Clinical trial NCT01343043
Conditions: Neoplasms
Keywords: T Cell Receptor Sarcoma Cell Therapy T Cell Therapy Previously treated NY-ESO-1 Metastatic Immuno-oncology
Sponsor: GlaxoSmithKline
Start date: 2012-09-27; Completion date: 2019-06-18
Enrollment: 50 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this early (pilot) clinical trial is to test the effects (both good and bad) of chemotherapy and adoptive immunotherapy with T cells engineered to recognize NY-ESO-1 peptide in patients with unresectable, metastatic or recurrent synovial sarcoma.

Detailed description:
Design

* Patients will undergo apheresis at the enrolling institution. PBMC will be shipped to a central manufacturer for gene transduction, activation and expansion, then cryopreserved and shipped back to the enrolling institution.
* The trial seeks to enroll up to 65 patients, that is, up to 20 patients in Cohort 1 and up to 15 patients in Cohorts 2-4. Depending on the cohort patients are enrolled in, patients will undergo lymphodepletion with cyclophosphamide with or without fludarabine.

  * Cohort 1: Complete
  * Cohort 2: Up to 15 patients may be enrolled to achieve at least 10 evaluable patients treated with NY-ESO-1ᶜ²⁵⁹T. Patients will undergo lymphodepletion with cyclophosphamide plus fludarabine on Days -3 and -2, and without fludarabine on Days -5 and -4.
  * Cohort 3: Up to 15 patients may be enrolled to achieve at least 10 evaluable patients treated with NY-ESO-1ᶜ²⁵⁹T. Patients will undergo lymphodepletion with cyclophosphamide only on Days -3 and -2. (Cohort Complete)
  * Cohort 4: Up to 15 patients may be enrolled to achieve at least 5 evaluable patients treated with NY-ESO-1ᶜ²⁵⁹T. Patients will undergo lymphodepletion with cyclophosphamide plus fludarabine on Days -7 to -5.

On Day 0, patients ≥40 kg will receive the minimum cell dose of at least 1x10⁹ transduced NY-ESO-1ᶜ²⁵⁹T cells with a maximum of 6x10⁹ transduced cells. The target dose for this protocol is 5x10⁹ transduced NY-ESO-1ᶜ²⁵⁹T cells. Patients \<40 kg will be dosed per body weight with a minimum 0.025x10⁹ transduced cells/kg, with a target dose of 0.125 x10⁹ transduced cells/kg.

* Patients will be monitored for toxicity, antitumor effects and immune endpoints.
* Patients who have a confirmed response, or have stable disease for \>3 months then progress may receive a 2nd T cell infusion, provided eligibility criteria are met. The 2nd treatment cell infusion will be administered in the same manner as the first. Patients who meet the eligibility criteria may receive a 2nd infusion of NY-ESO-1ᶜ²⁵⁹T no sooner than 60 days and no later than 2 years following completion of the first treatment.

Arms: arm 1: High NY-ESO-1 expression and the use of cyclophosphamide plus fludarabine as the lymphodepleting chemotherapy. arm 2: Low NY-ESO-1 expression and the use of cyclophosphamide plus fludarabine as the lymphodepleting chemotherapy. arm 3: High NYESO-1 expression and the use of cyclophosphamide only for lymphodepletion rather than fludarabine as the lymphodepleting chemotherapy. arm 4: High NY-ESO-1 expression and the use of reduced dose cyclophosphamide plus fludarabine regimen as the lymphodepleting chemotherapy.
Interventions: intervention 1: NY-ESO-1(c259)T Cells intervention 2: Fludarabine intervention 3: Cyclophosphamide
Intervention descriptions: intervention 1: Lymphodepleting chemotherapy followed by infusion with NY-ESO-1(c259) transduced autologous T cells. Subjects will receive one infusion of NY-ESO-1 genetically engineered T cells on Day 0. intervention 2: Fludarabine will be used as lymphodepleting chemotherapy. intervention 3: Cyclophosphamide will be used as lymphodepleting chemotherapy.

Protocol documents:
Prot_000.pdf: 
PROTOCOL NUMBER: GSK208466 (ADP-04511)
INVESTIGATIONAL PRODUCT: NY-ESO-1C259T
Protocol: GSK208466 (ADP-04511)
Version: 15
CONFIDENTIAL:  DO NOT 
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Page 1 of 100
Protocol Number GSK208466(ADP-04511)
A Pilot Study of Genetically Engineered NY-ESO-1 Specific NY-ESO-1c259
T cells in HLA-A2+ Patients with Synovial Sarcoma


PROTOCOL NUMBER: GSK208466 (ADP-04511)
INVESTIGATIONAL PRODUCT: NY-ESO-1C259T
Protocol: GSK208466 (ADP-04511)
Version: 15
CONFIDENTIAL:  DO NOT 
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CLINICAL STUDY PROTOCOL
A Pilot Study of Genetically Engineered NY-ESO-1 Specific (c259) T cells in HLA-A2+ Patients 
with Synovial Sarcoma
Product Name:
NY-ESO-1c259T
Protocol Number: GSK208466 (ADP-04511)
IND Number:  
14603
EudraCT Number:  2015-005594-21
Date:
V.12-17-10
FDA only
Amended:
V.01-20-11
Amended:
V.03-15-11
Amended:
V.08-11-11
Amended:
V.11-29-11
Amended:
V.03-07-12
CHOP only
Amended:
V.06-29-12
Amended:
V.05-28-13
Amended:
V.13-Aug-2013
Version E
Amended:
V.26-Sep-2013
Version F
Amended:
V.18-Dec-2013
Version G
Amended:
V.17-Sep-2014
Version H
Amended:
V.20-Feb-2015
Version I
Amended:
V.24-Apr-2015
Version 10 (J)
Amended:
V.30-Mar-2016
Version 11
Amended:
V.25-Jul-2016
Version 12
Amended: 
V.26-28-Mar-2017
Version 13
Amended:
18-July-2018
Version 14
Amended:
17-Oct-2018
Version 15
CONFIDENTIALITY STATEMENT
This document contains information which is the property of GlaxoSmithKline (GSK), and 
therefore is provided in confidence for your review.  It is understood that this information will not 
be disclosed to others without written approval from GSK.
DECLARATION
This study will be conducted in compliance with the Declaration of Helsinki (with amendments), 
and in accordance with local legal and regulatory requirements.


PPD
PPD


PROTOCOL NUMBER: GSK208466 (ADP-04511)
INVESTIGATIONAL PRODUCT: NY-ESO-1C259T
Protocol: GSK208466 (ADP-04511)
Version: 15
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SUMMARY OF CHANGES
Primary reason for amendment
Protocol GSK208466 (ADP-4511) Version 15 (15-OCT-2018) includes changes made to the protocol 
requested by the FDA as a result of safety events which included 2 reports of Guillain-Barré 
syndrome in subjects who have received chemotherapy and GSK3377794 during clinical trials.


PROTOCOL NUMBER: GSK208466 (ADP-04511)
INVESTIGATIONAL PRODUCT: NY-ESO-1C259T
Protocol: GSK208466 (ADP-04511)
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PROTOCOL SYNOPSIS
Title
A Pilot Study of Genetically Engineered NY-ESO-1 Specific NY-ESO-1(c259) T cells in 
HLA-A2+ Patients with Synovial Sarcoma
Background
Patients with unresectable, metastatic and recurrent synovial sarcomas have long-term survival 
rates of <30%.  Cytotoxic chemotherapy has not significantly improved survival for this high-risk 
group of patients.
A recent study (Robbins 2011) conducted by the NCI Surgery Branch demonstrated that adoptive 
immunotherapy using T cells genetically engineered to recognize NY-ESO-1 following 
lymphodepletion led to objective antitumor responses in four out of six patients with recurrent, 
metastatic synovial sarcoma.
Objectives
Primary:
Determine the response rate in patients with unresectable, metastatic or recurrent synovial 
sarcoma treated with lymphodepletion and Treg depletion followed by adoptive 
immunotherapy with T cells engineered to recognize an HLA-A2 restricted NY-ESO-1 
derived peptide (Cohort 1).
Determine the response rate and duration of response of adoptive immunotherapy with 
NY-ESO-1c259T cells in patients with synovial sarcoma and low-level expression of 
NY-ESO-1 (Cohort 2).
Determine the response rate and duration of response of adoptive immunotherapy with 
NY-ESO-1c259T cells in patients with synovial sarcoma treated with a lymphodepleting 
regimen containing cyclophosphamide as a single cytotoxic agent (Cohort 3).
Determine the response rate and duration of response of adoptive immunotherapy with 
NY-ESO-1c259T cells in patients with synovial sarcoma treated with a lymphodepleting 
regimen containing cyclophosphamide and fludarabine cytotoxic agents at reduced total 
doses relative to Cohort 1 (Cohort 4).
Secondary:
Determine the safety of treatment with adoptively transferred NY-ESO-1c259T. 
When possible, assess whether patients with progressive disease following NY-ESO-1c259T 
or who do not respond (Cohort 3 and 4) experience a response following a second dose.
Exploratory:
Evaluate 
persistence, 
phenotype 
and 
functionality 
of 
adoptively 
transferred 
NY-ESO-1c259T and correlate with clinical responses. 
Evaluate mechanisms of resistance and sensitivity to NY-ESO-1c259T.
Evaluate antigen spreading as a mechanism of response.


