy, all concurrent therapies, including 
medications, intubation, dialysis, oxygen, and blood products, should be recorded from the date 
of the informed consent through the Day 150 post-randomization visit or disease progression, 
whichever occurs first.  Refer to Section 6.3.4 for details surrounding subsequent cancer therapy.
Specific concomitant medication collection requirements and instructions are included in the 
CRF completion guidelines.
6.3.3.
Excluded Medications (Standard of Care Arm)
Treatment for lymphoma, such as chemotherapy, immunotherapy, targeted agents, radiation (TBI 
for HDT is allowed), and high-dose corticosteroid, other than defined/allowed in this protocol, 
and other investigational agents are prohibited, except as needed for change in lymphoma 
therapy after lack of response to the protocol-defined SOC therapy options.
If permissibility of a specific medication/treatment is in question, please contact the Kite Pharma 
medical monitor.
6.3.4.
Subsequent Therapy (Standard of Care Arm)
Subsequent therapy administered after SOC chemotherapy necessary to treat a subject’s disease, 
such as non-study specified chemotherapy, immunotherapy, targeted agents, as well as stem cell 
transplant and radiation therapy, will be recorded for all subjects randomized until the subject 
completes the long-term follow-up period, is considered lost to follow-up, withdraws consent, or 
dies.  If a subject progresses, sites are strongly encouraged to collect a biopsy confirming disease 
progression and to submit the biopsied tissue to the central laboratory.
6.3.5.
Toxicity Management (Standard of Care Arm)
Refer to the current regional product label, and follow institutional guidelines for toxicity 
management associated with the administration of each chemotherapy agent.

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7.
STUDY PROCEDURES
Research staff should refer to the SOAs for an outline of the procedures required.
The visit schedule for disease assessments, including CT scans, positron emission tomography 
(PET) scans, bone marrow biopsy, assessment of B-symptoms, physical exams needed to assess 
disease, and collection of subsequent new lymphoma therapy, is calculated from randomization.
An overview of study assessments/procedures is outlined below.  Refer to the CRF completion 
guidelines for data collection requirements and documentation of study procedures.
7.1.
Informed Consent
Before a subject’s participation in the clinical study, the investigator is responsible for obtaining 
written informed consent from the subject after adequate explanation of the study design, 
anticipated benefits, and the potential risks.  Subjects should sign the most current IRB/IEC 
approved Informed Consent Form (ICF) prior to any study-specific activity or procedure is 
performed.
The consent process and the subject’s agreement or refusal to participate in the study is to be 
documented in the subject’s medical records.  If the subject agrees to participate, the ICF is to be 
signed and personally dated by the subject and by the person who conducted the informed 
consent discussion.  The original signed ICF will be retained in accordance with institution 
policy and IRB/IEC requirements with a copy of the ICF provided to the subject.
All subjects who are enrolled into the study should be re-consented with any updated versions of 
the IRB/IEC approved ICF if relevant to their participation in the study.
7.2.
Screening
Investigative sites will maintain a log of all screened subjects who were reviewed and evaluated 
for study participation.  Information collected on the screening log should include limited 
information, such as the date of screening, date the subject was enrolled, or the reason for why 
the subject failed screening.
The screening period begins on the date the subject signs the IRB/IEC approved ICF and 
continues through confirmation of eligibility and randomization into the study.  Informed 
consent must be obtained before completion of any non-standard of care study-specific 
procedures.  Procedures that are part of standard of care are not considered study-specific 
procedures and may be performed prior to obtaining consent and used to confirm eligibility.  
Confirmation of this data must occur within the time allowance as outlined below and in the 
SOA.
After written informed consent has been obtained, Kite Pharma will assign a screening number 
to the subject.  Subsequently, the subject will be registered into the IXRS as described in the 
IXRS user manual.  Subjects who fail to meet the eligibility criteria will be allowed to rescreen 

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one time.  Subjects will perform the assessment that initially resulted in the subject failing 
screening, including any other procedures that fell outside of the designated screening window 
(ie, lab assessments or PET-CT scans).
Only subjects who meet the eligibility criteria listed in Section 5 will be randomized into the 
study.  If at any time prior to enrollment the subject fails to meet the eligibility criteria, the 
subject should be designated as a screen failure in the IXRS and on the subject screening log 
with the reasons for failing screening.
Refer to the SOA for a listing of study procedures to be completed during the screening period.
7.3.
Randomization
Once eligibility into the study has been confirmed, subjects will be randomized in a 1:1 ratio to 
receive axicabtagene ciloleucel or investigator choice of SOC chemotherapy as assigned by the 
IXRS.
To randomize a subject, an authorized site representative will log into IXRS where the system 
will assign a randomization number to the subject.  The randomization is accomplished by 
entering the pertinent information detailed in the IXRS user manual.  Randomization will be 
stratified by response to first-line therapy (primary refractory, vs relapse ≤ 6 months of first-line 
therapy vs relapse > 6 and ≤ 12 months of first-line therapy) and second-line age-adjusted IPI 
(0 to 1 vs 2 to 3) as assessed at the time of screening.
After data have been entered into the IXRS, a confirmation fax or email will be sent to the site to 
verify that the correct information has been entered.  The site representative will receive a single, 
unique randomization number for each subject and the randomization treatment assigned.  A 
subject will be considered enrolled/randomized into the study when a randomization number is 
assigned.
The randomization date is to be documented in the subject’s medical record and on the 
enrollment CRF.
Depending on which arm of the study subjects are randomized, subjects should initiate 
leukapheresis or SOC therapy within approximately 5 days of randomization in IXRS.
7.4.
Demographic Data
Demographic data will be collected as per country and local regulations and guidelines.  Where 
applicable, demographic data will include sex, date of birth, race, ethnicity, and country of 
enrollment to study their possible association with subject safety and treatment effectiveness.
7.5.
Medical and Treatment History
Relevant medical history prior to the start of adverse event reporting will be collected.  Relevant 
medical history is defined as data on the subject’s concurrent medical condition that would be 
typically shared in a referral letter.  All findings will be recorded in the CRFs.

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In addition to the medical history, all history related to the subject’s disease, treatment, and 
response to treatment will be collected and must date back to the original diagnosis.
For subjects who are being referred from another clinic or institution to the participating research 
center, copies from the subject’s chart should be obtained.
7.6.
Physical Exam, Vital Signs, and Performance Status
Physical exams will be performed during screening and at times noted in the SOA.  Changes 
noted in subsequent exams when compared to the baseline exam will be reported as an adverse 
event.
Vital signs, including blood pressure, heart rate, respiratory rate, oxygen saturation, and 
temperature, will be monitored and recorded at times outlined in the SOA.
In addition to the time points outlined in the SOA, it is recommended that vital signs be 
monitored during and after axicabtagene ciloleucel or SOC therapy and every 6 hours during any 
hospitalization.  Vital signs may be monitored more frequently as clinically indicated.
Performance status as measured by the ECOG scale will be performed to quantify the subject’s 
general well-being and ability to perform activities of daily life.
7.7.
Neurological Examination
A neurological examination will be performed with any abnormalities of the following recorded:  
level of consciousness, orientation, vision, cranial nerves and brain stem functions, pyramidal 
and extra pyramidal motor system, reflexes, muscle tone and trophic findings, coordination, 
sensory system, neuropsychological findings (eg, speech, cognition and emotion). A neurological 
assessment (which may include the Mini-Mental Status Exam [MMSE]) should be done prior to 
axicabtagene ciloleucel infusion on treatment day 0, then on treatment day 1, and every other day 
during the minimum 7-day observation period (refer to Appendix D for specific requirements of 
country regulatory agencies regarding duration of observation period).
Subjects will be specifically queried for neurological symptoms observed in the interval since the 
last baseline neurological examination.
7.8.
Cardiac Function
Each subject’s cardiac function, as measured by left ventricular ejection fraction (LVEF), will be 
assessed during the screening period to confirm study eligibility.  No evidence of pericardial 
effusion as required by eligibility will also be confirmed.  Both LVEF and pericardial effusion 
will be assessed prior to study entrance by ECHO.  An ECHO performed following the subjects 
last chemotherapy treatment and within 28 days prior to signing the consent may be used for 
confirmation of eligibility.
To establish a baseline, a 12-lead ECG will also be performed during the screening period.

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7.9.
Toxicity Evaluation
Specific to subjects who are randomized into the axicabtagene ciloleucel arm of the study and 
receive axicabtagene ciloleucel as part of their initial treatment, or as part of re-treatment, 
suspected related toxicities should be evaluated with the following:
•
For new onset symptoms potentially related to CRS, a physical exam, and assessments of 
vital signs (including pulse oximetry) and cardiopulmonary status should be performed.  
Refer to the SOA Table 2 for further details, Section 6.2.7, and the IB for CRS management.
•
For new onset neurologic symptoms, neurologic assessment should be performed at least 
daily until symptoms resolve to baseline.  For Grade ≥ 2 neurological symptoms, a brain 
MRI, electroencephalogram (EEG), and examination of CSF should be performed in addition 
to frequent neurologic assessment.  Additional evaluations of the CSF should be performed 
per institutional standard of care.  CSF samples (ie, if collected at baseline, and collected on 
study to assess neurological symptoms) will be submitted to the central laboratory.  Refer to 
the SOA Table 2 for further details, Section 6.2.7, and the IB for management.
•
For Grade ≥ 3 CRS, neurologic, or HLH symptoms, CRP and ferritin levels should be 
evaluated and followed.
7.10.
Disease Response Assessment
Subjects will be evaluated for disease response by the site investigator at times indicated in the 
SOA.  Disease assessments will be evaluated per the Lugano Classification {Cheson 2014}.  
Flow cytometric, molecular, or cytogenetic studies will not be used to determine response.
7.10.1.
Imaging
Screening fluorodeoxyglucose (FDG)-PET from skull base to mid-thighs and diagnostic quality 
contrast-enhanced (unless contraindicated) CT from skull base through lesser trochanters 
(PET-CT), along with the appropriate imaging of all other sites of disease, are required to 
confirm eligibility and to establish a baseline, which must be performed within 28 days prior to 
randomization and as close to the randomization date as possible.  Subjects will have their first 
post-treatment planned PET-CT tumor assessment within the Day 50 assessment period 
calculated from the subject’s randomization date.
Subjects’ disease will further be assessed and at regular intervals as highlighted in the SOA 
during the post treatment and long-term follow-up portion of the study.  PET-CTs will continue 
through Month 9 or until change in lymphoma therapy or disease progression, whichever comes 
first.  If subject’s disease has not progressed by Month 9, disease assessments can be evaluated 
per CT scans where a CR is suspected and per PET-CTs where a PR is suspected.  Subjects with 
symptoms suggestive of disease progression should be evaluated for progression at the time 
symptoms occur even if it is off schedule as per the SOA. PET-CT can be performed at any time 
disease progression is suspected.  FDG-PET assessment takes precedence over CT assessment 
for time points when both are available.  If only CT is available for a time point, assessment 
should include and may be affected by the PET-CT assessment at the prior time point.  Please 
refer to the imaging manual for further details.

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In addition to the investigator’s assessment, PET-CT scans of all subjects evaluated for disease 
response will be submitted to and reviewed by an independent central reviewer blinded to 
treatment arm.  For subjects who discontinue protocol therapy due to an assessment of 
progressive disease but for whom there was no change in lymphoma therapy, any additional 
imaging data, subsequent to the image in question, will be submitted to the central reviewer to 
confirm disease response.  Requirements for PET-CT scans and shipping requirements will be 
outlined in the study imaging manual.
If the subject is eligible for retreatment with axicabtagene ciloleucel, the last scan prior to 
retreatment will be considered the baseline for the purpose of evaluating the response to 
retreatment.
7.10.2.
Bone Marrow Biopsy and Aspirate
A subject’s bone marrow involvement should be confirmed by PET-CT or bone marrow biopsy 
and aspirate prior to randomization.  Confirmation of marrow involvement can be determined 
upon initial diagnosis of disease or if negative or unknown at initial diagnosis, at the time of 
relapse from first-line therapy.  If bone marrow involvement was not evaluated at the time of 
relapse and within 28 days of study entry, a PET-CT and/or bone marrow biopsy and aspirate 
will be performed to establish a baseline.
If there is evidence of baseline bone marrow involvement, if PET-CT is not available or if there 
are unexplained cytopenias or suspicion of bone marrow involvement, a bone marrow aspirate 
and biopsy will be performed in subjects who are being assessed for CR in order to confirm 
complete response.  The bone marrow aspirate and biopsy must show no evidence of disease by 
morphology or, if indeterminate by morphology, it must be negative by immunohistochemistry.  
Refer to Appendix B for treatment response assessment requirements per the Lugano 
Classification {Cheson 2014}.
7.11.
Laboratory
The below samples will be collected at the time points indicated in the SOA.  Additional samples 
(eg, blood, urine, CSF, tissue) may be collected as needed during the course of the study for 
further safety testing.
7.11.1.
Local Lab Analysis
•
Sodium (Na), potassium (K), chloride (Cl), bicarbonate (CO2), creatinine, glucose, albumin, 
calcium total, magnesium total (Mg), alkaline phosphatase, ALT/SGPT, AST/SGOT, total 
bilirubin, analyzed per the SOA
•
Baseline LDH at screening from a non-hemolyzed sample to be used for the assessment of 
the sAAIPI
•
CRP at leukapheresis, treatment day 0, treatment days 1-7, and for Grade ≥ 3 CRS, 
neurologic, HLH events.

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• 
Fenitin at leukapheresis, treatment day 0, ti·eatment days 1-7, and for Grade~ 3 CRS, 
neurologic, HLH events. 
• 
CBC with differential analyzed per the SOA 
• 
A urine or sernm sample will be collected and assessed locally for females of childbearing 
potential. If the screening pregnancy test is positive, the subjects should not be emolled. If a 
standard of care pregnancy test is collected during the course of the study, and the result is 
positive, the investigator should contact the Kite Phanna medical monitor for instrnctions. If 
a female paiiner of a male subject becomes pregnant during the conduct of the study, it must 
be repo1ted by contacting Kite Phaima medical monitor for instructions. 
• 
Serology Testing: For European Union (EU) sites, viral serologic tests (eg, HIV, Hep B, Hep 
C) will be caiTied out per institution guidelines and EU regulations. This may be done within 
the 30 days prior to leukapheresis and/or on the day of leukapheresis. 
7.11.2. 
Central Lab Analysis 
• 
Blood draws for levels of anti-CD19 CART cells by quantitative polymerase chain reaction 
( qPCR) analysis and monitoring of lymphocytes subsets, including return of n01mal B cells, 
will be perfo1med at intervals outlined in the SOA. 
• 
Blood draws for replication-competent reti·ovirns (RCR), ti·eatment-related antibody 
development, and cytokines will be perfonned at intervals outlined in the SOA or as 
clinically indicated. 
• 
Archived tumor samples will be submitted to central laborato1y for evaluation of CD 19 
expression and prognostic variables. Either fo1malin-fixed paraffin-embedded (FFPE) tumor 
block or 30 unstained slides are required. Should an archived tumor sample not be available, 
a fresh tumor sainple is required prior to initiation of chemotherapy to continue on study. 
Slides that have been previously stained with antibodies or other reagents ai·e not acceptable. 
• 
Additional analysis may include CD19 ex ression 
• 
• 
lysis of 
tumor-s ecific DNA alterations. 
7.11.2.1. 
Product Characteristics 
Sainples of apheresis material or final product will be retained and tested by the sponsor or 
specialty laborato1y for the pmpose of understanding the mechanism of action and safety profile 
of axicabtagene ciloleucel. 
CONFIDENTIAL 
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Axicabtagene ciloleucel; KTE-C19
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Clinical Protocol: KTE-C19-107 (ZUMA-7)
Amendment 6
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14 April 2023
7.11.2.2.
RCR Testing
Axicabtagene ciloleucel comprises T cells transduced with a γ-retroviral vector; hence, there is a 
theoretical risk for RCR developing in exposed subjects.  Additional information is provided in 
the Investigator’s Brochure. The timing of blood draws for determination of the presence of RCR 
is specified in the SOA or may be done or as clinically indicated.
RCR testing will occur at baseline, study Day 150 and Month 12. Thereafter, samples will be 
collected yearly until transition to the LTFU study and held for up to 15 years.  If a subject tests 
positive for RCR at any time point within the first year, samples will continue to be collected and 
tested yearly for up to 15 years or as clinically indicated.
7.12.
Patient Reported Outcomes
All PROs described below will be completed by the subject before any procedures are 
performed, excluding blood draws, and at the time points noted in the SOA.
The sponsor will provide training for relevant personnel (eg, key investigators) for the 
administration of the questionnaires so that subjects fill in the questionnaires as completely and 
accurately as possible.  It is important that the significance and relevance of the data are 
explained carefully to participating subjects so that they are motivated to comply with data 
collection {Fallowfield 1987}.  The measures are self-reported, and the subject must complete 
the questionnaires in private and should not be given help from relatives or clinic staff; help in 
interpreting the questions is not allowed.
Below is a description of each patient reported outcome, which are expected from all subjects 
who remain on-study at the scheduled assessments.  All PRO measures will be scored using their 
published administration and scoring manual.  For items with missing responses, the response 
will be managed as per the scoring manual.
7.12.1.
European Organisation for Research and Treatment of Cancer (EORTC) 
QLQ-C30 Version 3.0.
This measure provides a multi-dimensional assessment of health-related quality of life (HRQoL).  
The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life 
Questionnaire Cancer (QLQ-C30 version 3.0 includes the following content:
•
Five (5) multi-item functional scales (physical functioning, role functioning, emotional 
functioning, cognitive functioning, social functioning)
•
Three (3) multi-item symptom scales (fatigue, nausea and vomiting, pain)
•
Six (6) symptom single-item scales (dyspnea, insomnia, appetite loss, constipation, diarrhea, 
financial difficulties)
•
One (1) Global Health Status scale and
•
One (1) Global HRQoL scale

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Each scale is measured from 0 to 100 after a linear transformation.  Higher scores for functioning 
scales and for the Global Health Status or Global HRQoL scales indicate a higher level of 
functioning and a better HRQoL respectively, whereas higher scores in symptom scales represent 
a higher level of symptoms.
This instrument does not sum together all items that can potentially group differences and allows 
an assessment of change across the 15 different domains.  In its current version (version 3), the 
questionnaire takes approximately 11 minutes to complete.
7.12.2.
EuroQol Five Dimensions Questionnaire (EQ-5D-5L)
The Euro-QOL, Five Dimensions, Five Levels (EQ-5D-5L) questionnaire is a generic measure of 
health status that provides a simple descriptive profile and a single index value.  The EQ-5D-5L 
comprises 2 components:  a questionnaire covering 5 dimensions and a tariff of values based 
upon direct valuations of health states using a visual analog scale (VAS).
The EQ-5D-5L VAS is a 20-cm VAS for recording self-rated current HRQoL state and is used to 
describe the subjects’ health status on the day of the assessment.  The EQ-5D-5L VAS score is 
recorded by each subject for his or her current HRQoL state and scored 0 (“the worst health you 
can imagine”) to 100 (“the best health you can imagine”).
This questionnaire takes approximately 5 minutes to complete.
7.12.3.
Work Productivity and Activity Impairment Questionnaire (WPAI)
The Work Productivity and Activity Impairment Questionnaire (General Health V2.0 
[WPAI:GH]; see Appendix C) measures work and activity impairment during the past 7 days.  It 
contains 2 domains:  work and activity.
•
The work domain includes 5 items that ask the subject about how many hours of work were 
missed due to health problems, how many hours of work missed due to other reasons, how 
many hours the subject worked, and how health problems may have affected productivity.
•
The activity domain contains a single item that asks the subject how health problems affected 
his or her ability to do regular activities outside of their work.
The WPAI yields 4 types of scores: absenteeism, presenteeism, work productivity loss, and 
activity impairment.  WPAI outcomes are expressed as impairment percentages, with higher 
numbers indicating greater impairment and less productivity.
This questionnaire takes approximately 2 to 3 minutes to complete.

