A Phase 2 Multicenter Study of Axicabtagene Ciloleucel in Subjects With Relapsed/Refractory Indolent Non-Hodgkin Lymphoma (iNHL)
Phase: PHASE2
Conditions: Follicular Lymphoma, Marginal Zone Lymphoma, Indolent Non-Hodgkin Lymphoma
Sponsor: Kite, A Gilead Company

  
CLINICAL STUDY PROTOCOL
A PHASE 2 MULTICENTER STUDY OF AXICABTAGENE CILOLEUCEL IN 
SUBJECTS WITH RELAPSED/REFRACTORY INDOLENT NON-HODGKIN 
LYMPHOMA (INHL)
Protocol Number:
KTE-C19-105 (ZUMA-5)
USAN/INN:
Axicabtagene ciloleucel
Company Code:
KTE-C19
IND Number:
016278
ClinicalTrials.gov Identifier
NCT03105336
EU CT Number:
2023-505169-10-00
Clinical Study Sponsor:
Kite Pharma, Inc.
2400 Broadway
Santa Monica, CA 90404
United States of America
The medical monitor name and contact information is 
provided on the Key Study Team Contact List
Key Sponsor Contacts:
Original Protocol Date:
Protocol Amendment #1:
Protocol Amendment #2:
Protocol Amendment #3:
Protocol Amendment #4:
Protocol Amendment #5:
Protocol Amendment #6:
Protocol Amendment #7:
26 Nov 2016
29 Aug 2017
19 Jan 2018
07 Sep 2018
29 Nov 2018
24 Jul 2019
08 Jul 2020
22 Feb 2023
Protocol Amendment Number 
and Date:
Amendment #8
Date:
29 January 2024
This study will be conducted under United States (US) Food and Drug Administration (FDA) 
Investigational New Drug (IND) application regulations (21 Code of Federal Regulations Part 312); 
however, sites located in the European Economic Area, the United Kingdom, and Switzerland are not 
included under the IND application and are not considered to be IND application sites.
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 of Technical Requirements for Pharmaceuticals for 
Human Use (ICH) Good Clinical Practice (GCP) and applicable regulatory and local requirements.
 
 
 
 
 

Axicabtagene Ciloleucel; KTE-C19
Protocol KTE-C19-105
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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 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.

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PROTOCOL SYNOPSIS
Title:
A Phase 2 Multicenter Study of Axicabtagene Ciloleucel in 
Subjects with Relapsed/Refractory Indolent Non-Hodgkin 
Lymphoma (iNHL)
Indication:
Adult subjects with relapsed or refractory (r/r) B-cell iNHL 
of follicular lymphoma (FL) or marginal zone lymphoma 
(MZL) histological subtypes.
Study Design:
Study KTE-C19-105 is a Phase 2, multicenter, single-arm, 
open-label study of axicabtagene ciloleucel in subjects with 
r/r iNHL.
Up to approximately 160 subjects, including up to 
approximately 125 subjects with FL with at least 80 subjects 
with FL in the inferential analysis set, will be enrolled and 
treated with cyclophosphamide and fludarabine conditioning 
chemotherapy, followed by a target dose of 2 x 106 
autologous, genetically modified, anti-CD19 chimeric 
antigen receptor (CAR) T cells per kg body weight.
Each subject will proceed through the following study 
periods:
•
Screening
•
Enrollment/Leukapheresis
•
Conditioning chemotherapy
•
Investigational product (IP) treatment
•
Post-treatment assessment
•
Long-term follow-up
Study Objectives:
The primary objective is to evaluate the efficacy of 
axicabtagene ciloleucel, as measured by objective response 
rate (ORR), in subjects with relapsed or refractory (r/r) B-
cell iNHL.
Key secondary objectives are to characterize the safety 
profile, complete response (CR) rate, ORR among those 
subjects with 3 or more lines of prior therapy, CR rate 
among those subjects with 3 or more lines of prior therapy, 
and to determine duration of response (DOR), progression-
free survival (PFS), and overall survival (OS). Additional 
secondary objectives will include additional safety and 
pharmacokinetic/pharmacodynamic endpoints and the time 
to next therapy endpoint.

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Hypothesis:
Four hypotheses will be tested using a fixed sequence 
procedure in terms of ORR and CR to control the overall 
type I error at 1-sided alpha level of 0.025 with the 
following test order:
Hypothesis 1 (H1):  test for ORR as determined by central 
review, if significant then
Hypothesis 2 (H2):  test for CR rate as determined by central 
review, if significant then
Hypothesis 3 (H3):  test for ORR as determined by central 
review in the subjects who have had 3 or more prior lines of 
therapy, if significant then
Hypothesis 4 (H4):  test for CR rate as determined by central 
review in the subjects who have had 3 or more prior lines of 
therapy
The hypotheses H1 through H4 will be assessed at the time of 
the interim analysis 3, 4, and 5 and the primary analysis.
The H1 is that the ORR, as determined by central review, to 
axicabtagene ciloleucel is significantly greater than 40% in 
subjects with the FL histological subtype in the inferential 
analysis set.
The H2 is that the CR rate, as determined by central review, 
to axicabtagene ciloleucel is significantly greater than 15% 
in subjects with the FL histological subtype in the inferential 
analysis set.
The H3 is that the ORR, as determined by central review, to 
axicabtagene ciloleucel is significantly greater than 40% in 
subjects with FL in the inferential analysis set who have had 
3 or more prior lines of therapy.
The H4 is that the CR rate, as determined by central review, 
to axicabtagene ciloleucel is significantly greater than 15% 
in subjects with FL the inferential analysis set who have had 
3 or more prior lines of therapy.
No formal hypothesis testing is planned for MZL 
histological subtype. The analysis will be descriptive.
Primary Endpoint:
ORR, defined as complete response (CR) + partial response 
(PR) per the Lugano Classification {Cheson 2014} as 
determined by central review.  These assessments will be 
referred to as “central read” in this document.

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Secondary Endpoints:
•
CR rate, defined as CR per the Lugano Classification 
{Cheson 2014} by central read
•
ORR, defined as CR + PR per the Lugano Classification 
{Cheson 2014} by central read for those subjects who 
have had 3 or more prior lines of therapy
•
CR rate, defined as CR per the Lugano Classification 
{Cheson 2014} by central read for those subjects who 
have had 3 or more prior lines of therapy
•
Incidence of adverse events (AEs) and clinically 
significant changes in laboratory values
•
DOR
•
PFS
•
OS
•
Incidence of antibodies to axicabtagene ciloleucel
•
Levels of anti-CD19 CAR T cells in blood
•
Levels of cytokines in serum
•
Time to next therapy
Key Covariates for ORR and 
Other Key Safety and 
Efficacy Endpoints:
•
Age (< 65, ≥ 65 years)
•
Gender
•
Race
•
Ethnicity
•
Relapsed vs refractory disease status at study entry
•
Follicular Lymphoma International Prognostic Index 
(FLIPI) score
•
Eastern Cooperative Oncology Group (ECOG) 
performance status 0 or 1
•
Time to relapse from initiation of first anti-CD20-
chemotherapy combination therapy (≥ 24 months vs 
< 24 months)
•
Disease burden, as defined by Groupe d'Etude des 
Lymphomes Folliculaires (GELF) criteria
•
Histological diagnosis by both local and central 
pathology
•
Prior PI3K inhibitor
•
Number of prior lines of therapy (excluding single agent 
anti-CD20 antibody as a line of therapy)
•
Double refractory (subjects refractory to the first 2 lines 
of therapy)

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Sample Size:
Up to approximately 160 enrolled and treated subjects, 
including up to approximately 125 subjects with FL with at 
least 80 subjects with FL in the inferential analysis set.
Duration of Study 
Participation 
The duration of study participation for individual subjects 
will vary depending on a subject’s screening requirements, 
response to treatment, and survival.  After completing at 
least 60 months (FL subjects) or at least 24 months (MZL 
subjects) of assessments in this study since the initial 
axicabtagene ciloleucel infusion and after agreement by the 
Sponsor, subjects will transition to a separate Kite Pharma, 
Inc-sponsored long-term follow-up (LTFU) study, KT-US-
982-5968 where they will complete the remainder of the 
15 year follow-up assessments.  Additional information is 
available in Section 3.5.
Study Eligibility:
Refer to Section 5 for a detailed list of inclusion and 
exclusion criteria.
Treatment (IP):
Axicabtagene ciloleucel treatment consists of 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.  Refer to Section 6 for treatment details.
Conditioning Chemotherapy 
Treatment:
Axicabtagene ciloleucel is administered after a conditioning 
chemotherapy regimen consisting of fludarabine 
30 mg/m2/day and cyclophosphamide 500 mg/m2/day, 
administered x 3 days.  Refer to Section 6 for chemotherapy 
treatment details.
Procedures:
At specific time points as outlined in the schedule of 
assessments, subjects will undergo the following procedures:  
collection of informed consent; general medical history, 
including previous treatments for B-cell iNHL; physical 
exam (including neurological exam), including vital signs 
and performance status; blood draws for complete blood 
count (CBC); chemistry panels; cytokines; C-reactive 
protein; lymphocyte subsets; antibodies to axicabtagene 
ciloleucel; replication-competent retrovirus (RCR); and anti 
CD19 CAR T-cell analysis.  Women of childbearing 
potential will undergo a urine or serum pregnancy test.
Subjects will also undergo a baseline electrocardiogram 
(ECG), echocardiogram (ECHO), a positron emission 
tomography-computed tomography (PET-CT), possible bone 
marrow aspirate and biopsy, and leukapheresis.

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Data Safety Monitoring 
Board:
An independent Data Safety Monitoring Board (DSMB) will 
have ongoing oversight of the study and will monitor data 
during this study.
The DSMB will first meet to review safety data when 
10 subjects are enrolled and treated with axicabtagene 
ciloleucel and have had an opportunity to be followed for 
4 weeks from the date of axicabtagene ciloleucel infusion.
The DSMB will meet again to review the safety data when 
30 subjects are enrolled and treated with axicabtagene 
ciloleucel and have had an opportunity to be followed for 
4 weeks from the date of axicabtagene ciloleucel infusion.
The DSMB will meet again to review the safety data when 
30 subjects with FL in the inferential set are enrolled and 
treated with axicabtagene ciloleucel and have had an 
opportunity to be followed for 6 months from the date of 
axicabtagene ciloleucel infusion.
The DSMB will meet again to review the safety data when 
80 subjects with FL in the inferential analysis set have been 
enrolled and treated with axicabtagene ciloleucel and have 
had an opportunity to be followed for 6 months from the 
date of axicabtagene ciloleucel infusion.
The DSMB will meet again to review the safety data when 
80 subjects with FL in the inferential analysis set have been 
enrolled and treated with axicabtagene ciloleucel and have 
had an opportunity to be followed for 9 months from the first 
disease response assessment.
The DSMB will be chartered to make trial conduct 
recommendations based on an analysis of risk vs benefit.  
The DSMB may meet more often as needed.  Refer to 
Section 9.9.
Statistical Considerations:
The primary endpoint for the study is ORR per the Lugano 
Classification {Cheson 2014} as determined by central read.
The study will enroll and treat up to approximately 
160 subjects including up to approximately 125 subjects 
with FL with at least 80 subjects with FL in the inferential 
set. The study uses a single-arm design of the subjects with 
FL in the inferential analysis set to test for an improvement 
in response rates (ORR and CR rate), with descriptive 
analyses being conducted for the subjects with MZL.  For 
the test of primary efficacy in at least 80 subjects with FL in 

Axicabtagene Ciloleucel; KTE-C19
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the inferential analysis set, this study has approximately 93% 
power to test the null hypothesis that the ORR is 40% versus 
the alternative hypothesis that the ORR is 60% with a 
1-sided alpha level of 0.0237.
The following planned analyses will be performed.
•
Interim analysis 1 will be conducted after 10 subjects in 
the safety analysis set (Section 10.5) have been enrolled 
and treated with axicabtagene ciloleucel and have had an 
opportunity to be followed for 4 weeks.  This analysis 
will be for safety only.
•
Interim analysis 2 will be conducted after 30 subjects in 
the safety analysis set (Section 10.5) have been enrolled 
and treated with axicabtagene ciloleucel and have had an 
opportunity to be followed for 4 weeks.  This analysis 
will be for safety only.
•
Interim analysis 3 will be performed when 30 subjects in 
the FL inferential set have had the opportunity to be 
followed for 6 months after the axicabtagene ciloleucel 
infusion.  This interim analysis will be for safety and to 
assess early demonstration of efficacy.  This interim 
analysis is based on the interpolated alpha spending 
functions.  The nominal alpha level for the assessment of 
efficacy for this analysis is 0.0003. The study will not be 
stopped if early efficacy is demonstrated.  The analyses 
of the efficacy endpoints for MZL will be descriptive.
•
Interim analysis 4 will be performed when 80 subjects in 
the FL inferential analysis set have had the opportunity 
to be followed for 6 months after axicabtagene ciloleucel 
infusion.  The nominal alpha level for the assessment of 
efficacy for this analysis is 0.0005. The study will not be 
stopped if early efficacy is demonstrated.  The analyses 
of the efficacy endpoints for MZL will be descriptive.
•
Interim analysis 5 will be performed when 80 subjects in 
the FL inferential analysis set have had the opportunity 
to be followed for 9 months after the first disease 
assessment. The nominal alpha level for the assessment 
of efficacy for this analysis is 0.0005. The study will not 
be stopped if early efficacy is demonstrated.  The 
analyses of the efficacy endpoints for MZL will be 
descriptive.

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•
The primary analysis will occur after at least 80 subjects 
with FL in the inferential analysis set have been treated 
with axicabtagene ciloleucel and have had the 
opportunity to be followed for 12 months after the first 
disease response assessment.
•
Follow-up analysis 1 will be performed when 80 subjects 
in the FL inferential analysis set have had the 
opportunity to be followed for 18 months after 
axicabtagene ciloleucel infusion.  This analysis will be 
for safety and efficacy and will be descriptive.
•
Follow-up analysis 2 will be performed when 80 subjects 
in the FL inferential analysis set have had the 
opportunity to be followed for 24 months after 
axicabtagene ciloleucel infusion.  This analysis will be 
for safety and efficacy and will be descriptive.
•
Additional follow-up analyses may be performed as 
needed to satisfy regulatory requirements, and to 
perform long-term efficacy, safety, and survival follow-
up.
•
The final analysis will occur after all subjects transition 
to the LTFU study, KT-US-982-5869.

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Figure 1.
Study Schema
Abbreviations:  CAR, chimeric antigen receptor.
a.
Long-term Follow-up Period:  After completing at least 60 months (FL subjects) or at least 24 months (MZL subjects) of 
assessments in this study since the initial axicabtagene ciloleucel infusion and after agreement by the Sponsor, subjects will 
complete the remainder of the 15 year follow-up assessments in a separate Kite Pharma, Inc-sponsored long-term follow-up 
(LTFU) study, KT-US-982-5968.
Screening
Enrollment/Leukapheresis
Conditioning 
Chemotherapy Period
(Day –5 to Day –3)
Fludarabine 
30 mg/m2/day, 
Cyclophosphamide 
500 mg/m2/day 
Fludarabine and 
cyclophosphamide 
administered x 3 days
Investigational Product 
Treatment Period
(Day 0)
Subject is hospitalized prior 
to treatment with 
axicabtagene ciloleucel and 
remains hospitalized for 
observation for a minimum 
of 7 days after treatment 
unless otherwise required by 
country regulatory agencies. 
Axicabtagene ciloleucel at a 
target dose of 2 x 106 
anti-CD19 CAR T cells/kg 
to be infused intravenously.
Post-treatment Assessment Period
Long-term Follow-up Perioda

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TABLE OF CONTENTS
PROTOCOL SYNOPSIS................................................................................................................................................3
TABLE OF CONTENTS..............................................................................................................................................11
LIST OF TABLES........................................................................................................................................................13
LIST OF FIGURES ......................................................................................................................................................13
LIST OF ABBREVIATIONS.......................................................................................................................................14
1.
OBJECTIVES.......................................................................................................................................................17
2.
DISEASE BACKGROUND AND RATIONALE...............................................................................................18
2.1.
CD19 Target Expression .........................................................................................................................23
2.2.
Anti-CD19 Chimeric Antigen Receptor T-cell Product..........................................................................23
2.3.
Axicabtagene Ciloleucel Experience in Diffuse Large B-cell Lymphoma (ZUMA-1 Trial) .................24
2.4.
Other Axicabtagene Ciloleucel Study Results ........................................................................................24
2.5.
Benefit/Risk Assessment for the Study ...................................................................................................25
3.
STUDY DESIGN.................................................................................................................................................26
3.1.
General Study Design..............................................................................................................................26
3.2.
Participating Sites....................................................................................................................................27
3.3.
Number of Subjects .................................................................................................................................27
3.4.
Replacement of Subjects .........................................................................................................................27
3.5.
Study Duration.........................................................................................................................................27
3.5.1.
Study Duration for Individual Subjects.................................................................................27
3.5.2.
Completion of Study..............................................................................................................27
3.6.
Long-term Follow-up ..............................................................................................................................28
4.
SUBJECT SCREENING AND ENROLLMENT................................................................................................29
5.
SUBJECT ELIGIBILITY.....................................................................................................................................30
5.1.
Inclusion Criteria.....................................................................................................................................30
5.2.
Exclusion Criteria....................................................................................................................................31
6.
PROTOCOL TREATMENT................................................................................................................................33
6.1.
Treatment Terminology...........................................................................................................................33
6.2.
Study Treatment ......................................................................................................................................33
6.2.1.
Axicabtagene Ciloleucel........................................................................................................33
6.2.2.
Auxiliary/Non-Investigational Medicinal Products ..............................................................34
6.2.3.
Subsequent Therapy ..............................................................................................................36
6.3.
Rationale for Study Treatment Dosing:  Conditioning Chemotherapy and Axicabtagene 
Ciloleucel Dose .......................................................................................................................................36
6.3.1.
Conditioning Chemotherapy Dose ........................................................................................36
6.3.2.
Axicabtagene Ciloleucel Dose ..............................................................................................36
6.4.
Study Treatment Schedule.......................................................................................................................37
6.4.1.
Leukapheresis........................................................................................................................37
6.4.2.
Cyclophosphamide and Fludarabine (Days –5 Through –3 Before 
Infusion of Axicabtagene Ciloleucel)....................................................................................37
6.4.3.
Axicabtagene Ciloleucel (Day 0) ..........................................................................................38
6.5.
Toxicity Management..............................................................................................................................38
7.
STUDY PROCEDURES......................................................................................................................................39
7.1.
Informed Consent ....................................................................................................................................39

