An Open-Label Phase 1B/2 Study to Evaluate the Safety and Efficacy of Tabelecleucel in Combination With Pembrolizumab in Subjects With Platinum-pretreated, Recurrent/Metastatic Epstein-Barr Virus-Associated Nasopharyngeal Carcinoma
Phase: PHASE1
Conditions: Nasopharyngeal Carcinoma, Nasopharyngeal Neoplasms, Epstein-Barr Virus Infections, Epstein-Barr Viraemia, Epstein-Barr Virus-associated Nasopharyngeal Carcinoma (EBV+ NPC)
Sponsor: Atara Biotherapeutics

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Protocol Original 
ATA129-NPC-202, Date 09 AUG 2018 
Confidential
tabelecleucel 
Page 2 of 98
 
 
Atara Biotherapeutics, Inc. 
The information contained in this document cannot be used for any other purpose without prior written consent. 
 
 
INVESTIGATOR AGREEMENT 
Study Title: 
An Open-Label Phase 1B/2 Study to Evaluate the Safety and Efficacy 
of Tabelecleucel in Combination with Pembrolizumab in Subjects with 
Platinum-pretreated, Recurrent/Metastatic Epstein-Barr Virus-
Associated Nasopharyngeal Carcinoma 
Study Number: 
ATA129-NPC-202 
 
I have read and reviewed the protocol described above. I agree to comply with all applicable 
regulations including the International Council for Harmonisation of Technical Requirements for 
Pharmaceuticals for Human Use (ICH) guidelines on Good Clinical Practice (GCP) (ICH E6) 
and to conduct the study according to the protocol. 
I agree to provide copies of the protocol and the Investigator’s Brochures for tabelecleucel 
(ATA129) and pembrolizumab, which were provided by the sponsor, to all members of the study 
team. I will insure that they are fully trained regarding the investigational product and the 
conduct of the study. 
I agree to make available to sponsor personnel, their representatives and regulatory authorities, 
my subjects’ study records in order to verify the data that I have entered into the electronic case 
report forms. I am aware of my responsibilities as a study investigator as provided by the 
sponsor. 
 
 
 
Signature 
Date 
Printed Name 
 
Title 
 
Institution 
 
 

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Protocol Original 
ATA129-NPC-202, Date 09 AUG 2018 
Confidential
tabelecleucel 
Page 5 of 98
 
 
Atara Biotherapeutics, Inc. 
The information contained in this document cannot be used for any other purpose without prior written consent. 
 
 
During the Treatment Phase, subjects will receive two 21-day treatment cycles of combination immunotherapy 
and then undergo a response assessment at the Observation Visit. Based on the subject’s response to these initial 
2 cycles s/he may receive one additional consolidation cycle with the same tabelecleucel product or additional 
treatment cycles with tabelecleucel with the same or a different HLA restriction, if an appropriately matched 
product is available. Detailed designs and schema are described in the protocol. At any time during the Treatment 
Phase if a subject has a confirmed progressive disease (cPD), it is at the investigator’s discretion to continue 
treatment with tabelecleucel with a different HLA restriction (Switch Therapy, if available) without 
pembrolizumab. A maximum of 4 treatment/consolidation cycles and 1 Switch Therapy will be permitted. 
During the Maintenance Phase, subjects will receive tabelecleucel on Day 1 and pembrolizumab on Day 1, 
Day 21, Day 42, and Day 63 of 84-day maintenance cycles, which will continue until disease progression, 
unacceptable toxicity, or a total of 35 pembrolizumab infusions (including for treatment, consolidation, and 
maintenance) have been given. After completing an End-of-Treatment (EOT) Visit 30 days after the last dose of 
investigational product, subjects will enter quarterly follow-up until 12 months after the last dose of 
investigational product or until disease progression. During this last phase, survival and disease status will be 
collected through clinic visits or telephone contact. The end-of-study is defined as the date of the last quarterly 
follow-up. 
Definitions 
Subject replacement: Subjects who discontinue due to a DLT after receiving both pembrolizumab and 
tabelecleucel during the 21-day DLT assessment window will not be replaced; however, subjects who discontinue 
due to a DLT associated with the first infusion of pembrolizumab (ie, prior to any tabelecleucel infusion) will be 
replaced. Subjects who discontinue from Cohort 1 for any reason other than a DLT prior to completing the 
21-day DLT assessment window will be replaced until the required number of evaluable subjects complete the 
21-day DLT assessment window. Subjects will not be replaced in Cohort 2. 
DLT definition: All toxicities will be graded based on the investigator’s assessment using Common Terminology 
Criteria for Adverse Events (CTCAE) version 5, except for certain events described in the protocol which have a 
separate grading system. Specific toxicities (defined in the protocol) will be considered DLTs, if they are judged 
by the investigator to be possibly related or related to either investigational product tabelecleucel and/or 
pembrolizumab administration, excluding toxicities clearly not related to the investigational product, such as 
disease progression, environmental factors, unrelated trauma, etc. 
The DLT window of observation will be during Cycle 1 of the Treatment Phase (ie, during the first 21-day cycle; 
adverse events [AEs] meeting the definition of a DLT but occurring after this period will not be considered 
DLTs). 
Any subject experiencing a DLT will be withdrawn from treatment (both investigational products). 
MTD definition: The MTD is defined as the highest dose level at which the subject incidence of a DLTs during 
the first 21-day cycle of investigational product dosing is < 33%. 
RP2D definition: The RP2D is no higher than the MTD and is based on optimal benefit-risk, as determined by the 
SDRC. 
Study Population: Up to a total of 48 to 60 subjects will be enrolled in the study. Of the 48 to 60 subjects, 12 to 
24 subjects will enroll in phase 1B portion (Cohort 1) of the study, and 36 subjects will be enrolled in phase 2 
portion (Cohort 2) of the study. 
Subject Enrollment Criteria 
Subjects must undergo a tabelecleucel inventory check to ensure availability of an appropriately matched and 
restricted tabelecleucel cell product prior to undergoing screening procedures. The inventory check includes 
collection of the subject’s high-resolution HLA typing (DNA-based versus serologic assessment) and weight. 
Inclusion criteria 
A subject will be considered eligible to participate in this study if all of the following inclusion criteria are 
satisfied: 
1. Male or female  12 years of age 

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CCI

Protocol Original 
ATA129-NPC-202, Date 09 AUG 2018 
Confidential
tabelecleucel 
Page 7 of 98
 
 
Atara Biotherapeutics, Inc. 
The information contained in this document cannot be used for any other purpose without prior written consent. 
 
 
11. Adequate organ function per the following: 
System 
Laboratory Value 
Hematological 
 
 
ANC 
≥ 1,500/μL 
 
Platelets 
≥ 100,000/μL 
 
Hemoglobina 
≥ 9 g/dL or ≥ 5.6 mmol/L 
Renal 
 
 
Creatinine OR 
 
Measured or calculated creatinine 
clearanceb (GFR can also be used 
in place of creatinine or CrCl) 
≤ 1.5 x ULN OR 
≥ 30 mL/min for subject with creatinine levels > 1.5 x ULN 
Hepatic 
 
 
TBILI 
≤ 1.5 x ULN OR 
Direct bilirubin ≤ ULN for subjects with TBILI > 1.5 x ULN 
 
AST (SGOT) and ALT (SGPT) 
≤ 2.5 x ULN  
≤ 5 x ULN for subjects with liver metastases 
Coagulation 
 
 
INR or PT 
 
aPTT 
≤ 1.5 x ULN unless subject is receiving anticoagulant 
therapy as long as PT or aPTT is within therapeutic range of 
intended use of anticoagulants 
ANC: absolute neutrophil count; aPTT: activated partial thromboplastin time; ALT (SGPT): alanine 
aminotransferase (serum glutamic pyruvic transaminase), AST (SGOT): aspartate aminotransferase 
(serum glutamic oxaloacetic transaminase), GFR: glomerular filtration rate, INR: international 
normalized ratio; PT: prothrombin time; TBILI: total bilirubin ULN: upper limit of normal. 
a  Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) 
transfusion within last 2 weeks. 
b  Creatinine clearance should be calculated per institutional standard. 
 
12. Willing and able to provide written informed consent (pediatric subjects 12 to < 18 years of age must 
provide assent along with consent from the subject’s legally authorized representative) 
Exclusion criteria 
A subject will not be eligible to participate in the study if any of the following criteria are met: 
1. Disease that is suitable for local therapy administered with curative intent 
2. Requires vasopressor or ventilator support 
3. Received antithymocyte globulin or similar anti-T-cell antibody therapy ≤ 4 weeks prior to Cycle 1 
Day 1 
4. Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of 
immunosuppressive therapy within 7 days prior to Cycle 1 Day 1 of study treatment. The use of 
physiologic doses of corticosteroids may be approved after consultation with the sponsor’s medical 
monitor. 
5. Active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease 
modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, 
insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not 
considered a form of systemic treatment and is allowed. 
6. History or evidence of interstitial lung disease 
7. History of severe hypersensitivity (Grade ≥ 3) to pembrolizumab and/or any of its excipients 

Protocol Original 
ATA129-NPC-202, Date 09 AUG 2018 
Confidential
tabelecleucel 
Page 8 of 98
 
 
Atara Biotherapeutics, Inc. 
The information contained in this document cannot be used for any other purpose without prior written consent. 
 
 
8. Active infection requiring systemic therapy 
9. History of (non-infectious) pneumonitis that required steroids or current pneumonitis 
10. Received transfusion of blood products (including platelets or red blood cells) or administration of 
colony stimulating factors (including granulocyte-colony stimulating factor, granulocyte macrophage-
colony stimulating factor or recombinant erythropoietin) within 4 weeks prior to study Day 1 
11. Unresolved immunotherapy-related adverse events (AEs) or treatment for these events within 4 weeks 
prior to enrollment 
12. History of severe immunotherapy-related adverse effects (CTCAE grade 4; CTCAE grade 3 requiring 
treatment > 4 weeks) 
13. Received any non-oncology vaccine therapy used for prevention of infectious diseases for up to 30 days 
prior to enrollment. Examples include, but are not limited to: measles, mumps, rubella, chicken pox, 
yellow fever, rabies, bacille Calmette-Guerin, and typhoid vaccine. Seasonal flu vaccines that do not 
contain live virus are acceptable 
14. Known additional malignancy that is progressing or requires active treatment. Exceptions include basal 
cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative 
therapy or in situ cervical cancer 
15. Pregnancy or breastfeeding: females of childbearing potential must have a negative serum pregnancy 
test. The serum pregnancy must be confirmed negative within 72 hours of Cycle 1 Day 1 (first dose of 
investigational product) for the subject to be eligible. 
16. Female of childbearing potential or male with a female partner of childbearing potential unwilling to use 
a highly effective method of contraception (abstinence is acceptable) for the course of the study through 
120 days after the last study dose 
17. Inability to comply with study procedures 
18. Received chemotherapy or targeted small molecule therapy within 2 weeks of Cycle 1 Day 1. Subjects 
must have recovered (ie, grade ≤ 1 or at baseline) from AEs due to a previously administered agent. 
Subjects with grade ≤ 2 neuropathy or grade ≤ 2 alopecia are an exception to this criterion. 
19. Received prior radiotherapy within 2 weeks of Cycle 1 Day 1. Subjects must have recovered from all 
radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 
1-week washout is permitted for palliative radiation (≤ 2 weeks of radiotherapy) to non-central nervous 
system (CNS) disease. 
20. Antibody/biologic therapy within 4 weeks of Cycle 1 Day 1 or not recovered (ie, grade ≤ 1 or at 
baseline) from AEs due to agents administered more than 4 weeks earlier 
21. Carcinomatous meningitis; and/or active CNS metastases, unless metastases are treated and stable and 
the subject does not require systemic steroids. NOTE: Subjects with previously treated brain metastases 
may participate provided the metastases are stable (without evidence of progression by imaging [using 
the identical imaging modality for each assessment, either MRI or CT scan] for at least 4 weeks prior to 
first dose of investigational product and any neurologic symptoms have returned to baseline), have no 
evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to first 
dose of investigational product. This exception only relates to CNS metastases and does not include 
carcinomatous meningitis which is excluded regardless of clinical stability 
22. History or current evidence of any condition, therapy, or laboratory abnormality that might confound the 
results of the study, interfere with the subject’s participation for the full duration of the study, or is not in 
the best interest of the subject to participate, in the opinion of the treating investigator   
23. Known psychiatric or substance abuse disorders that would interfere with cooperation with the 
requirements of the study 
24. Known history of human immunodeficiency virus (HIV), known active hepatitis B virus (HBV; eg, 
hepatitis B surface antigen [HBsAg] reactive), or hepatitis C virus (HCV; eg, HCV ribonucleic acid 
[RNA] is detected) 
25. Prior treatment with any investigational product within 4 weeks of Cycle 1 Day 1 

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Protocol Original 
ATA129-NPC-202, Date 09 AUG 2018 
Confidential
tabelecleucel 
Page 11 of 98
 
 
Atara Biotherapeutics, Inc. 
The information contained in this document cannot be used for any other purpose without prior written consent. 
 
 
TABLE OF CONTENTS, LIST OF TABLES, AND LIST OF FIGURES 
Table of Contents 
Synopsis ...........................................................................................................................................3 
TABLE OF CONTENTS, LIST OF TABLES, AND LIST OF FIGURES ............................11 
Table of Contents .........................................................................................................................11 
List of Tables ................................................................................................................................14 
List of Figures ...............................................................................................................................15 
List of Abbreviations and Definitions of Terms ........................................................................16 
1 
INTRODUCTION............................................................................................................19 
1.1 
Pharmaceutical and Therapeutic Background – Pembrolizumab ..........................19 
1.1.1 
Preclinical and Clinical Studies ...............................................................................19 
1.1.2 
Pembrolizumab Background and Clinical Studies ................................................20 
1.1.3 
Justification for Pembrolizumab Dose ....................................................................20 
1.1.3.1 
Rationale for Pembrolizumab Adult Dose Selection..........................................20 
1.1.3.2 
Rationale for Pembrolizumab Pediatric Dose Selection ....................................21 
1.2 
Pharmaceutical and Therapeutic Background – Tabelecleucel ..............................21 
1.2.1 
Tabelecleucel and Epstein-Barr virus-specific cytotoxic T lymphocytes ............21 
1.2.2 
Clinical Experience with Tabelecleucel for EBV+ PTLD ......................................22 
1.2.3 
Justification for Dose ................................................................................................22 
1.2.3.1 
Dose Selection ........................................................................................................22 
1.2.3.2 
Rationale for More Than One Cycle of Tabelecleucel .......................................23 
1.2.3.3 
Rationale for Selection of Tabelecleucel Based on Human Leukocyte 
Antigen Restriction ...............................................................................................23 
1.2.3.4 
Rationale for Switching the Tabelecleucel Human Leukocyte Antigen 
Restriction During Treatment .............................................................................24 
1.3 
Nasopharyngeal Carcinoma and Rationale for Combination Therapy ..................25 
2 
OBJECTIVES ..................................................................................................................26 
2.1 
Primary Objectives ......................................................................................................26 
2.2 
Secondary Objectives ...................................................................................................26 
2.3 
Exploratory Objectives ................................................................................................26 
3 
INVESTIGATIONAL PLAN .........................................................................................27 
3.1 
Study Design .................................................................................................................27 
3.2 
Endpoints ......................................................................................................................30 
3.3 
Study Stopping Criteria ...............................................................................................31 
3.4 
Safety Data Review Committee ...................................................................................31 
3.5 
Dose and Dose De-escalation Plans .............................................................................32 
4 
SELECTION AND WITHDRAWAL OF SUBJECTS ................................................32 
4.1 
Number of Subjects ......................................................................................................32 
4.2 
Eligibility Criteria ........................................................................................................33 
4.2.1 
Inclusion Criteria ......................................................................................................33 
4.2.2 
Exclusion Criteria .....................................................................................................35 
4.3 
Contraception ...............................................................................................................37 
4.4 
Nursing Women ............................................................................................................37 
4.5 
Meals and Dietary Restrictions ...................................................................................37 
4.6 
Subject Withdrawal Criteria .......................................................................................38 

Protocol Original 
ATA129-NPC-202, Date 09 AUG 2018 
Confidential
tabelecleucel 
Page 12 of 98
 
 
Atara Biotherapeutics, Inc. 
The information contained in this document cannot be used for any other purpose without prior written consent. 
 
 
4.7 
Subject Replacement ....................................................................................................38 
5 
TREATMENT WITH INVESTIGATIONAL PRODUCT .........................................38 
5.1 
Description of Investigational Products .....................................................................38 
5.1.1 
Formulation ...............................................................................................................39 
5.1.2 
Packaging and Labeling ...........................................................................................39 
5.1.3 
Storage and Handling ...............................................................................................39 
5.2 
Administration of Investigational Products ...............................................................39 
5.2.1 
Timing of Dose Administration ...............................................................................40 
5.2.2 
Duration of Treatment and Subject Participation ................................................40 
5.2.3 
Definition of Dose-limiting Toxicity ........................................................................41 
5.2.4 
Discontinuation of Treatment with Investigational Products after 
Complete Response ...................................................................................................42 
5.2.5 
Dose Modifications ....................................................................................................42 
5.2.5.1 
Dose Modification and Toxicity Management for Immune-related AEs 
associated with Pembrolizumab ..........................................................................42 
5.2.5.2 
Dose modification and Toxicity Management of Infusion Reactions 
Related to Pembrolizumab ...................................................................................46 
5.2.5.3 
Other Allowed Dose Interruption for Pembrolizumab .....................................47 
5.2.5.4 
Dose Modification for Tabelecleucel ...................................................................48 
5.2.5.5 
Discontinuation of One Investigational Product ................................................48 
5.3 
Prior and Concomitant Medications/Therapies ........................................................48 
5.3.1 
Permitted Medications/Therapies ...........................................................................48 
5.3.1.1 
Rescue Medications and Supportive Care ..........................................................48 
5.3.2 
Prohibited Medications/Therapies ..........................................................................49 
6 
STUDY PROCEDURES .................................................................................................50 
6.1 
Inventory Check ...........................................................................................................50 
6.2 
Screening .......................................................................................................................50 
6.3 
Treatment/Consolidation Phase (21-day Cycles) ......................................................51 
6.3.1 
Treatment/Consolidation: Day 1 .............................................................................51 
6.3.2 
Treatment/Consolidation: Day 8 and Day 15 .........................................................52 
6.3.3 
Treatment/Consolidation, Observation: Days 16 to 21 .........................................53 
6.4 
Maintenance Phase (84-day Cycles) ...........................................................................53 
6.4.1 
Maintenance: Day 1 ..................................................................................................53 
6.4.2 
Maintenance: Day 21, Day 42, and Day 63 .............................................................54 
6.4.3 
Maintenance: Day 77 ................................................................................................55 
6.5 
End-of-Treatment Visit ................................................................................................55 
6.6 
Quarterly Follow-up ....................................................................................................56 
6.7 
Early Withdrawal .........................................................................................................56 
7 
EFFICACY AND SAFETY ASSESSMENTS ...............................................................56 
7.1 
Radiographic Tumor Assessments .............................................................................56 
7.1.1 
Rationale for Endpoints Related to RECIST .........................................................57 
7.1.2 
Tumor Imaging and Assessment of Disease ...........................................................57 
7.1.2.1 
Initial Tumor Imaging ..........................................................................................58 
7.1.2.2 
Tumor Imaging During the Study .......................................................................58 
7.1.2.3 
End-of-Treatment and Quarterly Follow-up Tumor Imaging .........................58 
7.1.3 
RECIST 1.1 Assessment of Disease .........................................................................59 

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Protocol Original 
ATA129-NPC-202, Date 09 AUG 2018 
Confidential
tabelecleucel 
Page 14 of 98
 
 
Atara Biotherapeutics, Inc. 
The information contained in this document cannot be used for any other purpose without prior written consent. 
 