PROTOCOL NUMBER: GSK208466 (ADP-04511)
INVESTIGATIONAL PRODUCT: NY-ESO-1C259T
Protocol: GSK208466 (ADP-04511)
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Eligibility
Inclusion Criteria
1. Pathologically or histologically confirmed synovial sarcoma that has been treated with a 
standard chemotherapy regimen containing ifosfamide and/or doxorubicin, is intolerant of or 
not actively responding to this regimen (i.e. the patient should not be taken prematurely off 
their primary regimen if they are continuing to respond to it) and remains:

unresectable or (intent is not to enroll patients with resectable tumors)

metastatic or

progressive/persistent or recurrent
2. Patients must have measurable disease in order to allow assessment of an anti-tumor response. 
See Section 5.4.
3. Pathologic review by a central laboratory designated by the Sponsor and confirming NY-ESO-
1 expression by immunohistochemistry (IHC).  Patients must have proven positive tumor 
sample for NY-ESO-1 as follows: 
Cohort 1
Positive expression is defined as 2+ or 3+ by IHC in ≥ 50% cells
Cohort 2 
Positive expression is defined as ≥ 1+ by IHC in ≥ 1% cells but not to exceed 2+ or 3+ in ≥ 50% cells 
Cohort 3
Positive expression is defined as 2+ or 3+ by IHC in ≥ 50% cells
Cohort 4
Positive expression is defined as 2+ or 3+ by IHC in ≥ 50% cells
4. HLA-A*02:01, HLA-A*02:05, and/or HLA-A*02:06 by high resolution testing 
5. Patient is ≥4 years of age on the day the Informed Consent is signed.
6. Patients must be >18 kg, for apheresis safety purposes.
7. Patients may have received salvage chemotherapy or other therapies.  Prior Therapies:
All previous cytotoxic chemotherapy, monoclonal antibody therapy, or immune therapy should be 
washed out 3 weeks before apheresis and must be completed at least 3 weeks prior to pre-infusion 
lymphodepleting chemotherapy.
Systemic corticosteroid or other immunosuppressive therapy should be washed out 2 weeks before 
apheresis and must be completed at least 2 weeks prior to pre-infusion lymphodepleting
chemotherapy.
Biologic or other approved molecular targeted small molecule inhibitors should be washed out 1 week 
or 5 half-lives (whichever is longer) before apheresis and must be completed at least 1 week or 5 half-
lives (whichever is longer) prior to pre-infusion lymphodepleting chemotherapy.


PROTOCOL NUMBER: GSK208466 (ADP-04511)
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Any grade 3 or 4 hematologic toxicity of previous therapy must have resolved to grade 2 or less 
(or to values specified below) prior to apheresis and any grade 3 or 4 toxicity must have resolved 
to grade 2 or less (or to values specified below) prior to pre-infusion lymphodepleting 
chemotherapy. 
8. Performance status: ECOG 0-1, or for children ≤10 years of age, Lansky >60 (Appendix 1).
9. Life expectancy >3 months.
10. Patient must have adequate organ function as indicated by the following laboratory values 
in the table below:
System
Laboratory Value
Hematological
Absolute Neutrophil count (ANC)
≥ 1.0 x109/L
Platelets
≥ 75 x109/L (not achieved by transfusion)
Renal
Creatinine clearance ≥ 40 ml/min 
Patients <65 yrs of age can be assessed using estimated creatinine clearance calculated 
using the Cockcroft and Gault formula:
Creatinine clearance =
(140 −age) ∗weight kg
72 ∗serum creatinine mg/dl (∗0.85 in females)
Patients ≥65 yrs of age must have renal function measured either by 24-hour urine 
creatinine collection or by nuclear medicine EDTA GFR measurement, 
according to standard practice at the treating institution.
Cardiac
Left ventricular ejection fraction 
≥40%, or Fractional Shortening ≥28%
11. Ability to give informed consent prior to any study-specific procedures.  Any standard of 
care procedures (e.g., lab tests, scans) can be used for purposes of assessing study eligibility 
as long as all other requirements as stated in the protocol are met.  For patients <18 years 
of age (or the legal minimum are in the relevant country) their legal guardian must give 
informed consent.  Pediatric patients will be included in age-appropriate discussion in order 
to obtain verbal assent.
12. Male or Female.  Contraceptive use by men or women should be consistent with local 
regulations regarding the methods of contraception for those participating in clinical 
studies.


PROTOCOL NUMBER: GSK208466 (ADP-04511)
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a.
Male Participants:
Male participants are eligible to participate if they agree to the following during the 
intervention period starting at the first dose of chemotherapy for at least 12 months 
after receiving the T-cell infusion, or 4 months after there is no evidence of persistence/ 
gene modified cells in the subject’s blood, whichever is longer.

Refrain from donating sperm.
Plus either: 

Be abstinent from heterosexual or homosexual intercourse as their preferred and usual 
lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent.
OR

Must agree to use contraception/barrier as detailed below:
o
Agree to use a male condom and should also be advised of the benefit for a 
female partner to use another highly effective method of contraception as a 
condom may break or leak when having sexual intercourse with a woman of 
childbearing potential (WOCBP) who is not currently pregnant.
o
Agree to use male condom when engaging in any activity that allows for 
passage of ejaculate to another person.
b.
Female Participants: 

A female participant is eligible to participate if she is not pregnant or breastfeeding, 
and at least one of the following conditions applies:
o
Is not a WOCBP as defined in Section 2.3.1.
OR
o
Is a WOCBP (as defined in Section 2.3.1) who will agree to use a barrier 
method (male condom) and use a contraceptive method that is highly effective 
(with a failure rate of <1% per year) as described in Section 2.3.1 during the 
intervention period and for at least 12 months after receiving the T-cell infusion, 
or 4 months after there is no evidence of persistence/ gene modified cells in the 
subject’s blood, whichever is longer.  A WOCBP should also agree not to 
donate eggs (ova, oocytes) for the purpose of reproduction during this period.  
The investigator should evaluate the effectiveness of the contraceptive method 
in relationship to the first dose of study intervention.

A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as 
required by local regulations) within 24 hours before the first dose of study 
intervention. 
If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy 
test is required.  In such cases, the participant must be excluded from participation if the serum 
pregnancy result is positive.


PROTOCOL NUMBER: GSK208466 (ADP-04511)
INVESTIGATIONAL PRODUCT: NY-ESO-1C259T
Protocol: GSK208466 (ADP-04511)
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The investigator is responsible for review of medical history, menstrual history, and recent 
sexual activity to decrease the risk for inclusion of a woman with an early undetected 
pregnancy.
Exclusion Criteria:
1. ALT >2.5xULN without documented liver metastases/tumor infiltration.
OR
Total Bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is 
fractionated and direct bilirubin <35%).
2. Current active liver or biliary disease (with the exception of Gilbert's syndrome or 
asymptomatic gallstones, liver metastases or otherwise stable chronic liver disease per 
investigator assessment).
NOTE: Stable chronic liver disease should generally be defined by the absence of ascites, 
encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices, 
persistent jaundice or cirrhosis.
3. Clinically significant systemic illness (e.g. serious active infections or significant cardiac, 
pulmonary, hepatic or other organ dysfunction), that in the judgment of the PI would 
compromise the patient’s ability to tolerate protocol therapy or significantly increase the 
risk of complications.
4. Untreated CNS metastasis.  Extradural masses that have not invaded the brain parenchyma 
or parameningeal tumors without evidence for leptomeningeal spread will not render the 
patient ineligible.  Patients with previous CNS tumor involvement that has been treated 
and is stable for at least 6 weeks are eligible. 
5. Previous treatment with genetically engineered NY-ESO-1 specific T cells.  
6. Pregnant or breastfeeding females (due to risk to fetus or newborn).
7. Uncontrolled intercurrent illness including, but not limited to:
a)
Clinically significant cardiac disease defined by congestive heart failure New York 
Heart Association (NYHA) Class >1.
b)
Uncontrolled clinically significant arrhythmia in last 6 months.
c)
Acute coronary syndrome (angina or myocardial infarction) in last 6 months.
d)
Severe aortic stenosis, symptomatic mitral stenosis
e)
Prior or active demyelinating disease.
8. QTc > 450 msec or QTc > 480 msec for patients with bundle branch block. 
NOTES: 

The QTc is the QT interval corrected for heart rate according to Bazett’s formula 
(QTcB), Fridericia’s formula (QTcF), and/or another method, machine-read or 
manually over-read.