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7.2.
Demographic Data...................................................................................................................................39
7.3.
Medical and Treatment History...............................................................................................................39
7.4.
Physical Exam, Vital Signs, Performance Status ....................................................................................39
7.5.
Bone Marrow Biopsy ..............................................................................................................................40
7.6.
Lumbar Puncture .....................................................................................................................................40
7.7.
Disease Response Assessment ................................................................................................................40
7.8.
Cardiac Function .....................................................................................................................................41
7.9.
Laboratory ...............................................................................................................................................41
7.9.1.
Local Lab Analysis................................................................................................................41
7.9.2.
Central Lab Analysis .............................................................................................................42
7.10.
Biomarkers ..............................................................................................................................................42
7.11.
Description of Study Periods...................................................................................................................44
7.11.1.
Screening ...............................................................................................................................44
7.11.2.
Rescreening ...........................................................................................................................46
7.11.3.
Enrollment/Leukapheresis.....................................................................................................46
7.11.4.
Conditioning Chemotherapy and Axicabtagene Ciloleucel Infusion....................................47
7.11.5.
Conditioning Chemotherapy Period......................................................................................49
7.11.6.
Investigational Product Treatment Period.............................................................................50
7.11.7.
Post-treatment Assessment Period ........................................................................................52
7.11.8.
Long-term Follow-up Period.................................................................................................54
7.11.9.
Retreatment............................................................................................................................55
8.
SUBJECT WITHDRAWAL ................................................................................................................................62
8.1.
Reasons for Removal from Treatment ....................................................................................................62
8.2.
Reasons for Removal from Study............................................................................................................63
9.
SAFETY REPORTING........................................................................................................................................64
9.1.
AEs ..........................................................................................................................................................64
9.2.
Reporting of AEs.....................................................................................................................................64
9.3.
Definition of SAEs ..................................................................................................................................66
9.4.
Reporting of SAEs...................................................................................................................................66
9.4.1.
Reporting Deaths...................................................................................................................68
9.5.
Diagnosis Versus Signs and Symptoms ..................................................................................................68
9.6.
Pregnancy and Lactation .........................................................................................................................68
9.7.
Hospitalization and Prolonged Hospitalization.......................................................................................69
9.8.
Abnormal Vital Sign Value.....................................................................................................................69
9.9.
DSMB......................................................................................................................................................69
10.
STATISTICAL CONSIDERATIONS.................................................................................................................71
10.1.
Hypothesis ...............................................................................................................................................71
10.2.
Study Endpoints.......................................................................................................................................72
10.2.1.
Primary ..................................................................................................................................72
10.2.2.
Secondary ..............................................................................................................................72
10.2.3.
Covariates..............................................................................................................................73
10.3.
Sample Size Considerations ....................................................................................................................74
10.4.
Statistical Assumptions ...........................................................................................................................75
10.5.
Analysis Subsets......................................................................................................................................75
10.6.
Access to Individual Subject Treatment Assignments ............................................................................75
10.7.
Interim Analysis ......................................................................................................................................76
10.8.
Planned Methods of Analysis..................................................................................................................76
10.8.1.
ORR.......................................................................................................................................77
10.8.2.
CRR.......................................................................................................................................77
10.8.3.
DOR.......................................................................................................................................77
10.8.4.
PFS ........................................................................................................................................77

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10.8.5.
OS..........................................................................................................................................77
10.8.6.
Time to Next Therapy ...........................................................................................................77
10.8.7.
Safety.....................................................................................................................................78
10.8.8.
Long-term Data Analysis ......................................................................................................78
10.8.9.
Follow-up Analysis ...............................................................................................................78
11.
REGULATORY OBLIGATIONS.......................................................................................................................79
11.1.
IRB/IEC...................................................................................................................................................79
11.2.
Subject Confidentiality............................................................................................................................79
11.3.
Investigator Signatory Obligations..........................................................................................................80
12.
PROTOCOL AMENDMENTS AND TERMINATION .....................................................................................81
13.
STUDY DOCUMENTATION AND ARCHIVE ................................................................................................82
14.
STUDY MONITORING AND DATA COLLECTION......................................................................................83
15.
PUBLICATION ...................................................................................................................................................84
16.
COMPENSATION...............................................................................................................................................85
17.
REFERENCES.....................................................................................................................................................86
ADDIN EN.REFLIST..........................................................................................................................................86
18.
APPENDICES......................................................................................................................................................92
18.1.
Sponsor and Investigator Signature Page................................................................................................93
18.2.
Country-specific Regulatory Agency Requirements - France.................................................................94
18.3.
Lugano Classification..............................................................................................................................95
18.3.1.
Complete Remission..............................................................................................................95
18.3.2.
Partial Remission...................................................................................................................96
18.3.3.
Stable Disease........................................................................................................................97
18.3.4.
Progressive Disease...............................................................................................................97
18.4.
Tabulated List of Investigational Medicinal Products and Auxiliary Medicinal Products for 
EU............................................................................................................................................................98
18.5.
Protocol Amendment History................................................................................................................100
18.5.1.
Amendment 8 (29 January 2024) ........................................................................................100
18.5.2.
Amendment 7 (22 February 2023) ......................................................................................101
18.6.
Pandemic Risk Assessment and Mitigation Plan ..................................................................................103
LIST OF TABLES
Table 1.
Treatment Outcomes in First-line Indolent Lymphoma..........................................................19
Table 2.
Investigational Treatments in Relapsed or Refractory iNHL..................................................21
Table 3.
Schedule of Assessments (1 of 2)............................................................................................57
Table 4.
Schedule of Assessments (2 of 2)............................................................................................60
Table 5
List of Investigational Medicinal Product ...............................................................................99
Table 6.
List of Auxiliary Medicinal Products ......................................................................................99
LIST OF FIGURES
Figure 1.
Study Schema ..........................................................................................................................10
Figure 2.
Anti-CD19 CAR......................................................................................................................24

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LIST OF ABBREVIATIONS
AE
Adverse event
ALL
Acute lymphoblastic leukemia
ALT
Alanine aminotransferase
ANC
Absolute neutrophil count
ASCT
Autologous stem cell transplant
AST
Aspartate aminotransferase
BUN
Blood urea nitrogen
CAR
Chimeric antigen receptor 
CBC
Complete blood count
CLL
Chronic lymphocytic leukemia
CMV
Cytomegalovirus
CNS
Central nervous system
CPF
Cell processing facility
CR
Complete response
CRF
Case report form
CRO
Contract research organization
CRP
C-reactive protein 
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
DVT
Deep vein thrombosis
ECG
Electrocardiogram
ECHO
Echocardiogram
ECOG
Eastern Cooperative Oncology Group
EFS
Event-free survival
EU
European Union
FAS
Full analysis set
FER
Ferritin
FDA
Food and Drug Administration
FL
Follicular lymphoma 
FLIPI
Follicular Lymphoma International Prognostic Index
GCP
Good Clinical Practice
GELF
Groupe d'Etude des Lymphomes Folliculaires

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GM-CSF
Granulocyte macrophage-colony stimulating factor
GOT
Glutamic-oxaloacetic transaminase
GPT
Glutamic-pyruvic transaminase
HDT
High-dose chemotherapy
HEENT
Head, eyes, ears, nose, and throat 
Hep
Hepatitis
HIV
Human immunodeficiency virus
IB
Investigator’s Brochure
ICF
Informed consent form
ICH
International Conference on Harmonisation of Technical Requirements for 
Pharmaceuticals for Human Use
ICU
Intensive care unit
ID
Identification
IFN
Interferon
IL
Interleukin
iNHL
Indolent non-Hodgkin lymphoma
IP
Investigational product
IPI
International Prognostic Index
IPM
Investigational Product Manual 
IRB/IEC
Institutional Review Board/Independent Ethics Committee
IV
Intravenous
LDH
Lactate dehydrogenase
LTFU
Long-term follow-up
LVEF
Left ventricular ejection fraction
MDS
Myelodysplastic syndrome
MZL
Marginal zone lymphoma
NCI
National Cancer Institute
NHL
Non-Hodgkin lymphoma
ORR
Overall response rate
OS
Overall survival
PBMC
Peripheral blood mononuclear cell
PCR
Polymerase chain reaction
PD
Progressive disease
PET-CT
Positron emission tomography-computed tomography
PFS
Progression-free survival 
PMBCL
Primary mediastinal B-cell lymphoma
PR
Partial response
qPCR
Quantitative polymerase chain reaction
RCR 
Replication-competent retrovirus
r/r
Relapsed or refractory 

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SAE
Serious adverse event
scFv
Single-chain variable fragment
SCT
Stem cell transplantation
SD
Stable disease
SmPC
Summary of product characteristics
SOA
Schedule of assessment
SUSAR
Suspected unexpected serious adverse reaction
TBI
Total body irradiation
TFL
Transformed follicular lymphoma
TNF
Tumor necrosis factor
UE
Unevaluable
ULN
Upper limit of normal
WBC
White blood cell
WHO
World Health Organization

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1.
OBJECTIVES
The primary objective is to evaluate the efficacy of axicabtagene ciloleucel, as measured by 
objective response rate (ORR), in subjects with relapsed or refractory (r/r) B-cell iNHL.
Key secondary objectives are to characterize the safety profile, complete response (CR) rate, 
ORR among those subjects with 3 or more lines of prior therapy, CR rate among those subjects 
with 3 or more lines of prior therapy, and to determine duration of response (DOR), progression-
free survival (PFS), and overall survival (OS). Additional secondary objectives will include 
additional safety and pharmacokinetic/pharmacodynamic endpoints and the time to next therapy 
endpoint.

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2.
DISEASE BACKGROUND AND RATIONALE
Indolent non-Hodgkin lymphomas comprise approximately one-third of malignant lymphomas 
{Gribben 2007}. Their presentation is typically insidious, with slow-growing lymphadenopathy, 
organomegaly, and cytopenias.  Systemic B symptoms (fever, weight loss, night sweats) and 
spontaneous tumor lysis or other oncologic emergencies are uncommon during initial stages 
{Freedman 2018, Gribben 2007, Tan 2013}.  The indolent lymphomas are further subdivided by 
histology, with FL, MZL (inclusive of splenic, nodal, and mucosa-associated lymphoid tissue 
subtypes), and small lymphocytic lymphoma making up the bulk of diagnoses {Al-Hamadani 
2015, Lunning 2012, The Non-Hodgkin's Lymphoma Classification Project 1997}.
FL is the most common iNHL and represents approximately 17% of non-Hodgkin lymphoma 
(NHL) cases in the United States {Al-Hamadani 2015}, with an incidence of 3.5 new cases per 
100,000 person years {Noone 2017}.  Like most iNHL subtypes, it is largely considered to be 
incurable with standard front-line therapies {Wang 2017}.  However, advances in the 
management of this disease over the last several decades have led to a substantial improvement 
in long-term survival, with 1 retrospective analysis demonstrating a median OS of nearly 
20 years from first diagnosis {Tan 2013}.
Despite these strides made in managing FL, outcomes in FL are quite varied {Kahl 2016}.  
Prognosis of newly diagnosed FL is predicted by one of several clinical risk stratification scores, 
such as the Follicular Lymphoma International Prognostic Index (FLIPI) {Solal-Céligny 2004} 
and the FLIPI-2 {Federico 2009}.  These scores are adaptations of the International Prognostic 
Index (IPI) used in aggressive lymphomas and have been shown to stratify patients by outcome 
into low-, intermediate-, or high-risk subsets.  High-risk patients with ≥ 3 FLIPI criteria have a 
5-year overall survival rate of 53%, whereas, low-risk patients with ≤ 1 FLIPI criterion have a 
5-year survival rate of over 90%.
Patients with limited stage disease may benefit from involved field radiation therapy, 
chemotherapy, and rituximab, or, in patients who are ineligible for radiation therapy due to 
disease site, observation {Freedman 2018}.  Low-risk patients with advanced stage disease may 
also be eligible for a period of close disease observation with regular imaging assessments 
{National Comprehensive Cancer Network 2018}.  The Groupe d’Etude des Lymphomes 
Folliculaires (GELF) criteria are commonly used to trigger treatment in such patients.  These 
criteria include bulky disease, B symptoms, splenomegaly, pleural effusions, peritoneal ascites, 
cytopenias, and leukemia (> 5.0 x 109/L malignant cells) {Brice 1997, National Comprehensive 
Cancer Network 2018}.  Patients with indications for systemic therapy are generally treated with 
one of a variety of regimens shown in Table 1.

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Table 1.
Treatment Outcomes in First-line Indolent Lymphoma
Regimen
N
Outcome
Reference
Rituximab + bendamustine 
514
Improved PFS vs R-CHOP 
(69.5 m vs 31.2 m) 
{Rummel 2013} 
Rituximab + CHOP
38
ORR 100%; DOR 83.5 months
{Czuczman 2004}
Rituximab + CVP
321
Improved TTP vs CVP (34 m vs 15 
m)
{Marcus 2008}
Rituximab (maintenance)
379
Improved 3-year PFS vs observation 
(82% vs 36%)
{Ardeshna 2014}
Rituximab + lenalidomide
103
ORR 90%; 3-year PFS 75.3%
{Fowler 2014} 
Abbreviations:  CHOP, cyclophosphamide, doxorubicin, vincristine, and prednisone; CVP, cyclophosphamide, vincristine, 
prednisone; DOR, duration of response; m, months; N, number; ORR, overall response rate; PFS, progression-free survival; 
R-CHOP, rituximab + cyclophosphamide, doxorubicin, vincristine, and prednisone; TTP, time to progression.
ORRs with front-line chemoimmunotherapy with an alkylator and anti-CD20 monoclonal 
antibody combination are nearly 100% {Flinn 2014}.  However, Casulo and colleagues recently 
showed that among 588 patients with FL who received first-line R-CHOP, approximately 20% 
relapsed within 2 years of diagnosis {Casulo 2015}.  Importantly, these patients had significantly 
worse outcomes overall, with 2-year OS of 64% and 5-year OS of 50%, respectively.  In 
contrast, patients without early disease progression had 5-year OS rates of 90%.
Similar findings were reported by Maurer and colleagues, who examined cases from the Mayo 
Clinic-University of Iowa Specialized Programs of Research Excellence Molecular 
Epidemiology Resource (SPORE MER) {Maurer 2016}.  Their analysis demonstrated that 
17% of patients treated with front-line combination chemotherapy with rituximab did not achieve 
event-free survival (EFS) at 12 months and 29% of patients did not achieve EFS at 24 months.  
These patients had poor OS outcomes, because they showed increased mortality when compared 
with an age- and sex-matched control group drawn from the US general population.  By contrast, 
patients who achieved EFS at 12 months and 24 months had mortality rates that were 
comparable to rates observed in the control population.
These studies reveal a population of patients who are not accurately identified by existing 
pretreatment prognostication tools like the FLIPI.  Whether current standard high-intensity 
salvage strategies, such as autologous stem cell transplantation (ASCT), can improve long-term 
survival outcomes remains to be determined.  Therefore, patients with FL who experience 
disease progression within 2 years of diagnosis and treatment with rituximab and chemotherapy 
represent a group with high need for new and efficacious treatments.
Another group of patients with a high unmet medical need consists of patients with iNHL who 
have relapsed following more than 1 line of combination chemotherapy, particularly those who 
progress rapidly following treatment.  Patients with iNHL who progress soon (eg, 6 months) 
after completing treatment are frequently referred to as refractory to agents contained in the 
regimen.  Such patients may be refractory to chemotherapy, rituximab, or both, and tend to have 
incomplete and short-lived responses.

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In 2014, a PI3Kδ inhibitor, idelalisib, was conditionally approved for use by the Food and Drug 
Administration (FDA) in patients who have relapsed with FL based on published data {Gopal 
2014, ZYDELIG 2016}.  In this study, 125 patients who were refractory to rituximab and an 
alkylating agent (defined as lack of response or had experienced relapse within 6 months of 
completing therapy) were given idelalisib 150 mg twice daily until disease progression, 
unacceptable drug toxicity, or patient death.  The ORR in the overall population was 57%, with 
6% achieving a CR.  The ORR in FL was 54% (39/72), and in MZL, it was 47% (7/15). The 
median PFS was 11 months, with a 12-month PFS rate of < 50%, highlighting the need for new 
therapies.
The drug was associated with significant gastrointestinal side effects with 43% of all treated 
patients experiencing any grade diarrhea (13% Grade 3 or higher) and 30% reporting nausea.  
Additionally, Grade 3 or higher elevations of alanine aminotransferase (ALT) and aspartate 
aminotransferase (AST) were seen in 13% and 8% of patients, respectively.  Cytopenias were 
common as well:  27% of patients had Grade 3 or higher neutropenia, and reductions in 
hemoglobin and platelets were each seen in roughly a quarter of patients.  Treatment was 
discontinued due to adverse events (AEs) in 25 patients (20%), and 42 patients (34%) required 
dose reductions.  Eleven patients died while receiving the study drug or within 30 days of 
discontinuation.
In 2017, a second PI3K inhibitor (PI3Kδ and PI3K inhibitor), copanlisib, received an 
accelerated approval by the FDA in patients who have relapsed with FL based on published data 
{ALIQOPA 2017, Dreyling 2017}.  In this study, 142 patients with iNHL who had > 2 prior 
lines of therapy were enrolled; 104 of these patients had FL.  Copanlisib was given intravenously 
at a dose of 60 mg on Day 1, Day 8, and Day 15 of a 28-day cycle. The ORR in the overall 
population was 59%, with 12% achieving a CR.  The median PFS was 11.2 months, and median 
DOR was 22.6 months.  The ORR in FL was 59% (61/104), and the ORR in MZL was 70% 
(16/23). The drug was associated with significant side effects, with 41% of patients experiencing 
Grade 3 or higher hyperglycemia, and 24% experiencing Grade 3 hypertension (> 160 mm Hg).  
Cytopenias were noted, with 24% of patients Grade 3 or higher neutropenia, and 7% 
experiencing Grade 3 or higher thrombocytopenia. Grade 3 or higher lung infection was 
observed in 16% of patients.
A number of agents, which are under investigation in relapsed FL, are summarized in {Kahl 
2016} and presented in Table 2.