 
11.2 
Ethics Review by the Institutional Review Board or Independent Ethics 
Committee .....................................................................................................................76 
11.3 
Informed Consent .........................................................................................................77 
12 
INVESTIGATOR’S RESPONSIBILITIES ..................................................................78 
12.1 
Study Reporting Requirements ...................................................................................78 
12.2 
Financial Disclosure and Obligations .........................................................................78 
12.3 
Investigator Documentation ........................................................................................78 
12.4 
Institutional Review Board ..........................................................................................79 
12.5 
Retention of Records ....................................................................................................79 
13 
PUBLICATIONS .............................................................................................................79 
14 
REFERENCES .................................................................................................................80 
15 
APPENDIX .......................................................................................................................85 
15.1 
Schedule of Assessments and Procedures ..................................................................85 
15.2 
Detailed of the Study Design .......................................................................................89 
15.2.1 
Complete or Partial Response after the Initial Two Treatment Cycles ..............89 
15.2.2 
Stable Disease after the Initial Two Treatment Cycles .........................................89 
15.2.3 
Unconfirmed Progressive Disease after the Initial Two Treatment Cycles ........90 
15.2.4 
Confirmed Progressive Disease after the Initial Two Treatment Cycles ............91 
15.3 
Performance Status Scales ...........................................................................................92 
15.4 
Corticosteroid Approximate Equivalent Doses .........................................................93 
15.5 
Description of the iRECIST Process for Assessment of Disease Progression .........94 
15.6 
Severity Grading Scales ...............................................................................................97 
15.6.1 
Acute GvHD ..............................................................................................................97 
15.6.2 
Chronic GvHD ..........................................................................................................98 
 
List of Tables 
Table 1 
Comparison of the Concentration of Alloreactive and EBV-Specific 
T Cells in Unselected Donor Lymphocytes and In Vivo-Generated 
EBV-CTLs ..................................................................................................................23 
Table 2 
Dose Cohorts...............................................................................................................28 
Table 3 
Initial Dose and Dose De-escalation Levels .............................................................28 
Table 4 
Investigational Products ............................................................................................39 
Table 5 
Dose Modification and Toxicity Management Guidelines for 
Immune-related Adverse Events Associated with Pembrolizumab ......................43 
Table 6 
Pembrolizumab Infusion Reactions Dose modification and Treatment 
Guidelines ...................................................................................................................46 
Table 7 
Imaging and Treatment after First Radiologic Evidence of Progressive 
Disease .........................................................................................................................60 
Table 8 
CIBMTR Acute GvHD: Clinical Stage ....................................................................97 
Table 9 
CIBMTR Acute GvHD: Severity Grading ..............................................................98 
 

Protocol Original 
ATA129-NPC-202, Date 09 AUG 2018 
Confidential
tabelecleucel 
Page 15 of 98
 
 
Atara Biotherapeutics, Inc. 
The information contained in this document cannot be used for any other purpose without prior written consent. 
 
 
List of Figures 
Figure 1 Overall Study Design Schema (Cohorts 1 and 2) ....................................................29 
Figure 2 Imaging and Treatment for Clinically Stable Subjects Treated with 
Tabelecleucel and Pembrolizumab after First Radiologic Evidence of 
Progressive Disease Assessed by the Investigator ...................................................61 
 

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Abbreviation 
Definition 
PR 
partial response 
PT 
prothrombin time 
PTLD 
post-transplant lymphoproliferative disease 
PTT 
partial thromboplastin time 
Q2W 
every 2 weeks 
Q3W 
every 3 weeks 
RECIST 
response evaluation criteria in solid tumors 
RNA 
ribonucleic acid 
RP2D 
recommended phase 2 dose 
SAE 
serious adverse event 
SD 
stable disease 
SDRC 
Safety Data Review Committee 
SOT 
solid organ transplant 
SUSAR 
serious unexpected suspected adverse reactions 
T1DM 
type 1 diabetes mellitus 
TBILI 
total bilirubin 
TEAE 
treatment-emergent adverse event 
TSH 
thyroid stimulating hormone 
ULN 
upper limit of normal 
 

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1 INTRODUCTION 
1.1 
Pharmaceutical and Therapeutic Background – Pembrolizumab 
The importance of an intact immune surveillance function in controlling outgrowth of neoplastic 
transformations has been known for decades [4]. Accumulating evidence shows a correlation 
between tumor-infiltrating lymphocytes in cancer tissue and favorable prognosis in various 
malignancies. In particular, the presence of cluster of differentiation (CD)8+ T cells and the ratio 
of CD8+ effector T-cells/ forkhead box P3 (FoxP3)+ regulatory T cells correlates with improved 
prognosis and long-term survival in solid malignancies, such as ovarian, colorectal, and 
pancreatic cancer; hepatocellular carcinoma; malignant melanoma; and renal cell carcinoma. 
Tumor-infiltrating lymphocytes can be expanded ex vivo and reinfused, inducing durable 
objective tumor responses in cancers such as melanoma [9,17].  
The programmed cell death protein-1 (PD-1) receptor-ligand interaction is a major pathway 
hijacked by tumors to suppress immune control. The normal function of PD-1, expressed on the 
cell surface of activated T cells under healthy conditions, is to down-modulate unwanted or 
excessive immune responses, including autoimmune reactions. PD-1 (encoded by the gene 
Pdcd1) is an immunoglobulin (Ig) superfamily member related to CD28 and cytotoxic 
T lymphocyte-associated protein-4 (CTLA-4) that has been shown to negatively regulate antigen 
receptor signaling upon engagement of its ligands (programmed death-ligand [PD-L]1 and/or 
PD-L2) [14,29].  
The structure of murine PD-1 has been resolved [50]. PD-1 and its family members are type I 
transmembrane glycoproteins containing an Ig-variable–type domain responsible for ligand 
binding and a cytoplasmic tail responsible for the binding of signaling molecules. The 
cytoplasmic tail of PD-1 contains 2 tyrosine-based signaling motifs, an immunoreceptor 
tyrosine-based inhibition motif, and an immunoreceptor tyrosine-based switch motif. Following 
T-cell stimulation, PD-1 recruits the tyrosine phosphatases, sarcoma homology 2 domain 
phosphatase-1 and -2, to the immunoreceptor tyrosine-based switch motif within its cytoplasmic 
tail, leading to the dephosphorylation of effector molecules such as CD3 zeta, protein kinase 
C-theta, and zeta-chain-associated protein kinase, which are involved in the CD3 T-cell signaling 
cascade [29,5,41,34]. The mechanism by which PD-1 down-modulates T-cell responses is 
similar to, but distinct from, that of CTLA-4, because both molecules regulate an overlapping set 
of signaling proteins [30,10]. As a consequence, the PD-1/PD-L1 pathway is an attractive target 
for therapeutic intervention in Epstein-Barr virus-associated nasopharyngeal carcinoma 
(EBV+ NPC; also referred to as NPC in this protocol).  
1.1.1 
Preclinical and Clinical Studies 
Therapeutic studies in mouse models have shown that administration of antibodies blocking 
PD-1/PD-L1 interaction enhances infiltration of tumor-specific CD8+ T cells and ultimately 
leads to tumor rejection, either as a monotherapy or in combination with other treatment 
modalities [3,6,16,32,42,43,48]. Anti-mouse PD-1 or anti-mouse PD-L1 antibodies have 
demonstrated antitumor responses in models of squamous cell carcinoma, pancreatic carcinoma, 
melanoma, acute myeloid leukemia and colorectal carcinoma [7,26,36,39,43]. In such studies, 

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tumor infiltration by CD8+ T cells and increased interferon-gamma (IFN-γ), granzyme B and 
perforin expression were observed, indicating that the mechanism underlying the antitumor 
activity of PD-1 checkpoint inhibition involved local infiltration and activation of effector T cell 
function in vivo [7]. Experiments have confirmed the in vivo efficacy of anti-mouse PD-1 
antibody as a monotherapy, as well as in combination with chemotherapy, in syngeneic mouse 
tumor models (refer to the pembrolizumab [MK-3475] Investigator’s Brochure).  
1.1.2 
Pembrolizumab Background and Clinical Studies 
Pembrolizumab is a potent humanized IgG4 monoclonal antibody with high specificity of 
binding to the PD-1 receptor, thus inhibiting its interaction with PD-L1 and PD-L2. Based on 
preclinical in vitro data, pembrolizumab has high affinity and potent receptor blocking activity 
for PD-1. Pembrolizumab has an acceptable preclinical safety profile and is in clinical 
development as an intravenous (IV) immunotherapy for advanced malignancies. Keytruda® 
(pembrolizumab) is indicated for the treatment of patients across a number of indications. For 
more details on specific indications refer to the pembrolizumab (MK-3475) Investigator’s 
Brochure.  
Refer to the pembrolizumab (MK-3475) Investigator’s Brochure/approved labeling for detailed 
background information.  
1.1.3 
Justification for Pembrolizumab Dose  
1.1.3.1 
Rationale for Pembrolizumab Adult Dose Selection 
The planned dose of pembrolizumab for this study is 200 mg every 3 weeks (Q3W; ie during the 
21-day treatment cycle). Based on the totality of data generated in the Keytruda development 
program, 200 mg Q3W is the appropriate dose of pembrolizumab for adults across all indications 
and regardless of tumor type. As outlined below, this dose is justified by the following: 
 Clinical data from 8 randomized studies demonstrating flat dose- and exposure-efficacy 
relationships from 2 mg/kg Q3W to 10 mg/kg every 2 weeks (Q2W) 
 Clinical data showing meaningful improvement in benefit-risk including overall survival 
(OS) at 200 mg Q3W across multiple indications 
 Pharmacology data showing full target saturation in both systemic circulation (inferred 
from pharmacokinetic [PK] data) and tumor (inferred from physiologically-based PK 
[PBPK] analysis) at 200 mg Q3W 
Among the 8 randomized dose-comparison studies, a total of 2,262 subjects were enrolled with 
melanoma and non-small cell lung cancer (NSCLC), covering different disease settings 
(treatment naïve, previously treated, PD-L1 enriched, and all-comers) and different treatment 
settings (monotherapy and in combination with chemotherapy). Five studies compared 2 mg/kg 
Q3W versus 10 mg/kg Q2W (KN001 Cohort B2, KN001 Cohort D, KN002, KN010, and 
KN021), and 3 studies compared 10 mg/kg Q3W versus 10 mg/kg Q2W (KN001 Cohort B3, 
KN001 Cohort F2 and KN006). All of these studies demonstrated flat dose- and exposure-
response relationships across the doses studied representing an approximate 5- to 7.5-fold 

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difference in exposure. The 2 mg/kg (or 200 mg fixed-dose) Q3W provided similar responses to 
the highest doses studied. Subsequently, flat dose-exposure-response relationships were also 
observed in other tumor types including head and neck cancer, bladder cancer, gastric cancer, 
and classical Hodgkin Lymphoma, confirming 200 mg Q3W as the appropriate dose independent 
of the tumor type. These findings are consistent with the mechanism of action of pembrolizumab, 
which acts by interaction with immune cells, and not via direct binding to cancer cells. 
Additionally, pharmacology data clearly show target saturation at 200 mg Q3W. First, PK data in 
KN001 evaluating target-mediated drug disposition conclusively demonstrated saturation of 
PD-1 in systemic circulation at doses much lower than 200 mg Q3W. Second, a PBPK analysis 
was conducted to predict tumor PD-1 saturation over a wide range of tumor penetration and 
PD-1 expression. This evaluation concluded that pembrolizumab at 200 mg Q3W achieves full 
PD-1 saturation in both blood and tumor. 
Finally, population PK analysis of pembrolizumab, which characterized the influence of body 
weight and other subject covariates on exposure, has shown that the fixed-dosing provides 
similar control of PK variability as weight-based dosing, with considerable overlap in the 
distribution of exposures from the 200 mg Q3W fixed dose and 2 mg/kg Q3W dose. Supported 
by these PK characteristics and given that fixed-dose has advantages of reduced dosing 
complexity and reduced potential of dosing errors, the 200 mg Q3W fixed-dose was selected for 
evaluation across all pembrolizumab protocols. 
1.1.3.2 
Rationale for Pembrolizumab Pediatric Dose Selection 
To date, pembrolizumab (2 mg/kg Q3W) has been evaluated in 85 pediatric subjects (aged 1 to 
18 years) with advanced melanoma, PD-L1 positive advanced, relapsed, or refractory solid 
tumors, or lymphoma. The exposures in pediatric subjects following the 2 mg/kg Q3W regimen 
were found to be similar to that observed in adult subjects. Pediatric data has also been 
incorporated in an integrated population PK analysis, which confirmed that a pembrolizumab 
dose of 2 mg/kg Q3W (up to a maximum of 200 mg Q3W) in pediatric subjects renders 
exposures similar to adults. Based on these results, the pediatric dose for evaluation in this study 
is 2 mg/kg Q3W (up to a maximum of 200 mg Q3W). 
1.2 
Pharmaceutical and Therapeutic Background – Tabelecleucel 
For detailed background information, refer to the tabelecleucel (ATA129) Investigator’s 
Brochure. 
1.2.1 
Tabelecleucel and Epstein-Barr virus-specific cytotoxic T lymphocytes 
Atara Biotherapeutics, Inc. is developing tabelecleucel (ATA129; allogeneic EBV-specific 
cytotoxic T lymphocytes [EBV-CTLs]). EBV-CTLs (including tabelecleucel) for the treatment 
of EBV-associated lymphoproliferative disorders (LPD)/lymphoma, post-transplant 
lymphoproliferative disease (PTLD), and NPC in clinical studies have been generated from 
high-resolution human leukocyte antigen (HLA)-typed, EBV+, related and unrelated primary 
stem cell donors. As for tabelecleucel, T cells from these donors are sensitized with autologous 
irradiated EBV-transformed B cells. The T cells are co-cultured with EBV-transformed 

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B lymphoblasts for 28 to 35 days with cytokine stimulation, and then characterized and 
cryopreserved for future use as a readily available T-cell immunotherapy [8]. 
1.2.2 
Clinical Experience with Tabelecleucel for EBV+ PTLD 
The clinical experience of tabelecleucel includes 5 clinical studies in subjects with EBV+ PTLD 
following allogeneic hematopoietic cell transplant (HCT) or solid organ transplant (SOT); for 
details refer to the current edition of the tabelecleucel (ATA129) Investigator’s Brochure. Safety 
results (from a 23 September 2017 analysis) of all 173 subjects treated in clinical studies and 
15 patients treated through expanded access show tabelecleucel to have a favorable benefit-risk 
profile in subjects with rituximab refractory EBV+ PTLD. Efficacy results (01 June 2017 
analysis) of the clinical studies of patients with rituximab refractory EBV+ PTLD have shown 
that tabelecleucel provides meaningful improvement in response rate and OS compared with 
currently available therapies and a favorable safety profile. Subjects with rituximab resistant, 
EBV+ PTLD following allogeneic HCT (N = 35) had a response rate of 65.7% and a 1-year OS 
of 69.5% (with a median on-study follow-up time of 12.0 months), which exceed the response 
rate of 0% reported for CHOP administration and median survival of 16 to 56 days, as reported 
in the literature [10,28,38,46]. In subjects with EBV+ PTLD following SOT (N = 14), the 
response rate was 50.0% and 1-year OS was 63.5%. 
1.2.3 
Justification for Dose 
1.2.3.1 
Dose Selection 
For dose selection, tabelecleucel has been evaluated in 2 studies (95-024 and 11-130) for the 
treatment of EBV+ LPDs or malignancies. In Study 95-024, the dose of tabelecleucel initially 
employed was 1 × 106 T cells/kg/dose weekly for 3 weeks followed by a 3-week period of 
observation. This dose provided a high effector EBV-CTL exposure while potentially 
co-transferring a cumulative dose of alloreactive cytotoxic T-lymphocyte precursors (CTLp) well 
below the threshold dose of 105 CTLp/kg, which was established for graft-versus-host disease 
(GvHD) in HLA-matched recipients [24] and the 0.5 × 104 CTLp/kg dose that has been 
associated with < 8% grade 2 acute GvHD or chronic GvHD after HLA non-identical transplants 
[27]. The number of EBV-specific CTL precursor (EBV-CTLp) and alloreactive CTLp detected 
in tabelecleucel administered to subjects in Study 95-024 are summarized in Table 1 and 
compared to doses that would be given were the subject to receive unselected donor 
lymphocytes. In this study, no recipient of tabelecleucel developed grade ≥ 2 acute GvHD or 
chronic GvHD; one subject developed a transient grade 1 skin rash, which cleared with topical 
steroid administration. 
 

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Table 1 
Comparison of the Concentration of Alloreactive and EBV-Specific 
T Cells in Unselected Donor Lymphocytes and In Vivo-Generated 
EBV-CTLs 
 
EBV-CTLs 
Median (range), N=19 
Unselected Donor 
Lymphocytes 
Median (range), N=5 
EBV-Specific: EBV-CTLp concentration /106 T cells 
1156 (66–6578) 
17 (5.7–33) 
Alloreactive: CTLp concentration /106 T cells 
5.6 (< 1.28–29) 
97 (2.8–223) 
Grade ≥ 2 de novo acute GvHD and de novo chronic risk; 
106 cells/kg in HLA-matched recipients 
0% 
32% 
Abbreviations: EBV: Epstein-Barr virus; CTL: cytotoxic T lymphocyte; CTLp: CTL precursor; GvHD: graft-
versus-host disease; HLA: human leukocyte antigen 
Source: Prockop et al [33] 
Because the dose of potentially reactive T cells was so low and no instance of acute grade 
≥ 2 GvHD had been recorded, the dose of tabelecleucel was increased to 2 × 106 cells/kg/dose 
for Study 11-130. The results from Study 11-130 showed a higher response rate (RR), higher 
proportion of long-term survivors, and no added toxicity compared with data from Study 95-024. 
These results support the selection of a tabelecleucel dose of 2 × 106 cells/kg/dose for the current 
study. 
1.2.3.2 
Rationale for More Than One Cycle of Tabelecleucel 
Studies have shown that in subjects with EBV+ PTLD following allogeneic HCT, tabelecleucel 
were usually cleared within 4 weeks, and were never detected beyond day 90 following the first 
infusion [14]. In Studies 95-024 and 11-130, increments in the frequencies of EBV-CTLp have 
been detected after each course but have persisted for no more than 2 to 4 weeks [1,8]. Because 
NPC subjects are not as immunosuppressed as subjects who have received an allogeneic HCT, 
tabelecleucel is expected to be cleared more rapidly and multiple cycles of tabelecleucel are 
recommended, including maintenance therapy for those achieving disease control. 
In subjects with NPC, the endogenous immune system is expected to eventually reject the 
partially HLA-matched tabelecleucel. Therefore, multiple administrations of tabelecleucel are 
expected to be required to optimize response. 
1.2.3.3 
Rationale for Selection of Tabelecleucel Based on Human Leukocyte 
Antigen Restriction 
The rationale for selecting tabelecleucel cell products that are specifically restricted by an HLA 
allele shared by the subject and the tabelecleucel product are from findings reported from the 
first 19 subjects treated on Study 95-024 [8]. Specifically, tabelecleucel derived from an HLA 
haplotype disparate donor restricted by HLA was ineffective in a subject with an 
EBV+ lymphoma because the subject and his tumor did not share the HLA allele. Subsequent 
treatment of the subject with tabelecleucel restricted by an HLA allele shared by the subject led 
to a complete remission of disease that has been durable to the present day, over 5 years later. 