PROTOCOL NUMBER: GSK208466 (ADP-04511)
INVESTIGATIONAL PRODUCT: NY-ESO-1C259T
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
The specific formula that will be used to determine eligibility and discontinuation for 
an individual subject should be determined prior to initiation of the study.  In other 
words, several different formulae cannot be used to calculate the QTc for an individual 
subject and then the lowest QTc value used to include or discontinue the subject from 
the trial.

For purposes of data analysis, QTcB, QTcF, another QT correction formula, or a 
composite of available values of QTc will be used as specified in the Reporting and 
Analysis Plan (RAP).
9. Active HIV, HBV, HCV or HTLV 1 or 2 infection as defined below (due to increased risk 
of complications during the lymphodepleting regimen and confounding effects on the 
immune system): 

Positive serology for HIV.

Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test 
result at screening or within 3 months prior to first dose of study treatment.  For 
potent immunosuppressive agents, subjects with presence of hepatitis B core 
antibody (HBcAb) should also be excluded.

Active hepatitis C subjects as demonstrated by test for hepatitis C RNA.  Subjects 
who are HCV antibody positive will be screened for HCV RNA by any RT PCR or 
bDNA assay.  Eligibility will be determined based on a negative screening value. 

Positive serology for HTLV 1 or 2.
10. Subject has history of active, chronic or recurrent (within the last year prior to enrolment) 
severe autoimmune or immune mediated disease requiring steroids or other 
immunosuppressive treatments.
Design
Patients will undergo apheresis at the enrolling institution.  PBMCs will be shipped to a central 
manufacturer for gene transduction, activation and expansion, then cryopreserved and shipped 
back to the enrolling institution.
Patients will undergo lymphodepletion with cyclophosphamide with or without fludarabine as 
outlined in the Treatment Schema.  Patients will receive transduced NY-ESO-1c259T.  Cell doses 
are specified in Section 3.2.7
The trial seeks to enroll up to 20 patients into Cohort 1 and up to 15 patients each into Cohorts 2 -
4. See Section 3.2 and Section 6.
Cohort 1:
Complete.  Patients must have proven positive, high tumor expression of NY-
ESO-1 defined as 2+ or 3+ by immunohistochemistry (IHC) in ≥ 50% cells.  Patients 
receive Regimen A lymphodepletion.
Cohort 2:
Closed to enrollment.  Up to 15 patients may be treated with NY-ESO-1c259T.  
Patients must have proven positive, low tumor expression of NY-ESO-1 defined as ≥ 1+ 
by IHC in ≥ 1% cells but not to exceed 2+ or 3+ in ≥ 50% cells.  Patients receive Regimen 
A lymphodepletion.  Up to an additional 5 patients considered unsuitable for Regimen A 


PROTOCOL NUMBER: GSK208466 (ADP-04511)
INVESTIGATIONAL PRODUCT: NY-ESO-1C259T
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for reasons that include, but are not limited to, advanced age, extent of prior therapies, or 
presence of co-morbidities may be enrolled to receive Regimen C.  
Cohort 3:
Closed to enrollment.  Up to 15 patients may be enrolled to achieve at least 10 
patients treated with NY-ESO-1c259T at a prespecified cell dose.  Patients must have proven 
positive, high tumor expression of NY-ESO-1 defined as 2+ or 3+ by IHC in ≥ 50% cells.  
Patients receive Regimen B lymphodepletion. 
Note: If insufficient activity is seen using cyclophosphamide-only lymphodepletion in 
cohort 3 and in combination with data across the Sponsor program using this regimen, 
Cohort 3 will cease enrolling and close.  Patients previously eligible for Cohort 3 will be 
enrolled to Cohort 4.  Cohort 4 is now open as Cohort 3 is closed.  See Section 3.2.3
Cohort 4: 
Closed to enrollment.  Up to 15 patients may be treated with NY-ESO-1c259T.  
Patients must have proven positive, high tumor expression of NY-ESO-1 defined as at least 
≥ 50% of cells that are 2+ and/or 3+ by IHC.  Patients receive Regimen C lymphodepletion.
Note: If insufficient activity is seen using reduced dose Regimen C lymphodepletion in 
Cohort 4, the cohort will cease enrolling and close.  The decision will be based on clinical 
judgment.  If the anti-tumor activity with Regimen C is determined to be suboptimal, then 
future subjects enrolled in Cohort 4 will receive Regimen A. See Section 3.2.4.
Patients ≥40kg will receive the minimum cell dose of at least 1x109 transduced NY-ESO-1c259T
cells with a maximum of 6x109 transduced cells.  The target dose for this protocol is 5x109
transduced NY-ESO-1c259T cells.  If the transduced cell dose is less than the minimum dose, 
manufacturing of additional transduced T-cells from excess banked leukapheresis product will be 
undertaken to achieve a total dose in the 1 x 109 – 6 x 109 range.
Patients <40 kg will be dosed per body weight with a minimum 0.025x109 transduced cells/kg, 
with a target dose of 0.125x109 transduced cells/kg.  
Patients will be monitored for toxicity, antitumor effects and immune endpoints.
Patients who have a confirmed response, or have stable disease for >3 months and then progress,
may receive a 2nd cycle of treatment, provided eligibility criteria are met.  The 2nd cycle of 
treatment following a confirmed response or stable disease will use the same lymphodepleting 
chemotherapy regimen as the first cycle of treatment.  Patients who meet the eligibility criteria 
may receive a 2nd treatment of NY-ESO-1c259T no sooner than 60 days and no later than 2 years
following completion of the first treatment.  Patients in Cohort 3 and 4 who do not show a response 
to treatment may receive a second dose of NY-ESO-1c259T using Regimen A lymphodepletion. 
Refer to Section 3.5.3 for information on eligibility for and details of second infusions.
Treatment Schema
At Apheresis:  Collect 1x108 PBMC/kg target (minimum 1.5x107 PBMC/kg) at participating site.  
Lymphodepletion
Regimen A
Day
Drug
Dose
Route
-5
Fludarabine
30 mg/m2
IV
-4
Fludarabine
30 mg/m2
IV


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-3
Fludarabine
30 mg/m2
IV
Cyclophosphamide
1800 mg/m2
IV
-2
Fludarabine
30 mg/m2
IV
Cyclophosphamide
1800 mg/m2
IV
0
NY-ESO-1c259T infusion
Regimen C
Day
Drug
Dose
Route
-7
Fludarabine
30 mg/m2
IV
Cyclophosphamide
600 mg/m2
IV
-6
Fludarabine
30 mg/m2
IV
Cyclophosphamide
600 mg/m2
IV
-5
Fludarabine
30 mg/m2
IV
Cyclophosphamide
600 mg/m2
IV
0
NY-ESO-1c259T infusion
Regimen B
Day
Drug
Dose
Route
-3
Cyclophosphamide
1800 mg/m2
IV
-2
Cyclophosphamide
1800 mg/m2
IV
0
NY-ESO-1c259T infusion