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Table 2.
Investigational Treatments in Relapsed or Refractory iNHL
Agent
Classification
N
ORR 
(%)
CR 
(%)
PFS/TTP
Reference
Lenalidomide vs 
Lenalidomide + 
rituximab
Immunomodulator vs 
Immunomodulator + anti-
CD20 mAb
45
46
53
76
20
39
mTTP (y)
1.1
2
{Leonard 
2015}
Duvelisib 
(IPI-145)
PI3K- and PI3K- inhibitor
83
41
0
mPFS (mo)
8.3
{Flinn 2016}
Ibrutinib
BTK inhibitor
40
37.5
12.5
mPFS (mo)
14
{Bartlett 
2018}
Venetoclax 
(ABT-199)
BCL-2 inhibitor
29
37.9
13.8
mPFS (mo)
11
{Davids 
2017}
Polatuzumab 
vedotin + 
Rituximab
Anti-CD79b antibody-drug 
conjugate
2.4 mg/kg
1.8 mg/kg:
+ anti-CD20 mAb
25
20
76
75
44
10
mPFS (mo)
15
Not reached
{Advani 
2015}
Obinutuzumab 
vs
Rituximab
Anti-CD20 mAbs:
Obinutuzumab 
Rituximab
74
75
44.6
33.3
NR
NR
mPFS (mo)
17.6
25.4
{Sehn 2015}
Abbreviations:  BCL-2, B-cell lymphoma-2; BTK, Bruton’s tyrosine kinase; CD, cluster of differentiation; CR, complete 
response; mAb. mo, month; mPFS, median progression-free survival; mTTP, median time to progression; N, number; NR, not 
reported; ORR, objective response rate; y, year.
Note:  Table adapted from {Kahl 2016}
High-dose chemotherapy (HDT) followed by ASCT is an option for patients who experience a 
disease relapse, and can result in subsequent remissions. Randomized data from the 
pre-rituximab era suggests improved PFS and OS for patients with relapsed FL who are treated 
with HDT/ASCT vs those who are treated with conventional chemotherapy alone {Schouten 
2003}. Retrospective single-institution data suggest that HDT/ASCT is associated with improved 
survival outcomes in patients with < 3 previous chemotherapies or low FLIPI scores compared 
with patients who had ≥ 3 prior chemotherapies or high FLIPI scores {Vose 2008}. This finding 
is supported in the setting of myeloablative therapy followed by ASCT in a retrospective study 
of patients treated at Dana Farber Cancer Institute and St. Bartholomew’s Hospital {Rohatiner 
2007}. This conditioning regimen yielded durable remissions, as 48% of patients were disease-
free after 10 years of follow-up. Further, after 12-years of follow-up, the remission duration 
curve plateaued at 48%, suggesting that some patients may be cured of their lymphoma with this 
treatment approach. However, this therapy was associated with a high risk of secondary myeloid 
dysplasia or acute myeloid leukemia, which resulted in 15 deaths in this study. The risk of the 
development of a secondary myeloid neoplasm is further underscored by Friedberg and 
colleagues {Friedberg 1999} in which the actuarial incidence of myelodysplastic syndrome 
(MDS) at 10 years following ASCT after cyclophosphamide/total body irradiation (TBI) was 
nearly 20%. Furthermore, outcomes following diagnosis of MDS in this population were dismal, 
with the majority of patients exhibiting poor-risk cytogenetics and a median OS of 9.4 months.

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The role of allogenic transplantation in relapsed FL is not clear.  Evens and colleagues showed 
similar failure-free survival, but inferior overall survival, due to increased nonrelapse mortality 
in patients treated with allogenic transplant compared with those treated with ASCT in the 
rituximab era {Evens 2013}.  Reducing the conditioning regimen for allogenic transplant does 
not seem to alleviate the treatment-related mortality, as shown in a larger retrospective study in 
which the 3-year nonrelapse mortality was 5% and 22% for ASCT and reduced-intensity 
allogenic transplant, respectively {Robinson 2013}.  Nevertheless, a small, retrospective, 
single-institution study suggested that patients with a remission duration of ≤ 12 months prior to 
initiating salvage therapy may show improved disease control and EFS with allogeneic transplant 
compared with ASCT {Lunning 2016}.
Although currently available therapies for relapsed/refractory iNHL show some benefit, 
additional therapies are needed.  Anti-CD19 chimeric antigen receptor (CAR) T cells with CD28 
and CD3ƺ signaling domains have shown promising activity in patients with B-cell cancers.  
While the majority of patients treated with CAR T cells thus far have had aggressive lymphoma 
and B-cell precursor leukemia, small numbers of subjects with indolent B-cell lymphomas have 
also been treated.  In 2009, Kite Pharma, Inc., (hereafter referred to as Kite or Kite Pharma) 
initiated a clinical trial in partnership with the National Cancer Institute (NCI; #NCT00924326) 
using CAR T cells in subjects with NHL and chronic lymphocytic leukemia (CLL).  The 
CAR T cells in the NCI study were manufactured using the same CAR construct used in 
axicabtagene ciloleucel.  Of the 43 subjects who were treated on that protocol, 7 subjects had 
iNHL {Kochenderfer 2012, Kochenderfer 2015, Kochenderfer 2017}.  The subjects with iNHL 
had a median age of 57 and a median of 3 prior therapies.  Study treatment for the first 4 subjects 
with iNHL was more intense than current designs and consisted of conditioning chemotherapy 
with cyclophosphamide (60 to 120 mg/kg) for 2 days followed by fludarabine (25 mg/m2) for 
5 days.  This conditioning regimen was followed by a single infusion of 3, 11, 13, or 30 x 106 
anti-CD19 CAR T cells/kg, which was then followed by high dose interleukin (IL)-2 
(720000 IU/kg every 8 hours for 4 to 10 doses, where toxicity precluded additional doses) 
{Kochenderfer 2012}.
The remaining 3 subjects received CAR T cells generated with an improved short-term culture 
method (6 to 10 days), at 1, 1, or 2 x 106 anti-CD19 CAR T cells/kg, respectively, and received 
and no post infusion IL-2 {Kochenderfer 2015, Kochenderfer 2017}.  One subject received a 
relatively high dose of conditioning chemotherapy, with 120 mg/kg cyclophosphamide 
{Kochenderfer 2015}.  Two subjects received less intense conditioning chemotherapy, with 
cyclophosphamide (300 or 500 mg/m2) for 3 days and with fludarabine (25 mg/m2) for 3 days 
{Kochenderfer 2017}.
The ORR and CR rate in the 6 subjects with iNHL evaluable for efficacy was 6/6 (100%) and 
4/6 (67%), respectively.  At the time of the data cutoff in December 2015, at a median follow-up 
of 24.9 months, 5/6 subjects with iNHL remained in response with a median DOR of 23.9 
(11+ to 64.6+) months. Grade ≥ 3 CAR-related AEs occurred in 50% of subjects; Grade ≥ 3 
CAR-related cytokine release syndrome (CRS) and neurotoxicity AEs occurred in 29% and 
36% of subjects, respectively.  All AEs resolved without routine use of tocilizumab or steroids.  
There were no CAR-related deaths.

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2.3.
Axicabtagene Ciloleucel Experience in Diffuse Large B-cell Lymphoma 
(ZUMA-1 Trial)
ZUMA-1 is a Phase 1/2 multicenter, open-label study evaluating the safety and efficacy of 
axicabtagene ciloleucel in adult subjects with refractory diffuse large B-cell lymphoma 
(DLBCL), primary mediastinal B-cell lymphoma (PMBCL), and transformed follicular 
lymphoma (TFL).  The primary analysis for the study, which has been completed, was based on 
analysis of the data from 101 subjects who had been followed for at least 6 months after infusion 
of axicabtagene ciloleucel.  The study met its primary endpoint: the ORR in these 101 subjects 
was 82% (95% confidence interval [CI]: 72% to 89%), which was significantly higher than the 
pre-specified control rate of 20% (p < 0.001).  The CR rate was 52% {Neelapu 2017}.  With a 
median follow-up of 15.4 months, 42% of subjects had ongoing durable responses.
Refer to the current axicabtagene ciloleucel IB for a summary of the safety and efficacy findings 
from this study.
2.4.
Other Axicabtagene Ciloleucel Study Results
Refer to the current axicabtagene ciloleucel IB for current study results.
CCI

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2.5.
Benefit/Risk Assessment for the Study
Refer to the current version of the IB for a summary of the known and potential benefits and 
risks associated with axicabtagene ciloleucel.

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3.
STUDY DESIGN
3.1.
General Study Design
Study KTE-C19-105 is a Phase 2, multicenter, open-label study evaluating the efficacy of 
axicabtagene ciloleucel in subjects with r/r B-cell iNHL of FL or MZL histological subtypes.
Up to approximately 160 subjects, including up to approximately 125 subjects with FL with at 
least 80 subjects with FL in the inferential analysis set, will be enrolled and treated with 
cyclophosphamide and fludarabine conditioning chemotherapy, followed by a target dose of 
2 x 106 anti-CD19 CAR T cells per kg body weight.
Each subject will proceed through the following study periods:
•
Screening
•
Enrollment/Leukapheresis
•
Conditioning chemotherapy
•
Investigational product (IP) treatment
•
Post-treatment assessment
•
Long-term follow-up (LTFU)
An independent Data Safety Monitoring Board (DSMB) will have ongoing oversight of this 
study and will review data during this study.  The DSMB will first meet to review safety data 
when 10 subjects in the safety analysis set have been enrolled and treated with axicabtagene 
ciloleucel and have had an opportunity to be followed for 4 weeks.  The DSMB will meet for a 
second time to review safety data after 30 subjects in the safety analysis set have been enrolled 
and treated with axicabtagene ciloleucel and have had an opportunity to be followed for 4 weeks. 
The DSMB will meet for a third time to review safety and efficacy data after 30 subjects with FL 
in the inferential analysis set have been enrolled and treated with axicabtagene ciloleucel and 
have had an opportunity to be followed for 6 months.  The DSMB will meet for a fourth time 
when 80 subjects with FL in the inferential analysis set have been enrolled and treated with 
axicabtagene ciloleucel and have had an opportunity to be followed for 6 months after 
axicabtagene ciloleucel infusion.  The DSMB will meet for a fifth time when 80 subjects with FL 
in the inferential analysis set have been enrolled and treated with axicabtagene ciloleucel and 
have had an opportunity to be followed for 9 months from the first disease response assessment.
The DSMB will also review serious adverse event (SAE) information and suspected unexpected 
serious adverse reactions (SUSARs) on a regular basis throughout the study.  The DSMB may 
meet more often as needed.

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For details surrounding the DSMB, refer to Section 9.9.
For study requirements assigned to each study period, refer to the schedule of assessments (SOA; 
Table 3 and Table 4) and Section 7 for details.
A study schema is represented in Figure 1.
3.2.
Participating Sites
Approximately 20 centers located in North America and Europe will participate in this study.  
During the conduct of the study, additional regions, countries, or sites may be added as 
necessary.
Sites that do not enroll a subject within 3 months of their site being activated will be considered 
for closure.
3.3.
Number of Subjects
Participants in this trial will be referred to as “subjects.”  It is anticipated that up to 
approximately 160 subjects, including up to approximately 125 subjects with FL with at least 
80 subjects with FL in the inferential analysis set, will be enrolled and treated in this study.
Refer to Section 10 for statistical considerations, including sample size estimations.
3.4.
Replacement of Subjects
Clinical trial subjects will continue to be enrolled until the specified numbers are attained in the 
safety analysis and inferential analysis sets.  Subjects who have not received axicabtagene 
ciloleucel will be retained in the analyses of disposition and safety, where appropriate 
(see Section 10.5).
3.5.
Study Duration
3.5.1.
Study Duration for Individual Subjects
The duration of participation for individual subjects will vary depending on a subject’s screening 
requirements, response to treatment, survival, and if applicable, timing of transition to the 
separate Kite Pharma, Inc-sponsored long-term follow-up (LTFU) study, KT-US-982-5968.  
After completing at least 60 months (FL subjects) or at least 24 months (MZL subjects) of 
assessments in this study since the initial axicabtagene ciloleucel infusion and after agreement by 
the Sponsor, subjects will transition to the LTFU study.
3.5.2.
Completion of Study
Completion of the study is defined as the time at which the last subject transitions to the LTFU 
study or, while still a participant in this study, is considered lost to follow-up, withdraws consent, 
or dies.  Upon activation of the LTFU study at the subject’s study site, the subject will complete 
LTFU assessments under the LTFU protocol.

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3.6.
Long-term Follow-up
After completing at least 60 months (FL subjects) or at least 24 months (MZL subjects) of 
assessments in this study since the initial axicabtagene ciloleucel infusion and after agreement by 
the Sponsor, subjects will transition to the LTFU study where they will complete the remainder 
of the 15 year follow-up assessments.  On the LTFU study, subjects will be monitored for the 
occurrence of late-onset targeted AEs/serious AEs (SAEs) suspected to be possibly related to 
axicabtagene ciloleucel, occurrence of any product-related SAEs and presence of replication-
competent retrovirus (RCR) and/or insertional mutagenesis.
In the LTFU study, subjects will continue assessments at timepoints contiguous with their 
timepoints  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.
Each subject who enters the screening period will receive a unique subject identification (ID) 
number.  This 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 subject ID number must remain constant throughout the entire clinical study; it 
must not be changed after enrollment or if the subject is rescreened or retreated.

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5.
SUBJECT ELIGIBILITY
5.1.
Inclusion Criteria
1) Histologically confirmed diagnosis of B-cell iNHL, with histological subtype limited to FL 
Grade 1, Grade 2, or Grade 3a or MZL nodal or extranodal, based on criteria established by 
the World Health Organization (WHO) 2016 classification
2) Relapsed or refractory disease after 2 or more prior lines of therapy. Prior therapy must have 
included an anti-CD20 monoclonal antibody combined with an alkylating agent. (Single 
agent anti-CD20 antibody will not count as line of therapy for eligibility.) Stable disease 
(without relapse) > 1 year from completion of last therapy is not eligible.
3) At least 1 measurable lesion according to the Lugano Response Criteria for Malignant 
Lymphoma {Cheson 2014}.  Lesions that have been previously irradiated will be considered 
measurable only if progression has been documented following completion of radiation 
therapy.
4) No known history or suspicion of central nervous system (CNS) involvement by lymphoma.
5) At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed since any prior 
systemic therapy and enrollment, except for systemic inhibitory/stimulatory immune 
checkpoint therapy.  At least 3 half-lives must have elapsed from any prior systemic 
inhibitory/stimulatory immune checkpoint molecule therapy and enrollment (eg, ipilimumab, 
nivolumab, pembrolizumab, atezolizumab, OX40 agonists, 4-1BB agonists).
6) Toxicities due to prior therapy must be stable and recovered to ≤ Grade 1 (except for 
clinically non-significant toxicities, such as alopecia).
7) Age 18 or older
8) Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
9) Absolute neutrophil count (ANC) ≥ 1000/uL
10) Platelet count ≥ 75000/uL
11) Absolute lymphocyte count ≥ 100/uL
12) Adequate renal, hepatic, pulmonary, and cardiac function defined as:
a) Creatinine clearance (as estimated by Cockcroft Gault) ≥ 60 mL/min
b) Serum ALT/AST ≤ 2.5 upper limit of normal (ULN)
c) Total bilirubin ≤ 1.5 mg/dl, except in subjects with Gilbert’s syndrome
d) Left ventricular ejection fraction (LVEF) ≥ 50%, no evidence of pericardial effusion as 
determined by an echocardiogram (ECHO), and no clinically significant arrhythmias

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e) No clinically significant pleural effusion
f)
Baseline resting oxygen saturation > 92% on room air
13) 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
1) Transformed FL or MZL
2) Small lymphocytic lymphoma
3) FL Histological Grade 3b
4) Lymphoplasmacytic lymphoma
5) History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg, cervix, 
bladder, breast) unless disease-free and without anticancer therapy for at least 3 years.
6) ASCT within 6 weeks of planned axicabtagene ciloleucel infusion
7) History of allogeneic stem cell transplantation
8) Prior CD19 targeted therapy, with the exception of subjects who received axicabtagene 
ciloleucel in this study and are eligible for retreatment
9) Prior CAR therapy or other genetically modified T-cell therapy
10) History of severe, immediate hypersensitivity reaction attributed to aminoglycosides
11) Presence or suspicion of fungal, bacterial, viral, or other infection that is uncontrolled or 
requiring intravenous (IV) antimicrobials for management.
12) History of human immunodeficiency virus (HIV) infection or active acute or chronic 
hepatitis (Hep B or Hep C) infection.  Subjects with a history of hepatitis infection must have 
cleared their infection as determined by standard serological and genetic testing per current 
Infectious Diseases Society of America (IDSA) guidelines or applicable country guidelines.
13) Presence of lymphoma that is known to involve the full thickness of the gastric wall.
14) 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.
15) Subjects with detectable cerebrospinal fluid malignant cells or known brain metastases or 
with a history of cerebrospinal fluid (CSF) malignant cells or brain metastases

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16) History or presence of non-malignant CNS disorder, such as seizure disorder, 
cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, cerebral edema, 
posterior reversible encephalopathy syndrome (PRES), or any autoimmune disease with CNS 
involvement
17) Subjects with cardiac atrial or cardiac ventricular lymphoma involvement
18) 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
19) Possible requirement for urgent therapy within 6 weeks after leukapheresis due to ongoing or 
impending oncologic emergency (eg, tumor mass effect, tumor lysis syndrome)
20) History of autoimmune disease (eg, Crohn’s disease, rheumatoid arthritis, systemic lupus 
erythematosus), resulting in end organ injury or requiring systemic immunosuppression or 
systemic disease modifying agents within the last 2 years.  Subjects with a history of 
autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone and 
subjects with controlled type 1 diabetes mellitus on a stable insulin regimen may be eligible 
for this study.
21) History of symptomatic deep vein thrombosis (DVT) or pulmonary embolism within 
6 months of enrollment. History of upper extremity line related DVT within 3 months of 
conditioning chemotherapy.
22) Any medical condition likely to interfere with assessment of safety or efficacy of study 
treatment
23) History of severe immediate hypersensitivity reaction to any of the agents used in this study
24) Treatment with a live, attenuated vaccine within 6 weeks prior to the planned start of the 
conditioning regimen or anticipation of need for such a vaccine during the course of the 
study
25) Women of childbearing potential who are pregnant or breastfeeding because of the 
potentially dangerous effects of the preparative chemotherapy on the fetus or infant.  Females 
who have undergone surgical sterilization or who have been postmenopausal for at least 
2 years are not considered to be of childbearing potential.
26) Subjects of either sex who are not willing to practice birth control from the time of consent 
through 12 months following conditioning chemotherapy administration or 12 months 
following axicabtagene ciloleucel infusion, whichever is longer.
27) 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
The following terms will be used to describe and define protocol treatment:
•
The conditioning chemotherapy regimen used for this study will be fludarabine and 
cyclophosphamide.
•
The IP for this study is named axicabtagene ciloleucel.
•
The term study treatment refers to all protocol-required therapies.
6.2.
Study Treatment
6.2.1.
Axicabtagene Ciloleucel
This section contains general information about axicabtagene ciloleucel and is not intended to 
provide specific instructions. Refer to the Investigational Product Manual (IPM) for details and 
instruction on storing, thawing, and administering axicabtagene ciloleucel.
Axicabtagene ciloleucel is supplied cryopreserved in cryostorage bags. The product in the bag is 
slightly cloudy, with cream to yellow color. The cryostorage bags containing axicabtagene 
ciloleucel arrive frozen in a liquid nitrogen dry shipper. The bags must be stored in vapor phase 
of liquid nitrogen, and the product remains frozen until the subject is ready for treatment to 
assure viable live autologous cells are administered to the subject. Several inactive ingredients 
are added to the product to assure viability and stability of the live cells through the freezing, 
thawing, and infusing 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, initials, 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. The 
product must not be thawed until the subject is ready for the infusion.
There have been no instances of accidental overdose of subjects in this program. 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 to any products that support the 
management of axicabtagene ciloleucel (eg, cryostorage bags, subject ID labels) in this study are 
identified, clinical site staff should report the problem per the instructions in the IPM.

