A Screening Protocol to Support Preliminary Eligibility for Clinical Trials Evaluating Safety and Efficacy of Adoptive Cell Therapies in Participants With Solid Tumors and Hematologic Malignancies
Phase: PHASE2
Conditions: Neoplasms
Sponsor: GlaxoSmithKline

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TITLE PAGE 
Protocol Title: A Screening Protocol to Support Preliminary Eligibility for Clinical 
Trials Evaluating Safety and Efficacy of Adoptive Cell Therapies in Participants with 
Solid Tumors and Hematologic Malignancies. 
Protocol Number: 213033 
Compound Number: 
None 
Study Phase: Phase 1/Phase 2 
Short Title:  Screening Protocol for Preliminary Eligibility Determination for Adoptive 
Cell Therapy Trials 
Sponsor Name and Legal Registered Address:  
GlaxoSmithKline Research & Development Limited 
980 Great West Road 
Brentford 
Middlesex, TW8 9GS 
UK 
Regulatory Agency Identifying Number(s):  
IND: N/A  
EudraCT:  N/A 
NCT:  
WHO: 
Other:  
Approval Date: 22-JUN-2021 
 
 
 
 
Copyright 2021 the GlaxoSmithKline group of companies.  All rights reserved.  
Unauthorised copying or use of this information is prohibited. 

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SPONSOR SIGNATORY: 
Protocol Title: A Screening Protocol to Support Preliminary Eligibility for Clinical 
Trials Evaluating Safety and Efficacy of Adoptive Cell Therapies in Participants with 
Solid Tumors and Hematologic Malignancies. 
Protocol Number: 213033 
Compound Number: 
None 
 
 
 
 
 
 
 
Gregg Fine, MD 
Vice President, Clinical Development 
Cell and Gene Therapies 
Oncology R&D 
 
Date 
 
 
 
The signed page is a separate document 
 
 
 
Medical Monitor Name and Contact Information  
May be found in the Study Reference Manual 
 
 

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TABLE OF CONTENTS 
PAGE 
1. 
PROTOCOL SUMMARY .......................................................................................... 4 
1.1. 
Synopsis ....................................................................................................... 4 
1.2. 
Schema ........................................................................................................ 8 
1.3. 
Schedule of Activities (SoA) for Study 213033 .............................................. 9 
2. 
INTRODUCTION .................................................................................................... 10 
2.1. 
Study Rationale .......................................................................................... 10 
2.2. 
Background ................................................................................................ 11 
2.3. 
Benefit/Risk Assessment ............................................................................ 12 
2.3.1. 
Risk Assessment ......................................................................... 12 
2.3.2. 
Benefit Assessment ..................................................................... 13 
2.3.3. 
Overall Benefit: Risk Conclusion .................................................. 13 
3. 
OBJECTIVES AND ENDPOINTS ........................................................................... 13 
4. 
STUDY DESIGN .................................................................................................... 14 
4.1. 
Overall Design ............................................................................................ 14 
4.1.1. 
Protocol Flow ............................................................................... 14 
4.2. 
Scientific Rationale for Study Design .......................................................... 14 
4.3. 
Justification for Dose .................................................................................. 14 
4.4. 
End of Study Definition ............................................................................... 15 
4.4.1. 
Study completion for participants ................................................. 15 
4.4.2. 
End of study ................................................................................. 15 
5. 
STUDY POPULATION ........................................................................................... 15 
5.1. 
Inclusion Criteria ......................................................................................... 15 
5.2. 
Exclusion Criteria ........................................................................................ 15 
5.3. 
Lifestyle Considerations .............................................................................. 16 
5.4. 
Screen Failures........................................................................................... 16 
6. 
STUDY INTERVENTION ........................................................................................ 17 
7. 
DISCONTINUATION OF STUDY INTERVENTION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL ..................................................................... 17 
7.1. 
Discontinuation of Study Intervention .......................................................... 17 
7.2. 
Participant Discontinuation/Withdrawal from the Study ............................... 17 
7.3. 
Lost to Follow-Up ........................................................................................ 17 
8. 
STUDY ASSESSMENTS AND PROCEDURES ..................................................... 18 
8.1. 
HLA Compatibility Testing ........................................................................... 19 
8.2. 
Efficacy Assessments ................................................................................. 19 
8.3. 
Safety Assessments ................................................................................... 19 
8.4. 
Serious Adverse Events .............................................................................. 19 
8.4.1. 
Time Period and Frequency for Collecting SAE 
Information ................................................................................... 19 
8.4.2. 
Method of Detecting SAEs ........................................................... 20 
8.4.3. 
Follow-up of SAEs ....................................................................... 20 
8.4.4. 
Regulatory Reporting Requirements for SAEs ............................. 20 
8.5. 
Pharmacokinetics ....................................................................................... 20 

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8.6. 
Genetics ..................................................................................................... 20 
8.7. 
Biomarkers ................................................................................................. 20 
8.8. 
Immunogenicity Assessments ..................................................................... 20 
8.9. 
Health Economics OR Medical Resource Utilization and Health 
Economics .................................................................................................. 21 
9. 
STATISTICAL CONSIDERATIONS ........................................................................ 21 
9.1. 
Statistical Hypotheses................................................................................. 21 
9.2. 
Sample Size Determination ........................................................................ 21 
9.3. 
Populations for Analyses ............................................................................ 21 
9.4. 
Statistical Analyses ..................................................................................... 21 
9.4.1. 
Safety Analyses ........................................................................... 21 
9.4.2. 
Other Analyses ............................................................................ 21 
9.5. 
Interim Analyses ......................................................................................... 22 
10. SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS ............................................................................................... 23 
10.1. 
Appendix 1: Regulatory, Ethical, and Study Oversight 
Considerations ............................................................................................ 23 
10.1.1. 
Regulatory and Ethical Considerations ........................................ 23 
10.1.2. 
Financial Disclosure ..................................................................... 23 
10.1.3. 
Informed Consent Process .......................................................... 24 
10.1.4. 
Data Protection ............................................................................ 25 
10.1.5. 
Dissemination of Clinical Study Data ........................................... 25 
10.1.6. 
Data Quality Assurance ............................................................... 25 
10.1.7. 
Source Documents ...................................................................... 26 
10.1.8. 
Study and Site Closure ................................................................ 26 
10.1.9. 
Publication Policy ......................................................................... 27 
10.2. 
Appendix 2: AE and SAE: Definitions and Procedures for 
Recording, Evaluating, Follow-up, and Reporting ....................................... 28 
10.2.1. 
Definition of AE ............................................................................ 28 
10.2.2. 
Definition of SAE .......................................................................... 29 
10.2.3. 
Recording and Follow-Up of AE and SAE .................................... 30 
10.2.4. 
Reporting of SAE to GSK ............................................................. 32 
10.3. 
Appendix 3: Abbreviations and Trademarks ................................................ 33 
11. REFERENCES ....................................................................................................... 35 
 
 
 

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1. 
PROTOCOL SUMMARY 
1.1. 
Synopsis 
Protocol Title: A Screening Protocol to Support Preliminary Eligibility for Clinical 
Trials Evaluating Safety and Efficacy of Adoptive Cell Therapies in Participants with 
Solid Tumors and Hematologic Malignancies. 
Short Title: Screening Protocol for Preliminary Eligibility Determination for Adoptive 
Cell Therapy Trials  
Rationale: 
Adoptive T-cell therapy (ACT) is a therapeutic approach that uses autologous (patient’s 
own) or allogeneic (donor) T lymphocytes, that are subsequently genetically engineered 
to express a tumor-targeting receptor, expanded in vitro and reinfused into the participant, 
with the aim of generating and propagating an anti-tumor T-cell immune response. T 
cells can be engineered through a variety of approaches. Two that are currently under 
intensive evaluation include: chimeric antigen receptors (CARs) and engineered T-cell 
receptors (TCRs). T cells are obtained from the participant by leukapheresis and then 
engineered to express either CARs or TCRs. CARs bind to cell surface expressed 
proteins, whereas TCRs bind to epitopes of internal tumor-associated antigens (TAAs) 
presented in complex with HLA molecules on the cell surface.    
GlaxoSmithKline (GSK) is developing both CAR and TCR T-cell therapies (TCR-T) for 
the investigational treatment of patients with various malignancies. New-York 
Esophageal Antigen-1 (NY-ESO-1) and Tumor antigen, cancer testis antigen (LAGE-1a) 
are members of the cancer-testis family of tumor antigens (CTAs). NY-ESO-1 is a 
cytoplasmic protein that is detectable in multiple cancer types including, but not limited 
to non-small cell lung cancer (NSCLC), bladder cancer, melanoma, liver cancer, synovial 
sarcoma, myxoid/round cell liposarcoma (MRCLS), and multiple myeloma. Specific 
peptide epitopes of the NY-ESO-1 or LAGE-1a protein are processed and presented on 
the surface of the tumor cell in complex with an human leukocyte antigen (HLA) 
molecule, which can be recognized by T cells. Therefore, targeting these CTAs through 
TCR T-cell therapies require participants to have HLA histocompatibility. The 
SLLMWITQCaa 157-165 peptide has been identified that is common to both NY-ESO-1 
and LAGE-1a antigens presented on the surface of HLA-A*02. T cells have been 
genetically engineered to express an affinity-enhanced TCR toward this SLLMWITQC 
peptide. The retained optimized TCR clone was called NY-ESO-1 c259 or c259. The T-
cell product (GSK3377794, lete-cel) consists of autologous T cells transduced with a 
self-inactivating lentiviral vector encoding the affinity enhanced NY-ESO-1 specific 
TCR (c259). 
GSK is developing lete-cel and several next generation products that contain this NY-
ESO-1 TCR for the investigational treatment of patients with various malignancies. The 
engineered T-cell receptor is compatible with HLA alleles (HLA-A*02:01, HLA-
A*02:05, and/or HLA-A*02:06), which are carried by roughly 45% of the world’s 
population and targets the presentation of TAAs, NY-ESO-1 and/or LAGE-1a.  