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TABLE OF CONTENTS
Summary of Changes....................................................................................................................................4
1
Introduction ...............................................................................................................................18
1.1
Objectives..................................................................................................................................18
1.1.1
Primary....................................................................................................................................................18
1.1.2
Secondary................................................................................................................................................18
1.1.3
Exploratory .............................................................................................................................................18
1.2
Endpoints...................................................................................................................................18
1.2.1
Primary Endpoints .................................................................................................................................18
1.2.2
Secondary Endpoints..............................................................................................................................18
1.2.3
Exploratory Endpoints...........................................................................................................................19
1.3
Background and Rationale.........................................................................................................19
1.3.1
Synovial Sarcoma ...................................................................................................................................19
1.3.2
Adoptive Immunotherapy with NY-ESO-1 Specific T Cells in Synovial Sarcoma...........................21
1.3.3
GSK208466(ADP-04511) Study Progress.............................................................................................23
1.3.4
Optimization of Lymphodepletion ........................................................................................................23
2
Eligibility Assessment and Enrollment .....................................................................................25
2.1
Inclusion Criteria.......................................................................................................................25
2.2
Exclusion Criteria......................................................................................................................28
2.3
Prohibited Concomitant Medication and Treatment..................................................................29
2.3.1
Contraception .........................................................................................................................................29
2.4
Patient Enrollment.....................................................................................................................32
2.4.1
Screening .................................................................................................................................................32
2.4.2
Screening Number..................................................................................................................................33
2.4.3
Study Identification Number.................................................................................................................33
2.4.4
Screen Failures........................................................................................................................................33
2.5
Data Collection..........................................................................................................................33
2.5.1
Source Documents ..................................................................................................................................34
2.5.2
Protocol Violations .................................................................................................................................34
3
Study Implementation................................................................................................................34
3.1
Study Design .............................................................................................................................34
3.2
Treatment Plan...........................................................................................................................35


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3.2.1
Cohort 1...................................................................................................................................................35
3.2.2
Cohort 2...................................................................................................................................................35
3.2.3
Cohort 3...................................................................................................................................................35
3.2.4
Cohort 4...................................................................................................................................................36
3.2.5
Apheresis .................................................................................................................................................36
3.2.6
T cell Transduction and Expansion ......................................................................................................36
3.2.7
Cell Dose..................................................................................................................................................37
3.3
Drug Administration..................................................................................................................37
3.3.1
Timing......................................................................................................................................................38
3.3.2
Lymphodepleting Chemotherapy and Cell Infusion ...........................................................................38
3.3.3
Lymphodepleting Regimens ..................................................................................................................38
3.3.4
Dose Adjustments for Fludarabine .......................................................................................................40
3.3.5
Dose Adjustments for Cyclophosphamide............................................................................................40
3.4
Mesna Administration ...............................................................................................................41
3.5
NY-ESO-1c259T Cell Administration.........................................................................................41
3.5.1
Premedication .........................................................................................................................................41
3.5.2
Cell Infusion............................................................................................................................................41
3.5.3
Second T Cell Infusions..........................................................................................................................42
3.6
Safety Considerations................................................................................................................44
3.6.1
Early Stopping Rule ...............................................................................................................................44
3.7
Study Withdrawal......................................................................................................................44
3.8
On-Study Protocol Evaluations .................................................................................................45
3.8.1
Screening Studies....................................................................................................................................45
3.8.2
Baseline Studies ......................................................................................................................................45
3.8.3
Baseline Research Studies......................................................................................................................46
3.8.4
Monitoring During Chemotherapy (Daily from first day of chemotherapy) ....................................47
3.8.5
Day 0: Clinical Monitoring During and After Cell Infusion...............................................................47
3.8.6
Monitoring Day 1 to Week 4..................................................................................................................47
3.8.7
On Treatment Evaluations After Week 4.............................................................................................48
3.9
Biologic studies .........................................................................................................................48
3.9.1
Monitoring Persistence/Expansion of NY-ESO-1c259T ........................................................................48
3.9.2
Monitoring Treg Depletion....................................................................................................................49


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3.9.3
Flow Cytometry ......................................................................................................................................49
3.9.4
Monitoring and Management of Replication-Competent Lentivirus.................................................50
3.9.5
Testing for RCL in Clinical Studies......................................................................................................50
3.9.6
RCL Safety Monitoring - Results..........................................................................................................51
3.9.7
Blood Volume Restrictions for Research Samples: .............................................................................51
3.10
Tumor Biopsy for Research.......................................................................................................51
3.10.1
Tumor Biopsy at Baseline, Month 2, and Disease Progression...........................................................51
3.11
Criteria for Completion of Interventional Phase, Transition to Long-Term Follow-up or 
Discontinuation..........................................................................................................................52
3.11.1
Interventional Phase: .............................................................................................................................52
3.11.2
Long-Term Follow-Up ...........................................................................................................................53
4
Supportive Care.........................................................................................................................54
4.1
Infection.....................................................................................................................................54
4.1.1
Cytomegalovirus.....................................................................................................................................54
4.1.2
Syphilis ....................................................................................................................................................54
4.2
Hematologic and Blood Product Support..................................................................................54
4.2.1
Blood Product Irradiation .....................................................................................................................54
4.2.2
CMV Screened Blood Products.............................................................................................................54
4.3
Treatment of Autoimmunity......................................................................................................55
4.4
Treatment of Cytokine Release Syndrome................................................................................55
4.5
Monitoring and management for Demyelinating Neuropathy and other Neurological events..57
4.6
Management of Graft-versus-Host Disease...............................................................................57
4.6.1
Diagnosis of GvHD .................................................................................................................................57
4.6.2
Grading of GvHD ...................................................................................................................................58
4.6.3
Management of GvHD ...........................................................................................................................59
4.7
Chemotherapy Symptom Management .....................................................................................60
4.7.1
Management of Neutropenia .................................................................................................................60
4.7.2
Management of Pancytopenia with Bone Marrow Failure.................................................................61
5
Response Criteria.......................................................................................................................62
5.1
Response Criteria for Radiographic Studies..............................................................................62
5.2
Tumor Response Evaluation – RECIST v1.1............................................................................62
5.3
Confirmatory Measurement/Duration of Response...................................................................64


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5.4
Measurable Disease...................................................................................................................65
5.5
Malignant Lymph Nodes...........................................................................................................65
5.6
Non-Measurable Disease...........................................................................................................65
5.7
Target Lesions ...........................................................................................................................65
5.8
Non-Target Lesions...................................................................................................................66
5.9
Metastatic Bone Lesions............................................................................................................66
5.10
Clinical Lesions.........................................................................................................................66
5.11
Guidelines for Evaluation of Measurable Disease.....................................................................66
5.12
Methods of Measurement..........................................................................................................66
5.13
Toxicity Criteria ........................................................................................................................66
6
Statistical Considerations ..........................................................................................................67
6.1
Overview Statistical Methods....................................................................................................67
6.2
Study Populations and Subgroups .............................................................................................67
6.3
Statistical Assumptions..............................................................................................................67
6.3.1
Cohorts 1, 3 and 4...................................................................................................................................67
6.3.2
Cohort 2...................................................................................................................................................68
6.3.3
Stopping Criteria for Cohorts 2, 3 and 4..............................................................................................69
6.4
Statistical Methods for Efficacy Endpoints...............................................................................70
6.5
Statistical Methods for Safety and Demographic Endpoints.....................................................70
7
Human Subjects Protections......................................................................................................71
7.1
Participation of Children ...........................................................................................................71
7.2
Evaluation of Benefits and Risks/Discomforts..........................................................................71
7.2.1
Potential Benefit of Adoptive Immunotherapy ....................................................................................71
7.2.2
Potential Risks of Adoptive Immunotherapy.......................................................................................71
7.2.3
Potential Risks of Lymphodepleting Chemotherapy...........................................................................72
7.2.4
Potential Risk of Tumor biopsy.............................................................................................................72
7.2.5
Potential Risk of Acute inflammatory demyelinating polyneuropathy / Guillain Barré Syndrome 
(GBS) .......................................................................................................................................................72
7.3
Consent and Assent Processes and Documentation...................................................................72
7.3.1
Screening Sample Consent.....................................................................................................................72
7.3.2
Protocol Consent.....................................................................................................................................73
8
Data Reporting...........................................................................................................................73