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6.2.2.
Auxiliary/Non-Investigational Medicinal Products
All other medications described throughout the Protocol are considered auxiliary or 
non-investigational medicinal products. These products are used in accordance with their 
authorized product information in any given country (eg, Package Insert, Summary of product 
characteristics [SmPC]) and institutional guidelines. The identified and potential risks, and risk 
minimization, should be managed as described within either the authorized product information 
and/or in accordance with institutional guidelines. A list of all auxiliary/non-investigational 
medicinal products is provided in Appendix 18.4.
6.2.2.1.
Conditioning Chemotherapy
Conditioning chemotherapy will be supplied by the investigative site unless otherwise noted.  
Conditioning chemotherapy should only commence when the product is available, if required by 
country regulatory agencies.  Sites should refer to the current product label for guidance on 
packaging, storage, preparation, administration, and toxicity management associated with the 
administration of both agents.
Subjects will receive a conditioning regimen consisting of fludarabine 30 mg/m2/day and 
cyclophosphamide 500 mg/m2/day, administered x 3 days to induce lymphocyte depletion and 
create an optimal environment for expansion of axicabtagene ciloleucel in vivo.
6.2.2.1.1.
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.
Refer to the most recent version of the package insert for specific details surrounding the 
administration of fludarabine.
6.2.2.1.2.
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.
Refer to the most recent version of the package insert for specific details surrounding the 
administration of cyclophosphamide.
6.2.2.1.3.
Mesna
Mesna is a detoxifying agent used to inhibit the hemorrhagic cystitis induced by 
cyclophosphamide.  The active ingredient mesna is a synthetic sulfhydryl compound designated 
as sodium-2-mercaptoethane sulfonate with a molecular formula of C2H5NaO3S2.  Mesna will be 

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administered around the cyclophosphamide dose according to institutional standards.  Refer to 
the most recent version of the package insert for specific details surrounding the administration 
of mesna.
6.2.2.2.
Concomitant Therapy
Investigators may additionally prescribe any other concomitant medications or treatment deemed 
necessary to provide adequate supportive care, including growth factor support (eg, G-CSF; 
granulocyte colony stimulating factor) and routine anti-emetic prophylaxis and treatment, except 
those medications listed in the excluded medications in Section 6.2.2.3.
All concurrent therapies, including medications, intubation, dialysis, oxygen, and blood products, 
should be recorded from the date of the informed consent through 3 months after completing 
treatment with axicabtagene ciloleucel.  After 3 months of follow-up, only targeted concomitant 
medications will be collected for 24 months after axicabtagene ciloleucel infusion or disease 
progression, whichever occurs first.  Targeted concomitant medications include gammaglobulin, 
immunosuppressive drugs, anti-infective drugs, and vaccinations.
For subjects who are not enrolled (eg, screen failure or who do not undergo leukapheresis), only 
concurrent therapies related to any SAE(s) will be recorded.
For subjects who are enrolled, but not dosed with axicabtagene ciloleucel, concurrent therapies 
will only be recorded from the date of the informed consent through 30 days after the last 
study-specific procedure (eg, leukapheresis, conditioning chemotherapy).  Specific concomitant 
medications collection requirements and instructions are included in the case report form (CRF) 
completion guidelines.
6.2.2.3.
Excluded Medications
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 
computed tomography (CT) scans with contrast are contraindicated (ie, subjects with contrast 
allergy or impaired renal clearance).  Such subjects should undergo 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 or 
other severe toxicities (eg, anaphylaxis).  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 
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If permissibility of a specific medication/treatment is in question, contact the Kite medical 
monitor.
6.2.3.
Subsequent Therapy
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 transplantation (SCT) and radiation therapy, will be recorded until one of the following 
happens: the subject transitions to the LTFU study, is considered lost to follow-up, withdraws 
consent, or dies.
For subjects who are enrolled but do not receive axicabtagene ciloleucel infusion, any additional 
anticancer therapy will also be collected until the subject completes their participation in the 
current study, is considered lost to follow-up, withdraws consent, or dies, whichever occurs first.
6.3.
Rationale for Study Treatment Dosing:  Conditioning Chemotherapy and 
Axicabtagene Ciloleucel Dose
6.3.1.
Conditioning Chemotherapy Dose
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 is a potent lymphodepleting regimen.
To improve the depth and duration of lymphocyte depletion, the conditioning chemotherapy dose 
will be cyclophosphamide (500 mg/m2) and fludarabine (30 mg/m2) both given for 3 concurrent 
days.  Cyclophosphamide (500 mg/m2) and fludarabine (30 mg/m2) both given for 3 concurrent 
days have been studied and tolerated in subjects with B-cell malignancies {O'Brien 2001}.  This 
regimen has been evaluated in the NCI study and is the dose of conditioning chemotherapy that 
is being studied in other studies in NHL at Kite.
6.3.2.
Axicabtagene Ciloleucel Dose
The rationale for the axicabtagene ciloleucel dose in this study is based on aggregate safety and 
efficacy data compiled from the KTE-C19-101 study as outlined in the axicabtagene ciloleucel 
IB.  Based on the favorable benefit/risk ratio observed in KTE-C19-101, a target dose of 2 x 106 
anti-CD19 CAR T cells/kg will be used for this protocol.

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6.4.3.
Axicabtagene Ciloleucel (Day 0)
All subjects will be hospitalized to receive treatment with axicabtagene ciloleucel followed by an 
observation period.  Subjects will remain in the hospital at a minimum through Day 7 
post-treatment with axicabtagene ciloleucel unless otherwise required by country regulatory 
agencies.  Refer to Section 18.3 for more information.
Subjects should not be discharged from the hospital until all axicabtagene ciloleucel-related 
non-hematological toxicities return to ≤ Grade 1 or 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 hospitalized for 
ongoing axicabtagene ciloleucel-related fever, hypotension, hypoxia, or ongoing central 
neurological toxicity > Grade 1 or if deemed necessary by the treating investigator.
6.4.3.1.
Axicabtagene Ciloleucel Premedication Dosing
The following axicabtagene ciloleucel infusion medications should be administered 
approximately 1 hour prior to infusion.  Alternatives to the recommendations below should be 
discussed with the Kite medical monitor.
•
Acetaminophen 650 mg PO (eg, Tylenol)
•
Diphenhydramine 12.5 to 25 mg IV or PO (eg, Benadryl)
6.4.3.2.
Axicabtagene Ciloleucel Dosing
Central venous access, such as a port or a peripherally inserted central catheter, is required for 
the administration of axicabtagene ciloleucel and for the hospitalization treatment period. 
Catheter care, per institutional guidelines, should be followed.  Materials and instructions for the 
thawing, timing, and administering of axicabtagene ciloleucel are outlined in the IPM.  The IPM 
must be reviewed prior to administration of axicabtagene ciloleucel.
Research sites should follow institutional guidelines for the infusion of cell products.
6.5.
Toxicity Management
To date, the following important risks have been identified with axicabtagene ciloleucel:  CRS, 
neurological events, infections, hypogammaglobinemia, and cytopenias.  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 that you 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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7.
STUDY PROCEDURES
Research staff should refer to the SOAs in Table 3 and Table 4 for an outline of the procedures 
required.  The visit schedule is calculated from axicabtagene ciloleucel infusion on Day 0.
An overview of study assessments/procedures is outlined below.  A description for each period 
of the study is provided in Section 7.11.  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 version of 
the IRB/IEC approved ICF if relevant to their participation in the study.
7.2.
Demographic Data
Demographic data will be collected to include sex, age, race, and ethnicity.
7.3.
Medical and Treatment History
Relevant medical history prior to the start of AE 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.
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 and reviewed.
7.4.
Physical Exam, Vital Signs, Performance Status
Physical exams, including neurological exam, will be performed during screening and at times 
noted in the SOA (refer to Table 3 and Table 4).  Changes noted in subsequent exams when 
compared to the baseline exam will be reported as an AE.

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During IP administration/hospitalization, vital signs, including blood pressure, heart rate, oxygen 
saturation, and temperature, will be monitored before and after the axicabtagene ciloleucel 
infusion and then routinely (every 4 to 6 hours) while hospitalized.  If the subject has a fever 
(temperature 38.3°C or greater) at any time during hospitalization, vital signs will be monitored 
more frequently as clinically indicated.
Performance status is measured by the ECOG scale and will be performed to quantify the 
subject’s general well-being and ability to perform activities of daily life.
7.5.
Bone Marrow Biopsy
Bone marrow aspirate and biopsy will be performed at screening, if not previously performed, to 
assess bone marrow involvement.
A repeat bone marrow aspirate and biopsy will be required to confirm a complete response to 
axicabtagene ciloleucel except among subjects known to be negative for bone marrow 
involvement.
To confirm a 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 Section 18.3 for treatment response assessment requirements per the Lugano 
Classification {Cheson 2014}.
7.6.
Lumbar Puncture
Subjects with symptoms of CNS malignancy, such as new onset severe headaches, neck 
stiffness, or any focal neurologic findings on physical exam, will have lumbar puncture 
performed at the screening visit for examination of CSF.  In addition, lumbar puncture should be 
performed for subjects with new onset of ≥ Grade 2 neurological event (see the axicabtagene 
ciloleucel IB) after axicabtagene ciloleucel infusion. Opening pressures for all lumbar punctures 
(LPs) should be measured and recorded in the subject’s site record whenever possible.
7.7.
Disease Response Assessment
Disease assessments will be evaluated for response per the Lugano Classification {Cheson 2014} 
by the site investigator at times indicated in the SOA (refer to Table 3 and Table 4).  All enrolled 
subjects will be monitored via fluorodeoxyglucose positron emission tomography (FDG–PET) 
with diagnostic quality contrast-enhanced CT and/or other scans as specified in the imaging 
manual.  Scans will be sent to a central imaging vendor to be reviewed by an independent central 
reviewer using the Lugano Classification {Cheson 2014}.
For subjects who discontinue the study due to an assessment of progressive disease (PD), any 
additional imaging data, subsequent to the image in question, may also be submitted to the 
central imaging vendor.  Refer to the study imaging manual for details regarding submission of 
scans to the imaging vendor.

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Flow cytometric, molecular, or cytogenetic studies will not be used to determine response.
Baseline positron emission tomography-computed tomography (PET-CT) scans of the neck, 
chest, abdomen, and pelvis, along with the appropriate imaging of all other sites of disease, are 
required.  Subjects will have their post-axicabtagene ciloleucel infusion planned PET-CT tumor 
assessments during the post-treatment and LTFU period per the SOA.  Additional CT scans will 
be performed at regular intervals as highlighted in the SOA during the LTFU portion of the 
study.
Post-axicabtagene ciloleucel administration disease assessments will be used to determine the 
time when PD occurs.  Subjects with symptoms suggestive of disease progression should be 
evaluated for progression at the time symptoms occur even if it is off schedule according to the 
SOA.
For subjects with disease progression who are 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, provided it was done within 28 days of retreatment.
7.8.
Cardiac Function
Each subject’s cardiac function will be assessed by an electrocardiogram (ECG) and ECHO 
during the screening period to confirm study eligibility.  Adequate LVEF and no evidence of 
pericardial effusion, as required by eligibility criteria, will be documented by ECHO.  An ECHO 
performed following the subject’s last chemotherapy treatment and within 28 days prior to 
signing the consent may be used for confirmation of eligibility.
7.9.
Laboratory
The below samples will be collected at the time points indicated in the SOA (refer to Table 3 and 
Table 4).  Additional samples (eg, blood, urine, CSF, tissue) may be collected, as needed, for 
additional safety testing.
7.9.1.
Local Lab Analysis
•
Sodium (Na), potassium (K), chloride (Cl), total CO2 (bicarbonate), creatinine, glucose, 
blood urea nitrogen (BUN) or urea (if BUN test cannot be analyzed by the local lab), 
albumin, calcium total, magnesium total (Mg), inorganic phosphorus, alkaline phosphatase, 
ALT/glutamic-pyruvic transaminase (GPT), AST/glutamic-oxaloacetic transaminase (GOT), 
total bilirubin direct bilirubin, lactate dehydrogenase (LDH), uric acid
•
C-reactive protein (CRP), ferritin (FER)
•
Complete blood count (CBC) with differential (if WBC counts are adequate per the local lab)
•
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.

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A urine or serum sample will be collected and assessed locally for females of childbearing 
potential.  If the screening pregnancy test is positive, the subjects should not be enrolled.  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 medical monitor for instructions.  If a female 
partner of a male subject becomes pregnant during the conduct of the study, it must be reported 
by contacting the Kite medical monitor for instructions.  See Section 9.6 for details.
7.9.2.
Central Lab Analysis 
•
Blood draws for PBMC (lymphocyte subsets, replication-competent retrovirus [RCR], and 
anti-CD19 CAR T cells) and cytokine analysis will be performed at intervals outlined in the 
SOA (refer to Table 3 and Table 4).
•
Serum samples will also be drawn for antibodies to axicabtagene ciloleucel.
For serum samples that demonstrate increased anti-axicabtagene ciloleucel antibodies at 
the Week 4 or Month 3 visit over baseline values, attempts should be made to obtain and 
test additional serum samples approximately every 3 months until the antibody levels 
return to baseline (or become negative) or up to 1 year from the completion of treatment, 
whichever occurs first. Samples that test positive in the screening enzyme-linked 
immunosorbent assay will undergo confirmatory analysis in a cell-based assay.
Archived tumor tissue will be collected for central confirmatory diagnosis, central 
pathology review, and evaluation of prognostic markers specific for iNHL and pertaining 
to the tumor immune environment. If an archival sample is not available, a fresh biopsy 
sample collection is strongly encouraged.
Additional analysis may include CD19 expression, gene expression profiling, and 
analysis of tumor-specific DNA alterations.  Remaining tumor samples may be stored for 
future exploratory analysis of DNA (somatic mutations) or tumor/immune-related RNA 
and protein markers.
•
CSF and possibly bone marrow samples will also be collected and analyzed at the central 
laboratory as outlined in the schedule of assessments (refer to Table 3 and Table 4) and per 
Section 7.5 and Section 7.6.
•
See central laboratory manual for details on sample collection, processing, and shipping 
instructions.
7.10.
Biomarkers
Biomarker analysis will be performed on blood and tumor samples to evaluate pharmacodynamic 
markers for axicabtagene ciloleucel.  Prognostic markers specific for iNHL and related to the 
tumor immune microenvironment may also be evaluated in archived and fresh tumor biopsies.

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For subjects who sign the optional portion of the consent form, on-study paired core biopsies of 
tumor will be performed at baseline (prior to conditioning chemotherapy) and between Day 7 
and Day 14, following axicabtagene ciloleucel infusion, when peak expansion and tumor 
infiltration with anti-CD19 CAR T cells is expected.  In addition, persisting, relapsing, or 
emerging lesions should also be biopsied to help determine eligibility for retreatment or 
mechanisms of tumor resistance.  Exploratory analysis of tumor or immune cell markers that 
correlate with response to axicabtagene ciloleucel or disease prognosis will be executed.
These samples, and any other components from these samples, may be stored up to 15 years 
from the last subject treated with axicabtagene ciloleucel to address exploratory research 
scientific questions related to the treatment or disease under study.  Each subject will have the 
right to have the sample material destroyed at any time by contacting the investigator who, in 
turn, can contact the sponsor.  The investigator should provide the sponsor the study and subject 
ID 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.
7.11.
Description of Study Periods
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 why the 
subject failed screening.
7.11.1.
Screening
The screening period begins on the date the subject signs the IRB/IEC approved ICF and 
continues through enrollment.  Informed consent must be obtained before completion of any 
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 (refer to Table 3 and Table 4).
After written informed consent has been obtained, subjects will be screened to confirm study 
eligibility and participation.  Only subjects who meet the eligibility criteria listed in Section 5 
and who commence leukapheresis will be enrolled 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 electronic CRF system with the reasons for failing screening.
In general, if a subject is screened and enrolled in the study, subjects must continue to meet all 
study inclusion and exclusion criteria at the time of administration of conditioning chemotherapy 
and at the time of axicabtagene ciloleucel infusion unless discussed in advance with and 
approved by the Kite medical monitor.

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The following assessments/procedures are to be completed during the screening period at the 
time points outlined in the SOA (refer to Table 3 and Table 4):
•
Medical history
•
Physical exam, including neurological exam, height, and weight
•
Vital signs, including blood pressure, heart rate, oxygen saturation, and temperature
Subjects with symptoms of CNS malignancy, such as new onset severe headaches, neck 
stiffness, or any focal neurologic findings on physical exam, will have lumbar puncture 
for examination of cerebral spinal fluid
•
ECOG performance status
•
ECG
•
ECHO
•
Imaging studies
Baseline PET-CT of the neck, chest, abdomen, and pelvis
■
PET-CT performed following the subject’s last line of therapy and prior to signing 
the consent may be used for confirmation of eligibility, provided that the scan was 
obtained < 28 days before the initiation of conditioning chemotherapy.
■
If PET-CT will be older than 28 days at the initiation of conditioning chemotherapy 
or if the subject receives any anticancer therapy with therapeutic intent (eg, radiation, 
supraphysiologic doses of steroids, chemotherapy) between the last PET-CT and 
conditioning chemotherapy, the PET-CT scan must be repeated to establish a new 
baseline.  PET-CT should be performed as close to enrollment as possible.
•
Bone marrow aspirate and biopsy as needed if not done previously
•
Labs
β-HCG pregnancy test (serum or urine) on all women of childbearing potential
Chemistry panel
CBC with differential
For 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.

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•
SAE reporting (refer to Section 9 for safety reporting guidelines)
•
Concomitant medications documentation and previous cancer treatment history
•
After eligibility is confirmed, submission of archival tumor tissue to the central lab and 
collection fresh tumor (for subjects who signed the optional portion of the consent)
7.11.2.
Rescreening
Subjects who are unable to complete or meet the eligibility criteria during the 28-day screening 
period may be permitted to rescreen.  Subjects will retain the same subject ID number assigned 
at the original screening.  If rescreening occurs within 28 days of the signing of the initial 
informed consent, only the procedures/assessments that did not originally meet the eligibility 
criteria need to be repeated.  All other initial screening procedures/assessments do not need to be 
repeated.
If rescreening occurs or leukapheresis is delayed more than 28 days from the initial informed 
consent date, subjects must be re-consented and repeat all screening procedures/assessments.  A 
subject will not be considered a screen failure until it is confirmed that the subject did not meet 
the eligibility criteria (ie, will not move forward to leukapheresis) and is no longer eligible for 
rescreening.
7.11.3.
Enrollment/Leukapheresis
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 Kite medical monitor prior to proceeding with leukapheresis.
Additionally, the investigator must review the last CBC with differential and chemistry panel 
drawn prior to the start of leukapheresis to confirm that Inclusion 112 (eg, creatinine clearance, 
serum ALT/AST, total bilirubin) continues to be met (see Section 5.1).
Before leukapheresis commences, the below criteria must be met.  If criteria are not met, 
leukapheresis must be delayed until the event resolves.  If leukapheresis is delayed beyond 
5 days, baseline CBC with differential and chemistry panel must be repeated.  If results are 
outside the eligibility criteria listed in Section 5, contact the Kite medical monitor prior to 
proceeding with leukapheresis.
•
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 leukapheresis is delayed beyond 28 days from the screening visit, screening procedures will be 
repeated to confirm that the subject remains eligible for enrollment (see Section  7.11.1).