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This screening study is designed to determine preliminary eligibility of participants who 
may be potential candidates for GSKs ACT studies by screening for appropriate 
biomarkers.  
The study will include collection of blood samples at local referral centers for facilitating 
HLA compatibility screening and referral of HLA-histocompatible patients to GSK TCR-
T cell investigational treatment trials. GSK-sponsored TCR-T trials are set up at a limited 
number of specialist centers due to the complex nature and requirements of ACT 
investigational treatment trials. Therefore, this screening study will facilitate testing for 
HLA-histocompatible patients over a wider geographic area at centers that do not have 
the ACT investigational treatment trials available. In the future, the screening study may 
be expanded to other centers including investigational treatment trial sites as well as 
include screening for additional biomarkers such as tumor antigen screening as defined 
by current and future investigational treatment studies.  
HLA compatibility testing within this protocol will facilitate closer-to-home testing for 
patients and reduce the burden of travelling to a trial site.. Additionally, due to the high 
screen fail rate associated with finding patients who are HLA compatible, there is a need 
to improve overall access to trials beyond the investigational treatment sites.  
In addition to ongoing studies, GSK has developed two master protocols (see below 
schema) for first time in human and for further development of a series of cell therapies. 
The master protocols are designed to facilitate the addition of new substudies 
investigating new tumor types and/or new cell therapy agents or combinations of agents. 
Future additional investigational treatment trials may exist as individual studies outside 
of the two master protocols described above. Through a simple and generally applicable 
design, this screening protocol is intended to broaden access to these and other current 
and future clinical trials by supporting screening outside the investigational treatment 
protocols.  
 
 
MRCLS – Myxoid/Round Cell Liposarcoma; NSCLC – Non-small cell lung cancer 
 

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O bjecti ves a n d E n d p oi nts  
Bel o w are c urre nt o bjecti ves a n d e n d p oi nts.  
O bjecti ves  
E n d p oi nts  
Pri m ar y ( O per ati o n al)  
•  Deter mi ne ger mli ne H L A ge n o t y p e of 
all e nr olle d partici pa nts.  
•  Pre vale nce of H L A -A * 0 2: 0 1, H L A -
A * 0 2: 0 5, or H L A -A * 0 2: 0 6 allele 
s u bt y pes  
O ver all Desi g n:  
T his is a m ultice nter pr ot oc ol t hat will i n v ol ve i nitial bi o mar ker scree ni n g t o deter mi ne 
p ote ntia l eli gi bilit y f or G S K’s A C T i n vesti gati o nal treat me nt trials.  
T his pr ot oc ol is desi g ne d t o facilitate scree ni n g f or H L A hist o c o m pati bilit y testi n g  b y 
bl o o d sa m ple a nal ysis i n partici pa nts dia g n ose d wit h vari o us mali g na n cies. T his will 
s u p p ort partici pa nt i de ntificati o n f or referral i nt o a n a p pr o priate G S K cell t hera p y 
i n vesti gati o nal treat me nt trial. It is a ntici pat e d t hat t his scree ni n g pr ot oc ol will s u p p ort 
cli nical trials of lete-cel, ne xt ge nerati o n N Y -E S O -1 T C R T -cell pr o d ucts ( e . g. 
G S K 3 9 0 1 9 6 1, G S K 3 8 4 5 0 9 7 , etc) a n d ot her G S K e n gi n eere d T -cell assets,  as t hese asse ts 
bec o me a v aila ble f or cli nical de vel o p me nt , a n d a d diti o nal t u m or t y p es as t h e 
i n vesti gati o nal treat me nt master pr ot oc ols e x pa n d a n d/ or as ot her i n vesti gati o nal 
treat me nt pr ot oc ols are i nitiate d.  
N u m ber of P artici p a nts:  
A p pr o xi matel y 1 0 0 0 p artici pa nts will be e nr olle d i n t his scree ni n g st u d y . T h e o verall 
n u m ber of partici p a nts  scree ne d u n d er t his pr ot oc ol will de pe n d u p o n t he recr uit me nt 
pr o gress o n i n vesti gati o nal treat me nt trials.   
Pr o ce d ures a n d  D ur ati o n:    
D uri n g st u d y Visit 1, all partici pa nts w h o c o nse nt t o t he scree ni n g st u d y a n d are 
deter mi ne d t o meet t he eli gi bilit y criteria f or St u d y 2 1 3 0 3 3 will pr o vi de t h e ma n dat or y  
scree ni n g sa m ples. Partici pa nts w h o c o nse nt t o t he scree ni n g st u d y are c o nsi dere d  
scree n e d i n t he st u d y. A  bl o o d sa m ple f or H L A co m pati bilit y testi n g  will be c ollecte d . 
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Details of HLA compatibility testing and of sample management are provide in the SRM. 
Participants who provide blood sample for HLA compatibility testing are considered 
enrolled in the study. 
If the participant is determined to have qualifying results for an intended investigational 
treatment protocol, then the participant may be considered for referral to GSK trial site to 
complete the rest of the eligibility assessments for the investigational treatment trial.  
If a participant is referred to a GSK investigational treatment study, depending on the 
specific requirements of the investigational treatment protocol, the test result from this 
screening study may be used. Compatibility testing may however need to be repeated, 
either with the sample that was already provided as part of this screening study, or in rare 
cases a fresh sample may need to be collected under the investigational treatment study. 
All participants who have provided a sample for testing will undergo a safety assessment 
for any serious adverse events (SAEs) assessed as related to protocol-mandated study 
procedures or adverse events (AEs) leading to study withdrawal.  
Active study involvement should typically be complete in ≤2 weeks for all participants.   
The screening protocol will remain open until all designated GSK-sponsored 
investigational ACT treatment clinical trials are closed to enrollment or at the discretion 
of GSK. 
 
Data Monitoring Committee:  There is no Data Monitoring Committee for this study. 
 
 

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1.2. 
Schema 

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1. 3.  
S c h e d ul e of A cti viti e s ( S o A)  f or St u d y 2 1 3 0 3 3 
Pr o c e d ure s  
Vi sit 1  
Vi sit 2 4 
 
I nf or m e d c o ns e nt 
X  
 
F o ot n ot e s:  
1
 i ncl u di n g c h e m ot h er a py, r a di ot h er a py 
a n d s ur g er i es will b e c oll ect e d f or all e nr oll e d Sy n ovi al S arc o m a / myx oi d/r o u n d c ell li p os arc o m a 
(M R C L S ) p artici p a nts; a n d will b e r ec or d e d i n t h e Scr e e ni n g e C R F. 
2. H u m a n L e uk ocyt e A nti g e n ( H L A ) s a m pl e –  o n e bl o o d s a m pl e (s e e S ecti o n  8. 1 ).  
3. If pri or m ol ec ul ar  H L A Cl ass I ty pi n g  H L A A r es ults ar e av ail a bl e, r ec or d i n t h e el ectr o nic c as e r e p ort 
f or m (e C R F ). Pri or H L A r es ult will n ot r e pl ac e t h e H L A g e n oty pi n g t h at is a m a n d at ory  p art of t his 
scr e e ni n g st u dy. If p ati e nt  is k n o w n t o b e p ositiv e f or  H L A 0 2: 0 1 , H L A A 0 2: 0 5 a n d/ or  H L A A 0 2: 0 6  t h e n 
p ati e nt c a n b e r ef err e d t o a n i nv esti g ati o n al sit e.   
4. Visit 2 is C o m pl eti o n / Wit h dr a w al a n d m ay occ ur r e m ot ely vi a t el e h e alt h  / p h o n e visit 
 
