A Phase 2 Multicenter Study Evaluating the Efficacy of KTE-X19 in Subjects With Relapsed/Refractory Mantle Cell Lymphoma
Phase: PHASE2
Conditions: Relapsed/Refractory Mantle Cell Lymphoma
Sponsor: Kite, A Gilead Company

Protocol Title: 
A Phase 2 Multicenter Study Evaluating the Efficacy ofKTE-X19 in Subjects with 
Relapsed/R.efractory Mantle Cell Lymphoma (ZUMA-2) 
Protocol Number: 
K1E-C19-102 
IND Number: 
016675 
EudraCT Number: 
2015-005008-27 
Clinical Stndy Sponsor: 
Kite Pharma, Inc. 
2400 Broadvw,y 
Santa Monica, CA 90404 
United States of America 
Key Sponsor Contact: 
PPD 
I 
Senior Director, Clinical Development 
PPD 
PPD 
P one:PPD 
Email:PPD 
I 
[PPD 
J 
StuclyMan!lger, CfinicOperations 
PPD -J 
P one:PPD 
Email:PPD 
I 
Version: 
Amendment# 6 
Date: 
29 October 2018 
CONFIDENTIALITY NOTICE 
This document contains proprietary and confidential information of Kite Pharma Inc., a wholly 
owned subsidiary of Gilead Sciences, Inc. The information must not be disclosed to any 
third party without the prior written consent of Kite Pharma, Inc. Questions regarding how this 
document should be used or the conduct of the clinical trial should be directed to the key sponsor 
contacts. 

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Clinical Protocol
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INVESTIGATOR’S AGREEMENT
I have read the attached protocol titled A Phase 2 Multicenter Study Evaluating the Efficacy of 
KTE-X19 in Subjects with Relapsed/Refractory Mantle Cell Lymphoma (ZUMA-2) dated
29 October 2018 and agree to abide by all provisions set forth therein.
I agree to comply with the International Conference on Harmonisation Tripartite Guideline on 
Good Clinical Practice and applicable national or regional regulations and guidelines.
I agree and will ensure that financial disclosure statements will be completed by:

Me (including, if applicable, my spouse, legal partner, and dependent children)

Sub-Investigators (including, if applicable their spouse, legal partner, and dependent 
children) at the start of the study and for up to one 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.
_____________________________________________________________________
Signature
______________________________________________________________________
Name of investigator
_____________________________________________________________________
Date

KTE-C19-102 
Kite Pharma, Inc.
Clinical Protocol
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CONFIDENTIAL
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PROTOCOL SYNOPSIS
Title: 
A Phase 2 Multicenter Study Evaluating the Efficacy of KTE-X19 in Subjects with 
Relapsed/Refractory Mantle Cell Lymphoma (ZUMA-2)
Indication:
The treatment of adult subjects with relapsed/refractory mantle cell lymphoma
(r/r MCL).
Study Design:
Study KTE-C19-102 is a Phase 2, multicenter, open-label study evaluating the efficacy 
of KTE-X19 in subjects with r/r MCL.
Cohort 1 will enroll and treat up to approximately 90 subjects with cyclophosphamide 
and fludarabine conditioning chemotherapy, followed by a target dose of 2 x 106 anti‑
CD19 CAR T cells per kg body weight. This cohort will include at least 60 but up to 
approximately 80 subjects treated with KTE-X19 (referred to as KTE-X19 subjects in 
this document) and 10 subjects treated with axicabtagene ciloleucel (referred to as 
axicabtagene ciloleucel subjects in this document). The KTE-X19 subjects in this 
cohort will form the basis for hypothesis testing on the primary endpoint.  
Cohort 2 will enroll and treat up to 40 KTE-X19 subjects with cyclophosphamide and 
fludarabine conditioning chemotherapy, followed by a target dose of 0.5 x 106 anti-
CD19 chimeric antigen receptor (CAR) T cells per kg body weight.
Each subject will proceed through the following study periods:

Screening 

Enrollment/Leukapheresis 

Bridging therapy if applicable

Conditioning chemotherapy 

Investigational product (IP) treatment 

Post-treatment assessment 

Long-term follow-up period
For study requirements assigned to each study period, refer to Section 7 for details.   
Study Objectives:
The primary objective is to evaluate the efficacy of KTE-X19, as measured by 
objective response rate (ORR), in subjects with r/r MCL. Secondary objectives will 
include assessing the safety and tolerability of KTE-X19, additional efficacy endpoints, 
and change in the European Quality of Life-5 Dimensions (EQ-5D) scores from 
baseline to Month 6.
Hypothesis:
This study uses an open-label 2-cohort design.
Among the Cohort 1 KTE-X19 subjects, with a target 50% response rate per 
independent review, an alternative hypothesis will be tested against a null hypothesis 
that the response rate is 25% or less. The hypothesis is that the ORR to KTE-X19 per
independent review is significantly greater than 25% in Cohort 1 KTE-X19 subjects.
No hypothesis will be tested in Cohort 1 axicabtagene ciloleucel subjects and Cohort 2
KTE-X19 subjects. Exploratory analyses will be conducted on the data collected from 
these subjects.

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Clinical Protocol
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Primary Endpoint:
ORR (complete response [CR] + partial response [PR]) per the Lugano Classification
(Cheson et al, 2014) per Independent Radiology Review Committee (IRRC) review
Secondary 
Endpoints:

Duration of response 

Best objective response (BOR)

ORR as determined by study investigators

Progression-free survival

Overall survival 

Incidence of adverse events (AEs) and clinically significant changes in laboratory 
values

Incidence of anti-CD19 CAR antibodies

Levels of anti-CD19 CAR T cells in blood

Levels of cytokines in serum

Changes over time in the EQ-5D scale score and visual analogue scale score
Exploratory 
Endpoints:
Sample Size:

Up to approximately 130 will be enrolled in the study: 

90 subjects in Cohort 1 (10 axicabtagene ciloleucel subjects and approximately 
80 KTE-X19 subjects) at 2 x 106 anti‑CD19 CAR T cells per kg body weight 

Up to 40 KTE-X19 subjects in Cohort 2 at 0.5 x 106 anti‑CD19 CAR T cells 
per kg body weight
Study Eligibility:
Refer to Section 5 for a detailed list of inclusion and exclusion criteria.
Treatment:
Bridging Therapy

At the discretion of the investigator, bridging therapy may be considered for 
subjects particularly with high disease burden at screening (eg, > 25% marrow 
involvement or ≥ 1000 leukemic phase mantle cells/mm3 in the peripheral 
circulation).  

Bridging therapy is allowed with (1) dexamethasone or other corticosteroid,
(2) ibrutinib, or (3) acalabrutinib.

If prescribed, bridging therapy must be administered after leukapheresis and 
completed at least 5 days prior to initiating conditioning chemotherapy. 

Refer to Section 6 for dosing and further details.
Conditioning Chemotherapy Treatment:

KTE-X19 or 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.
CCI

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Clinical Protocol
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Investigational Product:

KTE-X19 or 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 (Cohort 1) or 0.5 x 106 anti-CD19 CAR T cells/kg 
(Cohort 2).  Under circumstances where subjects initially respond and subsequently 
relapse, subjects may be eligible for a second course of conditioning chemotherapy 
and KTE-X19 or axicabtagene ciloleucel. Refer to Section 6 for treatment details 
and Section 7.12.10 for retreatment details.
Procedures:
At specific time points as outlined in the schedule of assessments, subjects will undergo 
the following assessments/procedures: collection of informed consent; general medical 
history, including previous treatments for MCL; physical exam, including vital signs 
and performance status; neurological assessments; blood draws for complete blood 
count (CBC), chemistry panels, cytokines, C-reactive protein, lymphocyte subsets, anti-
CD19 CAR antibodies, replication-competent retrovirus (RCR), and anti-CD19 CAR 
T cells analysis. Women of childbearing potential will undergo a urine or serum 
pregnancy test. 
Subjects will also undergo a baseline electrocardiogram (ECG), echocardiogram 
(ECHO), brain magnetic resonance image (MRI), a positron emission tomography-
computed tomography (PET-CT), bone marrow aspirate/biopsy, and leukapheresis. 
Routinely throughout the conduct of the study, subjects will be asked to complete the 
EQ-5D questionnaire, report concomitant medications and AEs, and will have their 
disease assessed.
Data Safety 
Monitoring Board:
An independent Data Safety Monitoring Board (DSMB) will review safety and/or 
efficacy data 4 times during this study. The DSMB will first meet to review safety data 
when 10 subjects in Cohort 1 have been enrolled and treated with anti-CD19 CAR T
cells and followed for 30 days. The DSMB will meet for the second time to review 
both safety and efficacy data after 20 subjects in Cohort 1 have been enrolled, treated,
and have had the opportunity to complete the 3-month disease assessment.  The DSMB 
will meet for the third time to review both safety and efficacy data after 10 subjects in 
Cohort 2 have been enrolled, treated, and have had the opportunity to be followed for 
30 days. The DSMB will meet for the fourth time to review safety data after 44 subjects 
in Cohort 1 have been enrolled, treated, and have had the opportunity to be followed for 
at least 30 days, with focus on the safety data from the 6 KTE-X19 subjects treated 
most recently in this cohort. 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 9.10 and Section 9.11.
Statistical 
Considerations:
This study uses an open-label, 2-cohort design. Among the Cohort 1 KTE-X19
subjects, with a target 50% response rate per independent review, an alternative 
hypothesis will be tested against a null hypothesis that the response rate is 25% or less. 
For the test of efficacy in the Cohort 1 KTE-X19 subjects, this study has at least
96% power to distinguish between an active therapy with a 50% true response rate from 
a therapy with a response rate of 25% or less with a 1-sided alpha level of 0.025. No 
hypothesis will be tested on Cohort 1 axicabtagene ciloleucel subjects and on Cohort 2.
Four interim analyses will be performed in Cohort 1, and 1 interim analysis will be 
performed in Cohort 2.  One primary analysis will be performed after 60 Cohort 1 
KTE-X19 subjects have been enrolled and treated and have had the opportunity to be
assessed for response 6 months after the Week 4 disease assessment.

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Clinical Protocol
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
Cohort 1 interim analysis 1 will be conducted after 10 subjects in Cohort 1 have 
been enrolled and treated with anti-CD19 CAR T cells and followed for 30 days.  
This interim analysis will be for safety only. 

Cohort 1 interim analysis 2 will be conducted after 20 subjects in Cohort 1 
(Section 10.5) have been enrolled and treated with anti-CD19 CAR T cells and 
have had the opportunity to be evaluated for response 3 months after the 
investigational product (IP) infusion. This interim analysis will be for safety and 
efficacy (futility only).

Cohort 1 interim analysis 3 will occur after 38 subjects treated with anti-CD19 
CAR T cells in Cohort 1 have had the opportunity to be assessed for response 
6 months after the IP infusion.

Cohort 1 interim analysis 4 will be conducted after 44 subjects in Cohort 1 have 
been enrolled and treated with anti-CD19 CAR T cells and have had the 
opportunity to be followed for at least 30 days after the IP infusion.  This interim 
analysis will assess safety only, with focus on the KTE-X19 subjects treated most 
recently in this cohort.  

Cohort 2 interim analysis will be conducted after 10 subjects in Cohort 2 have been 
enrolled and treated with KTE-X19 and have had the opportunity to be followed 
for 30 days after the KTE-X19 infusion.  This interim analysis will assess safety 
and efficacy.  
The primary analysis will occur after 60 KTE-X19 subjects in the modified intent-to-
treat (mITT) set of Cohort 1 have been enrolled and treated with KTE-X19 and have 
had the opportunity to be assessed for response 6 months after the Week 4 disease 
assessment.

KTE-C 19-1 02 
Clinical Protocol 
Kite Pharma, Inc. 
Figure 1. 
Study Schema 
Conditioning Chemotherafil'. 
Investigational Product (IP) 
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Study KTE-C 19-102 is a Phase 2, multi center, open-label study evaluating the efficacy of KTE-Xl9 in subjects with relapsed/refractory mantle cell 
lymphoma (r/r MCL). 
Up to approximately 130 subjects with r/r MCL will be enrolled into 2 separate cohorts designated as Cohort 1 and Cohort 2. 
• 
Cohort 1 will enroll and treat 90 subjects at a target dose of 2 x 106 anti-CD 19 CAR T cells/kg, including 10 axicabtagene ciloleucel subjects 
and approximately 80 KTE-X19 subjects. 
• 
Cohort 2 will enroll and treat up to approximately 40 KTE-Xl9 subjects at a target dose of0.5 x 106 anti-CD19 CART cells/kg. 
Final 
CONFIDENTIAL 
Page 7 of92 
29 October 2018 

KTE-C19-102 
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Clinical Protocol
Final
CONFIDENTIAL
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TABLE OF CONTENTS
INVESTIGATOR’S AGREEMENT.............................................................................................................................2
PROTOCOL SYNOPSIS ..............................................................................................................................................3
TABLE OF CONTENTS ..............................................................................................................................................8
LIST TABLES.............................................................................................................................................................11
LIST OF FIGURES.....................................................................................................................................................11
LIST OF ABBREVIATIONS......................................................................................................................................12
1.
OBJECTIVES.....................................................................................................................................................15
2.
DISEASE BACKGROUND AND RATIONALE..............................................................................................16
2.1.
First-line Therapy...................................................................................................................................16
2.2.
Therapy for Relapsed/Refractory MCL .................................................................................................17
2.3.
CD19 and Expression.............................................................................................................................19
2.4.
Anti-CD19 CAR T-cell Product.............................................................................................................19
2.4.1.
Axicabtagene Ciloleucel.......................................................................................................20
2.4.2.
KTE-X19..............................................................................................................................21
2.5.
Prior Experience with KTE-X19 and Other Anti-CD19 CAR T Cells...................................................21
2.6.
KTE-X19................................................................................................................................................24
3.
STUDY DESIGN................................................................................................................................................25
3.1.
General Study Design ............................................................................................................................25
3.2.
Participating Sites...................................................................................................................................26
3.3.
Number of Subjects................................................................................................................................26
3.4.
Replacement of Subjects........................................................................................................................26
3.5.
Study Duration .......................................................................................................................................26
3.5.1.
Study Duration for Individual Subjects................................................................................26
3.5.2.
Completion of Study ............................................................................................................26
4.
SUBJECT SCREENING AND ENROLLMENT...............................................................................................27
5.
SUBJECT ELIGIBILITY ...................................................................................................................................28
5.1.
Inclusion Criteria....................................................................................................................................28
5.2.
Exclusion Criteria...................................................................................................................................29
6.
PROTOCOL TREATMENT ..............................................................................................................................31
6.1.
Treatment Terminology..........................................................................................................................31
6.2.
Study Treatment.....................................................................................................................................31
6.2.1.
Bridging Therapy .................................................................................................................31
6.2.2.
Conditioning Chemotherapy ................................................................................................31
6.2.3.
KTE-X19..............................................................................................................................32
6.2.4.
Concomitant Therapy...........................................................................................................33
6.2.5.
Excluded Medications..........................................................................................................34
6.2.6.
Subsequent Therapy .............................................................................................................34
6.3.
Study Treatment Schedule .....................................................................................................................34
6.3.1.
Leukapheresis (Within Approximately 5 Days of Eligibility 
Confirmation).......................................................................................................................34
6.3.2.
Bridging Therapy (Administered after Leukapheresis and Completed at 
Least 5 Days Prior to Initiating Conditioning Chemotherapy).............................................35
6.3.3.
Cyclophosphamide and Fludarabine (Days –5 Through –3 Before 
Infusion of anti-CD19 CAR T cells)....................................................................................35

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6.3.4.
KTE-X19 or axicabtagene ciloleucel (Day 0, after Fludarabine and 
Cyclophosphamide)..............................................................................................................36
6.4.
Toxicity Management ............................................................................................................................37
7.
STUDY PROCEDURES ....................................................................................................................................38
7.1.
Informed Consent...................................................................................................................................38
7.2.
Demographic Data .................................................................................................................................38
7.3.
Medical and Treatment History..............................................................................................................38
7.4.
Physical Exam, Vital Signs, Performance Status, and European Quality of Life-5 Dimensions ...........39
7.5.
Neurological Assessment .......................................................................................................................39
7.6.
Bone Marrow Biopsy .............................................................................................................................40
7.7.
Lumbar Puncture....................................................................................................................................41
7.8.
Disease Response Assessment ...............................................................................................................41
7.9.
Cardiac Function ....................................................................................................................................42
7.10.
Magnetic Resonance Imaging ................................................................................................................42
7.11.
Laboratory..............................................................................................................................................42
7.11.1.
Biomarkers ...........................................................................................................................43
7.12.
Description of Study Periods..................................................................................................................45
7.12.1.
Screening..............................................................................................................................45
7.12.2.
Rescreening..........................................................................................................................46
7.12.3.
Enrollment/Leukapheresis....................................................................................................47
7.12.4.
Bridging Therapy .................................................................................................................48
7.12.5.
Conditioning Chemotherapy Period.....................................................................................48
7.12.6.
Investigational Product Treatment Period............................................................................50
7.12.7.
Requirements to Work Up Potential Infectious and/or Inflammatory 
States....................................................................................................................................52
7.12.8.
Post-treatment Assessment Period .......................................................................................53
7.12.9.
Long-term Follow-up Period................................................................................................55
7.12.10.
Retreatment ..........................................................................................................................56
8.
SUBJECT WITHDRAWL..................................................................................................................................61
8.1.
Reasons for Removal from Treatment ...................................................................................................61
8.2.
Reasons for Removal from Study ..........................................................................................................62
9.
SAFETY REPORTING......................................................................................................................................63
9.1.
AEs.........................................................................................................................................................63
9.2.
Reporting of AEs....................................................................................................................................63
9.3.
Definition of SAEs.................................................................................................................................64
9.4.
Reporting of SAEs and Non-serious CRS Events Grade ≥ 3.................................................................65
9.5.
Reporting Deaths....................................................................................................................................66
9.6.
Diagnosis Versus Signs and Symptoms .................................................................................................66
9.7.
Pregnancy and Lactation........................................................................................................................66
9.8.
Hospitalization and Prolonged Hospitalization......................................................................................67
9.9.
Abnormal Vital Signs Values.................................................................................................................67
9.10.
Data Safety Monitoring Board ...............................................................................................................68
9.11.
Criteria to Pause Enrollment ..................................................................................................................68
10.
STATISTICAL CONSIDERATIONS................................................................................................................69
10.1.
Hypothesis..............................................................................................................................................69
10.2.
Study Endpoints .....................................................................................................................................69
10.2.1.
Primary.................................................................................................................................69
10.2.2.
Secondary.............................................................................................................................69
10.2.3.
Exploratory Endpoints..........................................................................................................70
10.3.
Sample Size Considerations...................................................................................................................70
10.4.
Statistical Assumptions ..........................................................................................................................71