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8.1
Safety Reporting........................................................................................................................73
8.2
Definition of Adverse Event......................................................................................................73
8.3
Reporting of Adverse Events.....................................................................................................74
8.3.1
Assessment of Intensity ..........................................................................................................................74
8.3.2
Assessment of Causality .........................................................................................................................75
8.4
Reporting Serious Adverse Events (SAEs) ...............................................................................75
8.5
Reporting Criteria during Long Term Follow-Up (Years 1-15)................................................76
8.6
Cardiovascular and Death Events..............................................................................................77
8.7
Management of Encephalopathy Syndrome..............................................................................78
8.8
Pregnancy ..................................................................................................................................80
8.9
Timelines for Safety Reporting .................................................................................................81
9
Data Safety Monitoring Plan .....................................................................................................81
9.1
Safety Review Team..................................................................................................................82
9.1.1
Mandated Study Pause Due to GBS......................................................................................................82
9.2
Regulatory and Ethical Considerations, Including the Informed Consent Process ...................82
10
Appendices ................................................................................................................................83
10.1
Appendix 1: Performance Status ...............................................................................................83
10.2
Appendix 2: Schedule of Procedures.........................................................................................84
10.3
Appendix 3: Off-Treatment Procedures ....................................................................................87
10.4
Appendix 4: Long-Term Follow-Up Schedule..........................................................................87
10.5
Appendix 5: Draft letter to patients and physicians for long term follow-up for delayed adverse 
events.........................................................................................................................................89
10.5.1
Draft Patient Letter................................................................................................................................89
10.5.2
Draft Physician Letter............................................................................................................................90
10.6
Appendix 6: Liver Safety Required Actions and Follow up Assessments................................91
10.7
Appendix 7: Summary of Changes from Amendment 14 to Amendment 15 ...........................94
11
References .................................................................................................................................95


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1
Introduction
1.1
Objectives 
1.1.1
Primary

Determine the response rate in patients with unresectable, metastatic or recurrent synovial 
sarcoma treated with lymphodepletion and Treg depletion followed by adoptive 
immunotherapy with T cells engineered to recognize an HLA-A2 restricted NY-ESO-1 
derived peptide (Cohort 1)

Determine the response rate and duration of response of adoptive immunotherapy with 
NY-ESO-1c259T cells in patients with synovial sarcoma and low-level expression of 
NY-ESO-1 (Cohort 2)

Determine the response rate and duration of response of adoptive immunotherapy with 
NY-ESO-1c259T cells in patients with synovial sarcoma patients treated with a 
lymphodepleting regimen containing cyclophosphamide as a single cytotoxic agent 
(Cohort 3)

Determine the response rate and duration of response of adoptive immunotherapy with 
NY-ESO-1c259T cells in patients with synovial sarcoma treated with a lymphodepleting 
regimen containing cyclophosphamide and fludarabine cytotoxic agents at reduced total 
doses (Cohort 4)
1.1.2
Secondary

Determine the safety of treatment with adoptively transferred NY-ESO-1c259T.

When possible, assess whether patients with progressive disease following NY-ESO-1c259T
or who do not respond (Cohorts 3 and 4) experience a response following a second dose
1.1.3
Exploratory

Evaluate 
persistence, 
phenotype 
and 
functionality 
of 
adoptively 
transferred 
NY-ESO-1c259T and correlate with clinical responses

Evaluate mechanisms of resistance and sensitivity to NY-ESO-1c259T

Evaluate antigen spreading as a mechanism of response
1.2
Endpoints 
1.2.1
Primary Endpoints
The following endpoints will be evaluated in each cohort:

Objective Response Rate for each cohort per RECIST v1.1
1.2.2
Secondary Endpoints
The following endpoints will be evaluated in each cohort:


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1.2.2.1 Efficacy Endpoints

Duration of overall response per RECIST v1.1

Progression free survival per RECIST v1.1

Best Overall Response

Overall Survival
1.2.2.2 Safety Endpoints

AEs, including SAEs

Laboratory assessments, including chemistry, hematology, coagulation and anti-infused 
cell (NY-ESO-1c259T) antibodies

Correlate circulating cytokines with cytokine release syndrome

Correlate persistence of NY-ESO-1c259T over time with safety parameters
1.2.3
Exploratory Endpoints
The following endpoints will be evaluated in each cohort:

Objective Response Rate for subjects who receive a second infusion of NY-ESO-1c259T

Determine whether loss of NY-ESO-1 in the tumor is a mechanism of resistance

Correlate biomarkers in tumor tissue and blood with response following infusion of 
NY-ESO-1c259T

Correlate persistence, phenotype and functionality of NY-ESO-1c259T in the blood and or 
tumor with response to treatment 

Correlate clonal outgrowth, phenotype and activity of T cell populations with response 
following infusion of NY-ESO-1c259T

Determine whether T cell clonal outgrowth or enhancement of the endogenous anti-tumor 
immune response occurs following infusion of NY ESO 1c259T
1.3
Background and Rationale
1.3.1
Synovial Sarcoma
Synovial sarcomas account for approximately 6%–10% of all soft tissue sarcomas.  Approximately 
33% of synovial sarcomas occur in childhood, and approximately 20-25% of non-
rhabdomyosarcoma soft tissue sarcomas occurring in childhood are synovial sarcomas.  The peak 
incidence is in the third decade of life, and approximately 70% of patients with synovial sarcoma 
are less than 40 years of age.  Thus synovial sarcoma is primarily a disease of children and young 
adults (Herzog 2005). 
The most common primary site for synovial sarcoma is the distal lower extremity (63%) with a 
tendency for primary tumors to develop near the knee or ankle.  Synovial sarcomas also often 


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present as painless masses in the upper extremity, head, neck and trunk.  The lungs are a common 
site for distant metastases, occurring in 6% of patients in a recent series (Ferrari 2004).  Synovial 
sarcoma metastasizes to the lymph nodes more frequently than most sarcomas, with clinically 
evident lymph node metastases reported in 14-20% of cases (Tunn 2008). 
Histologically, synovial sarcoma consistently demonstrates a spindle cell fibrous stromal 
component, and a variable epithelial glandular component.  Tumors comprised exclusively of the 
spindle cell histology are classified as monophasic, whereas those comprised of spindle cell and 
epithelial components are classified as biphasic.  Immunohistochemistry typically reveals 
expression of keratin in the spindle cell component and epithelial membrane antigen in the 
epithelial component. 
A pathognomonic chromosomal translocation between chromosome X and 18is found in virtually 
all cases of synovial sarcoma.  The translocation involves the SYT gene at 18q11 and the SSX1, 
SSX2, or SSX4 gene at Xp11 (Clark 1994; de Leeuw 1995; Crew 1995).  The fusion transcript is 
found in both the spindle cell and epithelioid cells.  There is no clear evidence that the fusion 
partner effects prognosis, but the fusion partner does have a clear impact on histology and 
epidemiology, because essentially all SYT-SSX2+ tumors are monophasic (Kawai 1998) and there 
is an even male-to-female ratio for SYT-SSX1 but a 1:2 ratio for SYT-SSX2.  Haldar et al. modeled 
synovial sarcoma in mice by expressing the SYT-SSX translocation in myoblasts (Haldar 2007).  
The fusion protein was oncogenic only when expressed in myoblasts, but not when expressed
earlier or later in myogenesis, suggesting that the myoblast may be the cell of origin (Davis 2007).  
Interestingly, even in mouse model of synovial sarcoma, the majority of tumors occur near a joint, 
suggesting that microenvironmental factors in this area are uniquely suited to support growth of 
SYT-SSX tumors.
Like all soft tissue sarcomas, therapy for synovial sarcoma is largely focused on surgical excision 
with wide margins.  Indeed, synovial sarcoma does not appear to be curable without complete 
surgical excision and very few patients with distant metastases or recurrent synovial sarcoma are 
cured with standard therapies, regardless of the administration of chemotherapy (discussed below).  
Microscopic or macroscopic residual tumor is consistently an adverse prognostic factor (Andrassy 
2002; Andrassy 2001), therefore, excisions with margins <3 cm should be considered for second 
excision if possible without severe functional limitation.  Tumor size is an important prognostic 
factor as well.  The 5-year event-free survival rate was 66% in 86 patients with <5 cm sized SS 
treated in Milan compared with a rate of 24% for synovial sarcoma >5 cm2.  Adjuvant radiation 
therapy to 50-70 Gy provides a benefit in terms of the local control for patients with synovial 
sarcoma (Okcu 2001).  As a result, adjuvant radiation therapy is often recommended for synovial 
sarcomas >5 cm in maximal diameter (Wolden 2005).  In summary, size of tumor (>5 cm), axial 
location, high grade (grade 3), invasiveness of tumor, and detection of distant metastases are poor 
prognostic factors (Ferrari 2004; Okcu 2003; Ferrari 2008; Sultan 2009; Canter 2008).
Neoadjuvant or adjuvant chemotherapy for synovial sarcoma remains an area of controversy.  
Compared with other spindle cell sarcomas, synovial sarcoma appears to be somewhat more 
chemosensitive, with objective responses to chemotherapy reported in 40%–60% (Ferrari 2004; 
Pappo 2005).  Prior to the initiation of the EPSSG NRSTS trials, all pediatricpatients with synovial 
sarcoma enrolled in European trials received chemotherapy regardless of stage, with the same 
regimen used for rhabdomyosarcoma.  A retrospective study of this cohort that sought to 
investigate the potential impact of cytotoxic chemotherapy in this disease reported longer survival 
for children receiving adjuvant chemotherapy when tumors were >5 cm and high grade (Ferrari