I ncl usi o n a n d excl usi o n crit eri a 
X  
 
E at er n C o o p er ativ e O nc ol o gy Gr o u p ( E C O G ) 
st at us 
X  
 
H L A g e n oty pi n g 2,3 
X  
 
R evi e w of s eri o us a dv ers e ev e nts (S A Es ) t h at 
ar e 
r el at e d t o st u dy pr oc e d ur e(s) or  a dv ers e ev e nts 
(A Es ) a n d S A Es t h at l e a d t o st u dy wit h dr a w al  
X  
X  
C o nsi d er r ef err al t o a n a p pr o pri at e 
i nv esti g ati o n al tr e at m e nt tri al 
 
X  
C CI
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2. 
INTRODUCTION 
2.1. 
Study Rationale 
This screening study is designed to facilitate the identification of potential participants for 
GlaxoSmithKline (GSK) sponsored trials investigating engineered Adoptive Cell 
Therapy (ACT), via assessment of target biomarkers for preliminary eligibility for the 
investigational treatment trials.  Given the complexity of the engineered ACT preparation 
and administration, the ACT investigational treatment trials will be open at a limited 
number of tertiary medical centers in limited geographic areas. In the initial rollout, the 
screening study will be open at local referral sites and therefore will support 
identification of patients over a wider geographic area at centers that do not have the 
ACT investigational treatment trials available allowing closer-to-home testing and 
thereby reducing the burden for patients to travel to distant sites for initial screening. 
During this initial phase of study implementation, the screening study will include HLA 
compatibility testing to determine preliminary eligibility for GSK’s T-cell Receptor-
targeting (TCR T) investigational treatment trials.  
Currently enrolling trials for GSK T-cell therapy require participants to have the 
histocompatible HLA genotypes (HLA-A*02:01, HLA-A*02:05, or HLA-A*02:06), 
which are carried by roughly 45% of the world’s population [Gonzalez-Galarza, 2015]. 
More than 50% of screened participants will not carry a compatible HLA genotype. The 
screening protocol serves as a simple study to facilitate screening for HLA 
histocompatible participants. The screening protocol reduces the burden of travel to a 
distant T-cell investigational treatment site for participants who are HLA-incompatible 
for a GSK T-cell investigational treatment protocol. In addition to ongoing studies, GSK 
has developed two master protocols (see below schema) for first time in human and for 
further development of a series of cell therapies. The master protocols are designed to 
facilitate the addition of new substudies investigating new tumor types and/or new cell 
therapy agents or combinations of agents. Future additional investigational treatment 
trials may exist as individual studies outside of the two master protocols described above. 
Through a simple and generally applicable design, this screening protocol is expected to 
support participant enrollment into a range of ACT studies investigating an array of 
tumor types and evaluating a collection of  agents available now (such as lete-cel, 
GSK3901961 and GSK3845097) and in the future.  
 

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MRCLS – Myxoid/Round Cell Liposarcoma; NSCLC – Non-small cell lung cancer 
In the future, the screening study may be expanded to other centers including 
investigational treatment trial sites. Additionally, the study may include screening for 
additional biomarkers such as tumor antigen as defined by current and future 
investigational treatment studies; as well as use of local and decentralized laboratory 
testing options.  
2.2. 
Background 
Background for ACT 
ACT is a personalized therapeutic approach involving the infusion of a cancer patient’s 
own (autologous) or donor (allogenic) tumour-specific cytotoxic T cells with the goal of 
recognizing, binding, activating, proliferating and destroying tumor cells.  T cells can be 
engineered using two approaches that are currently under intensive evaluation: chimeric 
antigen receptors (CARs) and engineered TCRs.  T cells are obtained from the participant 
by leukapheresis and then engineered to express either CARs or TCRs. CARs bind to cell 
surface expressed proteins, whereas TCRs bind to epitopes of internal tumor-associated 
antigens (TAAs) presented in complex with HLA molecules on the cell surface.       
Background for Current GSK TCR T cells 
GSK is developing a number of different TCR T-cell therapies that target the cancer testis 
antigens (CTAs) New-York Esophageal Antigen-1 (NY-ESO-1) and Tumor antigen, 
cancer-testis antigen family (LAGE-1a), tumor-associated proteins found in several 
tumor types.  NY-ESO-1 and LAGE-1a are members of the cancer-testis family of tumor 
antigens (CTAs). Specific peptide epitopes of the NY-ESO-1 or LAGE-1a protein are 
processed and presented on the surface of the tumor cell in complex with an HLA 
molecule, which can be recognized by T cells. Therefore, targeting these CTAs require 
compatible HLA alleles in patients participating in the investigational treatment trials. 
The SLLMWITQCaa 157-165 peptide has been identified to be common to both NY-
ESO-1 and LAGE-1a antigens presented on the surface of HLA-A*02 molecules. The T 
cells for therapy have been genetically engineered to express an affinity-enhanced TCR 
toward the SLLMWITQC peptide. The retained optimized TCR clone was called NY-
ESO-1 c259 or c259. The T-cell product consists of autologous T cells transduced with a 
self-inactivating lentiviral vector encoding the affinity enhanced NY-ESO-1 specific 
TCR (c259).  
Previous clinical trials with GSK3377794 (lete-cel) have shown very encouraging 
responses in participants with synovial sarcoma: ORR=61% (n=18) [Robbins, 2015] and 
ORR=50% (n=12) [D'Angelo, 2018]; metastatic melanoma: overall response rate (ORR) 
= 55% (n=20) [Robbins, 2015]; and multiple myeloma: ORR = 60% (n=20) [Rapoport, 
2015]. Lete-cel is currently under clinical investigation in multiple indications including 
multiple myeloma, synovial sarcoma, myxoid/round cell liposarcoma, non-small cell lung 
cancer (NSCLC).  
Despite this encouraging clinical activity, not all patients receiving lete-cel or other ACTs 
have experienced a clinical benefit. Additionally, some patients who achieved responses 
have eventually relapsed with their disease [D'Angelo, 2018]. The likely mechanisms for 
the limited efficacy observed in some patients are multifold. To address this, GSK is 

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currently developing the next generations of TCR T-cell therapies such as GSK3901961, 
GSK3845097, etc. which comprise of efficacy-enhancing technologies embedded into 
lete-cel; as well as an array of other ACT products.  
One requirement of all TCR-directed therapies is that the engineered TCR must recognize 
a peptide epitope of the TAA that is processed and presented on the tumor cell surface, 
and forms the major histocompatibility complex (MHC). The lentiviral vectors used for 
manufacturing of TCR T cells express NY-ESO-1/LAGE-1a that is optimized to 
recognize the SLLMWITQC peptide fragment presented by HLA-A*02 on the cell 
surface. The final T-cell product is comprised of autologous CD4 and CD8 T cells that 
have been transduced with this lentiviral vector. GSK TCR T-cell therapies are 
engineered to enhance the recognition of presented peptides by HLA, and therefore those 
participants who have HLA histocompatibility   may potentiallyrespond to this TCR T 
cell therapy. Future versions of the GSK TCR T cells may target additional tumor 
antigens as presented by different HLA molecules.  
2.3. 
Benefit/Risk Assessment 
2.3.1. 
Risk Assessment 
No investigational product is used in this screening study; consequently, there are no 
risks due to exposure to study drug.  The primary risk to patients in this protocol is the 
risk associated with specimen collection.   
This screening protocol will include facilitation of HLA histocompatibility testing. To 
enable this, each patient is asked to provide a single sample of whole blood for HLA 
testing at the first visit following institutional standard procedure. The risks associated 
with this procedure are due to possible complications related to a blood draw, such as 
pain, bleeding and/or bruising and possible infection although serious complications are 
likely to be very rare. In majority of cases, this blood sample is expected to be collected 
with participants’ routine laboratory collections that are done as part of standard of care. 
Therefore, the HLA blood draw may not pose additional risk. 
There is a low likelihood for an additional blood draw for HLA histocompatibility testing 
under an investigational treatment protocol depending on how the test result was 
generated in the screening protocol and the requirements of the investigational treatment 
protocol.  HLA histocompatibility genotyping test carries a low risk of false positive or 
false negative test results. A false positive test result will mean that the participant may 
be eligible to enter the screening phase of a GSK TCR T-cell investigational treatment 
protocol and would proceed with additional screening in the master protocol.  A false 
negative test result would mean that the participant would not be eligible to enter the 
screening phase of a GSK TCR T-cell investigational treatment protocol.  
The sites are directed to take all appropriate safety measures to protect the well-being of 
the participant and to follow-up on any SAE that would be related to the study procedure. 