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7.13. 
Biomarkers 
Biomarker analysis will be perfo1med on product, blood, and tumor samples to evaluate 
predictive, phannacokinetic (PK), and phaimacodynamic markers for axicabtagene ciloleucel. 
A FFPE tumor block or 30 unstained slides ai·e required. Should an ai·chived tumor sample not 
be available, a fresh tumor sample is required prior to staii of chemotherapy to continue on 
study. Slides that have been previously stained with antibodies or other reagents are not 
acceptable. 
Tumor tissue analysis will include evaluation of CD 19 expression by immunohistochemistiy 
(IHC), gene expression profiling for cell of origin analysis, and centi·al anal sis of DNA 
alterations for sub-classification of DLBCL double- and ti-i le-hit status. 
Additional clinical specimens may be obtained as needed to assess safety in subjects or if novel 
findings are observed in this study. 
For subjects randomized to the axicabtagene ciloleucel aim: 
• 
Blood draws for levels of anti-CD 19 CAR T cells in blood 
• 
Blood draws for evaluation of sennn cytokines and chemokines. The following cytokines 
may be included in the panel: homeostatic, pro-inflammato1y and immune modulating 
cytokines IL-2, IL-6, IL-10, IL-12p40/p70, IL-15, IL-17a, tumor necrosis factor (TNF)-a, 
IFN-y, GM-CSF, and CRP, HLH related markers fen itin and IL-2Ra and chemokines 
MIP-la, MIP-1~, and IL-8. 
• 
CSF, and additional subject samples (eg, pleural fluid), will be obtained from subjects who 
develop Grade 2 neurologic events to enable evaluation of inflainmato1y cytokine and 
chemokine levels and also presence of anti-CD 19 CAR T cells. As applicable, lymphocyte 
populations residing in the CSF, or other subject samples, may also be monitored for the 
purpose of understanding the safety profile of axicabtagene ciloleucel. 
• 
Blood draws for RCR analysis (see Section 7.11.2.2). 
• 
A baseline sernm sample and additional sennn samples outlined in the SOA may be analyzed 
for development of antibodies if a ti·eatment-related hypersensitivity reaction is observed. 
• 
Baseline leuka heresis and final axicabtagene ciloleucel sam les will be collected and 
CONFIDENTIAL 
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14 April 2023 

Axicabtagene ciloleucel; KTE-C19 
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Clinical Protocol: KTE-Cl9-107 (ZUMA-7) 
Amendment6 
Each subject will have the right to have the sample material destroyed at any time 
by contacting the investigator who, in tum, can contact the centrnl laborato1y . The investigator 
should provide the sponsor with the study and subject number so that the sample can be located 
and destroyed. 
For subjects who withdraw consent, any samples that were not requested to be returned or 
destroyed will remain with the sponsor, and any data that may be generated will be entered in the 
study database. 
7.14. 
Post-treatment Follow-up 
After completing study treatment, all subjects will return to the clinic for post-treatment follow-
up visits. 
For subjects randomized to the axicabtagene ciloleucel aim of the study, if at any time during the 
post-treatment assessment period a subject did not respond to treatment, the subject will continue 
to undergo follow-up procedures and then be followed for survival and disease outcomes in the 
long-te1m follow-up po1tion of the study. 
Subjects randomized to the SOC aim and who respond to SOC therapy after 2 or 3 cycles 
( defined as achieving a PR or CR) should proceed to HDT and ASCT per institutional or national 
guidelines as outlined in Section 6.3.1.1. Subjects who are alive and do not have documented 
disease progression will continue to be followed for disease progression. 
Refer to the SOAs for a listing of study procedures and disease assessments to be completed 
during the post-treatment follow-up period. 
CONFIDENTIAL 
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14 April 2023 

Axicabtagene ciloleucel; KTE-C19
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Clinical Protocol: KTE-C19-107 (ZUMA-7)
Amendment 6
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14 April 2023
Table 2.
Schedule of Assessments Axicabtagene Ciloleucel Arm
Procedures
Screening
Leukapheresis
Conditioning 
Chemotherapy
IP Administration
Post Treatment Follow-up
All Post Treatment visits are calculated 
from date of  randomization
Day
Within 14 days 
of 
randomization
Randomization
Within approx. 
5 days after 
randomization
d-5
d-4
d-3
d-2
d-1
Treatment
d0
d1 – 7m
Day 50
(-7 to +21 days)
Day 100
(± 14 days)
Day 150
(± 14 days)
Medical history 
X
Physical exama
X
X
X
X
Neurological assessment
X
Xb
QODb
X
Weight (plus height at 
screening)
X
X 
Vital signs (BP, HR, RR, O2 
sat, temp)
X
X
X
X
X
ECOG performance status
X
ECG
X
ECHOc
X
PET-CT disease assessmentd
PET-CTd
PET-CT
PET-CT
PET-CT
Archived tumor samplee
Xe
Pregnancy test (serum or 
urine)
X
X
Blood draw for chemistry 
panel
X
X
X
X
X
X
X
X
Blood draw for CBC 
w/differential
X
X
X
X
X
X
X
X
Blood draw for anti-
axicabtagene ciloleucel 
antibodiesf
X
Xf
Blood draw for LDH
X
IXRS/Randomization call
X
Lumbar Punctureg
Xg
Blood draw for CRP/Ferritin
X
X
X

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Procedures
Screening
Leukapheresis
Conditioning 
Chemotherapy
IP Administration
Post Treatment Follow-up
All Post Treatment visits are calculated 
from date of  randomization
Day
Within 14 days 
of 
randomization
Randomization
Within approx. 
5 days after 
randomization
d-5
d-4
d-3
d-2
d-1
Treatment
d0
d1 – 7m
Day 50
(-7 to +21 days)
Day 100
(± 14 days)
Day 150
(± 14 days)
Blood draw for PBMCs and 
additional analysish
X
d1, 3 & 
7h 
Xh
Xh
Xh
Blood draw for cytokinesh
X
X
d1, 3 & 
7h  
Xh 
Xh
Blood draw for serology (EU 
sites)l
Xl
Xl
EORTC QLQ-C30i
X
X
X
X
X 
X
EQ-5D-5Li
X
X
X
X
X 
X
WPAIi
X
X
X
X
X 
X
Leukapheresis 
X
Fludarabine/Cyclophosphamid
e
X
X
X
Axicabtagene ciloleucel 
infusion IV
X
Adverse eventsj/ Concomitant 
medicationk 
X
X
X
X
X
X
X
X
X
X
X
 X
Abbreviations:  D, day; IP, investigational product; BP, blood pressure; HR, heart rate; ECOG, Eastern Cooperative Oncology Group; ECG, electrocardiogram; ECHO, 
echocardiogram; PET-CT, positron emission tomography computer tomography; CBC, complete blood count; LDH, lactate dehydrogenase; IXRS, Interactive Voice/Web (X) 
Response System; CRP, C-reactive protein; PBMC, peripheral blood mononuclear cell; EORTC QLQ-C30, European Organisation for Research and Treatment of Cancer Quality 
of Life Questionnaire Cancer-30; EQ-5D-5L,Euro-QOL, Five Dimensions, Five Levels; WPAI, Work productivity and activity impairment questionnaire.
a
Physical Exam: Subjects with new-onset symptoms related to CRS should undergo physical examination at least daily until symptoms resolve to baseline.  Subjects with 
symptoms of central nervous system malignancy such as new onset severe headaches, neck stiffness, seizures, encephalopathy, cranial nerve deficits, or any focal neurologic 
findings on physical exam will have a brain MRI and lumbar puncture for examination of cerebral spinal fluid.
b
Neurologic assessment: A neurological assessment should be done prior to axicabtagene ciloleucel infusion on treatment day 0, then on treatment day 1 and every other day 
during the minimum 7-day observation period.  For new onset of neurologic symptoms, neurologic assessment should be performed at least daily until symptoms resolve to 
baseline.
c
Echo: Performed following the subjects last chemotherapy treatment and within 28 days prior to signing the consent may be used for confirmation of eligibility
d
PET-CT disease assessment:  PET-CT should be performed as close to randomization as possible and within 28 days prior to randomization. If bone marrow involvement was 
not evaluated at the time of relapse and within 28 days of study entry, a PET-CT or a bone marrow biopsy will be performed to establish a baseline. PET-CT shall be 
performed at any time disease progression is suspected. If there is evidence of baseline bone marrow involvement, if PET-CT is not available or if there are unexplained 
cytopenias or suspicion of bone marrow involvement, a bone marrow aspirate and biopsy will be performed in subjects who are being assessed for CR in order to confirm 
complete response.

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e
Archived tumor sample:  Archived tumor samples will be submitted to central laboratory for evaluation of CD19 expression and prognostic variables. Either FFPE tumor 
block or 30 unstained slides are required.  Should an archived tumor sample not be available, a fresh tumor sample is required prior to start of chemotherapy to continue on 
study. Slides that have been previously stained with antibodies or other reagents are not acceptable.  Screen failed subjects’ archived samples should not be submitted.
f
Blood draw for anti-axicabtagene ciloleucel antibodies: Baseline antibody samples to be collected prior to start of leukapheresis.  If positive at baseline or Day 50 additional 
samples will be collected every 3 months until titers return to baseline or up to 12 months post axicabtagene ciloleucel infusion.
g
Lumbar Puncture:  Subjects with new onset Grade ≥ 2 neurologic symptoms post axicabtagene ciloleucel infusion will have lumbar puncture performed to assess cerebral 
spinal fluid.
h
Blood draws for PBMCs, cytokines, and additional analysis per Section 7.11.2: PBMC blood will be used for the analysis of tests that include anti-CD19 CAR T cells, 
lymphocytes, and RCR, and will be collected at baseline (prior to initiation of conditioning chemotherapy), day 1, 3, 7 and study Days 50, 100, and 150.  Blood draws for 
cytokines will be collected at baseline (prior to initiation of conditioning chemotherapy), treatment day 0, 1, 3, 7, and study Days 50 and 150.  Blood draws for RCR will be 
collected at baseline, study Day 150, and then per LTFU SOA.  If, following the minimum 7-day observation period, the subject is admitted to the hospital with any 
axicabtagene ciloleucel related adverse events, blood samples for anti-CD19 CAR T cells and cytokines will be collected on day of admission, then weekly, and on day of 
discharge. If the subject experiences a Grade ≥3 axicabtagene ciloleucel-related toxicity such as Grade 3 CRS or neurologic event, one additional blood draw for cytokines 
will be taken at the time of the Grade ≥3 axicabtagene ciloleucel-related toxicity and upon resolution of the event.  Blood and serum samples may also be used for further 
anti-CD19 CAR T cell, RCR and immunogenicity evaluation as clinically indicated.
i
EORTC QLQ-C30/EQ-5D-5L/WPAI: To be completed by the subject before any procedures are performed-excluding blood draws.
j
Adverse Events: The investigator is responsible for reporting all adverse events observed by the investigator or reported by the subject that occur after randomization through 
the Day 150 post-randomization visit or until the initiation of new lymphoma therapy, whichever occurs first.
k
Concomitant medications should be recorded from the date of the informed consent through the Day 150 post-randomization visit, and targeted concomitant therapies from 
this visit until Month 12, or until a change in lymphoma therapy, or disease progression whichever occurs first.
l
For European Union (EU) sites, viral serologic tests (eg, HIV, Hep B, Hep C) will be carried out per institution guidelines and EU regulations. This may be done within the 
30 days prior to leukapheresis and/or on the day of leukapheresis.
m
Subjects will be monitored daily through day 7 after treatment with axicabtagene ciloleucel unless otherwise required by country regulatory agencies (refer to Appendix D). 
All assessments described in this table for day 1-7, are applicable between days 7 and 10 if required by country regulatory agencies.

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Table 3.
Schedule of Assessments SOC Chemotherapy Arm
Post Treatment visits are calculated 
from date of randomization
Procedures
Screening
Treatment Period
Cycle 1 and Cycle 2
Disease Assessment
calculated from date 
of randomization
Treatment Period
HDT-ASCT or 
Cycle 3–HDT-
ASCT (optional)
Post HDT-ASCT
Post Tx FU
Day
Within 14 
days of 
randomization
Randomization
Cycle 1
Within 
approx. 5 days 
after 
randomization Cycle 2
Day 50
(-7 to +21 days)
HDT-ASCT or 
Cycle 3-HDT-
ASCT
D100
(± 14 days)
Day 150
(± 14 days)
Medical history
X
Physical exama
X
X
X
X
Neurological assessment
X
X
Weight (plus height at screening)
X
Vital signs (BP, HR, RR, O2 sat, 
temp)
X
X
X
X
ECOG performance status
X
ECG
X
ECHOb
X
PET-CT disease assessmentc
PET-CTc
PET-CT
PET-CT
PET-CT
Archived tumor sampled
X
Pregnancy test (serum or urine)
X
X
Blood draw for chemistry panel
X
X
X
X
X
X
X
Blood draw for CBC w/differential
X
X
X
X
X
X
X
Blood draw for LDH
X
Blood draw for additional analysisj
X
X
X
X
IXRS / Randomization call
X
EORTC QLQ-C30e
X
X
X
day of transplant
X
X
EQ-5D-5Le
X
X
X
day of transplant
X
X
WPAIe
X
X
X
day of transplant
X
X 
SOC chemotherapyf
X
X
X (Cycle 3 is 
optional)

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Post Treatment visits are calculated 
from date of randomization
Procedures
Screening
Treatment Period
Cycle 1 and Cycle 2
Disease Assessment
calculated from date 
of randomization
Treatment Period
HDT-ASCT or 
Cycle 3–HDT-
ASCT (optional)
Post HDT-ASCT
Post Tx FU
Day
Within 14 
days of 
randomization
Randomization
Cycle 1
Within 
approx. 5 days 
after 
randomization Cycle 2
Day 50
(-7 to +21 days)
HDT-ASCT or 
Cycle 3-HDT-
ASCT
D100
(± 14 days)
Day 150
(± 14 days)
Leukapheresisg
Xg
HDTg
Xg
CD34+ stem cell infusiong
Xg
Adverse eventsh/ Concomitant 
medicationi
X
X
X
X
X
X
X
Abbreviations:  HDT, high-dose therapy; ASCT, autologous stem cell transplant; Tx, treatment; FU, follow-up; BP, blood pressure; HR, heart rate; ECOG, Eastern Cooperative 
Oncology Group; ECG, electrocardiogram; ECHO, echocardiogram; PET-CT, positron emission tomography computer tomography; CBC, complete blood count; LDH, lactate 
dehydrogenase; IXRS, Interactive Voice/Web (X) Response System; EORTC QLQ-C30, European Organisation for Research and Treatment of Cancer Quality of Life 
Questionnaire Cancer-30; EQ-5D-5L,Euro-QOL, Five Dimensions, Five Levels; WPAI, Work productivity and activity impairment questionnaire; SOC, standard of care.
a
Physical Exam: Subjects with symptoms of central nervous system malignancy such as new onset severe headaches, neck stiffness, seizures, encephalopathy, cranial nerve 
deficits, or any focal neurologic findings on physical exam will have lumbar puncture for examination of cerebral spinal fluid.
b
Echo: Performed following the subjects last chemotherapy treatment and within 28 days prior to signing the consent may be used for confirmation of eligibility.
c
PET- CT disease assessment:  PET-CT should be performed as close to randomization as possible and within 28 days prior to randomization. If bone marrow involvement 
was not evaluated at the time of relapse and within 28 days of study entry, a PET-CT or a bone marrow biopsy will be performed to establish a baseline. PET-CT should be 
performed at any time disease progression is suspected. If there is evidence of baseline bone marrow involvement, if PET-CT is not available or if there are unexplained 
cytopenias or suspicion of bone marrow involvement, a bone marrow aspirate and biopsy will be performed in subjects who are being assessed for CR in order to confirm 
complete response.
d
 Archived tumor sample:  Archived tumor samples will be submitted to central laboratory for prognostic variables. Either FFPE tumor block or 30 unstained slides are 
required.  Should an archived tumor sample not be available, a fresh tumor sample is required prior to the start of second-line combination chemotherapy regimen to continue 
on study. Slides that have been previously stained with antibodies or other reagents will not be acceptable for study entrance. Screen failed subjects’ archived samples should 
not be submitted.
e
EORTC QLQ-C30/EQ-5D-5L/WPAI: To be completed by the subject before any procedures are performed-excluding blood draws.
f
SOC Dosing and Administration Refer to Section 6.3.1 for investigator choice of SOC regimens and dosing details.  If adequate disease response (CR or PR) is demonstrated 
after the second or third cycle of chemotherapy, HDT-ASCT may be initiated.
g
Leukapheresis, HDT, and CD34+ stem cell infusion procedures performed for subjects undergoing HDT-ASCT only.  This occurs if adequate disease response (CR or PR) is 
demonstrated after two or three cycles of chemotherapy.
h
Adverse Events: The investigator is responsible for reporting all adverse events observed by the investigator or reported by the subject that occur after randomization through 
the Day 150 post-randomization visit or until the initiation of new lymphoma therapy, whichever occurs first.
i
Concomitant medications will only be recorded from the date of the informed consent through 30 days after the last study specific procedure.
j
Blood draws for additional analyses per Section 7.11.2.