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These data illustrate that administration of a tabelecleucel cell product matched via a restricting 
HLA allele shared on the subject’s NPC tumor is required for product efficacy. 
Clinical experience with tabelecleucel including a summary of safety is described in the 
tabelecleucel (ATA129) Investigator’s Brochure. 
1.2.3.4 
Rationale for Switching the Tabelecleucel Human Leukocyte Antigen 
Restriction During Treatment 
The rationale to switch tabelecleucel to a different shared HLA restriction in subjects who have 
not achieved a partial response (PR) or complete response (CR) after an initial course of 
tabelecleucel derives from Study 95-024 [8]. In 3 subjects with an EBV+ lymphoma following 
allogeneic HCT who received tabelecleucel derived from the allogeneic HCT donor, the 
lymphoma was genetically shown to be of donor origin, and the tabelecleucel T cells generated 
from the donor by sensitization in vitro with autologous B cells transformed by the B95.8 EBV 
strain (different from the subject’s EBV+ lymphoma), were unable to lyse an endogenous 
EBV+ B-cell line generated from the subject’s lymphoma. The fact that the tabelecleucel T cells 
from the donor that were sensitized with the endogenous EBV+ B-cell line grown from the 
subject could lyse the EBV+ B-cell line and also lyse B cells transformed by the B95.8 EBV 
strain provided evidence that the endogenous EBV strain inducing the lymphoma lacked an 
antigen targeted by the tabelecleucel T cells sensitized with the B95.8 EBV transformed B cells 
rather than any defect in antigen processing or presentation of EBV antigens by the endogenous 
EBV+ B-cell line. In a similar case of a subject who failed treatment, donor-derived T cells 
sensitized with an autologous EBV B95.8 transformed B-cell line were unable to lyse the 
EBV+ tumor cells of the subject due to a mutation in the endogenous strain of EBV that resulted 
in deletion of two EBV-specific peptides presented by a specific HLA that were exclusively 
targeted by the donor-derived T cells used for treatment [13]. 
Based on these findings in Study 11-130, it was hypothesized that selection of an alternate 
tabelecleucel cell product restricted by a different HLA allele and therefore likely specific for a 
different EBV epitope expressed by the subject’s lymphoma might prove effective given the low 
probability that the second epitope would also be mutated or deleted. Eight allogeneic HCT 
recipients underwent Switch Therapy with tabelecleucel from a different donor, restricted by a 
different HLA allele shared by the subject’s disease; of the 8 subjects, 4 achieved CR and 
1 achieved a durable PR. As with the infusions of tabelecleucel with the initial HLA restriction, 
no toxicities were observed following the infusions of tabelecleucel with a different HLA 
restriction. In one of these cases, the investigators were also able to isolate spontaneously 
transformed B cells from the subject’s EBV+ lymphoma. These B cells, bearing the endogenous 
strain of EBV, were not lysed by T cells from donors that were restricted by one HLA allele and 
had failed to arrest progression of disease, but were lysed by T cells from a tertiary donor that 
were restricted by another HLA allele.  
While these findings support the hypothesis that Switch Therapy may lead to further lymphoma 
response and are being further evaluated in ongoing phase 3 studies in lymphoma; it is expected 
that a similar benefit may be observed in NPC as well. Hence, these findings support selecting an 

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alternative HLA restricted tabelecleucel cell product in subjects who fail to respond to 
tabelecleucel initially used for treatment. 
1.3 
Nasopharyngeal Carcinoma and Rationale for Combination Therapy 
NPC is an undifferentiated squamous cell carcinoma with a worldwide incidence of 
approximately 80,000 new cases per year. NPC has an incidence of approximately one new case 
per year per 100,000 in the United States with children ≤ 16 years of age comprising about 10% 
of cases [1] and is endemic in southeast Asia with an incidence approximately 30 times higher. 
The World Health Organization classifies NPC as 3 types. The type 2b (III) nonkeratinizing 
undifferentiated form is the most common and is most strongly associated with EBV infection of 
the cancerous cells. Despite improvements in first-line and second-line treatments, advanced 
NPC has a poor prognosis. High-risk features include a Stage of IIb or higher, age greater than 
50 years, EBV viremia, and high expression of PD-L1. The most commonly used treatments for 
head and neck cancers are platinum agents, taxanes, 5-fluorouracil, methotrexate and cetuximab; 
similar therapies are used for children. Subjects with low-stage disease have a 94% disease-free 
survival rate, while the rate is 38% to 80% for those with high-stage disease. Five-year survival 
is 80% (Stage I and II), 62% (Stage III), and < 10% (Stage IV). 
The association between NPC and EBV is well known. EBV infection induces the expression of 
immunogenic peptides on the membrane of infected cells, and these virus-related antigens may 
be used as targets for antitumor immunotherapy-based treatment strategies [21]. 
The potential of autologous EBV-directed T-cell immunotherapy for NPC has been shown in 
several recent clinical studies. However, as it is not possible to generate autologous EBV-CTLs 
from all subjects, the use of EBV-directed immunotherapy with tabelecleucel has been 
investigated. Prockop et al [34] treated 14 subjects with metastatic EBV-associated NPC with 
tabelecleucel selected from a bank of more than 300 lines generated from EBV+ HCT donors by 
sensitization of T cells with irradiated EBV-transformed B-cell lines. Cells were administered in 
cycles of 3 weekly doses of 1 to 2 x 106 cells/kg for a median of 2 cycles (range: 1 to 4 cycles). 
The results of this study showed that tabelecleucel has sufficient diversity to treat non-Caucasian 
subjects with NPC. Nine subjects were Asian, 3 were black, and 1 was Hispanic. Subjects had 
progressed after first (N=6) second (N=7) or third (N=1) line therapy. Tabelecleucel infusions 
were well tolerated without toxicities. One subject achieved a CR (documented by biopsy); 
lasting 21.2 months, 2 PRs lasting 3.5 and 6.7 months and one subject had stable disease (SD) 
lasting 7.4 months. All 4 subjects who achieved CR, PR or SD were alive at 20.4 to 48.3 months 
post therapy, and 11 subjects were alive at a median of 18.1 months (range: 3.0 to 48.4 months) 
after start of immunotherapy.  
Given the minimal toxicities and ready availability, use of tabelecleucel for treatment of NPC is 
a promising option for combination with other therapies, such as PD-1/PD-L1 inhibition. 
Pembrolizumab is a PD-L1 inhibitor with a demonstrated objective response rate (ORR) of 
25.9% amongst 27 subjects with advanced, unresectable NPC which demonstrated ≥ 1% PD-L1 
expression in tumor using immunohistochemistry (IHC) analysis [18]; however, despite this, a 
proportion of subjects do not respond, and some responders relapse after immunotherapy. 
Exhaustion of the subject’s own endogenous T-cell response is a potential contributing factor, 

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CCI

Protocol Original 
ATA129-NPC-202, Date 09 AUG 2018 
Confidential
tabelecleucel 
Page 28 of 98
 
 
Atara Biotherapeutics, Inc. 
The information contained in this document cannot be used for any other purpose without prior written consent. 
 
 
all 12 subjects in Cohort 1 will receive tabelecleucel at 2 x 106 cells/kg/dose and pembrolizumab 
at the recommended dose level. 
A Safety Data Review Committee (SDRC) composed of representatives from the sponsor and 
the principal investigators or designated sub-investigators from all sites enrolling subjects in 
Cohort 1 will review reported DLTs and cumulative safety data to determine further enrollment. 
The data review will occur as soon as possible after Cycle 1 Day 21 of the last subject in 
Cohort 1. After the SDRC review, 36 subjects will be enrolled in Cohort 2 and treated with the 
combination at the recommended dose level. 
 
Table 2 
Dose Cohorts 
Cohort 
Number of Subjects 
Prior Therapy 
1 
12 to 24 
Checkpoint inhibitor naïve a or PD-1/PD-L1 failures (ie, refractory to or 
relapsed after PD-1/PD-L1 treatment) 
At least 6 of the 12 subjects must have disease that is refractory to an 
anti-PD-1 or anti-PD-L1 monoclonal antibody for each dose level 
explored 
2 
36 
Checkpoint inhibitor naïve a subjects 
a  
Checkpoint inhibitor naïve have never received pembrolizumab or other anti-PD-1, anti-PD-L1, anti-PD-L2, 
anti-CD137, anti-OX40 or anti-CTLA-4 antibodies 
 
Table 3 
Initial Dose and Dose De-escalation Levels 
 
Tabelecleucel Dose (cells/kg)  
Pembrolizumab  
Adult Dose (mg) 
Pembrolizumab  
Pediatric Dose (mg/kg) 
Dose level 1 
2 × 106 on Day 1, Day 8 and Day 15 
200 on Day 1 
2 on Day 1 
Dose level 2 
1 × 106 on Day 1, Day 8 and 
Day 15 
200 on Day 1 
2 on Day 1 
 

Protocol Original 
ATA129-NPC-202, Date 09 AUG 2018 
Confidential
tabelecleucel 
Page 29 of 98
 
 
Atara Biotherapeutics, Inc. 
The information contained in this document cannot be used for any other purpose without prior written consent. 
 
 
Figure 1 
Overall Study Design Schema (Cohorts 1 and 2) 
 
Response
assessment
Stable disease (SD)
CR or
PR
Inventory Check and Screening
End-of-Treatment (EOT) at 30 days from last dose, then Quarterly Follow-up for 1 year from last dose
cPD
SD
uPD
cPD
Response 
assessment
Treatment cycle:
Day 1 pembrolizumab and 
Days 1, 8, 15 tabelecleucel 
(current HLA restriction) 
Response
assessment
Maintenance cycles:
Day 1, 21, 42, 63 pembrolizumab 
and Day 1 tabelecleucel
(current HLA restriction)
Complete response (CR) 
or Partial response (PR)
Response
assessment
Consolidation cycle:
Day 1 pembrolizumab and 
Days 1, 8, 15 tabelecleucel 
(current HLA restriction) 
Unconfirmed
progressive disease (uPD)
Response 
assessment
Treatment cycle:
Day 1 pembrolizumab and 
Days 1, 8, 15 tabelecleucel 
(current HLA restriction) 
cPD
SD
Confirmed
progressive disease (cPD)
Response
assessment
Treatment cycle:
Day 1 pembrolizumab and 
Days 1, 8, 15 tabelecleucel 
(switch HLA restriction) 
Response
assessment
Treatment cycle:
Day 1 pembrolizumab and 
Days 1, 8, 15 tabelecleucel 
(switch HLA restriction) 
cPD
CR, PR, 
or SD
CR, PR, 
or SD
Response
assessment
Discontinue pembrolizumab 
and Treatment cycle:
Days 1, 8, 15 tabelecleucel 
(switch HLA restriction)
Response
assessment
2 Treatment cycles:
Day 1 pembrolizumab and 
Days 1, 8, 15 tabelecleucel
Consolidation cycle:
 Days 1, 8, 15 
tabelecleucel 
(current HLA restriction) 
CR or
PR
Response
assessment
Maintenance cycles:
Day 1, 21, 42, 63 
pembrolizumab
 and Day 1 tabelecleucel
(current HLA restriction)
cPD
CR, PR, 
or SD
cPD
 
 
NOTE: A maximum of 4 treatment/consolidation cycles and 1 switch of tabelecleucel to a different 
HLA restriction (Switch Therapy) is permitted if an appropriately matched product is available. 
*  For a clinically stable subject with first radiographic evidence of progressive disease by RECIST 1.1 (ie, 
unconfirmed PD [uPD]), it is at the discretion of the investigator not continue treating the subject with the 
assigned treatment per protocol until cPD at least 28 days from the date of the scan first suggesting progressive 
disease. If radiographic progression is not confirmed by immune (i)RECIST per the investigator, then the 
subject may continue on treatment as described above in consultation with the sponsor’s medical monitor. 

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CCI

Protocol Original 
ATA129-NPC-202, Date 09 AUG 2018 
Confidential
tabelecleucel 
Page 32 of 98
 
 
Atara Biotherapeutics, Inc. 
The information contained in this document cannot be used for any other purpose without prior written consent. 
 
 
The sponsor’s medical monitor and global safety officer will review data on an ongoing basis 
and may suspend dosing and/or enrollment and convene a SDRC meeting at any time based on 
emerging safety data. 
3.5 
Dose and Dose De-escalation Plans 
The study dose and dose de-escalation plans, which will include applicable review(s) by the 
SDRC (Section 3.4), is described as follows:  
 At the 2 × 106 dose level:  
 If ≤ 1 of the first 6 subjects in Cohort 1 experiences DLTs, the next 6 subjects will be 
enrolled in Cohort 1 at the 2 × 106 dose level. 
o If ≤ 3 of the 12 total subjects in Cohort 1 experience DLTs, Cohort 2 will proceed 
with enrollment of 36 subjects at the 2 × 106 dose level. 
 If ≥ 2 of the first 6 subjects experience DLTs, the dose will be de-escalated to 1 × 106, 
and the next 6 subjects will be enrolled in Cohort 1 at the lower dose level of 1 × 106. 
Continue with the steps for the 1 × 106 dose level. 
o If ≥ 4 of the 12 total subjects experience DLTs, the dose will be de-escalated to 
1×106 and the next 6 subjects will be enrolled in Cohort 1 at the lower dose level 
of 1 × 106. Continue with the steps for the 1 x 106 dose level. 
 At the 1 × 106 dose level:  
 If ≤ 1 of the first 6 subjects experiences DLTs, the next 6 subjects will be enrolled in 
Cohort 1 at the 1 × 106 dose level. 
o If ≤ 3 of the 12 total subjects in Cohort 1 experience DLTs, Cohort 2 will proceed 
with enrollment of 36 subjects at the 1 × 106 dose level. 
 If ≥ 2 of the first 6 subjects or > 4 of the 12 total subjects experience DLTs, all further 
enrollment will be stopped and continued dosing of current subjects receiving active 
treatment will be evaluated by SDRC for an individual benefit-risk assessment.  
4 SELECTION AND WITHDRAWAL OF SUBJECTS 
4.1 
Number of Subjects 
Up to a total of 48 to 60 subjects will be enrolled in the study. The phase 1B portion (Cohort 1) 
of the study will enroll 12 to 24 subjects. For each dose level explored in Cohort 1, at least 
6 subjects must have disease that is refractory to a PD-1 or PD-L1 monoclonal antibody. The 
other subjects enrolled to Cohort 1 will be checkpoint inhibitor naïve subjects (have never 
received pembrolizumab or any other anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, 
anti-OX40 or anti-CTLA-4 antibodies). The phase 2 portion (Cohort 2) of the study will enroll 
36 subjects who are checkpoint inhibitor naïve. 

Protocol Original 
ATA129-NPC-202, Date 09 AUG 2018 
Confidential
tabelecleucel 
Page 33 of 98
 
 
Atara Biotherapeutics, Inc. 
The information contained in this document cannot be used for any other purpose without prior written consent. 
 
 
4.2 
Eligibility Criteria 
Subjects must undergo a tabelecleucel inventory check to ensure availability of an appropriately 
matched and restricted tabelecleucel cell product prior to undergoing screening procedures. 
The inventory check includes collection of the subject’s high-resolution HLA typing 
(DNA-based versus serologic assessment) and weight. 
Investigators may submit de-identified information (ie, historically available high-resolution 
HLA typing and current weight) for potential subjects being referred from outside institutions (as 
long as the referring physician has documented in the potential subject’s chart that s/he was 
notified that their data was being sent through a study investigator to Atara Biotherapeutics, Inc. 
and that the potential subject consented for this to be done). This de-identified information will 
be used to determine whether an appropriately HLA-matched product is available to warrant a 
referral to the study site for potential study participation. 
4.2.1 
Inclusion Criteria 
A subject will be considered eligible to participate in this study if all of the following inclusion 
criteria are satisfied: 
1. Male or female  12 years of age 
2. Incurable, locally recurrent or metastatic NPC (World Health Organization type II/III) in 
whom the EBV nucleic acid or antigens have been demonstrated in tissue biopsy samples 
3. Subjects must have had prior receipt of platinum-containing regimen, either: 
a. For the treatment of recurrent or metastatic disease, or 
b. Experienced progression of disease within 6 months following completion of a 
platinum-based combination therapy as part of (neo)adjuvant chemotherapy. Note: 
Patients who had only concurrent chemoradiation therapy without (neo)adjuvant 
therapy and then recurred/metastasized must have progressed on at least 1 
platinum-containing regimen for their recurrent/metastatic disease before study entry. 
4. Phase 1B (Cohort 1): 
a. Checkpoint inhibitor naïve (have never received pembrolizumab or any other 
anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-OX40 or anti-CTLA-4 
antibodies) 
OR 
b. Refractory to an anti-PD-1 or anti-PD-L1 monoclonal antibody approved by the local 
regulatory agency either as monotherapy or in combination with other checkpoint 
inhibitors or therapies according to their approved label. To be considered refractory 
to an anti-PD-1 or anti-PD-L1 monoclonal antibody, all of the following criteria must 
be met:  
i. Received at least 2 doses of anti-PD-1 or anti-PD-L1 monoclonal antibody at a 
local regulatory agency-approved dose and schedule. 

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CCI

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System 
Laboratory Value 
Hepatic 
 
 
TBILI 
≤ 1.5x ULN OR 
Direct bilirubin ≤ ULN for subjects with TBILI > 1.5 x ULN 
 
AST (SGOT) and ALT (SGPT) 
≤ 2.5 x ULN  
≤ 5 x ULN for subjects with liver metastases 
Coagulation 
 
 
INR or PT 
 
aPTT 
≤ 1.5 x ULN unless subject is receiving anticoagulant therapy as 
long as PT or aPTT is within therapeutic range of intended use of 
anticoagulants 
ANC: absolute neutrophil count; aPTT: activated partial thromboplastin time; ALT (SGPT): alanine 
aminotransferase (serum glutamic pyruvic transaminase), AST (SGOT): aspartate aminotransferase (serum 
glutamic oxaloacetic transaminase), GFR: glomerular filtration rate, INR: international normalized ratio; 
PT: prothrombin time; TBILI: total bilirubin; ULN: upper limit of normal. 
a  
Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) 
transfusion within last 2 weeks. 
b  
Creatinine clearance should be calculated per institutional standard. 
 
12. Willing and able to provide written informed consent (pediatric subjects 12 to < 18 years 
of age must provide assent along with consent from the subject’s legally authorized 
representative) 
4.2.2 
Exclusion Criteria 
A subject will not be eligible to participate in the study if any of the following criteria are met: 
1. Disease that is suitable for local therapy administered with curative intent 
2. Receives vasopressor or ventilator support 
3. Received antithymocyte globulin or similar anti-T cell antibody therapy ≤ 4 weeks prior 
to Cycle 1 Day 1 
4. Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other 
form of immunosuppressive therapy within 7 days prior to Cycle 1 Day 1of study 
treatment. The use of physiologic doses of corticosteroids may be approved after 
consultation with the sponsor’s medical monitor. 
5. Active autoimmune disease that has required systemic treatment in past 2 years (ie, with 
use of disease modifying agents, corticosteroids or immunosuppressive drugs). 
Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement 
therapy for adrenal or pituitary insufficiency) is not considered a form of systemic 
treatment and is allowed. 
6. History or evidence of interstitial lung disease 
7. History of severe hypersensitivity (Grade ≥ 3) to pembrolizumab and/or any of its 
excipients 
8. Active infection requiring systemic therapy 

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9. History of (non-infectious) pneumonitis that required steroids or current pneumonitis 
10. Received transfusion of blood products (including platelets or red blood cells) or 
administration of colony stimulating factors (including granulocyte-colony stimulating 
factor, granulocyte macrophage-colony stimulating factor or recombinant erythropoietin) 
within 4 weeks prior to study Day 1 
11. Unresolved immunotherapy-related AEs or treatment for these events within 4 weeks 
prior to enrollment 
12. History of severe immunotherapy-related adverse effects (Common Terminology Criteria 
for Adverse Events [CTCAE] grade 4 or CTCAE grade 3 requiring treatment > 4 weeks) 
13. Received any non-oncology vaccine therapy used for prevention of infectious diseases 
for up to 30 days prior to enrollment. Examples include, but are not limited to: measures, 
mumps, rubella, chicken pox, yellow fever, rabies, bacille Calmette-Guerin, and typhoid 
vaccine. Seasonal flu vaccines that do not contain live virus are acceptable. 
14. Known additional malignancy that is progressing or requires active treatment. Exceptions 
include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has 
undergone potentially curative therapy or in situ cervical cancer. 
15. Pregnancy or breastfeeding; females of childbearing potential must have a negative 
serum pregnancy test. The serum pregnancy must be confirmed negative within 72 hours 
of Cycle 1 Day 1 (first dose of investigational product) for the subject to be eligible. 
16. Female of childbearing potential or male with a female partner of childbearing potential 
unwilling to use a highly effective method of contraception (abstinence is acceptable) for 
the course of the study through 120 days after the last study dose. 
17. Inability to comply with study procedures 
18. Received chemotherapy or targeted small molecule therapy within 2 weeks of Cycle 1 
Day 1. Subjects must have recovered (ie, grade ≤ 1 or at baseline) from AEs due to a 
previously administered agent. Subjects with grade ≤ 2 neuropathy or grade ≤ 2 alopecia 
are an exception to this criterion. 
19. Received prior radiotherapy within 2 weeks of Cycle 1 Day 1. Subjects must have 
recovered from all radiation-related toxicities, not require corticosteroids, and not have 
had radiation pneumonitis. A 1-week washout is permitted for palliative radiation 
(≤ 2 weeks of radiotherapy) to non-central nervous system (CNS) disease. 
20. Antibody/biologic therapy within 4 weeks of Cycle 1 Day 1 or not recovered (ie, grade 
≤ 1 or at baseline) from AEs due to agents administered more than 4 weeks earlier 
21. Carcinomatous meningitis and/or active CNS metastases, unless metastases are treated 
and stable and the subject does not require systemic steroids NOTE: Subjects with 
previously treated brain metastases may participate provided they are stable (without 
evidence of progression by imaging [using the identical imaging modality for each 
assessment, either magnetic resonance imaging (MRI) or computed tomography (CT) 
scan] for at least four weeks prior to the first dose of investigational product and any 
neurologic symptoms have returned to baseline), have no evidence of new or enlarging 

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brain metastases, and are not using steroids for at least 7 days prior to first dose of 
investigational product. This exception does not include carcinomatous meningitis which 
is excluded regardless of clinical stability. 
22. History or current evidence of any condition, therapy, or laboratory abnormality that 
might confound the results of the study, interfere with the subject’s participation for the 
full duration of the study, or is not in the best interest of the subject to participate, in the 
opinion of the treating investigator 
23. Known psychiatric or substance abuse disorders that would interfere with cooperation 
with the requirements of the study 
24. Known history of human immunodeficiency virus (HIV), known active hepatitis B virus 
(HBV; eg, hepatitis B surface antigen [HBsAg] reactive), or hepatitis C virus (HCV; eg, 
HCV ribonucleic acid [RNA] is detected) 
25. Prior treatment with any investigational product within 4 weeks of Cycle 1 Day 1 
26. Prior treatment with EBV T cells 
4.3 
Contraception 
Tabelecleucel and pembrolizumab may have adverse effects on a fetus in utero. Furthermore, it 
is not known if these investigational products have transient adverse effects on the composition 
of sperm. 
Females of childbearing potential and males with a female partner of childbearing potential must 
be willing to use a highly effective method of contraception. 
In order to participate in the study, subjects of childbearing potential must adhere to the 
contraception requirement (described above) from the day of investigational product initiation 
(or 14 days prior to the initiation of investigational product for oral contraception) throughout the 
study period up to 120 days after the last dose of investigational product. If there is any question 
that a subject of childbearing potential will not reliably comply with the requirements for 
contraception, that subject should not be entered into the study. 
4.4 
Nursing Women 
It is unknown whether tabelecleucel and pembrolizumab is excreted in human milk. Since many 
drugs are excreted in human milk, and because of the potential for serious adverse reactions in 
the nursing infant, subjects who are breastfeeding are not eligible for enrollment. 
4.5 
Meals and Dietary Restrictions 
Subjects should maintain a normal diet unless modifications are required to manage an adverse 
event (AE) such as diarrhea, nausea or vomiting. 