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10.5.
Analysis Subsets.....................................................................................................................................71
10.6.
Access to Individual Subject Treatment Assignments ...........................................................................72
10.7.
Interim Analysis.....................................................................................................................................72
10.7.1.
Interim Analysis and Early Stopping Rules .........................................................................72
10.7.2.
Safety Interim Analysis........................................................................................................72
10.7.3.
Efficacy Interim Analysis.....................................................................................................72
10.7.4.
Other Interim Analysis .........................................................................................................73
10.8.
Planned Methods of Analysis.................................................................................................................73
10.8.1.
ORR......................................................................................................................................73
10.8.2.
Best Objective Response......................................................................................................73
10.8.3.
DOR .....................................................................................................................................74
10.8.4.
PFS.......................................................................................................................................74
10.8.5.
OS.........................................................................................................................................74
10.8.6.
Safety....................................................................................................................................74
10.8.7.
Long-term Data Analysis .....................................................................................................74
11.
REGULATORY OBLIGATIONS......................................................................................................................75
11.1.
Independent Review Board/Independent Ethics Committee..................................................................75
11.2.
Subject Confidentiality...........................................................................................................................75
11.3.
Investigator Signatory Obligations.........................................................................................................75
12.
PROTOCOL AMENDMENTS AND TERMINATION ....................................................................................76
13.
STUDY DOCUMENTATION AND ARCHIVE ...............................................................................................77
14.
STUDY MONITORING AND DATA COLLECTION.....................................................................................78
15.
PUBLICATION..................................................................................................................................................79
16.
COMPENSATION .............................................................................................................................................80
17.
REFERENCES ...................................................................................................................................................81
18.
APPENDIX.........................................................................................................................................................86
18.1.
Appendix 1:  Revised IWG Response Criteria for Malignant Lymphoma.............................................86
18.1.1.
Complete Response..............................................................................................................86
18.1.2.
Partial Response ...................................................................................................................86
18.1.3.
Stable Disease ......................................................................................................................87
18.1.4.
Progressive Disease..............................................................................................................87
18.2.
Appendix 2:  Lugano Classification.......................................................................................................88
18.2.1.
Complete Response..............................................................................................................88
18.2.2.
Complete Radiologic Response............................................................................................88
18.2.3.
Partial Response ...................................................................................................................89
18.2.4.
Stable Disease ......................................................................................................................90
18.3.
Appendix 3:  Monitoring of Subjects After IP Administration per Country Regulatory 
Agencies.................................................................................................................................................92

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LIST TABLES
Table 1.
Treatment Outcomes in First-line MCL .................................................................................17
Table 2.
Outcomes with Available Therapies in r/r MCL ....................................................................19
Table 3.
Treatment Outcomes in r/r MCL After Progressing on Ibrutinib ...........................................19
Table 4.
Subject Disposition, Full Analysis Set ...................................................................................21
Table 5.
Overall Summary of AEs, Safety Analysis Set ......................................................................22
Table 6.
Subject Listing of Deaths, Safety Analysis Set ......................................................................23
Table 7.
Subject Incidence of Frequent (≥ 10%) Grade 3 or Higher Treatment-emergent 
Adverse Events by Preferred Terms and Worse Grade, Safety Analysis Set (n = 28) ...........23
Table 8.
Schedule of Assessments (1 of 2)...........................................................................................58
Table 9.
Schedule of Assessment (2 of 2) ............................................................................................60
Table 10.
5-point Scale (5PS).................................................................................................................88
LIST OF FIGURES
Figure 1.
Study Schema...........................................................................................................................7
Figure 2.
Anti-CD19 Chimeric Antigen Receptor.................................................................................20
Figure 3.
Bone Marrow Assessment Schema ........................................................................................40

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LIST OF ABBREVIATIONS
Abbreviation
Definition
AE
Adverse event
alloSCT
Allogeneic stem cell transplant
ALT
Alanine aminotransferase
ANC
Absolute neutrophil count
AST
Aspartate aminotransferase
AUC
Area under curve
autoSCT
Autologous stem cell transplant
BTKi
Bruton’s tyrosine kinase inhibitor
CAR
Chimeric antigen receptor 
CBC
Complete blood count
CLL
Chronic lymphocytic leukemia
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
CT
Computed tomography
CTCAE
Common Terminology Criteria for Adverse Events
DOR
Duration of response
DSMB
Data Safety Monitoring Board
ECG
Electrocardiogram
ECHO
Echocardiogram
ECOG
Eastern Cooperative Oncology Group
EQ-5D
European Quality of Life-5 Dimensions
GCP
Good Clinical Practices
GOT
Glutamic-oxaloacetic transaminase
GPT
Glutamic-pyruvic transaminase
HEENT
Head, ears, eyes, nose, and throat
HIV
Human immunodeficiency virus

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Abbreviation
Definition
HLH
Hemophagocytic lymphohistiocytosis
IB
Investigator’s Brochure
ICF
Informed consent form
ICH
International Conference on Harmonisation
ID
Identification
IP
Investigational product
IRB/IEC
Institutional Review Board/Independent Ethics Committee
IRRC
Independent Radiology Review Committee 
IV
Intravenous
IWG
International Working Group 
LDH
Lactate dehydrogenase
LTFU
Long-term follow-up
LVEF
Left ventricular ejection fraction
MCL
Mantle cell lymphoma
mITT
Modified intent-to-treat
MMSE
Mini-Mental Status Exam
MRI
Magnetic resonance imaging
NCI
National Cancer Institute
NHL
Non-Hodgkin lymphoma
ORR
Objective 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
PR
Partial response
qPCR
Quantitative polymerase chain reaction
RCR 
Replication-competent retrovirus
r/r
Relapsed/refractory
SAE
Serious adverse event
SCT
Stem cell transplant
SD
Stable disease

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Abbreviation
Definition
SOA
Schedule of assessment
SUSAR
Suspected unexpected serious adverse reaction 
TEAE
Treatment-emergent adverse event
VAS
Visual analogue scale
WBC
White blood cell

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1.
OBJECTIVES
The primary objective is to evaluate the efficacy of KTE-X19, as measured by objective 
response rate (ORR), in subjects with relapsed/refractory (r/r) mantle cell lymphoma (MCL). 
Secondary objectives will include assessing the safety and tolerability of KTE-X19, additional 
efficacy endpoints, and the change in the European Quality of Life-5 Dimensions (EQ-5D)
scores from baseline to Month 6.

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2.
DISEASE BACKGROUND AND RATIONALE
Mantle cell lymphoma is an aggressive, generally incurable, B-cell malignancy, representing 
approximately 6% of non-Hodgkin lymphomas (NHLs). Approximately 4000  new cases are 
diagnosed yearly in the United States (Leukemia & Lymphoma Society 2014).  The lymphoma 
cells are thought to originate from naïve pregerminal center B cells within the mantle zone, and 
they typically express CD5, CD19, CD20, surface IgM, and surface IgD (Dreyling 2014), but not 
CD11c (Kraus et al, 2010).  More than 95% of MCLs carry translocation t(11;14)(q13;q32),
which places the cyclin D1 gene in proximity of the immunoglobulin heavy chain locus, 
resulting in overexpression of cyclin D1, which can be detected by cytogenetics or fluorescence 
in situ hybridization (National Comprehensive Cancer Network 2017).  Most patients are male, 
and the median age of diagnosis is 68 years (Fakhri and Kahl 2017).  Patients typically present 
with advanced lymphadenopathy, and also show extranodal involvement of the spleen, bone 
marrow, and gastrointestinal (GI) tract (Dreyling et al, 2014; Rajabi and Sweetenham 2015; 
National Comprehensive Cancer Network 2017; Vose 2017).  Prognosis varies based on clinical 
and laboratory parameters and can be estimated using the mantle cell international prognostic 
index.  This index uses the 4 independent prognostic factors of age, performance status, lactate 
dehydrogenase (LDH), and leukocyte count to classify patients as low risk (60% to 83% 5-year 
overall survival [OS]), intermediate (35% to 63% 5-year OS), or high risk (20% to 34% 5-year 
OS) (Hoster et al, 2008; Hoster et al, 2014).  
2.1.
First-line Therapy
Most patients require systemic therapy at the time of diagnosis.  First-line therapy for MCL 
typically includes chemotherapy in combination with a CD20 targeting antibody (Table 1). 
Combination regimens include rituximab with cyclophosphamide, doxorubicin vincristine, and 
prednisone (R-CHOP); rituximab with cyclophosphamide, vincristine, and prednisone (R-CVP);
and bendamustine and rituximab (BR) (Lenz et al, 2005; Kluin-Nelemans  et al, 2012; Flinn et 
al, 2014).  Treatment intensification for younger patients with regimens, such as rituximab in 
combination with fractionated cyclophosphamide, vincristine, doxorubicin and dexamethasone 
(hyper-CVAD) alternating with high-dose methotrexate and cytarabine (MA) 
(R-HyperCVAD/MA) (Romaguera et al, 2005; Romaguera et al, 2010), or high-dose 
chemotherapy followed by autologous stem cell transplant (autoSCT) in first remission
(Dreyling et al, 2005), have led to improved outcomes at the expense of additional toxicity. 
Despite high initial response rates to these therapies, almost all patients eventually develop 
progressive disease. 

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Table 1.
Treatment Outcomes in First-line MCL
Regimen
N
Outcome
Reference
R-CHOP v CHOP
122
ORR1  94 v 75%;  CR 34 v 7%, 
mTTF = 21 v 14 m
(Lenz et al, 2005)
R-CHOP v R-FC
560
ORR 86 v 78%; CR 34 v 40%; 4 yr 
OS 62 v 47%
(Kluin-Nelemans et al, 
2012)
BR v R-CHOP/R-CVP
74
ORR 94 v 85%; CR 50 v 27%
(Flinn et al, 2014)
R-HyperCAD/MA
97
CR 77%, mTTF= 4.6 y
(Romaguera et al, 2005)
(Romaguera et al, 2010)
ASCT v IFN-α in first remission
122
mPFS 39 v 17m;  2 year OS 86 v 
82%
(Dreyling et al, 2005)
Abbreviations:  ASCT, autologous stem cell transplant; BR, bendamustine + rituximab; CHOP, cyclophosphamide + doxorubicin 
+ vincristine + prednisone; IFN-α, interferon-alpha; CR, complete response; R-CHOP, rituximab + cyclophosphamide + 
doxorubicin + vincristine + prednisone; R-CVP, rituximab + cyclophosphamide + vincristine + prednisone; R-FC, rituximab + 
fludarabine + cyclophosphamide; R-HyperCAD, rituximab + fractionated cyclophosphamide +  vincristine + doxorubicin + 
dexamethasone; m, month; MA, methotrexate + cytarabine; mPFS, median progression-free survival; mTTF, median time-to-
treatment failure; ORR, objective response rate; OS, overall survival; y, year.
2.2.
Therapy for Relapsed/Refractory MCL
There is no established paradigm for the treatment of r/r MCL.  Treatment options includes 
cytotoxic chemotherapy, proteasome inhibitors, immunomodulatory drugs, tyrosine kinase 
inhibitors, and stem cell transplant (SCT). The choice of regimen is influenced by prior therapy, 
comorbidities, and tumor chemosensitivity. 
Cytotoxic chemotherapy combination regimens used in r/r MCL include fludarabine, 
cyclophosphamide (FC), although this regimen is less efficacious in the relapsed setting than as a 
first-line treatment, and is associated with substantial toxicities (Cohen et al, 2001).  For patients 
with poorer fitness, less intensive therapies are considered based on first-line treatment data,
including rituximab alone, chlorambucil, cladribine, or thalidomide, usually in combination with 
rituximab, but these single cytotoxic agent-based regimens have limited efficacy compared to
multi-agent approaches (Foran et al, 2000; Kaufmann et al, 2004; Inwards et al, 2008; Sachanas 
et al, 2011).  
Stem cell transplant has a role in r/r MCL, although its use is limited to those patients who are 
younger and have good fitness.  AutoSCT is more commonly used than allogeneic, and, in 
eligible patients, results in approximately 25% to 35% event-free survival after 2 to 3 years of 
follow-up (Ketterer et al, 1997; Vose et al, 2000).  Allogeneic stem cell transplant (alloSCT) has 
been investigated in multiple single institution and registry studies in relapsed and refractory 
disease, including patients who have previously undergone autoSCT.  Results from these studies 
are variable, likely in part due to selection bias in single institution and registry based studies, but 
suggest approximately 25% of patients undergoing alloSCT achieve durable remissions if their 
disease is demonstrated to be chemosensitive prior to transplant (Rajabi and Sweetenham 2015). 

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However, in these studies, alloSCT has been associated with high morbidity and non-relapse 
mortality, mostly due to graft versus host disease and its complications and affecting 30% to 
40% of patients.
The agents bortezomib, lenalidomide, ibrutinib, and acalabrutinib have been approved in the 
United States within the last 10 years for the treatment of r/r MCL (see Table 2), and 
temsirolimus is approved in the EU. Bortezomib is an inhibitor of the 26S proteasome and was 
evaluated in a single‑arm, open-label, multicenter trial of 155 patients with r/r MCL who had 
received at least 1 prior therapy (Fisher et al, 2006).  Thirty-seven percent had disease refractory 
to the last treatment regimen.  The ORR based on independent radiologic review of computed 
tomography (CT) scans was 31%, including 6% complete responses.  The median duration of 
response (DOR) was 9.3 months, and the median time to progression was 6.1 months 
(bortezomib USPI).  The most common Grade 3 or greater toxicities were peripheral neuropathy 
(13%), fatigue (12%), and thrombocytopenia (11%).  
Lenalidomide, a second-generation thalidomide derivative, was studied in a single-arm, open-
label, multicenter, trial of 134 patients with r/r MCL (Goy et al, 2013).  Patients were required to 
have received prior treatment with an anthracycline or mitoxantrone, cyclophosphamide, 
rituximab, and bortezomib. Fifty-three percent had 4 or more prior therapies, 60% had disease 
refractory to bortezomib, and 29% had a prior autoSCT.  The ORR based on independent 
radiologic review of CT scans was 26%; 1% achieved a complete response (CR) (lenalidomide 
USPI).  The median DOR was 16.6 months, and the median progression-free survival (PFS) was 
4 months.  The most common Grade 3 or Grade 4 adverse events (AEs) were neutropenia (43%), 
thrombocytopenia (28%), anemia (11%), pneumonia (8%), and fatigue (7%). 
Ibrutinib is a covalent inhibitor of Bruton’s tyrosine kinase.  The safety and efficacy of ibrutinib 
was evaluated in a single-arm, open-label, multicenter, trial of 111 patients with r/r MCL who 
had received at least 1, but no more than 5 prior therapies (Wang et al, 2013). The ORR based 
on investigator review of CT scans was 68%, including 21% complete responses.  The median 
DOR was 17.5 months, and the median PFS was 13.9 months.  The most common Grade 3 or 
higher toxicities were neutropenia (16%), thrombocytopenia (11%), and diarrhea (6%).  
Despite available therapies, almost all patients with r/r MCL die from progressive disease (refer 
to Table 3).  Martin et al, conducted a large (n = 114) retrospective cohort study of response and 
survival in patients treated after primary or acquired ibrutinib resistance (Martin et al, 2016).  Of 
the 104 patients with data available, 73 patients underwent subsequent treatment after stopping 
ibrutinib, and 61 subjects were evaluable for efficacy.  Outcomes were poor, with an ORR of 
26%, CR rate of 7%, and median OS of 5.8 months. Cheah et al, reported similar results (ORR 
32% and median OS of 8.4 months) in a cohort of 31 patients (Cheah et al, 2015). There are 
limited other data on the efficacy of bortezomib, lenalidomide, or other agents in patients who
have progressed on ibrutinib therapy.  There is an urgent unmet need for new treatment options 
that can induce durable responses in a significant fraction of patients.  
Most recently, acalabrutinib, an oral Bruton’s tyrosine kinase inhibitor (BTKi), was approved in 
the US for the treatment of relapsed or refractory MCL (acalabrutinib USPI).  This agent was 
studied in an open-label, multicenter, Phase 2 study of 124 patients with MCL who had at least 
1 prior therapy (median 2 prior lines of therapy; range:  1 to 5 prior lines), and those who had

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previously been treated with any BTKi were excluded from the study (acalabrutinib USPI ; 
Wang et al, 2017).  Thus, this population was less heavily pretreated compared with patients in 
the trials of bortezomib, lenalidomide, and ibrutinib.  After a median follow-up of 15.2 months, 
the ORR was 81% and the CR rate was 40% (acalabrutinib USPI).  Among all treated patients, 
the medians for DOR, PFS, and OS were not reached, and the 12-month PFS and OS rates were 
67%, and 87%, respectively.  The most common Grade 3 and higher AEs were neutropenia 
(13 patients, 10%), anemia (11 patients, 9%), and pneumonia (6 patients, 5%) (Wang et al, 
2017).
Table 2.
Outcomes with Available Therapies in r/r MCL
Regimen
N
Outcome
Reference
Bortezomiba
155
ORR 31%;  CR 8%, DOR 9.3m
(Fisher et al, 2006)
Lenalidomideb
134
ORR 26%; CR 7%; DOR 16.6m
(Goy et al, 2013)
Ibrutinib
111
ORR 68%; CR 21%; DOR 17.5m
(Wang et al, 2013)
Acalabrutinib
124
ORR 81%; CR 40%; DOR NR
(Wang et al, 2017)
Abbreviations:  CR, complete response; DOR, duration of response; m, month; NR, no response; ORR, objective response rate.
a
Retrospective cohort studies of patients with primary or acquired ibrutinib resistant MCL treated with salvage therapy.  
b
Patients enrolled in this study had not failed ibrutinib.
Table 3.
Treatment Outcomes in r/r MCL After Progressing on Ibrutinib
N
Outcome
Reference
61
ORR 26%;  CR rate 7%, mOS 5.8m
(Martin et al, 2016)
31
ORR  32% 19% CR rate; mOS 8.4m
(Cheah et al, 2015)
Abbreviations:  CR, complete response; m, month; mOS, median overall survival; ORR, objective response rate.
2.3.
CD19 and Expression
CD19 is a 95 kD transmembrane protein expressed only in the B-cell lineage. It is expressed in 
all normal B cells starting at the pre-B-cell stage until the final differentiation stage and is not 
expressed in pluripotent hematopoietic stem cells or most plasma cells.  The pattern of CD19 
expression is maintained in B-cell malignancies, including all subtypes of B-cell NHL, chronic 
lymphocytic leukemia (CLL), and non-T-cell acute lymphoblastic leukemia (Blanc et al, 2011)
with the exception of multiple myeloma.
2.4.
Anti-CD19 CAR T-cell Product
Anti-CD19 chimeric antigen receptor (CAR) T cells are autologous human T cells that have been 
engineered to express an extracellular single-chain variable fragment with specificity for CD19 
linked to an intracellular signaling part comprised of signaling domains from CD28 and CD3ζ 
(CD3-zeta) molecules arranged in tandem. 