Axicabtagene ciloleucel; KTE-C19
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Clinical Protocol: KTE-C19-107 (ZUMA-7)
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7.15.
Long-term Follow-up (Axicabtagene Ciloleucel and Standard of Care Arms)
All subjects will be followed in the long-term follow-up period for disease assessments and 
survival status per the SOA (Table 4) until the transition to the separate LTFU study. Subjects 
will begin the long-term follow-up period beginning at the Month 9 visit and will be assessed as 
follows:
•
Every 3 months (± 28 days) through Month 24
•
Every 6 months (± 28 days) between Month 24 and Month 60
SOC Arm Only:
•
All subjects in the SOC arm will discontinue participation in the study after completion of 
the Month 60 visit and assessments.
Axicabtagene Ciloleucel Arm Only:
•
After Month 60, all subjects who received at least one dose of axicabtagene ciloleucel as 
protocol therapy will return to the clinic once annually for up to 15 years.
•
All subjects who received at least one dose of axicabtagene ciloleucel as protocol therapy 
will be transitioned to the separate LTFU study after providing signed informed consent for 
the LTFU study and after completing at least 60 months of assessments in the parent study, 
KTE-C19-107. Until this time point, subjects will complete the post-treatment follow up 
period as per the SOA (Table 4).
•
In the LTFU study, subjects will continue assessments at timepoints contiguous with the 
long-term follow up period time points in this study.
SOC and Axicabtagene Ciloleucel Arms:
Subjects who did not respond to treatment may receive off protocol therapy but will continue to 
be followed for disease assessments (if progression was not documented), subsequent anticancer 
therapy, and survival.
Subjects may also be contacted by telephone to confirm survival status and subsequent new 
lymphoma therapy use.  Should a subject require lab collection, labs may be collected at the 
clinic or at an outside facility to reduce the subject burden.
If a subject fails to return to the clinic for a scheduled protocol specific visit, sites will need to 
make 2 attempts by a combination of telephone and mail/email to contact the subject.  Sites must 
document both attempts to contact the subject.  If a subject does not respond within 1 month after 
the second contact, the subject will be considered lost to follow-up, and no additional contact 
will be required.

Axicabtagene ciloleucel; KTE-C19
Kite Pharma, Inc.
Clinical Protocol: KTE-C19-107 (ZUMA-7)
Amendment 6
CONFIDENTIAL
Page 62
14 April  2023
Subjects who are unable or unwilling to return to the study site may have follow up data for this 
period obtained from clinical, laboratory, and/or diagnostic assessments conducted by the 
referring healthcare provider (HCP) and/or general practitioner (GP). In addition, other health 
status information may be obtained from the subject and/or the subject’s referring HCP and/or 
GP via telephone or email communication. This information will be used to detect late-onset 
targeted SAEs that may be related to study therapy.
Subjects and/or the subject’s referring HCPs and/or GPs may be contacted directly by telephone 
or email to confirm survival status and obtain information about targeted concomitant medication 
use, subsequent anticancer therapy use, and late-onset targeted SAEs (if the SAE does not 
require a test to be performed in the clinic).
Refer to the SOA (Table 4) for a listing of study procedures and disease assessments to be 
completed during the long-term follow-up period.
Subjects who are enrolled/randomized but did not receive investigational product, or received 
therapy but didn’t respond to treatment, will be followed in the long-term follow-up period until 
Month 60 (refer to Section 3.5.3) and will undergo the following assessments at the time points 
outlined in the SOA (Table 4):
•
Subsequent therapy for the treatment of NHL
•
Survival status: Subjects and/or the subject’s referring HCPs and/or GPs may be contacted 
directly by telephone or email to assess survival status
•
Disease assessments per protocol
•
AEs/SAEs per Section 9

Axicabtagene ciloleucel; KTE-C19
Kite Pharma, Inc.
Clinical Protocol: KTE-C19-107 (ZUMA-7)
Amendment 6
CONFIDENTIAL
Page 63
14 April  2023
Table 4.
Schedule of Assessments Long-term Follow-up Period
Long-term Follow-up Period 1
Each visit calculated from randomization
(all visits have ± 28 day window)
Long-term Follow-up 
Period 2
Each visit calculated 
from randomization
(all visits have 
± 3 month window)
Procedure 
Axicabtagene Ciloleucel Arm and Standard of Care Arm
Axicabtagene 
Ciloleucel Arm Only
Visit frequency
Month
9
Month
12
Month
15
Month
18
Month
21
Month
24
Month
30
Month
36
Month
42
Month
48
Month
54
Month
60
Month 72 and 
Annually Thereafter 
to 15 Years*
Physical exama
X
X
X
X
X
X
 
 
 
 
 
 
 
PET-CT scan/CT 
Scan disease 
assessmentb
PET-
CT
PET-
CT/CTb
PET-
CT/CTb
PET-
CT/CTb
PET-
CT/CTb
PET-
CT/CTb
PET-
CT/CTb
PET-
CT/CTb
PET-
CT/CTb
PET-
CT/CTb
PET-
CT/CTb
PET-
CT/CTb
Xb 
Survival statusc
X
X
X
X
X
X
X
X
X
X
X
X
Xc
CBC 
w/differentiald
X
X
X
X
X
X
 
 
 
 
 
 
 
Blood draw for 
PBMCs and 
additional analysise
X
X
 
X
 
X
 
X
 
X
 
X
 Xe
Targeted SAEsf
X
X
X
X
X
X
X
X
X
X
X
X
Xf
Subsequent 
therapy for NHLg
X
X
X
X
X
X
X
X
X
X
X
X
Xg
PROsh
X
X
X
X
X
X
 
 
 
 
 
 
 
Abbreviations:  PBMC, peripheral blood mononuclear cell; PET-CT, positron emission tomography computer tomography; CT, computed tomography; CBC, complete blood  
count; SAE, serious adverse event; NHL, non-Hodgkin lymphoma; PRO, patient reported outcome.
*After completing at least 60 months of assessments in this study, all subjects who received at least one dose of axicabtagene ciloleucel as protocol therapy will be transitioned to a 
separate LTFU study, after providing informed consent, to complete the remainder of the 15-year follow-up period.
a
Physical exams will continue through the first 24 months
b
PET-CT will continue through Month 9 or until disease progression, whichever comes first. If subject’s disease has not progressed by Month 9, disease assessments will be 
evaluated per CT scans where a CR is suspected and per PET-CTs where a PR is suspected. PET-CT should be performed at any time disease progression is suspected. If 
subject’s disease has not progressed by Month 60, the status of the subject’s primary malignant disease will be monitored per local standard of care. The subject’s disease 
status does not need to be assessed at the investigative site. Records from the referring HCP and/or GP may be obtained for subjects who are unable or unwilling to return to 
the investigative sites.
c
Survival status: Subjects and/or the subject’s referring HCPs and/or GPs may be contacted directly by telephone or email to assess survival status.

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Clinical Protocol: KTE-C19-107 (ZUMA-7)
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d
CBC w/differential: Subjects will continue to provide samples for CBC w/diffs and lymphocyte subsets through Month 24.
e
Blood draws for analysis, such as RCR (for subjects randomized into the axicabtagene ciloleucel arm), PBMCs, and additional analysis per Section 7.11.2 and the timepoints 
specified in the laboratory manual. Samples for RCR will continue to be collected yearly until transition to the LTFU study and tested as clinically indicated.
f
Targeted SAEs are defined as and include neurological, hematological, infections, autoimmune disorders, and secondary malignancies and should be reported for up to 5 or 
15 years for SOC or axicabtagene ciloleucel arms, respectively, or until disease progression, whichever occurs first. After Month 60 targeted SAEs will be reported through 
15 years or until disease progression and/or start of subsequent anticancer therapy, whichever occurs first. These events will be identified from routine safety assessments (ie, 
physical examination and laboratory assessments) performed as standard of care (not required to be performed at the study site).
g
Subsequent therapy will be collected for all enrolled subjects until the end of the subject’s participation in this study or, while still a participant in this study, the subject is 
considered lost to follow-up, withdraws consent, or dies. Subjects and/or the subject’s referring HCPs and/or GPs may be contacted directly by telephone or email to collect 
information about subsequent therapy.Refer to Sections 6.2.6 and 6.3.4 for more details.
h
PROs include the following assessments: EORTC QLQ-C30, EQ-5D-5L, & WPAI

Axicabtagene ciloleucel; KTE-C19
Kite Pharma, Inc.
Clinical Protocol: KTE-C19-107 (ZUMA-7)
Amendment 6
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14 April 2023 
8.
SUBJECT WITHDRAWAL
Subjects have the right to withdraw from the study at any time and for any reason without 
prejudice to their future medical care by the physician or at the institution.
Subjects can decline to continue to receive study required treatment and/or other protocol 
required procedures at any time during the study but continue to participate in certain follow-up 
elements of the study.  This is referred to as partial withdrawal of consent.
If partial withdrawal of consent occurs, the investigator must discuss with the subject the 
appropriate process for discontinuation from investigational product, study treatment, or other 
protocol-required therapies and must discuss options for continued participation, completion of 
procedures, and the associated data collection as outlined in the SOA including the following:
•
Survival status, including the cause of death
•
Safety reporting, including new malignancies; SAEs related to axicabtagene ciloleucel and 
targeted SAEs including, but not limited to, neurologic events, infections, blood disorders, or 
immune disorders; and pregnancies
•
Targeted concomitant medications as per the SOA and Section 6.2.4.9
•
Subsequent therapies
•
Central laboratory samples (per the SOA)
The level of follow-up and method of communication should also be discussed between the 
research staff and the subject and documented in the source documents.
Withdrawal of full consent from a study means that the subject does not wish to receive further 
protocol required therapy or undergo procedures and the subject does not wish to continue 
further study follow-up.  Subject data collected up to withdrawal of consent will be retained and 
included in the analysis of the study, and, where permitted by local regulations, publicly 
available data (death records) can be included after withdrawal of consent.  The investigator is to 
discuss with the subject appropriate procedures for withdrawal from the study.
As part of the study sites may be asked to conduct searches of public records, such as those 
establishing survival status, if available, to obtain survival data for any subject for whom the 
survival status is not known, per the applicable local laws.  Sites may be also asked to also 
retrieve autopsy reports to confirm the status of disease at the time of death, if possible, per the 
applicable local laws.
The investigator and/or sponsor can also decide to withdraw a subject from the investigational 
product and/or other protocol-required therapies, protocol procedures, or the study as a whole or 
at any time prior to study completion.

Axicabtagene ciloleucel; KTE-C19
Kite Pharma, Inc.
Clinical Protocol: KTE-C19-107 (ZUMA-7)
Amendment 6
CONFIDENTIAL
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14 April 2023 
8.1.
Reasons for Removal from Treatment
Reasons for removal from protocol required investigational products or procedures include any 
of the following:
•
AE
•
Disease progression
•
Subject request/noncompliance
•
Product not available
•
Lost to follow-up
•
Death
•
Decision by sponsor
8.2.
Reasons for Removal from Study
Reasons for removal of a subject from the study are as follows:
•
Subject withdrawal of consent from further follow-up
•
Investigator decision
•
Lost to follow-up
•
Death
•
Termination of the study by the sponsor
•
Other (eg, noncompliance)

Axicabtagene ciloleucel; KTE-C19
Kite Pharma, Inc.
Clinical Protocol: KTE-C19-107 (ZUMA-7)
Amendment 6
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Page 67
14 April 2023 
9.
SAFETY REPORTING
9.1.
Adverse Events
An AE is defined as any untoward medical occurrence in a clinical trial subject.  The event does 
not necessarily have a relationship with study treatment.  The investigator is responsible for 
ensuring that any AEs observed by the investigator or reported by the subject are recorded in the 
subject’s medical record.
The definition of AEs includes worsening of a pre-existing medical condition.  Worsening 
indicates that the pre-existing medical condition has increased in severity, frequency, and/or 
duration or has an association with a worse outcome. When recording such events, provide 
descriptions that the pre-existing condition has changed (eg, more frequent headaches for a 
subject with pre-existing headaches).  A pre-existing condition that has not worsened during the 
study or involves an intervention, such as elective cosmetic surgery or a medical procedure while 
on study, is not considered an AE.
Interventions for pretreatment conditions (such as elective cosmetic surgery) or medical 
procedures that were planned before study participation are not considered adverse events.  
Hospitalization for study treatment infusions or precautionary measures per institutional policy 
are not considered AEs.
The term “disease progression” as assessed by measurement of malignant lesions on radiographs 
or other methods should not be reported as AEs.  Death due to disease progression in the absence 
of signs and symptoms should be reported with the preferred term “B-cell lymphoma”.
For situations when an AE or SAE is due to the disease under investigation, report the signs and 
symptoms.  Worsening of signs and symptoms of the malignancy under study should also be 
reported as AEs in the appropriate section of the CRF.
The investigator’s clinical judgment is used to determine whether a subject is to be removed 
from treatment due to an AE.  In the event of a subject requests to withdraw from protocol-
required therapies or the study due to an AE, the subject should undergo the procedures outlined 
in the Day 150 post-randomization visit of the SOA.
9.2.
Reporting of Adverse Events
The investigator is responsible for reporting all AEs observed by the investigator or reported by 
the subject that occur after randomization through the Day 150 post-randomization visit or 
change in lymphoma therapy, whichever occurs first.  For subjects who are enrolled but do not 
receive axicabtagene ciloleucel, the AE reporting period ends 30 days after the last procedure 
(eg, leukapheresis, conditioning chemotherapy).
The investigator must provide the information listed below regarding the AEs being reported:
•
AE diagnosis or syndrome (if not known, signs or symptoms)

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Clinical Protocol: KTE-C19-107 (ZUMA-7)
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•
Dates of onset and resolution
•
Severity
•
Assessment of relatedness to investigational product, conditioning chemotherapy, or study 
procedures
•
Action taken
Adverse event grading scale used will be the NCI Common Terminology Criteria for Adverse 
Events (CTCAE) version 4.03.  A copy of the grading scale can be downloaded from the CTEP 
home page (http://ctep.cancer.gov).  CRS events will be reported using the grading scale outlined 
in the Investigator Brochure.
In reviewing adverse events, investigators must assess whether the adverse event is possibly 
related to 1) axicabtagene ciloleucel or SOC chemotherapy, 2) conditioning chemotherapy (for 
subjects enrolled into the axicabtagene ciloleucel arm of the study), 3) any protocol-required 
study procedure or treatment (ie, HDT ASCT), 4) disease progression, 5) concurrent disease, 6) 
concomitant medication, or 7) other.  The relationship is indicated by a yes or no response and 
entered into the CRF.  A yes response should indicate that there is evidence to suggest a causal 
relationship between the study treatment or procedure and the AE.  Additional relevant data with 
respect to describing the AE will be collected in the CRFs.
The investigator is expected to follow reported AEs until stabilization or resolution.  If a subject 
begins a new lymphoma therapy, the AE reporting period for non-SAEs ends at the time the new 
treatment is started.
9.2.1.
Reporting Abnormal Laboratory Findings
The investigator is responsible for reviewing laboratory test results and determining whether an 
abnormal value in an individual study subject represents a clinically significant change from the 
subject’s baseline values.  In general, abnormal laboratory findings without clinical significance 
(based on the investigator's judgment) are not to be recorded as AEs.  However, abnormal 
laboratory findings that result in new or worsening clinical sequelae, require therapy, or 
adjustment in current therapy are considered AEs.  Where applicable, clinical sequelae (not the 
laboratory abnormality) are to be recorded as the AE.
An abnormal laboratory test result must be reported as an adverse event if it is a change from 
baseline and meets any of the following criteria:
•
Associated with clinical symptoms
•
Results in a medical intervention (eg, potassium supplementation for hypokalemia or iron 
replacement therapy for anemia) or a change in concomitant therapy
•
Clinically significant in the investigator’s judgment

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Clinical Protocol: KTE-C19-107 (ZUMA-7)
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9.3.
Definition of Serious Adverse Events
An SAE is defined as an adverse event that meets at least 1 of the following serious criteria:
•
Fatal
•
Life-threatening (places the subject at immediate risk of death)
•
Requires in-patient hospitalization or prolongation of existing hospitalization
•
Results in persistent or significant disability/incapacity
•
Congenital anomaly/birth defect
•
Other medically important serious event
An AE would meet the criterion of “requires hospitalization” if the event necessitated an 
admission to a healthcare facility (eg, overnight stay).
Events that require an escalation of care when the subject is already hospitalized should be 
recorded as an SAE.  Examples of such events include movement from routine care in the 
hospital to the ICU or if that event resulted in a prolongation of the existing planned 
hospitalization.
If an investigator considers an event to be clinically important, but it does not meet any of the 
serious criteria, the event could be classified as an SAE with the criterion of “other medically 
important serious event.”
The terms “severe” and “serious” are not synonymous. Severity refers to the intensity of an AE 
according to NCI CTCAE criteria; the event itself may be of relatively minor medical 
significance and, therefore, may not meet the seriousness criteria. Severity and seriousness need 
to be independently assessed for each AE recorded on the electronic CRF.
9.4.
Reporting of Serious Adverse Events
The investigator is responsible for reporting all SAEs observed by the investigator or reported by 
the subject that occur after signing of the informed consent through the Day 150 post-
randomization visit or until the initiation of new lymphoma therapy, whichever occurs first.  
After the Day 150 post-randomization visit only targeted SAEs will be reported.  Targeted SAEs 
are defined as and include neurological, hematological, infections, autoimmune disorders, and 
secondary malignancies and should be reported for up to 5 or 15 years for SOC or axicabtagene 
ciloleucel arms, respectively, or until disease progression, whichever occurs first.
Serious adverse events, which the investigator assesses as related to axicabtagene ciloleucel, 
should be reported regardless of the time period.

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Clinical Protocol: KTE-C19-107 (ZUMA-7)
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14 April 2023 
For subjects who screen fail or are enrolled but do not receive axicabtagene ciloleucel, the 
reporting period for SAEs ends 30 days after the last procedure (eg, screen procedure, 
leukapheresis, conditioning chemotherapy).
All SAEs must be submitted via email to Safety_FC@gilead.com within 24 hours following the 
investigator’s knowledge of the event. After the electronic SAE system is available, all SAEs 
must be submitted to Kite via the eSAE system within 24 hours of the investigator’s knowledge 
of the event.  If the eSAE system is unavailable (eg, system outage), then the SAE must be 
submitted using the SAE Report Form and emailed to the SAE Reporting 
mailbox: Safety_FC@gilead.com.
After completion of this study and database closure, any relevant information on ongoing SAEs 
must be submitted to Kite within 24 hours after the investigator’s knowledge of the event using 
the portable document format (PDF) version of the paper SAE Report Form and sent via e-mail 
to the SAE Reporting mailbox: Safety_FC@gilead.com.
All SAEs will be reported to the health authorities per local reporting guidelines.
Disease progression of the malignancy is not considered an AE.  However, signs and symptoms 
of disease progression may be recorded as AEs or SAEs and indicated as due to disease 
progression on the eCRF.  If the malignancy has a fatal outcome before Day 150 post-
randomization visit, then the event “B-cell lymphoma” must be recorded as an SAE with the 
outcome fatal.
Death must be reported if it occurs during the SAE reporting period, irrespective of any 
intervening treatment.
Any death occurring after randomization and prior to Day 150 post-randomization visit, 
regardless of attribution to treatment, requires expedited reporting within 24 hours.  Any death 
occurring after the Day 150 post-randomization visit requires expedited reporting within 
24 hours only if it is considered related to treatment.
9.4.1.
Reporting Deaths
Deaths occurring during the protocol-specified AE reporting period that investigators attribute 
solely to progression of underlying lymphoma should be recorded as SAEs and on the AE 
electronic CRF with the preferred term “B-cell lymphoma” and must be reported to the sponsor 
immediately. Death is an outcome and not a distinct event. For deaths not due to the underlying 
malignancy, the event or condition that caused or contributed to the fatal outcome should be 
recorded on the AE form. The term “unexplained death” should be captured if the cause of death 
is not known. However, every effort should be made to capture the established cause of death, 
which may become available later (eg, after autopsy). Deaths occurring during the post-study 
survival follow-up period that are due to underlying cancer should be recorded on the Survival 
Status CRF and the Death Summary Page.