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4.6 
Subject Withdrawal Criteria 
A subject may withdraw either from (1) investigational product treatment only, in which case the 
subject will continue protocol defined follow-up assessments or (2) study participation, in which 
case investigational product and study assessments will be discontinued. Whenever possible, 
continue protocol-defined follow-up after the subject has discontinued investigational product 
treatment (refer to Section 6.7). 
Investigational product treatment may be discontinued for any of the following reasons: 
 Occurrence of an AE that precludes further treatment, refer to Section 5.2.5 
 Achieves a sustained CR, refer to Section 5.2.4 
 Receives a prohibited treatment, such as use of a different investigational product or 
non-protocol anti-NPC therapy 
 Decision (by subject or investigator) that continued investigational product treatment is 
not in the subject’s best interest 
Study participation may be discontinued for any of the following reasons: 
 Withdrawal of consent by subject or subject’s legally authorized representative  
 Early closure of the study by the sponsor 
 Subject is lost to follow-up  
4.7 
Subject Replacement 
Subjects who discontinue due to a DLT after receiving both pembrolizumab and tabelecleucel 
during the 21-day DLT assessment window will not be replaced; however, subjects who 
discontinue due to a DLT associated with the first infusion of pembrolizumab (ie, prior to any 
tabelecleucel infusion) will be replaced. Subjects who discontinue from Cohort 1 for any reason 
other than a DLT prior to completing the 21-day DLT assessment window will be replaced until 
the required number of evaluable subjects complete the 21-day DLT assessment window. 
Subjects will not be replaced in Cohort 2. 
5 TREATMENT WITH INVESTIGATIONAL PRODUCT 
5.1 
Description of Investigational Products 
The treatments to be used in this study are outlined below in Table 4.  
 

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Table 4 
Investigational Products 
Investigational 
Product Name 
Dosage 
Formulation 
Unit Dose 
Strength(s) 
Dosage Level(s) 
Route of 
Administration 
Sourcing 
Pembrolizumab  
Solution for 
infusion 
100 mg/vial 
200 mg Q3W  
(adults, ≥ 18 years) 
2 mg/kg Q3W 
(children, 12 to < 18 years) 
IV infusion 
Merck 
Tabelecleucel 
Sterile aqueous 
suspension 
Up to 5×107 
cells/mL 
1 or 2 × 106 cells/kg  
IV infusion 
Atara 
 
5.1.1 
Formulation 
Tabelecleucel is formulated as a sterile aqueous suspension intended for IV administration. The 
product contains 10% dimethyl sulfoxide, 15% human serum albumin, and buffered saline. 
Pembrolizumab is provided as a sterile solution of 100 mg in 4 mL (25 mg/mL). 
Refer to the Investigational Product Manual for details of dose preparation. 
5.1.2 
Packaging and Labeling 
Tabelecleucel is supplied in single-use vials. 
Pembrolizumab is supplied in a single-use vial for IV infusion. 
5.1.3 
Storage and Handling 
Tabelecleucel will be shipped to study sites where it will be stored in a liquid nitrogen-charged 
canister until ready for dose preparation. To prepare the product for infusion, the frozen vial is to 
be thawed and the dose prepared as specified in the Investigational Product Manual. Once 
thawed, the product must be used immediately; the unused portion must not be refrozen or 
reused and must be discarded. The thawed product is to be handled or transported at ambient 
room temperature. 
Pembrolizumab should be stored refrigerated at 2° to 8°C (36° to 46°F) and should not be 
frozen or shaken. Protect from light. 
Refer to the Investigational Product Manual for detailed instructions for storage and handling of 
the products. 
5.2 
Administration of Investigational Products 
A treatment/consolidation cycle in the Treatment Phase of the study will last 3 weeks (21 days) 
and consist of 1 dose of pembrolizumab administered on Day 1 and 3 doses of tabelecleucel 
administered on Day 1, Day 8 (± 2), and Day 15 (± 2) of each cycle; pembrolizumab will be 
administered approximately 1 hour before tabelecleucel. 

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During the Maintenance Phase of the study, a maintenance cycle will last 84 days. Subjects will 
receive pembrolizumab on Day 1, Day 21 (± 2), Day 42 (± 2), and Day 63 (±2) and tabelecleucel 
on Day 1 of each 84-day cycle; pembrolizumab will be administered approximately 1 hour 
before tabelecleucel. 
Pembrolizumab: Pembrolizumab will be administered using IV infusion on Day 1 of the 21-day 
treatment/consolidation cycle after all procedures and assessments have been completed (except 
vital signs, which will be measured before and after all investigational product infusions). 
Pembrolizumab will be administered as a dose of 200 mg (adults ≥ 18 years of age) or 2 mg/kg 
(children 12 to < 18 years of age) using a 30-minute IV infusion. Investigators should make 
every effort to target infusion timing to be as close to 30 minutes as possible. However, given the 
variability of infusion pumps from study site to site, a window between -5 minutes and 
+10 minutes is permitted, ie, infusion time is 30 minutes (-5 min/+10 min). 
The Pharmacy Manual contains specific instructions for the preparation of the pembrolizumab 
infusion and administration of infusion solution. 
Tabelecleucel: Tabelecleucel will be selected for each subject from the bank of available 
tabelecleucel cell products based on matching ≥ 2 HLA alleles, at least one of which is a 
restricting HLA allele, shared between the tabelecleucel source material (donor) and the subject.  
Tabelecleucel will be administered via a slow IV push over 5 to 10 minutes at a dose of 
2 × 106 cells/kg body weight (the Cohort 1 de-escalation dose is 1.0 × 106 cells/kg) after all 
procedures and assessments have been completed (except vital signs, which will be measured 
before and after all investigational product infusions). 
5.2.1 
Timing of Dose Administration 
On the study days in which both investigational products are administered (ie, Day 1 of 
treatment/consolidation cycles and Day 1 of maintenance cycles), tabelecleucel will be 
administered 1 hour (± 10 minutes) after the completion of pembrolizumab. 
Note: Dosing interruptions are permitted in the case of medical/surgical events or logistical 
reasons (ie, elective surgery, unrelated medical events, subject vacation, holidays) not related to 
the administration of investigation product. Subjects should be placed back on the treatment 
schedule within 3 weeks of the scheduled interruption, unless otherwise discussed with the 
sponsor’s medical monitor. The reason for dose interruption should be documented in the 
subject's study record. 
5.2.2 
Duration of Treatment and Subject Participation 
The duration of treatment is dependent on a subject’s response to treatment and is estimated to be 
approximately 2 years for subjects with a response to treatment (CR, PR, or SD): a maximum of 
4 treatment/consolidation cycles (21-day cycles of 3 infusions of tabelecleucel and 1 of 
pembrolizumab) and maintenance cycles (84-day cycles of 4 infusions of pembrolizumab and 

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1 of tabelecleucel) until up to a total of 35 pembrolizumab infusions (including for treatment, 
consolidation, and maintenance) have been given. 
After treatment/consolidation and maintenance cycles, subjects will have an End-of-Treatment 
visit (30 days after the last dose of investigational product) and then enter Quarterly Follow-up 
for 12 months after the last dose of investigational product. Before receiving any treatment, 
subjects must undergo a tabelecleucel inventory check and screening, with screening up to 
28 days prior to the first dose of investigational product.  
5.2.3 
Definition of Dose-limiting Toxicity 
All toxicities will be graded based on the investigator’s assessment using CTCAE version 5, 
except for certain events described in Section 8.3, which have a separate grading system. 
The DLT window of observation will be during Treatment Cycle 1 only (ie, during the first 
21-day cycle; adverse events (AEs) meeting the definition of a DLT but occurring after this 
period will not be considered DLTs). 
The occurrence of any of the following toxicities during Treatment Cycle 1 will be considered a 
DLT, if assessed by the investigator to be possibly related or related to investigational product 
administration (either tabelecleucel and/or pembrolizumab), excluding toxicities clearly not 
related to the investigational product, such as disease progression, environmental factors, 
unrelated trauma, etc.:  
 Grade 4 nonhematologic toxicity (not laboratory). 
 Grade 4 hematologic toxicity lasting ≥7 days, except thrombocytopenia: 
 Grade 4 thrombocytopenia of any duration 
 Grade 3 thrombocytopenia associated with bleeding that requires a platelet 
transfusion 
 Any nonhematologic AE grade ≥ 3 in severity should be considered a DLT, with the 
following exceptions: grade 3 fatigue lasting ≤ 3 days; grade 3 diarrhea, nausea, or 
vomiting without use of anti-emetics or anti-diarrheals per standard of care; grade 3 rash 
without use of corticosteroids or anti-inflammatory agents per standard of care. 
 Any grade 3 or grade 4 non-hematologic laboratory value if: 
 Clinically significant medical intervention is required to treat the subject, or 
 The abnormality leads to hospitalization, or 
 The abnormality persists for > 1 week. 
 The abnormality results in a Drug-induced Liver Injury (DILI)  
 Exceptions: Clinically nonsignificant, treatable, or reversible laboratory abnormalities 
including liver function tests, uric acid, etc. 

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 Febrile neutropenia grade 3 or grade 4: 
 Grade 3 is defined as ANC < 1000/mm3 with a single temperature of 
> 38.3 degrees C (101 degrees F) or a sustained temperature of ≥ 38 degrees C 
(100.4 degrees F) for more than 1 hour 
 Grade 4 is defined as ANC < 1000/mm3 with a single temperature of > 38.3 degrees 
C (101 degrees F) or a sustained temperature of ≥ 38 degrees C (100.4 degrees F) for 
more than 1 hour, with life-threatening consequences and urgent intervention 
indicated. 
 Prolonged delay (> 2 weeks) in initiating Cycle 2 due to treatment-related toxicity. 
 Any treatment-related toxicity that causes the subject to discontinue treatment during 
Cycle 1. 
 Missing > 25% of pembrolizumab or tabelecleucel doses as a result of investigational 
product-related AE(s) during the first cycle. 
 Grade 5 toxicity. 
Any subject experiencing any DLT will be withdrawn from treatment (both investigational 
products). Whenever possible, protocol-defined follow-up will be continued after the subject has 
discontinued investigational product treatment (refer to Section 6.7). 
MTD definition: The MTD is defined as the highest dose level at which the subject incidence of 
a DLTs during the first 21-day cycle of investigational product dosing is < 33%. 
RP2D definition: The RP2D is no higher than the MTD and is based on optimal benefit-risk, as 
determined by the SDRC. 
5.2.4 
Discontinuation of Treatment with Investigational Products after 
Complete Response 
Discontinuation of treatment may be considered for subjects who have attained a confirmed CR 
that have been treated for at least 6 weeks with tabelecleucel and 24 weeks with pembrolizumab 
and had at least 2 treatments with pembrolizumab and 1 cycle tabelecleucel beyond the date 
when the initial CR was observed.  
While subjects achieving a CR may discontinue treatment, they will not be considered to have 
discontinued the study unless consent is withdrawn. If study consent is not withdrawn the subject 
will complete an End-of-Treatment visit and enter in the Quarterly Follow-up Phase of the study. 
5.2.5 
Dose Modifications 
5.2.5.1 
Dose Modification and Toxicity Management for Immune-related AEs 
associated with Pembrolizumab 
AEs associated with pembrolizumab exposure may represent an immunologic etiology. These 
immune-related AEs (irAEs) may occur shortly after the first dose or several months after the 

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last dose of pembrolizumab treatment and may affect more than one body system 
simultaneously. Therefore, early recognition and initiation of treatment is critical to reduce 
complications. Based on existing clinical study data, most irAEs were reversible and could be 
managed with interruptions of pembrolizumab, administration of corticosteroids and/or other 
supportive care. For suspected irAEs, ensure adequate evaluation to confirm etiology or exclude 
other causes. Additional procedures or tests such as bronchoscopy, endoscopy, skin biopsy may 
be included as part of the evaluation. Based on the severity of irAEs, withhold or permanently 
discontinue pembrolizumab and administer corticosteroids. Dose modification and toxicity 
management guidelines for irAEs associated with pembrolizumab are provided in Table 5, and 
refer to the approved label. See Section 5.3.1.1 for supportive care guidelines, including use of 
corticosteroids. 
Table 5 
Dose Modification and Toxicity Management Guidelines for 
Immune-related Adverse Events Associated with Pembrolizumab 
General instructions: 
Corticosteroid taper should be initiated upon AE improving to Grade 1 or less and continue to taper over at least 
4 weeks. 
For situations where pembrolizumab has been withheld, pembrolizumab can be resumed after AE has been reduced 
to Grade 1 or 0 and corticosteroid has been tapered. Pembrolizumab should be permanently discontinued if AE does 
not resolve within 12 weeks of last dose or corticosteroids cannot be reduced to ≤ 10 mg prednisone or equivalent 
per day within 12 weeks.  
For severe and life-threatening irAEs, IV corticosteroid should be initiated first followed by oral steroid. Other 
immunosuppressive treatment should be initiated if irAEs cannot be controlled by corticosteroids. 
irAEs 
Toxicity 
grade or 
conditions  
Action taken to 
pembrolizumaba 
irAE management 
with corticosteroid 
and/or other 
therapies  
Monitor and follow-up  
Pneumonitis  
Grade 2 
Withhold  
Administer 
corticosteroids 
(initial dose of 
1-2 mg/kg 
prednisone or 
equivalent) followed 
by taper 
Monitor subjects for signs and 
symptoms of pneumonitis 
Evaluate subjects with 
suspected pneumonitis with 
radiographic imaging and 
initiate corticosteroid 
treatment 
Add prophylactic antibiotics 
for opportunistic infections 
Grade 3 or 4, 
or recurrent 
Grade 2 
Permanently 
discontinue 
Diarrhea / Colitis  Grade 2 or 3 
Withhold 

Protocol Original 
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Confidential
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irAEs 
Toxicity 
grade or 
conditions  
Action taken to 
pembrolizumaba 
irAE management 
with corticosteroid 
and/or other 
therapies  
Monitor and follow-up  
Grade 4 
Permanently 
discontinue 
Administer 
corticosteroids 
(initial dose of 
1-2 mg/kg 
prednisone or 
equivalent) followed 
by taper 
Monitor subjects for signs and 
symptoms of enterocolitis (ie, 
diarrhea, abdominal pain, 
blood or mucus in stool with 
or without fever) and of bowel 
perforation (ie, peritoneal 
signs and ileus). 
Subjects with Grade ≥ 2 
diarrhea suspecting colitis 
should consider GI 
consultation and performing 
endoscopy to rule out colitis.  
Subjects with diarrhea/colitis 
should be advised to drink 
liberal quantities of clear 
fluids. If sufficient oral fluid 
intake is not feasible, fluid and 
electrolytes should be 
substituted via IV infusion. 
AST / ALT 
elevation or 
Increased TBILI 
Grade 2 
Withhold 
Administer 
corticosteroids 
(initial dose of 
0.5-1 mg/kg 
prednisone or 
equivalent) followed 
by taper 
Monitor with liver function 
tests (consider weekly or more 
frequently until liver enzyme 
value returned to baseline or is 
stable 
Grade 3 or 4  
Permanently 
discontinue 
Administer 
corticosteroids 
(initial dose of 
1-2 mg/kg 
prednisone or 
equivalent) followed 
by taper 
Type 1 diabetes 
mellitus (T1DM) 
or 
Hyperglycemia 
 
Newly onset 
T1DM or  
Grade 3 or 4 
hyperglycemia 
associated 
with evidence 
of -cell 
failure 
Withhold 
Initiate insulin 
replacement therapy 
for subjects with 
T1DM  
Administer anti-
hyperglycemic in 
subjects with 
hyperglycemia  
Monitor subjects for 
hyperglycemia or other signs 
and symptoms of diabetes. 
Hypophysitis 
Grade 2 
Withhold 

Protocol Original 
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Confidential
tabelecleucel 
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irAEs 
Toxicity 
grade or 
conditions  
Action taken to 
pembrolizumaba 
irAE management 
with corticosteroid 
and/or other 
therapies  
Monitor and follow-up  
Grade 3 or 4  
Withhold or 
permanently 
discontinue 
Administer 
corticosteroids and 
initiate hormonal 
replacements as 
clinically indicated.  
Monitor for signs and 
symptoms of hypophysitis 
(including hypopituitarism 
and adrenal insufficiency)  
Hyperthyroidism  Grade 2 
Continue  
Treat with non-
selective beta-
blockers (eg, 
propranolol) or 
thionamides as 
appropriate  
Monitor for signs and 
symptoms of thyroid 
disorders.  
Grade 3 or 4  
Withhold or 
permanently 
discontinue 
Hypothyroidism 
Grade 2-4 
Continue  
Initiate thyroid 
replacement 
hormones (eg, 
levothyroxine or 
liothyroinine) per 
standard of care 
Monitor for signs and 
symptoms of thyroid 
disorders.  
Nephritis and 
Renal 
dysfunction 
Grade 2 
Withhold  
Administer 
corticosteroids 
(prednisone 
1-2 mg/kg or 
equivalent) followed 
by taper. 
Monitor changes of renal 
function 
Grade 3 or 4  
Permanently 
discontinue 
Myocarditis 
Grade 1 or 2 
Withhold 
Based on severity of 
AE administer 
corticosteroids 
Ensure adequate evaluation to 
confirm etiology and/or 
exclude other causes 
Grade 3 or 4 
Permanently 
discontinue 
All other irAEs 
Intolerable/ 
persistent 
Grade 2 
Withhold 
Based on type and 
severity of AE 
administer 
corticosteroids  
Ensure adequate evaluation to 
confirm etiology and/or 
exclude other causes 
Grade 3 
Withhold or 
discontinue based 
on the type of 
event. Events that 
require 
discontinuation 
include and not 
limited to: 
Guillain-Barre 
Syndrome, 
encephalitis 
Grade 4 or 
recurrent 
Grade 3  
Permanently 
discontinue 

Protocol Original 
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Confidential
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irAEs 
Toxicity 
grade or 
conditions  
Action taken to 
pembrolizumaba 
irAE management 
with corticosteroid 
and/or other 
therapies  
Monitor and follow-up  
Abbreviations: AE: adverse event; ALT: alanine aminotransferase; AST: aspartate aminotransferase; irAE: 
immune-related AE; IV: intravenous(ly); T1DM: type 1 diabetes mellitus; TBILI: total bilirubin. 
NOTE: For subjects with Grade 3 or Grade 4 immune-related endocrinopathy where withhold of pembrolizumab 
is required, pembrolizumab may be resumed when AE resolves to grade ≤ 2 and is controlled with hormonal 
replacement therapy or achieved metabolic control (in case of T1DM).  
a   
Withhold or permanently discontinue pembrolizumab is at the discretion of the investigator or treating 
physician.  
 
5.2.5.2 
Dose modification and Toxicity Management of Infusion Reactions 
Related to Pembrolizumab 
Pembrolizumab may cause severe or life-threatening infusion reactions including severe 
hypersensitivity or anaphylaxis. Signs and symptoms usually develop during or shortly after drug 
infusion and generally resolve completely within 24 hours of completion of infusion. Dose 
modification and toxicity management guidelines on pembrolizumab associated infusion 
reactions are provided in Table 6. 
 
Table 6 
Pembrolizumab Infusion Reactions Dose modification and 
Treatment Guidelines 
CTCAE Grade 
Treatment 
Premedication at 
Subsequent Dosing 
Grade 1 
Mild reaction; infusion 
interruption not 
indicated; intervention 
not indicated 
Increase monitoring of vital signs as medically indicated until 
the subject is deemed medically stable in the opinion of the 
investigator. 
None 
Grade 2 
Requires therapy or 
infusion interruption 
but responds promptly 
to symptomatic 
treatment (eg, 
antihistamines, 
NSAIDs, narcotics, IV 
fluids); prophylactic 
medications indicated 
for ≤ 24 hrs. 
Stop Infusion. 
Additional appropriate medical therapy may include but is not 
limited to: 
IV fluids 
Antihistamines 
NSAIDs 
Acetaminophen 
Narcotics 
Increase monitoring of vital signs as medically indicated until 
the subject is deemed medically stable in the opinion of the 
investigator. 
Subject may be 
premedicated 
1.5 hours 
(± 30 minutes) prior 
to infusion of 
pembrolizumab with: 
Diphenhydramine 
50 mg PO (or 
equivalent dose of 
antihistamine). 
Acetaminophen 500 
to 1000 mg PO (or 
equivalent dose of 
analgesic). 