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Leukapheresis should occur within approximately 5 days from eligibility confirmation.
After a subject commences leukapheresis, the subject will be considered enrolled into the study.
The following procedures/requirements will occur on the leukapheresis collection day and as 
outlined in the SOA (refer to Table 3 and Table 4):
•
Vital signs, including blood pressure, heart rate, oxygen saturation, and temperature
•
Weight
•
Labs (to be drawn prior to leukapheresis, on the day of, or day before leukapheresis)
Chemistry panel
CRP, FER
CBC with differential
Blood draw for PBMCs (includes lymphocyte subsets and baseline RCR), cytokines, and 
antibodies to axicabtagene ciloleucel
Blood draw for leukapheresis
•
AE/SAE reporting
•
Concomitant medications documentation
7.11.4.
Conditioning Chemotherapy and Axicabtagene Ciloleucel Infusion
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 CRP) are diagnoses of exclusion that require a documented workup to establish.
Conditioning chemotherapy and axicabtagene ciloleucel infusion should only be initiated when it 
is reasonably assured that cell infusion can safely proceed.
Refer to Section 7.11.4.1 for workup requirements for potential infectious and/or inflammatory 
states.

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7.11.4.1.
Requirement to Workup Potential Infections and/or Inflammatory States
In the absence of an identified source of infection (eg, line infection or pneumonia on chest 
X-ray), the minimum workup to be performed prior to administration of conditioning 
chemotherapy and/or axicabtagene ciloleucel comprises the following:
•
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 uric acid (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 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])
•
If a CNS process is suspected, appropriate brain imaging and subsequent lumbar puncture 
with cytology, culture, Gram stain, and viral polymerase chain reaction (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 workup 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.

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If the above workup was triggered due to CRP > 100mg/L, CRP should be repeated.  If CRP 
continues to increase significantly, an evaluation should be performed for any other potential 
infectious or inflammatory condition that was not previously evaluated.
7.11.5.
Conditioning Chemotherapy Period
If any of the following criteria are met prior to the initiation of conditioning chemotherapy, the 
workup listed in Section 7.11.4.1 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
•
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 segments/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, eyes, ears, nose, and throat (HEENT), 
and cardiac, vascular, respiratory, gastrointestinal, integumentary, and neurological systems, 
must not reveal evidence of infection/inflammation.
•
The subject must not have received systemic antimicrobials for the treatment of a known or 
suspected infection within 48 hours before conditioning chemotherapy (prophylactic use of 
antimicrobials 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 consult (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 workup 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.

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After the above criteria are met, then the subject can proceed with conditioning chemotherapy.
The following procedures will be completed during Day –5 to Day –1 at the time points outlined 
in the SOA (refer to Table 3 and Table 4):
•
Vital signs, including blood pressure, heart rate, oxygen saturation, and temperature
•
Labs (to be drawn prior to chemotherapy)
Chemistry panel
CBC with differential
•
Fludarabine and cyclophosphamide administration
•
AE/SAE reporting
•
Concomitant medications documentation
7.11.6.
Investigational Product Treatment Period
If any of the following criteria are met prior to the initiation of axicabtagene ciloleucel infusion, 
then the workup listed in Section 7.11.4.1 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 suggestive of infectious process between enrollment and 
start of axicabtagene ciloleucel infusion (eg, WBC > 20,000, rapidly increasing WBC, or 
differential with high percentage of segments/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.

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•
The subject must not have received systemic antimicrobials for the treatment of a known or 
suspected infection within 48 hours before axicabtagene ciloleucel (prophylactic use of 
antimicrobials is allowed).
•
Treatment course of any antimicrobials given for known or suspected antecedent infection 
should be complete as per infectious disease service 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 consult (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 workup performed (eg, bacterial or 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.
After the above criteria are met, the subject can proceed with administration of axicabtagene 
ciloleucel.
If the axicabtagene ciloleucel infusion is delayed > 2 weeks, protocol guidelines should be 
followed regarding the need for repeat conditioning chemotherapy.
Subjects will remain in the hospital through at least Day 7 following treatment with axicabtagene 
ciloleucel (please also refer to Section 18.2 for France).  Subjects should not be discharged from 
the hospital until all axicabtagene ciloleucel-related non-hematological toxicities return to Grade 
1 or return to baseline.  Subjects may be discharged with non-critical and clinically stable or 
slowly improving toxicities (eg, renal insufficiency), even if > Grade 1, if deemed appropriate by 
the investigator.  Subjects should remain hospitalized for ongoing axicabtagene ciloleucel-related 
fever, hypotension, hypoxia, or ongoing central neurological toxicity > Grade 1 or if deemed 
necessary by the treating investigator.
Given the possibility that a subject could develop CRS or neurological event in the outpatient 
setting after discharge, subjects and their family members/caregivers should be educated on 
potential symptoms of these syndromes, such as fever, dyspnea, confusion, aphasia, dysphasia, 
somnolence, encephalopathy, ataxia, or tremor.  If subjects develop these symptoms, they should 
be instructed to immediately contact the investigator or seek immediate medical attention.
During this period, the following procedures will be completed at the time points outlined in the 
SOA (refer to Table 3 and Table 4):
•
Daily physical and neurological exams are at the discretion of the investigator during 
hospitalization unless required by local ethics committees or regulatory agencies.
•
Vital signs, including blood pressure, heart rate, oxygen saturation, and temperature, every 
4 to 6 hours during hospitalization

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•
Labs (before axicabtagene ciloleucel infusion, as described in the SOA)
Chemistry panel
CBC with differential (if WBCs are adequate per the local lab)
•
Blood draw for PBMCs (includes lymphocyte subsets and anti-CD19 CAR T cells) and 
cytokines
•
Infusion of axicabtagene ciloleucel
•
As applicable, lumbar puncture for subjects with new onset Grade ≥ 2 neurologic symptoms 
after axicabtagene ciloleucel infusion.
•
Collection of fresh tumor sample(s) for subjects who signed the optional portion of the 
consent (any time between Day +7 and Day +14)
•
AE/SAE reporting (refer to Section 9 for safety reporting guidelines)
•
Concomitant medications documentation
Monitoring of CRP, FER, and LDH (only if LDH is elevated at baseline) levels may assist with 
the diagnosis and define the clinical course in regard to CRS/neurological event.  It is, therefore, 
recommended that CRP, FER, and LDH (if elevated at baseline) be monitored daily starting at 
Day 0 and continued through hospitalization.  In addition, lactate should be monitored as 
clinically indicated.
7.11.7.
Post-treatment Assessment Period
After completing axicabtagene ciloleucel infusion and discharged from the hospital, all subjects 
will be followed in the post-treatment assessment period.  Counting from Day 0 (axicabtagene 
ciloleucel infusion), subjects will return to the clinic at the following intervals.
•
Week 2 (± 2 days)
•
Week 4 (± 3 days)
•
Month 2 (± 1 week)
•
Month 3 (± 1 week)
Subjects will allow key sponsor contacts to continue to access medical records so that 
information related to a subject’s health condition and initial treatment response may be 
obtained.  The following procedures will be completed for subjects as outlined in the SOA 
(refer to Table 3 and Table 4):
•
Physical exam, including neurological exam
•
Vital signs, including blood pressure, heart rate, oxygen saturation, and temperature

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•
Disease assessment per the SOA (Note:  If the PET-CT is not of high enough resolution to 
accurately quantify lesion size, the scan must be repeated.)
•
As applicable, bone marrow aspirate and biopsy to confirm response (ie, for subjects 
presenting with bone marrow involvement prior to therapy or if new abnormalities in the 
peripheral blood counts or blood smear cause clinical suspicion of bone marrow involvement 
with lymphoma after treatment)
•
Labs
β-HCG pregnancy test (serum or urine) on all women of childbearing potential
Chemistry panel
CBC with differential
Blood draw for PBMCs (includes lymphocyte subsets, anti-CD19 CAR T cells, and RCR 
analysis), cytokines, and anti-axicabtagene ciloleucel antibodies
•
AE/SAE reporting (refer to Section 9 for safety reporting guidelines)
•
Concomitant medications documentation
If a subject is subsequently re-admitted to the hospital with any axicabtagene ciloleucel-related 
AEs, the following procedures will be performed as outlined in the SOA (refer to Table 3 and 
Table 4):
•
The labs below will be collected on the day of hospital re-admission and then weekly through 
the date of hospital discharge.
Blood draw for PBMCs (anti-CD19 CAR T cells)
Blood draw for cytokines
•
If the subject has a new or ongoing Grade 3 or higher neurologic event, in addition to the labs 
above, blood draw for cytokines will be collected every other day through the date of hospital 
discharge.
At any time during the post-treatment assessment period, if a subject did not respond to treatment 
(ie, did not achieve a CR or partial response [PR]) or progresses following a response and is 
either not eligible for retreatment or chooses not to pursue retreatment, the subject will proceed 
directly to the Month 3 visit and be followed for safety, survival, subsequent therapy, and disease 
outcomes in the LTFU period.  A PBMC sample (for anti-CD19 CAR T cells, RCR) and tumor 
biopsy (for exploratory biomarker analysis) should be collected at the time of progression and 
prior to starting any subsequent anticancer therapy.

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7.11.8.
Long-term Follow-up Period
All enrolled subjects will be followed in the LTFU period for safety, survival, and disease status, 
if applicable.  Subjects will begin the LTFU period after they have completed the Month 3 visit 
following axicabtagene ciloleucel infusion (whether they have responded to treatment or they 
went straight to the Month 3 visit due to disease progression), and will transition to the LTFU 
study after providing signed informed consent.
•
Month 6 (± 2 weeks)
•
Month 9 (+ 1 month)
•
Month 12 (+ 1 month)
•
Month 15 (± 2 weeks)
•
Month 18 (± 2 weeks)
•
Every 6 months (± 1 month) between Month 24 to Month 60
•
If not already transitioned to the LTFU study, every 12 months (± 1 month) from Month 72 
to Year 15
The following procedures will be completed for subjects who are enrolled and receive 
axicabtagene ciloleucel at the time points outlined in the SOA (refer to Table 3 and Table 4):
•
Physical exam, including neurological exam, through Month 24
•
Disease assessment per the SOA.  Diagnostic PET-CT may be used to document disease 
recurrence or progression if suspected.
•
Survival status
•
Labs
CBC with differential through Month 24
Blood draw for PBMCs (includes lymphocyte subsets, anti-CD19 CAR T cells, and RCR 
analysis) and anti-axicabtagene ciloleucel antibodies (refer to Section 7.9)
•
Targeted AE/SAE reporting - (refer to Section 9 for safety reporting guidelines)
•
Targeted concomitant medications documentation (for 24 months after axicabtagene 
ciloleucel infusion or until disease progression, whichever comes first)
Including gammaglobulin, immunosuppressive drugs, anti-infective medications, and 
vaccinations
•
Subsequent therapy for the treatment of lymphoma

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Subjects may also be contacted by telephone to confirm survival status and report targeted 
concomitant medications use.
If a subject progresses in the LTFU phase, the subject will continue to be followed for survival 
status, any secondary malignancies, and subsequent therapy for the treatment of NHL.  A PBMC 
sample (for anti-CD19 CAR T cells) and tumor biopsy (for exploratory biomarker analysis) 
should be collected at the time of progression and prior to starting any subsequent anticancer 
therapy. Also, if a subject develops a secondary malignancy during the study, every effort will be 
made to assay for RCR in blood and in a biopsy sample of the neoplastic tissue as clinically 
indicated (refer to Section 6.4.2.1 of the IB for additional details on the sponsor’s testing 
procedure). Secondary malignancies are defined as new malignancies that are suspected to be 
possibly related to axicabtagene ciloleucel (ie, plausibly associated with axicabtagene ciloleucel 
and without compelling alternate etiologies).
Subjects who are enrolled/leukapheresed, but did not receive axicabtagene ciloleucel treatment, 
will be followed only until the end of this study and will undergo the following 
procedures/assessments at the time points outlined in the SOA (refer to Table 3 and Table 4):
•
Subsequent therapy
•
Survival status–subjects may be contacted by telephone to confirm survival status
•
Disease assessment per standard of care
•
AE/SAE reporting and concomitant medications documentation until 30 days after last 
procedure (eg, leukapheresis, conditioning chemotherapy)
Should the subject fail 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 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.
Subjects who undergo a consolidation SCT will be contacted to confirm the status of their 
disease, survival status, and will have blood collected for PBMCs per the LTFU schedule.
7.11.9.
Retreatment
Subjects who achieve a response of PR or better at the 3-month disease assessment, but 
subsequently experience disease progression, may have an option to receive a second course of 
conditioning chemotherapy and axicabtagene ciloleucel.
The following criteria must be met to be considered for a repeat course of therapy:
•
Subject has at least PR or CR at the Month 3 disease assessment, but subsequently 
experienced progression of disease at a later time.

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•
CD19 expression on tumor cells confirmed locally by biopsy after disease progression and 
prior to treatment
•
Subject continues to meet the original study eligibility criteria with the exception of prior 
axicabtagene ciloleucel use in this study.  Screening assessments should be repeated if 
clinically indicated, as determined by the investigator, to confirm eligibility.
•
Subject has not received subsequent therapy for the treatment of lymphoma.
•
Subject did not experience Grade 4 CRS, Grade 4 neurological event, or any other 
life-threatening toxicity 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 
retreatment.
•
Subject does not have known neutralizing antibodies (exception:  if a non-neutralizing 
KTE-C19 antibody develops, subject may be retreated if he or she meets the original study 
eligibility criteria).
Retreatment for all eligible subjects must occur within 24 months after the initial axicabtagene 
ciloleucel infusion.  The decision to retreat with axicabtagene ciloleucel should be made in 
consultation with the Kite medical monitor.  In addition, a discussion regarding benefits and risks 
of retreatment, including the need to undergo leukapheresis a second time for the manufacturing 
of axicabtagene ciloleucel, should occur with the subject prior to performing any study-related 
procedures or treatment.  This conversation should also be recorded in the subject’s source 
document.Allowance for retreatment is based on clinical experience reported in the 2 studies 
conducted at the pediatric {Lee 2015} and Surgery Branch {Kochenderfer 2015} of the NCI 
where 6 subjects in total have been retreated upon progression.  Three (3) of the retreated 
subjects (indolent lymphoma/leukemia) experienced durable responses to retreatment after an 
initial response and disease progression.
A maximum of 1 retreatment course may occur per subject.
Retreated subjects will remain on this study, following the same treatment schedule and 
procedural requirements per the initial treatment, until they are eligible to transfer to the LTFU 
study (please refer to Section 3.6).

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Table 3.
Schedule of Assessments (1 of 2)
Procedures
Screening
Enrollment/
Leukapheresis
Conditioning Chemotherapy
Period
IP 
Administration 
Period
Post-treatment Follow-up
(each visit calculated from Day 0)
Day
Within 28 
days of 
enrollment
-5
-4
-3
-2
-1
0
1 – 711
Week 2
(± 2 
days)
Week 
4
(± 3 
days)
Month 
2
(± 1 
week)
Month 
3
(± 1 
week)
Medical history 
X
Physical exam (with 
neurological exam)
X
X
X12
X
X
X
X
Weight (plus height at screening)
X
X 
Vital signs (BP, HR, O2 sat, 
temp)
X
X
X
X
X
X
X
X
X
X
X
Lumbar Puncture1
X
X
ECOG Performance Status
X
ECG
X
ECHO
X
Disease assessment (PET and/or 
CT, bone marrow aspirate and 
biopsy)2
PET-CT
PET-
CT
PET-CT
Archival/Fresh tumor to central 
lab3,4
X
between Day 7 & 
Day 14
Pregnancy test (serum or urine)
X
X
Viral serologic tests 
(except for US sites)10
X
Blood draw for chemistry panel9
X
X
X
X
X
X
X
X
X
X
X
Blood draw for CBC 
w/differential
X
X
X
X
X
X
X
X
X
X
X
Blood draw for CRP, Ferritin
X

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Procedures
Screening
Enrollment/
Leukapheresis
Conditioning Chemotherapy
Period
IP 
Administration 
Period
Post-treatment Follow-up
(each visit calculated from Day 0)
Day
Within 28 
days of 
enrollment
-5
-4
-3
-2
-1
0
1 – 711
Week 2
(± 2 
days)
Week 
4
(± 3 
days)
Month 
2
(± 1 
week)
Month 
3
(± 1 
week)
Blood draw for anti-KTE-C19 
antibody5
X
X
X
Blood draw for PBMCs6,7 
X
Day 77
X
X
X
Blood draw for cytokines7,8
X
X
Day 
3,77
X
X
Leukapheresis 
X
Fludarabine/Cyclophosphamide
X
X
X
KTE-C19 infusion IV
X
Adverse events/Concomitant 
medication
X
Abbreviations:  BP, blood pressure; HR, heart rate; sat, saturation; temp, temperature; ECOG, Eastern Cooperative Oncology Group; ECG, electrocardiogram; ECHO, 
echocardiogram; PET, positron emission tomography; CT, computed tomography; CBC, complete blood count; CRP, C-reactive protein; PBMC, peripheral blood mononuclear 
cell; IV, intravenous; IP, investigational product.
1
Lumbar Puncture:  Subjects with symptoms of CNS malignancy (eg, new onset severe headaches, neck stiffness, or focal neurological findings) will have lumbar puncture 
performed at screening to assess CSF for possible CNS involvement.  Subjects with new onset Grade ≥ 2 neurologic symptoms post-axicabtagene ciloleucel infusion will 
have lumbar puncture performed to assess CSF.  Opening pressures for all lumbar punctures (LPs) should be measured and recorded whenever possible.
2
PET and/or CT (neck-chest-abdomen-pelvis)/disease assessment:  All scans will be submitted to the central imaging vendor to be read by a central independent reviewer.  If 
PET-CT performed > 28 days prior to the initiation of conditioning chemotherapy, the baseline PET-CT scans must be repeated.  Screening PET-CT should be completed as 
close to enrollment as possible.  PET-CT will be performed at the Week 4, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, and Month 24 visits and at any 
subsequent scheduled or unscheduled visit if there is clinical concern for disease progression. After Month 24, PET-CT will be performed if disease recurrence is suspected. 
Otherwise, surveillance imaging will be diagnostic CT without PET.  A bone marrow aspirate and biopsy will be required to confirm a complete response to axicabtagene 
ciloleucel except among subjects known to be negative for bone marrow involvement within 4 weeks of screening. As applicable, bone marrow aspirate and biopsy will be 
performed if new abnormalities in the peripheral blood counts or blood smear cause clinical suspicion of bone marrow involvement with lymphoma after treatment. See 
Section 7.9 and Section 7.11.
3
For archival tumor samples, either formalin-fixed paraffin embedded (FFPE) tumor block or 20 unstained slides is accepted.  If not able to send a FFPE block or at least 
20 unstained slides, refer to the central lab manual for further instruction.  Site must attempt to ship archived tumor samples to the central laboratory after eligibility has been 
confirmed and prior to the start of conditioning chemotherapy.  Fresh tumor sample for subjects who sign the optional portion of consent (refer to Section 7.10) will be 
collected and shipped after eligibility has been confirmed and prior to the start of conditioning chemotherapy.  Post-treatment fresh tumor samples (if applicable) will be 
collected/submitted any time between Day 7 and Day 14.  See Section 7.10.