Axicabtagene ciloleucel; KTE-C19
Kite Pharma, Inc.
Clinical Protocol: KTE-C19-107 (ZUMA-7)
Amendment 6
CONFIDENTIAL
Page 71
14 April 2023 
9.5.
Diagnosis Versus Signs and Symptoms
For AEs, a diagnosis (if known) should be recorded on the AE form in lieu of signs and 
symptoms. The exception is for CRS, where both the diagnosis and signs and symptoms should 
be captured on the AE form. Signs and symptoms of the underlying cancer should also be 
recorded. However, the investigator should state that these signs and symptoms are due to the 
underlying disease.
9.6.
Pregnancy and Lactation
There is no relevant clinical experience with axicabtagene ciloleucel in pregnant or lactating 
women, and animal reproductive studies have not been performed.  Women of childbearing 
potential must have a negative pregnancy test prior to enrollment because of the potentially 
dangerous effects of the preparative chemotherapy on the fetus.  Women of childbearing 
potential should be monitored according to local and country-specific regulations. This 
experimental therapy should not be administered to pregnant women or women who are 
breastfeeding. Refer to Appendix E for the definition of childbearing potential.
Female subjects and female partners of male subjects are recommended to use highly effective 
contraception (method must achieve an annual failure rate of < 1%) for at least 6 months after 
completing conditioning chemotherapy or 6 months after axicabtagene ciloleucel dosing, 
whichever is longer.  Male subjects are recommended not to father a child for 6 months after 
completing conditioning chemotherapy or 6 months after axicabtagene ciloleucel dosing, 
whichever is longer. Refer to Appendix E for a complete list of highly effective contraception 
methods.
Any pregnancy or breastfeeding in a female subject enrolled into the study must be reported, 
regardless of the time after axicabtagene ciloleucel infusion or within 6 months after 
conditioning chemotherapy, whichever is longer. If the pregnancy occurs in a female partner of a 
male subject within 6 months after completing conditioning chemotherapy or the administration 
of axicabtagene ciloleucel, whichever is longer, the pregnancy must be reported. All such 
pregnancies must be reported to Kite Patient Safety and Pharmacovigilance using the Pregnancy 
Report Form within 24 hours after becoming aware of the pregnancy. Information regarding the 
pregnancy and/or the outcome will be requested by the sponsor. Pregnancy Report Forms should 
be reported to Kite Patient Safety and Pharmacovigilance at Safety_FC@gilead.com or 
fax: +1 (650) 522-5477.
The pregnancy itself is not considered an AE nor is an induced elective abortion to terminate a 
pregnancy without medical reasons. Any premature termination of pregnancy (eg, a spontaneous 
abortion, an induced therapeutic abortion due to complications or other medical reasons) must be 
reported within 24 hours as an SAE. The underlying medical reason for this procedure should be 
recorded as the AE term. Any SAE occurring as an adverse pregnancy outcome after the study 
has been completed must be reported to Kite Patient Safety and Pharmacovigilance.

Axicabtagene ciloleucel; KTE-C19
Kite Pharma, Inc.
Clinical Protocol: KTE-C19-107 (ZUMA-7)
Amendment 6
CONFIDENTIAL
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14 April 2023 
The pregnant subject or subject partner should receive appropriate monitoring and care until the 
conclusion of the pregnancy. The outcome should be reported to Kite Patient Safety and 
Pharmacovigilance using the Pregnancy Outcome Report Form. If the end of the pregnancy 
occurs after the study has been completed, the outcome should be reported directly to Kite 
Patient Safety and Pharmacovigilance.
Pregnancies of female partners of male study subjects exposed to axicabtagene ciloleucel or 
other study drugs must also be reported and relevant information should be submitted to Kite 
Patient Safety and Pharmacovigilance using the pregnancy and pregnancy outcome forms within 
24 hours. If the end of the pregnancy occurs after the study has been completed, the outcome 
should be reported directly to Kite Patient Safety and Pharmacovigilance.
If a lactation case occurs in a female subject in the study, the lactation case must be reported to 
Kite Patient Safety and Pharmacovigilance within 24 hours after the investigator’s awareness of 
the event using the Special Situations Reporting Form. In addition to reporting a lactation case 
during the study, investigators should monitor for pregnancy and lactation cases throughout the 
long-term follow-up period. Report the lactation case and Special Situations Reporting Forms to 
Kite Patient Safety and Pharmacovigilance at Safety_FC@gilead.com or fax: +1 (650) 522-5477.
9.7.
Hospitalization and Prolonged Hospitalization
Any AE that results in hospitalization or prolonged hospitalization should be documented and 
reported as an SAE, as described in Section 9.4.
The following hospitalization scenarios are not considered to be SAEs:
•
Hospitalization for palliative care or hospice care
•
Planned hospitalization required by the protocol (eg, for monitoring the subject or to perform 
an efficacy measurement for the study)
•
Planned hospitalization for a pre-existing condition
•
Hospitalization due to progression of the underlying cancer
9.8.
Abnormal Vital Sign Values
Not all vital sign abnormalities qualify as an AE. A vital sign result must be reported as an AE if 
it is a change from baseline and meets any of the following criteria:
•
Accompanied by clinical symptoms
•
Results in a medical intervention or a change in concomitant therapy
•
Clinically significant in the investigator’s judgment

Axicabtagene ciloleucel; KTE-C19
Kite Pharma, Inc.
Clinical Protocol: KTE-C19-107 (ZUMA-7)
Amendment 6
CONFIDENTIAL
Page 73
14 April 2023 
It is the investigator’s responsibility to review all vital sign findings. Medical and scientific 
judgment should be exercised when deciding whether an isolated vital sign abnormality should 
be classified as an AE. However, if a clinically significant vital sign abnormality is a sign of a 
disease or syndrome (eg, high blood pressure), only the diagnosis (ie, hypertension) should be 
recorded on the CRF.
9.9.
Data Safety Monitoring Board
An independent DSMB will meet every 6 months after the first subject is randomized to review 
safety data and will review safety and efficacy data at the time of the planned interim futility 
analysis.  The DSMB will be chartered to make trial conduct recommendations based on an 
analysis of risk versus benefit.  The DSMB may meet more often as needed.
The DSMB will also review SAE information and suspected unexpected serious adverse 
reactions (SUSARs) on a regular basis throughout subject treatment in the study.  The DSMB 
may request additional safety or efficacy data or recommend modifying the study conduct.  The 
sponsor may request additional reviews by the DSMB.  Data submitted to the DSMB may be 
monitored or unmonitored to facilitate timely DSMB review.
At the time of expedited reporting of SUSARs to FDA, Kite Pharma (or designee) will 
concurrently submit these reports to the DSMB Chair.  The DSMB Chair will also review SAE 
narrative reports monthly.

Axicabtagene ciloleucel; KTE-C19
Kite Pharma, Inc.
Clinical Protocol: KTE-C19-107 (ZUMA-7)
Amendment 6
CONFIDENTIAL
Page 74
14 April 2023 
10.
STATISTICAL CONSIDERATIONS
10.1.
Hypothesis
The hypothesis is that axicabtagene ciloleucel will prolong EFS compared to SOC therapy in 
adult subjects with relapsed/refractory DLBCL.  The hypothesized treatment effect corresponds 
to a 50% improvement in the EFS time.
10.2.
Study Endpoints
10.2.1.
Primary
EFS is defined as the time from randomization to the earliest date of disease progression per 
Lugano Classification {Cheson 2014}, commencement of new lymphoma therapy, or death from 
any cause.  The following criteria will be used to further define events and event times:
•
Subjects with established PR or CR and subsequently commence new lymphoma therapy 
(including radiotherapy, except for TBI as noted below) in the absence of documented 
disease progression will have EFS time defined as the time from randomization to the last 
evaluable disease assessment prior to the new lymphoma therapy
•
Subjects with best response of SD and subsequently commence new lymphoma therapy 
(including radiotherapy, except for TBI as noted below) in the absence of documented 
disease progression will have EFS time defined as the time from randomization to the first 
time SD was established prior to the new lymphoma therapy
•
Subjects who commence new lymphoma therapy (including radiotherapy, except for TBI as 
noted below) in the absence of any evaluable disease assessment will have the EFS event 
date imputed as the randomization date
•
Subjects with best response of SD up to and including Day 150 assessment post-
randomization will be considered to have an EFS event.  For such subjects, the EFS time will 
be defined as the time from randomization to the first time SD was established up to and 
including the Day 150 disease assessment
The following criteria will be used to further define censoring times:
•
Subjects alive, in response, and with no new therapy will be censored at the last evaluable 
disease assessment
•
Subjects with no evaluable disease assessment by Day 150 assessment post-randomization 
will not be considered to have an EFS event, and the EFS time will be censored at the 
randomization date
•
The EFS time for subjects in the axicabtagene ciloleucel arm who undergo SCT in the 
absence of any documented progression or new therapy will be censored on the day of SCT

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•
For subjects in the SOC arm, TBI, HDT, and SCT that occur while the subject is in response 
from protocol-specified induction therapy will not be considered an EFS event.  The EFS 
time for SOC arm subjects alive, progression-free, and with no new lymphoma therapy will 
be censored at the last evaluable disease assessment date
•
At the time of the interim analysis of EFS, subjects who have not had the opportunity to be 
followed to the Day 150 disease assessment and who do not have an EFS event will be 
censored at the last evaluable disease assessment prior to Day 150
For the primary analysis of EFS, disease progression events and censoring times will be 
determined by blinded central review.  Events of subsequent new lymphoma therapy and death 
will be based on the clinical trial database.  A sensitivity analysis for EFS in which subjects in 
the axicabtagene ciloleucel arm who undergo SCT while in an axicabtagene ciloleucel-induced 
response are imputed to have an EFS event at the time of SCT will be performed.
The primary analysis of EFS will be conducted when all subjects have had the opportunity to be 
followed to the Month 9 disease assessment, and 250 EFS events have been observed.  If more 
than 250 EFS events are observed at the time of the data cutoff for the primary analysis, all 
observed events will be used in the analysis.
At the time of the interim analysis of EFS, subjects who have not had the opportunity to be 
followed to the Day 150 disease assessment and who do not have an EFS event will be censored 
at the last evaluable disease assessment prior to Day 150.
10.2.2.
Key Secondary
ORR is defined as the incidence of either a complete response or a partial response by the 
Lugano Classification {Cheson 2014} as determined by blinded central review.  All subjects that 
do not meet the criteria for an objective response by the analysis cutoff date will be considered 
non-responders.  For the derivation of ORR in both arms, disease assessments obtained after 
randomization and up through an observation of progression per Lugano Classification will be 
used.  In both arms, derivation of best response will include all assessments until an EFS event, 
including any assessments obtained after SCT for the SOC arm.
OS is defined as the time from randomization to death from any cause.  Subjects who have not 
died by the analysis data cutoff date will have survival time censored at their last date known to 
be alive.  For subjects alive or dead after the data cutoff date, survival time will be censored at 
the data cutoff date.
10.2.3.
Secondary
EFS based on investigator disease assessments:  EFS based on investigator disease assessments 
will use the same definition as EFS, except that progression events and censoring times will be 
based on the investigator disease assessments.

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Modified EFS (mEFS): mEFS is defined the same way as EFS, except that failure to attain CR or 
PR by Day 150 assessment is not considered as an event. mEFS will be analyzed per blinded 
centrnl review and per investigator disease assessments. 
PFS is defined as the time from randomization to disease progression per Lugano Classification 
{Cheson 2014} as detennined by investigator review or death from any cause. Subjects alive 
and not meeting the criteria for progression at the analysis data cutoff date will have PFS time 
censored at the last evaluable disease assessment. Subjects who receive subsequent new 
lymphoma therapy (with the exception of HDT, TBI for HDT, and SCT while in a protocol 
therapy induced response) in the absence of documented disease progression will be censored at 
their last evaluable disease assessment date prior to the commencement of the subsequent new 
lymphoma therapy. SCT that occurs while a subject is in response from a protocol therapy will 
not be considered a PFS event, and such subjects will be censored for PFS at the of the last 
evaluable disease assessment date prior to the SCT for subjects in the axicabtagene ciloleucel 
aim and will be censored at the last evaluable disease assessment date including assessments 
after SCT for subjects in the SOC aim for the primaiy analysis of PFS. Disease outcomes will be 
based on investigator assessment. 
DOR is derived only ainong subjects who experience an objective response per Lugano 
Classification {Cheson 2014} as dete1mined by blinded central review and is defined as the time 
from first objective response to disease progression per the Lugano Classification or death from 
any cause. Subjects not meeting the criteria for progression or death by the analysis data cutoff 
date will have DOR censored at their last evaluable disease assessment date. Subjects who 
receive subsequent new lymphoma therapy (with the exception ofHDT, TBI for HDT, and SCT 
while in a protocol therapy induced response) in the absence of documented progression will 
have DOR censored at the last evaluable disease assessment prior to the commencement of the 
new lymphoma therapy. For the primaiy analysis of DOR, DOR will be censored at the last 
evaluable disease assessment date prior to the SCT for subjects undergo SCT while in protocol 
therapy induced response in the axicabtagene ciloleucel aim, and will be censored at the last 
evaluable disease assessment date including assessments after SCT for subjects in the SOC aim. 
Incidence of adverse events and clinical significant changes in safety lab values, including 
antibodies to axicabtagene ciloleucel. 
Changes in EORTC QLQ-C30 domains from screening to post baseline. 
Changes in the EQ-5D-5L index and VAS scores from screening to post baseline. 
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I 
I 
I 
10.2.5. 
Analysis Subsets 
Kite Phruma, Inc. 
Amendment6 
The prima1y analysis of all efficacy endpoints, unless noted othe1w ise, will be conducted on the 
full analysis set (FAS), defined as all randomized subjects. Subjects will be analyzed according 
to the treatment first randomized regardless of treatment received. 
The safety analysis set is defined as the subset of all randomized subjects who receive at least 
one dose of axicabtagene ciloleucel as protocol therapy or SOC chemotherapy as protocol 
therapy. Subjects will be analyzed by the protocol therapy received. 
The safety analysis set - ASCT is defined as the subset subjects randomized to the SOC aim who 
undergo transplant as paii of protocol therapy. 
The primaiy analysis of HRQoL will be perfo1med on the subset of subjects in the FAS who 
have a baseline and at Day 150 post-randomization assessment. 
10.2.6. 
Covariates 
The following baseline covariates may be used to examine efficacy and/or safety in subgroups or 
covariate analyses: 
• 
Geographic region (No1i h America, Em-ope) 
• 
ECOG perfo1mance status at screening (0, 1) 
• 
Age at randomization(:::: 65, < 65) 
• 
Sex 
• 
Race/ethnicity 
• 
Response to first-line therapy (primaiy refracto1y, relapse::; 6 months of first line therapy vs 
relapse > 6 and::; 12 months of first-line therapy) 
• 
Age-adjusted IPI (0 to 1 vs 2 to 3) at time of screening 
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•
Disease type (DLBCL, TFL)
•
Molecular subgroup (germinal center B-cell like [GBC], activated B-cell like [ABC])
•
Double hit (C-MYC alterations and either BCL-2 or BCL-6 alterations) status by FISH
•
Triple hit (BCL-2, BCL-6, and C-MYC alterations) status by FISH
For the primary analysis of efficacy, the IXRS values of response to first-line therapy and age-
adjusted IPI will be used.  Sensitivity analyses may be conducted with values collected in EDC.  
Covariate levels that are sparse (ie, less than 30 events for time to event analyses or subjects for 
ORR analyses) may be collapsed for purposes of statistical modeling.  If this occurs, the strata 
for relapse ≤ 6 months of first-line therapy and relapse from 6 to 12 months of first-line therapy 
will be collapsed first.
10.3.
Sample Size Considerations
An EFS hazard ratio (test/control arm) of 0.67 is hypothesized in the FAS set.  Assuming an 
exponential distribution for EFS and a median EFS of 4 months in the SOC arm, this implies a 
50% relative improvement in EFS and corresponds to median EFS of 4 versus 6 months (control 
vs test arm).  The primary analysis is planned when 250 EFS events have been observed; the 
study has been sized to achieve approximately 90% power at the 1-sided 2.5% significance level 
to detect a 50% improvement in EFS.  The minimum effect size that can be determined to be 
statistically significant is an EFS hazard ratio of 0.79, or a 27% relative improvement in EFS.  
Further, assuming a concave accrual distribution with 50% of accrual in the last 33% of the 
accrual period of 24 months and a 10% rate (5% by month 1 and cumulative 10% by month 8) of 
loss to follow-up in the axicabtagene ciloleucel arm and 15% rate (10% by month 1 and 
cumulative 15% by month 8) of loss to follow-up in the SOC arm, it is anticipated that the event 
goal will be achieved if 350 subjects are randomized (175/arm) and will occur approximately 
31 months after the first subject is randomized.  One interim futility analysis of EFS will be 
conducted after 135 EFS events have been observed.  The interim analysis will not allow early 
stopping for efficacy.
The study will have an overall alpha of 2.5% with 1-sided testing.  To preserve the overall 
significance level, statistical testing of the primary and key secondary efficacy endpoints will 
follow a hierarchical scheme.  EFS will be tested first at the primary EFS analysis.  Conditional 
on a statistically significant improvement in EFS, ORR will be tested at the 2.5% level at the 
time of the primary EFS analysis.  Conditional on a statistically significant improvement in EFS 
and ORR, OS will be tested up to 3 times at an overall 1-sided alpha level of 2.5%.
For the analysis of ORR, response rates of 36% and 78% in the control and test arms are 
assumed.  ORR will be tested with a stratified (randomization factors) Cochran-Mantel-Haenszel 
test at the 2.5% level among subjects with measurable disease at baseline.