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2004), but no difference in survival with adjuvant chemotherapy in patients with smaller tumors 
or low grade tumors.  Similarly, a multicenter, multivariate review of pediatric synovial sarcoma 
patients by Okcu et al. revealed that chemotherapyresponses resulted in longer survival in clinical 
group III patients (Okcu 2003).  Thus, although randomized studies have not been undertaken, 
most pediatric oncologists recommend neoadjuvant or adjuvant chemotherapy for children with 
high-risk synovial sarcoma.  High-risk is typically defined as high-grade histology and size >5 cm 
or axial primary, or metastatic disease.
Some recent non-randomized analyses of adult patients with synovial sarcomas >5 cm also report 
a survival advantage for patients treated with ifosfamide-containing regimens (Canter 2008; Eilber 
2007).  However, other reviews of synovial sarcoma in adults have not shown a positive effect of 
chemotherapy (Palmerini 2009).  In a non-randomized study from Milan, chemotherapy appeared 
to improve survival in synovial sarcoma, regardless of size, for younger patients (0–16 years old), 
but did improve overall survival rates in patients >17 years old, suggesting that age may influence
clinical behavior of synovial sarcoma (Ferrari 2004).  Indeed, differences in the 5-year survival 
curves for pediatric synovial sarcoma (60%–83%) versus adult synovial sarcoma (50%–70%) 
suggest that older age itself may be an adverse risk factor (Sultan 2009; Palmerini 2009).  This is 
not likely accounted for by different attitudes regarding chemotherapy, since a SEER analysis 
showed that the 0- to 9-year-old age group had better outcomes than the 10- to 18-year-old age 
group, who were likely to have been treated in a similar fashion (Sultan 2009).  Similar adverse 
effects of age on prognosis are seen in Ewing’s sarcoma, although the basis for this remains unclear 
and there are no known age associated biologic differences in synovial sarcoma.  
In summary, the consensus regarding chemotherapy is not clear for adult patients with high-risk 
synovial sarcoma, but it is clear that unresectable, metastatic and recurrent synovial sarcomas are 
nearly universally fatal.  Thus, new therapies are needed for patients with these high-risk features. 
1.3.2
Adoptive Immunotherapy with NY-ESO-1 Specific T Cells in Synovial Sarcoma
NY-ESO-1 is a member of the cancer-testis family of tumor antigens.  NY-ESO-1 is expressed in 
approximately 70-80% of cases of synovial sarcoma, reportedly at high levels.  Scanlan et al (2002) 
reported that in synovial sarcoma 16/ 21 specimens showed diffuse homogeneous staining but in 
5 specimens (23%) this was heterogeneous. Lai et al (2012) evaluated NY-ESO-1 expression by 
immunohistochemistry in 417 tumors including 50 stage IV synovial sarcomas and reported that 
38/ 50 (76%) expressed NY-ESO-1 in a strong and diffuse pattern (2-3+, >50–70% of tumor cells), 
3 cases showed weak and focal expression (1+ <10% tumor cells) and 9 cases were negative for 
NY-ESO-1.  Endo et al (2015) reported NY-ESO-1 staining intensity of 2 – 3+ by 
immunohistochemistry in >50% of tumor cells in 34/69 (49.3%) synovial sarcomas.  
An HLA-A2 binding peptide corresponding to amino acids 157 to 165 of NY-ESO-1 
(SLLMWITQC) can be recognized by NY-ESO-1 reactive T cells (Zeng 2002) and NY-ESO-1 
epitopes are also recognized in the context of multiple HLA class II restriction elements (Jager
1998; Jager 2000).  Several studies have demonstrated antibodies against NY-ESO-1 in patients 
with cancer.  In one study, 10 out of 12 patients bearing NY-ESO-1 positive tumors demonstrated 
antibodies directed against this antigen (Gnjatic 2006), suggesting that among tumor associated 
antigens, NY-ESO-1 may be particularly immunogenic.  Tumor vaccine trials have immunized 
with immunodominant Class I and II restricted peptides as well as recombinant NY-ESO-1 
proteins.  Thus far, clinical responses have been observed in a small percentage of patients treated 
with NY-ESO-1 vaccines alone (Bioley 2009; Old 2008).  


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Recently, T cells recognizing the immunodominant class I restricted HLA-A2 binding peptide 
have been used to clone a specific T cell receptor capable of recognizing this MHC restricted 
antigen.  Further genetic engineering enhanced the affinity of this T cell receptor toward the 
SLLMWITQC peptide bound to HLA-A2.  The result is a high affinity T cell receptor designated 
as 1G4a95:LY TCR (c259 TCR), which shows pre-clinical activity in vitro and in vivo against 
NY-ESO-1 expressing HLA-A2+ tumors (Robbins 2008).  The 1G4a95:LY TCR mediates 
efficient recognition by CD8+ T cells of the HLA-A2 bound peptide 157-165 and also mediates 
sufficient avidity to render CD4+ T cells capable of recognizing the 157-165 peptide in the context 
of HLA-A2 (Robbins 2008).  This co-receptor independent recognition implies high avidity of the 
1G4a95:LY TCR, a potentially important property of clinically active T cell receptors.  The 
enhanced TCR binds with varying affinity to HLA-A2 subtypes.  There is not much data evaluating 
the TCR in subtypes other than HLA-A201, but binding affinities are similar for HLA-A201 and 
HLA-A205, whereas binding to HLA-A206 is much higher.  
Between 2008 and 2010 a clinical trial of adoptive immunotherapy following lymphodepletion 
using T cells expressing IG4a95:LY TCR was carried out in the Surgery Branch of the National 
Cancer Institute.  Patients with NY-ESO-1 expressing tumors refractory to standard therapy were 
eligible
Patients with HLA-A2+, NY-ESO-1 synovial sarcomas and melanomas underwent apheresis for 
collection of mononuclear cells.  They then received lymphodepletion with cyclophosphamide (60 
mg/kg/d x2) and fludarabine (25mg/m2/d x 5).  PBMC were treated with anti-CD3 antibody and 
transduced with a retrovirus encoding 1G4a 95:LY TCR.  A secondary T cell expansion was 
carried out with anti-CD3 antibody, and a median of 5x1010 T cells were generated for therapy 
(range 1.6 x 109 – 13 x 1010; approximately 1.9 x 109/kg- 2.2 x 108/kg).  A median of 78% (range 
63-87%) of the transferred CD8+ T cells and 65% (range 57-79%) of the transferred CD4+ T cells 
bound the NY-ESO-1 tetramer, and median of 92% (range 85-96%) of the total CD3+ T cells 
bound an anti-BV13.1 antibody, which binds the beta chain on the genetically transduced TCR.  
With the exception of one patient, the cell infusions were comprised of >67% CD8+ T cells.  
Lower, but substantial levels, also bound the NY-ESO-1 tetramer and all of the products 
recognized peptide pulsed target cells at concentration of 0.1-0.01 nM of NY-ESO-1:157-165. 
NY-ESO-1 specific T cells were infused after conditioning, then high dose IL2 was administered 
every 8 hours to tolerance (Robbins 2011; Robbins 2015).
The cell dose for the initial pilot study (Cohort 1) of GSK208466 (ADP-04511) protocol was 
chosen to largely replicate the doses administered in the Robbins et al study (Robbins 2011).  The 
4 patients with synovial sarcoma in that study who had clinical responses following treatment with 
NY-ESO-1 specific T cells received absolute doses ranging from 16-83 x 109 cells.  Assuming 
average weights of 70 kg, this translates to a dose of 0.2-1 x 109/kg.  No toxicity attributed to the 
cells was reported in that study and the goal in the current study is to replicate the cell product as 
closely as possible.  Therefore, a target dose of 5x109 transduced cells was chosen with a minimum 
of 1x109 transduced cells and a maximum overall dose of 6x109 cells as it falls closely within the 
cell dose where clinical responses without significant toxicity were observed.  
A recent update to the study reported 11 of 18 patients (61%) with synovial sarcoma and 11 of 20 
patients (55%) with melanoma demonstrated objective clinical responses.  The estimated overall 
three and five year survival rates for patients with synovial cell sarcoma were 38% and 14%, 
respectively, while the corresponding estimated survival rates for patients with melanoma were 
both 33% (Robbins 2015).