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2. 3. 2.  
B e n efit A s s e s s m e nt  
T he m ost direct p ote ntial be nefit t o partici pa nt s i n t his scree ni n g st u d y is t o deter mi ne if 
t he y h a ve q ualif yi n g scree ni n g test res ults, a n d t heref ore, ma y  be eli gi ble t o e nter t he 
scree ni n g p h ase of a G S K T C R T -cell i n vesti gati o nal treat me nt pr ot oc ol  or p ote ntiall y 
ot her T C R st u dies t hat re q uire H L A c o m p ati bilit y testi n g. H o w e ver, t here is n o g uara ntee 
of f urt her eli gi bilit y f or or be nefit fr o m treat me nt u n der i n vesti gati o nal treat me nt 
pr ot oc ol.  
Partici pa nts w h o are d eter mi ne d n ot t o ha ve t he c o m pati ble H L A ge n o t y pe ma y o btai n 
t his i nf or mati o n at t heir l ocal cli nic rat h er t han b y  tra veli n g t o a p ossi bl y dista nt 
i n vesti gati o nal treat me nt trial site f or t he H L A c o m pati bilit y ass ess me nt ; t here b y 
decreasi n g t he o verall b ur de n o n t he patie nt.  
2. 3. 3.  
O v er all B e n efit:  Ri s k C o n cl u si o n  
A ke y  be nefit t o partici pa nts is t he o p p ort u nit y t o be assesse d f or t heir preli mi nar y 
eli gi bilit y f or a G S K T C R  T -cell i n vesti gati o nal treat me nt pr ot oc ol wit h  mi ni mal 
l o gistical iss ues.  T his be nefit w o ul d be of partic ular val ue t o partici pa nts w h o are 
deter mi ne d t o be  i neli gi ble o n i nitial scree ni n g  f or a G S K T C R T -cell i n vesti gati o nal 
treat me nt pr ot oc ol.  T he pri mar y ris k s i n t his scree ni n g pr ot o c ol are t h ose ass ociate d wit h 
bl o o d dra w f or H L A c o m pati bilit y testi n g a n d t he descri be d  ris ks of false p ositi ve a n d/ or 
false ne gati ve test res ults. H o we ver, t he bl o o d sa m ple f or H L A c o m pati bilit y t esti n g ma y 
be c ollecte d at t he sa me ti me as ot her r o uti ne la b orat or y c ollecti o ns a n d t heref ore d oes 
n ot p ose a d diti o nal ris k.  B ala n ci n g t h e be nefits of earl y i de ntificati o n of k e y eli gi bilit y 
criteria, l oc all y t o re d uce b ur de n  of tra vel a n d t he l o w ris ks ass ociate d wit h a bl o o d dra w , 
t he be nefits a p p ear t o o ut wei g h t h e ris ks.    
 
3.  
O B J E C TI V E S A N D E N D P O I N T S 
O bjecti ves  
E n d p oi nts  
Pri m ar y ( O per ati o n al)  
•  Deter mi ne ger mli ne H L A ge n o t y p e of 
all e nr olle d partici pa nts.  
•  Pre vale nce of H L A -A * 0 2: 0 1, H L A -
A * 0 2: 0 5, or H L A -A * 0 2: 0 6 allele 
s u bt y pes  
 
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4. 
STUDY DESIGN 
4.1. 
Overall Design 
This multicenter screening study will assess initial biomarker status to facilitate referral 
of eligible patients for further evaluation to a GSK cell therapy trial site enrolling 
participants with various malignancies. This screening protocol will support clinical trials 
of lete-cel, GSK3901961 & GSK3845097, in tumor types currently under investigation as 
well as additional indications and other GSK cell therapy assets in the future. 
Recruitment to these studies can be challenging due to the high screen fail rate on key 
eligibility criteria, such as compatible HLA genotype, investigation of rare tumor types 
and / or wide distribution of care of the potential patient population compared to a 
relatively small number of sites where ACT investigational treatment trials may be 
conducted.   
4.1.1. 
Protocol Flow 
 
4.2. 
Scientific Rationale for Study Design 
This screening study will prospectively assess biomarkers to determine preliminary 
eligibility for GSK’s ACT investigational treatment trials. Initially, the screening study 
will facilitate screening for participants for compatible HLA genotype. In the future, 
additional biomarkers (e.g. tumor antigens) may be assessed and will be introduced by 
protocol amendment. 
This screening study facilitates the identification and referral of patients who are positive 
for expression of target biomarkers into appropriate GSK ACT investigational treatment 
trials, especially trials in rare tumor types such as synovial sarcoma, or of projected high 
screen fail rates such as NSCLC.  
4.3. 
Justification for Dose 
Not applicable. 

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4.4. 
End of Study Definition 
4.4.1. 
Study completion for participants 
Participants are considered to have completed the study once all specified sample 
collection and/or study procedures have been completed, or they die, or withdraw from 
the study, or the study ends (whichever occurs first). 
4.4.2. 
End of study 
End of study is defined once all follow-up assessments are complete and all participants 
are referred to the eligible investigational treatment protocol, or died or are lost to follow-
up (Section 7.3). The screening protocol will remain open until all designated GSK-
sponsored adoptive cell therapy clinical trials are closed to enrollment and the last 
participant in the screening study has completed their last visit or until a date otherwise 
determined at the discretion of GSK. 
 
5. 
STUDY POPULATION 
Prospective approval of protocol deviations to recruitment and enrollment criteria, also 
known as protocol waivers or exemptions, is not permitted. The inclusion and exclusion 
criteria are only applicable for the purposes of this screening protocol. Each TCR T-cell 
investigational treatment protocol will have additional criteria that are specific to that 
investigational treatment and the tumor type(s) under investigation. 
5.1. 
Inclusion Criteria 
Participants are eligible to be included in the study only if all the following criteria apply:   
1. Able to provide written informed consent. 
2. Histologically or cytologically confirmed diagnosis of locally advanced high-risk 
(metastatic or unresectable) solid tumor or hematological malignancy. Refer to 
SRM for additional disease characteristics and eligible tumor types. 
3. Male or female ≥18 years of age (or ≥10 years of age with synovial sarcoma or 
MRCLS).  
4. Life expectancy of >6 months. 
5. Performance status: ECOG 0-1 
5.2. 
Exclusion Criteria 
Participants are excluded from the study if any of the following criteria apply: 
1. Any serious and/or unstable pre-existing medical, psychiatric disorder or other 
conditions that could interfere with the subject’s safety, obtaining informed 
consent or compliance to the screening study procedures. 

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2. Any prior treatment with oncology cell and/or gene therapy (including TCR-T 
therapy or chimeric antigen receptor- T cells [CAR-T] therapy) unless agreed in 
advance with Sponsor. 
3. Prior gene therapy using an integrating vector unless agreed in advance with 
Sponsor. 
4. Any other prior malignancy that is not in complete remission. Exceptions include:  
a. completely resected non-melanoma skin cancer, or successfully treated in situ 
carcinoma (melanoma in situ, basal cell carcinoma, prostate ca in-situ, periosteal 
osteosarcoma) 
b. previous malignancies that have been definitively treated, and have been in 
remission for 5 years may be enrolled upon consultation with sponsor Medical 
Monitor or designee 
5.  Clinically significant systemic illness:  
a. serious active infections or significant cardiac, pulmonary, hepatic or other 
organ dysfunction, that in the judgment of the Investigator would compromise the 
participant’s ability to tolerate procedures in a investigational treatment study 
such as leukapheresis or lymphodepletion, or significantly increase the risk of 
complications OR  
b. prior or active demyelinating disease 
6. Previous treatment with genetically engineered NY-ESO-1-specific T cells, NY-
ESO1 vaccine, or NY-ESO-1 targeting antibody. 
7. Previous allogeneic hematopoietic stem cell transplant within the last 5 years or 
solid organ transplant. 
5.3. 
Lifestyle Considerations 
No restrictions are required. 
5.4. 
Screen Failures 
Screen failures are defined as participants who consent to participate in the clinical study, 
but who are not subsequently entered in the study. A minimal set of screen failure 
information is required to ensure transparent reporting of screen failure participants to 
meet the Consolidated Standards of Reporting Trials (CONSORT) publishing 
requirements and to respond to queries from regulatory authorities. Minimal information 
includes participant identifier, demography, screen failure details, eligibility criteria, 
protocol deviations, and any SAEs related to protocol-mandated study procedures and, 
for certain tumor types, medical history, disease characteristics including sites of 
metastasis and prior lines of anti-cancer treatments. 
Individuals who do not meet the criteria for participation in this study (screen failure) 
may be rescreened under this screening protocol or directly under the investigational 
treatment protocol.  
Consent to another GSK TCR T-cell investigational treatment protocol is allowed. 