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An anti-CD19 CAR vector construct has been designed, optimized, and initially tested at the 
Surgery Branch of the National Cancer Institute (NCI; 09-C-0082; IND 13871) 
(Figure 2)(Kochenderfer et al, 2009; Kochenderfer et al, 2010) is derived from the variable 
region of the anti-CD19 monoclonal antibody FMC63 (Nicholson et al, 1997)CD19 CAR T cells 
(Kowolik et al, 2006)-cell activation.  These fragments were cloned into the murine stem cell 
virus-based vector, utilized to genetically engineer the autologous T cells.  Treatment with anti-
CD19 CAR T cells is currently being administered to subjects with CD19+ B-cell malignancies 
in ongoing NCI protocol (09-C-0082; IND 13871). The same CAR vector construct will be used 
in this study. The same CAR vector construct will be used in this study.
Figure 2.
Anti-CD19 Chimeric Antigen Receptor
Abbreviations:  CAR, chimeric antigen receptor; scFV, single-chain variable region fragment; LTR, long terminal repeat.
2.4.1.
Axicabtagene Ciloleucel
Axicabtagene ciloleucel is manufactured for subjects with lymphomas that are characterized as
not being associated with circulating tumor cells (ie, diffuse large B-cell lymphoma, primary 
mediastinal B-cell lymphoma, and follicular lymphoma).  Briefly, peripheral blood mononuclear 
cells (PBMCs) are obtained by leukapheresis and Ficoll separation.  PBMCs are activated by 
culturing with an anti-CD3 antibody in the presence of recombinant IL-2.  Stimulated cells are 
transduced with a retroviral vector containing an anti-CD19 CAR gene and propagated in culture 
to generate sufficient engineered T cells for administration.  
Patients with r/r MCL may have tumor cells in the peripheral blood, which is associated with a 
poor prognosis (Argatoff et al, 1997).  When the first 10 subjects in Cohort 1 were dosed with 
axicabtagene ciloleucel, it was observed that the incidence and amount of circulating leukemic 
CD28 
S' LTR 
scfv 
CD3( 
3' LTR 
CAR vector construct 
Viral vector 
Target binding domain: 
antibody derived (scFv) 
CAR-engineered 
Tcell 
CAR-engineered 
Tcell 
Tumor cell 

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phase MCL appeared to be higher than rates that are typically for MCL (Argatoff et al, 1997; 
Cheah et al, 2015; Cheah et al, 2016).  Because the axicabtagene ciloleucel manufacturing 
process is not optimized to remove circulating tumor cells from the manufacturing process 
stream, all subsequent patients were dosed using KTE-X19.  
2.4.2.
KTE-X19
KTE-X19 is manufactured for subjects with lymphomas that are characterized by having high 
numbers of CD19-expressing circulating tumor cells (B-cell acute lymphoblastic leukemia, CLL,
and MCL).  Briefly, from the leukapheresis product, the T cells in the harvested leukocytes are 
enriched by binding to magnetic beads coated with anti-CD4 and anti-CD8 antibodies.  T cells
are activated by culturing with anti-CD3 and anti-CD28 antibodies, and are then transduced with 
a retroviral vector containing an anti-CD19 CAR gene. These engineered T cells are then
propagated in culture to generate a sufficient number of cells for administration.  
2.5.
Prior Experience with KTE-X19 and Other Anti-CD19 CAR T Cells
Refer to the current KTE-X19 Investigator’s Brochure (IB) for the most current anti-CD19 CAR 
T cells nonclinical and clinical information.
In regards to ZUMA-2, the interim analysis 2 of Cohort 1 was performed and was reviewed by 
the Data Safety Monitoring Board (DSMB) for safety and futility. The DSMB recommended 
that the study proceed without any changes to the study conduct. Only the safety data from this 
interim analysis are reported in detail below.  As of 31 Dec 2017, 28 subjects have been enrolled, 
treated with conditioning chemotherapy and KTE-X19 (see Table 4).  Four subjects died on 
study: 3 due to progressive disease and 1 due to an adverse event (AE) (organizing pneumonia, 
which was considered related to conditioning chemotherapy but unrelated to KTE-X19).
Table 4.
Subject Disposition, Full Analysis Set
axicabtagene 
ciloleucel
(N=13)
KTE-X19
(N=28)
Cohort 1
(N=43)
Subjects Enrolled n(%)
13 (100)
28 (100)
43 (100)
Subjects Leukapheresed n(%)
13 (100)
28 (100)
43 (100)
Subjects treated with Conditioning Chemotherapy n(%)
11 (85)
28 (100)
40 (93)
Primary reason for ending study for subjects treated with KTE-X19 n(%)
1 (8)
4 (14)
5 (12)
   Death
1 (8)
4 (14)
5 (12)
Note: Percentages are based on number of subjects enrolled.
Data Source: ADSL
Output Source: Table 14.1.2
PROGRAM NAME: t_disp
DATE: 12:13/07FEB2018
Table 5 presents an overall summary of treatment-emergent adverse events (TEAEs) in Cohort 1 
that were reported by 31 DEC 2017. Twenty-seven subjects (96%) in Cohort 1 KTE-X19
subjects experienced TEAE(s) of Grade 3 or higher, including 1 Grade 5 event (organizing 
pneumonia) that is not considered to be KTE-X19-related (see Table 6). The most frequently 
(≥10%) reported incidences of Grade 3 or higher TEAEs by preferred terms are summarized in
Table 7.

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The incidence of cytokine release syndrome (CRS) and neurologic toxicities in the KTE-X19‑
treated subjects in Cohort 1 are also summarized in Table 5. Five subjects (18%) have 
experienced Grade 3 or Grade 4 CRS, and 13 subjects (46%) have experienced Grade 3 or 
Grade 4 neurologic toxicities.  No Grade 5 (death) CRS or neurologic toxicity has been reported.
Table 5.
Overall Summary of AEs, Safety Analysis Set
axicabtagene 
ciloleucel
(N=10)
n (%)
KTE-X19
(N=28)
n (%)
Cohort 1
(N=38)
n (%)
Any TEAE 
10 (100)
28 (100)
38 (100)
  Worst Grade 5
0 (0)
1 (4)
1 (3)
  Worst Grade ≥3
10 (100)
27 (96)
37 (97)
Any Serious TEAE 
8 (80)
22 (79)
30 (79)
  Worst Grade 5
0 (0)
1 (4)
1 (3)
  Worst Grade ≥3
8 (80)
22 (79)
30 (79)
Any TE CRS
10 (100)
27 (96)
37 (97)
  Worst Grade 5
0 (0)
0 (0)
0 (0)
  Worst Grade ≥3
3 (30)
5 (18)
8 (21)
Any TE Neurologic Toxicities infusion
8 (80)
17 (61)
25 (66)
  Worst Grade 5
0 (0)
0 (0)
0 (0)
  Worst Grade ≥3
6 (60)
13 (46)
19 (50)
Abbreviations: TEAE, treatment-emergent adverse event; TE, treatment-emergent.
Note: CRS events were graded by Lee et al 2014. All other events were graded by Common Terminology Criteria for Adverse 
Events (CTCAE) version 4.03.
Treatment-emergent adverse event (TEAE) is an AE with a start date on or after the infusion date of anti-C19 CAR T cells.
Data Source: ADSL, ADAE
Output Source: Table 14.4.1.0
PROGRAM NAME: T_AE_SUMRY
DATE: 12:14/07FEB2018

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Table 6.
Subject Listing of Deaths, Safety Analysis Set
Subject ID
Age/Sex
Leukapheresis
date
Conditioning
Chemotherapy
start date/
end date
KTE-X19
infusion date
Death date/
Study Day
Primary cause
of death
Progressive 
Disease
Progressive 
Disease
Progressive 
Disease
Adverse Event 
(Organizing 
pneumonia)
Data Source: ADSL, ADAE
Output Source: \\sasprod01\stat_prog\KTE-C19\KTE-C19-102\analysis\C1IA3\program\tfl\output\L_16_6_1_DEATH_SAF_C1
PROGRAM NAME: L_DEATH        DATE: 11:28/02MAR2018
Table 7.
Subject Incidence of Frequent (≥ 10%) Grade 3 or Higher Treatment-
emergent Adverse Events by Preferred Terms and Worse Grade, Safety 
Analysis Set (n = 28)
MedDRA Preferred Term n(%)
Any Grade 3 
or Higher
Worst
Grade 3
Worst
Grade 4
Worst
Grade 5
Subjects with any Grade 3 or Higher TE Adverse Event
27 (96)
11 (39)
15 (54)
1 (4)
    Anaemia
15 (54)
15 (54)
0 (0)
0 (0)
    Platelet count decreased
11 (39)
6 (21)
5 (18)
0 (0)
    Neutropenia
10 (36)
7 (25)
3 (11)
0 (0)
    Neutrophil count decreased
9 (32)
4 (14)
5 (18)
0 (0)
    White blood cell count decreased
8 (29)
4 (14)
4 (14)
0 (0)
    Encephalopathy
7 (25)
3 (11)
4 (14)
0 (0)
    Hypertension
5 (18)
5 (18)
0 (0)
0 (0)
    Acute kidney injury
4 (14)
1 (4)
3 (11)
0 (0)
    Confusional state
4 (14)
4 (14)
0 (0)
0 (0)
    Aphasia
3 (11)
3 (11)
0 (0)
0 (0)
    Hypotension
3 (11)
2 (7)
1 (4)
0 (0)
    Hypoxia
3 (11)
1 (4)
2 (7)
0 (0)
    Pneumonia
3 (11)
3 (11)
0 (0)
0 (0)
    Pyrexia
3 (11)
3 (11)
0 (0)
0 (0)
    Respiratory failure
3 (11)
1 (4)
2 (7)
0 (0)
Abbreviations:  MedDRA, Medical Dictionary for Regulatory Activities; TE, treatment-emergent.
Note: Preferred terms are sorted in descending order of total frequency count.
Adverse events are coded using MedDRA Version 19.0 and graded per CTCAE 4.03.
Percentages are calculated using the total number of subjects in the treatment group as the denominator.
Data Source: ADSL, ADAE
Output Source: \\sasprod01\stat_prog\KTE-C19\KTE-C19-
102\analysis\C1IA3\program\tfl\output\T_14_3_8_1_2_G3_TEAE_SAF_XLP
PROGRAM NAME: T_G3_TEAE
DATE: 11:25/02MAR2018
PPD

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2.6.
KTE-X19
Kite Pharma, Inc., (hereafter referred to as Kite) is developing an eACT™ (KTE-X19) that 
targets CD19 expression on B-cell malignancies. The CAR vector construct is identical to the 
one used in the NCI protocol (09-C-0082; IND 13871).  Kite, in conjunction with the NCI 
Surgery Branch, has developed a rapid, closed, and bead-less process for the generation of the 
anti-CD19 CAR T cells.  Closing the process retains the characteristics of the T-cell product 
(Better et al, 2014).  Refer to the current IB for more details.

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3.
STUDY DESIGN
3.1.
General Study Design
Study KTE-C19-102 is a Phase 2, multicenter, open-label study evaluating the safety and 
efficacy of KTE-X19 in subjects with r/r MCL. 
This study is designed to examine the safety and efficacy of KTE-X19 in patients who have r/r 
MCL that has progressed on prior chemotherapy, anti-CD20 antibody, and ibrutinib or 
acalabrutinib.  The study will evaluate the ORR and durability of response after treatment with 
KTE-X19.  An open-label, 2-cohort design is used, with a target ORR in the alternative 
hypothesis of 50% and a futility criterion that the ORR is no more than 25%. Up to 
approximately 130 subjects with r/r MCL in total will be enrolled and treated to evaluate the 
efficacy of KTE-X19.  Cohort 1 will treat up to approximately 90 subjects at a target dose of 
cells/kg, including up to approximately 80 KTE-X19 subjects and 
10 axicabtagene ciloleucel subjects. The Cohort 1 KTE-X19 subjects will form the basis for 
statistical hypothesis testing on the primary endpoint. Cohort 2 will treat up to 40 KTE-X19
subjects at a target dose of 
anti-CD19 CAR T cells/kg.
Each subject will proceed through the following study periods:

Screening 

Enrollment/Leukapheresis 

Bridging therapy, if applicable

Conditioning chemotherapy 

Investigational product (IP) treatment 

Post-treatment assessment 

Long-term follow-up (LTFU)
An independent DSMB will review safety and/or efficacy data 4 times during this study. The 
DSMB will first meet to review safety data when 10 Cohort 1 subjects have been enrolled and 
treated with anti-CD19 CAR T cells and followed for 30 days.  The DSMB will meet for the 
second time to review safety and efficacy data after 20 Cohort 1 subjects have been enrolled and 
treated with anti-CD19 CAR T cells and have had the opportunity to complete the 3-month 
disease assessment.  The DSMB will meet for the third time to review both safety and efficacy 
data after 10 subjects in Cohort 2 have been enrolled and treated with KTE-X19 and have had 
the opportunity to be followed for 30 days. The DSMB will meet for the fourth time to review 
safety data after 44 subjects in Cohort 1 have been enrolled and treated with anti-CD19 CAR 
T cells and have had the opportunity to be followed for at least 30 days, with focus on the safety 
data from the 6 KTE-X19 subjects treated most recently in this cohort. 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. 
CCI
CCI
-
-

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For details surrounding the DSMB, refer to Section 9.10 and Section 9.11.
For study requirements assigned to each study period, refer to the schedule of assessments 
(SOAs) and Section 7 for details.
A study schema is included in Figure 1.
3.2.
Participating Sites
Approximately 40 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 130 subjects will be enrolled and treated in this study.
It should be noted that Kite may choose to close enrollment at any time. Refer to Section 10 for 
statistical considerations of the protocol, including sample size estimations.
3.4.
Replacement of Subjects
Subjects will continue to be enrolled until the specified numbers of subjects are attained in the 
modified intent-to-treat (mITT) set.  Subjects who have not received the target dose of 
anti-CD19 CAR T cells will be retained in the analyses of disposition and safety, where 
appropriate (refer to Section 10.5). 
3.5.
Study Duration
3.5.1.
Study Duration for Individual Subjects 
The duration of the study for individual subjects will vary. For a subject who completes the 
entire protocol from the date of informed consent through the completion of the LTFU period,
the duration of the study will take approximately 15 years to complete. However, individual 
study duration will vary depending on a subject’s screening requirements, response to treatment,
and survival. 
The need for prolonged follow-up is based on the potential persistence of gene transfer vectors in 
treated subjects.
3.5.2.
Completion of Study
Completion of the study is defined as the time at which the last subject completes the LTFU
period visit, is considered lost to follow-up, withdraws consent, or dies. 

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4.
SUBJECT SCREENING AND ENROLLMENT
All subjects must sign and date the Independent 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, which starts when the subject signs the informed 
consent form, 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. The subject identification will never be changed even if the subject is rescreened.
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
101)
Pathologically confirmed MCL, with documentation of either overexpression of cyclin 
D1 or presence of t(11;14)
102)
Up to 5 prior regimens for MCL.  Prior therapy must have included:
Anthracycline or bendamustine-containing chemotherapy, and
Anti-CD20 monoclonal antibody therapy, and
Ibrutinib or acalabrutinib
103)
Relapsed or refractory disease, defined by the following:
Disease progression after last regimen, or
Refractory disease is defined failure to achieve a partial response (PR) or CR to the last 
regimen
104)
At least 1 measurable lesion. Lesions that have been previously irradiated will be 
considered measurable only if progression has been documented following completion of 
radiation therapy
If the only measurable disease is lymph node disease, at least 1 lymph node should be 
≥2 cm
105)
Magnetic resonance imaging (MRI) of the brain showing no evidence of central nervous 
system (CNS) lymphoma
106)
At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed since any prior
systemic therapy or BTKi (ibrutinib or acalabrutinib) at the time the subject is planned 
for leukapheresis, 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 at the time the subject is planned for leukapheresis 
(eg, ipilimumab, nivolumab, pembrolizumab, atezolizumab, OX40 agonists, 4-1BB 
agonists). 
107)
Toxicities due to prior therapy must be stable and recovered to ≤ Grade 1 (except for 
clinically non-significant toxicities such as alopecia)
108)
Age 18 years or older
109)
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

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110)
Absolute neutrophil count (ANC) ≥ 1 000/uL
111)
Platelet count ≥ 75 000/uL
112)
Absolute lymphocyte count ≥ 100/uL
113)
Adequate renal, hepatic, pulmonary, and cardiac function defined as:
Creatinine clearance (as estimated by Cockcroft Gault) ≥ 60 cc/min 
Serum alanine aminotransferase/aspartate aminotransferase ≤2.5 upper limit of normal 
(ULN)
Total bilirubin ≤ 1.5 mg/dl, except in subjects with Gilbert’s syndrome
Cardiac ejection fraction ≥ 50%, no evidence of pericardial effusion as determined by an 
echocardiogram (ECHO), and no clinically significant electrocardiogram (ECG) findings
No clinical significant pleural effusion
Baseline oxygen saturation > 92% on room air
114)
Females of childbearing potential must have a negative serum or urine pregnancy test.  
Females who have undergone surgical sterilization or who have been postmenopausal for 
at least 2 years are not considered to be of childbearing potential.
5.2.
Exclusion Criteria
201)
History of malignancy other than nonmelanomatous skin cancer or carcinoma in situ 
(eg, cervix, bladder, breast) unless disease-free for at least 3 years 
202)
AutoSCT within 6 weeks of planned KTE-X19 or axicabtagene ciloleucel infusion 
203)
History of allogeneic stem cell transplantation
204)
Prior CD19 targeted therapy with the exception of subjects who received KTE-X19 or 
axicabtagene ciloleucel in this study and are eligible for re-treatment
205)
Prior CAR therapy or other genetically modified T-cell therapy
206)
History of severe, immediate hypersensitivity reaction attributed to aminoglycosides 
207)
Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring
intravenous (IV) antimicrobials for management.  Simple urinary tract infection (UTI)
and uncomplicated bacterial pharyngitis are permitted if responding to active treatment
and after consultation with the Kite medical monitor
208)
History of human immunodeficiency virus (HIV) infection or acute or chronic active 
hepatitis B or C infection. Subjects with a history of hepatitis infection must have cleared 
their infection as determined by standard serological and genetic testing.