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Table 6 
Pembrolizumab Infusion Reactions Dose modification and 
Treatment Guidelines 
CTCAE Grade 
Treatment 
Premedication at 
Subsequent Dosing 
If symptoms resolve within 1 hour of stopping drug infusion, 
the infusion may be restarted at 50% of the original infusion 
rate (eg, from 100 mL/hour to 50 mL/hour). Otherwise dosing 
will be held until symptoms resolve and the subject should be 
premedicated for the next scheduled dose. 
Subjects who develop Grade 2 toxicity despite adequate 
premedication should be permanently discontinued from 
further study drug treatment 
Grade 3 or Grade 4 
Grade 3: 
Prolonged (ie, not 
rapidly responsive to 
symptomatic 
medication and/or 
brief interruption of 
infusion); recurrence 
of symptoms 
following initial 
improvement; 
hospitalization 
indicated for other 
clinical sequelae (eg, 
renal impairment, 
pulmonary infiltrates) 
Grade 4: 
Life-threatening; 
pressor or ventilator 
support indicated 
Stop Infusion. 
Additional appropriate medical therapy may include but is not 
limited to: 
Epinephrine** 
IV fluids 
Antihistamines 
NSAIDs 
Acetaminophen 
Narcotics 
Oxygen 
Pressors 
Corticosteroids 
Increase monitoring of vital signs as medically indicated until 
the subject is deemed medically stable in the opinion of the 
investigator. 
Hospitalization may be indicated. 
**In cases of anaphylaxis, epinephrine should be used 
immediately. 
Subject is permanently discontinued from further study drug 
treatment. 
No subsequent 
dosing 
Abbreviations: IV: intravenous(ly), NSAID: nonsteroidal anti-inflammatory drug, PO: per os/by mouth. 
Appropriate resuscitation equipment should be available at the bedside and a physician readily available during 
the period of drug administration. For further information, please refer to CTCAE version 5. 
 
5.2.5.3 
Other Allowed Dose Interruption for Pembrolizumab  
Pembrolizumab may be interrupted for situations other than treatment emergent related AEs such 
as medical / surgical events or logistical reasons not related to study therapy. Subjects should be 
placed back on study therapy within 3 weeks of the scheduled interruption, unless otherwise 
discussed with the sponsor’s medical monitor. The reason for dose interruption should be 
documented in the subject's study record.  

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5.2.5.4 
Dose Modification for Tabelecleucel 
If ≥ 2 of the initial 6, or ≥ 4 of the initial 12 Cohort 1 subjects experience a DLT in the first 
21 days, the dose of tabelecleucel will be reduced to 1 x 106 cells/kg/dose, and the subsequent 
12 subjects will be treated with the combination of tabelecleucel at 1 x 106 cells/kg/dose and 
pembrolizumab at the recommended dose level. Otherwise, all 12 subjects in Cohort 1 will 
receive tabelecleucel at 2 x 106 cells/kg/dose and pembrolizumab at the recommended dose level. 
An SDRC composed of representatives from the sponsor and the principal investigators or 
designated sub-investigators from all sites enrolling subjects in Cohort 1 will review reported 
DLTs and cumulative safety data to determine further enrollment. The data review will occur as 
soon as possible after Cycle 1 Day 21 of the last subject in Cohort 1. For additional details on 
dose stopping rules (refer to Section 3.3 for additional details). 
5.2.5.5 
Discontinuation of One Investigational Product 
Upon approval by the medical monitor, a subject may continue to receive 1 investigational 
product if the other is withheld or discontinued for any reason other than due to a DLT observed 
during the first 21 days of combination treatment.  
5.3 
Prior and Concomitant Medications/Therapies 
5.3.1 
Permitted Medications/Therapies 
All treatments that the investigator considers necessary for a subject’s welfare may be 
administered at the discretion of the investigator in keeping with the community standards of 
medical care; however, refer to prohibited medications and therapies in Section 5.3.1.1. All 
concomitant medication will be recorded, including all prescription, over-the-counter, herbal 
supplements, and IV medications and fluids. If changes occur during the study period, 
documentation of drug dosage, frequency, route, and date should also be recorded. 
The investigator or qualified designee will review prior medication use, including any 
protocol-specified washout requirement, and record prior medication taken by the subject within 
30 days before the first dose of investigational product and 30 days after the last dose of 
investigational product should be recorded. Concomitant medications administered after 30 days 
after the last dose of investigational product should be recorded if related to any serious AEs 
(SAEs) and AEs of special interest as defined in Section 8.2. 
5.3.1.1 
Rescue Medications and Supportive Care  
Subjects should receive appropriate supportive care measures as deemed necessary by the 
investigator. Suggested supportive care measures for the management of AEs with potential 
immunologic etiology are outlined along with the dose modification guidelines in Section 5.2.5 
(Table 5). Where appropriate, these guidelines include the use of oral or intravenous treatment 
with corticosteroids, as well as additional anti-inflammatory agents if symptoms do not improve 
with administration of corticosteroids. Note that several courses of steroid tapering may be 
necessary as symptoms may worsen when the steroid dose is decreased. For each disorder, 
attempts should be made to rule out other causes such as metastatic disease or bacterial or viral 

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infection, which might require additional supportive care. The treatment guidelines are intended 
to be applied when the investigator determines the events to be related to pembrolizumab.  
If a pembrolizumab-related toxicity requires > 0.5 mg/kg of prednisone equivalent, then 
tabelecleucel should be held until the steroids are tapered to below 0.5 mg/kg. 
Note: If after the evaluation the event is determined not to be related to pembrolizumab, the 
investigator does not need to follow the treatment guidance (as outlined below). Refer to Table 5 
in Section 5.2.5 for guidelines regarding dose modification and supportive care. 
It may be necessary to perform conditional procedures such as bronchoscopy, endoscopy, or skin 
photography as part of evaluation of the event. 
5.3.2 
Prohibited Medications/Therapies 
Medications or vaccinations specifically prohibited in the exclusion criteria (Section 4.2.2) are 
not allowed during the ongoing study. If there is a clinical indication for any medication or 
vaccination specifically prohibited during the study, discontinuation from study therapy or 
vaccination may be required. The investigator should discuss any questions regarding this with 
the sponsor’s medical monitor. The final decision on any supportive therapy or vaccination rests 
with the investigator and/or the subject's primary physician. However, the decision to continue 
the subject on study therapy requires the mutual agreement of the investigator, the sponsor, and 
the subject. 
Listed below are specific restrictions for concomitant therapy or vaccination during the course of 
the study: 
 Antineoplastic systemic chemotherapy or biological therapy  
 Immunotherapy not specified in this protocol 
 Chemotherapy not specified in this protocol 
 Investigational products other than pembrolizumab or tabelecleucel 
 Radiation therapy  
 Note: Radiation therapy to a symptomatic solitary lesion or to the brain may be 
allowed at the investigator’s discretion 
 Live vaccines within 30 days prior to the first dose of investigational product and while 
participating in the study. Examples of live vaccines include, but are not limited to, the 
following: measles, mumps, rubella, varicella/zoster, yellow fever, rabies, bacille 
Calmette-Guerin, and typhoid vaccine. Seasonal influenza vaccines for injection are 
generally killed virus vaccines and are allowed. However, intranasal influenza vaccines 
(eg, Flu-Mist®) are live attenuated vaccines and are not allowed. 
 Systemic glucocorticoids for any purpose other than to modulate symptoms from an AE 
that is suspected to have an immunologic etiology. The use of physiologic doses of 
corticosteroids may be approved after consultation with the sponsor’s medical monitor. 

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 Note: Inhaled steroids are allowed for management of asthma. 
Subjects who, in the assessment of the investigator, require the use of any of the aforementioned 
treatments for clinical management should be removed from the study. All treatments that the 
investigator considers necessary for a subject’s welfare may be administered at the discretion of 
the investigator in keeping with the community standards of medical care.  
There are no prohibited therapies during Quarterly Follow-up Phase. 
6 STUDY PROCEDURES 
Study assessments and procedures are tabulated in Section 15.2.  
6.1 
Inventory Check 
Subjects must undergo a tabelecleucel inventory check to ensure availability of an appropriately 
matched and restricted tabelecleucel cell product prior to undergoing screening procedures. 
Within 5 to 10 days prior to screening, the following required assessments/procedures will be 
collected or performed after consent is signed: 
 Written informed consent by the subject or the subject’s legally authorized representative  
 High resolution HLA typing (HLA-A, -B, -C, -DRB1, -DQB1) of the subject  
 Cytomegalovirus (CMV) antibody status (local laboratory) 
 Demographics 
 Subject weight 
 AEs considered at least possibly related to study procedure(s) after first informed consent 
NOTE: 
Subjects with historical high-resolution HLA typing may submit their data for this 
inventory check as described in Section 4.2. 
6.2 
Screening 
Within 28 days prior to study enrollment (Cycle 1 Day 1), the following required 
assessments/procedures will be collected or performed after consent is signed, unless otherwise 
specified: 
 Written informed consent by the subject or the subject’s legally authorized representative  
 Verification that subject meets all inclusion and exclusion criteria 
 Complete medical history 
 Physical examination 
 Height and weight 

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Protocol Original 
ATA129-NPC-202, Date 09 AUG 2018 
Confidential
tabelecleucel 
Page 56 of 98
 
 
Atara Biotherapeutics, Inc. 
The information contained in this document cannot be used for any other purpose without prior written consent. 
 
 
 Radiographic assessments (including CT with contrast or MRI) as described in 
Section 7.1 
6.6 
Quarterly Follow-up 
Quarterly Follow-up will occur every 90 ± 14 days for 12 months after the last dose of 
investigational product (tabelecleucel and/or pembrolizumab) or until disease progression. The 
last Quarterly Follow-up Visit will be considered the end-of-study for the subject. The following 
assessments/procedures will be performed: 
 Radiographic assessments including CT with contrast or MRI for subjects with CR, PR, 
or SD who did not complete maintenance cycles until 35 infusions of pembrolizumab 
was given or until disease progression - as described in Section 7.1 
 Survival and disease status (ie, an investigator assessment based on clinical and 
radiographic assessments) 
 For AEs reporting, refer to Section 8.5 
6.7 
Early Withdrawal 
For subjects who discontinue early from treatment, consolidation, or maintenance, the reason for 
discontinuation should be provided and the End-of-Treatment visit should be performed. The 
subject will be entered into Quarterly Follow-up, unless consent is withdrawn, for 12 months 
after the last dose of investigational product (tabelecleucel and/or pembrolizumab). 
For a subject who discontinues early from quarterly follow-up, the reason for discontinuation 
should be provided and the last Quarterly Follow-up Visit will be considered the end-of-study for 
the subject. 
7 EFFICACY AND SAFETY ASSESSMENTS 
7.1 
Radiographic Tumor Assessments 
Local site study team reading (investigator assessment with site radiology reading) based on 
RECIST 1.1 and immune (i)RECIST will be used to determine subject eligibility and clinical 
treatment decisions during the course of the study. RECIST 1.1 will be adapted to account for the 
unique tumor response characteristics seen with treatment of pembrolizumab to immune 
iRECIST. Immunotherapeutic agents such as pembrolizumab may produce antitumor effects by 
potentiating endogenous cancer-specific immune responses. The response patterns seen with 
such an approach may extend beyond the typical time course of responses seen with cytotoxic 
agents and can manifest a clinical response after an initial increase in tumor burden or even the 
appearance of new lesions. Standard RECIST 1.1 may not provide an accurate response 
assessment of immunotherapeutic agents such as pembrolizumab. Therefore, RECIST 1.1 will be 
used with the adaptations described in Section 15.5. 
Disease progression will be based on radiographic measurements according RECIST 1.1 and 
iRECIST. For clinically stable subjects, if imaging shows progressive disease (unconfirmed 

Protocol Original 
ATA129-NPC-202, Date 09 AUG 2018 
Confidential
tabelecleucel 
Page 57 of 98
 
 
Atara Biotherapeutics, Inc. 
The information contained in this document cannot be used for any other purpose without prior written consent. 
 
 
progressive disease), it is at the discretion of the investigator to keep a subject on treatment with 
investigational product or to stop treatment with investigational product until repeat imaging is 
performed 4-6 weeks later in order to confirm progressive disease since T-cell infiltration of a 
tumor can cause the appearance of radiographic progression in subjects who subsequently 
respond [49]. Subjects who are deemed clinically unstable are not required to have repeat 
imaging for confirmation prior to stopping treatment. This decision will be based on clinical 
judgment of a subject's overall clinical condition, including performance status, clinical 
symptoms, and laboratory data, and in consultation with the sponsor’s medical monitor. 
When feasible, subjects should not be discontinued until progression is confirmed. This 
allowance to continue treatment despite initial radiologic progression takes into account the 
observation that some subjects can have a transient tumor flare in the first few months after the 
start of immunotherapy, but with subsequent disease response. 
7.1.1 
Rationale for Endpoints Related to RECIST 
The central radiology vendor will perform retrospective IRR of scans in support of primary and 
secondary study objectives. OS will be included as it is a standard assessment of clinical benefit 
in subjects with NPC. ORR and the duration of response by RECIST 1.1 criteria as assessed by 
IRR will serve as additional measures of efficacy. 
RECIST 1.1 will be used to determine the dates of progression as this methodology is accepted 
by regulatory authorities. Since the treatment assignment is unblinded, images read by a central 
imaging vendor blinded to treatment assignment (ie, IRR) can minimize bias in the response 
assessments. In addition, final determination of radiologic progression will be based on the 
central imaging vendor assessment of progression, rather than site study team assessment. 
7.1.2 
Tumor Imaging and Assessment of Disease 
The process for image collection and transmission to the central imaging vendor for IRR can be 
found in the Radiology Manual. Tumor imaging may be acquired by CT or MRI. For the 
abdomen and pelvis, contrast-enhanced MRI may be used when CT with iodinated contrast is 
contraindicated, or when mandated by local practice. The same imaging technique regarding 
modality, ideally the same scanner, and the use of contrast should be used in a subject throughout 
the study to optimize the reproducibility of the assessment of existing and new tumor burden and 
improve the accuracy of the assessment of response or progression based on imaging. Note: for 
the purposes of assessing tumor imaging, the term “investigator” refers to the investigator at the 
study site and/or the radiological reviewer located at the site or at an offsite facility. 
Imaging should include the chest, abdomen, pelvis, as well as the head and neck. Brain imaging 
is required for all subjects at screening. MRI is preferred; however, CT imaging will be 
acceptable, if MRI is medically contraindicated. 
Expedited confirmation of measurable disease based on RECIST 1.1 by IRR at screening will be 
used to determine subject eligibility. Confirmation by the central imaging vendor that the 
subject’s imaging shows at least 1 lesion that is appropriate for selection as a target lesion per 
RECIST 1.1 is required prior to subject treatment. 

Protocol Original 
ATA129-NPC-202, Date 09 AUG 2018 
Confidential
tabelecleucel 
Page 58 of 98
 
 
Atara Biotherapeutics, Inc. 
The information contained in this document cannot be used for any other purpose without prior written consent. 
 
 
All scheduled images for all study subjects from the study sites will be submitted to the central 
imaging vendor for IRR. In addition, images (including via other modalities) that are obtained at 
an unscheduled time point to determine disease progression, as well as imaging obtained for 
other reasons, but captures radiologic progression based on investigator assessment, should also 
be submitted to the central imaging vendor for IRR. 
7.1.2.1 
Initial Tumor Imaging 
Initial tumor imaging at screening must be performed prior to the date of the first dose of 
investigational product. The study site study team must review screening images to confirm the 
subject has measurable disease per RECIST 1.1. The screening images must be submitted to the 
IRR vendor for retrospective confirmation of measurable disease per RECIST 1.1 for eligibility 
prior to the date of the first dose of investigational product. Tumor imaging performed as part of 
routine clinical management is acceptable for use as screening tumor imaging if it is of 
diagnostic quality and can be assessed by the central imaging vendor.  
If brain imaging is performed to document the stability of existing metastases, MRI should be 
used if possible. If MRI is medically contraindicated, CT with contrast is an acceptable 
alternative. 
7.1.2.2 
Tumor Imaging During the Study 
The first on study imaging assessment should be performed after Treatment Cycle 2 Day 15 
between Days 16 to 21, and thereafter, after each treatment and consolidation cycle Day 15 
between Days 16 to 21. Subsequent tumor imaging should be performed during the Maintenance 
Phase on Day 77 (± 2 days) of each cycle, at the end-of-treatment (30 ± 5 days after the last dose 
of investigational product), and during the Quarterly follow-up phase (every 90 ± 14 days), or 
more frequently if clinically indicated. 
Objective response should be confirmed by a repeat imaging assessment. Tumor imaging to 
confirm an initial treatment response of PR or CR will occur during the subsequent consolidation 
cycle. 
Per iRECIST (Section 7.1.4), disease progression should be confirmed by the study 
site 4 to 8 weeks after site-assessed first radiologic evidence of progressive disease in clinically 
stable subjects. Subjects, who have unconfirmed disease progression may continue on treatment 
at the discretion of the investigator until progression is confirmed by the site, provided they have 
met the conditions detailed in Section 7.1.4. Subjects who receive confirmatory imaging do not 
need to undergo the next scheduled tumor imaging if it is less than 4 weeks later; tumor imaging 
may resume at the subsequent scheduled imaging time point, if clinically stable. Subjects, who 
have confirmed disease progression by iRECIST, as assessed by the study site, will discontinue 
treatment with investigational products. Exceptions are detailed in Section 7.1.4. 
7.1.2.3 
End-of-Treatment and Quarterly Follow-up Tumor Imaging 
For subjects who discontinue treatment with investigational products, tumor imaging should be 
performed at the End-of-Treatment Visit (30 ± 5 days after the last dose of investigational 

Protocol Original 
ATA129-NPC-202, Date 09 AUG 2018 
Confidential
tabelecleucel 
Page 59 of 98
 
 
Atara Biotherapeutics, Inc. 
The information contained in this document cannot be used for any other purpose without prior written consent. 
 
 
product). If previous imaging was obtained within 4 weeks prior to the date of discontinuation, 
then imaging at treatment discontinuation is not mandatory. For subjects who discontinue both 
investigational products due to documented disease progression, this is the final required tumor 
imaging if the investigator elects not to implement iRECIST. 
For subjects who discontinue study treatment without documented disease progression, every 
effort should be made to continue monitoring disease status by tumor imaging using the same 
imaging schedule used while on treatment until the start of a new anticancer treatment, disease 
progression, pregnancy, death, withdrawal of consent, or the end of the study, whichever occurs 
first. 
7.1.3 
RECIST 1.1 Assessment of Disease 
RECIST 1.1 will be used by IRR as the primary measure for assessment of tumor response, date 
of disease progression, and as a basis for all protocol guidelines related to disease status (e.g., 
discontinuation of study treatment). Although RECIST 1.1 references a maximum of 5 target 
lesions in total and 2 per organ, this protocol allows a maximum of 10 target lesions in total and 
5 per organ, if clinically relevant to enable a broader sampling of tumor burden.  
Imaging will be repeated during subsequent treatment/consolidation cycles (between 
Days 16 to 21), maintenance cycles on Day 77 of each cycle, End-of-Treatment (30 ± 5 days 
after the last dose of investigational product), and Quarterly Follow-up every 90 (± 14) days for 
12 months after the last dose of investigational product or until disease progression. Refer to the 
study Schedule of Assessments (Section 15.1), as well as in the Procedures: Section 6.3, 
Section 6.4.3, Section 6.5, and Section 6.6, respectively.  
7.1.4 
iRECIST Assessment of Disease 
iRECIST is based on RECIST 1.1 but adapted to account for the unique tumor response seen 
with immunotherapeutic drugs. A description of the adaptations and iRECIST process is 
provided in Section 15.5 with additional details in the iRECIST publication [40]. A summary of 
imaging and treatment requirements after first radiologic evidence of progression is provided in 
Table 7 and illustrated as a flowchart in Figure 2. 
iRECIST will be used by the investigator to assess tumor response and progression and make 
treatment decisions. When clinically stable, subjects should not be discontinued until progression 
is confirmed by the investigator, working with local radiology, according to the rules outlined in 
Section 15.5, and in consultation with the sponsor’s medical monitor. This allowance to continue 
treatment despite initial radiologic progressive disease takes into account the observation that 
some subjects can have a transient tumor flare in the first few months after the start of 
immunotherapy, and then experience subsequent disease response. This data will be captured in 
the clinical database. 
 

Protocol Original 
ATA129-NPC-202, Date 09 AUG 2018 
Confidential
tabelecleucel 
Page 60 of 98
 
 
Atara Biotherapeutics, Inc. 
The information contained in this document cannot be used for any other purpose without prior written consent. 
 