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An OS hazard ratio of 0.73 is hypothesized in the FAS set.  Assuming an exponential distribution 
for OS and a median OS of 15.8 months in the control arm, this implies a 37% relative 
improvement in OS and corresponds to median OS of 15.8 versus 21.6 months.  The primary OS 
analysis is planned when approximately 210 deaths have been observed or no later than 5 years 
after the first subject is randomized with a first interim analysis of OS occurring at the time of 
primary EFS analysis and a second interim analysis when approximately 160 deaths have been 
observed or no later than 4 years after the first subject is randomized.
Stratified (randomization factors) log-rank tests will be used to test the null hypothesis of no 
difference in EFS and OS using an overall 1-sided alpha level of 2.5%.  A stratified 
(randomization factors) Cochran-Mantel-Haenszel test will be used to test ORR at an overall 
1-sided alpha level of 2.5%.
The EFS analyses are event-driven and will occur when the required number of events have been 
observed.
The study testing scheme is provided in Figure 2.
Figure 2.
Study Testing Scheme
Enrollment over 24 months
EFS futility 
analysis 
(135 
events)
DSMB
19 mos
24
EFS primary 
analysis 250 
events)
Alpha=2.5%
31 mos
ORR primary 
analysis
Alpha=2.5%
OS interim analysis 
1
Rho Family 
Alpha=0.1% alpha 
allocation
OS primary analysis 
~210 events)
Alpha=2%
60 mos
DSMB safety reviews Q6 months until the primary EFS analysis
All testing will be performed at the 1-sided 2.5% level.
Hierarchical testing of EFS, followed by ORR, followed by OS.
Three analyses of OS are planned; a first interim analysis at the time of the primary EFS analysis, a second interim analysis when 
approximately 160 deaths have been observed or no later than 4 years after the first subject is randomized, and a primary OS analysis 
when approximately 210 deaths have been observed or no later than 5 years after the first subject is randomized.
EFS analyses are event-driven and will occur when the required number of events have been observed regardless of anticipating timing.
48 mos
OS interim 
analysis 2
Rho Family 
Alpha=0.4%

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10.4.
Access to Individual Subject Treatment Assignments
This is an open-label study where subjects and investigators will be aware of treatment received.  
Data handling procedures will be devised to reduce potential sources of bias and maintain the 
validity and credibility of the study.  These procedures will be outlined in the study statistical 
analysis plan and Trial Integrity Document.
10.5.
Interim Analysis and Early Stopping Guidelines
10.5.1.
Safety Interim Analysis
The DSMB will review safety data every 6 months from the time the first subject is randomized 
until the primary EFS analysis.  Additionally, the DSMB will review safety and efficacy data at 
the time of the planned interim EFS analysis.  The DSMB will also review SAE information and 
SUSARs on a regular basis throughout the study.  The sponsor may request additional reviews 
by the DSMB if safety concerns are identified.  The DSMB may meet more often as needed.
10.5.2.
Efficacy Interim Analysis
One interim analysis of EFS and 2 interim analyses of OS are planned.
The interim EFS analysis is for futility and will occur when 135 EFS events have been observed.  
An O’Brien-Fleming spending function of the Lan-DeMets family will be used to allocate the 
type II error between the interim and primary analyses.  The futility stopping rule is non-binding.  
Under the null hypothesis, the probability of stopping for futility at this interim analysis is 
approximately 60%.  One hundred thirty-five (135) EFS events are anticipated to occur 
approximately 19 months after the first subject is randomized.
Conditional upon statistically significant tests of EFS and ORR, testing of OS will be performed.  
Two interim analyses of OS will occur, a first at the time of the primary EFS analysis and a 
second when approximately 160 deaths have been observed or no later than 4 years after the first 
subject is randomized.  A spending function of the Rho family with parameter (rho = 6) will be 
used to allocate the alpha between the 2 interim analysis of OS and the primary analysis of OS 
with 0.1% and 0.4% at the interim OS analyses 1 and 2 respectively, and 2% at the primary 
analysis of OS.  Approximately 110 and 160 OS events are anticipated at the time of the interim 
OS analyses 1 and 2 respectively.
10.6.
Planned Method of Analysis
The analysis objectives and timing of analyses are described in Section 10.1, Section 10.2, and 
Section 10.3.  Prior to the primary efficacy analysis, modeling and monitoring of cumulative 
EFS events will be performed to determine a data cutoff date to achieve the planned analysis 
target event goal.
The primary analysis of EFS will be conducted when all randomized subjects have had the 
opportunity to be followed to the Month 9 disease assessment and 250 EFS events as determined 
by blinded central review have been observed. If more than 250 EFS events are observed at the 
time of the data cutoff for the primary analysis, all observed events will be used in the analysis. 

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The primary analysis of OS will occur when approximately 210 deaths have been observed or no 
later than 5 years after the first subject is randomized.
Subsequent to data collection for the data cutoff date for the primary analysis of EFS and OS, the 
total observed number of events will be determined.  If this is below the specified lower limit, 
then a sufficiently later data cutoff date will be used for which the observed total events are at or 
above the limit.
The interim and primary analyses of EFS will be based on disease progression events and 
censoring times as determined by blinded central review.  A sensitivity analysis of EFS will be 
based on disease assessments and censoring times based on investigator disease assessment.  
ORR assessments will be based on blinded central review.  Analysis of DOR will use disease 
assessments based on blinded central review, and analysis of PFS will use disease assessments 
provided by the investigator.
The Clinical Study Report (CSR) will be written at the time of the primary EFS analysis and will 
include results of the first interim analysis of OS. Results of the second interim analysis and the 
primary analysis of OS will be written shortly after each analysis is completed, or no later than 
5 years after the first subject is randomized.
10.6.1.
Event-free Survival
The analysis of EFS will be conducted on the FAS.  A stratified (randomization stratification 
factors) log-rank test will be used for the primary comparison of EFS.  Additionally, stratified 
(randomization factor) Cox regression models will be used to provide the estimated EFS hazard 
ratio and 2-sided 95% confidence intervals for axicabtagene ciloleucel relative to SOC.  The 
median EFS time and event-free rates at 3-month intervals will be provided.  The stratification 
factors as collected in the randomization system at the time of the subjects’ randomization will 
be used for stratified analyses (log-rank test and Cox regression models). Sensitivity analyses 
will be performed using the actual stratification factor values, in which the strata for relapse 
≤ 6 months of first-line therapy and relapse from 6 to 12 months of first-line therapy will be 
determined based on the time of completion of the first-line therapy.
EFS hazard ratios will be assessed in subgroups defined by covariates in Section 10.2.6.
Sensitivity analyses of EFS will be performed to assess ascertainment time bias in disease 
progression as follows:
•
Progression events that occur in between scheduled assessments will be moved forward to 
the next scheduled assessment after the observed progression
•
Progression events that occur in between scheduled assessments will be moved backward to 
the last scheduled assessment prior to the progression
•
EFS events that occur after more than one missed visit will be censored at the last evaluable 
disease assessment or visit prior to the observed progression

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•
Additionally, a sensitivity analysis for EFS will be performed as follows:
•
A sensitivity analysis in which subjects in the axicabtagene ciloleucel arm who undergo SCT 
while in an axicabtagene ciloleucel induced response are considered to have an EFS event on 
the date of SCT, with EFS time defined as time from randomization to the date of SCT.
EFS based on investigator disease assessments will be analyzed with the same methods as EFS.  
The concordance of progression events and EFS time per the investigator and per blinded central 
review will be summarized.
10.6.2.
ORR
The analysis of ORR will be conducted on the FAS.  The subject incidence of objective response 
and best response will be summarized.  An exact binomial 2-sided 95% confidence interval will 
be generated for the objective response rate and best response rates for each treatment arm.  
Wilson’s score method with continuity correction will be used to calculate 95% confidence 
intervals for the difference in objective response rates between treatment arms {Newcombe 
1998}.
Conditional upon demonstrating a statistically significant improvement in EFS, testing of ORR 
will be performed with a stratified (randomization factor) Cochran-Mantel-Haenszel test for the 
common odds ratio of response.
Odds ratios for ORR will be assessed in subgroups defined by covariates in Section 10.2.6.
10.6.3.
OS
The analysis of OS will be conducted on the FAS.  A stratified (randomization stratification 
factors) log-rank test will be used for the primary comparison of OS.  Additionally, stratified 
(randomization factor) Cox regression models will be used to provide the estimated OS hazard 
ratio and 2-sided 95% confidence intervals for axicabtagene ciloleucel relative to SOC.  The 
median OS time and event-free rates at 6-monthly intervals will be provided.  The stratification 
factors as collected in the randomization system at the time of the subjects’ randomization will 
be used for stratified analyses (log-rank test and Cox regression models). Sensitivity analyses 
will be performed using the actual stratification factor values, in which the strata for relapse 
≤ 6 months of first-line therapy and relapse from 6 to 12 months of first-line therapy will be 
determined based on the time of completion of the first-line therapy. OS hazard ratios will be 
assessed in subgroups defined by covariates in Section 10.2.6.
Sensitivity analyses of OS to address the confounding effect from treatment switching, will be 
conducted using the Rank Preserving Structural Failure Time Model and Inverse Probability of 
Censoring Weights, 2-stage Cox regression model and 
 
CCI

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10.6.4.
Progression-free Survival, Duration of Response, and Time to Next Therapy
The analysis of PFS, DOR, and time to next therapy will be performed using the same methods 
as the analysis of EFS, with p-values from the log-rank test being descriptive.
10.6.5.
Safety
A TEAE is defined as any AE that begins on or after the first dose of study treatment 
(axicabtagene ciloleucel infusion or SOC), excluding bridging therapy.  Subject incidence rates 
of TEAEs, including all, serious, fatal, CTCAE Grade 3 or higher, and treatment related AEs 
reported will be tabulated by preferred term and system organ class coded with the Medical 
Dictionary for Regulatory Activities (MedDRA).  Changes in laboratory values and vital signs 
will be summarized with descriptive statistics.  The incidence of concomitant medications will be 
summarized.
Tables and/or narratives of deaths through the long-term follow-up and treatment related SAEs 
will be provided.
The incidence, prevalence, duration, and reversibility of cytopenias will be summarized.
10.6.6.
Pharmacokinetic Analyses
For subjects in the axicabtagene ciloleucel arm, anti-CD19 CAR T levels measured in peripheral 
blood  will be summarized with descriptive statistics.
10.6.7.
Immunogenicity Analyses
The subject incidence of antibodies to axicabtagene ciloleucel will be summarized.
10.6.8.
Health-related Quality of Life
Changes in EORTC QLQ-C30 domains and the EQ-5D-5L index and VAS scores from 
screening to the Month 24 post-randomization visit will be summarized with descriptive 
statistics. The WPAI will be scored per the instrument development algorithm 
(http://www.reillyassociates.net/WPAI_Scoring.html).  Changes in the WPAI score from 
screening to Month 24 post-randomization visit will be summarized with descriptive statistics.  
In addition, the mean/median changes in EORTC QLQ-C30 domains, the EQ-5D-5L index, VAS 
scores, and WPAI score from screening over time will be present with plots.
10.6.9.
Cytokines, Product Characteristics, and Molecular and Histological 
Characteristics
Among subjects in the axicabtagene ciloleucel arm, summaries of cytokines over time will be 
provided.
The proportions of cell phenotypes in the axicabtagene ciloleucel product will be summarized.

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Analyses of tumor molecular and histologic characteristics by levels of PD-L1, and molecular 
and cytogenetic subclassifications will be summarized in the statistical analysis plan.
10.6.10.
Long-term Data Analysis
All subjects who received at least one dose of axicabtagene ciloleucel as protocol therapy will be 
followed for survival for up to approximately 15 years after randomization; LTFU assessment 
will be performed on subjects after transition to the LTFU study (refer to Section 3.5.2 and 
Section 3.5.3). No formal hypothesis testing will be performed based on data obtained after the 
primary analysis of OS.  Descriptive estimates of key efficacy and safety analyses may be 
updated to assess the overall treatment profile.

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11.
REGULATORY OBLIGATIONS
This study will be conducted in accordance with the protocol and with the following:
•
Consensus ethical principles derived from international guidelines including the Declaration 
of Helsinki
•
Applicable International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) 
Guidelines
•
Applicable laws and regulations
11.1.
Independent Review Board/Independent Ethics Committee
A copy of the protocol, ICF, and any additional subject or trial information such as subject 
recruitment materials must be submitted to each site’s respective IRB/IEC for approval.  After 
approval is obtained from the IRB/IEC, all documents must be provided to the key sponsor 
contact before subject recruitment can begin.
The investigator must also receive IRB/IEC approval for all protocol and ICF changes or 
amendments. Investigators must ensure that ongoing/continuous IRB/IEC approval (ie, annual 
approval) is provided throughout the conduct of the study according to applicable law.  Copies of 
IRB/IEC approval are to be forwarded to the key sponsor contact for archiving.
During the course of the study, investigators are to submit site-specific and study serious adverse 
events (provided to the site by the key sponsor contact) along with any protocol deviations to 
their IRB/IEC in accordance with their respective IRB/IEC policies.
11.2.
Subject Confidentiality
Subject confidentiality must be maintained for all material submitted to the key sponsor contact.  
The following rules are to be applied.
•
Subjects will be identified by a unique identification number.
•
Year of birth/age at time of enrollment will be reported according with local laws and 
regulations.
For reporting of serious adverse events, subjects will be identified by their respective subject 
identification number, initials, and year of birth (as per their local reporting requirements for 
both initials and year of birth).
Per country-specific regulations and ICH/GCP guidelines, investigators and institutions are 
required to permit authorization to the sponsor, Contract Research Organization (CRO), 
IRB/IEC, and regulatory agencies to subject’s original source documents for verification of study 
data.  The investigator is responsible for informing potential subjects that such individuals will 
have access to their medical records which includes personal information.

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11.3.
Investigator Signatory Obligations
Each clinical study report will be signed by the coordinating investigator.  The coordinating 
investigator will be identified by Kite Pharma under the following criteria:
•
A recognized expert in the disease setting
•
Provided significant contributions to the design or analysis of study data
•
Participate in the study and enrolled a high number of eligible subjects

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12.
PROTOCOL AMENDMENTS AND TERMINATION
If the protocol is amended, the Sponsor and Investigator Signature Page with the amendment and 
the IRB/IEC approval of the amendment must be obtained.  Documentation acknowledging 
approval from both parties are to be submitted to the key sponsor contact.
Both Kite Pharma and the investigator reserve the right to terminate the investigator’s 
participation in the study as per the terms of the agreement in the study contract.  The 
investigator is to provide written communication to the IRB/IEC of the trial completion or early 
termination and provide the CRO with a copy of the correspondence.
Kite Pharma reserves the unilateral right, at its sole discretion, to determine whether to 
manufacture axicabtagene ciloleucel and provide it to sites and subjects after the completion of 
the study and before treatment becomes commercially available.

Axicabtagene ciloleucel; KTE-C19
Kite Pharma, Inc.
Clinical Protocol: KTE-C19-107 (ZUMA-7)
Amendment 6
CONFIDENTIAL
Page 88
14 April 2023 
13.
STUDY DOCUMENTATION AND ARCHIVE
The investigator will maintain a list of qualified staff to whom study responsibilities have been 
delegated.  These individuals authorized to fulfil these responsibilities should be outlined and 
included in the Delegation of Authority Form.
Source documents are original documents, data, and records for which the study data are 
collected and verified.  Examples of such source documents may include, but are not limited to, 
hospital records and patient charts; laboratory, pharmacy, radiology and records; subject diaries; 
microfiches; correspondence; and death registries.  CRF entries may be considered as source data 
if the site of the original data collection is not available.  However, use of the CRFs as source 
documentation as a routine practice is not recommended.
The investigator and study staff are responsible for maintaining a comprehensive and centralized 
filing system of all subject records that are readily retrieved to be monitored and or audited at 
any time by the key sponsor contact, regulatory authorities and IRB/IECs.  The filing system will 
include at minimum:
•
Subject content including ICFs and subject identification lists
•
Essential documents for the conduct of this clinical study (protocols and protocol 
amendments, IB, copies of pre-study documentation, and all IRB/IEC and sponsor 
communication)
•
Proof of receipt, experimental treatment flow records, and experimental product-related 
correspondence
Original source documents supporting entries into CRFs must be maintained at the site and 
readily available upon request.  No study documents should be discarded without prior written 
agreement between Kite Pharma and the investigator.  If storage is no longer available to archive 
source documents or must be moved to an alternative location, the research staff should notify 
the key sponsor contact prior to shipping the documents.
Traceability records for the product, from procurement through manufacture to administration of 
the product, should be kept by each relevant party (eg, the sponsor and investigator/institution) 
for a minimum of 30 years after the expiry date of the product, or longer if required by the terms 
of the clinical trial authorization or by agreement with Kite. Before, during, and after completion 
or termination of the study, each party should hold the necessary information available at all 
times to ensure bidirectional traceability, linking the subject information at the procurement site 
to the product and subject information at the study site to the product, while ensuring the data 
protection legally required for the subject.

Axicabtagene ciloleucel; KTE-C19
Kite Pharma, Inc.
Clinical Protocol: KTE-C19-107 (ZUMA-7)
Amendment 6
CONFIDENTIAL
Page 89
14 April 2023 
If the investigator cannot provide for this archiving requirement at the study site for any or all of 
the documents, special arrangements must be made between the investigator and Kite to store 
these records securely away from the site so that they can be returned sealed to the investigator 
in case of an inspection. When source documents are required for the continued care of the 
subject, appropriate copies should be made for storage away from the site.
If a subject transfers to another study site, the investigator must notify Kite in advance before 
assigning the subject’s study records to another party or moving them to another location.

Axicabtagene ciloleucel; KTE-C19
Kite Pharma, Inc.
Clinical Protocol: KTE-C19-107 (ZUMA-7)
Amendment 6
CONFIDENTIAL
Page 90
14 April 2023 
14.
STUDY MONITORING AND DATA COLLECTION
The key sponsor contacts, monitors, auditors, or regulatory inspectors are responsible for 
contacting and visiting the investigator for the purpose of inspecting the facilities and verifying 
source documents and records assuring that subject confidentially is respected.
The monitor is responsible for source document verification of CRF data at regular intervals 
during the study.  Protocol adherence, accuracy, and consistency of study conduct and data 
collection with respect to local regulations will be confirmed.  Monitors will have access to 
subject records as identified in Section 13.
By signing the investigator agreement, the investigator agrees to cooperate with the monitor to 
address and resolve issues identified during monitoring visits.
In accordance with ICH/GCP, and the audit plan, a site may be chosen for a site audit.  A site 
audit would include, but is not limited to, an inspection of the facility(ies), review of subject- and 
study-related records, for compliance with protocol requirements as well as ICH/GCP, and 
applicable local regulations.
All data will be collected in an eCRF system.  All entries must be completed in English, and 
concomitant medications should be identified by trade names.  For additional details about 
completing CRFs, please refer to the CRF completion guidelines.