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1.3.3
GSK208466(ADP-04511) Study Progress 
As of February 2017, 36 patients were enrolled.  15 of these patients were enrolled in Cohort 1 
(completed enrolment), 5 patients in Cohort 3 (completed enrollment) and 16 have been enrolled 
in Cohorts where enrolment is ongoing (6 subjects in Cohort 2 and 10 subjects in Cohort 4).  
The following is a brief summary of Cohort 1.  Patients with unresectable, metastatic or recurrent 
synovial sarcoma underwent lymphodepletion with 30 mg/m2 fludarabine daily on days -5 through 
-2, and 1800 mg/m2 cyclophosphamide daily on days -3 and -2 prior to NY-ESO-1c259T 
administration on day 0.  119 patients were screened to identify 15 patients who were fully eligible 
and were enrolled in Cohort 1.  Three of these patients were unable to receive NY-ESO-1c259T cell 
infusion due to disease progression between the time of screening prior to apheresis and the 
baseline assessment prior to lymphodepletion.  12 patients received NY-ESO-1c259T.  2 of these 
patients had poor cell growth and did not meet the minimum dose requirement of 1x109 transduced 
cells.  Protocol exceptions were granted for each of these 2 patients to infuse these cells despite 
not meeting minimum dose requirements, and these patients are considered fully evaluable for 
safety endpoints.  As a result, 10 patients meet the minimum requirements defined at the time of 
protocol design for efficacy evaluation of the 15 enrolled, therefore Cohort 1 has completed 
enrollment and is now closed.  Of the 10 patients who received 1x109 transduced cells, 6 have a 
confirmed response per RECIST: 1 patient had a complete response (CR) which was maintained 
from month three up to month nine before relapse.  In 5 patients with partial response (PR), the 
response continued for up to four to 10 months.  
Preliminary safety data in 16 subjects who have received T-cell infusion (including 12 subjects in 
Cohort 1 and 4 in subsequent Cohorts) is briefly summarized (from Investigator Brochure dated 
12 April 2016).  The most common adverse events (non-laboratory) occurring in more than 5 
subjects include nausea, pyrexia, cough, dyspnea, diarrhea, fatigue, dizziness, headache, rash 
maculo-papular, sinus tachycardia, vomiting, musculoskeletal pain, anxiety, constipation, cytokine 
release syndrome and pruritus.  Cytokine Release Syndrome (CRS) was reported in 6 patients; in 
3 patients this was Grade 3 or 4.  Laboratory abnormalities reported as Grade ≥3 treatment related 
adverse events in 2 or more subjects include anemia, lymphocyte, neutrophil, platelet and white 
blood cell counts decreased, and hypophosphatemia.  Serious AEs (SAE) reported in 2 or more 
subjects include pyrexia, cytokine release syndrome, febrile neutropenia, neutrophil count 
decrease, dyspnea, lymphocyte count decrease, and platelet count decrease.  One fatal SAE of bone 
marrow failure (reported as bone marrow hypocellular and aplastic anemia) was reported in a 
patient enrolled in Cohort 2.
In addition, one subject in the ATTACK-OG clinical trial sponsored by The Christie Hospital NHS 
Foundation Trust [NCT01795976] experienced fatal gastrointestinal bleeding with gangrenous 
necrosis of the small bowel in the setting of rash, enterocolitis and bone marrow failure after initial 
bone marrow recovery.
As of January 2017, 64 patients have been treated in Sponsored NY-ESO-1c259T studies.  Please 
refer to the NY-ESO-1c259T Investigator Brochure for additional information.
1.3.4
Optimization of Lymphodepletion
Animal studies and numerous clinical trials have documented the capacity for a “preparative 
regimen” to augment the efficacy of adoptive cell therapy (Dudley 2002).  The biological effects 
of such “preparative regimens” are likely manifold, and it remains unclear which of these effects 


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is necessary and/or sufficient to augment immunotherapy efficacy (Klebanoff 2005).  Current 
paradigms hold that “preparative regimens” augment expansion of adoptively transferred T cells 
by induction of T cell lymphopenia, which results in increased levels of homeostatic cytokines 
including interleukin-7 and interleukin-15, which sustain T cell proliferation (Fry 2001; Fry 2001; 
Cui 2009; Gattinoni 2005).  Lymphodepleting regimens also induce transient reductions in 
suppressive T cell populations, which may augment proliferation of adoptively transferred T cells; 
however it is unclear which cytotoxic agents best achieve this.  Lymphodepleting regimens may 
also induce damage to the lining of the gastrointestinal tract, which could allow transit of 
lipopolysaccharide across the mucosal barrier and may augment innate immunity, which may in 
turn augment T cell proliferation.  Cytotoxic regimens also induce reductions granulocytic and 
monocytic hematopoietic cells, which may modulate suppressive effect of myeloid derived 
suppressor cells. 
Finally, cytotoxic agents may also induce tumor cell death within the 
microenvironment, which may render it more accessible to antigen activated T cells.  Given that 
the primary factor responsible for augmenting expansion of adoptive transferred T cells remains 
unclear, it is not surprising that we have a limited understanding of which preparative regimens 
are most effective in this regard.  
This clinical trial utilized lymphodepletion in Cohort 1 designed primarily to induce T cell 
depletion by use of both cyclophosphamide and fludarabine, a common conditioning strategy in 
recent gene modified adoptive T cell research.  Some evidence indicates that cyclophosphamide 
as a single agent might achieve depletion of Treg lymphocytes without global depletion of the 
lymphocyte compartments, therefore reducing the depth of immunosuppression caused by 
lymphodepleting chemotherapy (Klebanoff 2005); however in some circumstances Tregs can be 
resistant to cyclophosphamide and this is thought to be the mechanism for efficacy of 
cyclophosphamide in graft-versus-host disease prophylaxis in the post- allogeneic transplant 
setting (Kanakry 2013).  In order to establish whether cyclophosphamide alone can deliver an 
environment that allows activity of the therapeutic cells without the potential additional toxicity 
of an additional chemotherapeutic agent, Cohort 3 of this study and other Sponsor studies are 
evaluating the use of cyclophosphamide as a single-drug lymphodepleting regimen. 
Recent evidence suggests that preparation for successful engraftment and expansion of gene 
modified adoptive cellular therapy may depend not just on the depth of cytoreduction but 
additionally on the specific action of some cytotoxic drugs.  Recent studies in lymphoma, chronic 
leukemia and acute leukemia using a chimeric antigen receptor showed increased T cell expansion, 
persistence and disease-free survival when fludarabine was added in to a previously 
cyclophosphamide-only preparative regimen (Turtle 2015).  Based on this emerging data, in light 
of our previous demonstrated efficacy in cohort 1, if there is insufficient activity in Cohort 3 and 
across the Sponsor’s NY-ESO-1 program using cyclophosphamide as a single drug agent we will 
cease evaluating this option. 
The lymphodepleting regimen in Cohort 1 in which objective tumor responses have been observed 
used a cyclophosphamide dose of 1800 mg/m2/day for 2 days, in addition to fludarabine 30 
mg/m2/day for 4 days.  This is a similar regimen to that used in reduced-intensity conditioning for 
hematopoietic stem cell transplantation (Paplham 2014), and while effective it has not been 
established that this is the best preparative strategy.  Effective lymphodepletion has been 
demonstrated in studies using chimeric antigen receptors using reduced cyclophosphamide dosing 
than previously used in this study, together with fludarabine (Batlevi 2016).  In Cohort 4, in order 
to establish whether efficacy can be maintained with less intensive lymphodepleting 