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6. 
STUDY INTERVENTION 
No investigational drug will be used in Study 213033.  Consequently, the following 
sections are not applicable to this protocol: 
• Section 6.1:  Study Intervention(s) Administered 
• Section 6.2:  Preparation/Handling/Storage/Accountability 
• Section 6.3:  Measures to Minimize Bias:  Randomization and Blinding 
• Section 6.4:  Study Intervention Compliance 
• Section 6.5:  Treatment Overdose 
• Section 6.6:  Concomitant Therapy 
• Section 6.7:  Dose Modification 
• Section 6.8:  Continued Access to Study Intervention after the End of the Study 
 
7. 
DISCONTINUATION OF STUDY INTERVENTION AND 
PARTICIPANT DISCONTINUATION/WITHDRAWAL 
7.1. 
Discontinuation of Study Intervention 
Not applicable. 
7.2. 
Participant Discontinuation/Withdrawal from the Study 
A participant may withdraw from the study at any time at his/her own request or may be 
withdrawn at any time at the discretion of the investigator for safety, behavioral, 
compliance or administrative reasons. This is expected to be uncommon. 
The participant will be permanently discontinued from the study at that time. 
If the participant withdraws consent for disclosure of future information, the sponsor may 
retain and continue to use any data collected before such a withdrawal of consent. 
If a participant withdraws from the study, he/she may request destruction of any samples 
taken and not tested, and the investigator must document this in the site study records. 
A participant will be determined to have withdrawn from study early for any of the 
following reasons: 
• The participant is able to but did not provide the required sample(s). 
•  The participant withdraws consent  
•  Death of any cause 
• Any other reasons 
7.3. 
Lost to Follow-Up 
A participant will be considered lost to follow-up if he or she is unable to be contacted by 
the study site.  

T M F -1 3 8 3 7 2 0 1  
C O N FI D E N TI A L  
 
 
 
2 1 3 0 3 3  
 
1 8  
 
T he f oll o wi n g acti o ns m ust be ta ke n if a p artici pa nt fails t o ret ur n t o t he cli nic f or a 
re q uire d st u d y visit: 
•  T he site m ust atte m pt t o c o ntact t he partici pa nt a n d resc he d ul e t he misse d visit as 
s o o n as p ossi ble a n d c o u nsel t he partici pa nt o n t h e i m p orta nce of mai ntai ni n g t he 
assi g ne d visit sc he d ul e a n d ascert ai n w het her or  n ot t he partici pa nt wis hes t o 
a n d/ or s h o ul d c o nti n ue i n t he st u d y. 
•  Bef ore a p artici pa nt is dee me d l ost t o f oll o w u p, t he i n vesti gat or or desi g n ee m ust 
ma ke e ver y eff ort t o re gai n c o ntact wit h t he partici pa nt ( w here p ossi ble, 3 
tele p h o ne calls a n d, if necessar y, a certifie d letter t o t he partici pa nt’s last k n o w n 
maili n g a d dress or l ocal e q ui vale nt met h o ds). T hese c o ntact atte m pts s h o ul d be 
d oc u me nte d i n t he partici pa nt’s me dical r ec or d.  
•  S h o ul d t he partici pa nt c o nti n ue t o be u nreac ha ble, he/s he will be c o nsi dere d t o 
ha ve wit h dra w n fr o m t he st u d y.  
Disc o nti n uati o n of s pecific sites or of t he st u d y as a w h ole are ha n dle d as p art of 
A p pe n di x 1 . 
 
8.  
S T U D Y A S S E S S M E N T S A N D P R O C E D U R E S  
•  
St u d y pr oce d ures a n d t heir ti mi n g are s u m marize d i n t he S o A.  
•  
Pr ot oc ol wai vers or e x e m pti o ns are n ot all o we d .  
•  
A d here n ce t o t he st u d y d esi g n re q uire me nts, i ncl u di n g t h ose s pecifie d i n t he S o A, is 
esse ntial a n d re q uire d f or st u d y c o n d u ct.  
•  
All scree ni n g e v al uati o ns m ust be c o m plete d  a n d re vie we d t o c o nfir m t hat p ote ntial 
partici pa nts meet all eli gi bilit y criteria. T h e i n vesti gat or will mai ntai n a scree ni n g 
l o g t o rec or d det ails of all partici pa nts scree ne d a n d t o c o nfir m eli gi bilit y or rec or d 
reas o ns f or scree ni n g fail ure, as a p plica ble.  
•  
T he ma xi m u m a m o u nt of bl o o d c ollecte d fr o m eac h partici pa nt o ver t h e d urati o n of 
t he st u d y will n ot e x cee d 1 0  m L.  If f or a n y reas o n t here is a nee d f or a d diti o nal 
sa m ple, a d diti o nal bl o o d dra w ma y be re q uir e d. 
•  
Data c ollecti o n : Patie nts dia g n ose d wit h cert ai n ca ncers w h o u n d er g o H L A 
c o m pati bilit y testi n g  i n t he scree ni n g pr ot oc ol ma y be t ar gete d f or a re gistrati o nal or  
re gistrati o n i nte nt cell t hera p y i n vesti gati o nal treat me nt st u d y. T heref ore, i n s u p p ort 
of t he i n vesti gati o nal A C T treat me nt trials  t he a d diti o nal data  bel o w  will be c ollecte d  
f or s uc h i n dicati o ns.  At t his ti me, t his a p plies t o s y n o vial sarc o ma a n d M R C L S b ut 
ma y a p pl y t o ot her i n dicati o ns i n f ut ure.  
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8.1. 
HLA Compatibility Testing 
HLA compatibility testing at the allelic level (4-digit) will be carried out on a mandatory 
whole blood sample as described in the SRM.   
Participants who have previously been determined to have the compatible HLA genotype 
(HLA-A*02:01, HLA-A*02:05, or HLA-A*02:06) using a high-resolution test may be 
referred to the GSK investigational treatment study without repeating the HLA 
compatibility testing under this screening study. Such participants will undergo repeat 
HLA compatibility testing as specified in the GSK investigational treatment study.     
8.2. 
Efficacy Assessments 
Not applicable. 
8.3. 
Safety Assessments 
All participants will be followed for all SAEs related to protocol-mandated procedure(s), 
and AEs or SAEs leading to withdrawal from the study. 
8.4. 
Serious Adverse Events 
The definition of an AE and SAE can be found in Appendix 2. 
The investigator and any qualified designees are responsible for detecting, documenting, 
and reporting events that meet the definition of an SAE and remain responsible for 
following up SAEs that are considered related to the study procedure(s), or that caused 
the participant to withdraw early whether or not related to study procedures (see Section 
7). AEs (SAE for this case) will be reported by the participant (or, when appropriate, by a 
caregiver, surrogate, or the participant's legally authorized representative). 
8.4.1. 
Time Period and Frequency for Collecting SAE Information 
• 
All SAEs assessed as related to protocol-mandated procedure(s) or both AEs and 
SAEs leading to early study withdrawal (whether or not related to study procedures) 
will be collected from the signing of the informed consent form (ICF) until 
conclusion of study participation (completes study, withdraws early, or screen fails), 
at the time points specified in the SoA (Section 1.3).   
• 
All SAEs assessed as related to protocol-mandated procedure(s) or leading to early 
study withdrawal (whether or not related to study procedures) will be recorded and 
reported to the sponsor or designee immediately and under no circumstance should 
this exceed 24 hours, as indicated in Appendix 2. The investigator will submit any 
updated SAE data to the sponsor within 24 hours of it being available. 
• 
Investigators are not obligated to actively seek SAEs after the conclusion of the 
study participation. However, if the investigator learns of any SAE, including a 
death, at any time after a participant has been discharged from the study, and he/she 
considers the event to be reasonably related to a study procedure, the investigator 
must promptly notify the sponsor. 