Axicabtagene ciloleucel; KTE-C19
Kite Pharma, Inc.
Clinical Protocol: KTE-C19-107 (ZUMA-7)
Amendment 6
CONFIDENTIAL
Page 91
14 April 2023 
15.
PUBLICATION
Authorship of publications from data generated in ZUMA-7 will be determined based on the 
uniform requirements for manuscripts submitted to biomedical journals (as outlined in the 
International Committee of Medical Journal Editors December 2013), which states authorship 
should be based on:
•
Substantial contributions to the conception or design of the work, acquisition of data, 
analysis, or interpretation of data for the work; and
•
Drafting the article or revising it critically for important intellectual content; and
•
Final approval of the version to be published; and
•
Agreement to be accountable for all aspects of the work in ensuring that questions related to 
the accuracy or integrity of any part of the work are appropriately investigated or resolved
When a large, multicenter group has conducted the work, the group should identify the 
individuals who accept direct responsibility for the manuscript.  This individual should fully 
meet the criteria for authorship defined above.
Funding, collection of data, or general supervision of the research alone or in combination does 
not qualify an individual for authorship.
Any publication, in any form, that is derived from this study must be submitted to Kite Pharma 
for review and approval.  The study contract between the institution, principal investigation, and 
Kite Pharma or its delegate will outline the requirements for publication review.

Axicabtagene ciloleucel; KTE-C19
Kite Pharma, Inc.
Clinical Protocol: KTE-C19-107 (ZUMA-7)
Amendment 6
CONFIDENTIAL
Page 92
14 April 2023 
16.
COMPENSATION
Kite Pharma will provide compensation for study-related illness or injury pursuant to the 
information outlined in the injury section of the ICF.

Axicabtagene ciloleucel; KTE-C19
Kite Pharma, Inc.
Clinical Protocol: KTE-C19-107 (ZUMA-7)
Amendment 6
CONFIDENTIAL
Page 93
14 April 2023 
17.
REFERENCES
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management of diffuse large B-cell lymphoma. Br J Haematol 2016;174 (1):43-
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Recommendations for initial evaluation, staging, and response assessment of 
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Crump M, Kuruvilla J, Couban S, MacDonald DA, Kukreti V, Kouroukis CT, et al. Randomized 
Comparison of Gemcitabine, Dexamethasone, and Cisplatin Versus 
Dexamethasone, Cytarabine, and Cisplatin Chemotherapy Before Autologous 
Stem-Cell Transplantation for Relapsed and Refractory Aggressive Lymphomas: 
NCIC-CTG LY.12. Journal of Clinical Oncology 2014;32 (31):3490-6.

Axicabtagene ciloleucel; KTE-C19
Kite Pharma, Inc.
Clinical Protocol: KTE-C19-107 (ZUMA-7)
Amendment 6
CONFIDENTIAL
Page 94
14 April 2023 
Darrington DL, Vose JM, Anderson JR, Bierman PJ, Bishop MR, Chan WC, et al. Incidence and 
characterization of secondary myelodysplastic syndrome and acute myelogenous 
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Fallowfield L. Quality-of-Life: the objective measurement of subjective responses to cancer and 
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Feugier P, Van Hoof A, Sebban C, Solal-Celigny P, Bouabdallah R, Ferme C, et al. Long-term 
results of the R-CHOP study in the treatment of elderly patients with diffuse large 
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Clin Oncol 2005;23 (18):4117-26.
Flowers CR, Sinha R, Vose JM. Improving outcomes for patients with diffuse large B-cell 
lymphoma. CA: A Cancer Journal for Clinicians 2010;60 (6):393-408.
Gattinoni L, Klebanoff CA, Palmer DC, Wrzesinski C, Kerstann K, Yu Z, et al. Acquisition of 
full effector function in vitro paradoxically impairs the in vivo antitumor efficacy 
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Gisselbrecht C, Glass B, Mounier N, Singh Gill D, Linch DC, Trneny M, et al. Salvage regimens 
with autologous transplantation for relapsed large B-cell lymphoma in the 
rituximab era. J Clin Oncol 2010;28 (27):4184-90.
Gopal AK, Press OW, Shustov AR, Petersdorf SH, Gooley TA, Daniels JT, et al. Efficacy and 
safety of gemcitabine, carboplatin, dexamethasone, and rituximab in patients with 
relapsed/refractory lymphoma: a prospective multi-center phase II study by the 
Puget Sound Oncology Consortium. Leuk Lymphoma 2010;51 (8):1523-9.
Green TM, Young KH, Visco C, Xu-Monette ZY, Orazi A, Go RS, et al. Immunohistochemical 
double-hit score is a strong predictor of outcome in patients with diffuse large B-
cell lymphoma treated with rituximab plus cyclophosphamide, doxorubicin, 
vincristine, and prednisone. J Clin Oncol 2012;30 (28):3460-7.
Guglielmi C, Gomez F, Philip T, Hagenbeek A, Martelli M, Sebban C, et al. Time to relapse has 
prognostic value in patients with aggressive lymphoma enrolled onto the Parma 
trial. J Clin Oncol 1998;16 (10):3264-9.
Hamlin PA, Zelenetz AD, Kewalramani T, Qin J, Satagopan JM, Verbel D, et al. Age-adjusted 
International Prognostic Index predicts autologous stem cell transplantation 
outcome for patients with relapsed or primary refractory diffuse large B-cell 
lymphoma. Blood 2003;102 (6):1989-96.

Axicabtagene ciloleucel; KTE-C19
Kite Pharma, Inc.
Clinical Protocol: KTE-C19-107 (ZUMA-7)
Amendment 6
CONFIDENTIAL
Page 95
14 April 2023 
Howlader N, Noone A, Krapcho M, Miller D, Bishop K, Altekruse S, et al. SEER Cancer 
Statistics Review, 1975-2013. National Cancer Institute. Bethesda, MD, 
http://seer.cancer.gov/csr/1975_2013/, based on November 2015 SEER data 
submission, posted to the SEER web site, April 2016. 2015.
Klebanoff CA, Gattinoni L, Torabi-Parizi P, Kerstann K, Cardones AR, Finkelstein SE, et al. 
Central memory self/tumor-reactive CD8+ T cells confer superior antitumor 
immunity compared with effector memory T cells. Proc Natl Acad Sci U S A 
2005;102 (27):9571-6.
Kochenderfer JN, Dudley ME, Feldman SA, Wilson WH, Spaner DE, Maric I, et al. B-cell 
depletion and remissions of malignancy along with cytokine-associated toxicity in 
a clinical trial of anti-CD19 chimeric-antigen-receptor-transduced T cells. Blood 
2012;119 (12):2709-20.
Kochenderfer JN, Dudley ME, Kassim SH, Somerville RP, Carpenter RO, Stetler-Stevenson M, 
et al. Chemotherapy-Refractory Diffuse Large B-Cell Lymphoma and Indolent B-
Cell Malignancies Can Be Effectively Treated With Autologous T Cells 
Expressing an Anti-CD19 Chimeric Antigen Receptor. J Clin Oncol 2015;33 
(6):540-9.
Kochenderfer JN, Feldman SA, Zhao Y, Xu H, Black MA, Morgan RA, et al. Construction and 
Preclinical Evaluation of an Anti-CD19 Chimeric Antigen Receptor. J 
Immunother 2009;32 (7):689-702.
Kochenderfer JN, Somerville RPT, Lu T, Shi V, Bot A, Rossi J, et al. Lymphoma remissions 
caused by anti-CD19 chimeric antigen receptor T cells are associated with high 
serum interleukin-15 levels. J Clin Oncol 2017;Mar 14: doi: 
10.1200/JCO.2016.71.3024.
Kochenderfer JN, Yu Z, Frasheri D, Restifo NP, Rosenberg SA. Adoptive transfer of syngeneic 
T cells transduced with a chimeric antigen receptor that recognizes murine CD19 
can eradicate lymphoma and normal B cells. Blood 2010;116 (19):3875-86.
Kowolik CM, Topp MS, Gonzalez S, Pfeiffer T, Olivares S, Gonzalez N, et al. CD28 
costimulation provided through a CD19-specific chimeric antigen receptor 
enhances in vivo persistence and antitumor efficacy of adoptively transferred T 
cells. Cancer Res 2006;66 (22):10995-1004.
Lignon J, Sibon D, Madelaine I, Brice P, Franchi P, Briere J, et al. Rituximab, Dexamethasone, 
Cytarabine, and Oxaliplatin (R-DHAX) Is an Effective and Safe Salvage Regimen 
in Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma. Clinical Lymphoma 
Myeloma and Leukemia 2010;10 (4):262-9.
Locke FL, Neelapu SS, Bartlett NL, Siddiqi T, Chavez JC, Hosing CM, et al. Phase 1 Results of 
ZUMA-1: A Multicenter Study of KTE-C19 Anti-CD19 CAR T Cell Therapy in 
Refractory Aggressive Lymphoma. Mol Ther 2017;25 (1):285-95.

Axicabtagene ciloleucel; KTE-C19
Kite Pharma, Inc.
Clinical Protocol: KTE-C19-107 (ZUMA-7)
Amendment 6
CONFIDENTIAL
Page 96
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Martelli M, Ferreri AJM, Agostinelli C, Di Rocco A, Pfreundschuh M, Pileri SA. Diffuse large 
B-cell lymphoma. Critical Reviews in Oncology / Hematology 2013;87 (2):146-
71.
Martin A, Conde E, Arnan M, Canales MA, Deben G, Sancho JM, et al. R-ESHAP as salvage 
therapy for patients with relapsed or refractory diffuse large B-cell lymphoma: the 
influence of prior exposure to rituximab on outcome. A GEL/TAMO study. 
Haematologica 2008;93 (12):1829-36.
Morton LM, Wang SS, Devesa SS, Hartge P, Weisenburger DD, Linet MS. Lymphoma 
incidence patterns by WHO subtype in the United States, 1992-2001. Blood 
2006;107 (1):265-76.
Newcombe RG. Interval estimation for the difference between independent proportions: 
comparison of eleven methods. Stat Med 1998;17 (8):873-90.
Nicholson IC, Lenton KA, Little DJ, Decorso T, Lee FT, Scott AM, et al. Construction and 
characterisation of a functional CD19 specific single chain Fv fragment for 
immunotherapy of B lineage leukaemia and lymphoma. Mol Immunol 1997;34 
(16-17):1157-65.
O'Brien SM, Kantarjian HM, Cortes J, Beran M, Koller CA, Giles FJ, et al. Results of the 
fludarabine and cyclophosphamide combination regimen in chronic lymphocytic 
leukemia. J Clin Oncol 2001;19 (5):1414-20.
Philip T, Guglielmi C, Hagenbeek A, Somers R, Van der Lelie H, Bron D, et al. Autologous 
bone marrow transplantation as compared with salvage chemotherapy in relapses 
of chemotherapy-sensitive non-Hodgkin's lymphoma. N Engl J Med 1995;333 
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Sehn LH, Gascoyne RD. Diffuse large B-cell lymphoma: optimizing outcome in the context of 
clinical and biologic heterogeneity. Blood 2015;125 (1):22-32.
Stone RM, Neuberg D, Soiffer R, Takvorian T, Whelan M, Rabinowe SN, et al. Myelodysplastic 
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Swerdlow SH, Campo E, Pileri SA, Harris NL, Stein H, Siebert R, et al. The 2016 revision of the 
World Health Organization classification of lymphoid neoplasms. Blood 
2016;127 (20):2375-90.
Van Den Neste E, Schmitz N, Mounier N, Gill D, Linch D, Trneny M, et al. Outcome of patients 
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Axicabtagene ciloleucel; KTE-C19
Kite Pharma, Inc.
Clinical Protocol: KTE-C19-107 (ZUMA-7)
Amendment 6
CONFIDENTIAL
Page 97
14 April 2023 
van Imhoff GW, McMillan A, Matasar MJ, Radford J, Ardeshna KM, Kuliczkowski K, et al. 
Ofatumumab Versus Rituximab Salvage Chemoimmunotherapy in Relapsed or 
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Rituximab improves the treatment results of DHAP-VIM-DHAP and ASCT in 
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Large B-Cell Lymphoma: CALGB/Alliance 50303. Blood (ASH Annual Meeting 
Abstracts) 2016:Abstract #469 

Axicabtagene ciloleucel; KTE-C19
Kite Pharma, Inc.
Clinical Protocol: KTE-C19-107 (ZUMA-7)
Amendment 6
CONFIDENTIAL
Page 98
14 April 2023 
18.
APPENDICES
Appendix A.
Sponsor and Investigator Signature Page
Appendix B.
Lugano Classification {Cheson 2014}
Appendix C.
Patient Reported Outcomes
Appendix D.
Country-specific Regulatory Agency Requirements
Appendix E.
Childbearing Potential and Birth Control
Appendix F.
Pandemic Risk Assessment and Mitigation Plan
Appendix G.
Protocol Amendment History

Axicabtagene ciloleucel; KTE-C19
Kite Pharma, Inc.
Clinical Protocol: KTE-C19-107 (ZUMA-7)
Amendment 6
CONFIDENTIAL
Page 99
14 April 2023 
Appendix A.
Sponsor and Investigator Signature Page
KITE PHARMA, INC.
2400 BROADWAY
SANTA MONICA, CA 90404
STUDY ACKNOWLEDGMENT
A Phase 3, Randomized, Open-Label Study Evaluating the Efficacy of Axicabtagene Ciloleucel 
versus Standard of Care Therapy in Subjects with Relapsed/Refractory Diffuse Large B Cell 
Lymphoma (ZUMA-7)
Amendment 6, 14 April 2023
This protocol has been approved by Kite Pharma, Inc. The following signature documents this 
approval.
[Refer to the appended electronic signature]
Kite Medical Monitor Name (Printed) 
Signature
[Refer to the appended electronic signature]
Date
INVESTIGATOR STATEMENT
I have read the protocol, including all appendices, and I agree that it contains all necessary details 
for me and my staff to conduct this study as described. I will conduct this study as outlined herein 
and will make a reasonable effort to complete the study within the time designated.
I agree to comply with the International Council for Harmonisation of Technical Requirements 
for Pharmaceuticals for Human Use (ICH) Harmonised Tripartite Guideline on Good Clinical 
Practice and applicable national or regional regulations and guidelines. I will provide all study 
personnel under my supervision copies of the protocol and access to all information provided by 
Kite Pharma, Inc. I will discuss this material with them to ensure that they are fully informed 
about the investigational product and study.
I agree and will ensure that financial disclosure statements will be completed by:
•
Me (including, if applicable, my spouse, legal partner, and dependent children)
•
Subinvestigators (including, if applicable, their spouse, legal partner, and dependent children) 
at the start of the study and for up to 1 year after the study is completed.
I agree to ensure that the confidential information contained in this document will not be used for 
any purpose other than the conduct of the clinical investigation without prior written consent 
from Kite Pharma, Inc.
Principal Investigator Name (Printed)
Signature
Date
Study Site Number
PPD

Axicabtagene ciloleucel; KTE-C19
Kite Pharma, Inc.
Clinical Protocol: KTE-C19-107 (ZUMA-7)
Amendment 6
CONFIDENTIAL
Page 100
14 April 2023 
Appendix B.
Lugano Classification {Cheson 2014}
Please refer to imaging manual and {Cheson 2014} for details of assessment.
5-Point Scale (5PS) {Barrington 2014}
Score 
Description 
1 
No uptake above background 
2 
Uptake ≤  mediastinum 
3 
Uptake > mediastinum but ≤ liver 
4 
Uptake moderately higher than liver 
5 
Uptake markedly higher than liver and/or new lesions
X 
New areas of uptake unlikely to be related to lymphoma.  
Complete Remission:
Complete Metabolic Response (CMR) for PET-CT-Based Response
The designation of CMR requires all of the following:
•
A 5PS (5-point scale) score of 1, 2, or 3, with or without a residual mass.
In Waldeyer’s ring or extranodal sites with high physiologic uptake or with activation 
within spleen or marrow, uptake may be greater than normal mediastinum and/or liver. In 
this circumstance, CMR may be inferred if uptake at sites of initial involvement is no 
greater than surrounding normal tissue even if the tissue has high physiologic uptake.
•
No new sites of disease should be observed.
•
No evidence of FDG-avid disease in bone marrow
Complete Radiologic Response (CRR) for CT-Based Response
The designation of CRR requires all of the following:
•
Target nodes/nodal masses must regress to ≤ 1.5 cm in longest transverse diameter of a lesion 
(LDi)
•
No extralymphatic sites of disease
•
Absent nonmeasured lesion
•
Organ enlargement regress to normal

Axicabtagene ciloleucel; KTE-C19
Kite Pharma, Inc.
Clinical Protocol: KTE-C19-107 (ZUMA-7)
Amendment 6
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•
No new sites of disease should be observed.
•
Bone marrow normal by morphology; if indeterminate, IHC negative
Partial Remission:
Partial Metabolic Response (PMR) for PET-CT Based Response
The designation of PMR requires all of the following:
•
A 5PS score of 4 or 5, with reduced uptake compared to baseline (screening), and residual 
mass(es) of any size.
Note:
At interim, these findings suggest responding disease.
At end of treatment (EOT), these findings suggest residual disease.
•
No new sites of disease should be observed.
•
Residual uptake higher than uptake in normal bone marrow but reduced compared with 
baseline (diffuse uptake compatible with reactive changes from chemotherapy allowed).
If there are persistent focal changes in the marrow in the context of a nodal response, 
consideration should be given to further evaluation with MRI or biopsy or an interval scan.
Partial Radiologic Response (PRR) for CT-Based Response
The designation of PRR requires all of the following:
•
≥ 50% decrease in sum of the product of the perpendicular diameters (SPD) of up to 6 target 
measurable nodes and extranodal sites.
When a lesion is too small to measure on CT, assign 5 mm x 5 mm as the default value
When no longer visible, 0 x 0 mm
For a node  > 5 mm x 5 mm, but smaller than normal, use actual measurement for 
calculation
•
Absent/normal, regressed, but no increase of nonmeasured lesions.
•
Spleen must have regressed by > 50% in length beyond normal
•
No new sites of disease should be observed.