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4
Archived tumor tissue will be collected for central confirmatory diagnosis, central pathology review, and evaluation of prognostic markers specific for iNHL and pertaining to 
the tumor immune microenvironment. If an archival sample is not available, a fresh biopsy sample collection is strongly encouraged.
5
Blood draw for anti-axicabtagene ciloleucel antibody:  Baseline antibody sample to be collected prior to start of conditioning chemotherapy and a post-axicabtagene ciloleucel 
infusion sample will be collected at the Month 3 visit; see Section 7.9.
6
PBMCs blood draw for the analysis of lymphocytes, anti-CD19 CAR T cells, and RCR.  See Section 7.10.  Day 7 blood draws for PBMCs that fall on a weekend or public 
holiday may be drawn on Day 6 or Day 8 (Day 5 only if Day 6 or Day 8 cannot be done).
7
If, following discharge from initial hospitalization, the subject is subsequently re-admitted to the hospital with any axicabtagene ciloleucel-related adverse events, blood 
samples for PBMCs (anti-CD19 CAR T cells) and cytokines will be collected on day of admission, then weekly while hospitalized, and on the day of discharge.  If the subject 
has a new or ongoing Grade 3 or higher neurological event, blood samples for cytokines will be collected every other day while hospitalized, and on the day of discharge.
8
A blood draw for cytokines will be drawn at Day 3 and Day 7.  Day 3 blood draws for cytokines that fall on a weekend or public holiday may be drawn on Day 2 or Day 4 
(Day 1 only if Day 2 or Day 4 cannot be done).  Day 7 blood draws for cytokines that fall on a weekend or public holiday may be drawn on Day 6 or Day 8 (Day 5 only if 
Day 6 or Day 8 cannot be done).  If the subject experiences Grade 3 axicabtagene ciloleucel-related toxicity, such as Grade 3 CRS or neurological event, one additional blood 
draw for cytokines will be taken at the time of Grade 3 related toxicity.
9
Urea is an acceptable alternative if BUN cannot be analyzed by the local lab.
10
Except for US sites, viral serologic tests will be done at screening or at the time of leukapheresis or within the 30 days prior to leukapheresis (see Section 7.9.1).
11
Subjects will remain in the hospital through Day 7 after treatment with axicabtagene ciloleucel unless otherwise required by country regulatory agencies (see Section 18.2)
12
Daily physical and neurological exams are at the discretion of the investigator during hospitalization unless required by local ethics committees or regulatory agencies.

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Table 4.
Schedule of Assessments (2 of 2)
Procedure
LTFU Period1 
(Each visit calculated from Day 0)
Visit Frequency
Month 
6
Month 
9
Month 
12
Month 
15
Month 
18
Month 
24
Month 
30
Month 
36
Month 
42
Month 
48
Month 
54
Month 
60
Month 
72 and 
Annually 
Until 
Year 15
(± 2 
weeks)
(+ 1 
month)
(+ 1 
month)
(± 2 
weeks)
(± 2 
weeks)
(± 1 
month)
(± 1 
month)
(± 1 
month)
(± 1 
month)
(± 1 
month)
(± 1 
month)
(± 1 
month)
(± 1 
month)
Physical exam (with neurological 
exam)2
X
X
X
X
X
X
PET/CT disease assessment3
PET-
CT
PET-
CT
PET-
CT
PET-
CT
PET-
CT
PET-
CT
CT3
CT3
CT3
CT3
Survival status
X
X
X
X
X
X
X
X
X
X
X
X
X
CBC w/differential4
X
X
X
X
X
X
Anti-KTE-C19 antibody5
Blood draw for PBMCs6
X
X
X
X
X
X
X
X5
Targeted AE/SAEs related to 
axicabtagene ciloleucel infusion7
X
X
X
X
X
X
X
X
X
X
X
X
X
Targeted concomitant medication8
X
X
X
X
X
X
X
X
X
X
X
X
X
Subsequent therapy for NHL9
X
X
X
X
X
X
X
X
X
X
X
X
X
Abbreviations:  LTFU, long-term follow-up; PET, positron emission tomography; CT, computed tomography; CBC, complete blood count; PBMC, peripheral blood mononuclear 
cell; AE, adverse event; SAE, serious adverse event; NHL, non-Hodgkin lymphoma. 
1
 After completing at least 60 months (FL subjects) or at least 24 months (MZL subjects) of assessments in this study since the initial axicabtagene ciloleucel infusion and after 
agreement by the Sponsor, subjects will complete the remainder of the 15 year follow-up assessments in a separate Kite Pharma, Inc-sponsored long-term follow-up (LTFU) 
study, KT-US-982-5968.
2
Physical exams (including neurological exam) will continue through the first 24 months.
3
The Month 9 and Month 12 PET/CT disease assessment should occur at the Month 9 + 1 month and Month 12 + 1 month, respectively.  PET-CT scans/disease assessments 
will continue every 3 months through Month 18 and at Month 24 or until disease progression, whichever comes first. After Month 24, PET-CT will be performed if disease 
recurrence is suspected. Otherwise, surveillance imaging will be diagnostic CT without PET.  
4
Subjects will continue to provide samples for CBC w/differentials and lymphocyte subsets through Month 24.
5
Anti-axicabtagene ciloleucel antibodies post-3-month samples; refer to Section 7.9.
6
Blood draw for PBMCs includes the analysis of lymphocytes, anti-CD19 CAR T cells, and RCR.  RCR will be tested at baseline, Month 3, Month 6 and Month 12.  In the 
LTFU, samples will be collected yearly and may be held for up to 15 years from the last subject treated with axicabtagene ciloleucel.

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7
Targeted AEs and SAEs related to axicabtagene ciloleucel infusion will be collected for 15 years, until disease progression, or until initiation of subsequent anticancer therapy 
(whichever occurs first)..  All new malignancies are to be reported for all subjects through 15 years after initial axicabtagene ciloleucel infusion, including those whose 
disease progresses and/or those who receive subsequent anticancer therapy. 
8
Targeted concomitant medications will be collected for 24 months after axicabtagene ciloleucel infusion or until disease progression (whichever occurs first).
9
Subsequent therapy administered after axicabtagene ciloleucel infusion for a subject’s disease, such as non-study specified chemotherapy, immunotherapy, targeted agents, as 
well as stem cell transplant and radiation therapy, must be collected until subject completes the LTFU period, is considered lost to follow-up, withdraws consent, or dies.  
Subjects may be contacted by telephone to collect information about subsequent therapy for iNHL and to assess survival status.

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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 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 IP, 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.  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 for 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.  Sites may be also asked to also retrieve autopsy reports to confirm 
status of disease at the time of death.
The investigator and/or sponsor can also decide to withdraw a subject from the IP and/or other 
protocol-required therapies, protocol procedures, or the study as a whole at any time prior to 
study completion.
8.1.
Reasons for Removal from Treatment
Reasons for removal from protocol-required IPs or procedures include any of the following:
•
AE
•
Subject request
•
Product not available
•
Lost to follow-up
•
Death
•
Decision by sponsor

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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

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9.
SAFETY REPORTING
9.1.
AEs
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.  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 AEs.  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 as the primary tumor type (eg, FL).
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 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 
Month 3 visit of the SOA (refer to Table 3 and Table 4).
9.2.
Reporting of AEs
The investigator is responsible for ensuring that all AEs observed by the investigator or reported 
by the subject that occur from enrollment (ie, commencement of leukapheresis) through 
3 months after treatment with axicabtagene ciloleucel infusion or until the initiation of another 
anticancer therapy, whichever occurs first.  After 3 months, targeted AEs (eg, neurological, 
hematological, infections, autoimmune disorders, and secondary malignancies) related to 
axicabtagene ciloleucel infusion will be monitored and reported for 15 years after initial 
treatment with axicabtagene ciloleucel, until disease progression, or the initiation of subsequent 
anticancer therapy, whichever occurs first.

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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)
•
Dates of onset and resolution
•
Severity
•
Assessment of relatedness to IP, conditioning chemotherapy, or study procedures
•
Action taken
AE 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 Cancer 
Therapy Evaluation Program (CTEP) home page (http://ctep.cancer.gov).  CRS events will be 
reported using the grading scale outlined in the axicabtagene ciloleucel IB.
In reviewing AEs, investigators must assess whether the AE is possibly related to 1) the IP 
(axicabtagene ciloleucel), 2) conditioning chemotherapy, or 3) any protocol-required study 
procedure.  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 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 AE 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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The investigator is expected to follow reported AEs until stabilization or resolution.  If a subject 
begins a new anticancer therapy, the AE reporting period for non-SAEs ends at the time the new 
treatment is started.
9.3.
Definition of SAEs
An SAE is defined as an AE that meets at least 1 of the following serious criteria:
•
Fatal
•
Life-threatening (places the subject at immediate risk of death)
•
Requires subject 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 intensive care unit (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 SAEs
The investigator is responsible for reporting all SAEs observed by the investigator or reported by 
the subject that occur after signing of the screening informed consent through 3 months after the 
axicabtagene ciloleucel infusion, until disease progression, or until the initiation of subsequent 
anticancer therapy, whichever comes first.  After 3 months, only serious targeted AEs (eg, 
neurological, hematological, infections, autoimmune disorders, and secondary malignancies) 
related to axicabtagene ciloleucel infusion are to be reported for 15 years after initial 
axicabtagene ciloleucel infusion, until disease progression, or until the initiation of subsequent 

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anticancer therapy, whichever occurs first. All new malignancies are to be reported for all 
subjects through 15 years, including those whose disease progresses and/or those who receive 
subsequent anticancer therapy. New malignancies are defined as the development of any new 
malignancies occurring after axicabtagene ciloleucel infusion. Secondary malignancies are 
defined as new malignancies that are suspected to be possibly related to axicabtagene ciloleucel 
(ie, plausibly associated with axicabtagene ciloleucel and without compelling alternate 
etiologies).
SAEs that the investigator assesses as related to axicabtagene ciloleucel should be reported 
regardless of the time period.
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 study-specific procedure (eg, screen 
procedure, leukapheresis, conditioning chemotherapy).
All SAEs must be reported within 24 hours of the investigator’s knowledge of the event.  SAEs 
will be reported through the electronic database capture (EDC) system.  This is called eSAE 
reporting.  If the eSAE system is unavailable, reports will be submitted by emailing a completed 
SAE report form to
.
After completion of ZUMA-5 study and database closure, any relevant information on ongoing 
SAEs must be submitted to Kite within 24 hours of the investigator’s knowledge of the event 
using the paper SAE Report Form and sent via email to the SAE Reporting mailbox: 
.
Subsequently, 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 being indicated as due to disease 
progression.  If the malignancy has a fatal outcome within 3 months of the last day of the 
conditioning therapy or axicabtagene ciloleucel, then the event malignant neoplasm progression 
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 the first dose of chemotherapy, for the purpose of pre-conditioning and 
within 3 months of the axicabtagene ciloleucel infusion, regardless of attribution to treatment, 
requires expedited reporting within 24 hours.  Any death occurring greater than 3 months after 
the axicabtagene ciloleucel infusion requires expedited reporting within 24 hours only if it is 
considered related to treatment.
PPD
PPD

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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 “Follicular Lymphoma, Marginal Zone Lymphoma, or 
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.
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.  This experimental therapy 
should not be administered to pregnant women or women who are breastfeeding.
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 12 months after 
administration of conditioning chemotherapy or 12 months after axicabtagene ciloleucel dosing, 
whichever is longer.  Male subjects are recommended to not father a child for 12 months after 
conditioning chemotherapy or 12 months after axicabtagene ciloleucel dosing, whichever is 
longer.  If a pregnancy occurs in a female subject enrolled into the study at any time after 
infusion or a female partner of a male subject within 12 months of completing conditioning 
chemotherapy or axicabtagene ciloleucel infusion, whichever is longer, the pregnancy must be 
reported to the key sponsor contact.  Pregnancies should be reported within 24 hours of the 
investigator’s knowledge of the pregnancy event.  Information regarding the pregnancy and/or 
the outcome may be requested by the sponsor.
If a lactation case occurs while the female subject is taking protocol-required therapies, report 
the lactation case to the key sponsor contact.  Any lactation case should be reported to the key 
sponsor contact within 24 hours of the investigator’s knowledge of the event.

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In addition to reporting a lactation case during the study, investigators should monitor for 
lactation cases that occur after the last dose of protocol-required therapies through 12 months.
9.7.
Hospitalization and Prolonged Hospitalization
Any AE that results in hospitalization or prolonged hospitalization should be documented and 
reported as a SAE, as described in Section 9.3.
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 Value
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
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.
DSMB
An independent DSMB will have ongoing oversight of the study and will monitor data during 
this study.  The DSMB will first meet to review safety data when 10 subjects have been treated 
with axicabtagene ciloleucel (see Section 10.5) and have had an opportunity to be followed for 
4 weeks.  The DSMB will meet again to review safety data after 30 subjects have been treated 
with axicabtagene ciloleucel and have had an opportunity to be followed for 4 weeks.  The 
DSMB will meet again to review safety and efficacy data after 30 subjects with FL in the 
inferential analysis set have been enrolled and treated with axicabtagene ciloleucel and have had 
an opportunity to be followed for 6 months after axicabtagene ciloleucel infusion.  The DSMB 

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will meet for a fourth time when 80 subjects with FL in the inferential analysis set have been 
enrolled and treated with axicabtagene ciloleucel and have had an opportunity to be followed for 
6 months after axicabtagene ciloleucel infusion.  The DSMB will meet for a fifth time when 
80 subjects with FL in the inferential analysis set have been enrolled and treated with 
axicabtagene ciloleucel and have had an opportunity to be followed for 9 months from the first 
disease response assessment.
The DSMB will be chartered to make trial conduct recommendations based on an analysis of risk 
vs benefit.  The DSMB may meet more often as needed. The DSMB can make a 
recommendation to the sponsor to discontinue the study early based on the guidelines in the 
DSMB charter.
The DSMB will also review SAE information and SUSARs on a regular basis throughout subject 
treatment in the study.  The DSMB may request additional safety data or modify the study 
conduct.  The sponsor may request additional reviews by the DSMB if safety concerns are 
identified.  Data submitted to the DSMB may be monitored or unmonitored to facilitate and 
ensure timely DSMB review.
At the time of expedited reporting of SUSARs to regulatory authorities, Kite (or designee) will 
concurrently submit these reports to the DSMB chair.  The DSMB chair will also review SAE 
narrative reports monthly.  Finally, the DSMB or Kite may request additional analyses of safety 
data if a safety concern arises during the course of the trial.

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10.
STATISTICAL CONSIDERATIONS
10.1.
Hypothesis
Four hypotheses will be tested using a fixed sequence procedure in terms of ORR and CR rate as 
determined by central review to control the overall type I error at 1-sided alpha level of 0.025 
with the following testing order:
•
Hypothesis 1 (H1): test for ORR, as determined by central review; if significant then
•
Hypothesis 2 (H2): test for CR rate, as determined by central review; if significant then
•
Hypothesis 3 (H3): test for ORR, as determined by central review, in the subjects who have 
had 3 or more lines of prior therapy; if significant then
•
Hypothesis 4 (H4): test for CR rate, as determined by central review, in the subjects who have 
had 3 or more lines of prior therapy
The hypotheses H1 through H4 will be assessed at the time of the interim analysis 3, 4, and 5 and 
the primary analysis.
The H1 is that the ORR, as determined by central review, to axicabtagene ciloleucel is 
significantly greater than 40% in subjects with FL in the inferential analysis set. The targeted 
response rate is 60%.
The H2 is that the CR rate, as determined by central review, to axicabtagene ciloleucel is 
significantly greater than 15% in subjects with FL in the inferential analysis set.
The H3 is that the ORR, as determined by central review, to axicabtagene ciloleucel is 
significantly greater than 40% in subjects with FL in the inferential analysis set who have had 
3 or more lines of prior therapy.
The H4 is that the CR rate, as determined by central review, to axicabtagene ciloleucel is 
significantly greater than 15% in subjects with FL in the inferential analysis set who have had 
3 or more lines of prior therapy.
An alpha spending function will be used to allocate the alpha level between the interim analysis 
3, interim analysis 4, and interim analysis 5, and the primary analysis.  Using the O’Brien-
Fleming boundary of the Lan-DeMets family of alpha spending functions, the nominal 1-sided 
alpha used to test for efficacy at interim analysis 3, interim analysis 4, and interim analysis 5 are 
0.0003, 0.0005, and 0.0005, respectively, and the nominal 1-sided alpha used to test for efficacy 
at the primary analysis is 0.0237.  If the criteria for early efficacy are met for H1, the same alpha 
spending function will be applied to test H2 at each interim analysis; otherwise, H2 through H4 
will not be tested until the primary analysis. If the criteria for early efficacy are met for H1 and 
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tested until the primary analysis. If the criteria for early efficacy are met for H1, H2, and H3, the 
same alpha spending function will be applied to test H4; otherwise, H4 will not be tested until the 
primary analysis. The study will not be stopped if early efficacy is demonstrated.
No formal hypothesis testing is planned for the MZL histological subtype. The analyses will be 
descriptive.
10.2.
Study Endpoints
10.2.1.
Primary
ORR is defined as the incidence of a CR or a PR by the Lugano Classification {Cheson 2014} as 
determined by the central reader.  All subjects who do not meet the criteria for an objective 
response by the analysis data cutoff date will be considered nonresponders.
10.2.2.
Secondary
The CR rate is defined as the incidence of CR as best response to treatment by the Lugano 
Classification {Cheson 2014} as determined by the central reader.
ORR is defined as the incidence of a CR or a PR by the Lugano Classification {Cheson 2014} as 
determined by the central reader for those subjects who have had 3 or more lines of prior 
therapy.
The CR rate is defined as the incidence of CR as best response to treatment by the Lugano 
Classification {Cheson 2014} as determined by the central reader for those subjects who have 
had 3 or more lines of prior therapy.
ORR per investigator read is defined as the incidence of a CR or a PR by the Lugano 
Classification {Cheson 2014} as determined by the investigator.  All subjects who do not meet 
the criteria for an objective response by the analysis cutoff date will be considered 
nonresponders.
Best objective response is defined as the incidence of CR, PR, stable disease (SD), PD, or 
non-evaluable (NE) as best response to treatment by the Lugano Classification {Cheson 2014}.  
Response may be defined per central read or investigator read.
DOR is defined only for subjects who experience an objective response and is the time from the 
first objective response to disease progression per {Cheson 2014} or death due to any cause.  
Response and progression may be defined per central read or investigator read.  Subjects not 
meeting the criteria for progression or death due to any cause by the analysis data cutoff date will 
be censored at their last evaluable disease assessment date.  Subjects who receive any subsequent 
anticancer therapy (including SCT or retreatment with axicabtagene ciloleucel) in the absence of 
prior documented progression will be censored at the last evaluable disease assessment prior to 
the subsequent anticancer therapy.  The DOR for subjects who progress or die after any 
subsequent anticancer therapy, including SCT or retreatment with axicabtagene ciloleucel, will 
be censored at the last evaluable disease assessment prior to the subsequent anticancer therapy.