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8.4.2. 
Method of Detecting SAEs 
• 
The method of recording, evaluating, and assessing causality of SAEs and the 
procedures for completing and transmitting SAE reports are provided in Appendix 2. 
• 
Care will be taken not to introduce bias when detecting SAEs. Open-ended and non-
leading verbal questioning of the participant is the preferred method to inquire about 
SAE occurrence.  
8.4.3. 
Follow-up of SAEs 
After the initial SAE report, the investigator is required to proactively follow each 
participant at subsequent visits/contacts. All SAEs assessed as related to protocol-
mandated procedure(s), or leading to early study withdrawal (whether or not related to 
study procedures), will be followed until the event is resolved, stabilized, otherwise 
explained, or the participant is lost to follow-up (as defined in Section 7.3). Further 
information on follow-up procedures is given in Appendix 2. 
8.4.4. 
Regulatory Reporting Requirements for SAEs 
• 
Prompt notification by the investigator to the sponsor of a SAE is essential so that 
legal obligations and ethical responsibilities towards the safety of participants and 
the safety of a study intervention under clinical investigation are met.  
• 
The sponsor has a legal responsibility to notify both the local regulatory authority 
and other regulatory agencies about the safety of a study intervention under clinical 
investigation. The sponsor will comply with country-specific regulatory 
requirements relating to safety reporting to the regulatory authority, Institutional 
Review Boards (IRB)/Independent Ethics Committees (IEC), and investigators. 
• 
Investigator safety reports must be prepared for suspected unexpected serious 
adverse reactions (SUSAR) according to local regulatory requirements and sponsor 
policy and forwarded to investigators as necessary. 
• 
An investigator who receives an investigator safety report describing a SAE or other 
specific safety information e.g., summary or listing of SAE from the sponsor will 
review and then file it along with the Investigator’s Brochure (IB) and will notify the 
IRB/IEC, if appropriate according to local requirements. 
8.5. 
Pharmacokinetics 
Not applicable. 
8.6. 
Genetics 
Not applicable. 
8.7. 
Biomarkers 
Not applicable. 
8.8. 
Immunogenicity Assessments 
Not applicable 

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8.9. 
Health Economics OR Medical Resource Utilization and 
Health Economics 
Not applicable 
 
9. 
STATISTICAL CONSIDERATIONS 
9.1. 
Statistical Hypotheses 
This is a screening protocol. No hypothesis will be tested under this protocol. 
9.2. 
Sample Size Determination 
Approximately 1000 participants will be enrolled in this screening study. The overall 
number of participants screened under this protocol will depend upon the recruitment 
progress on investigational treatment trials. Enrolment will continue until minimum 
sample size defined for investigational treatment protocols have been reached or until 
decided by GSK. 
9.3. 
Populations for Analyses 
For purposes of data summarization and reporting, the following populations are defined: 
Population 
Description 
Screened 
All participants who sign the ICF 
Enrolled 
All participants who provide sample for biomarker assessment 
9.4. 
Statistical Analyses 
9.4.1. 
Safety Analyses 
All safety analyses will be performed on all patients who provided informed consent.  
Data will be listed and summarized according to the GSK reporting standards, where 
applicable.  Complete details will be documented in the Reporting and Analysis Plan 
(RAP).  Any deviations from, or additions to, the original analysis plan described in this 
protocol will be documented in the RAP and final study report. 
SAE data will be summarized overall; by tumor type; and by HLA subtype.  These 
summaries will be categorized by frequency and proportion of total subjects.  All SAEs 
will be coded using the standard Medical Dictionary for Regulatory Activities (MeDRA).  
Summary of AEs leading to study withdrawal will also be provided. 
9.4.2. 
Other Analyses 
Primary Objective:  

T M F -1 3 8 3 7 2 0 1  
C O N FI D E N TI A L  
2 1 3 0 3 3  
2 2  
C o m pati ble H L A  ge n o t y pes f or H L A-A l oc us  will be  liste d a n d s u m marize d b y t u m or 
t y pe. Se p arate s u m maries of H L A-A ma y b e gi ve n  b y et h nicit y.  T he p atie nt data  a n d 
H L A res ult o btai ne d f or t he p ur p ose d of eli gi bilit y deter mi nati o n i nt o t he G S K 2 0 8 4 6 7 
st u d y ma y  be us e d f or t h e f ut ure re g ulat or y  re gistrati o ns.   
9. 5.  
I nt eri m A n al y s e s 
N o i nteri m a nal ysis is pla n ne d f or t his st u d y.  T h e data fr o m t his st u d y ma y be use d 
a n yti me t o s u p p ort dat a a nal ysis o n t he cell t hera p y i n vesti gati o nal treat me nt st u dies t hat 
t he partici pa nts will be referre d t o. 
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10. 
SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS 
10.1. 
Appendix 1: Regulatory, Ethical, and Study Oversight 
Considerations 
10.1.1. 
Regulatory and Ethical Considerations 
This study will be conducted in accordance with the protocol and with: 
• 
Consensus ethical principles derived from international guidelines 
including the Declaration of Helsinki and Council for International 
Organizations of Medical Sciences (CIOMS) International Ethical 
Guidelines 
• 
Applicable International Council of Harmonization (ICH) Good Clinical 
Practice (GCP) Guidelines 
• 
Applicable laws and regulations 
• 
The protocol, protocol amendments, ICF, IB and other relevant documents 
(e.g., advertisements) must be submitted to an IRB/IEC by the investigator 
and reviewed and approved by the IRB/IEC before the study is initiated.  
• 
Any amendments to the protocol will require IEC/IRB approval before 
implementation of changes made to the study design, except for changes 
necessary to eliminate an immediate hazard to study participants.  
• 
Protocols and any substantial amendments to the protocol will require 
health authority approval prior to initiation except for changes necessary to 
eliminate an immediate hazard to study participants. 
• 
The investigator will be responsible for the following: 
- 
     Providing written summaries of the status of the study to the 
IRB/IEC annually or more frequently in accordance with the 
requirements, policies, and procedures established by the IRB/EC 
- 
     Notifying the IRB/IEC of SAE or other significant safety findings 
as required by IRB/IEC procedures 
- 
     Providing oversight of the conduct of the study at the site and 
adherence to requirements of 21 Code of Federal Regulation (CFR), 
ICH guidelines, the IRB/IEC, European regulation 536/2014 for 
clinical studies (if applicable), and all other applicable local 
regulations 
10.1.2. 
Financial Disclosure 
Investigators and sub-investigators will provide the sponsor with sufficient, accurate 
financial information as requested to allow the sponsor to submit complete and accurate 
financial certification or disclosure statements to the appropriate regulatory authorities. 
Investigators are responsible for providing information on financial interests during the 
course of the study and for 1 year after completion of the study. 

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10.1.3. 
Informed Consent Process 
• 
The investigator or his/her representative will explain the nature of the study to the 
participant or his/her legally authorized representative and answer all questions 
regarding the study.  
• 
Participants must be informed that their participation is voluntary. Participants or 
their legally authorized representative will be required to sign a statement of 
informed consent that meets the requirements of 21 CFR 50, local regulations, ICH 
guidelines, Health Insurance Portability and Accountability Act (HIPAA) 
requirements, where applicable, and the IRB/IEC or study center.  
• 
The medical record must include a statement that written informed consent was 
obtained before the participant was enrolled in the study and the date the written 
consent was obtained. The authorized person obtaining the informed consent must 
also sign the ICF. 
• 
Where country and/or local regulations allow, electronic consenting may be 
permitted. For such participants, blood sample collection must be performed at the 
next feasible scheduled visit to the site. Where applicable country and local 
regulations; and infrastructure for home healthcare allow, upon approval by the 
sponsor, home healthcare visit may take place at a location other than the clinical 
trial site to perform study assessments including but not limited to blood sample 
collection. 
• 
Participants must be re-consented to the most current version of the ICF(s) during 
their participation in the study.  
• 
A copy of the ICF(s) must be provided to the participant or the participant’s legally 
authorized representative.  
• 
Participants who are rescreened are required to sign a new ICF. Such participants 
will be assigned a unique subject identifier at the time of rescreening. 
• 
GSK (alone or working with others) may use participant’s coded study data and 
samples and other information to carry out this study; understand the results of this 
study; learn more about the study intervention or about the study disease; publish the 
results of these research efforts; work with government agencies or insurers to have 
the study intervention approved for medical use or approved for payment coverage. 
 
The ICF may contain a separate section that addresses the use of remaining mandatory 
samples for optional exploratory research in accordance with standard operating 
procedure (SOP)-GSKF-410. The investigator or authorized designee will explain to each 
participant the objectives of the exploratory research. Participants will be told that they 
are free to refuse to participate and may withdraw their consent at any time and for any 
reason during the storage period. A separate signature will be required to document a 
participant's agreement to allow any remaining specimens to be used for exploratory 
research. Participants who decline to participate will not provide this separate signature. 