Axicabtagene ciloleucel; KTE-C19
Kite Pharma, Inc.
Clinical Protocol: KTE-C19-107 (ZUMA-7)
Amendment 6
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Page 102
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SD:
No Metabolic Response (NMR) for PET-CT Based Response
The designation of NMR requires all of the following:
•
A 5PS score of 4 or 5, with no significant change in FDG uptake compared to baseline 
(screening) at an interim time point or end of treatment.
•
No new sites of disease should be observed.
•
No change from baseline in bone marrow
Stable Radiologic Disease (SRD) for CT-Based Response
The designation of SRD requires all of the following:
•
< 50% decrease from baseline in the sum of the product of the perpendicular diameters 
(SPD) of up to 6 dominant, measurable nodes and extranodal sites; no criteria for progressive 
disease are met
•
No increase consistent with progression in nonmeasured lesion and organ enlargement
•
No new sites of disease should be observed.
PD:
Progressive Metabolic Disease (PMD) for PET-CT Based Response
The designation of PMD requires at least 1 of the following:
•
A 5PS score 4 or 5 with an increase in intensity of uptake from nadir and/or
•
New FDG-avid foci consistent with lymphoma at interim or end of treatment assessment
•
New FDG-avid foci consistent with lymphoma rather than another etiology (eg, infection, 
inflammation). If uncertain regarding etiology of new lesions, biopsy or interval scan may be 
considered
•
New or recurrent FDG-avid foci in bone marrow.
Progressive Radiologic Disease (PRD) for CT- Based Response
The designation of PRD requires at least 1 of the following:
•
An individual node/lesion must be abnormal with:
Longest traverse diameter (LDi) > 1.5 cm and

Axicabtagene ciloleucel; KTE-C19
Kite Pharma, Inc.
Clinical Protocol: KTE-C19-107 (ZUMA-7)
Amendment 6
CONFIDENTIAL
Page 103
14 April 2023 
Increase by ≥ 50% from cross product of LDi and perpendicular diameter (PPD) nadir 
and
An increase in LDi or SDi, shortest axis perpendicular to the LDi, (SDi) from nadir
■
0.5 cm for lesions ≤ 2 cm
■
1.0 cm for lesions > 2 cm
In the setting of splenomegaly, the splenic length must increase by > 50% of the extent of 
its prior increase beyond baseline (eg, a 15-cm spleen must increase to > 16 cm). If no 
prior splenomegaly, must increase by at least 2 cm from baseline;
New or recurrent splenomegaly
•
New or clear progression of preexisting nonmeasured lesions
•
New lesion
Regrowth of previously resolved lesions
A new node > 1.5 cm in any axis
A new extranodal site > 1.0 cm in any axis; if < 1.0 cm in any axis, its presence must be 
unequivocal and must be attributable to lymphoma
Assessable disease of any size unequivocally attributable to lymphoma
•
New or recurrent bone marrow involvement

Axicabtagene ciloleucel; KTE-C19
Kite Pharma, Inc.
Clinical Protocol: KTE-C19-107 (ZUMA-7)
Amendment 6
CONFIDENTIAL
Page 104
14 April 2023 
Appendix C.
Patient Reported Outcomes
EORTC QLQ C-30
EORTC QI..Q-C30 (l.-emoo 3) 
\Ve are interested m some 
about you amd yom ~
. Please a.nsv.er 
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,cuclmg die mmmer dist best awlie. to, you. Thare a,:e no "ri,§1:d" or •"nrong" an.sv.-ers. 1rhe mfonnafi.on th.a: ·you 
p,ror.idi, i;vill ..,,.,,.i,,. st:ticlly confidential 
Please fill in your inifuJ.s: 
Yoorbii&h!e (Da.y, Man6i, Yea:r): 
Today's date 
,-, 
Year), 
31 
I 
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Axicabtagene ciloleucel; KTE-C19
Kite Pharma, Inc.
Clinical Protocol: KTE-C19-107 (ZUMA-7)
Amendment 6
CONFIDENTIAL
Page 105
14 April 2023 
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Axicabtagene ciloleucel; KTE-C19
Kite Pharma, Inc.
Clinical Protocol: KTE-C19-107 (ZUMA-7)
Amendment 6
CONFIDENTIAL
Page 106
14 April 2023 
EQ-5D-5L
ECl-SD-SL 
Health Questionnaire• 
English version for the UK 
UK (En,gfish} C 2009 EuroQol Group E Q-50"' is a t rade m arl< aUhe EuroQol Group 

Axicabtagene ciloleucel; KTE-C19
Kite Pharma, Inc.
Clinical Protocol: KTE-C19-107 (ZUMA-7)
Amendment 6
CONFIDENTIAL
Page 107
14 April 2023 
Under each heading, please tick llie ONE box that best desoribes your health TODAY. 
MOBILITY 
I have no problems ini v.ra I king about 
I have slight prob ems in walking about 
I have moderate probl,ems in walking1 about 
I have severe prolll,ems in walk1i11g about 
I am unable 1o wa I k about 
SELF-CARE 
I have no problems washing or dressing myself 
I have slight problems washing or dressi111g myself 
I have moderate pmbl,ems washing or dressing myself 
I have severe prohlems washing or dressing myself 
I am unable 1o wash or diress myself 
USUAL ACTIV TIES (e.g. work, study, housework, fami{yor 
leisure· activities) 
I have no problems dai ng my usual activibes 
I have slight problems doi 119 my usual activities 
I have moderate probl,ems doing my usual activities 
I have severe prohlems doing my usual activities 
I am una b e 1o do my usual activities 
PAINI I ms.COMFORT 
I have no pain or discomfort 
I have slight pain or discomfort 
I have moderate pain or discomfort: 
I have severe pain or discomfort 
I have extreme pain or discomfort: 
ANXIETY / DEPRESS ON 
I am not anx:ioLls or depress,ed 
I am slightly anxious or depressed 
I am moderately anxious or depressed 
I am severely anxious or depressed 
I am extremely anxious or depr,essed 
2 
UK ~nglish} @ 2009 ISumQol Group EQ-:50111 is a trade marl< of,the ISumQoJ Group 

Axicabtagene ciloleucel; KTE-C19
Kite Pharma, Inc.
Clinical Protocol: KTE-C19-107 (ZUMA-7)
Amendment 6
CONFIDENTIAL
Page 108
14 April 2023 
• 
We would likie to koow how good or bad your health is TODAY. 
• 
This scale is numbered from Oto 1100. 
• 
100 means the best health you can imagine. 
0 means the wors,t health you can imagine. 
• 
Mart. an X on the scale to indicate how your health is TODAY. 
• 
,ow. please write the number you marked 011 the scale in the box 
below. 
YOUIRHEALTIHTODAY = D 
3 
UK (English} @ 2009 EuroQoJ' Group EQ-50"' is a trade mark aUhe EuroQoJ Group 
lihe best hetillh 
you can imag·ne 
T 
100 
t 
95 
90 
! 
85 
T 
80 
-I-
75 
70 
t 
65 
60 
55 
+ 
50 
t 
45 
40 
35 t 
30 
25 
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20 
15 
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you am imagine 

Axicabtagene ciloleucel; KTE-C19
Kite Pharma, Inc.
Clinical Protocol: KTE-C19-107 (ZUMA-7)
Amendment 6
CONFIDENTIAL
Page 109
14 April 2023 
WPAI Questionnaire (V2.0) (SAMPLE)
~ork Productiviity .and Activity Impairment Questionnaire: 
General Health V2.0 (WPAl:GH) 
The following questions ask about the effect of your health prob ems on your ability to 
work and perform reg,ula1r a.ctivilies. By health problems we mean any physical or 
emotional prolb1lem or symptom. Please filf in the blanks or circle a number, as indicated: 
1. 
Are you currently employed (working for pay)? 
NO 
YES 
ff NO, check "NO" and skip to question 6. 
The next quesliions am about the pa,st seven days, not including today. 
2. 
During 11he past seven days, how many hours did you miss trom wo:rk because of 
your health problems? Include hours you missed on sick days, times you went in 
Jafe, left early, etc., because of your health probfems. Do 110.f include time you 
missed to participate in this study. 
HOURS 
3. 
During 11he past seven days, how many hours did you miss from wo:rk because of 
any other reason, such as vacatio:n, holidays, time off to participate in this study? 
HOURS 
4. 
During 11he past seven days, how many hours did you actually work? 
__ HOURS (lf"0", skip to question 6.) 
WPAtGtt V2.o ~us Engtisfl) 
1 

Axicabtagene ciloleucel; KTE-C19
Kite Pharma, Inc.
Clinical Protocol: KTE-C19-107 (ZUMA-7)
Amendment 6
CONFIDENTIAL
Page 110
14 April 2023 
5. 
During the past s,even days, how much did your heal~h problems affect your 
productivity while you we re worldn g? 
Think about days you were limited in the amount or kind of work you could do, 
days you accomplished Jess than you would like, or days you could naf do your 
work as carefully as usual. rt heaJfh problems affected your work onfy a little, 
choose a fow number. Choose a high number if health problems affected your 
work a greaf deal. 
Consider only how much heallih pmbllems affected 
productivity while you were woridng. 
H eallih 
Health p:roblems 
problems had ---------------- completely 
no effect on my 
O 1 
2 
3 
4 
5 
'6 
7 
-8 
9 10 
prevented me 
work 
from working 
CIRCLE A NUMBER 
6. 
During the past s,even days, how much did your heali1h problems affect your abillity 
to do your reg1ular datlry activities, other i han work at a job? 
By regular activities, we mean fhe usual activities you do, such as work around the 
house, shopping, childcare, exercising, studying~ etc. Think about times you were 
limited in the amount or kind of activities you could do and times you accomplished 
Jess than you would like. If health problems affected your activities only a lime, 
choose a fow number. Choose a high number if health problems affected your 
activities a great deal. 
Consider only how much hea'lth problems affected your ability 
to do your regular daily aciMties, other than work at a job. 
Health problems 
Health p:roblems 
had nio ,effect on ---------------- completely 
my daily 
O 1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
prevented me 
actiivities 
from doing my 
datlry activities 
CIRCLE A NUMBER 
WPAtGl:l V2.0 (US English) 
2 

Axicabtagene ciloleucel; KTE-C19
Kite Pharma, Inc.
Clinical Protocol: KTE-C19-107 (ZUMA-7)
Amendment 6
CONFIDENTIAL
Page 111
14 April 2023 
Appendix D.
Country-specific Regulatory Agency Requirements
Germany and Switzerland 
Protocol Section 
Country-specific Requirement 
Section 7.6
Section 7.7
Section 7.9
Section 7.11.1
The post-infusion monitoring of subjects in this protocol will be extended by 
monitoring on day 8, day 9, and day 10, according to procedures outlined in 
Table 2, column “IP administration period, 1-7.” The subject may stay 
hospitalized or return to the clinic daily for this extended monitoring at the 
discretion of the investigator.
The daily monitoring will include vital signs (see Section 7.6), blood draw 
for chemistry panel with CRP, blood draw for CBC w/differential (see 
Section 7.11.1), and neurological assessment (which may include MMSE 
[see Section 7.7]). Any observed toxicity will be evaluated according to 
Section 7.9 of this protocol and managed according to the IB.
Abbreviations: CBC, complete blood count; CRP, C-reactive protein; IP, investigational product; MMSE, Mini-Mental Status 
Examination.
France
Abbreviations: ANSM, National Agency for the Safety of Medicines and Health Products; CAR, chimeric antigen receptor; 
CBC, complete blood count; CRP, C-reactive protein; IP, investigational product; MMSE, Mini-Mental Status Examination.
Switzerland
Protocol Section 
Country-specific Requirement 
Section 5.2
The additional exclusion criterion, applicable to Switzerland only, specifies 
the excipients of the CryoStor used in the cryopreservation of CAR T cells 
and frequently for CD34+ stem cells, and is as follows:
History of severe immediate hypersensitivity reaction to tocilizumab or any 
of the agents used in this study, including the excipients DMSO and Dextran 
40 present in CryoStor.
Abbreviations: CAR, chimeric antigen receptor; DMSO, dimethyl sulfoxide.
Protocol Section 
Country-specific Requirement 
Section 7.6
Section 7.7
Section 7.9
Section 7.11.1
The post-infusion monitoring of subjects in this protocol will be extended by 
monitoring on day 8, day 9, and day 10, according to procedures outlined in 
Table 2, column “IP administration period, 1-7.” The ANSM recommends a 
10-day hospitalization after infusion of any CAR T-cell product.
The daily monitoring will include vital signs (see Section 7.6), blood draw 
for chemistry panel with CRP, blood draw for CBC w/differential (see 
Section 7.11.1), and neurological assessment (which may include MMSE 
[see Section 7.7]). Any observed toxicity will be evaluated according to 
Section 7.9 of this protocol and managed according to the IB.

Axicabtagene ciloleucel; KTE-C19
Kite Pharma, Inc.
Clinical Protocol: KTE-C19-107 (ZUMA-7)
Amendment 6
CONFIDENTIAL
Page 112
14 April 2023 
Sweden
Protocol Section
Country-specific Requirement
N/A 
1. RISK AND BENEFIT ASSESSMENT
Kite Pharma is conducting a global Phase 3, randomized, open-label study to 
evaluate the efficacy of axicabtagene ciloleucel versus standard of care 
therapy in subjects with relapsed/refractory diffuse large B cell lymphoma 
(Protocol number KTE-C19-107 [ZUMA-7]).
1.1. Important Identified and Potential Risks related to IMP
The risks of axicabtagene ciloleucel/KTE-C19 therapy are well described. 
Two important identified risks, which are not commonly encountered in 
general oncology practice, include CRS and neurologic events. These events 
have an early onset, generally within 1 week after the therapy, and are mostly 
reversible (> 95%). Additional important identified risks include cytopenias, 
infection and hypogammaglobulinemia. Strategies have been developed to 
monitor for and manage these Adverse Events (AEs) and are included in the 
most recent version of the Investigator Brochure (IB). The important potential 
risks associated with axicabtagene ciloleucel/KTE-C19 are replication 
competent retrovirus (RCR), secondary malignancy, autoimmune disorders 
reactivation/new onset, immunogenicity and tumor lysis syndrome (TLS).
1.2. Mitigation of IMP-related risks
1.2.1. Subject selection (inclusion/exclusion criteria)
The inclusion and exclusion criteria described in section 5 of the protocol 
ensure patients most at risk with regards to the identified important and 
potential risks associated with axicabtagene ciloleucel are not included in the 
study.
Inclusion criteria:
•
106. No known history or suspicion of central nervous system (CNS) 
involvement by lymphoma
•
110. Adequate bone marrow, renal, hepatic, pulmonary and cardiac 
function defined as:
o
Absolute neutrophil count (ANC) ≥1000/μL
o
Platelet count ≥ 75,000/μL
o
Absolute lymphocyte count ≥ 100/μL
o
Cardiac ejection fraction ≥ 50%, no evidence of pericardial effusion 
as determined by an echocardiogram (ECHO), and no clinically 
significant electrocardiogram (ECG) findings
o
Baseline oxygen saturation > 92% on room air
Exclusion criteria:
•
208. History of severe, immediate hypersensitivity reaction attributed to 
aminoglycosides

Axicabtagene ciloleucel; KTE-C19
Kite Pharma, Inc.
Clinical Protocol: KTE-C19-107 (ZUMA-7)
Amendment 6
CONFIDENTIAL
Page 113
14 April 2023 
Protocol Section
Country-specific Requirement
•
209. Presence of fungal, bacterial, viral, or other infection that is 
uncontrolled or requiring intravenous (IV) antimicrobials for 
management. Simple urinary tract infection (UTI) and uncomplicated 
bacterial pharyngitis are permitted if responding to active treatment.
•
213. Subjects with detectable cerebrospinal fluid malignant cells or 
known brain metastases, or with a history of cerebrospinal fluid 
malignant cells or brain metastases
•
214. History or presence of non-malignant CNS disorder such as seizure 
disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar 
disease, or any autoimmune disease with CNS involvement
•
218. History of autoimmune disease, requiring systemic 
immunosuppression and/or systemic disease modifying agents within the 
last 2 years.
1.2.2. Subject Monitoring
All subjects will receive axicabtagene ciloleucel infusion at a health care 
facility, followed by daily monitoring at a health care facility for at least 
7 days to monitor for signs and symptoms of CRS and neurologic events. 
Alternatively, subjects may be hospitalized to receive their axicabtagene 
ciloleucel infusion and be observed for CRS and neurologic events in the 
hospital setting, if deemed appropriate by the investigator.
If subjects are hospitalized, subjects should not be discharged from the 
hospital until all axicabtagene ciloleucel related non-hematological toxicities 
resolve to ≤ Grade 1 or return to baseline. Subjects may be discharged with 
non-critical and clinically stable or improving toxicities (eg renal 
insufficiency) even if > Grade 1, if deemed appropriate by the investigator. 
Subjects should remain in a hospital for ongoing axicabtagene ciloleucel 
related fever, hypotension, hypoxia, or ongoing neurologic events > Grade 1, 
or if deemed necessary by the investigator. Subjects should be instructed to 
remain within proximity of the clinical study site for at least 4 weeks 
following axicabtagene ciloleucel infusion. Subjects and their family 
members/caregivers should be educated on potential CRS and neurologic 
symptoms such as fever, dyspnea, confusion, aphasia, dysphasia, somnolence, 
encephalopathy, ataxia, or tremor. Subjects or their family 
members/caregivers should be instructed to immediately contact the treating 
investigator or seek immediate medical attention if any of these symptoms 
develop.
Toxicity management
The goal of CRS management in anti-CD19 chimeric antigen receptor (CAR) 
T-cell therapy is to prevent life-threatening conditions while preserving the 
benefits of antitumor effects. Carefully monitor subjects for signs and 
symptoms of CRS.