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PFS is defined as the time from the axicabtagene ciloleucel infusion date to the date of disease 
progression per {Cheson 2014}or death due to any cause.  Subjects not meeting the criteria for 
progression or death due to any cause by the analysis data cutoff date will be censored at their 
last evaluable disease assessment date.  Subjects who receive any subsequent anticancer therapy 
(including SCT or retreatment with axicabtagene ciloleucel) in the absence of prior documented 
progression will be censored at the last evaluable disease assessment prior to the subsequent 
anticancer therapy.  The PFS for subjects who progress or die after any subsequent anticancer 
therapy, including SCT or retreatment with axicabtagene ciloleucel, will be censored at the last 
evaluable disease assessment prior to the subsequent anticancer therapy.
OS is defined as the time from axicabtagene ciloleucel infusion to the date of death due to any 
cause.  Subjects who have not died by the analysis data cutoff date will be censored at their last 
date known to be alive prior to the data cutoff date.  Survival for subjects known to be alive or 
determined to have died after the data cutoff date will be censored at the data cutoff date.
Other secondary endpoints are as follows:
•
Incidence of AEs and clinically significant changes in laboratory values
•
Incidence of anti-axicabtagene ciloleucel antibodies
•
Levels of anti-CD19 CAR T cells in blood
•
Levels of cytokines in serum
•
Time to next therapy: defined as the time from the axicabtagene ciloleucel infusion date to 
the start of the subsequent new lymphoma therapy or death from any cause. Subjects who 
have not received subsequent new therapy and are still alive will be censored at the last 
contact date.
10.2.3.
Covariates
The following covariates may be used in efficacy and safety analyses
•
Age (< 65, ≥ 65 years)
•
Gender
•
Race
•
Ethnicity
•
Histological diagnosis (eg, FL, MZL), by both local and central pathology
•
FLIPI (age > 60, Hgb < 12, Stage 3 or 4, > 4 nodal sites, elevated LDH)

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•
ECOG status (0 vs 1)
•
Disease burden as defined by any of the following GELF criteria (subject meets the criteria 
for high tumor bulk versus subject does not meet the criteria for high tumor bulk)
Involvement of ≥ 3 nodal sites, each with a diameter of ≥ 3 cm
Any nodal or extra-nodal tumor mass with a diameter of ≥ 7 cm
B symptoms
Splenomegaly
•
Relapsed vs refractory status at study entry
•
Time to relapse from initiation of first anti-CD20-chemotherapy combination therapy 
(≥ 24 months, < 24 months)
•
Prior PI3K inhibitor
•
Number of prior lines of therapy (excluding single agent anti-CD20 antibody as a line of 
therapy)
•
Double refractory (subjects refractory to the first 2 lines of therapy)
10.3.
Sample Size Considerations
The trial uses a single-arm design to estimate the ORR in subjects with r/r B-cell iNHL treated 
with axicabtagene ciloleucel.  The target response rate in subjects with FL is 60%.
Up to approximately 160 subjects, including up to approximately 125 subjects with FL with at 
least 80 subjects with FL in the inferential analysis set, will be enrolled and treated.
The primary efficacy endpoint for this study in at least 80 subjects with FL in the inferential 
analysis set has 93% power to test the null hypothesis that the ORR is 40% versus the alternative 
hypothesis that the ORR is 60% with a 1-sided alpha level of 0.0237.
Within the inferential analysis set, interim analysis 3, 4, and 5 will be performed when 
30 subjects with FL have had the opportunity to be followed for response for 6 months after 
axicabtagene ciloleucel infusion, when 80 subjects with FL have had the opportunity to be 
followed for response for 6 months after axicabtagene ciloleucel infusion, and when 80 subjects 
with FL have had the opportunity to be followed for response 9 months after the first disease 
response assessment. These interim analyses will be for safety and to assess early demonstration 
of efficacy.  The interim analyses are based on the interpolated alpha spending function.  The 
nominal alpha levels for the assessment of efficacy are 0.0003, 0.0005, and 0.0005.  The study 
will not be stopped if early efficacy is demonstrated and the primary analysis will occur after at 
least 80 subjects with FL in the inferential analysis set and have had the opportunity to be 
followed for 12 months after the first disease response assessment.

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10.4.
Statistical Assumptions
Treatment outcomes for subjects with r/r iNHL who have had > 2 prior regimens are exemplified 
by the clinical trials of the PI3K-inhibitors, idelalisib (Zydelig®) {Gopal 2014}, and copanlisib 
(Aliqopa) {Dreyling 2017}. In these trials, the ORRs were 57% and 59%, respectively, with CR 
rates of 6% and 12%, respectively. See Section 2.
In the current trial, it is anticipated that most subjects will have had prior treatment with at least 
one of these agents; thus, an ORR < 40% or CR < 15% would not be of clinical interest.
10.5.
Analysis Subsets
The following analysis sets are defined:
The pivotal cohort is defined by the eligibility criteria specified below:
1) Histologically confirmed diagnosis of B-cell iNHL, with histological subtype limited to FL 
Grade 1, Grade 2, or Grade 3a or MZL nodal or extranodal, based on criteria established by 
the WHO 2016 classification
2) Relapsed or refractory disease after 2 or more prior lines of therapy. Prior therapy must have 
included an anti-CD20 monoclonal antibody combined with an alkylating agent. (Single 
agent anti-CD20 antibody will not count as a line of therapy for eligibility). Stable disease 
(without relapse) > 1 year from completion of last therapy is not eligible.
a) The safety analysis set will consist of all subjects treated with any dose of axicabtagene 
ciloleucel.
b) The inferential analysis set will consist of all enrolled subjects who meet the eligibility 
criteria for the pivotal cohort and were treated with any dose of axicabtagene ciloleucel.  
This analysis set will be used for all analyses of objective response and endpoints based 
on objective response (best overall response, DOR, PFS).
c) The full analysis set (FAS) will consist of all enrolled subjects and will be used for the 
summary of subject disposition, sensitivity analyses of ORR and PFS, and subject listings 
of deaths.
10.6.
Access to Individual Subject Treatment Assignments
This is a single-arm, open-label study, and subjects and investigators will be aware of treatment 
received.  Data handling procedures for the study 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, DSMB charter, and trial integrity document.

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10.7.
Interim Analysis
The DSMB will review safety data after 10 subjects in the safety analysis set have been enrolled 
and treated with axicabtagene ciloleucel and have had an opportunity to be followed for 4 weeks 
for safety.  This analysis will be for safety only.
The DSMB will meet again to review safety data after 30 subjects in the safety analysis set have 
been enrolled and treated with axicabtagene ciloleucel and have had an opportunity to be 
followed for 4 weeks.  This analysis will be for safety only.
The DSMB will meet again to review safety and efficacy data after 30 subjects with FL in the 
inferential analysis set have been enrolled and treated with axicabtagene ciloleucel and have had 
an opportunity to be followed for 6 months after axicabtagene ciloleucel infusion.  This analysis 
will be for safety and efficacy.
The DSMB will meet again to review the safety data when 80 subjects with FL in the inferential 
analysis set have been enrolled and treated with axicabtagene ciloleucel and have had an 
opportunity to be followed for 6 months after axicabtagene ciloleucel infusion.
The DSMB will meet again to review the safety data when 80 subjects with FL in the inferential 
analysis set have been enrolled and treated with axicabtagene ciloleucel and have had an 
opportunity to be followed for 9 months from the first disease assessment date.
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.
10.8.
Planned Methods of Analysis
The interim analysis 5 will be performed when at least 80 subjects with FL in the inferential 
analysis set have had the opportunity to be followed for 9 months after the first disease response 
assessment.  The primary efficacy analysis of response rate will be performed when at least 80 
subjects with FL in the inferential analysis set have had the opportunity to be followed for 
12 months after the first disease response assessment.  A clinical study report (CSR) will be 
prepared and provided to the regulatory agency(ies). The CSR will be written based on the data 
collected and analyzed from the primary analysis. Kite will ensure that the report meets the 
standards set out in the International Conference on Harmonisation (ICH) Guideline for Structure 
and Content of Clinical Study Reports (ICH E3). After the primary analysis, additional follow-up 
analyses of efficacy and safety will be performed as needed to satisfy regulatory requirements 
and to perform long-term efficacy, safety, and OS follow-up. The final analysis will occur when 
all subjects have completed the study.
The primary analysis for ORR as primary endpoint will be based on central review of disease 
assessments per the Lugano Classification {Cheson 2014}.  The ORR based on investigator 
review of the disease assessment will be used as the sensitivity analysis for ORR.
Efficacy summaries will be presented by histological subtype (eg, FL and MZL) and overall.

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10.8.1.
ORR
The subject incidence of objective response will be calculated and 2-sided 95% confidence 
intervals will be calculated with the Clopper-Pearson method. An exact binomial test will be 
used to compare the ORR per central read among the subjects with FL and among the subjects 
with FL who have had 3 or more lines of prior therapy to the hypothesized historical control rate 
of 40%.
The incidence of subjects with CR, PR, SD, PD, and NE as best overall response to treatment 
and exact 2-sided 95% confidence intervals about the incidence will be generated.
10.8.2.
CRR
The subject incidence of CR will be calculated.  The 2-sided 95% confidence intervals will be 
provided about the CR rate, calculated with the Clopper-Pearson method.  An exact binomial test 
will be used to compare the observed CR rate per central read among the subjects with FL and 
among the subjects with FL who have had 3 or more lines of prior therapy to the hypothesized 
historical control rate of 15% if ORR is statistically significant.
10.8.3.
DOR
Kaplan-Meier plots, estimates, and 2-sided 95% confidence intervals will be generated for DOR. 
Kaplan-Meier estimates will be provided for the proportion of subjects who are alive and 
progression-free at 3-month time intervals. The number of subjects censored or having events 
will be summarized, as well as the reasons for censoring and the event type (PD or death).  
Analyses will be generated for DOR per central read and per investigator read. The reverse 
Kaplan-Meier approach {Schemper 1996} will be used to estimate the follow-up time for DOR.
10.8.4.
PFS
Kaplan-Meier plots, estimates, and 2-sided 95% confidence intervals will be generated for PFS. 
Kaplan-Meier estimates of the proportion of subjects alive and progression-free at 3-month 
intervals will be provided. The number of subjects censored or having events will be 
summarized, as well as the reasons for censoring and the event type (PD or death).
10.8.5.
OS
Kaplan-Meier plots, estimates, and 2-sided 95% confidence intervals will be generated for OS.  
Estimates of the proportion of subjects alive at 3-month, 6-month, and 12-month intervals will be 
provided.
10.8.6.
Time to Next Therapy
Kaplan-Meier plots, estimates, and 2-sided 95% confidence intervals will be generated for time 
to next therapy.

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10.8.7.
Safety
Safety summaries will be provided by FL, MZL, and overall. AEs will be graded using the 
CTCAE version 4.03 or above.  Subject incidence rates of all AEs, including serious AEs, fatal 
AEs, Grade 3 or higher AEs, and treatment -related AEs will be reported throughout the conduct 
of the study and will be tabulated by preferred terms and system organ class.  Changes in 
laboratory values and vital signs will be summarized with descriptive statistics.  The incidence of 
concomitant medication use will be summarized.
Tables and/or narratives of deaths through the LTFU and treatment-related SAEs will be 
provided.
10.8.8.
Long-term Data Analysis
All subjects will be followed for survival for up to approximately 15 years after the last subject 
receives his or her last axicabtagene ciloleucel infusion.  LTFU data analysis will be performed 
on subjects in the study and after transition to the LTFU study.  No formal hypothesis testing will 
be performed based on data obtained after the cutoff for the primary analysis.  Descriptive 
estimates of key efficacy and safety analyses may be updated to assess the overall treatment 
profile.
10.8.9.
Follow-up Analysis
After the primary analysis, additional follow-up analyses of efficacy and safety will be 
performed as needed to satisfy regulatory requirements and to perform long-term efficacy, 
safety, and OS follow-up.

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11.
REGULATORY OBLIGATIONS
11.1.
IRB/IEC
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.  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 SAEs 
(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
The investigator must assure that the subjects’ anonymity will be strictly maintained and that 
their identities are protected from unauthorized parties. Only an ID code and any other unique 
identifier(s) as allowed by local law (such as year of birth) will be recorded on any form or 
biological sample submitted to Kite or the laboratory. Laboratory specimens must be labeled in 
such a way as to protect subject identity while allowing the results to be recorded for the proper 
subject (refer to specific laboratory instructions for further information). Subject data will be 
processed in accordance with all applicable regulations.
Kite has established processes in place to ensure the security and confidentiality of data records 
and personal information. This includes the following: restricting access, via secure login 
information for individual authorized users, to electronic personal data and study data systems; 
pseudonymization of study subject data; encryption of all personal data in transit and at rest; and 
a robust data privacy and security due diligence process with third party vendors, which includes 
a written contract with each vendor to abide by privacy and security obligations. Processes are 
also in place to avoid loss of information. Should a data security breach occur, Kite will follow 
its relevant standard operating procedures to mitigate the impact. Kite will abide by all available 
national and international data protection legislation. Further details on what personal data are 
collected, where they are stored, how they are processed and who will have access is described in 
the study country-specific patient information sheets.
The investigator agrees that all information received from Kite, including but not limited to the 
IB, this protocol, eCRFs, the study drug, site initiation visit presentation slides, and any other 
study information, remain the sole and exclusive property of Kite during the conduct of the study 
and thereafter. This information is not to be disclosed to any third party (except employees or 
agents directly involved in the conduct of the study or as required by law) without prior written 
consent from Kite. The investigator further agrees to take all reasonable precautions to prevent 
the disclosure by any employee or agent of the study site to any third party or otherwise into the 
public domain.

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Subject confidentiality must be maintained at all material submitted to the key sponsor contact.  
The following rules are to be applied.
•
Subjects will be identified by a unique ID number
•
Date of birth or year of birth/age at time of enrollment will be reported in accordance with 
local laws and regulations
For reporting of SAEs, subjects will be identified by their respective subject ID number, initials, 
and date of birth or year of birth (as per their local reporting requirements for both initials and 
date of birth).
Per regulations and International Conference on Harmonisation of Technical Requirements for 
Pharmaceuticals for Human Use (ICH)/Good Clinical Practice (GCP) guidelines, investigators 
and institutions are required to permit authorization to the sponsor, contract research 
organization (CRO), IRB/IEC, and regulatory agencies to access 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.
11.3.
Investigator Signatory Obligations
Each clinical study report will be signed by the coordinating investigator.  The coordinating 
investigator will be identified by Kite 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 investigator’s agreement with the amendment and the IRB/IEC 
approval of the amendment must be obtained.  Documentation acknowledging approval from 
both parties is to be submitted to the key sponsor contact.
Both Kite 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 sponsor with a copy of the correspondence.
Kite reserves the unilateral right, at its sole discretion, to determine whether to manufacture 
axicabtagene ciloleucel T cells and provide them to sites and subjects after the completion of the 
study and before treatment becomes commercially available.

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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, and radiology 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 ID lists
•
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 and the investigator.  Should storage no longer be available to archive 
source documents or must be moved to an alternative location, the research staff should notify 
the key sponsor contact prior to the shipping the documents.
Traceability records for the product, from procurement through manufacture to the 
administration of the product, should be kept by each relevant party (eg, the sponsor and the 
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 the sponsor. 
Before, during, and after completion or termination of the trial, 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 product, while ensuring the data protection legally required for the subject.
If the investigator cannot provide 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 the 
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 is transferred 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.

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14.
STUDY MONITORING AND DATA COLLECTION
The key sponsor contact, 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’s 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, and compliance with protocol requirements as well as ICH/GCP and 
applicable regulatory policies.
All data will be collected in an electronic CRF system.  All entries must be completed in English, 
and concomitant medications should be identified by trade names.  For additional details 
surrounding the completion of CRFs, refer to the CRF completion guidelines.

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15.
PUBLICATION
Authorship of publications from data generated in study KTE-C19-105 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 for 
review and approval.  The study contract among the institution, principal investigator, and Kite 
or its delegate will outline the requirements for publication review.

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16.
COMPENSATION
Kite will provide compensation for study-related illness or injury pursuant to the information 
outlined in the injury section of the ICF.

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17.
REFERENCES
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watch-and-wait approach in patients with advanced-stage, asymptomatic, non-
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2014;15 (4):424-35.
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of imaging in the staging and response assessment of lymphoma: consensus of the 
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Clin Oncol 2014;32 (27):3048-58.
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Oncol 1997;15 (3):1110-7.
Casulo C, Byrtek M, Dawson KL, Zhou X, Farber CM, Flowers CR, et al. Early Relapse of 
Follicular Lymphoma After Rituximab Plus Cyclophosphamide, Doxorubicin, 
Vincristine, and Prednisone Defines Patients at High Risk for Death: An Analysis 
From the National LymphoCare Study. J Clin Oncol 2015;33 (23):2516-22.

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Cheson BD, Fisher RI, Barrington SF, Cavalli F, Schwartz LH, Zucca E, et al. 
Recommendations for initial evaluation, staging, and response assessment of 
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Kinase Inhibition by Copanlisib in Relapsed or Refractory Indolent Lymphoma. J 
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Dudley ME, Yang JC, Sherry R, Hughes MS, Royal R, Kammula U, et al. Adoptive cell therapy 
for patients with metastatic melanoma: evaluation of intensive myeloablative 
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Evens AM, Vanderplas A, LaCasce AS, Crosby AL, Nademanee AP, Kaminski MS, et al. Stem 
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rituximab: a comprehensive analysis from the NCCN lymphoma outcomes 
project. Cancer 2013;119 (20):3662-71.
Federico M, Bellei M, Marcheselli L, Luminari S, Lopez-Guillermo A, Vitolo U, et al. Follicular 
lymphoma international prognostic index 2: a new prognostic index for follicular 
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project. J Clin Oncol 2009;27 (27):4555-62.
Flinn IW, Miller CB, Ardeshna KM, Tetreault S, Assouline SE, Zinzani PL, et al. Dynamo: A 
Phase 2 Study Demonstrating the Clinical Activity of Duvelisib in Patients with 
Relapsed Refractory Indolent Non-Hodgkin Lymphoma. Blood 2016;128 
(22):1218.
Flinn IW, van der Jagt R, Kahl BS, Wood P, Hawkins TE, Macdonald D, et al. Randomized trial 
of bendamustine-rituximab or R-CHOP/R-CVP in first-line treatment of indolent 
NHL or MCL: the BRIGHT study. Blood 2014;123 (19):2944-52.
Fowler NH, Davis RE, Rawal S, Nastoupil L, Hagemeister FB, McLaughlin P, et al. Safety and 
activity of lenalidomide and rituximab in untreated indolent lymphoma: an open-
label, phase 2 trial. Lancet Oncol 2014;15 (12):1311-8.