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10.1.4. 
Data Protection 
• 
Participants will be assigned a unique identifier by the sponsor. Any participant 
records or datasets that are transferred to the sponsor will contain the identifier only; 
participant names or any information which would make the participant identifiable 
will not be transferred.  
• 
The participant must be informed that his/her personal study-related data will be 
used by the sponsor in accordance with local data protection law. The level of 
disclosure must also be explained to the participant who will be required to give 
consent for their data to be used as described in the informed consent.  
• 
The participant must be informed that his/her medical records may be examined by 
Clinical Quality Assurance auditors or other authorized personnel appointed by the 
sponsor, by appropriate IRB/IEC members, and by inspectors from regulatory 
authorities. 
10.1.5. 
Dissemination of Clinical Study Data 
• 
Where required by applicable regulatory requirements, an investigator signatory will 
be identified for the approval of the clinical study report.  The investigator will be 
provided reasonable access to summary tables, figures, and relevant reports and will 
have the opportunity to review the complete study results at a GSK site or other 
mutually-agreeable location. 
• 
GSK will also provide the investigator with the full summary of the study results.  
The investigator is encouraged to share the summary results with the study subjects, 
as appropriate. 
• 
The procedures and timing for public disclosure of the protocol and results summary 
and for development of a manuscript for publication for this study will be in 
accordance with GSK Policy. 
• 
GSK intends to make anonymized participant-level data from this trial available to 
external researchers for scientific analyses or to conduct further research that can 
help advance medical science or improve patient care. This helps ensure the data 
provided by trial participants are used to maximum effect in the creation of 
knowledge and understanding. 
10.1.6. 
Data Quality Assurance 
• 
All participant data relating to the study will be recorded on printed or electronic 
case report form (eCRF) unless transmitted to the sponsor or designee electronically 
(e.g., laboratory data). The investigator is responsible for verifying that data entries 
are accurate and correct by physically or electronically signing the case report form 
(CRF).  
• 
Guidance on completion of CRFs will be provided in eCRF completion guidelines. 
• 
The investigator must permit study-related monitoring, audits, IRB/IEC review, and 
regulatory agency inspections and provide direct access to source data documents.  
• 
Monitoring details describing strategy (e.g., risk-based initiatives in operations and 
quality such as Risk Management and Mitigation Strategies and Analytical Risk-
Based Monitoring), methods, responsibilities and requirements, including handling 

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of noncompliance issues and monitoring techniques (central, remote, or on-site 
monitoring) are provided in the Monitoring Plan. 
• 
The sponsor or designee is responsible for the data management of this study 
including quality checking of the data. Detailed information about study data 
collection and management process including systems used can be found in the study 
Data Management Plan. 
• 
The sponsor assumes accountability for actions delegated to other individuals (e.g., 
Contract Research Organizations). 
• 
Records and documents, including signed ICF, pertaining to the conduct of this study 
must be retained by the investigator for 25 years from the issue of the final Clinical 
Study Report (CSR)/ equivalent summary unless local regulations or institutional 
policies require a longer retention period. No records may be destroyed during the 
retention period without the written approval of the sponsor. No records may be 
transferred to another location or party without written notification to the sponsor.  
10.1.7. 
Source Documents 
• 
Source documents provide evidence for the existence of the participant and 
substantiate the integrity of the data collected. Source documents are filed at the 
investigator’s site. 
• 
Data reported on the CRF or entered in the eCRF that are transcribed from source 
documents must be consistent with the source documents or the discrepancies must 
be explained. The investigator may need to request previous medical records or 
transfer records, depending on the study. Also, current medical records must be 
available. 
• 
Definition of what constitutes source data and its origin can be found in eCRF 
completion guidelines. 
• 
The investigator must maintain accurate documentation (source data) that supports 
the information entered in the CRF. 
• 
Study monitors will perform ongoing source data verification to confirm that data 
entered into the CRF by authorized site personnel are accurate, complete, and 
verifiable from source documents; that the safety and rights of participants are being 
protected; and that the study is being conducted in accordance with the currently 
approved protocol and any other study agreements, ICH GCP, and all applicable 
regulatory requirements. 
10.1.8. 
Study and Site Closure 
GSK or its designee reserves the right to close the study site or terminate the study at any 
time for any reason at the sole discretion of GSK. Study sites will be closed upon study 
completion. A study site is considered closed when all required documents and study 
supplies have been collected and a study-site closure visit has been performed. 
The investigator may initiate study-site closure at any time, provided there is reasonable 
cause and sufficient notice is given in advance of the intended termination. 

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Reasons for the early closure of a study site by the sponsor or investigator may include 
but are not limited to: 
• 
Failure of the investigator to comply with the protocol, the requirements of the 
IRB/IEC or local health authorities, the sponsor's procedures, or GCP guidelines 
• 
Inadequate recruitment of participants by the investigator 
• 
Discontinuation of further study activity development 
 
If the study is prematurely terminated or suspended, the sponsor shall promptly inform 
the investigators, the IECs/IRBs, the regulatory authorities, and any contract research 
organization(s) used in the study of the reason for termination or suspension, as specified 
by the applicable regulatory requirements. The investigator shall promptly inform the 
subject and should assure appropriate participant follow-up 
10.1.9. 
Publication Policy 
• 
The results of this study may be published or presented at scientific meetings. If this 
is foreseen, the investigator agrees to submit all manuscripts or abstracts to the 
sponsor before submission. This allows the sponsor to protect proprietary 
information and to provide comments.  
• 
The sponsor will comply with the requirements for publication of study results. In 
accordance with standard editorial and ethical practice, the sponsor will generally 
support publication of multicenter studies only in their entirety and not as individual 
site data. In this case, a coordinating investigator will be designated by mutual 
agreement. 
• 
Authorship will be determined by mutual agreement and in line with International 
Committee of Medical Journal Editors authorship requirements. 

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10.2. 
Appendix 2: AE and SAE: Definitions and Procedures for 
Recording, Evaluating, Follow-up, and Reporting 
10.2.1. 
Definition of AE 
AE Definition 
• 
An AE is any untoward medical occurrence in a clinical study participant, 
temporally associated with the use of a study intervention, whether or not 
considered related to the study intervention. 
• 
NOTE: An AE can therefore be any unfavorable and unintended sign (including 
an abnormal laboratory finding), symptom, or disease (new or exacerbated) 
temporally associated with the use of a study intervention. 
 
Events Meeting the AE Definition 
• 
Any abnormal laboratory test results (hematology, clinical chemistry, or 
urinalysis) or other safety assessments (e.g., electrocardiogram (ECG), 
radiological scans, vital signs measurements), including those that worsen from 
baseline, considered clinically significant in the medical and scientific judgment of 
the investigator (i.e., not related to progression of underlying disease). 
• 
Exacerbation of a chronic or intermittent existing condition including either an 
increase in frequency and/or intensity of the condition. 
• 
New conditions detected or diagnosed after study intervention administration even 
though it may have been present before the start of the study. 
• 
Signs, symptoms, or the clinical sequelae of a suspected drug-drug interaction. 
• 
Signs, symptoms, or the clinical sequelae of a suspected overdose of either study 
intervention or a concomitant medication. Overdose per se will not be reported as 
an AE/SAE unless it is an intentional overdose taken with possible suicidal/self-
harming intent. Such overdoses should be reported regardless of sequelae. 
 
Events NOT Meeting the AE Definition  
• 
Any abnormal safety assessments which are associated with the underlying 
disease, unless judged by the investigator to be more severe than expected for the 
participant’s condition. 
• 
The disease/disorder being studied or expected progression, signs, or symptoms of 
the disease/disorder being studied, unless more severe than expected for the 
participant’s condition. 
• 
Medical or surgical procedure (e.g., endoscopy, appendectomy): the condition that 
leads to the procedure is the AE. 

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• 
Situations in which an untoward medical occurrence did not occur (social and/or 
convenience admission to a hospital). 
• 
Anticipated day-to-day fluctuations of existing disease(s) or condition(s) present 
or detected at the start of the study that do not worsen. 
10.2.2. 
Definition of SAE 
If an event is not an AE per definition above, then it cannot be an SAE even if serious 
conditions are met (e.g., hospitalization for signs/symptoms of the disease under study, 
death due to progression of disease). 
A SAE is defined as any untoward medical occurrence that, at any dose: 
• 
Results in death 
• 
Is life-threatening 
The term 'life-threatening' in the definition of 'serious' refers to an event in which the 
participant was at risk of death at the time of the event. It does not refer to an event, 
which hypothetically might have caused death, if it were more severe. 
Requires inpatient hospitalization or prolongation of existing hospitalization 
In general, hospitalization signifies that the participant has been detained (usually 
involving at least an overnight stay) at the hospital or emergency ward for observation 
and/or treatment that would not have been appropriate in the physician’s office or 
outpatient setting. Complications that occur during hospitalization are AE. If a 
complication prolongs hospitalization or fulfills any other serious criteria, the event is 
serious. When in doubt as to whether “hospitalization” occurred or was necessary, the 
AE should be considered serious. 
Hospitalization for elective treatment of a existing condition that did not worsen from 
baseline is not considered an AE. 
Results in persistent disability/incapacity 
• 
The term disability means a substantial disruption of a person’s ability to conduct 
normal life functions. 
• 
This definition is not intended to include experiences of relatively minor medical 
significance such as uncomplicated headache, nausea, vomiting, diarrhea, 
influenza, and accidental trauma (eg, sprained ankle) which may interfere with or 
prevent everyday life functions but do not constitute a substantial disruption. 