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209)
Presence of any in-dwelling line or drain (eg, percutaneous nephrostomy tube, 
in-dwelling Foley catheter, biliary drain, or pleural/peritoneal/pericardial 
catheter). Ommaya reservoirs and dedicated central venous access catheters, such as a 
Port-a-Cath or Hickman catheter, are permitted.
210)
Subjects with detectable cerebrospinal fluid malignant cells or brain metastases or with a 
history of CNS lymphoma, cerebrospinal fluid malignant cells, or brain metastases
211)
History or presence of CNS disorder, such as seizure disorder, cerebrovascular 
ischemia/hemorrhage, dementia, cerebellar disease, cerebral edema, posterior reversible 
encephalopathy syndrome, or any autoimmune disease with CNS involvement
212)
History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, active 
arrhythmias, or other clinically significant cardiac disease within 12 months of 
enrollment
213)
Subjects with cardiac atrial or cardiac ventricular lymphoma involvement
214)
History of symptomatic deep vein thrombosis or pulmonary embolism within the last 6 
months of enrollment  
215)
Possible requirement for urgent therapy due to ongoing or impending oncologic 
emergency (eg, tumor mass effect, tumor lysis syndrome)
216)
Primary immunodeficiency
217)
Any medical condition likely to interfere with assessment of safety or efficacy of study 
treatment
218)
History of severe immediate hypersensitivity reaction to any of the agents used in this 
study 
219)
Live vaccine ≤ 6 weeks prior to planned start of conditioning regimen
220)
Women of childbearing potential who are pregnant or breastfeeding because of the 
potentially dangerous effects of the preparative chemotherapy on the fetus or infant 
221)
Subjects of both genders who are not willing to practice birth control from the time of 
consent through 6 months after the completion of KTE-X19 or axicabtagene ciloleucel
infusion
222)
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.
223)
History of autoimmune disease (eg Crohn’s disease, rheumatoid arthritis, systemic lupus) 
resulting in end organ injury or requiring systemic immunosuppression/systemic disease 
modifying agents within the last 2 years

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6_ 
PROTOCOL TREATMENT 
6.1. 
Treatment Terminology 
The following te1ms will be used to describe and define protocol treatment: 
• 
Bridging therapy, if administered, after discussion with the medical monitor will be 
dexamethasone, ibrntinib, or acalabrntinib. 
• 
The conditioning chemotherapy regimen used for this study will be fludarabine and 
cyclophosphainide. 
• 
The IP for this study is named KTE-X19 and axicabtagene ciloleucel. 
• 
The te1m study treatment refers to all protocol-required therapies. 
6.2. 
6.2.1. 
Study Treatment 
Bridging Therapy 
Bridging therapy will be supplied by the investigative site unless othe1wise noted. Sites should 
refer to the cmTent product label for guidance on packaging, storage, preparation, administration, 
and toxicity management. At the discretion of the investigator and after discussion with the 
medical monitor, bridging therapy may be considered for any subject, particularly those with 
high disease bmden at screening (eg, > 25% manow involvement and/or :::: 1000 leukeinic phase 
mantle cells/mm3 in the peripheral circulation). 
Bridging therapy is to be administered after leukapheresis and must be completed at least 5 days 
prior to initiating conditioning chemotherapy. 
If bridging therapy is administered, the subject must undergo another positron emission 
tomography-computed tomography (PET-CT) to assess disease status prior to receiving 
conditioning chemotherapy and subsequent anti-CD19 CAR T cells infusion. 
6.2.2. 
Conditioning Chemotherapy 
Conditioning chemotherapy will be supplied by the investigative site unless othe1w ise noted. 
Sites should refer to the cunent product label for guidance on packaging, storage, preparation, 
administration, and toxicity management associated with the administration of both agents. 
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Subjects will receive a non-myeloablative conditioning regimen consisting of 
 
 to induce 
lymphocyte depletion and create an optimal environment for expansion of anti-CD19 CAR T 
cells in vivo. Conditioning chemotherapy should only commence when the product is 
available, if required by country regulatory agencies.
6.2.2.1.
Fludarabine 
Fludarabine phosphate (hereafter, fludarabine) 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.
6.2.2.2.
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.
6.2.2.3.
Mesna
Mesna is a detoxifying agent used to inhibit the hemorrhagic cystitis induced by chemotherapy. 
The active ingredient mesna is a synthetic sulfhydryl compound designated as sodium-2-
mercaptoethane sulfonate with a molecular formula of C2H5NaO3S2. 
Mesna will be 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.
6.2.3.
KTE-X19
Refer to the current version of the IB regarding KTE-X19 and related clinical experience.  Refer 
to the Investigational Product Manual for details and instruction on storage and administration of 
KTE-X19.  
KTE-X19 is supplied cryopreserved in cryostorage bags.  The product in the bag is slightly 
cloudy, with cream to yellow color. The cryostorage bags containing KTE-X19 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 infusion process.
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KTE-X19 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 infonnation (eg, initials, subject ID number) is essential. Do not infuse the product 
if the infonnation on the subject-specific label does not match the intended subject. The volume 
of KTE-X19 infused, the thaw start/stop time, and KTE-X19 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. Refer to the Investigational Product Manual for details and instruction on 
storage, thawing, and administi·ation of KTE-X19. 
If any problems related to the use of KTE-X19 or any products that suppo1i the management of 
KTE-X19 (eg, cryostorage bags, subject identification labels) required in this study are 
identified, refer to the cmTent Investigational Product Manual for info1mation regarding issue 
repo1iing and resolution. 
6.2.3.1. 
Dose Rationale 
This study is designed to evaluate safe :efficac of two anti-C 
. 
. . 
The recommended ti·eatment re imen for Coho1i I 
is based on the favorable safety:efficacy profile seen in the 
ZUMA-I ti·ial- a Phase 1/2 multicenter study investigating the safety and efficacy of 
axicabtagene ciloleucel in subjects with refracto1y aggressive NHL, which met its primaiy 
endpoint with an ORR of 82% and CR rate of 54% (Locke et al, 2017). 
At the time of the interim analysis 3, 13 subjects (46%) had experienced Grade 3 or Grade 4 
nemologic toxicities (Section 2.5). A phaimacokinetic analysis of KTE-X19 in subjects dosed 
with KTE-X19 in ZUMA-2 Coho1i I (data cutoff: 15 June 2017) demonsu-ated an approximate 
3- to 4-fold higher peak expansion and cumulative exposme (area under curve (AUC)o-2s) 
relative to that seen in subjects ti·eated in ZUMA-I ). Given that CAR T cell peak and AUC0-2s 
are associated with Grade 3 or higher nemologic toxicities in ZUMA-I patients (Neelapu et al, 
2016), the sponsor opted to reduce the KTE-XI 9 target dose to -
anti-CD 19 CAR 
T cells/kg to evaluate safety:efficacy of a lower dose. Therefore, subjects emolled into ZUMA-2 
Coho1i 2 are administered a target dose of-
anti-CD19 CAR T cells/kg, with a 
maximum dose of-
anti-CD19 CAR T cells for subjects ~ 100 kg. 
6.2.4. 
Concomitant Therapy 
Investigators may additionally prescribe any other conc01nitant medications or ti·eatment deemed 
necessaiy to provide adequate suppo1iive cai·e, including growth factor suppo1i ( eg, G-CSF) and 
routine anti-emetic prophylaxis and ti·eatment except those medications listed in the excluded 
medication Section 6.2.5. 
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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 anti-CD19 CAR T cells. After 3 months of follow-up, only targeted concomitant 
medication will be collected for 24 months after anti-CD19 CAR T cells infusion or disease 
progression, whichever occurs first. Targeted concomitant medications include gammaglobulin, 
immunosuppressive drugs, anti-infective drugs, and vaccinations.
For subjects who are enrolled, but not dosed with anti-CD19 CAR T cells, 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).  For subjects who are not 
enrolled (eg, screen failure or not leukapheresed), only concurrent therapies related to any 
serious adverse events (SAEs) will be recorded.
Specific concomitant medication collection requirements and instructions are included in the
case report form (CRF) completion guidelines.
6.2.5.
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 anti-CD19 CAR T cells administration unless used for 
bridging therapy (refer to Section 6.3.2).  
Corticosteroids and other immunosuppressive drugs should also be avoided for 3 months after 
anti-CD19 CAR T cells administration unless used to manage anti-CD19 CAR T cell related 
toxicities (refer to Section 6.4).  Other medications that may interfere with evaluation of the IP, 
such as non-steroidal anti-inflammatory agents, should also be avoided for the same time period 
unless medically necessary. 
Treatment for the subject’s 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 
anti-CD19 CAR T cells infusion. If permissibility of a specific medication/treatment is in 
question, contact the Kite medical monitor.
6.2.6.
Subsequent Therapy 
Subsequent therapy administered after anti-CD19 CAR T cells infusion for a subject’s disease,
such as non-study specified chemotherapy, immunotherapy, targeted agents, as well as SCT and 
radiation therapy, must be documented until subject completes the LTFU period, is considered 
lost to follow-up, withdraws consent, or dies.   
6.3.
Study Treatment Schedule
6.3.1.
Leukapheresis (Within Approximately 5 Days of Eligibility Confirmation)
Subjects will undergo leukapheresis to obtain leukocytes (white blood cells [WBCs]) for the 
manufacturing of KTE-X19 or axicabtagene ciloleucel.  Leukapheresed cells obtained at 
participating centers will be shipped to the cell processing facility (CPF) overnight as described 
in the Investigational Product Manual.    

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Mononuclear cells will be obtained by leukapheresis (12 to 15 liter apheresis with a goal to target 
approximately 5 to 10 x 109 mononuclear cells). The leukapheresed cells are then packaged for 
expedited shipment to the CPF as described in the Investigational Product Manual. 
Upon ~mival at the CPF, each subject's leukapheresed product will be processed to emich for the 
T cell containing PBMC fraction. T cells are then stimulated to expand and transduced with a 
retroviral vector to introduce the CAR gene. The T cells are then expanded and c1yopreserved to 
generate the IP per CPF standard operating procedures (SOPs). After the product has passed 
certain release tests, it will be shipped back to the treating facility. Following completion of each 
subject's conditioning chemotherapy regimen, subjects will receive their respective KTE-X19 or 
axicabtagene ciloleucel infusion. 
6.3.2. 
Bridging Therapy (Administered after Leukapheresis and Completed at 
Least 5 Days Prior to Initiating Conditioning Chemotherapy) 
At the discretion of the investigator and after discussion with the medical monitor, bridging 
therapy may be considered for any subject, pa1t icularly those with high disease burden at 
screening (eg, > 25% maITow involvement and/or~ 1000 leukemic phase mantle cells/mm3 in 
the peripheral circulation). 
Bridging therapy is to be administered after leukapheresis and must be completed at least 5 days 
prior to initiating conditioning chemotherapy. 
If bridging therapy is administered, the patient must undergo another PET-CT to assess disease 
status prior to receiving conditioning chemotherapy and subsequent anti-CD19 CAR T cells 
infusion. 
6.3.3. 
Cyclophosphamide and Fludarabine (Days -5 Through -3 Before Infusion of 
anti-CD19 CART cells) 
Subjects will receive a non-myeloablative conditioning regimen consisting of cyclophosphamide 
and fludarabine to induce lymphocyte depletion and create an optimal environment for expansion 
of anti-CD19 CART cells in vivo. Sub'ects will initiate conditionin chemothera 
with 
cyclophosphainide and fludarabine 
before 
the receiving anti-CD19 CART cells. The 3-day conditioning chemotherapy regimen will be 
administered in an outpatient setting. 
The 3-day conditioning regimen of fludarabine and cyclophosphainide is described below. 
Hydration for cyclophosphamide may alternatively be perfonned according to local institutional 
guidelines. 
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
IV hydration with 1 L of 0.9% NaCl given prior to cyclophosphamide on the day of infusion 
followed by:

Cyclophosphamide 500 mg/m2 IV over approximately 60 minutes followed by:

 


Add mesna per institutional guidelines 
Subjects should be instructed to drink plenty of liquids during and for 24 hours following the 
chemotherapy (approximately 2 liters/24 hours). In general, subjects should be kept well-
hydrated, but closely monitored, to prevent fluid overload. Another balanced crystalloid solution 
(such as Ringer’s lactate) can be used in place of 0.9% NaCl if deemed more appropriate in the 
investigator’s opinion.
6.3.3.1.
Dosing Rationale
Administration of conditioning chemotherapy correlates with clinical responses to adoptive cell 
therapy (Dudley et al, 2008). Specifically, there appears to be a link between adequate 
lymphodepletion and adoptively-transferred T-cell expansion and function.  The depth and 
duration of the lymphodepletion in pre-clinical models correlate with the anti-tumor activity of 
the adoptively-transferred, tumor-specific CD8+ T cells (Gattinoni et al, 2005).  
Lymphodepletion may function by eradicating cytokine sinks for the transferred cells, 
eliminating regulatory T cells, or enhancing the activation of antigen-presenting cells (Klebanoff 
et al, 2005).  Combined treatment with cyclophosphamide and fludarabine represents a potent 
lymphodepleting regimen.  The ZUMA-1 study of axicabtagene cilouleucel in aggressive large 
B-cell lymphoma used the same cyclophosphamide/fludarabine conditioning regimen that is 
being used in the ZUMA-2 study (axicabtagene ciloleucel USPI).  This regimen was tolerated 
prior to infusion of the cellular product and resulted in a favorable risk‑benefit profile.  Similar 
doses of cyclophosphamide and fludarabine have been administered to subjects with B-cell 
malignancies prior to anti-CD19 CAR T cell infusion (NCI Protocol 09‑C‑0082) (Kochenderfer 
et al, 2016) and were shown to increase levels of cytokines known to support T-cell expansion 
and survival (Kochenderfer et al, 2017).  This treatment combination was also used as a reduced 
non-myeloablative conditioning regimen for patients with B-cell malignancies who were 
undergoing alloSCT and resulted in tolerable toxicities (Khouri et al, 1998).
6.3.4.
KTE-X19 or axicabtagene ciloleucel (Day 0, after Fludarabine and 
Cyclophosphamide)
All subjects will be hospitalized to receive treatment with KTE-X19 or axicabtagene ciloleucel
followed by an observation period of at least 7 days unless otherwise required by country 
regulatory agencies (refer to Section 18.3). 
CCI
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The following pre anti-CD19 CAR T cells 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 (500 mg to 1000 mg in EU) 
• 
Diphenhydramine 12.5 mg to 25 mg IV or 25 mg PO 
Subjects in Coho1t 1 will receive anti-CD19 CART cells treatment consisting of a single 
infusion of CAR-transduced autologous T cells administered intravenously at a target dose 
anti-CD19 CART cells/kg. A minimum dose of-
anti-CD19 CART cells/kg may be 
administered for subjects in Coho1t 1. Subjects in Coho1t 2 will receive KTE-X19 treatment 
consisting of a sin le infusion of CAR-transduced autologous T cells administered intravenously 
at a target dose of 
anti-CD19 CART cells/kg. For subjects weighing > 100 kg, a 
maximum flat dose of 
anti-CD19 CAR T cells will be administered for Cohort 1 or-
anti-CD19 CART cells for Coho1t 2. Refer to the Investigational Product Manual for all 
details sunounding the dosing of anti-CD19 CAR T cells. 
Subjects will remain in the hospital through Day 7 after treatment with anti-CD19 CART cells. 
Subjects should not be discharged from the hospital until all anti-CD19 CAR T cells-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 anti-CD19 CART cells-related fever, hypotension, hypoxia, or 
ongoing central neurological toxicity > Grade 1, or if deemed necessa1y by the treating 
investigator. 
6.4. 
Toxicity Management 
To date, the following impo1tant risks have been identified with KTE-X19 and axicabtagene 
ciloleucel: CRS, neurologic toxicity, infections, and cytopenias. Refer to Section 6 of the 
cmTent 1B for details regarding these events and management guidance. 
As the safety experience with KTE-X19 increases, the management guidance may be updated. 
Therefore, it is impo1tant that you always refer to the most cunent version of the KTE-X19 1B 
for guidance regarding managing KTE-X19 related toxicities. 
Additional infonnation and management recommendations can also be found in the IB regarding 
important potential risks associated with KTE-X19, 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 (Table 8 and Table 9) for an outline of the procedures 
required. The visit schedule is calculated from anti-CD19 CAR T cells 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 7.12. 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, ethnicity, and country of enrollment
to study their possible association with subject safety and treatment effectiveness.
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 subjects chart should be obtained.