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Freedman A. Follicular lymphoma: 2018 update on diagnosis and management. Am J Hematol 
2018;93 (2):296-305.
Friedberg JW, Neuberg D, Stone RM, Alyea E, Jallow H, LaCasce A, et al. Outcome in patients 
with myelodysplastic syndrome after autologous bone marrow transplantation for 
non-Hodgkin's lymphoma. J Clin Oncol 1999;17 (10):3128-35.
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 
of adoptively transferred CD8+ T cells. J Clin Invest 2005;115 (6):1616-26.
Gopal AK, Kahl BS, de Vos S, Wagner-Johnston ND, Schuster SJ, Jurczak WJ, et al. PI3Kdelta 
inhibition by idelalisib in patients with relapsed indolent lymphoma. N Engl J 
Med 2014;370 (11):1008-18.
Gribben JG. How I treat indolent lymphoma. Blood 2007;109 (11):4617-26.
Kahl BS, Yang DT. Follicular lymphoma: evolving therapeutic strategies. Blood 2016;127 
(17):2055-63.
Klebanoff CA, Khong HT, Antony PA, Palmer DC, Restifo NP. Sinks, suppressors and antigen 
presenters: how lymphodepletion enhances T cell-mediated tumor 
immunotherapy. Trends Immunol 2005;26 (2):111-7.
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;35 (16):1803-13.
Kochenderfer JN, Wilson WH, Janik JE, Dudley ME, Stetler-Stevenson M, Feldman SA, et al. 
Eradication of B-lineage cells and regression of lymphoma in a patient treated 
with autologous T cells genetically engineered to recognize CD19. Blood 
2010a;116 (20):4099-102.

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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 2010b;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.
Lee DW, Kochenderfer JN, Stetler-Stevenson M, Cui YK, Delbrook C, Feldman SA, et al. T 
cells expressing CD19 chimeric antigen receptors for acute lymphoblastic 
leukaemia in children and young adults: a phase 1 dose-escalation trial. Lancet 
2015;385 (9967):517-28.
Leonard JP, Jung SH, Johnson J, Pitcher BN, Bartlett NL, Blum KA, et al. Randomized Trial of 
Lenalidomide Alone Versus Lenalidomide Plus Rituximab in Patients With 
Recurrent Follicular Lymphoma: CALGB 50401 (Alliance). J Clin Oncol 2015;33 
(31):3635-40.
Lunning MA, Migliacci JC, Hilden P, Devlin SM, Castro-Malaspina H, Giralt S, et al. The 
potential benefit of allogeneic over autologous transplantation in patients with 
very early relapsed and refractory follicular lymphoma with prior remission 
duration of </=12 months. Br J Haematol 2016;173 (2):260-4.
Lunning MA, Vose JM. Management of Indolent Lymphoma: Where Are We Now and Where 
Are We Going [Author Manuscript]. Blood Rev 2012;26 (6):279-88.
Marcus R, Imrie K, Solal-Celigny P, Catalano JV, Dmoszynska A, Raposo JC, et al. Phase III 
study of R-CVP compared with cyclophosphamide, vincristine, and prednisone 
alone in patients with previously untreated advanced follicular lymphoma. J Clin 
Oncol 2008;26 (28):4579-86.
Maurer MJ, Bachy E, Ghesquieres H, Ansell SM, Nowakowski GS, Thompson CA, et al. Early 
event status informs subsequent outcome in newly diagnosed follicular 
lymphoma. Am J Hematol 2016;91 (11):1096-101.
National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology B-
Cell Lymphomas. Version 3.2018. 13 April.  2018:
Neelapu SS, Locke FL, Bartlett NL, Lekakis LJ, Miklos DB, Jacobson CA, et al. Axicabtagene 
Ciloleucel CAR T-Cell Therapy in Refractory Large B-Cell Lymphoma. N Engl J 
Med 2017;377 (26):2531-44.
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.

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Noone A, Howlader N, Krapcho M, Miller D, Brest A, Yu M, et al. SEER Cancer Statistics 
Review, 1975-2015. National Cancer Institute. Bethesda, MD, 
https://seer.cancer.gov/csr/1975_2015/, based on November 2017 SEER data 
submission, posted to the SEER web site, April 2018. 2017.
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.
Robinson SP, Canals C, Luang JJ, Tilly H, Crawley C, Cahn JY, et al. The outcome of reduced 
intensity allogeneic stem cell transplantation and autologous stem cell 
transplantation when performed as a first transplant strategy in relapsed follicular 
lymphoma: an analysis from the Lymphoma Working Party of the EBMT. Bone 
Marrow Transplant 2013;48 (11):1409-14.
Rohatiner AZ, Nadler L, Davies AJ, Apostolidis J, Neuberg D, Matthews J, et al. Myeloablative 
therapy with autologous bone marrow transplantation for follicular lymphoma at 
the time of second or subsequent remission: long-term follow-up. J Clin Oncol 
2007;25 (18):2554-9.
Rummel MJ, Niederle N, Maschmeyer G, Banat GA, von Grunhagen U, Losem C, et al. 
Bendamustine plus rituximab versus CHOP plus rituximab as first-line treatment 
for patients with indolent and mantle-cell lymphomas: an open-label, multicentre, 
randomised, phase 3 non-inferiority trial. Lancet 2013;381 (9873):1203-10.
Schemper M, Smith TL. A note on quantifying follow-up in studies of failure time. Control Clin 
Trials 1996;17 (4):343-6.
Schouten HC, Qian W, Kvaloy S, Porcellini A, Hagberg H, Johnsen HE, et al. High-dose therapy 
improves progression-free survival and survival in relapsed follicular non-
Hodgkin's lymphoma: results from the randomized European CUP trial. J Clin 
Oncol 2003;21 (21):3918-27.
Schuster SJ, Svoboda J, Chong EA, Nasta SD, Mato AR, Anak O, et al. Chimeric Antigen 
Receptor T Cells in Refractory B-Cell Lymphomas. N Engl J Med 2017;377 
(26):2545-54.
Sehn LH, Goy A, Offner FC, Martinelli G, Caballero MD, Gadeberg O, et al. Randomized Phase 
II Trial Comparing Obinutuzumab (GA101) With Rituximab in Patients With 
Relapsed CD20+ Indolent B-Cell Non-Hodgkin Lymphoma: Final Analysis of the 
GAUSS Study. J Clin Oncol 2015;33 (30):3467-74.
Solal-Céligny P, Roy P, Colombat P, White J, Armitage JO, Arranz-Saez R, et al. Follicular 
Lymphoma International Prognostic Index. Blood 2004;104 (5):1258-65.

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Tan D, Horning SJ, Hoppe RT, Levy R, Rosenberg SA, Sigal BM, et al. Improvements in 
observed and relative survival in follicular grade 1-2 lymphoma during 4 decades: 
the Stanford University experience. Blood 2013;122 (6):981-7.
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Lymphoma Study Group Classification of Non-Hodgkin's Lymphoma. Blood 
1997;89 (11):3909-18.
Vose JM, Bierman PJ, Loberiza FR, Lynch JC, Bociek GR, Weisenburger DD, et al. Long-term 
outcomes of autologous stem cell transplantation for follicular non-Hodgkin 
lymphoma: effect of histological grade and Follicular International Prognostic 
Index. Biol Blood Marrow Transplant 2008;14 (1):36-42.
Wang TP, Scott JH, Barta SK. The evolving role of targeted biological agents in the management 
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Information. Foster City, CA. Revised: September.  2016:

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18.
APPENDICES
Section 18.1
Sponsor and Investigator Signature Page
Section 18.2
Country-specific Regulatory Agency Requirements - France
Section 18.3
Lugano Classification
Section 18.4
Tabulated List of Investigational Medicinal Product and Auxilary Medicinal Products for EU
Section 18.5
Protocol Amendment History
Section 18.6
Pandemic Risk Assessment and Mitigation Plan

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18.1.
Sponsor and Investigator Signature Page
KITE PHARMA, INC.
2400 BROADWAY
SANTA MONICA, CA 90404
STUDY ACKNOWLEDGMENT
A PHASE 2 MULTICENTER STUDY OF AXICABTAGENE CILOLEUCEL IN SUBJECTS 
WITH RELAPSED/REFRACTORY INDOLENT NON-HODGKIN LYMPHOMA (INHL)
Amendment 8.0, 29 January 2024
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 the 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

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18.2.
Country-specific Regulatory Agency Requirements - France
The postinfusion 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 3, column “IP 
Administration Period, D1 to 7”. The L'Agence nationale de sécurité du médicament et des 
produits de santé (ANSM) recommends a 10-day hospitalization after infusion of any CAR 
T-cell product.
The daily monitoring will include vital signs (see Section 7.4), blood draw for chemistry panel 
with CRP (see Section 7.11.6), blood draw for CBC w/differential (see Section 7.9), and 
physical/neurological assessment. Any observed toxicity will be managed according to 
Section 6.5 of this protocol.

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18.3.
Lugano Classification
Refer to the 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.  
18.3.1.
Complete Remission
18.3.1.1.
Complete Metabolic Response (CMR) for Positron Emission Tomography-
computed (PET-CT) Based Response
The designation of complete metabolic response (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 extra-nodal 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
18.3.1.2.
Complete Radiologic Response for CT-based Response
The designation of complete radiologic response (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 extra-lymphatic sites of disease
•
Absent non-measured lesion
•
Organ enlargement regress to normal
•
No new sites of disease should be observed.
•
Bone marrow normal by morphology; if indeterminate, immunohistochemistry (IHC) negative

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18.3.2.
Partial Remission
18.3.2.1.
Partial Metabolic Response for PET-CT-based Response
The designation of partial metabolic response (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 magnetic resonance imaging (MRI) or 
biopsy or an interval scan.
18.3.2.2.
Partial Radiologic Response for CT-based Response
The designation of partial radiologic response (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 extra-nodal 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 non-measured lesions
•
Spleen must have regressed by > 50% in length beyond normal.
•
No new sites of disease should be observed.

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18.3.3.
Stable Disease
18.3.3.1.
No Metabolic Response for PET-CT-based Response
The designation of no metabolic response (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
18.3.3.2.
Stable Radiologic Disease for CT-based Response
The designation of stable radiologic disease (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 extra-nodal sites; no criteria for 
progressive disease are met
•
No increase consistent with progression in non-measured lesion and organ enlargement.
•
No new sites of disease should be observed.
18.3.4.
Progressive Disease
18.3.4.1.
Progressive Metabolic Disease for PET-CT-based Response
The designation of progressive metabolic disease (PMD) requires at least 1 of the following:
•
A 5PS score of 4 or 5 with an increase in intensity of uptake from baseline, and/or
•
New FDG-avid foci consistent with lymphoma at interim or end of treatment assessment
•
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

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18.3.4.2.
Progressive Radiologic Disease for CT-based Response
The designation of progressive radiologic disease (PRD) requires at least 1 of the following:
•
An individual node/lesion must be abnormal with:
Longest traverse diameter (LDi) > 1.5 cm, and
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 pre-existing non-measured lesions
•
New lesion
Regrowth of previously resolved lesions
A new node > 1.5 cm in any axis
A new extra-nodal 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
18.4.
Tabulated List of Investigational Medicinal Products and Auxiliary 
Medicinal Products for EU
A list of all investigational and auxiliary medicinal products which can be used in Protocol 
KTE-C19-105 is provided in Table 5 and Table 6 in compliance with EU Reg. 536/2014 Annex I 
Section D No. 17 lit. f. All the investigational and auxiliary medicinal products used in the 
clinical trial are authorized in the EU and are used in accordance with their authorized product 
information in any given country (eg, Package Insert, SmPC) and institutional guidelines.

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Table 5
List of Investigational Medicinal Product
Investigational Medicinal Products
Further information on dosage, dose regimen, route 
of administration and treatment period
Axicabtagene ciloleucel
Please refer to Section 6.2.1 of the protocol
Table 6.
List of Auxiliary Medicinal Products
AxMPsa
Further information on dosage, dose regimen, route 
of administration and treatment period
Acetaminophen (paracetamol) or equivalent
Diphenhydramine or equivalent
Please refer to Section 6.4.3.1 of the protocol
Cyclophosphamide (as lymphodepleting 
chemotherapy)
Fludarabine (as lymphodepleting chemotherapy)
Mesna
Please refer to Sections 6.3.1 and 7.11.4.1 of the 
protocol.
Tocilizumab
Dexamethasone (as toxicity management)
Methylprednisolone
These AxMPs are not all specified in the protocol, 
however, are suggested within the standard of care 
toxicity management guidelines referred to in 
Section 6.5 of the protocol and further discussed in 
Sections 6.5.1 and 6.5.2 of the IB
Abbreviations: AxMP, auxiliary medicinal product; IB, Investigator’s Brochure.
a
All AxMPs listed have marketing authorization in all countries participating in ZUMA-5. No AxMP is classified as a 
narcotic, psychotropic, radiopharmaceutical, or orphan medicine.

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Amendment 8
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18.5.
Protocol Amendment History
High-level summaries of the history of this study’s amendments are provided in tabular form in 
the subsections below (from the most recent amendment to the oldest), with changes listed in 
order of importance. Minor changes such as the correction of typographic errors, grammar, or 
formatting are not detailed.
Earlier separate summaries of changes for previous amendments are available upon request.
A separate tracked change (red-lined) document comparing Amendment 7 to this amendment 
(Amendment 8) will be made available.
18.5.1.
Amendment 8 (29 January 2024)
Section Number and Name 
High-level Description of Change
Brief Rationale
Synopsis and Section 10.2.3
One of the key covariates for ORR 
was changed from “Time to relapse 
from completion of first anti-CD20 
chemotherapy” to “time to relapse 
from initiation of first anti-CD20 
chemotherapy”
The change was made to address 
the discrepancy between the 
protocol and SAP Version 4.0.
Section 2.5
A benefit/risk assessment section 
was added in which a reference to 
the IB was made.
Benefit/risk assessment of 
axicabtagene ciloleucel was 
provided to align with the Clinical 
Trials Regulation (Regulation [EU] 
No 536/2014).
•
A description and a list of 
investigational and auxiliary 
medicinal products were added. 
To accommodate this change, 
the ‘Axicabtagene Ciloleucel’ 
section that was previously in 
Section 6.2.2 was moved to 
Section 6.2.1.
•
The additional information was 
added to provide a list of 
investigational and authorized 
auxiliary medicinal products 
used in the study and to align 
with the Clinical Trials 
Regulation (Regulation [EU] 
No 536/2014).
•
The approximate number of 
subjects who have received the 
various doses of axicabtagene 
ciloleucel in this study so far 
was removed.
•
The information is not 
necessary to be presented in the 
protocol.
Sections 6.2.1, 6.2.2, and 18.4
•
Instructions for reporting of 
any problems related to the use 
of axicabtagene ciloleucel was 
revised.
•
The revision was provided for 
clinical site staff to report any 
problems related to the use of 
axicabtagene cilolceucel 
according to the instructions in 
the IPM.

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Section Number and Name 
High-level Description of Change
Brief Rationale
Section 9.9
A sentence was added to reflect that 
the DSMB can make a 
recommendation to the sponsor to 
discontinue the study early based on 
the guidelines in the DSMB charter.
The added sentence was provided 
to align with the Clinical Trials 
Regulation (Regulation [EU] No 
536/2014).
Section 11.2
Additional paragraphs regarding 
subject confidentiality were added.
The additional paragraphs were 
provided to align with the Clinical 
Trials Regulation (Regulation [EU] 
No 536/2014).
Abbreviations: DSMB, Data Safety Monitoring Board; EU, European Union; IB, Investigator’s Brochure; IPM, Investigational 
Product Manual; ORR, objective response rate; SAP, statistical analysis plan.
18.5.2.
Amendment 7 (22 February 2023)
Section Number and Name 
High-level Description of Change
Brief Rationale
Synopsis, Study Schema, Sections 
3.5, 3.6, 6.2.5, 7.11.8, 7.11.9, 
10.8.8, Table 4
The timing of subject transition to a 
separate long-term follow-up 
protocol (KT-US-982-5968) was 
defined. 
New guidance added to reference 
transition to the LTFU study.
Section 9.2, 9.4, Table 4
Timeline for reporting targeted AEs 
and SAEs was lengthened.  
Additionally, clarification was 
added that only targeted AEs and 
SAEs related to axicabtagene 
ciloleucel need to be reported from 
3 months through 15 years, until 
disease progression, or until the 
initiation of subsequent anticancer 
therapy.
Timeline for reporting targeted AEs 
and SAEs was lengthened due to 
regulatory agency feedback.  
Clarification that only targeted AEs 
and SAEs need to be reported from 
3 months to 15 years added due to 
regulatory agency feedback.
Section 7.11.8, Section 9.4
Updated definition of secondary 
malignancies
Clarification.
Section 9.4
Included details for SAE reporting 
after completion of study and 
database closure.
Clarification.
Section 6.2.5 
Language added clarifying 
collection of anticancer therapy 
information for subjects who are 
enrolled but do not receive 
axicabtagene ciloleucel infusion.  
Clarification.
Section 7.11.9
Retreatment limited to 24 months 
after initial axicabtagene ciloleucel 
infusion.
Retreatment limit added to align 
with other Kite studies.
Section 5.2, 9.6
Updated contraception language 
from 6 months to 12 months.
Contraception language updated 
due to regulatory agency feedback.

Axicabtagene Ciloleucel; KTE-C19
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Amendment 8
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Section Number and Name 
High-level Description of Change
Brief Rationale
Section 13
Study documentation and archive 
language updated.
Clarification.
Section 18.8
Pandemic Risk Assessment and 
Mitigation Plan Language added.
New section added to summarize 
potential risks associated with 
subjects being unable to attend 
study visits.
Section 6.4.3, 7.11.6, 18.2
Added country-specific regulatory 
agency requirements for post-
infusion monitoring of subjects in 
France.
Addition of appendix previously 
added to a country-specific French 
protocol amendment to the global 
amendment. (Consolidation of PA6 
& PA 6.1 [France] protocols)
Throughout, as needed 
Minor changes. 
Clarification/correction.

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Kite Pharma, Inc.
Amendment 8
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18.6.
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 it has been approved by 
the local ethics committee/institutional review board. The consent process will be 
documented and confirmed by normal consent procedure at the investigative site at the 
earliest opportunity.

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Protocol KTE-C19-105
Final
Kite Pharma, Inc.
Amendment 8
CONFIDENTIAL
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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 protocol deviations related to the pandemic.
b) Study monitors may be unable to carry out source data review or source data verification, 
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 study 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:
a) There may be an increased amount of missing data because of a 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.
b) 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.

amd-8-prot-KTE-C19-105
ELECTRONIC SIGNATURES
Signed by
Meaning of Signature
Server Date
(dd-MMM-
yyyy hh:mm:ss)
Clinical Development
eSigned
29-Jan-2024
17:02:20
PPD