Axicabtagene ciloleucel; KTE-C19
Kite Pharma, Inc.
Clinical Protocol: KTE-C19-107 (ZUMA-7)
Amendment 6
CONFIDENTIAL
Page 114
14 April 2023 
Protocol Section
Country-specific Requirement
The CRS grading scale and a CRS management algorithm are provided in 
section 6.5 of the Investigator’s Brochure to direct the investigators. This 
CRS management strategy is based on the experience to date with 
axicabtagene ciloleucel/KTE-C19 in addition to other anti-CD19 CAR T-cell 
products (Lee et al, 2014).
Carefully monitor subjects for signs and symptoms of neurologic events. Rule 
out other causes of neurologic symptoms. The neurologic events management 
algorithm is provided in section 6.5 of the investigator’s brochure. This 
neurologic event management strategy is based on the experience to date with 
axicabtagene ciloleucel/KTE-C19 in addition to other anti-CD19 CAR T-cell 
products (Brudno and Kochenderfer 2016).
1.3. Benefit-Risk Analysis
Patients with r/r DLBCL especially primary refractory and early relapse 
within 1 year of firstline rituximab-based chemoimmunotherapy have poor 
prognosis even with high-dose therapy-autologous stem cell transplant 
(HDT-ASCT). Because these patients likely are resistant to chemotherapy, 
they may benefit from therapies with different mechanisms of action. 
Immunotherapy, which is based on the enhancement of an immune response 
against the tumor, is a promising approach to treating many cancer types. 
T-cells play an important role in destroying diseased cells throughout the 
body. Studies with immune checkpoint inhibitors and bi-specific T-cell 
engagers have demonstrated the potential of T-cells to treat cancer. T-cells 
need to possess the appropriate specificity for a tumor, be present in sufficient 
numbers, and overcome any local immunosuppressive factors to be effective. 
Chimeric antigen receptor (CAR) engineered T-cells may address these issues 
and are a promising approach for cancer therapy.
Axicabtagene ciloleucel is an engineered autologous T-cell immunotherapy 
by which a patient’s own T cells are collected and subsequently genetically 
altered to recognize CD19. CD19 is expressed on the cell surface of B-cell 
malignancies. In ZUMA-1, which investigated the safety and efficacy of 
axicabtagene ciloleucel in subjects with refractory aggressive NHL, 
axicabtagene ciloleucel significantly improved ORR (P < 0.0001) compared 
to historical control. The ORR was 83% with a complete response (CR) rate 
of 58%. With a median follow up of 27.1 months, 39% of subjects had 
ongoing responses (37% in CR). 76% of patients in ZUMA-1 were refractory 
to 2nd or later line of therapy and 23% had an early relapse after ASCT. AEs, 
which can be severe or occasionally life-threatening, were well defined, 
generally reversible, and manageable, with no apparent long-term 
consequences other than B-cell aplasia. The most common events were 
cytopenias, which are expected from the conditioning chemotherapy, as well 
as CRS and neurologic events. The rates of severe CRS and neurologic events 
decreased over the course of the ZUMA-1 study, whereas efficacy remained 
consistent. In an analysis of data from the PARMA and CORAL trial the 
ORR to salvage therapy in less heavily pretreated patients with an early 
relapse after 1st line chemoimmunotherapy was only 40% and 46% 
respectively (Guglielmi et al, 1998) (Gisselbrecht et al, 2010). Axicabtagene 

Axicabtagene ciloleucel; KTE-C19
Kite Pharma, Inc.
Clinical Protocol: KTE-C19-107 (ZUMA-7)
Amendment 6
CONFIDENTIAL
Page 115
14 April 2023 
Protocol Section
Country-specific Requirement
ciloleucel may even have a further improved efficacy and tolerability in this 
patient population with less chemo-refractory disease and lower disease 
burden. Therefore axicabtagene ciloleucel will be compared to standard of 
care (SOC) as 2nd line therapy in patients with chemo-refractory DLBCL or 
an early relapse after 1st line chemoimmunotherapy in the proposed ZUMA-7 
study.
1.4. Conclusion
Treatment of patients with r/r DLBCL remains challenging and there is a 
significant unmet need for better therapies in these patients. This patient 
population has a specifically poor prognosis even with HDT-ASCT.
ZUMA-7 is a randomized and controlled study against standard of care as 
determined by the investigator based on guidance from the protocol. This 
design is expected to allow for appropriate assessment of the benefit of 
axicabtagene ciloleucel in patients with r/r DLBCL compared to current 
standard of care treatment, while maintaining an acceptable safety profile for 
the important identified risks of CRS, neurologic events, cytopenias, 
infections and hypogammaglobulinemia.
2. SPONSOR REPORTING REQUIREMENTS
Depending on relevant local legislation or regulations, including the 
applicable US FDA Code of Federal Regulations, the EU Clinical Trials 
Directive (2001/20/EC) and relevant updates, and other country-specific 
legislation or regulations, Kite may be required to expedite to worldwide 
regulatory agencies reports of SAEs, serious adverse drug reactions (SADRs), 
or suspected unexpected serious adverse reactions (SUSARs). In accordance 
with the EU Clinical Trials Directive (2001/20/EC), the sponsor or a specified 
designee will notify worldwide regulatory agencies and the relevant IEC in 
concerned Member States of applicable SUSARs as outlined in current 
regulations.
Assessment of expectedness for SAEs will be determined by Kite using 
reference safety information specified in the investigator’s brochure or 
relevant local label as applicable.
All investigators will receive a safety letter notifying them of relevant 
SUSAR reports associated with any study IMP. The investigator should 
notify the IRB or IEC of SUSAR reports as soon as is practical, where this is 
required by local regulatory agencies, and in accordance with the local 
institutional policy.
3. CONTACT PERSON FOR MEDICAL AND SAFETY QUERIES
Investigators can contact the European medical monitor for medical and 
safety queries:

Axicabtagene ciloleucel; KTE-C19 
Kite Phruma, Inc. 
Clinical Protocol: KTE-Cl9-107 (ZUMA-7) 
Amendment6 
Protocol Section 
CONFIDENTIAL 
Country-specific Requirement 
European Medical Monitor 
PPD 
Executive D1rector, Clinical Development 
Mobile Phone: PPD 
Email: PPD 
---------
Urgent Safety Issues Contag 
PPD 
a .;:::::J 
" l 
d 
'd 
. l 
Vice Presi ent Puaimacovigi ance an Epi ellllo ogy 
EU QPPV 
Phone: ""'P'""P_..D 
______ _ 
Email: PPD 
......_ ___ _ 
Adverse event and SUSAR repoiting 
Safety _FC@gilead.com 
Relevant SAEs will be repoited to MP A by the sponsor in accordance with 
local requirements. This includes SUSARs from all applicable trial sites. 
4. STUDY DISCONTINUATION 
Both the sponsor and the investigator reseive the light to teiminate the study 
at any time. Should this be necessaiy, both paities will aiTange 
discontinuation procedures and notify the appropiiate regulatoiy 
authoiity(ies), IRBs, and IECs. In teiminating the study, Kite and the 
investigator will assure that adequate consideration is given to the protection 
of the subjects' interests. 
5. REFERENCES 
Brndno JN, Kochenderfer JN. Toxicities of Chimeiic Antigen Receptor T 
Cells: Recognition and Management.. Blood. 2016;127(26):3321-30. 
Gisselbrecht C, Glass B, Monnier N, Singh Gill D, Linch DC, Tmeny M, et 
al. Salvage regimens with autologous ti·ansplantation for relapsed lai·ge 
B-cell lymphoma in the iituximab era. J Clin Oncol. 2010;28(27):4184-
90. 
Guglielmi C, Gomez F, Philip T, Hagenbeek A, Maitelli M, Sebban C, et al. 
Time to relapse has prognostic value in patients with aggressive 
lymphoma enrolled onto the Paima tiial. J Clin Oncol. 
1998;16(10):3264-9. 
Lee DW, Gai·dner R, Poiter DL, Louis CU, Ahmed N, Jensen M, Grnpp SA, 
Mackall CL. Cunent concepts in the diagnosis and management of 
cytokine release syndrome. Blood. 2014;124(2):188-95. 
Page 116 
14 April 2023 

Axicabtagene ciloleucel; KTE-C19
Kite Pharma, Inc.
Clinical Protocol: KTE-C19-107 (ZUMA-7)
Amendment 6
CONFIDENTIAL
Page 117
14 April 2023 
Appendix E.
Childbearing Potential and Birth Control
This study will follow the recommendations from the Clinical Trials Facilitation Group (CTFG) 
{Clinical Trials Facilitation and Coordination Group (CTFG) 2020}, as described below.
1. Definition of Childbearing Potential
A woman is considered of childbearing potential (ie, fertile) following menarche and until 
becoming postmenopausal unless permanently sterile. Permanent sterilization methods include 
hysterectomy, bilateral salpingectomy, and bilateral oophorectomy.
A postmenopausal state is defined as no menses for 12 months without an alternative medical 
cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used 
to confirm a postmenopausal state in women not using hormonal contraception or hormonal 
replacement therapy. However in the absence of 12 months of amenorrhea, a single FSH 
measurement is insufficient.
For the purpose of this study, a man is considered fertile after puberty unless permanently sterile 
by bilateral orchidectomy.
2. Birth Control Methods That May Be Considered as Highly Effective
Methods that can achieve a failure rate of less than 1% per year when used consistently and 
correctly are considered as highly effective birth control methods. Such methods include:
•
Combined (estrogen- and progesterone-containing) hormonal contraception associated with 
inhibition of ovulationa:
Oral
Intravaginal
Transdermal
•
Progestogen-only hormonal contraception associated with inhibition of ovulationa:
Oral
Injectable
Implantablea
•
Intrauterine device (IUD)a
a  Contraception methods that in the context of this guidance are considered to have low user dependency.

Axicabtagene ciloleucel; KTE-C19
Kite Pharma, Inc.
Clinical Protocol: KTE-C19-107 (ZUMA-7)
Amendment 6
CONFIDENTIAL
Page 118
14 April 2023 
•
Intrauterine hormone-releasing system (IUS)a
•
Bilateral tubal occlusiona
•
Vasectomized partnera,b
•
Sexual abstinencec
3. Unacceptable Birth Control Methods
Birth control methods that are unacceptable include periodic abstinence (calendar, 
symptothermal, postovulation methods), withdrawal (coitus interruptus), spermicides only, and 
lactational amenorrhoea method (LAM). A female condom and a male condom should not be 
used together.
b  Vasectomized partner is a highly effective birth control method provided that partner is the sole sexual partner of 
the woman of childbearing potential trial participant and that the vasectomized partner has received medical 
assessment of the surgical success.
c  In the context of this guidance sexual abstinence is considered a highly effective method only if defined as 
refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The 
reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the 
preferred and usual lifestyle of the subject.

Axicabtagene ciloleucel; KTE-C19
Kite Pharma, Inc.
Clinical Protocol: KTE-C19-107 (ZUMA-7)
Amendment 6
CONFIDENTIAL
Page 119
14 April 2023 
Appendix F.
Pandemic Risk Assessment and Mitigation Plan
During an ongoing pandemic, potential risks associated with subjects being unable to attend 
study visits have been identified for this study.
These risks can be summarized as follows:
1) Subject safety monitoring and follow-up:
a) Subjects may be unable or unwilling to come to the investigational site for their 
scheduled study visits as required per protocol.
Mitigation plan: For subjects who may be unable or unwilling to visit the investigational 
site for their scheduled study visits as required per protocol, the principal investigator or 
qualified delegate will conduct a remote study visit, via phone or video conferencing, to 
assess the subjects within the target visit window date whenever possible. During the 
remote study visit, the following information at minimum will be reviewed:
i)
Confirm if subject has experienced any adverse events (AEs)/serious adverse events 
(SAEs)/special situations (including pregnancy) and follow-up on any unresolved 
AEs/SAEs.
ii) Review the current list of concomitant medications and document any new 
concomitant medications.
iii) If applicable, confirm electronic/paper diary questionnaires and patient-reported 
outcomes have been completed and transmitted.
b) Subjects may be unable or unwilling to travel to the site for planned assessments (eg, 
blood draws, imaging, physical exams).
Mitigation plan: Local laboratories or other vendors may be utilized as appropriate to 
monitor subject safety until the subject can return to the site for their regular follow-up 
per protocol. Any changes in the party conducting laboratory assessments for the study 
because of the pandemic will be documented accordingly. Pregnancy testing may be 
performed using a home urine pregnancy test if local laboratory pregnancy testing is not 
feasible. Central lab kits may be sent to subject’s local hospital lab for sample collection. 
Relevant imaging (eg, PET-CT, CT) can be done at the subject’s local hospital and 
images transferred or sent to the investigative site. Physical exams can be completed by a 
local physician with results sent to investigative site.
c) Subjects may be unable or unwilling to attend the study visit to sign an updated informed 
consent form version.
Mitigation plan: The site staff will follow their approved informed consent process and 
remain in compliance with the local ethics committee/institutional review board and 
national laws and regulations. Remote consent will be allowed if has been approved by 

Axicabtagene ciloleucel; KTE-C19
Kite Pharma, Inc.
Clinical Protocol: KTE-C19-107 (ZUMA-7)
Amendment 6
CONFIDENTIAL
Page 120
14 April 2023 
the local ethics committee/institutional review board. The consent process will be 
documented and confirmed by normal consent procedure at the investigative site at the 
earliest opportunity.
2) Protocol and monitoring compliance:
a) Protocol deviations may occur in situations where scheduled visits or procedures cannot 
be conducted as planned per protocol.
Mitigation plan: If it is not possible to complete a required procedure at a 
protocol-specified time point, an unscheduled visit should be conducted as soon as 
possible when conditions allow so that the required procedure can be performed. The 
situation should be recorded and explained as a protocol deviation. Any missed subject 
visits must be reported in the eCRF, if possible, and recorded as deviations to the 
protocol because of the pandemic, so that they can be appropriately documented and 
described in the clinical study report. Any remote study visits that are conducted in lieu 
of clinic visits because of the pandemic will be documented as a protocol deviation 
related to the pandemic.
b) Study monitors may be unable to carry out source data review or source data verification, 
or study drug accountability or assess protocol and Good Clinical Practice compliance. 
This may lead to delays in source data verification, an increase in protocol deviations, or 
underreporting of AEs.
Mitigation plan: The study monitor is to remain in close communication with the site to 
ensure ongoing data entry and query resolution. Remote source data verification may be 
arranged if allowed by local regulation and the Study Monitoring Plan. The study monitor 
is to reference the Study Monitoring Plan for guidance on how to conduct an off-site 
monitoring visit. The study staff is to save and document all relevant communication in 
the study files. The status of sites that cannot accept monitoring visits and/or subjects 
on-site, must be tracked centrally and updated on a regular basis.
3) Missing data and data integrity:
There may be an increased amount of missing data because of subject’s missing 
visits/assessments. This could have an impact on the analysis and the interpretation of 
clinical study data.
Mitigation plan: Implications of a pandemic on methodological aspects for the study will be 
thoroughly assessed and documented, and relevant actions will be taken as appropriate (eg, 
modification of the statistical analysis plan) and in compliance with regulatory authorities’ 
guidance. Overall, the clinical study report will describe the impact of the pandemic on the 
interpretability of study data.

Axicabtagene ciloleucel; KTE-C19
Kite Pharma, Inc.
Clinical Protocol: KTE-C19-107 (ZUMA-7)
Amendment 6
CONFIDENTIAL
Page 121
14 April 2023 
Risks will be assessed continuously, and temporary measures will be implemented to mitigate 
these risks as part of a mitigation plan, as described above. These measures will be 
communicated to the relevant stakeholders as appropriate and are intended to provide alternate 
methods that will ensure the evaluation and assessment of the safety of subjects who are enrolled 
in this study.
Since these potential risks are considered mitigated with the implementation of these measures, 
the expected benefit-risk assessment of axicabtagene ciloleucel in study subjects remains 
unchanged.

Axicabtagene ciloleucel; KTE-C19
Kite Pharma, Inc.
Clinical Protocol: KTE-C19-107 (ZUMA-7)
Amendment 6
CONFIDENTIAL
Page 122
14 April 2023 
Appendix G.
Protocol Amendment History
A high-level summary of this amendment is provided in tabular form in the subsection below. 
Minor changes such as the correction of typographic errors, grammar, or formatting are not 
detailed.
Earlier separate summaries of changes are available upon request.
A separate tracked change (red-lined) document comparing the previous protocol version 
(Amendment 5, dated 25 June 2020) and USA country-specific version (Amendment 5.1, dated 
16 September 2020) to this amendment will be made available upon the publication of this 
protocol.
•
Amendment 6 (Dated 14 April 2023)
•
Changes from Amendment 5 (dated 25 June 2020) to Amendment 6 (dated 14 April 2023) 
are detailed below:
Section Number and Name
High-level Description of Change
Brief Rationale
Title Page
Section 7.15 Long-term Follow-
up (Axicabtagene Ciloleucel 
and Standard of Care Arms)
Section 8 Subject Withdrawal
Section 13 Study 
Documentation and Archive
Section 18, Appendix A: 
Sponsor and Investigator 
Signature Page
Section 18, Appendix E: 
Childbearing Potential and 
Birth Control
Minor administrative changes have been 
made throughout the protocol to align with 
Kite’s latest protocol template.
To align with Kite’s latest 
recommendations and 
processes
Protocol Synopsis
Study Schema
Section 3.5 Duration of Study 
and Subject Participation
Section 7.11.2.2 RCR Testing
Section 7.15 Long-term Follow-
up (Axicabtagene Ciloleucel 
and Standard of Care Arms)
Table 4 Schedule of Assessment 
Long-term Follow-up Period
Clarification provided regarding study 
duration, visit frequency, and assessments for 
subjects randomized to the SOC and 
axicabtagene ciloleucel arms.
Additional updates included to clarify the 
transition of subjects to the separate LTFU 
study. 
For clarification
Protocol Synopsis, Statistical 
Considerations section
Section 10.2.1 Study Endpoints 
Primary
Reference to an acceptable lower limit for the 
observed total EFS events to trigger the 
primary analysis has been removed at the 
request of the regulatory agency.
Additional minor changes made for 
alignment of language in protocol 
Requested by a regulatory 
agency

Axicabtagene ciloleucel; KTE-C19
Kite Pharma, Inc.
Clinical Protocol: KTE-C19-107 (ZUMA-7)
Amendment 6
CONFIDENTIAL
Page 123
14 April 2023 
Section Number and Name
High-level Description of Change
Brief Rationale
Section 10.3 Sample Size 
Considerations
Section 10.6 Planned Method of 
Analysis
amendments 5 25 June 2020 and 5.1 16 
September 2020.
Section 6.2.4.7 Axicabtagene 
Ciloleucel Retreatment
Retreatment eligibility criteria updated to 
reflect the maximum time after the initial 
axicabtagene ciloleucel infusion a subject can 
be retreated.
For clarification
Section 9.4 Reporting of 
Serious Adverse Events
Safety reporting email updated to: 
Safety_FC@gilead.com. Clarification added 
regarding any relevant information on 
ongoing SAEs post the database closure, 
which must be submitted to Kite within 
24 hours after the investigator’s knowledge 
of the event.
For clarification
Section 10.6.6 Pharmacokinetic 
Analyses
Anti-CD19 CAR T levels measured in 
peripheral blood will be summarized with 
descriptive statistics.
For clarification
Section 18 Appendix D 
Country-specific Regulatory 
Agency Requirements
Section 5.2 Exclusion Criterion 
# 222
Country specific requirements added from 
separate documents for harmonization of the 
protocol to prepare for the EU CTR 
transition. 
Requested by a regulatory 
agency
Section 18 Appendix F 
Pandemic Risk Assessment and 
Mitigation Plan
Addition of an appendix providing guidelines 
around pandemic risk assessments and 
mitigation plan.
Added for site guidelines 
around pandemic risk 
assessment.
Section 18 Appendix G 
Protocol Amendment History
Addition of an appendix (Protocol 
Amendment History added) presenting a 
high-level summary of changes for the 
amendment. 
Addition to reflect Protocol 
Amendment 6 changes.  

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