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7.4.
Physical Exam, Vital Signs, Performance Status, and European Quality of 
Life-5 Dimensions
Physical exams will be performed during screening and at times noted in the SOA. Changes 
noted in subsequent exams when compared to the baseline exam will be reported as an AE. 
During IP administration/hospitalization, vital signs, including blood pressure, heart rate, oxygen 
saturation, and temperature, will be monitored before and after the anti-CD19 CAR T cells
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 as 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.
The EQ-5D will be completed by the subject, prior to any other assessment, at the screening visit 
and at other times noted in the SOA.  Subjects who are blind or illiterate may have the EQ-5D 
questions read to them by the study staff.  The study staff, however, cannot interpret any of the 
questions for the subject.  A subject may be exempt from completing the questionnaire if he or 
she is unable to read the questionnaire in one of the country languages available.
The EQ-5D is a 2-page generic patient questionnaire for assessing the overall health status of a 
subject.  The EQ-5D consists of a 5-dimension descriptive system, including questions on 
mobility, self-care, usual activities, pain/comfort, and anxiety/depression, and a visual analogue 
scale (VAS) that allows the respondent to record health on a vertical scale (eg, best health to 
worst health), thus allowing a quantitative measure of health outcome.  
7.5.
Neurological Assessment 
Neurological assessments will be standardized by using the Mini-Mental State Examination 
(MMSE) standard version 2.0. The MMSE is a 5 to 10 minute, 11-question measure that 
examines various areas of cognitive function: orientation, attention, immediate recall, short-term 
recall, language, and the ability to follow simple verbal and written commands.
The MMSE is divided into 2 sections.  The first part requires vocal responses to the examiner's 
questions. In the second part of the exam, the subject is asked to follow verbal and written 
instructions, write a sentence spontaneously, and copy a geometric figure. 
A full neurological assessment will be completed during screening to establish a baseline.  For 
subjects enrolled in Cohort 1, subsequent post-baseline assessments will be performed before 
anti-CD19 CAR T cells administration on Day 0, Day 1, Day 3, Day 5, Day 7, and every other 
day while hospitalized, as well as on Day 28 and Month 3.  For subjects enrolled in Cohort 2, a 
subsequent post-baseline assessment will be performed on Day 28. If the assessment shows 
neurologic function has not returned to baseline (± 3 points) on Day 28, then the MMSE will 
continue to be performed at Month 3 and every 3 months until the results have returned to 
baseline (± 3 points) or until Month 24.

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Every attempt should be made to dedicate a single research staff member familiar with or trained 
in the administration of the MMSE to conduct the assessment to minimize inter-rater variability.  
If CNS symptoms persist, continue to perform the MMSE every 2 days until resolution of 
symptoms or discharged from the hospital.
7.6.
Bone Marrow Biopsy
A bone marrow aspirate/biopsy will be performed at screening, if not previously performed
within 4 weeks of signing consent, to assess bone marrow involvement.  The bone marrow
aspirate and biopsy will be assessed and confirmed for the presence of MCL. Subjects with a 
positive bone marrow at screening or those who do not have a baseline bone marrow biopsy 
available, must undergo another bone marrow aspirate and biopsy upon first determination of a 
complete response via PET. Subjects with a negative bone marrow aspirate/biopsy (ie, no MCL)
at screening, and patients with a partial metabolic response, stable disease (SD) or progressive 
disease (PD) at any disease response assessment time point do not require a follow-up bone 
marrow aspirate and biopsy (Figure 3) 
Figure 3.
Bone Marrow Assessment Schema
Abbreviations: BM, bone marrow; ICF, informed consent form; PET-CT, positron emission tomography-computed 
tomography; CR, complete response.
To confirm a CR, 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.  
After CR is confirmed by bone marrow biopsy, additional bone marrow biopsies are only 
required in case of clinical suspicion of disease progression in the bone marrow only. Refer 
to Section 7.8, Appendix 1 (Section 18.1), and Appendix 2 (Section 18.2) for treatment response 
assessment requirements per the revised International Working Group (IWG) Response Criteria 
for Malignant Lymphoma (Cheson et al, 2007) and Lugano Classification (Cheson et al, 2014).
Not Done 
Must repeat BM biopsy to 
confirm CR irrespective of 
PET-CT findings upon 
response assessment 
Screening BM 
Biopsy 
Done within 1 month before ICF or 
anytime during the Screening period 
Positive for Mantle Cell 
Lymphoma 
Negative for Mantle 
Cell Lymphoma 
No need to repeat BM 
biopsy to confirm CR 

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Bone maiTow aspirate/biopsy should also be considered to evaluate hemophagocytic 
lymphohistiocytosis (HLH) as indicated (refer to the cmTent IB). A po1iion of the bone maiTow 
sample collected to evaluate HLH or other toxicities should be submitted to the central 
laborato1y as outlined in the central laborato1y manual. 
7.7. 
Lumbar Puncture 
Subjects with symptoms of central nervous system malignancy, such as new onset severe 
headaches, neck stiffness, or any focal neurologic findings on physical exam, will have lumbar 
puncture perfo1med at the screening visit for examination of cerebral spinal fluid. In addition, 
lumbai· puncture should be perfonned as applicable for subjects with new onset of~ Grade 2 
neurologic toxicities after anti-CD19 CART cells infusion (refer to the cmTent IB). Adequate 
platelet suppo1i should be provided prior to perfo1ming a lumbar puncture ( eg, platelet 
> 50 000/mm3). 
7.8. 
Disease Response Assessment 
Subjects will be evaluated for disease response by the site investigator at times indicated in the 
SOA. For subjects enrolled in Coho1i 1, disease assessments will be evaluated per the revised 
IWG Response Criteria for Malignant Lymphoma as described in Appendix 1 (Section 18.1) 
(Cheson et al, 2007). Flow cytometric, molecular, or cytogenetic studies will not be used to 
dete1mine response. For subjects enrolled in Coho1i 2, disease assessments by the site 
investigator will be evaluated per the Lugano Classification, as described in Appendix 2 
(Section 18.2) (Cheson et al, 2014). 
Baseline 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 first post anti-CD19 
CAR T cells infusion planned PET-CT tumor assessment 4 weeks following the anti-CD19 
CART cells infusion and at regular intervals as highlighted in the SOA during the post-
treatment and LTFU po1iion of the study. 
Post anti-CD19 CART cells administration disease assessments will be used to detennine the 
time when progressive disease occurs. Subjects with symptoms suggestive of disease 
progression should be evaluated for progression at the time symptoms occur even if it is off 
schedule as per the SOA. 
A bone man ow aspirate and biopsy will be perfonned in subjects who are being assessed for CR, 
as described in Appendix 1 (Section 18.1) and Appendix 2 (Section 18.2). Per the revised IWG 
Response Criteria for Malignant Lymphoma (Cheson et al, 2007) and Lugano Classification 
(Cheson et al, 2014), a bone man ow aspirate and biopsy must be perfo1med when the subject 
had bone maiTow involvement with lymphoma prior to therapy or if new abno1malities in the 
peripheral blood counts or blood smear cause clinical suspicion of bone maiTow involvement 
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with lymphoma after treatment.  Furthermore, if bone marrow involvement before the start of the 
study was unknown, a bone marrow evaluation must be conducted to confirm a CR.  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 to assign a CR to treatment.  
In addition to the investigator’s assessment, Independent Radiology Review Committee (IRRC)
review per Lugano Classification (Cheson et al, 2014) will be performed for both Cohort 1 and 
Cohort 2. PET-CT scans of all subjects evaluated for disease response will be submitted to and 
reviewed by an independent central reviewer. For subjects who discontinue the study due to an 
assessment of progressive disease, any additional imaging data, subsequent to the image in 
question, will be submitted to the central reviewer to confirm disease status. 
If the subject is eligible for retreatment with KTE-X19, the last scan prior to retreatment will be 
considered the baseline for the purpose of evaluating the response to retreatment.
Requirements for acquisition of PET-CT scans and submission requirements will be outlined in 
the study imaging manual.
7.9.
Cardiac Function 
Each subject’s cardiac function as measured by ECHO will be assessed during the screening 
period to confirm study eligibility. Both left ventricular ejection fraction (LVEF) and pericardial 
effusion will be assessed prior to study entrance 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.
To establish a baseline, an ECG will also be performed during screening.
7.10.
Magnetic Resonance Imaging
Each subject will undergo a screening brain MRI, with contrast whenever possible or without 
contrast in case of contraindication, to rule out CNS metastasis during the screening period of the 
study. Evaluation of any new onset of ≥ Grade 2 neurologic toxicity should include a brain MRI 
as described in the current IB.
7.11.
Laboratory
The below samples will be collected at the time points indicated in the SOA. Additional samples 
(eg, blood, urine, CSF, tissue) may be collected as needed for further safety testing.

Local lab analysis:
Sodium, potassium, chloride, total bicarbonate, creatinine, glucose, blood urea nitrogen 
or urea (if blood urea nitrogen test cannot be analyzed by the local lab), albumin, calcium 
total magnesium total, inorganic phosphorus, alkaline phosphatase, alanine 
aminotransferase/glutamic-pyruvic transaminase (ALT/GPT), aspartate 
aminotransferase/glutamic-oxaloacetic transaminase (AST/GOT), total bilirubin, 
direct bilirubin, LDH, uric acid 

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-
C-reactive protein (CRP) with chemistry panel 
-
Complete blood count (CBC) with differential 
A urine or sernm sample will be collected and assessed locally for females of childbearing 
potential. If the screening pregnancy test is positive, the subjects should not be emolled. If a 
standard of care pregnancy test is collected during the course of the study and the result is 
positive, the investigator should contact the Kite medical monitor for instr11ctions. If a female 
paiiner of a male subject becomes pregnant during the conduct of the study, it must be repo1ied 
by contacting Kite medical monitor for instructions. 
For EU sites, a serology (eg, HIV, hepatitis B, hepatitis C, syphilis) test will be caITied out per 
institutional guidelines and EU regulations. This may be within the 30 days prior to 
leukapheresis and/or on the day of leukapheresis. 
• 
Cent:I'al lab analysis: 
-
Blood draws for PBMC (lymphocyte subsets, replication-competent retr·ovirns [RCR], 
and anti-CD19 CAR T cells) and cytokine analysis will be perfo1med at intervals outlined 
in the SOA. 
-
Sernm samples will also be drawn for anti-CD19 CAR antibodies and human anti-bovine 
antibodies 
For sennn sainples that demonstr·ate increased anti-CD19 CAR antibodies at the 
Month 3 visit over baseline values, attempts should be made to obtain and test 
additional sernm sainples approximately eve1y 3 months until the antibody levels 
retmn to baseline ( or becomes negative) or up to 1 year from the completion of 
tr·eatment, whichever occurs first. 
-
Archived tumor tissue will be collected for centr·al path review and evaluation of 
prognostic mai·kers specific for MCL and pe1iaining to the tumor immune 
environment. Additional analysis may include CD19 ex ression, 
rofilin and anal sis of DNA alterations. 
-
CSF and possibly bone mairnw samples will also be collected and analyzed at the centr·al 
laborato1y as outlined in the schedule of assessments and per Section 7 .11.1. 
-
See centr·al laborato1y manual for details on sample collection, processing, and shipping 
instructions. 
7.11.1. 
Bio markers 
Biomai·ker analysis will be perfonned on blood and tumor samples to evaluate predictive and 
phaim acodynamic markers for anti-CD19 CART cells. Prognostic markers specific for MCL 
and related to the tumor immune environment may also be evaluated in ai·chived and fresh tumor 
biopsies. 
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The presence, expansion, persistence, and immunophenotype oftransduced anti-CD19 CAR 
T cells will be monitored in the blood by flow cytomeby. Expansion and persistence will also be 
monitored by a CD19 CAR specific quantitative polymerase chain reaction (qPCR) assay. 
Levels of senun cytokines will also be evaluated in the blood. 
included in the anel: 
Cerebral spinal fluid (CSF), as well as any additional subject samples ( eg, plemal fluid), should 
be collected from subjects who develop a nemologic toxicity or CRS to enable evaluation of 
inflammato1y cytokines and chemokine levels. As applicable, lymphocyte populations residing 
in the CSF or other additional subject samples may also be monitored for the pmpose of 
understanding the safety profile of KTE-X19. 
Because anti-CD19 CAR T cells comprises reti·oviral vector ti·ansduced T cells, the presence of 
RCR in the blood of treated subjects will be monitored. 
In addition, baseline leukapheresis and final anti-CD19 CAR T cells samples will be banked 
and ma 
· 
· 
· 
Archived tmnor tissue will be collected for centi·al pathologic review and evaluation of 
prognostic markers specific for MCL and pe1iaining to the tmnor immune 
environment. Additional analysis ma include CD19 ex ression ene ex ression rofiling, and 
anal sis of somatic DNA alterations. 
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These samples and any other components from these samples may be stored up to 15 years 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 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. 
7.12.
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 for why 
the subject failed screening.
7.12.1.
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.
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 on the subject screening log with the reasons for failing screening.
The following assessments/procedures are to be completed during the screening period at the 
time points outlined in the SOA:

Medical history

EQ-5D questionnaire (prior to any other assessments/procedures being performed)

Physical examination, including height and weight

Vital signs, including blood pressure, heart rate, oxygen saturation, and temperature
Subjects with symptoms of central nervous system 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.

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• 
ECOG perfo1mance status 
• 
Neurological assessment with MMSE 
• 
ECG 
• 
L VEF (ECHO) and pericardia! effusion assessment (ECHO) 
• 
Imaging studies 
-
Brain MRI 
-
Baseline PET-CT of the neck, chest, abdomen, and pelvis 
PET-CT perfo1med following the subject's last line of therapy and prior to signing 
the consent may be used for confnmation of eligibility 
If PET-CT will be > 28 days at the initiation of conditioning chemotherapy or if the 
subject receives any anti-cancer therapy between screening and conditioning 
chemotherapy (including bridging therapy), the scans must be repeated to establish a 
new baseline. PET CT should be perfo1med as close to emolhnent as possible. 
• 
Bone manow aspirate/biopsy as needed (if not done within 4 weeks prior to screening) 
• 
Labs 
-
~-HCG pregnancy test (sernm or urine) on all women of childbearing potential 
-
Chemistiy panel with CRP 
-
CBC with differential 
• 
SAE repo1iing (refer to Section 9 for safety reporting guidelines) 
• 
Concomitant medications documentation and previous cancer u-eatment histo1y 
• 
7.12.2. 
Rescreening 
Subjects who are unable to complete or meet the eligibility criteria during the 28-day screening 
period will be pe1mitted to rescreen one time. Subjects will retain the same subject ID number 
that was assigned at the original screening. If rescreening occurs within 28 days of the signing of 
the original info1med consent, only the procedure(s)/assessment(s) 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 signing of the original infonned consent, subjects must be re-consented and repeat all 
screening procedures/assessments. 
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7.12.3.
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.
Before leukapheresis commences, the criteria listed below 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.
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:

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; if CRP is ≥ 100 mg/L, a call must be made to the Kite medical monitor before 
proceeding with conditioning chemotherapy.
CBC with differential
Cytokine levels 
Anti-CD19 CAR antibodies
Blood draw for PBMCs (includes lymphocyte subsets, anti-CD19 CAR T cells) 

Leukapheresis

AE/SAE reporting 

Concomitant medications documentation 

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7.12.4.
Bridging Therapy 
If prescribed, bridging therapy with either a corticosteroid or ibrutinib (or acalabrutinib) must be 
administered after leukapheresis and completed at least 5 days prior to initiating conditioning 
chemotherapy (refer to Section 6.3.2). If bridging therapy is administered, PET-CT scans (and 
bone marrow aspirate/biopsy, if applicable) must be repeated prior to the start of conditioning 
chemotherapy to establish a new baseline. 

AE/SAE reporting 

Concomitant medications documentation 
7.12.5.
Conditioning Chemotherapy Period
If any screening assessments or procedures are repeated between screening and the start of 
conditioning chemotherapy and results are outside the eligibility criteria (Section 5), contact the 
Kite medical monitor for approval prior to proceeding with conditioning chemotherapy.
If PET-CT will be older than 28 days at the initiation of conditioning chemotherapy or if the 
subject receives any anti-cancer therapy with therapeutic intent (eg, radiation, supraphysiologic 
doses of steroids, or chemotherapy) between the last PET-CT and conditioning chemotherapy, 
the diagnostic CT portion of the scan must be repeated to establish a new baseline.
7.12.5.1.
Requirements for Initiating Conditioning Chemotherapy 
Administration of anti-CD19 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 anti-CD19 CAR T cells infusion should only be initiated after it is 
reasonably assured that cell infusion can safely proceed.
If any of the following criteria are met prior to the initiation of conditioning chemotherapy, then 
the workup listed in Section 7.12.7 must be performed to determine the potential cause if there is 
no identified source of infection.  

Temperature > 38° Celsius within 72 hours of conditioning chemotherapy

CRP > 100 mg/L anytime between enrollment to start of conditioning chemotherapy

WBC count or WBC differential, that is suggestive of infectious process, and is observed
between enrollment and the initiation of conditioning chemotherapy (eg, WBC > 20 000/µL, 
rapidly increasing WBC, or differential with high percentage of segs/bands)

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Additionally:

If any screening assessments or procedures are repeated between confirmation of eligibility
and the start of conditioning chemotherapy and results are outside the eligibility criteria listed 
in Section 5, then the condition must resolve prior to proceeding with conditioning 
chemotherapy.

Complete history and physical exam, including head, ears, eyes, nose, and throat (HEENT) 
exam; 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 and in consultation with infectious disease service (if applicable).

The 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, polymerase chain reaction (PCR), stool studies, imaging studies) must be 
negative.  If clinical suspicion is for an infection for which cultures are unlikely to be 
positive within 48 hours (eg, fungal infection), adequate time must be allowed for cultures to 
become positive.
Once the above criteria are met, then the subject can proceed with conditioning chemotherapy.
7.12.5.2.
Conditioning Chemotherapy Administration 
The following procedures will be completed during 
at the time points outlined 
in the SOA:

Vital signs, including blood pressure, heart rate, oxygen saturation, and temperature

Labs (to be drawn prior to chemotherapy)
Chemistry panel with CRP
CBC with differential

Fludarabine and cyclophosphamide administration

AE/SAE reporting 

Concomitant medications documentation 
CCI

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7.12.6.
Investigational Product Treatment Period
Subjects will be hospitalized to receive treatment with anti-CD19 CAR T cells followed by a
minimum 7-day observation period unless otherwise required by country regulatory agencies 
(refer to Section 18.3). 
7.12.6.1.
Requirements for Initiating KTE-X19 Infusion
If any of the following criteria are met prior to the initiation of KTE-X19 infusion, then the 
workup listed in Section 7.12.7 must be performed to determine the potential cause if there is no 
identified source of infection.  

Temperature > 38° Celsius within 72 hours of KTE-X19 infusion

CRP > 100 mg/L anytime between enrollment to start of  conditioning chemotherapy

WBC count or WBC differential, which is suggestive of infectious process, and is observed
between enrollment and the initiation of KTE-X19 infusion (eg, WBC > 20 000/µL, rapidly 
increasing WBC, or differential with high percentage of segs/bands)
Additionally:

If any screening assessments or procedures are repeated between confirmation of eligibility 
and the start of KTE-X19 infusion and results are outside the eligibility criteria listed in 
Section 5, then the condition must resolve prior to proceeding with KTE-X19 infusion 
(except for peripheral blood cell counts that have been impacted by conditioning 
chemotherapy).