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Is a congenital anomaly/birth defect 
Other situations: 
• 
Medical or scientific judgment should be exercised in deciding whether SAE 
reporting is appropriate in other situations such as important medical events that 
may not be immediately life-threatening or result in death or hospitalization but 
may jeopardize the participant or may require medical or surgical intervention to 
prevent one of the other outcomes listed in the above definition. These events 
should usually be considered serious. 
Examples of such events include invasive or malignant cancers, intensive 
treatment in an emergency room or at home for allergic bronchospasm, blood 
dyscrasias or convulsions that do not result in hospitalization, or development of 
drug dependency or drug abuse. 
All participants will be followed for all SAEs related to study procedures and for all 
SAEs leading to withdrawal from the study. 
The investigator and any qualified designees are responsible for detecting, documenting, 
and reporting events that meet the definition of an SAE and remain responsible for 
following up SAEs that are considered related to the study procedure(s) or that caused the 
participant to withdraw early, whether or not related to study procedures (see Section 7). 
10.2.3. 
Recording and Follow-Up of AE and SAE 
AE and SAE Recording 
• 
When an AE/SAE occurs, it is the responsibility of the investigator to review all 
documentation (e.g. hospital progress notes, laboratory, and diagnostics reports) 
related to the event. 
• 
The investigator will then record all relevant AE/SAE information in the CRF. 
• 
It is not acceptable for the investigator to send photocopies of the participant’s 
medical records to GSK in lieu of completion of the GSK /AE/SAE CRF page. 
• 
There may be instances when copies of medical records for certain cases are 
requested by GSK. In this case, all participant identifiers, with the exception of the 
participant number, will be redacted on the copies of the medical records before 
submission to GSK. 
• 
The investigator will attempt to establish a diagnosis of the event based on signs, 
symptoms, and/or other clinical information. Whenever possible, the diagnosis 
(not the individual signs/symptoms) will be documented as the AE/SAE. 
Assessment of Intensity 
• 
The Investigator will make an assessment of intensity for each AE and SAE 
reported during the study according to the National Cancer Institute Common 
Terminology Criteria for Adverse Events (NCI-CTCAE v 5.0).  

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Assessment of Causality 
• 
The investigator is obligated to assess the relationship between study intervention 
[defined as investigational intervention and each occurrence of each AE/SAE. 
• 
A "reasonable possibility" of a relationship conveys that there are facts, evidence, 
and/or arguments to suggest a causal relationship, rather than a relationship cannot 
be ruled out. 
• 
The investigator will use clinical judgment to determine the relationship. 
• 
Alternative causes, such as underlying disease(s), concomitant therapy, and other 
risk factors, as well as the temporal relationship of the event to study intervention 
administration will be considered and investigated. 
• 
The investigator will also consult the IB and/or Product Information, for marketed 
products, in his/her assessment. 
• 
For each AE/SAE, the investigator must document in the medical notes that 
he/she has reviewed the AE/SAE and has provided an assessment of causality. 
• 
There may be situations in which an SAE has occurred, and the investigator has 
minimal information to include in the initial report to GSK. However, it is very 
important that the investigator always make an assessment of causality for 
every event before the initial transmission of the SAE data to GSK. 
• 
The investigator may change his/her opinion of causality in light of follow-up 
information and send an SAE follow-up report with the updated causality 
assessment. 
• 
The causality assessment is one of the criteria used when determining regulatory 
reporting requirements. 
 
Follow-up of AE and SAE 
• 
The investigator is obligated to perform or arrange for the conduct of supplemental 
measurements and/or evaluations as medically indicated or as requested by GSK 
to elucidate the nature and/or causality of the AE or SAE as fully as possible. This 
may include additional laboratory tests or investigations, histopathological 
examinations, or consultation with other health care professionals. 
• 
If a participant dies during participation in the study or during a recognized 
follow-up period, the investigator will provide GSK with a copy of any post-
mortem findings including histopathology.  
• 
New or updated information will be recorded in the originally completed CRF. 
• 
The investigator will submit any updated SAE data to GSK within 24 hours of 
receipt of the information. 

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10.2.4. 
Reporting of SAE to GSK 
SAE Reporting to GSK via Electronic Data Collection Tool 
• 
The primary mechanism for reporting SAE to GSK will be the electronic data 
collection tool. 
• 
If the electronic system is unavailable, then the site will use the paper SAE data 
collection tool (see next section) in order to report the event within 24 hours. 
• 
The site will enter the SAE data into the electronic system as soon as it becomes 
available. 
• 
The investigator or medically-qualified sub-investigator must show evidence 
within the eCRF (e.g., check review box, signature, etc.) of review and verification 
of the relationship of each SAE to study participation (causality) within 72 hours 
of SAE entry into the eCRF. 
• 
After the study is completed at a given site, the electronic data collection tool will 
be taken off-line to prevent the entry of new data or changes to existing data. 
• 
If a site receives a report of a new SAE from a study participant or receives 
updated data on a previously reported SAE after the electronic data collection tool 
has been taken off-line, then the site can report this information on a paper SAE 
form (see next section) or to the medical monitor/SAE coordinator by telephone. 
• 
Contacts for SAE reporting can be found in the SRM. 
 
SAE Reporting to GSK via Paper CRF 
• 
Facsimile transmission of the SAE paper CRF could be an alternative method to 
transmit this information to the medical monitor or the SAE coordinator if 
eCRF is not available. 
• 
In rare circumstances and in the absence of facsimile equipment, notification by 
telephone is acceptable with a copy of the SAE data collection tool sent by 
overnight mail or courier service. 
• 
Initial notification via telephone does not replace the need for the investigator to 
complete and sign the SAE CRF pages within the designated reporting time 
frames. 
• 
Contacts for SAE reporting can be found in the SRM. 
 

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10.3. 
Appendix 3: Abbreviations and Trademarks 
ACT 
Adoptive Cell Therapy 
AE 
Adverse event 
CAR 
Chimeric Antigen Receptor 
CAR-T 
Chimeric Antigen Receptor -T cell 
CFR 
Code of Federal Regulation 
CIOMS 
Council for International Organizations of Medical Sciences 
CONSORT 
Consolidated Standards of Reporting Trials 
CRF 
Case Report Form 
CSR 
Clinical study report 
CTA 
Cancer testis antigens 
ctDNA 
Circulating tumor DNA 
CV 
Cardiovascular 
DLBCL 
Diffuse Large B-cell Lymphoma 
DNA 
Deoxyribonucleic acid 
DOR 
Duration of response 
eCRF 
Electronic case report form 
ECG 
Electrocardiogram 
ECOG 
Eastern Cooperative Oncology Group 
GCP 
Good Clinical Practice 
GSK 
GlaxoSmithKline 
HIPAA 
Health Insurance Portability and Accountability Act 
HLA 
Human Leukocyte Antigen 
IB 
Investigator’s Brochure 
ICF 
Informed Consent Form 
ICH 
International Council of Harmonization 
IEC 
Independent Ethics Committee 
IRB 
Institutional Review Board 
LAGE-1a 
Tumour antigen, cancer-testis antigen family 
MedDRA 
Medical Dictionary for Regulatory Activities 
MHC 
Major histocompatibility complex 
mL 
Milliliter 
MRCLS 
Myxoid/round cell liposarcoma 
NSCLC 
Non-small cell lung cancer 
NY-ESO-1 
New-York Esophageal Antigen-1 
ORR 
Overall Response rate 
RAP 
Reporting and Analysis Plan 
SAE 
Serious adverse event 
SOA 
Schedule of Activities 
SOP 
Standard Operating Procedure 
SRM 
Study reference manual 
SUSAR 
Suspected unexpected serious adverse reaction 
TAA 
Tumor-associated antigen 
TCR T 
T-cell Receptor-targeting 

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Trademark Information 
Trademarks of the GlaxoSmithKline 
group of companies 
 
Trademarks not owned by the 
GlaxoSmithKline group of companies 
None 
 
MeDRA 
 

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11. 
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Antitumor Activity Associated with Prolonged Persistence of Adoptively Transferred 
NY-ESO-1c259T Cells in Synovial Sarcoma. Cancer Discov. 2018 Aug; 8(8):944-957. 
Gonzalez-Galarza FF, Takeshita LY, Santos EJ, Kempson F, Maia MH, Silva AL, et al. 
Allele frequency net 2015 update: new features for HLA epitopes, KIR and disease and 
HLA adverse drug reaction associations. Nucleic Acid Research 2015; 28:D784-8.   
Website: www.allelefrequencies.net  
Rapoport AP, Stadtmauer EA, Binder-Scholl GK, Goloubeva O, Vogl DT, Lacey SF, et 
al.  NY-ESO-1-specific TCR-engineered T cells mediate sustained antigen-specific 
antitumor effects in myeloma. Nat. Med. 2015; 21:914–921. 
Robbins PF, Kassim SH, Tran TL, Crystal JS, Morgan RA, Feldman SA, et al. A pilot 
trial using lymphocytes genetically engineered with an NY-ESO-1- reactive T-cell 
receptor: long-term follow-up and correlates with response. Clin. Cancer Res. 2015; 
21:1019–1027.