 
Table 7 
Imaging and Treatment after First Radiologic Evidence of 
Progressive Disease 
 
Clinically Stable 
Clinically Unstable 
Imaging 
Treatment 
Imaging 
Treatment 
First radiologic 
evidence of 
progressive 
disease by 
RECIST 1.1  
Repeat imaging 
at 4 to 8 weeks to 
confirm 
progressive 
disease. 
May continue study 
treatment at the 
investigator’s 
discretion while 
awaiting 
confirmatory tumor 
imaging by site by 
iRECIST, see 
Figure 1a 
Repeat imaging 
at 4 to 8 weeks to 
confirm 
progressive 
disease per 
investigator’s 
discretion only. 
Discontinue 
pembrolizumab. 
May be allowed to be 
treated with a 
tabelecleucel product 
with a different HLA 
restriction (if available) 
in consultation with the 
sponsor’s medical 
monitor, see Figure 1. 
Repeat tumor 
imaging confirms 
progressive 
disease (iCPD) by 
iRECIST per 
investigator 
assessment 
No additional 
imaging required. 
Discontinue 
pembrolizumab 
(exception is possible 
upon consultation 
with Sponsor). 
May be allowed to be 
treated with a 
tabelecleucel product 
with a different HLA 
restriction in 
consultation with the 
sponsor’s medical 
monitor, see Figure 1. 
No additional 
imaging required. 
Not applicable 
Repeat tumor 
imaging shows 
iUPD by iRECIST 
per investigator 
assessment 
Repeat imaging 
at 4 to 8 weeks to 
confirm 
progressive 
disease. May 
occur at next 
regularly 
scheduled 
imaging visit. 
Continue study 
treatment at the 
investigator’s 
discretion, see 
Figure 1a 
Repeat imaging 
at 4 to 8 weeks to 
confirm 
progressive 
disease per 
investigator’s 
discretion only. 
Discontinue 
pembrolizumab. 
May be allowed to be 
treated with a 
tabelecleucel product 
with a different HLA 
restriction (if available) 
in consultation with the 
sponsor’s medical 
monitor, see Figure 1 
Repeat tumor 
imaging shows 
iSD, iPR, or iCR 
by iRECIST per 
investigator 
assessment. 
Continue 
regularly 
scheduled 
imaging 
assessments. 
Continue study 
treatment at the 
investigator’s 
discretion. Refer to 
Figure 1 for details. 
Continue 
regularly 
scheduled 
imaging 
assessments. 
May restart study 
treatment if condition has 
improved and/or 
clinically stable per 
investigator’s discretion. 
Next tumor imaging 
should occur according 
to the regular imaging 
schedule. Refer to 
Figure 1 for details. 

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Table 7 
Imaging and Treatment after First Radiologic Evidence of 
Progressive Disease 
 
Clinically Stable 
Clinically Unstable 
Imaging 
Treatment 
Imaging 
Treatment 
Abbreviations: IRR: Independent Radiographic Review; iCPD: iRECIST confirmed progressive disease;  
iCR: iRECIST complete response; iRECIST: modified Response Evaluation Criteria in Solid Tumors 1.1 for 
immune-based therapeutics; iSD: iRECIST stable disease; iUPD: iRECIST unconfirmed progressive disease; 
RECIST 1.1: Response Evaluation Criteria in Solid Tumors 1.1.  
a 
For a clinically stable subject with first radiographic evidence of progressive disease by RECIST 1.1 (ie, 
unconfirmed progressive disease), it is at the discretion of the investigator not continue treating the subject 
with the assigned treatment per protocol until cPD at least 28 days from the date of the scan first suggesting 
progressive disease. If radiographic progression is not confirmed by iRECIST per the investigator, then the 
subject may continue on treatment and follow the regular imaging schedule intervals until cPD at a later point 
by the study site in consultation with the medical monitor. 
Figure 2 
Imaging and Treatment for Clinically Stable Subjects Treated with 
Tabelecleucel and Pembrolizumab after First Radiologic Evidence of 
Progressive Disease Assessed by the Investigator 
RECIST 1.1 PD identified by 
investigatior – subject clinically stable
Repeat tumor imaging at 4 to 8 weeks
Does investigator 
confirm PD per 
iRECIST?
NO – does not confirm per iRECIST
YES – confirms PD per iRECIST
1. Subject may remain on 
investigational product at investigator 
discretion.
2. Regular imaging schedule followed; 
unscheduled imaging if clinically 
indicated.
3. Future imaging and subject 
management per iRECIST. Continue 
to submit imaging to vendor.
1. Subject discontinues investigational 
product.
2. Exception possible upon sponsor 
consultation.
3. Tumor imaging done only if needed 
for follow-up.
 
 
7.2 
Laboratory Assessments 
7.2.1 
Local Laboratory Tests 
Routine safety laboratory tests will be performed by local laboratories and results from these 
tests will be reported. 
A serum pregnancy test will be performed. 
CMV antibody will be collected at the study sites and analysis will be performed by the local 
laboratory. 

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7.2.3 
Reporting Routine Laboratory Abnormalities 
Laboratory test results along with appropriate normal ranges are to be reported routinely in the 
appropriate electronic data capture form. In addition, the investigator is responsible for reviewing 
laboratory test results and determining whether they meet AE reporting criteria (see Section 8), 
in which case they are to be reported on the adverse event form as well. 
8 ADVERSE EVENTS 
An AE is any untoward medical occurrence in a patient or clinical investigation subject 
administered a pharmaceutical product and which does not necessarily have to have a causal 
relationship with this treatment. An AE can therefore be any unfavorable and unintended sign 
(eg, an abnormal laboratory value), symptom, or disease temporally associated with the use of 
the investigational product, whether or not considered related to the investigational product [19].  
Out of range laboratory values that are assessed as clinically meaningful per investigator’s 
medical judgement must be reported as AEs with severity grading (see Section 8.3), even if they 
are asymptomatic. The investigator is responsible for reviewing all laboratory test results (either 
collected as per protocol or for any other reason) and determining whether an abnormal value in 
an individual subject is clinically meaningful. When part of a clinical condition, the underlying 
diagnosis should be listed as the AE in preference to the abnormal laboratory value (eg, anemia 
rather than low hemoglobin). If a unifying diagnosis is not available, then the sign(s)/symptom(s) 
must be reported as AE(s) in addition to the laboratory abnormality. 
A laboratory value that is determined to be erroneous does not require reporting as an AE; 
however, any AE resulting from an action taken to treat a subject with an erroneous laboratory 
value should be reported as such (eg, an adverse reaction or worsening medical condition 
resulting from any clinical intervention based on the laboratory result). 
Investigators must report all AE terms (ie, diseases/diagnoses, symptoms, or signs) and 
determine their seriousness criteria (Section 8.1) and severity grade (Section 8.3), as well as 
assess their relationship to the investigational product (Section 8.4). 
If an AE changes seriousness criteria or severity grade, that event will be ended and a new AE 
with the changed seriousness criteria or severity grade will be recorded. Changes to other AE 
attributes (eg, causality) should be evaluated by the investigator to determine if a new event 
should be recorded. 
Treatment-emergent AEs (TEAEs) are defined as events not present prior to the initiation of 
study product or any event already present that worsens in either intensity of frequency following 
exposure to study treatment.  
An AE does not include the following: 
 Medical or surgical procedures (eg, surgery, endoscopy, dental extraction, transfusion); 
the condition that necessitates the procedure is the AE 

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 Any pre-existing disease or condition or laboratory abnormality which is present prior to 
the start of the study product and that does not worsen 
 Situations where an adverse medical event has not occurred (ie, hospitalization for 
elective surgery, social admission) 
8.1 
Serious Adverse Events 
An SAE is defined as an AE that in the view of either the investigator or the sponsor: 
 Results in death 
 Is life-threatening, defined as an event in which the subject was, in the judgment of the 
investigator, at immediate risk of death. This does not include an AE that, had it occurred 
in a more serious form, might have caused death. 
 Requires in-patient hospitalization or prolongation of existing hospitalization 
 Results in persistent or significant disability/incapacity 
 Is a congenital anomaly/birth defect 
In addition, important medical experiences that may not result in death, are not life-threatening, 
or do not require hospitalization may be considered SAEs when, based upon appropriate medical 
judgment, they may jeopardize the subject and may require medical or surgical intervention to 
prevent one of the outcomes listed in the definition. Examples of such medical events include 
allergic bronchospasm requiring intensive treatment in an emergency room or at home, blood 
dyscrasia or convulsions that do not result in in-patient hospitalization, or the development of 
drug dependency or drug abuse. 
NOTE:  In addition to the above criteria, AEs meeting any of the following criteria, although 
not SAEs per ICH definition, are reportable to the sponsor in the same timeframe as 
SAEs to meet certain local requirements: 
 New cancer (that is not a condition of the study) 
 AE associated with an overdose 
 AEs of special interest (refer to Section 8.2) 
All subjects with SAEs must be followed up until no further resolution is expected. 
8.1.1 
Serious versus Severe Adverse Events 
To avoid confusion between the terms “serious” and “severe” which have different implications 
in the context of a clinical study, the following definitions are provided [19]: 
The term “severe” is used to describe the intensity (severity) of a specific event (as in mild/ 
grade 1, moderate/grade 2, severe/grade 3, life-threatening/grade 4, and death/grade 5). 
However, the event itself may be of only minor medical significance (eg, a severe headache). 
This is not the same as “serious”, which is based on a subject/event outcome or action criteria 

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associated with events that threaten a subject’s life or function. Seriousness (not severity) serves 
as a guide to the sponsor to determine regulatory reporting obligations. 
8.1.2 
Serious Adverse Event Definition Clarifications 
Death is a result of an SAE, and not an SAE itself. The event that, in the investigator’s judgment, 
caused the death is the SAE. 
Life-threatening means that the subject was at immediate risk of death from the event as it 
occurred. Life-threatening does not include an event that might have led to death, had it occurred 
with greater severity. 
In-patient hospitalization means the subjects has been formally admitted to a hospital for a 
medical cause, for any length of time. This may or may not be overnight. It does not include 
presentation and care within an emergency department (although an emergency department visit 
may define a medically important event, which is considered an SAE). 
The principal investigator should attempt to establish a diagnosis of an event based on signs, 
symptoms, and test results or other medical information (when obtained). In such cases, the 
diagnosis should be documented as the AE rather than the individual signs or symptoms. 
8.2 
Adverse Events of Special Interest 
An AE of special interest (serious or non-serious) is one of scientific and medical concern 
specific to the sponsor’s product or program, for which ongoing monitoring and rapid 
communication by the investigator to the sponsor can be appropriate. Such an event might 
warrant further investigation in order to characterize and understand it. All AEs of special 
interest must be reported in a manner similar to SAEs (see Section 8.5.1). 
8.2.1 
Adverse Events of Special Interest for Pembrolizumab 
AEs of special interest for pembrolizumab for this study include:  
1. An overdose of sponsor's product, as defined in Section 8.2.3, that is not associated with 
clinical symptoms or abnormal laboratory results 
2. An elevated AST or ALT value that is ≥ 3 x ULN and an elevated TBILI value that is 
≥ 2 x ULN and, at the same time, an alkaline phosphatase value that < 2 x ULN, as 
determined by protocol-specified laboratory testing or unscheduled laboratory testing 
NOTE: These criteria are based upon available regulatory guidance documents. The 
purpose of the criteria is to specify a threshold of abnormal hepatic tests that may require 
an additional evaluation for an underlying etiology. The study site guidance for 
assessment and follow-up of these criteria can be made available. It may also be 
appropriate to conduct additional evaluation for an underlying etiology in the setting of 
abnormalities of liver blood tests including AST, ALT, TBILI, and alkaline phosphatase 
that do not meet the criteria noted above. In these cases, the decision to proceed with 
additional evaluation will be made through consultation between the study investigators 

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and the sponsor’s medical monitor. However, abnormalities of liver blood tests that do not 
meet the criteria noted above are not AEs of special interest for this study. 
8.2.2 
Adverse Events of Special Interest and Possible Risks for Tabelecleucel 
Tabelecleucel consists of partially HLA-matched, human-derived products using healthy donor 
PBMCs as starting material. Because of these features, several AEs of special interest (noted in 
italics in this section) will be monitored in this study. Infusion reactions and transmission of 
infectious disease can occur with any human-derived product and therefore, such events are 
considered of special interest. Other T-cell products, specifically chimeric antigen receptor 
(CAR)-T cells, have been associated with cytokine release syndrome (CRS); though this 
phenomenon has not been observed in studies with tabelecleucel cell products, this AE is also 
considered of special interest. Because tabelecleucel is generated from starting material 
consisting of donor material that includes donor T cells, GvHD is also an AE of special interest. 
As with any investigational product, there are potential risks associated with tabelecleucel; these 
risks are listed below for convenience. However, please refer to the current edition of 
tabelecleucel (ATA129) Investigator’s Brochure for further details, including risk mitigation, as 
well as for up to date risk information. 
 Tumor flare reaction 
 GvHD 
 CRS 
 Marrow or organ rejection 
 Transmission of CMV infection 
 Transmission of other infections 
 Infusion-related reactions 
8.2.3 
Treatment of Overdose 
For this study, an overdose of pembrolizumab will be defined as any dose of 1000 mg or 
≥ 5 times the indicated dose.  
No specific information is available on the treatment of overdose of pembrolizumab. In the event 
of overdose, the subject should be observed closely for signs of toxicity. Appropriate supportive 
treatment should be provided if clinically indicated. 

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8.3 
Severity (or Grading) of Adverse Events 
The severity of each AE will be determined using a severity grading system, which could be 
either the CTCAE or the categorical descriptions (mild, moderate, severe, life-threatening, or 
death); refer to CTCAE version 5 [47] If the event is listed in the CTCAE tables, the grading 
scale with clinical descriptions will be used to determine the grade of the event. If the event is 
not listed in the CTCAE tables, the categorical descriptions will be used, and clinical judgement 
should be applied to map the severity of the event to the CTCAE grade. 
NOTE: the CTCAE system should not be used as a restrictive selection of event terms; ie, the 
diagnosis term should never be altered to accommodate the CTCAE grade. If the exact term is 
not listed in the CTCAE, the severity of the event may be based on the closest/similar medical 
concept from the CTCAE or based on the severity alternative options and mapped to the 
appropriate CTCAE grade. 
For the following AEs, which are not described in the CTCAE, refer to the indicated information 
for a recommended severity grading system. 
 Acute GvHD: refer to Section 15.6.1 
 Chronic GvHD: refer to Section 15.6.2 
8.4 
Relationship of Adverse Events to Investigational Product 
The investigator must assess and report all AEs and evaluate for their relationship to the study 
product (tabelecleucel or pembrolizumab) according to the following definitions: 
Unrelated: The AE is definitely not associated with administration of investigational product and 
is judged related to causes other than the investigational product. This category also applies 
when there is considerable likelihood of a cause other than the investigational product. 
Possibly Related: A causal relationship between treatment with the investigational product and 
the AE is at least a reasonable possibility, ie, the relationship cannot be ruled out. This implies a 
lesser degree of certainty about causality than a related AE. Additional evidence to suggest a 
suspected adverse reaction includes: 
 Occurrence of uncommon AEs that are known to be strongly associated with 
investigation product exposure (eg, anaphylaxis, angioedema, blood dyscrasias, 
rhabdomyolysis, hepatic injury, Stevens-Johnson Syndrome) 
 Occurrence of AEs that are uncommon in the study population, but not commonly 
associated with investigational product exposure (eg, intussusception in healthy infants) 
Related: A causal relationship between the investigational product administration and the AE is 
definite or very likely. 
These criteria, in addition to the principal investigator’s clinical judgment, should be used as a 
guide for determining the causal assessment. If the event is considered unrelated to 

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investigational product administration, then an alternative explanation should be provided, as 
applicable. 
8.5 
Adverse Event Reporting Requirements 
AEs, including SAEs will be reported by the subject (or, when appropriate, by the subject's 
legally authorized representative) to the investigator. The investigator, who is a qualified 
physician, and any designees are responsible for detecting, assessing, documenting, and 
reporting events that meet the definition of an AE in the electronic case report form (eCRF). 
Investigators remain responsible for following up AEs for outcome. 
AE reporting requirements are as follows: 
 AEs assessed by the investigator as at least possibly related to study procedure(s) 
occurring from the date that the first informed consent is signed to before the first dose of 
investigational product  
 All AEs, related and unrelated, occurring from the first administration of any 
investigational product through 30 days after the last investigational product  
 AEs assessed by the investigator as at least possibly related to any investigational product 
or study procedure(s) occurring after 30 days from the last investigational product exposure  
In addition, for the indicated events, refer to the following sections:  
 Deaths, see Section 8.5.1 
 SAEs, including AEs of special interest, see Section 8.5.1 
 Pregnancies and exposures during lactation, see Section 8.5.2 
 Laboratory abnormalities as an AEs, see Section 8 
Disease progression without secondary complications should be reported as an AE of disease 
progression (eg, a new metastasis or tumor increase) and not the indication for which subject 
entered the study (ie, EBV+ NPC). If the event is a complication of disease progression, the 
complication should be reported along with the event of disease progression (eg, a recent 
increase in bronchial tumor leading to pneumonia should be reported as “disease progression” 
and “pneumonia”). 
8.5.1 
Serious Adverse Event Reporting Requirements 
The sponsor must be notified immediately regarding information on any life-threatening or fatal 
SAE that is attributed to the investigational product by the investigator. This is to be followed by 
submission of written case details in eCRF and on the required paper reporting forms within 
24 hours of the study site’s knowledge of the event and as described in the eCRF completion 
guide and the safety reporting instructions in the study manual.  
All SAEs, including AEs of special interest, occurring from the first dose of investigational 
product through 90 days following the last dose of investigational product, or through 30 days 

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following cessation of investigational product if the subject initiates a new non-protocol therapy 
for EBV+ NPC, whichever is shorter, must be reported to sponsor within 24 hours of the study 
site’s knowledge of the event. 
All deaths occurring within 30 days after the last dose of investigational product must be 
reported to the sponsor within 24 hours of the study site’s knowledge of the event. 
The core information when reporting an SAE is as follows: 
 Subject’s study identification number, principal investigator’s name, and site number 
 SAE information: event term, onset date, severity and causal relationship to the study 
product 
 Seriousness Criteria: eg, death, life-threatening, in-patient hospitalization, prolongation of 
existing hospitalization, a persistent or significant disability or incapacity, or other 
important medical event 
 A summary of relevant medical history, pertinent laboratory data or other test results 
 The first and last dates of investigational product administration, and indication whether 
the investigational product was discontinued or the schedule of administration was 
modified 
 NOTE: Care should be taken to redact any identification information (name, address, 
etc.) from any records being sent in to the sponsor/designee for safety review to protect 
subject confidentiality 
In the event of an SAE, the report should be sent within 24 hours with as much information as is 
available at the time (including discharge summaries, autopsy reports, death certificates, or any 
other pertinent documentation). Supplemental information may be provided using a follow-up 
report and should not delay the initial report. The sponsor, or designee, may contact the 
investigational site to solicit additional information or to follow-up on the event. 
Collect and maintain in the medical record all pertinent information and medical judgments from 
colleagues who assisted in the treatment and follow-up of the subject, including hospital 
discharge summaries, progress notes, admission or emergency room notes, and discharge 
summaries. The investigator should supply the sponsor and the Independent Ethics Committee 
(IRB)/ Independent Ethics Committee (IEC) with any additional requested information (eg, 
resolution information, autopsy reports, death certificates). 
8.5.2 
Pregnancy Reporting Requirements 
All pregnancies or lactations in a female subject or the female partner of a male subject occurring 
after the informed consent form is signed and through 120 days following the last dose of 
investigational product, or through 30 days following cessation of investigational product if the 
subject initiates a new non-protocol therapy for NPC is initiated, whichever is shorter must be 
reported to the sponsor within 24 hours of the study site’s knowledge of the event per the study 

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guidance documents. Neither pregnancy, lactation, nor an induced elective abortion to terminate 
a pregnancy for non-medical reasons is considered an AE.  
A female subject who inadvertently becomes pregnant during treatment with investigational 
product will be immediately discontinued from treatment. A male subject who causes his partner 
to become pregnant will not need to discontinue from treatment. The investigator should counsel 
the subject/subject’s female partner regarding the unknown risks of tabelecleucel and 
pembrolizumab on the fetus and the need to inform the investigator of the outcome of the 
pregnancy. The subject/subject’s female partner must also be encouraged to schedule regular 
prenatal visits with an appropriately qualified health care provider and should inform the 
investigator of any problems with the pregnancy. The investigator will contact the female subject 
(or female partner of a male subject, if consent is given) at least monthly and document the 
subject’s (or female partner’s) status until the pregnancy has been completed or terminated. 
The outcome of the pregnancy will be reported to the sponsor without delay and within 24 hours 
if the outcome is an SAE (ie, important medical event) including: death (fetal death, neonatal 
death [including all neonatal deaths that occur within 1 month of the expected birth date ie, either 
before or after the expected birth date], infant death occurring 1 month after birth, if the 
investigator assesses the death as possibly related to in utero exposure to study treatment, 
miscarriage and stillbirth), abortion (spontaneous abortion, induced therapeutic abortion to 
terminate a pregnancy due to complications or other medical reasons, or missed abortion), 
congenital anomaly (live birth or aborted fetus), or other disabling or life-threatening 
complication to the mother or newborn (eg, blighted ovum, benign hydatidiform mole). The 
investigator will make every effort to obtain permission to follow the outcome of the pregnancy 
and report the condition of the fetus or newborn to the sponsor. If the end of pregnancy occurs 
after the study has been completed, the outcome should be reported directly to the sponsor. 
8.5.3 
Investigator Reporting to the Institutional Review Board/Independent 
Ethics Committee 
AEs/SAEs are to be reported to the local IRB/IEC, according to the policy of the local 
committee/board. If reporting is required, a copy of the IRB/IEC notification must be maintained 
at the site. 
8.5.4 
Sponsor Reporting Requirements 
The sponsor or its designee is responsible for submitting expedited safety reports to the 
regulatory agency(s) for all confirmed serious unexpected suspected adverse reactions 
(SUSARs). These reports will comply with local and regional requirements and with the ICH 
Guideline [19]. The sponsor or designee will notify the appropriate regulatory authority within 
7 days (for fatal or life-threatening SUSARs) after the sponsor’s initial receipt of the information 
or 15 days (for all other SUSARs) after the sponsor determines that the information qualifies for 
reporting. The sponsor or designee will notify the investigators and IRBs, unless the investigator 
is responsible for informing the IRB directly. The sponsor (or designee) will follow safety 
reporting guidelines according to regional and local requirements. 