Complete history and physical exam, including HEENT exam, 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 KTE-X19 infusion (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 (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 administration of KTE-X19.
If the KTE-X19 infusion is delayed > 2 weeks, protocol guidelines should be followed regarding 
the need for repeat conditioning chemotherapy.
7.12.6.2.
Hospitalization for KTE-X19 Infusion
Subjects will remain in the hospital through Day 7 after treatment with anti-CD19 CAR T cells
unless otherwise required by country regulatory agencies (refer to Section 18.3).  Subjects 
should not be discharged from the hospital until all anti-CD19 CAR T cells-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 anti-CD19 CAR T cells-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 a neurologic toxicity 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 principal investigator or seek immediate medical 
attention. 
During this period, the following procedures will be completed at the time points outlined in the 
SOA:

Neurological assessment including MMSE
MMSE will be administered before treatment with anti-CD19 CAR T cells on Day 0, 
then on Day 1, and every other day while hospitalized for subjects enrolled in Cohort 1. 
MMSE will not be administered during the investigational treatment period for subjects 
enrolled in Cohort 2.  

Vital signs, including blood pressure, heart rate, oxygen saturation, and temperature, every 
4 to 6 hours during hospitalization

Labs (before anti-CD19 CAR T cells infusion, as described in the SOA)
Chemistry panel with CRP
CBC with differential
Cytokine levels 
Blood draw for PBMCs (includes lymphocyte subsets, anti-CD19 CAR T cells, and RCR 
analysis)

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• 
illfusion of KTE-X19 or axicabtagene ciloleucel 
• 
• 
• 
AE/SAE repo1iing (refer to Section 9 for safety repo1iing guidelines) 
• 
Concomitant medications documentation 
Monitoring of CRP, fenitin, and LDH (only ifLDH is elevated at baseline) levels may assist 
with the diagnosis and define the clinical course in regards to CRS/neurologic toxicity. It is, 
therefore, recommended that CRP, fenitin, and LDH (if elevated at baseline) be monitored daily 
staiiing at Day O and continuing through hospitalization. ill addition, lactate should be 
monitored as clinically indicated. 
7.12.7. 
Requirements to Work Up Potential Infectious and/or Inflammatory States 
ill the absence of an identified source of infection (eg, line infection, pneumonia on chest x-day), 
the minimum workup to be perfo1med prior to administration of conditioning chemotherapy 
and/or KTE-X19 consists of: 
• 
Call Kite medical monitor 
• 
illfectious Disease service consult (if available) 
• 
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 perfo1med (prior to the initiation of antimicrobials if clinically 
feasible): 
-
Blood cultures (aerobic and anaerobic x2 bottles each) and UA and urine culture. 
Deep/induced sputum culture if clinically indicated. 
-
All indwelling lines such as central venous catheters should be examined for any signs of 
infection and additional cultures should be drawn from the line 
-
Nasophai-yngeal-throat swab or equivalent assay for viral infection such as influenza A/B 
(including HlNl ), pai·ainfluenza 1/2/3, adenovims, respirato1y syncytial vims, 
coronavims, metapneumovims 
-
Collection of fungal cultures and markers as appropriate ( eg, galactomannan, fungitell) 
-
Collection of appropriate sernm viral studies ( eg, cytomegalovirus [CMV]) 
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Clinical Protocol
Final
CONFIDENTIAL
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
If a central nervous system process is suspected, appropriate brain imaging and subsequent 
lumbar puncture with cytology, culture, Gram stain, and viral PCR should be performed  

Any additional sign or symptom-directed investigation should be performed as clinically 
indicated
Prior to proceeding with conditioning chemotherapy and/or KTE-X19 infusion, the above 
workup must not suggest the presence of an active infection, and all requirements for 
conditioning chemotherapy and/or KTE-X19 infusion must be satisfied. If the KTE-X19
infusion is delayed > 2 weeks following conditioning chemotherapy, protocol guidelines should 
be followed regarding the need for repeat conditioning chemotherapy. 
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. 
7.12.8.
Post-treatment Assessment Period
After completing anti-CD19 CAR T cells infusion and being discharged from the hospital, all 
subjects will be followed in the post-treatment assessment period. Counting from Day 0 (anti-
CD19 CAR T cells 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 subjects’ health condition and initial treatment response may be obtained.
The following procedures will be completed for subjects as outlined in the SOA:

EQ-5D questionnaire prior to any other assessments/procedures being performed.

Neurological assessment including MMSE. For subjects enrolled in Cohort 1, the MMSE 
will be performed on Week 4 and Month 3. For subjects enrolled in Cohort 2, the MMSE 
will be performed on Day 28. If the assessment has not returned to baseline (± 3 points) on 
Day 28, then continue to perform the MMSE at Month 3 and every 3 months until the results 
have returned to baseline (± 3 points) or until Month 24.

PET-CT for disease assessment: If the PET-CT is not of high enough resolution, the scan 
must be repeated. Refer to the current version of the imaging site manual for detailed 
instructions.

KTE-C19-102 
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Clinical Protocol
Final
CONFIDENTIAL
Page 54 of 92
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
As applicable, bone marrow aspirate/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)

Physical exam 

Vital signs, including blood pressure, heart rate, oxygen saturation, and temperature

Labs
β-HCG pregnancy test (serum or urine) on all women of childbearing potential
Chemistry panel with CRP
CBC with differential
Anti-CD19 CAR antibodies
Cytokine levels 
Blood draw for PBMCs (includes lymphocyte subsets, anti-CD19 CAR T cells, and RCR 
analysis)

AE/SAE reporting (refer to Section 9 for safety reporting guidelines)

Concomitant medications documentation
If a subject is discharged from the hospital and is subsequently re-admitted to the hospital with 
any anti-CD19 CAR T cells related AEs, the following procedures will be performed as 
outlined in the SOA:

Anti-CD19 CAR T cell levels on day of admission, then weekly, and on day of discharge

Cytokine levels on day of admission, then weekly, and on day of 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 PR) or progresses following a response and is either not eligible for 
re-treatment or chooses not to pursue re-treatment, the subject will proceed directly to the 
Month 3 visit and be followed for survival, subsequent therapy, and disease outcomes in the 
LTFU period.  A PBMC sample (for anti-CD19 CAR T cells) and serum (for cytokine 
evaluation) should be collected at the time of progression and prior to starting any subsequent 
anti-cancer therapy.
Upon disease progression, sites are encouraged to collect a tumor biopsy and to submit a portion 
of the tumor tissue to the central laboratory for exploratory biomarker analysis.

KTE-C19-102 
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Clinical Protocol
Final
CONFIDENTIAL
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7.12.9.
Long-term Follow-up Period
All enrolled subjects will be followed in the LTFU period for survival and disease status if 
applicable. Subjects will begin the LTFU period after they have completed the Month 3 visit of 
the post-treatment assessment period (whether they have responded to treatment or went straight 
to the Month 3 visit due to disease progression).

Every 3 months (± 2 weeks) through Month 18

Every 6 months (± 1 month) between Month 24 to Month 60

Beginning with Year 6, Month 72 (± 3 months), subjects will return to the clinic 1 time 
annually up to 15 years.  
The following procedures will be completed for subjects who are enrolled and receive anti-
CD19 CAR T cells at the time points outlined in the SOA:

EQ-5D questionnaire (prior to any other assessments/procedures being performed)

For subjects enrolled in Cohort 2, if the MMSE performed on Day 28 and Month 3 has not 
returned to baseline (± 3 points), then continue to perform the MMSE at Month 6 and every 
3 months until the results have returned to baseline (± 3 points) or until Month 24. 

Physical exam

PET-CT scan/disease assessment: through 24 months or until disease progression, whichever 
occurs first.  If subject’s disease has not progressed by Month 24, disease assessments will 
continue to be performed per standard of care.

Survival status

Labs
CBC with differential
Anti-CD19 CAR antibodies (refer to Section 7.11)
Blood draw for PBMCs (includes lymphocyte subsets, anti-CD19 CAR T cells, and RCR 
analysis)

Targeted AE/SAE reporting (for 24 months or until disease progression whichever occurs 
first) (refer to Section 9 for safety reporting guidelines)

Targeted concomitant medication documentation (for 24 months or until disease progression, 
whichever comes first)
Including gammaglobulin, immunosuppressive drugs, anti-infective, and vaccinations 

KTE-C 19-102 
Clinical Protocol 
Kite Phanna, Inc. 
• 
Subsequent therapy for the treatment of lymphoma 
• 
Subjects may also be contacted by telephone to confnm survival status and repo1t targeted 
concomitant medication use. 
Final 
If a subject progresses in the L TFU phase, the subject will continue to be followed for survival 
status and subsequent therapy for the treatment of NHL. A PBMC sample (for anti-CD19 CAR 
T cells) and sennn (for cytokine evaluation) should be collected at the time of progression and 
prior to staiting any subsequent anti-cancer therapy. 
Upon disease progression, sites are encouraged to collect a tumor biopsy and to submit a po1t ion 
of the tumor tissue to the central laborato1y for explorato1y biomarker analysis. 
The following procedures/assessments will be completed for subjects who are emolled, but do 
not receive anti-CD19 CAR T cells, at the time points outlined in the SOA: 
• 
Subsequent therapy 
• 
Smv ival status - subjects may be conta.cted by telephone to confmn smv ival status 
• 
Disease assessment per standard of care: 
• 
AE/SAE repo1t ing and concomitant medication documentation until 30 days after last 
procedure (eg, leukapheresis, conditioning chemotherapy) 
If the subject fails to return to the clinic for a scheduled protocol-specific visit, sites will need to 
make 2 attempts by a combination of telephone and mail to contact the subject. Sites must 
document both attempts to conta.ct 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 conta.ct 
will be required. 
Subjects who undergo an alloSCT will be contacted to confnm the sta.tus of their disease and 
smv ival status and will have blood collected for PBMCs per the LTFU schedule. 
7.12.10. 
Retreatment 
Subjects who achieved a PR or CR will have an option to receive a second course of 
conditioning chemotherapy and KTE-X19 under the following conditions: 
• 
Subject had a PR or CR at the Month 3 disease assessment 
• 
Subject's disease subsequently progressed greater than 3 months after axicabtagene 
ciloleucel or KTE-X19 infusion 
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Clinical Protocol
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CONFIDENTIAL
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
CD19 tumor expression confirmed locally by biopsy after disease progression and prior to re-
treatment. A portion of the biopsy should be sent to the central laboratory.

Subject continues to meet the original study eligibility criteria with exception of prior 
axicabtagene ciloleucel or KTE-X19 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 a Grade 4 CRS event per Lee 2014 (except for Grade 4 
hematology laboratory events, including pancytopenia, anemia, neutropenia, neutropenic 
fever, leukopenia, and thrombocytopenia) or Grade 4 neurologic toxicity

Toxicities related to conditioning chemotherapy (fludarabine and cyclophosphamide), with 
the exception of alopecia, have resolved to ≤ Grade 1 or returned to baseline prior to 
re-treatment.

Subject does not have known neutralizing antibodies (exception: if a non-neutralizing 
antibody develops, subjects may be retreated if they meet the original study eligibility 
criteria).
The decision to administer re-treatment should be made in consultation with the Kite medical 
monitor.  In addition, a discussion regarding benefits and risks of retreatment and including the 
need to undergo leukapheresis a second time for the manufacturing of KTE-X19 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.  
A maximum of 1 retreatment course may occur per subject.  Subjects who are retreated must
follow the same treatment schedule and procedural requirements per the initial treatment.
Allowance for retreatment is based on clinical experience reported in the 2 studies conducted at 
the pediatric (Lee et al, 2015) and Surgery Branch (Kochenderfer et al, 2015) of the NCI where 
6 subjects in total have been re-treated upon progression. Three of the re-treated subjects 
(indolent lymphoma/leukemia) experienced durable responses to retreatment after an initial 
response and disease progression.   

KTE-C19-102 
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Clinical Protocol
Final
CONFIDENTIAL
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Table 8.
Schedule of Assessments (1 of 2)
Procedures
Screening
Enrollment/
Leukapheresis
Bridging 
Therapy Period
Conditioning Chemotherapy
Period
IP Administration 
Period10
Post-treatment Follow-up
(each visit calculated from Day 0)
Day
Within 
28 days of 
enrollment
Within 
approx. 5 days 
of eligibility 
confirmation
Completed within 
5 days prior to 
Conditioning 
Chemotherapy
-5
-4
-3
-2
-1
0
1 - 7
Week 2
(± 2 days)
Week 4
(± 3 days)
Month 2
(± 1 week)
Month 3
(± 1 week)
Medical history 
X
ECOG Performance Status
X
EQ-5D Questionnaire
X
X
X
Neurological assessment 
including MMSE6for Cohort 1
X
X
QOD
X
X
Neurological assessment 
including MMSE8 for Cohort 2
X
X
X
ECG
X
ECHO
X
Archival/Fresh tumor to central lab 1
X
between Day 7 & Day14
Brain MRI
X
PET-CT/ disease assessment 2
X
X
X
X
Bone Marrow Assessment9
X
X
X
Physical exam
X
X
X
X
X
Vital signs (BP, HR, O2 sat, temp)
X
X
X
X
X
X
X
X
X
X
X
X
Weight (plus height at screening)
X
X
Pregnancy test (serum or urine)
X
X
Lumbar Puncture 3
X
X
Blood draw for Chemistry panel
with CRP
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 C-reactive 
protein (CRP)
X
X
X
X
X
X
X
X
X
X
X
Blood draw for Anti-CD19 CAR
antibody 4
X
X
X
Blood draw for PBMCs 5, 7
X
X
Day 7
X
X
X
Blood draw for cytokines7
X
X
Day 3 & 7
X
X
Leukapheresis 
X
Bridging Therapy (if applicable)
X

KTE-C 19-102 
Clinical Protocol 
Procedm·es 
Day 
Fludarabine/Cyclophosphamide 
KTE-Xl9 infusion IV 
Adverse events/ 
Concomitant medication 
Sc.reening 
Within 
28 days of 
enl'Ollment 
X 
Enrollment/ 
Leukapheresis 
Within 
approx. 5 days 
of eligibility 
confirmation 
Schedule of Assessments Footnotes 
Bridging 
Therapy Period 
Completed "'ithin 
5 days pt-ior to 
Conditioning 
Chemotherapy 
Kite Pha1ma, Inc. 
Final 
Conditioning Chemotherapy 
IP Administration 
Post-treatment Follow-up 
Period 
Pet-iod1' 
(each visit calculated from Day 0) 
Week2 
Week4 
Month2 
Month 3 
-5 
-4 
-3 
-2 
-1 
0 
1 - 7 
(±2 days) 
(±3 days) 
(± 1 week) 
(± 1 week) 
X 
X 
X 
X 
Abbl'eviations: EQ-5D, Eul'opean Quality ofLife-5 Dimensions; MMSE, Mini-Mental Sta tus Exam; MRI, magnetic l'esonance imaging; BP, blood pl'essul'e; HR, heal't 
l'ate; sat, satul'ation; temp, tempel'atul'e; ECOG, Eastel'n Coope1·ative Oncology Gl'oup; ECG, electl'ocal'diogl'am; ECHO, echocal'diogl'am; PET-CT, positl'on elnission 
tomogl'aphy-computed tomogl'aphy; CAR, chime1ic antigen l'eceptol'; AE, advel'se event; SAE, sel'ious advel'se event; NHL, non-Hodgkin lymphoma; CBC, complete 
blood count; CRP, C-l'eactive pl'otein; PBMC, pel'iphel'al blood mononucleal' cell; IV, intl'avenous; IP, investi ational l'oduct; a 
l'oximate. 
1 
Al·chival tumor sam le: Either FFPE tumor block or u to 20 unstained slides. 
2 
ec -C est-Abdomen-Pelvis)/disease assessment: If PET-CT perfo1med > 28 days prior to the initiation of conditioning chemotherapy, baseline scans must be repeated. 
Screening PET-CT should be completed as close to enrolhuent as possible. A repeat baseline PET-CT is required after bridging therapy and prior to conditioning chemotherapy. 
3 
Lumbar Puncture: Subjects with symptoms of CNS malignancy (eg, new onset severe headaches, neck stiffness, or focal neurological findings) will have lumbar puncttu·e 
pe1fo1med at screening to assess cerebral spinal fluid for possible CNS involvement. Sub' ects with new onset Grade c:: 2 netu·ologic s 
11 toms after KTE-X19 infusion will 
have huuber tmcttu·e erformed to assess cerebral s inal fluid. 
4 
B oo 
aw or Anti-CD19 CAR anti o y: Base me anti o y samp e to 
Anti-CD19 CAR post 3-month samples; 
see Section 7 .11. 
5 
PBMCs: Blood draw for PBMCs include the analysis oflymphocytes, anti KTE-X19 CART cells, and RCR. 
6 
MMSE: Subjects enrolled in Coho1t 1 will have the MMSE assessment at screening, before KTE-X19 administl'ation on Day 0, eve1y other day through hospitalization, 
Day 28, and Month 3. 
7 
If subject is subsequently re-admitted to the hospital with any KTE-X19 related adverse events, blood samples for KTE-X19 CAR T cells and cytokines will be collected on 
day of admission, then weekly, and on day of discharge. Blood samples for anti-CD19 CART cells and cytokines should also be collected at the time of disease progression. 
8 
MMSE: Subjects enrolled in Coho1t 2 will have the MMSE assessments at screening and Day 28. If the assessment has not rettuned to baseline (± 3 points) on Day 28, then 
continue to pe1fo1m the MMSE at Month 3 and eve1y 3 months until the results have retmned to baseline (± 3 points) or until Month 24. 
9 
Bone Mal'l'OW Assessment: Bone ma1l'Ow aspirate/biopsy as needed (if not done within 4 weeks before screening). As applicable, bone ma1l'Ow aspirate/biopsy will be 
pe1fo1med to confom complete response (ie, for subjects presenting with bone ma1Tow involvement prior to therapy or if new abno1malities in the peripheral blood counts or 
blood smear cause clinical suspicion of bone marrow involvement with lymphoma after treatinent). Bone ma1Tow samples may also be collected for subjects who develop 
toxicities after KTE-X19 infusion and will be analyzed centi·ally. See Section 7.11. A repeat bone ma1l'Ow biopsy (if applicable) is required after bridging therapy and prior 
to conditioning chemotherapy. Aftel' CR is confil'med by bone mal'l'OW biopsy, additional bone mal'l'OW biopsies al'e only l'equired in case of clinical suspicion of 
disease pl'ogl'ession in the bone mal'l'OW only. 
10 
Refel' to Section 18.3 fol' l'equil'ements by countl'y l'egulatol'y agencies. 
CONFIDENTIAL 
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Clinical Protocol
Final
CONFIDENTIAL
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Table 9.
Schedule of Assessment (2 of 2)
Procedure
Long-term Follow-up Period 1
(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 
Thereafter
EQ-5D Questionnaire
X
Neurological assessment including 
MMSE10for Cohort 2
X
X
X
X
X
X
Physical exam1
X
X
X
X
X
X
PET-CT Disease Assessment2
X
X
X
X
X
X
X2
X2
X2
X2
X2
X2
X2
Bone Marrow Assessment11
X
X
X
X
X
X
Survival Status
X
X
X
X
X
X
X
X
X
X
X
X
X
CBC w/differential 3
X
X
X
X
X
X
Anti-CD19 CAR antibody 4
Blood draw for PBMCs 5
X
X
X
X
X
X
X
X
X
X
Targeted AE/SAEs 6
X
X
X
X
X
X
Targeted concomitant medication 7
X
X
X
X
X
X
X
X
X
X
X
X
X
Subsequent therapy for NHL 8
X
X
X
X
X
X
X
X
X
X
X
X
X
1
Physical exams will continue through the first 24 months.
2
PET Scans/disease assessments will continue through Month 24 or until disease progression, whichever comes first. If subject’s disease has not progressed by Month 24, 
disease assessments will continue to be performed per standard of care.
3
Subjects will continue to provide samples for CBC with differential and lymphocyte subsets through Month 24.
4
Anti-CD19 CAR antibodies post 3-month samples; refer to Section 7.11.
5
Blood draw for PBMCs include the analysis of lymphocytes, anti KTE-X19 CAR T cells, and RCR.
6
Targeted AEs and SAEs will continue for 24 months or until disease progression (whichever occurs first).
7
Targeted concomitant medications will continue for 24 months or until disease progression (whichever occurs first).
8
Subsequent therapy administered after KTE-X19 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 NHL and to assess survival status.
9
10
MMSE: For subjects enrolled in Cohort 2, if the MMSE performed on Day 28 and Month 3 have not returned to baseline (± 3 points), then continue to perform the MMSE at 
Month 6 and every 3 months until the results have returned to baseline (± 3 points) or until Month 24. 
11
Bone Marrow Assessment: As applicable, bone marrow aspirate/biopsy will be performed to confirm complete 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).  After CR is confirmed by bone marrow biopsy, additional bone marrow biopsies are only required in case of clinical suspicion of 
disease progression in the bone marrow only.
CCI
CCI