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9.5 
Sample Size Determination 
The estimated ORR for treatment with the combination of tabelecleucel and pembrolizumab is 
≥ 45%. The comparator ORR deemed uninteresting is 20%. Based on the exact binomial test at 
the 1-sided alpha = 0.025 significance level, a sample size of 36 subjects will provide 90% power 
to detect a true ORR of at least 45%. 
10 DATA COLLECTION, RETENTION, AND MONITORING 
10.1 Data Collection and Retention 
10.1.1 
Data Collection Instruments 
The investigator will prepare and maintain adequate and accurate source documents designed to 
record all observations and other pertinent data for each subject treated with the investigational 
product. 
Designated study personnel at each site will enter data from source documents corresponding to 
a subject’s visit into the protocol-specific eCRF when the information corresponding to that visit 
is available. Subjects will not be identified by name in the study database or on any study 
documents to be collected by the sponsor (or designee), but will be identified by a site number, 
subject number. 
If a correction is required for an eCRF, the time and date stamps track the person entering or 
updating eCRF data and creates an electronic audit trail. 
The investigator is responsible for reviewing and signing all information collected on subjects 
enrolled this study for completeness and accuracy. A copy of the eCRF will remain at the 
investigator’s site at the completion of the study. 
10.1.2 
Data Management Procedures 
The data will be entered into a validated database. The sponsor-designated data management 
group will be responsible for data processing, in accordance with sponsor’s and/or designee’s 
standard operating procedures for clinical studies. Database lock will occur once quality 
assurance procedures have been completed. 
All procedures for the handling and analysis of data will be conducted using good computing 
practices meeting ICH Good Clinical Practice (GCP) and applicable regional or national 
regulations for the handling and analysis of data for clinical studies. 
10.1.3 
Electronic Case Report Forms 
The eCRF will be provided by the sponsor or its representatives and should be completed in 
accordance with applicable guidelines. Each eCRF should be filled out completely by the 
investigator or designee as stated in the Delegation of Authority Log. All data entry in the eCRF 
should have corresponding source documentation filed in the subject study records. 

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All data will be stored in a validated database that is compliant with ICH GCP and regional or 
national regulations. The principal investigator is responsible for ensuring the timely completion 
and submission of the eCRFs. The principal investigator must review, electronically sign and 
date the eCRFs at the time of study completion. 
10.1.4 
Data Quality Control and Reporting 
After data have been entered into the study database, a system of computerized data validation 
checks will be implemented and applied to the database on a regular basis. Queries are entered, 
tracked and resolved through the electronic data capture system directly. Queries shall be replied 
to and when applicable updates to data will be done in the study database. All changes to the 
study database will be documented in the system’s audit trail. 
10.1.5 
Archiving of Data 
The database is safeguarded against unauthorized access by established security procedures; 
appropriate backup copies of the database and related software files will be maintained. 
Databases are backed up by the database administrator in conjunction with any updates or 
changes to the database. 
At critical junctures of the protocol (eg, production of interim and final reports), data for analysis 
will be locked and cleaned per established procedures, if applicable. 
10.1.6 
Source Document Maintenance 
Source documents are defined as documentation of the observations and activities of a clinical 
study. Source documents may include, but are not limited to, study progress notes, e-mail 
correspondence, subject quality of life surveys, subject diaries (if applicable), computer 
printouts, laboratory data, and recorded data from automated instruments. All source documents 
for this study will be maintained by the investigator in accordance with ICH GCP and applicable 
regional or national regulations and made available to the sponsor/sponsor’s representative or 
regulatory authority. The official signed informed consent form (ICF) for each subject will be 
maintained as a source document, and a copy provided to the subject or their legal representative. 
When paper source documents are used, ICH GCP and applicable regional or national 
regulations document guidelines should be followed. For example, incorrect entries should be 
crossed out with a single pen stroke. Corrections must be made adjacent to the item to be altered, 
initialed and dated with the reason for the correction if necessary by the investigator or designee. 
Overwriting of data or use of liquid correction fluid is not allowed. 
10.1.7 
Investigational Product Accountability 
At all times, a record of the investigational product inventory and investigational product 
accountability must be maintained. Inventory and accountability records must be readily 
available to the study monitor, the sponsor, and any regulatory authority. The investigator, in 
conjunction with the site infusion lab/pharmacist, is responsible for ensuring accountability of all 
used and unused investigational product. 

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All received, dispensed, and returned investigational product supplies are to be reconciled on an 
ongoing basis and will be recorded on the Investigational Product Accountability Log. Following 
investigational product accountability verification by the study monitor, the study site may return 
all used investigational product supplies to the sponsor or designee (tabelecleucel only). 
Following investigational product accountability verification by the study monitor, the site may 
return all unused investigational product supplies to the sponsor or designee. During the conduct 
of the study, it is preferable that used cryovials be returned to the sponsor or designee; however, 
used cryovials may be destroyed on-site if required per institutional policy, and destruction is 
performed ensuring compliance with ICH GCP and applicable regional or national regulations. 
10.2 Study Monitoring and Administrative Considerations 
10.2.1 
Study Monitoring 
The monitor, as a representative of the sponsor and/or designee, has the obligation to follow the 
study closely. As such, the monitor may visit the investigative site at periodic intervals, and 
maintain necessary contact through telephone, e-mail, and letter. The monitor will maintain 
current personal knowledge of the study through observation, review of study records and source 
documentation, and discussion on the conduct of the study with the investigator and study staff. 
The monitor, as authorized by the sponsor, will be given direct access to all study related 
documentation (such as medical charts/records, laboratory reports, diagnostic reports, etc.).  
10.2.2 
Documentation of Protocol Deviations 
A protocol deviation is a departure from the procedures and/or processes described in the 
protocol as prepared by the sponsor, agreed to by the investigator or sub-investigator, and 
approved by the IRB/IEC. 
Protocol deviations should be reported to the sponsor or designee as they occur or are discovered 
and should be documented as appropriate in the source record. In addition, protocol deviations 
should be reported to the IRB/IEC per IRB/IEC guidelines. The monitor will document 
deviations discovered throughout the course of monitoring visits, or medical review of the 
clinical database. These deviations and corrective actions, when appropriate, will be reviewed 
and discussed with the sponsor and the investigators as applicable. 
Study monitoring will be performed in accordance with ICH GCP, the sponsor’s and/or the 
designee’s procedures, the protocol, and applicable local regulations. 
10.2.3 
Study Completion 
Atara Biotherapeutics, Inc. requires the availability of the following data and materials before the 
site close out visit can take place including the following: 
 Laboratory findings, clinical data, and all study test results from inventory check through 
the last study visit 

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 eCRFs (including queries) properly completed by appropriate study staff and 
electronically signed and dated by the investigator 
 Complete drug accountability records for all drug shipped to the site (drug inventory log 
and an inventory of returned or destroyed investigational product) 
 Copies of all IRB/IEC documentation including approvals of the original protocol, 
amendments (if applicable), informed consent documents and other notifications, if 
appropriate 
 A summary of the study prepared by the investigator (ie, the IRB/IEC summary letter) 
 A Financial Disclosure Form will be collected at the close-out visit, and up to 1 year 
following completion of the study 
After the study site close-out visit is completed, IRB/IEC acknowledgment of study closure must 
be provided to Atara Biotherapeutics, Inc. or its representative. 
10.2.4 
Audits and Inspections 
During and/or after completion of the study, quality assurance auditors acting on behalf of 
sponsor or a regulatory authority may wish to perform on-site audits/inspections (ICH GCPs). 
The purpose of an audit, which is independent from routine monitoring, is to evaluate study 
conduct and compliance with the protocol, procedures, ICH GCP, and applicable regional or 
national regulations. 
The investigators accept that by endorsing the protocol signature page that the sponsor, IRB/IEC 
or regulatory authorities may conduct an inspection to verify compliance of the study with 
ICH GCP. Representatives of the sponsor, IRB/IEC or regulatory authority may be permitted 
direct access to source documents. If a regulatory authority, or IRB/IEC notifies the investigator 
of an inspection, the investigator agrees to immediately notify the sponsor and provide the 
reason, if any, for the audit/inspection. The investigator agrees to promptly provide the sponsor 
with copies of any feedback (eg, Food and Drug Administration form 483, audit reports) issued 
at the end of the audit/inspection. 
10.2.5 
Confidentiality 
Data collected during this study may be used to support the development, registration or 
marketing of investigational product or for related publications. Investigators, members of the 
study team, monitors, auditors, and regulators should handle all study specimens, evaluation 
forms, reports, and other records in a manner that protects the privacy and confidentiality of 
study subjects. These individuals should all be fully informed of relevant national/local 
laws/regulations related to privacy and confidentiality. 
To protect subject confidentiality, only the sponsor’s subject identification code and age should 
be recorded on any form or biological sample submitted to the sponsor or its designee’s, 
IRB/IEC or laboratories. Investigators must establish secure safeguards to maintain the privacy 
of any screening logs that associate the sponsor’s subject identification code to subject names 
and addresses. 

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All required written authorization, including the ICF is to be obtained from each subject and/or 
their legal representative prior to enrollment into the study in accordance with the applicable 
requirements (eg, the Health Insurance Portability and Accountability Act of 1996 Standards for 
Privacy of Individually Identifiable Health Information), and all applicable updates (eg, 
2013 Omnibus Rule), and any other applicable regional or national requirements.  
The investigator and/or relevant site staff involved with this study may not disclose or use for 
any purpose other than performance of the study, any data, record, or other unpublished, 
confidential information. Prior written agreement from the sponsor or its designee must be 
obtained for the disclosure of any said confidential information to other parties. 
10.2.6 
Financing and Insurance 
The financing and insurance for this study are outlined in the clinical study agreement. 
10.2.7 
Study Termination Criteria 
The sponsor has every intention of completing the study. However, the sponsor reserves the right 
to terminate a study site or this clinical study at any time. Reasons for termination may include, 
but are not limited to: 
 Unacceptable safety and tolerability of tabelecleucel or pembrolizumab 
 Serious or persistent noncompliance by the investigator with the protocol, clinical 
research agreement, ICH GCP, and applicable regional or national regulations in 
conducting the study 
 IRB/IEC decision to terminate or suspend approval for the investigator 
 Subject enrollment is unsatisfactory 
11 ETHICS 
11.1 Ethical Conduct of the Study 
The investigator agrees that the study will be conducted according to the principles of the 
ICH GCP. The investigator will conduct all aspects of this study in accordance with all national, 
state, and local laws or regulations. 
11.2 Ethics Review by the Institutional Review Board or Independent Ethics 
Committee 
ICH GCP and applicable regional or national regulations require that approval be obtained from 
an IRB/IEC prior to participation of human subjects in research studies. Prior to the study start, 
the protocol, Investigator’s Brochure, ICF, advertisements to be used for subject recruitment, and 
any other written information regarding this study to be provided to the subject or subject’s 
legally authorized representative must be approved by the IRB/IEC. Documentation of all 
IRB/IEC approvals/acknowledgements, and of the IRB/IEC compliance with ICH GCP, will be 

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maintained by the site and made available for review and collection of copies by the sponsor or 
its designee. 
All IRB/IEC approvals should be signed by the IRB/IEC Chairman or designee and must identify 
the IRB/IEC by name and address, the clinical protocol by title and/or protocol number, 
amendment/version number and/or version date, and the date approval and/or favorable opinion 
was granted. 
The investigator is responsible for performing the study in accordance with the IRB/IEC 
approved protocol/amendment(s). In the event of any deviation, the information will be reported 
to the sponsor and major deviations will be reported to the IRB/IEC as soon as possible or 
according to the local IRB/IEC guidelines.  
Investigators will submit all written safety updates (provided by the sponsor) to the IRB/IEC, 
according to local IRB/IEC review requirements. The investigator is responsible for informing 
the IRB/IEC of the progress of the clinical study, reporting any non-administrative changes to 
the protocol, at intervals not exceeding 1 year or as otherwise specified by the IRB/IEC. The 
investigator and/or designee must supply the sponsor or its designee with written documentation 
of continued review of the clinical research. Investigators will provide a final report to the 
IRB/IEC when the study is complete, per IRB/IEC guidelines. 
11.3 Informed Consent 
Written informed consent in compliance with ICH GCP and applicable regional or national 
regulations and study site requirements will be obtained from each subject (or legally acceptable 
representative, as necessary) prior to the subject’s entering the study or the performance of any 
study related procedures. An ICF template will be provided by the sponsor to study sites. Once 
study-specific modifications are proposed or made by the study site, the ICF must be reviewed 
and approved by the sponsor and/or its designee, prior to IRB/IEC submission. Once reviewed 
and all modifications agreed to by the sponsor and study site, the ICF will be submitted by the 
investigator and/or designee to his or her IRB/IEC for review and approval prior to the start of 
the study. If the ICF is revised during the course of the study, the subject and legally acceptable 
representative, if necessary, must sign the revised ICF if still participating in the study and as 
stipulated by the IRB/IEC. If applicable, the ICF will be provided in a certified translation of the 
subject’s language.  
Before any study procedures and enrollment, each prospective subject and legally acceptable 
representative, if necessary, will be given a full explanation of the study and provided sufficient 
time to read the IRB/IEC-approved ICF. Once the investigator or designee is assured that the 
subject understands the implications of participating in the study, the subject will be asked to 
give consent for participation by signing and dating the ICF. The investigator or designee will 
also sign and date the ICF and document in the source documentation the time informed consent 
was obtained. The ICF must be signed by both the subject and investigator or designee prior to 
any study-related procedures. 
If a potential subject is illiterate, visually impaired, and/or physically unable to provide a written 
signature, and does not have legally acceptable representative, the investigator must provide an 

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impartial witness to read the ICF to the subject and must allow for questions. Thereafter, both the 
subject and the witness must sign the ICF to attest that informed consent was freely given and 
understood. 
In this study, assent will be obtained from the pediatric subject and consent from the subject’s 
legally acceptable representative, except if the subject is very young, as defined by local law will 
apply. A pediatric subject is defined as a person who has not attained the legal age for consent 
for treatments or procedures involved in clinical studies, under the applicable law of the 
jurisdiction in which the clinical study will take place. The IRB/IEC will determine the process 
for obtaining and documenting the assent process for pediatric subjects. The assent form will be 
in a language appropriate to the pediatric subject’s age, experience, maturity and condition. A 
subject who reaches the age of maturity (ie, 18 years in most jurisdictions) during the course of 
the study will be provided the ICF for re-consent. 
Once the signed and dated ICF (or assent form, as appropriate) has been obtained, a copy will be 
provided to the subject and legally acceptable representative, if necessary. The official signed 
and dated ICF and assent form will be placed in the subject’s medical records at the study site, 
along with documentation of the informed consent process. 
12 INVESTIGATOR’S RESPONSIBILITIES 
12.1 Study Reporting Requirements 
By participating in this study, the investigator agrees to submit reports of SAEs according to the 
timeline and method outlined in the protocol and study guidance documents. In addition, the 
investigator agrees to submit annual reports to his/her IRB/IEC as appropriate. 
12.2 Financial Disclosure and Obligations 
According to ICH GCP and applicable regional or national regulations, the sponsor is required to 
completely and accurately disclose or certify information concerning the financial interests of the 
investigators. Investigators will also disclose if they are full- or part-time employees of regional 
or national authorities. Therefore, the investigator and relevant study staff (those that are listed as 
sub-investigators on the site Form 1572) must provide the sponsor and/or designee with 
sufficient, accurate financial certification of any financial arrangements that exist with the 
sponsor or in relation to the investigational product. In addition, the investigator and relevant 
study staff must provide to the sponsor and/or designee a commitment to promptly update this 
information if any relevant changes occur during the course of the study and for 1 year following 
the completion of the study. 
12.3 Investigator Documentation 
Prior to beginning the study, the investigator will provide the essential documentation in 
compliance with ICH GCP and applicable regional or national regulations. 

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12.4 Institutional Review Board 
See Section 11.2. 
12.5 Retention of Records 
All essential study documentation (source documents, consent/assent forms, eCRFs, laboratory 
test results, and investigational product inventory records) at the study site should be retained in 
accordance with ICH GCP guidelines until at least 2 years after the last approval of a marketing 
application in an ICH region and until there are no pending or planned marketing applications or 
until at least 2 years following the formal discontinuation of development of the investigational 
product. Essential documents should be retained for a longer duration if required by a local 
regulatory authority or by agreement with Atara Biotherapeutics, Inc. The investigator must 
obtain written permission from Atara Biotherapeutics, Inc. before destroying essential 
documents. 
The investigator/ study site will provide details of storage location for all study-related 
documentation to the sponsor or designee both during and after the study. 
13 PUBLICATIONS 
Atara Biotherapeutics, Inc. encourages publication of results obtained during the conduct of the 
clinical research that it sponsors. Publication includes presenting interim or final results in a 
peer-reviewed medical journal, or as an abstract and poster or oral presentation at a scientific 
meeting, or any other public presentation of clinical study results. Neither the institutions nor the 
investigators are permitted to publish the results of the study, in part, or entirely without the 
written authorization of the sponsor. The sponsor shall have the right to review and comment on 
any proposed publication prior to submission and may edit or remove any confidential 
information contained in the proposed publication. Additionally, the sponsor may delay the 
publication to establish and preserve its proprietary rights. 
First Publication: The results of the entire multicenter study will be presented in a first 
publication after database lock, with authorship being determined by the sponsor and 
investigators using the criteria defined by the International Committee of Medical Journal 
Editors. At least 2 sponsor representatives will also be included as co-authors on the first 
publication of the results of the entire multicenter study to allow recognition of the sponsor’s 
involvement in the design, clinical operations and management of the study. 
Additional Publications: Subsequent publications of results of additional analyses must make 
reference to the first publication. Publications must include at least 2 sponsor staff to allow 
recognition of the sponsor’s role. In all publications, the study must be identified by the study’s 
identification number/code. 

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14 REFERENCES 
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Chemnitz JM, Parry RV, Nichols KE, June CH, Riley JL, SHP-1 and SHP-2 Associate 
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Disis, ML. Immune Regulation of Cancer. J Clin Oncol. 2010; 28 (29):4531-4538. doi: 
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Doubrovina E, Oflaz-Sozmen B, Prockop SE, Kernan NA, Abramson S, 
Teruya-Feldstein J, et al. Adoptive immunotherapy with unselected or EBV-specific 
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Dudley ME, Wunderlich JE,Yang JC, Sherry RM, Topalian SL, Restifo NP, Royal RE, 
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Fox CP, Burns D, Parker AN, Peggs KS, Harvey CM, Natarajan S, et al. EBV-associated 
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Francisco LM, Sage PT, Sharpe AH. The PD-1 pathway in tolerance and autoimmunity. 
Immunological Reviews. 2010;0105-2896. 

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Protocol Original 
 
ATA129-NPC-202, Date 09 AUG 2018 
Confidential 
tabelecleucel 
Page 88 of 98 
 
 
Atara Biotherapeutics, Inc. 
The information contained in this document cannot be used for any other purpose without prior written consent. 
 