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Clinical Protocol
Final
CONFIDENTIAL
Page 61 of 92
29 October 2018
8.
SUBJECT WITHDRAWL
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.
Withdraw 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 withdraw of consent will be retained and
included in the analysis of the study, and, where permitted by local regulations, publically
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 or at any time prior to 
study completion.
8.1.
Reasons for Removal from Treatment
Reasons for removal from protocol-required investigational products or procedures include any 
of the following:

AE

Subject request

Product not available

Lost to follow-up

Death

Decision by sponsor

KTE-C19-102 
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Clinical Protocol
Final
CONFIDENTIAL
Page 62 of 92
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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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Clinical Protocol
Final
CONFIDENTIAL
Page 63 of 92
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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, MCL). 
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. If 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. 
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 anti-CD19 CAR T cell infusion are monitored and reported.
After 3 months, targeted AEs (eg, neurological, hematological, infections, autoimmune 
disorders, and secondary malignancies) will be monitored and reported for 24 months after 
treatment with anti-CD19 CAR T cells or until disease progression, whichever occurs first.
See Section 9.4 for reporting of non-serious CRS events Grade ≥ 3.

KTE-C19-102 
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Clinical Protocol
Final
CONFIDENTIAL
Page 64 of 92
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For subjects who are enrolled but do not receive anti-CD19 CAR T cells, the AE reporting 
period ends 30 days after the last study-specific procedure (eg, leukapheresis, conditioning 
chemotherapy). 
The investigator must address the below AEs:

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 CTEP home 
page (http://ctep.cancer.gov). CRS events will be reported using the Lee grading scale (Lee et al, 
2014), as outlined in the current IB. In reviewing AEs, investigators must assess whether the AE
is possibly related to 1) the IP (axicabtagene ciloleucel or KTE-X19), 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.
The investigator is expected to follow reported AEs until stabilization or resolution. If a subject 
begins a new anti-cancer therapy, the AE reporting period for non-serious AE ends at the time 
the new treatment is started.
9.3.
Definition of SAEs
A SAE is defined as an adverse event that meets at least 1 of the following serious criteria:

Fatal

Life-threatening (places the subject at immediate risk of death)

Requires in-patient hospitalization or prolongation of existing hospitalization

Results in persistent or significant disability/incapacity

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
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 adverse event according to NCI CTCAE criteria; the event itself may be of relatively 
minor medical significance and, therefore, may not meet the seriousness criteria.  Severity 
(ie, grade) and seriousness need to be independently assessed for each adverse event 
recorded on the eCRF.
9.4.
Reporting of SAEs and Non-serious CRS Events Grade ≥ 3
The investigator is responsible for reporting all SAEs observed by the investigator or reported by 
the subject that occur after signing of the consent through 3 months after the anti-CD19 CAR T
cell infusion. After 3 months, only serious targeted AEs (eg, neurological, hematological, 
infections, autoimmune disorders, and secondary malignancies) observed by the investigator or 
reported by the subject will be reported for 24 months after anti-CD19 CAR T cell infusion or 
until disease progression, whichever occurs first.  For subjects who screen fail or are enrolled but 
do not receive anti-CD19 CAR T cells, the reporting period for SAEs ends 30 days after the last 
procedure (eg, screen procedure, leukapheresis, conditioning chemotherapy). 
Serious events that the investigator assesses as related to axicabtagene ciloleucel or KTE-X19
should be reported regardless of the time period.
All SAEs and non-serious CRS events ≥ Grade 3 (Lee et al, 2014) must be submitted via email 
to 
within 24 hours following the investigator’s knowledge of the event
using a SAE Report Form. Subsequently, all SAEs will be reported in accordance with EU 
guidelines, or, if applicable, as per local reporting guidelines. 
Progression of the malignancy during the study should not be reported as an SAE. SAEs 
associated with disease progression may be reported as an SAE. If the malignancy has a fatal 
outcome within 3 months of the last day of the conditioning therapy or anti-CD19 CAR T cell-
infusion, then the event leading to death must be recorded as an SAE with CTCAE Grade 5.
PPD

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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 anti-CD19 CAR T cell infusion, regardless of attribution to 
treatment, requires expedited reporting within 24 hours. Any death occurring greater than 
3 months after the anti-CD19 CAR T cell infusion requires expedited reporting within 24 hours 
only if it is considered related to treatment.
9.5.
Reporting Deaths
Deaths that occur during the protocol-specified adverse event reporting period that are 
attributed by the investigator solely to progression of underlying lymphoma should be 
recorded as SAEs with the preferred term “B-cell lymphoma” and must be reported 
immediately to the sponsor.  Death is an outcome and not a distinct event.  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 during the post-study 
survival follow-up that are due to underlying cancer should be recorded only on the 
Survival Status CRF.
9.6.
Diagnosis Versus Signs and Symptoms
For adverse events, a diagnosis (if known) rather than individual signs and symptoms 
should be recorded on the AE form.  The exception is for CRS where both the diagnosis 
and signs and symptoms will be captured on the CRF AE form.  For signs and symptoms of 
the underlying cancer, the signs and symptoms should be captured.  However, on the AE 
form, the investigator should state that these signs and symptoms are due to the underlying 
disease.
9.7.
Pregnancy and Lactation
There is no relevant clinical experience with KTE-X19 in pregnant or lactating women, and 
animal reproductive studies have not been performed.  Women of childbearing potential must 
have a negative pregnancy test prior to enrollment because of the potentially dangerous effects of 
the preparative chemotherapy on the fetus.  Women of childbearing potential should be 
monitored according to local and country-specific regulations. This experimental therapy should 
not be administered to pregnant women or women who are breastfeeding.
Female subjects and female partners of male subjects are recommended to use highly effective 
contraception (method must achieve an annual failure rate of < 1%) for at least 6 months after 
conditioning chemotherapy dosing. Male subjects are recommended to not father a child for 
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If a pregnancy occurs in either a female subject enrolled into the study or a female partner of a 
male subject within 6 months of completing conditioning chemotherapy, the pregnancy must be 
reported to the key sponsor contact.  Information regarding the pregnancy and/or the outcome 
may be requested by the key sponsor. 
In addition to reporting any pregnancies occurring during the study, investigators should monitor 
for pregnancies that occur after the last dose of anti-CD19 CAR T cell infusion through 
6 months for female subjects and for 6 months for the female partner of the male subjects.
The pregnancy should be reported to the key sponsor contact within 24 hours of the 
investigator’s knowledge of the pregnancy event. 
If a lactation case occurs while the female subject is taking protocol-required therapies, report 
the lactation case to the key sponsor contact.
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 6 months.
Any lactation case should be reported to the key sponsor contact within 24 hours of the 
investigator’s knowledge of the event.
9.8.
Hospitalization and Prolonged Hospitalization
Any adverse event that results in hospitalization or prolonged hospitalization should be 
documented and reported as a serious adverse event as described in Section 9.4.  
The following hospitalization scenarios are not considered to be serious adverse events:

Hospitalization for palliative care or hospice care

Planned hospitalization required by the protocol (eg, for monitoring of 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
9.9.
Abnormal Vital Signs Values
Not all vital sign abnormalities qualify as an adverse event.  A vital sign result must be 
reported as an adverse event 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

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It is the investigator’s responsibility to review all vital sign findings.  Medical and scientific 
judgment should be exercised in deciding whether an isolated vital sign abnormality should 
be classified as an adverse event.  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.
9.10.
Data Safety Monitoring Board
An independent DSMB will review safety and/or efficacy data 4 times during this study. The 
DSMB will first meet to review safety data when 10 subjects in Cohort 1 have been enrolled and 
treated with anti-CD19 CAR T cells and followed for 30 days. The DSMB will meet for the 
second time to review both safety and efficacy data after 20 subjects in Cohort 1 have been 
treated with anti-CD19 CAR T cells and have had the opportunity to complete the 3-month 
disease assessment.  The DSMB will meet for the third time to review both safety and efficacy 
data after 10 subjects in Cohort 2 have been treated with KTE-X19 and have had the opportunity 
to be followed for 30 days. The DSMB will meet for the fourth time after 44 subjects in 
Cohort 1 have been treated with anti‑CD19 CAR T cells and have had opportunity to be 
followed for 30 days after the IP infusion. 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. 
At the time of expedited reporting of suspected unexpected serious adverse reactions (SUSARs) 
to health 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.
9.11.
Criteria to Pause Enrollment
As part of its oversight of the study, the DSMB also will assess criteria to pause enrollment after 
10, 20, 30, and 50 subjects in Cohort 1 have been treated with axicabtagene ciloleucel or
KTE-X19 and have had the opportunity to be followed for 30 days.  Enrollment will be paused if 
any of the following criteria is met:

Subject incidence of Grade 5 axicabtagene ciloleucel or KTE-X19 related AEs within 
30 days is > 10%
or

Subject incidence of the following Grade 4 axicabtagene ciloleucel or KTE-X19-related 
AEs lasting more than 7 days is > 33%:
Neurologic toxicity
CRS (per Lee 2014 criteria)
Other non-hematological Grade 4 SAE
Infection (treatment-related)

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10.
STATISTICAL CONSIDERATIONS
10.1.
Hypothesis
This study uses an open-label, 2-cohort design. An alternative hypothesis will be tested among 
Cohort 1 KTE-X19 subjects with a target 50% ORR per independent review against a null 
hypothesis that the ORR is 25% or less. The hypothesis is that the ORR to KTE-X19 in 
Cohort 1 KTE-X19 subjects is significantly greater than 25%. No hypothesis will be tested in 
Cohort 1 axicabtagene ciloleucel subjects and Cohort 2 subjects. 
10.2.
Study Endpoints
10.2.1.
Primary

ORR: Defined as the incidence of a CR or a PR per the Lugano Classification (Cheson et al, 
2014), as determined by the IRRC.  All subjects who do not meet the criteria for an objective 
response by the analysis cutoff date will be considered non-responders, including the subjects 
without any evaluable assessment and those without any assessment.
10.2.2.
Secondary

DOR:  For subjects who experience an objective response, DOR is defined as the time from 
their first objective response to disease progression or death. Subjects not meeting the 
criteria for progression or death by the analysis data cutoff date will be censored at their last 
evaluable disease assessment date and their response will be noted as ongoing  

Best objective response:  the incidence of CR, PR, SD, progressive disease, or unevaluable as 
best response to treatment

ORR (as determined by investigators):  For subjects enrolled in Cohort 1, ORR, as 
determined by study investigators, is defined as the incidence of either a CR or PR per the 
revised IWG Response Criteria for Malignant Lymphoma (Cheson et al, 2007).  For subjects 
enrolled in Cohort 2, ORR, as determined by investigators, is defined as the incidence of 
either a CR or PR per the Lugano Classification (Cheson et al, 2014). All subjects who do 
not meet the criteria for an objective response by the analysis data cutoff date will be 
considered non-responders, including the subjects without any evaluable assessment and 
those without any assessment.

PFS: defined as the time from the anti‑CD19 CAR T-cell infusion date to the date of disease 
progression or death from any cause. Subjects not meeting the criteria for progression by the 
analysis data cutoff date will be censored at their last evaluable disease assessment date.      

OS:  defined as the time from anti‑CD19 CAR T cell infusion to the date of death from any 
cause. Subjects who have not died by the analysis data cutoff date will be censored at the 
last date known alive or the data cutoff date for analysis, whichever is earlier.

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
Incidence of AEs and clinically significant changes in laboratory values

Incidence of anti-CD19 CAR antibodies, levels of anti-CD19 CAR T cells in blood, and 
levels of cytokines in serum

Changes over time in the EQ-5D scale score and EQ-5D VAS score
10.2.3.
Exploratory Endpoints

ORR and duration of second response among subjects retreated with anti‑CD19 CAR T cells
(Section 7.12.10)
10.3.
Sample Size Considerations
This study uses an open-label, 2-cohort design to test for an improvement in ORR. Up to 
approximately 130 subjects with r/r MCL will be enrolled and treated with anti‑CD19 CAR 
T cells, including 10 axicabtagene ciloleucel subjects and up to approximately 80 KTE-X19
subjects in Cohort 1 and up to 40 KTE-X19 subjects in Cohort 2. The primary analysis will be 
conducted after 60 Cohort 1 KTE-X19 subjects have been enrolled and treated and have had the 
opportunity to be evaluated for response 6 months after the Week 4 disease assessment. For the 
test of efficacy, 60 KTE-X19 subjects in Cohort 1 will provide at least 96% power to distinguish 
between an active therapy with a 50% true response rate from a therapy with a response rate of 
25% or less (undesirable response rate, for purposes of futility assessment) with a 1-sided alpha 
level of 0.025.  No hypothesis will be tested in Cohort 1 axicabtagene ciloleucel subjects or
Cohort 2 subjects. Exploratory analyses will be conducted on the data collected from these 
subjects. 
In Cohort 1, 4 interim analyses will be performed:  

Cohort 1 interim analysis 1 will be conducted after 10 subjects in Cohort 1 have been 
enrolled and treated with anti‑CD19 CAR T cells and have had the opportunity to be
followed for 30 days. This interim analysis will be for safety only.

Cohort 1 interim analysis 2 will be conducted after 20 subjects in Cohort 1 have been 
enrolled and treated with anti‑CD19 CAR T cells and have had the opportunity to be 
evaluated for response 3 months after treatment with anti‑CD19 CAR T cells.  In this 
interim analysis, the DSMB will review data for both safety and efficacy (futility only).

Cohort 1 interim analysis 3 will occur after 38 subjects in Cohort 1 have been treated with 
anti‑CD19 CAR T cells and have had the opportunity to be assessed for response 6 months 
after the treatment with anti‑CD19 CAR T cells. This interim analysis will be performed 
for a Kite internal review of the accumulating data of safety and efficacy.

Cohort 1 interim analysis 4 will occur after 44 subjects in Cohort 1 have been treated with 
anti‑CD19 CAR T cells and have had the opportunity to be followed for at least 30 days.  In 
this interim analysis, the DSMB will review data for safety only, with focus on the 6 KTE-X19
subjects treated most recently in this cohort.

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In Cohort 2, one interim analysis will be performed:

Cohort 2 interim analysis will be conducted after 10 subjects in Cohort 2 have been enrolled 
and treated with KTE-X19 and have had the opportunity to be followed for 30 days after 
treatment with KTE-X19.  This interim analysis will be for safety and efficacy.
Accrual to the study will continue during all interim analyses.
One primary analysis will be performed:

The primary analysis will be performed with both Cohort 1 and Cohort 2 after 60 KTE-X19
subjects in Cohort 1 have been enrolled and treated and have had the opportunity to be 
assessed for response 6 months after the Week 4 disease assessment.
At the primary analysis, the inferential testing will be performed with data from the Cohort 1
KTE-X19 subjects only, using a 1-sided alpha level of 0.025. This procedure preserves the 
designated overall alpha level (1-sided) of 0.025 and has at least 96% power when 60 KTE-X19
subjects are included.  EAST version 6.4 were used for power calculation and evaluation of the 
operating characteristics of this design.
For Cohort 1, a rho (parameter = 0.30) beta spending function will be used to allocate the beta 
level between the futility analysis and the primary efficacy analysis.  
10.4.
Statistical Assumptions
As described in Section 3, an open-label, 2-cohort design is used. A target response rate of 50% 
and a historical control rate of 25% are assumed for statistical inference. The responses from 
subjects in the study population are assumed to be independent and follow binomial distribution,
and, thus, the exact binomial test will be used to test the statistical hypothesis.
10.5.
Analysis Subsets 

mITT set:  will consist of all subjects enrolled and treated with anti‑CD19 CAR T cells at 
any dose.  This analysis set will be used for analyses of the efficacy endpoints (objective 
response rate, best objective response, DOR, PFS, OS) for the study.