 
Evaluation 
Inventory 
Checka 
Screeninga 
Treatment/Consolidation Cycles 
with Observation (21-day)a 
Maintenance Cycles  
with Observation (84-day)a 
EOT 
Visita 
Quarterly 
Follow-upa 
Day 
1 
Day 
8 
Day 
15 
Day 
21 
Day 
1 
Days 
21, 42, 63 
Day 
77 
u) Cohort 1, checkpoint inhibitor (PD-1/PD-L1) failed subjects, and Cohort 2 (optional): at least 1 day after Cycle 1 Day 8 and prior to Cycle 1 Day 15 
core needle, incisional or excisional biopsy is required; hematology and coagulation panels must be performed prior to biopsy. NOTE: Fine needle aspirate 
is not considered adequate for the purposes of this biopsy.  
v) Radiographic assessments include MRI or CT with contrast. 
w) Cohort 1, checkpoint inhibitor (PD-1/PD-L1) failed subjects only: initial evidence of progressive disease with confirmation assessment for retrospective 
analysis at a central vendor. 
x) Radiographic assessments will be performed at Screening and between Day 16 to Day 21 of Treatment/Consolidation Cycle 2 and beyond. During the 
Maintenance Phase, radiographic assessments will be performed on Day 77 (± 2 days) of each 84-day cycle. Radiographic assessments will also be 
performed at EOT and during Quarterly Follow-up for subjects who have achieved a CR, PR, or have SD but did not complete maintenance cycles or had 
disease progression.  
y) Pembrolizumab will be administered prior to tabelecleucel. During treatment/consolidation cycles, pembrolizumab will be administered on Day 1 (unless 
the subject has confirmed disease progression) and tabelecleucel on Day 1, Day 8 and Day 15 of each cycle. During the maintenance cycles, 
pembrolizumab will be administered on Day 1, Day 21, Day 42, and Day 63, and tabelecleucel on Day 1 of each cycle. Tabelecleucel will be administered 
1 hour (± 10 minutes) after the administration of pembrolizumab only if no infusion reactions related to pembrolizumab are observed/reported or in the 
case of such a reaction, the subject has recovered. 
 

Protocol Original 
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15.2 Detailed of the Study Design 
After the inventory check and screening, all subjects will receive two 21-day treatment cycles of 
combination immunotherapy (tabelecleucel on Days 1, 8, and 15 with pembrolizumab on Day 1) 
and then undergo a response assessment at the Observation Visit (refer to Figure 1). Subjects will 
receive different subsequent treatment, consolidation, and/or maintenance cycles depending on 
their initial response assessment as follows: 
 For CR or PR, refer to Section 15.2.1 
 For an SD response, refer to Section 15.2.2 
 For a uPD response, refer to Section 15.2.3 
 for a cPD response, refer to Section 15.2.4 
15.2.1 
Complete or Partial Response after the Initial Two Treatment Cycles 
A subject who achieves a CR or PR after the initial 2 treatment cycles will receive a 
Consolidation Cycle with tabelecleucel with the same HLA restriction on Days 1, 8, and 15 and 
pembrolizumab on Day 1 and have a response assessment at the Observation Visit (refer to 
Figure 1). Subsequent treatment is dependent on the response as follows: 
 CR, PR, or SD: The subject will then receive maintenance cycles (84-day) of 
combination immunotherapy (pembrolizumab on Days 1, 21, 42, and 63 with 
tabelecleucel with the same HLA restriction on Day 1) and a response assessment at 
Day 77. Maintenance cycles will continue until disease progression, unacceptable 
toxicity, or a total of 35 pembrolizumab infusions (including for treatment, consolidation, 
and maintenance) have been given. The subject will then complete an End-of-Treatment 
visit with a response assessment at 30 days after the last dose of investigational product, 
and then enter Quarterly Follow-up for 12 months from last dose of investigational 
product or until disease progression. 
 cPD: The subject will complete an End-of-Treatment visit (30 days after the last 
investigational product dose) and enter Quarterly Follow-up for 12 months after the last 
investigational product dose. 
15.2.2 
Stable Disease after the Initial Two Treatment Cycles 
A subject who has SD after the initial 2 treatment cycles will receive Switch Therapy, ie a 
treatment cycle with tabelecleucel with a different HLA restriction, if an appropriately matched 
product is available on Days 1, 8, and 15 and pembrolizumab on Day 1 and then a response 
assessment at the Observation Visit (refer to Figure 1). Subsequent treatment is dependent on the 
response as follows: 

Protocol Original 
ATA129-NPC-202, Date 09 AUG 2018 
Confidential
tabelecleucel 
Page 90 of 98
 
 
Atara Biotherapeutics, Inc. 
The information contained in this document cannot be used for any other purpose without prior written consent. 
 
 CR or PR: The subject will receive a consolidation cycle with tabelecleucel with the same 
HLA restriction on Days 1, 8, and 15 and pembrolizumab on Day 1 followed by a 
response assessment at the Observation Visit. The subject will then receive maintenance 
cycles (84-day) of combination immunotherapy (pembrolizumab on Days 1, 21, 42, and 
63 with tabelecleucel with the same HLA restriction on Day 1) and a response assessment 
at Day 77. Maintenance cycles will continue until disease progression, unacceptable 
toxicity, or a total of 35 pembrolizumab infusions (including for treatment, consolidation, 
and maintenance) have been given. The subject will then complete an End-of-Treatment 
visit with a response assessment at 30 days after the last dose of investigational product, 
and then enter Quarterly Follow-up for 12 months from last dose of investigational 
product or until disease progression. 
 SD: The subject will receive another treatment cycle with tabelecleucel with the same 
HLA restriction on Days 1, 8, and 15 and pembrolizumab on Day 1 followed by a 
response assessment at the Observation Visit. If the response is CR, PR, or SD, the 
subject will enter receive maintenance cycles. If the response is cPD, the subject will 
complete an End-of-Treatment visit (30 days after the last investigational product dose) 
and enter Quarterly Follow-up for 12 months after the last investigational product dose. 
 uPD: The subject will receive another treatment cycle with tabelecleucel with the same 
HLA restriction on Days 1, 8, and 15 and pembrolizumab on Day 1 followed by a 
response assessment at the Observation Visit. As described above, if the response is CR, 
PR, or SD, the subject will receive maintenance cycles. If the response is cPD, the subject 
will complete an End-of-Treatment visit (30 days after the last investigational product 
dose) and enter Quarterly Follow-up for 12 months after the last investigational product 
dose. 
 cPD: The subject will complete an End-of-Treatment visit (30 days after the last 
investigational product dose) and enter Quarterly Follow-up for 12 months after the last 
investigational product dose. 
15.2.3 
Unconfirmed Progressive Disease after the Initial Two Treatment Cycles 
A subject who has uPD after the initial 2 treatment cycles will receive another treatment cycle 
with tabelecleucel with the same HLA restriction on Days 1, 8, and 15 and pembrolizumab on 
Day 1 and then a response assessment at the Observation Visit (refer to Figure 1). Subsequent 
treatment is dependent on the response as follows: 
 CR or PR: The subject will then receive maintenance cycles (84-day) of combination 
immunotherapy (pembrolizumab on Days 1, 21, 42, and 63 with tabelecleucel with the 
same HLA restriction on Day 1) and a response assessment at Day 77. Maintenance 
cycles will continue until disease progression, unacceptable toxicity, or a total of 
35 pembrolizumab infusions (including for treatment, consolidation, and maintenance) 
have been given. The subject will then complete an End-of-Treatment visit with a 
response assessment at 30 days after the last dose of investigational product, and then 

Protocol Original 
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Confidential
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enter Quarterly Follow-up for 12 months from last dose of investigational product or until 
disease progression.  
 SD: The subject will receive Switch Therapy, ie a treatment cycle with tabelecleucel with 
a different HLA restriction, if an appropriately matched product is available on Days 1, 8, 
and 15 followed by a response assessment at the Observation Visit. If the response is CR, 
PR, or SD, the subject will receive maintenance cycles. If the response is cPD, the subject 
will complete an End-of-Treatment visit and enter Quarterly Follow-up for 12 months 
after the last investigational product dose. 
 cPD: The subject will discontinue pembrolizumab and receive Switch Therapy, ie a 
treatment cycle with tabelecleucel with a different HLA restriction, if an appropriately 
matched product is available on Days 1, 8, and 15 followed by a response assessment at 
the Observation Visit. Subsequent treatment is dependent on the response as follows: 
 CR, PR, or SD: The subject will receive a consolidation cycle with tabelecleucel with 
the same HLA restriction on Days 1, 8, and 15 followed by a response assessment at 
the Observation Visit. The subject will then complete an End-of-Treatment visit with 
a response assessment at 30 days after the last dose of investigational product, and 
then enter Quarterly Follow-up for 12 months from last dose of investigational 
product or until disease progression. 
 cPD: The subject will then complete an End-of-Treatment visit (30 days after the last 
investigational product dose) and enter Quarterly Follow-up for 12 months after the 
last investigational product dose. 
15.2.4 
Confirmed Progressive Disease after the Initial Two Treatment Cycles 
A subject who has a cPD will discontinue pembrolizumab and receive Switch Therapy, ie a 
treatment cycle with tabelecleucel with a different HLA restriction, if an appropriately matched 
product is available on Days 1, 8, and 15 followed by a response assessment at the Observation 
Visit (refer to Figure 1). Subsequent treatment is dependent on the response as follows: 
 CR, PR, or SD: The subject will receive a consolidation cycle with tabelecleucel with the 
same HLA restriction on Days 1, 8, and 15 followed by a response assessment at the 
Observation Visit. The subject will then complete an End-of-Treatment visit with a 
response assessment at 30 days after the last dose of investigational product, and then 
enter Quarterly Follow-up for 12 months from last dose of investigational product or until 
disease progression. 
 cPD: The subject will then complete an End-of-Treatment visit (30 days after the last 
investigational product dose) and enter Quarterly Follow-up for 12 months after the last 
investigational product dose. 

Protocol Original 
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Confidential
tabelecleucel 
Page 92 of 98
 
 
Atara Biotherapeutics, Inc. 
The information contained in this document cannot be used for any other purpose without prior written consent. 
 
15.3 Performance Status Scales 
ECOG Performance Status for Subjects Aged > 16 Years 
ECOG Grade 
Status 
0 
Fully active, able to carry on all pre-disease performance without restriction. 
1 
Restricted in physically strenuous activity but ambulatory and able to carry out work of a light 
or sedentary nature, eg, light housework, office work. 
2 
Ambulatory and capable of all self-care but unable to carry out any work activities. Up and 
about more than 50% of waking hours. 
3 
Capable of only limited self-care; confined to bed or chair more than 50% of waking hours. 
4 
Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 
5 
Dead. 
 
Lansky Scoring for Subjects Aged 1 to 16 Years 
Lansky Score 
Status 
100 
Fully active, normal 
90 
Minor restrictions in physically strenuous activity 
80 
Active, but tires more quickly 
70 
Both greater restriction of and less time spent in play activity 
60 
Up and around, but minimal active play; keeps busy with quieter activities 
50 
Gets dressed but lies around much of the day, no active play but able to participate in all quiet 
play and activities 
40 
Mostly in bed; participates in quiet activities 
30 
In bed; needs assistance even for quiet play 
20 
Often sleeping; play entirely limited to very passive activities 
10 
No play; does not get out of bed 
0 
Unresponsive 
 

Protocol Original 
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Confidential
tabelecleucel 
Page 93 of 98
 
 
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15.4 Corticosteroid Approximate Equivalent Doses 
 
Glucocorticoid 
Approximate Equivalent Dose 
(mg) 
Half-life (Biologic) 
(hours) 
Short-Acting 
Cortisone 
2.5 
8–12 
Hydrocortisone 
2.0 
8–12 
Intermediate-Acting 
Methylprednisolone 
0.4 
18–36 
Prednisolone 
0.5 
18–36 
Prednisone 
0.5 
18–36 
Triamcinolone 
0.4 
18–36 
Long-Acting 
Betamethasone 
0.06–0.075 
36–54 
Dexamethasone 
0.075 
36–54 
Values reflect equivalent doses to prednisone 0.5 mg 
Source: http://www.globalrph.com/corticocalc.htm 
 

Protocol Original 
ATA129-NPC-202, Date 09 AUG 2018 
Confidential
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15.5 Description of the iRECIST Process for Assessment of Disease Progression 
Assessment at Screening and Prior to RECIST 1.1 Progression 
Until radiographic disease progression based on RECIST 1.1, there is no distinct iRECIST 
assessment. 
Assessment and Decision at RECIST 1.1 Progression 
For subjects who show evidence of radiological progressive disease by RECIST 1.1 as 
determined by the investigator, the investigator will decide whether to continue a subject on 
study treatment until repeat imaging is obtained (using iRECIST for subject management (see 
Table 7 and Figure 2). This decision by the investigator should be based on the subject’s overall 
clinical condition. 
Clinical stability is defined as the following:  
 Absence of symptoms and signs indicating clinically significant progression of disease 
 No decline in ECOG performance status  
 No requirements for intensified management, including increased analgesia, radiation, or 
other palliative care 
Any subject deemed clinically unstable should be discontinued from study treatment at the site-
assessed first radiologic evidence of progressive disease and is not required to have repeat tumor 
imaging for confirmation of progressive disease by iRECIST. 
If the investigator decides to continue treatment, the subject may continue to receive study 
treatment and the tumor assessment should be repeated 4 to 8 weeks later to confirm progressive 
disease by iRECIST, per investigator assessment. Images should continue to be sent in to the 
central imaging vendor for potential retrospective IRR. 
Tumor flare may manifest as any factor causing radiographic progression per RECIST 1.1, 
including: 
 Increase in the sum of diameters of target lesion(s) identified at baseline to ≥ 20% and 
≥ 5 mm from nadir 
 Note: The iRECIST publication uses the terminology “sum of measurements”, but 
“sum of diameters” will be used in this protocol, consistent with the original 
RECIST 1.1 terminology. 
 Unequivocal progression of non-target lesion(s) identified at baseline 
 Development of new lesion(s) 
iRECIST defines new response categories, including iUPD (unconfirmed progressive disease) 
and iCPD (confirmed progressive disease). For purposes of iRECIST assessment, the first visit 

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showing progression according to RECIST 1.1 will be assigned a visit (overall) response of 
iUPD, regardless of which factors caused the progression. 
At this visit, target and non-target lesions identified at baseline by RECIST 1.1 will be assessed 
as usual. 
New lesions will be classified as measurable or non-measurable, using the same size thresholds 
and rules as for baseline lesion assessment in RECIST 1.1. From measurable new lesions, up to 
5 lesions total (up to 2 per organ), may be selected as New Lesions – Target. The sum of 
diameters of these lesions will be calculated and kept distinct from the sum of diameters for 
target lesions at baseline. All other new lesions will be followed qualitatively as 
New Lesions – Non-target. 
Assessment at the Confirmatory Imaging 
On the confirmatory imaging, the subject will be classified as progression confirmed (with an 
overall response of iCPD), or as showing persistent unconfirmed progression (with an overall 
response of iUPD), or as showing disease stability or response (iSD/iPR/iCR). 
Confirmation of Progression 
Progression is considered confirmed, and the overall response will be iCPD, if ANY of the 
following occurs: 
 Any of the factors that were the basis for the initial iUPD show worsening 
 For target lesions, worsening is a further increase in the sum of diameters of ≥5 mm, 
compared to any prior iUPD time point 
 For non-target lesions, worsening is any significant growth in lesions overall, 
compared to a prior iUPD time point; this does not have to meet the “unequivocal” 
standard of RECIST 1.1 
 For new lesions, worsening is any of these: 
o An increase in the new lesion sum of diameters by ≥5 mm from a prior iUPD time 
point  
o Visible growth of new non-target lesions  
o The appearance of additional new lesions 
 Any new factor appears that would have triggered progressive disease by RECIST 1.1 
Persistent iUPD 
Progression is considered not confirmed, and the overall response remains iUPD, if: 
 None of the progression-confirming factors identified above occurs AND 
 The target lesion sum of diameters (initial target lesions) remains above the initial 
progressive disease threshold (by RECIST 1.1) 

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Additional imaging for confirmation should be scheduled 4 to 8 weeks from the imaging on 
which iUPD is seen. This may correspond to the next visit in the original visit schedule. The 
assessment of the subsequent confirmation imaging proceeds in an identical manner, with 
possible outcomes of iCPD, iUPD, and iSD/iPR/iCR. 
Resolution of iUPD 
Progression is considered not confirmed, and the overall response becomes iSD/iPR/iCR, if: 
 None of the progression-confirming factors identified above occurs, AND 
 The target lesion sum of diameters (initial target lesions) is not above the initial 
progressive disease threshold.  
The response is classified as iSD or iPR (depending on the sum of diameters of the target 
lesions), or iCR if all lesions resolve. 
In this case, the initial iUPD is considered to be pseudo-progression, and the level of suspicion 
for progression is “reset”. This means that the next visit that shows radiographic progression, 
whenever it occurs, is again classified as iUPD by iRECIST, and the confirmation process is 
repeated before a response of iCPD can be assigned. 
Management Following the Confirmatory Imaging 
If repeat imaging does not confirm progressive disease per iRECIST, as assessed by the 
investigator, and the subject continues to be clinically stable, study treatment may continue and 
follow the regular imaging schedule. If progressive disease is confirmed, subjects will be 
discontinued from study treatment. 
NOTE: If a subject has confirmed radiographic progression (iCPD) as defined above, but the 
subject is achieving a clinically meaningful benefit, an exception to continue study treatment 
may be considered following consultation with the Sponsor. In this case, if study treatment is 
continued, tumor imaging should continue to be performed following the intervals as outlined in 
Section 7.1.2 and submitted to the central imaging vendor. 
Detection of Progression at Visits After Pseudo-progression Resolves 
After resolution of pseudo-progression (i.e., achievement of iSD/iPR/iCR), iUPD is indicated by 
any of the following events: 
 Target lesions 
 Sum of diameters reaches the progressive disease threshold (≥ 20% and ≥ 5 mm 
increase from nadir) either for the first time, or after resolution of previous 
pseudo-progression. The nadir is always the smallest sum of diameters seen during 
the entire study, either before or after an instance of pseudo-progression. 
 Non-target lesions 

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 If non-target lesions have never shown unequivocal progression, their doing so for the 
first time results in iUPD. 
 If non-target lesions have shown previous unequivocal progression, and this 
progression has not resolved, iUPD results from any significant further growth of 
non-target lesions, taken as a whole. 
 New lesions 
 New lesions appear for the first time 
 Additional new lesions appear 
 Previously identified new target lesions show an increase of ≥ 5 mm in the new lesion 
sum of diameters, from the nadir value of that sum 
 Previously identified non-target lesions show any significant growth 
If any of the events above occur, the overall response for that visit is iUPD, and the iUPD 
evaluation process (see Assessment at the Confirmatory Imaging above) is repeated. Progression 
must be confirmed before iCPD can occur. 
The decision process is identical to the iUPD confirmation process for the initial PD, with one 
exception: if new lesions occurred at a prior instance of iUPD, and at the confirmatory imaging 
the burden of new lesions has increased from its smallest value (for new target lesions, the sum 
of diameters is ≥ 5 mm increased from its nadir), then iUPD cannot resolve to iSD or iPR. It will 
remain iUPD until either a decrease in the new lesion burden allows resolution to iSD or iPR, or 
until a confirmatory factor causes iCPD. 
Additional details about iRECIST are provided in the iRECIST publication [40]. 
15.6 Severity Grading Scales 
15.6.1 
Acute GvHD 
For acute GvHD, the clinical stage and severity should be evaluated according to the criteria 
outlined by the CIBMTR, as provided in Table 8 and Table 9, respectively. 
 
Table 8 
CIBMTR Acute GvHD: Clinical Stage 
Stage 
Skin 
Liver 
GI 
Upper GI 
Body Surface Area 
Bilirubin (mg/dL) 
Diarrhea (mL/day) 
Nausea 
1 
< 25% 
2–3 
500–1000 
Present 
2 
25–50% 
3.1–6 
1000–1500 
― 
3 
Generalized 
erythroderma 
6.1–15 
> 1500 
― 

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Table 8 
CIBMTR Acute GvHD: Clinical Stage 
Stage 
Skin 
Liver 
GI 
Upper GI 
Body Surface Area 
Bilirubin (mg/dL) 
Diarrhea (mL/day) 
Nausea 
4 
Bullae 
> 15 
Pain ± ileus 
― 
Source: https://www.cibmtr.org/meetings/materials/crpdmc/pages/fall10Arora.aspx 
 
Table 9 
CIBMTR Acute GvHD: Severity Grading 
Overall Acute 
GvHD Grade 
Skin Stage 
Liver Stage 
GI Stage 
Upper GI Stage 
I 
1–2 
0 
0 
0 
II 
1–3 
1 
1 
1 
III 
2–3 
2–4 
2–3 
― 
IV 
4 
― 
4 
― 
Note: The clinical stage is ascertained per criteria in Table 8.  
Source: https://www.cibmtr.org/meetings/materials/crpdmc/pages/fall10Arora.aspx 
 
15.6.2 
Chronic GvHD 
For chronic GvHD, severity (ie, mild, moderate, severe) is defined by a global scoring algorithm 
described by the NIH consensus criteria [20]. The severity of the chronic GvHD event is then 
mapped to appropriate CTCAE grade.