Inferential analysis set: will consist of the first 60 treated KTE-X19 subjects in 
Cohort 1. This analysis set will be used for the hypothesis testing of the primary 
endpoint ORR at the time of the primary analysis, as well as the analyses on the key 
secondary endpoints (best objective response [BOR], DOR, PFS, and OS).

Safety analysis set:  defined as all subjects treated with any dose of anti‑CD19 CAR T cells.
This analysis set will be used for all analysis of safety.

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 key secondary endpoints,
and subject listings of deaths.

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10.6.
Access to Individual Subject Treatment Assignments
This is an open-label, 2-cohort 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.
10.7.
Interim Analysis
10.7.1.
Interim Analysis and Early Stopping Rules
An independent DSMB will be formed to review accumulating safety data after 10 subjects in 
Cohort 1 have been enrolled and treated with anti‑CD19 CAR T cells and have had the 
opportunity to be followed for 30 days for safety. The DSMB will review accumulating safety 
and efficacy data after 20 subjects in Cohort 1 have been treated with anti‑CD19 CAR T cells
and have had the opportunity to complete the 3-month disease assessment after the treatment 
with anti‑CD19 CAR T cells. The DSMB will also review safety and efficacy after 10 subjects 
in Cohort 2 have been treated with KTE-X19 and have had opportunity to be followed for 
30 days after the KTE-X19 infusion. The DSMB will review safety again after 44 subjects in 
Cohort 1 have been enrolled and treated with anti‑CD19 CAR T cells and have had the 
opportunity to be followed for 30 days after the treatment with anti‑CD19 CAR T cells, with 
focus on the safety data from the 6 KTE-X19 subjects treated most recently within this cohort.
The DSMB will also monitor safety criteria to pause enrollment (see Section 9.11).
10.7.2.
Safety Interim Analysis  
The DSMB will review the safety data only twice, after 10 and 44 subjects in Cohort 1 have been 
enrolled and treated with anti‑CD19 CAR T cells and have had the opportunity to be followed 
for 30 days for safety, respectively. 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 modifying 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.  
10.7.3.
Efficacy Interim Analysis
In Cohort 1, two efficacy interim analyses will be performed.  
Interim analysis 2 (Efficacy analysis 1) will be conducted after 20 subjects have been treated 
with anti‑CD19 CAR T cells and have had the opportunity to be followed for 3 months after the 
treatment with anti‑CD19 CAR T cells.  This interim analysis will be for futility only.  If more 
than 5 responses are observed in the first 20 subjects, accrual in Cohort 1 will continue. 

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Interim analysis 3 (Efficacy analysis 2) will be conducted after 38 subjects in Cohort 1 have been 
treated with anti‑CD19 CAR T cells and have had the opportunity to be assessed for response 
6 months after the treatment with anti‑CD19 CAR T cells. This interim analysis will be 
performed for a Kite internal review of the accumulating data of safety and efficacy.
A rho (parameter = 0.30) beta spending function will be used to allocate the beta level between 
this futility analysis and the primary efficacy analysis in Cohort 1.    
In Cohort 2, one interim analysis will be conducted after 10 KTE-X19 subjects have been 
enrolled and have had the opportunity to be followed for 30 days after treatment with KTE-X19. 
This interim analysis will be for safety and efficacy.  
10.7.4.
Other Interim Analysis
The sponsor reserves the right to conduct additional analyses of safety and efficacy during the 
time between the planned interim analyses and primary analysis for regulatory interaction 
purposes. If conducted, no formal hypothesis testing will be performed in such analyses.
10.8.
Planned Methods of Analysis
The primary analysis will be performed after 60 KTE-X19 subjects in Cohort 1 have been 
treated and have had the opportunity to be evaluated for response 6 months after the Week 4 
disease assessment. In this primary analysis, inferential testing of efficacy will be performed 
with data from Cohort 1 KTE-X19 subjects only, and the analysis with the data from Cohort 1 
axicabtagene ciloleucel subjects and Cohort 2 will be descriptive. Additional analyses may 
occur after the primary analysis has been completed.  These additional analyses will be 
descriptive and will occur after inferential testing in Cohort 1 has been performed.  The final 
analysis will occur when all subjects in both cohorts have completed the study.  
The primary endpoint of ORR will be based on IRRC review of disease assessments in the mITT 
set.  Analyses of ORR based on investigator review of disease assessments will also be 
performed.
10.8.1.
ORR
The incidence of objective response and exact 2-sided 95% confidence intervals will be 
generated for Cohort 1 KTE-X19 subjects, Cohort 1 axicabtagene ciloleucel subjects, and 
Cohort 2 subjects.  An exact binomial test will be used to compare the observed ORR per IRRC 
review in Cohort 1 KTE-X19 subjects to a response rate of 25%.
10.8.2.
Best Objective Response
The incidence of subjects with CR, PR, SD, progressive disease, and unevaluable as best 
response to treatment and exact 2-sided 95% confidence intervals about the incidence will be 
generated for Cohort 1 KTE-X19 subjects, Cohort 1 axicabtagene ciloleucel subjects, and 
Cohort 2 subjects.

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10.8.3.
DOR
Kaplan-Meier estimates and 2-sided 95% confidence intervals will be generated for DOR for 
Cohort 1 KTE-X19 subjects, Cohort 1 axicabtagene ciloleucel subjects, and Cohort 2 subjects.
DOR will be derived using disease assessments obtained on study prior to initiation of new anti-
cancer therapy (including SCT).  The DOR for subjects who undergo SCT while in remission
will be censored at the last evaluable assessment date prior to SCT; a sensitivity analysis will be 
conducted in which disease assessments obtained after SCT are included in the derivation of 
DOR. 
10.8.4.
PFS
Kaplan-Meier estimates and 2-sided 95% confidence intervals will be generated for PFS time for 
Cohort 1 KTE-X19 subjects, Cohort 1 axicabtagene ciloleucel subjects, and Cohort 2 subjects.
Estimates of the proportion of subjects alive and progression-free at 3-month intervals will be 
provided.
10.8.5.
OS
Kaplan-Meier estimates and 2-sided 95% confidence intervals will be generated for OS for 
Cohort 1 KTE-X19 subjects, Cohort 1 axicabtagene ciloleucel subjects, and Cohort 2 subjects.
Estimates of the proportion of subjects alive at 3-month intervals will be provided.
10.8.6.
Safety
Subject incidence rates of AEs, including all, serious, fatal, CTCAE version 4.03 Grade 3 or
higher, and TEAEs with onsets on or after the date of KTE-X19 or axicabtagene ciloleucel
infusion, 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 medications will be summarized.
Tables and/or narratives of deaths through the LTFU and treatment related SAEs will be 
provided.
10.8.7.
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 KTE-X19 or axicabtagene ciloleucel infusion. No formal hypothesis 
testing will be performed based on data obtained after the primary analysis. Descriptive 
estimates of key efficacy and safety analyses may be updated to assess the overall treatment 
profile.

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11.
REGULATORY OBLIGATIONS 
11.1.
Independent Review Board/Independent Ethics Committee 
A copy of the protocol, ICF, and any additional subject or trial information, such as subject 
recruitment materials, must be submitted to each site’s respective IRB/IEC for approval. After
approval is obtained from the IRB/IEC, all documents must be provided to the key sponsor 
contact before subject recruitment can begin.
The investigator must also receive IRB/IEC approval for all protocol and ICF changes or 
amendments. Investigators must ensure that ongoing/continuous IRB/IEC approval (ie, annual 
approval) is provided throughout the conduct of the study. 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
Subject confidentiality must be maintained for all material submitted to the key sponsor contact. 
The following rules are to be applied.

Subjects will be identified by a unique ID number.

Date of birth or year of birth/age at time of enrollment will be reported according 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 federal regulations and International Conference on Harmonisation/Good Clinical Practice
(ICH/GCP) guidelines, investigators and institutions are required to permit authorization to the 
sponsor, Contract Research Organization (CRO), IRB/IEC, and regulatory agencies to subject’s
original source documents for verification of study data. The investigator is responsible for 
informing potential subjects that such individuals will have access to their medical records,
which includes personal information.
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

Participated 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 CRO with a copy of the correspondence.
Kite reserves the unilateral right, at is sole discretion, to determine whether to manufacture CAR
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. Example of such source documents may include, but are not limited to,
hospital records and patient charts; laboratory, pharmacy, radiology, and records; subject diaries;
microfiches; correspondence; and death registries. CRF entries may be considered as source data 
if the site of the original data collection is not available. However, use of the CRFs as source 
documentation as a routine practice is not recommended.
The investigator and study staff are responsible for maintaining a comprehensive and centralized
filing system of all subject records that are readily retrieved to be monitored and/or audited at 
any time by the key sponsor contact, regulatory authorities, and IRB/IECs. The filing system 
will include at minimum:

Subject content including ICFs and subject 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.

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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 tradenames. For further 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-C19-102 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 re 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.
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Hoster E, Dreyling M, Klapper W, Gisselbrecht C, van Hoof A, Kluin-Nelemans HC, et al. A new 
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Inwards DJ, Fishkin PA, Hillman DW, Brown DW, Ansell SM, Kurtin PJ, et al. Long-term results of the 
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Kaufmann H, Raderer M, Wöhrer S, Püspök A, Bankier A, Zielinski C, Chott A, Drach J. Antitumor 
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Ketterer N, Salles G, Espinouse D, Dumontet C, Neidhardt-Berard EM, Moullet I, et al. Intensive therapy 
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patients with mantle-cell lymphoma. N Engl J Med. 2012;367(6):520-31.
Kluin-Nelemans  HC, Hoster  E, Hermine  O, Walewski  J, Trneny  M, Geisler  CH, et al. Treatment of 
Older Patients with Mantle-Cell Lymphoma. New England Journal of Medicine. 2012;367(6):520-31.
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 
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Construction and preclinical evaluation of an anti-CD19 chimeric antigen receptor. J Immunother. 
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Meeting Abstracts. 2016;34(15_suppl):LBA3010.
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Anti-CD19 Chimeric Antigen Receptor T Cells Are Associated With High Serum Interleukin-15 Levels. J 
Clin Oncol. 2017;35(16):1803-13.
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transduced with a chimeric antigen receptor that recognizes murine CD19 can eradicate lymphoma and 
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efficacy of adoptively transferred T cells. Cancer Res. 2006;66(22):10995-1004.
Kraus TS, Sillings CN, Saxe DF, Li S, Jaye DL. The role of CD11c expression in the diagnosis of mantle 
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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 
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Lenz G, Dreyling M, Hoster E, Wormann B, Duhrsen U, Metzner B, et al. Immunochemotherapy with 
rituximab and cyclophosphamide, doxorubicin, vincristine, and prednisone significantly improves 
response and time to treatment failure, but not long-term outcome in patients with previously untreated 
mantle cell lymphoma: results of a prospective randomized trial of the German Low Grade Lymphoma 
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18.
APPENDIX
18.1.
Appendix 1:  Revised IWG Response Criteria for Malignant Lymphoma
Information in this section has been taken from (Cheson et al, 2007).
18.1.1.
Complete Response
Complete response (CR) requires all of the following: 

Complete disappearance of all detectable clinical evidence of disease and disease-related 
symptoms if present before therapy. 

Typically fluorodeoxyglucose (FDG)-avid lymphoma (large cell, mantle cell, and follicular 
lymphomas are all typically FDG-avid):  In subjects with no pre-treatment positron emission 
tomography (PET) scan or when the PET scan was positive before therapy, a post-treatment 
residual mass of any size is permitted as long as it is PET negative.  

Variably FDG-avid lymphomas/FDG avidity unknown:  In subjects without a pre-treatment 
PET scan or if a pre-treatment PET scan was negative, all lymph nodes and nodal masses 
must have regressed to normal size (≤ 1.5 cm in greatest diameter if > 1.5 cm before 
therapy).  Previously involved nodes that were 1.1 to 1.5 cm in their long axis and more than 
1 cm in their short axis before treatment must have decreased to ≤ 1.0 cm in their short axis 
after treatment.  

The spleen and/or liver, if considered to be enlarged before therapy on basis of physical exam 
or CT scan, must should be normal size on CT scan and not be palpable on physical 
examination, and nodules thought to represent lymphoma must no longer be present.  

A bone marrow aspirate and biopsy is performed only when the patient had bone marrow 
involvement with lymphoma 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.  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.  The biopsy core sample must be a minimum of 20 mm in length. 
18.1.2.
Partial Response
A partial response (PR) requires all of the following:

≥50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest 
dominant nodes or nodal masses.  Dominant nodes or nodal masses should be clearly 
measurable in at least 2 perpendicular dimensions, should be from different regions of the 
body if possible, and should include mediastinal and retroperitoneal nodes if possible.  

No increase in size of nodes, liver, or spleen and no new sites of disease.  

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
If multiple splenic and hepatic nodules are present, they must regress by ≥ 50% in the SPD.  
There must be a > 50% decrease in the greatest transverse diameter for single nodules.   

Bone marrow is irrelevant for determination of a PR.  If subject has persistent bone marrow 
involvement and otherwise meets criteria for CR, then the subject will be considered a PR.

Typically FDG-avid lymphoma:  for subjects with no pre-treatment PET scan or if the PET 
scan was positive before therapy, the post-treatment PET scan should be positive in at least 
1 previously involved site.  Note: in subjects with follicular lymphoma or mantle cell 
lymphoma, a PET scan is only indicated in subjects with 1 or at most 2 residual masses that 
have regressed by 50% on CT scan.
18.1.3.
Stable Disease
Stable disease (SD) requires:

Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for 
progressive disease.  PET should be positive in typically FDG-avid lymphomas.
18.1.4.
Progressive Disease
Progressive disease (PD) is defined by at least one of the following:  

≥ 50% increase from nadir in the sum of the products of at least 2 lymph nodes, or, if a single 
node is involved, at least a 50% increase in the product of the diameters of this 1 node  

Appearance of a new lesion > 1.5 cm in any axis even if other lesions are decreasing in size

≥50% increase in size of splenic or hepatic nodules 

At least a 50% increase in the longest diameter of any single previously identified node more 
than 1 cm in its short axis

Lesions should be PET positive in typically FDG-avid lymphomas unless the lesion is too 
small to be detected by PET (< 1.5 cm in its long axis by CT).

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18.2.
Appendix 2:  Lugano Classification
Refer to imaging manual and (Cheson et al, 2014) for details of assessment.
Table 10.
5-point Scale (5PS)
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
From (Barrington et al, 2014)
18.2.1.
Complete Response
18.2.1.1.
Complete Metabolic Response
The designation of complete metabolic response (CMR) for PET-CT-based response requires all 
of the following:

A 5-point scale (5PS) score of 1, 2, or 3, with or without a residual mass
In Waldeyer’s ring or extranodal sites with high physiologic uptake or with activation 
within spleen or marrow, uptake may be greater than normal mediastinum and/or liver.
In this circumstance, CMR may be inferred if uptake at sites of initial involvement is no 
greater than surrounding normal tissue even if the tissue has high physiologic uptake.

No new sites of disease should be observed.
18.2.2.
Complete Radiologic Response 
The designation of complete radiologic response (CRR) for CT-based response requires all of the 
following:

Target nodes/nodal masses must regress to ≤ 1.5 cm in longest transverse diameter of a lesion 
(LDi).

No extralymphatic sites of disease

Absent non-measured lesion

Organ enlargement regress to normal (eg, an enlarged spleen at baseline must be ≤13 cm at 
assessment)

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
No new sites of disease should be observed.

Bone marrow normal by morphology; if indeterminate, immunohistochemistry negative 
18.2.3.
Partial Response
18.2.3.1.
Partial Metabolic Response
The designation of partial metabolic response (PMR) for PET-CT-based response 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, these findings suggest residual disease.

No new sites of disease should be observed.
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 or biopsy 
or an interval scan.
18.2.3.2.
Partial Radiologic Response
The designation of partial radiologic response (PRR) for CT-based response requires all of the 
following:

≥50% decrease in the SPD of up to 6 target measurable nodes and extra-nodal sites
When a lesion is too small to measure by CT, assign 5 mm x 5 mm as the default value.
For a node > 5 mm x 5 mm, but smaller than normal, use actual measurements for 
calculation.

Absent/normal, regressed, but no increase of non-measured lesions

Spleen must have regressed by > 50% in length beyond normal (ie, ≤13 cm).  For example, 
if the spleen is 15 cm at baseline, it must be ≤14 cm at assessment to classify as a PRR. 

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18.2.4.
Stable Disease
18.2.4.1.
No Metabolic Response
The designation of no metabolic response (NMR) for PET-CT-based response 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.
18.2.4.1.1.
Stable Radiologic Disease
The designation of stable radiologic disease (SRD) for CT-based response requires all of the 
following:

< 50% decrease from baseline in the SPD of up to 6 dominant, measurable nodes and extra-
nodal sites; no criteria for progressive disease (PD) are met

No increase consistent with progression in non-measured lesion and organ enlargement

No new sites of disease should be observed.
18.2.4.2.
PD
18.2.4.2.1.
Progressive Metabolic Disease
The designation of progressive metabolic disease (PMD) for PET-CT-based response requires at 
least 1 of the following:

A 5PS score 4 or 5 with an increase in intensity of uptake from baseline, and/or

New FDG-avid foci consistent with lymphoma at interim or end of treatment assessment

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.
18.2.4.3.
Progressive Radiologic Disease
The designation of progressive radiologic disease (PRD) for CT-based response requires at least 
1 of the following:

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
An individual node/lesion must be abnormal with:
LDi > 1.5 cm, and
Increase by ≥ 50% from cross-product of LDi and perpendicular diameter (PPD) nadir,
and
An increase in LDi or shortest axis perpendicular to the LDi fromnadir
■
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, the increase must be ≥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 tolymphoma

New or recurrent bone marrow involvement

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18.3.
Appendix 3: Monitoring of Subjects After IP Administration per Country 
Regulatory Agencies
Germany:
The post-infusion monitoring of subjects, described in Section 7.12.6.2 in this protocol, will 
be extended by monitoring on Day 8, Day 9, and Day 10, according to procedures outlined 
in Table 8, column “IP administration period, 1-7.” The subject may stay hospitalized or 
return to the clinic daily for this extended monitoring at the discretion of the investigator. 
The daily monitoring will include vital signs (see Section 7.4), blood draw for chemistry 
panel with C-reactive protein (CRP), blood draw for complete blood count (CBC) with 
differential (see Section 7.11), and neurological assessment, including Mini-Mental Status 
Exam (MMSE) (see section 7.5). Any observed toxicity will be managed according to 
Section 6.4 of this protocol.