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chemotherapy, we will assess a fludarabine-cyclophosphamide combination regimen at a reduced 
total dose of each drug.
2
Eligibility Assessment and Enrollment
2.1
Inclusion Criteria
1. Pathologically or histologically confirmed synovial sarcoma that has been treated with a 
standard chemotherapy regimen containing ifosfamide and/or doxorubicin, is intolerant of 
or not actively responding to this regimen (i.e. the patient should not be taken prematurely 
off their primary regimen if they are continuing to respond to it) and remains:

unresectable or (intent is not to enroll patients with resectable tumors)

metastatic or

progressive/persistent or recurrent
2. Patients must have measurable disease in order to allow assessment of an anti-tumor 
response.  See Section 5.4.
3. Pathologic review by a central laboratory designated by the Sponsor and confirming NY-
ESO-1 expression by immunohistochemistry (IHC).  Patients must have proven positive 
tumor sample for NY-ESO-1 as follows:
Cohort 1
Positive expression is defined as 2+ or 3+ by IHC in ≥ 50% cells
Cohort 2 
Positive expression is defined as ≥ 1+ by IHC in ≥ 1% cells but not to exceed 2+ or 3+ in 
≥ 50% cells 
Cohort 3
Positive expression is defined as 2+ or 3+ by IHC in ≥ 50% cells
Cohort 4
Positive expression is defined as 2+ or 3+ by IHC in ≥ 50% cells
4. HLA-A*02:01, HLA-A*02:05, and/or HLA-A*02:06 by high resolution testing 
5. Patient is ≥4 years of age on the day the Informed Consent is signed.
6. Patients must be >18 kg, for apheresis safety purposes.
7. Patients may have received salvage chemotherapy or other therapies.  Prior Therapies:
All previous cytotoxic chemotherapy, monoclonal antibody therapy, or immune therapy 
should be washed out 3 weeks before apheresis and must be completed at least 3 weeks 
prior to pre-infusion lymphodepleting chemotherapy.
Systemic corticosteroid or other immunosuppressive therapy should be washed out 2 weeks 
before apheresis and must be completed at least 2 weeks prior to pre-infusion 
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Biologic or other approved molecular targeted small molecule inhibitors should be washed 
out 1 week or 5 half-lives (whichever is longer) before apheresis and must be completed at 
least 1 week or 5 half-lives (whichever is longer) prior to pre-infusion lymphodepleting
chemotherapy.
Any grade 3 or 4 hematologic toxicity of previous therapy must have resolved to grade 2 
or less (or to values specified below) prior to apheresis and any grade 3 or 4 toxicity must 
have resolved to grade 2 or less (or to values specified below) prior to pre-infusion 
lymphodepleting chemotherapy. 
8. Performance status: ECOG 0-1, or for children ≤10 years of age, Lansky >60 (Appendix 1).  
9. Life expectancy >3 months.
10. Patient must have adequate organ function as indicated by the following laboratory values 
in the table below: 
System
Laboratory Value
Hematological
Absolute Neutrophil count 
(ANC)
≥ 1.0 x109/L
Platelets
≥ 75 x109/L (not achieved by transfusion)
Renal
Creatinine clearance ≥ 40 ml/min 
Patients <65 yrs of age can be assessed using estimated creatinine clearance calculated 
using the Cockcroft and Gault formula:
Creatinine clearance =
(140 −age) ∗weight kg
72 ∗serum creatinine mg/dl (∗0.85 in females)
Patients ≥65 yrs of age must have renal function measured either by 24-hour urine 
creatinine collection or by nuclear medicine EDTA GFR measurement, according to 
standard practice at the treating institution.
Cardiac
Left ventricular ejection fraction 
≥40%, or Fractional Shortening ≥28%
11. Ability to give informed consent prior to any study-specific procedures.  Any standard of 
care procedures (e.g., lab tests, scans) can be used for purposes of assessing study eligibility 
as long as all other requirements as stated in the protocol are met.  For patients <18 years 
of age (or the legal minimum age in the relevant country) their legal guardian must give 
informed consent.  Pediatric patients will be included in age-appropriate discussion in order 
to obtain verbal assent.


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12. Male or Female.  Contraceptive use by men or women should be consistent with local 
regulations regarding the methods of contraception for those participating in clinical 
studies.
a.
Male Participants:
Male participants are eligible to participate if they agree to the following during the 
intervention period starting at the first dose of chemotherapy for at least 12 months 
after receiving the T-cell infusion, or 4 months after there is no evidence of persistence/ 
gene modified cells in the subject’s blood, whichever is longer.

Refrain from donating sperm.
Plus either: 

Be abstinent from heterosexual or homosexual intercourse as their preferred and usual 
lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent.
OR

Must agree to use contraception/barrier as detailed below:
o
Agree to use a male condom and should also be advised of the benefit for a 
female partner to use another highly effective method of contraception as a 
condom may break or leak when having sexual intercourse with a woman of 
childbearing potential who is not currently pregnant.
o
Agree to use male condom when engaging in any activity that allows for 
passage of ejaculate to another person.
b.
Female Participants: 
A female participant is eligible to participate if she is not pregnant or breastfeeding, 
and at least one of the following conditions applies:
o
Is not a WOCBP as defined in Section 2.3.1.
OR
o
Is a WOCBP (as defined in Section 2.3.1) who will agree to use a barrier 
method (male condom) and use a contraceptive method that is highly effective 
(with a failure rate of <1% per year) as described in Section 2.3.1 during the 
intervention period and for at least 12 months after receiving the T-cell infusion, 
or 4 months after there is no evidence of persistence/ gene modified cells in the 
subject’s blood, whichever is longer.  A WOCBP should also agree not to 
donate eggs (ova, oocytes) for the purpose of reproduction during this period.  
The investigator should evaluate the effectiveness of the contraceptive method 
in relationship to the first dose of study intervention.

A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as 
required by local regulations) within 24 hours before the first dose of study 
intervention. 


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If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy 
test is required.  In such cases, the participant must be excluded from participation if the serum 
pregnancy result is positive.
The investigator is responsible for review of medical history, menstrual history, and recent 
sexual activity to decrease the risk for inclusion of a woman with an early undetected 
pregnancy.
2.2
Exclusion Criteria
1. ALT >2.5xULN without documented liver metastases/tumor infiltration.
OR
2. Total Bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is 
fractionated and direct bilirubin <35%).
3. Current active liver or biliary disease (with the exception of Gilbert's syndrome or 
asymptomatic gallstones, liver metastases or otherwise stable chronic liver disease per 
investigator assessment).
NOTE: Stable chronic liver disease should generally be defined by the absence of ascites, 
encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices, 
persistent jaundice or cirrhosis.
4. Clinically significant systemic illness (e.g. serious active infections or significant cardiac, 
pulmonary, hepatic or other organ dysfunction), that in the judgment of the PI would 
compromise the patient’s ability to tolerate protocol therapy or significantly increase the 
risk of complications.
5. Untreated CNS metastasis.  Extradural masses that have not invaded the brain parenchyma 
or parameningeal tumors without evidence for leptomeningeal spread will not render the 
patient ineligible.  Patients with previous CNS tumor involvement that has been treated 
and is stable for at least 6 weeks are eligible. 
6. Previous treatment with genetically engineered NY-ESO-1 specific T cells.  
7. Uncontrolled intercurrent illness including, but not limited to:
a)
Clinically significant cardiac disease defined by congestive heart failure New York 
Heart Association (NYHA) Class >1.
b)
Uncontrolled clinically significant arrhythmia in last 6 months.
c)
Acute coronary syndrome (angina or myocardial infarction) in last 6 months.
d)
Severe aortic stenosis, symptomatic mitral stenosis.
8. Pregnant or breastfeeding females (due to risk to fetus or newborn).
9. QTc > 450 msec or QTc > 480 msec for patients with bundle branch block. 
NOTES: 


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
The QTc is the QT interval corrected for heart rate according to Bazett’s formula 
(QTcB), Fridericia’s formula (QTcF), and/or another method, machine-read or 
manually over-read.

The specific formula that will be used to determine eligibility and discontinuation for 
an individual subject should be determined prior to initiation of the study.  In other 
words, several different formulae cannot be used to calculate the QTc for an individual 
subject and then the lowest QTc value used to include or discontinue the subject from 
the trial.

For purposes of data analysis, QTcB, QTcF, another QT correction formula, or a 
composite of available values of QTc will be used as specified in the Reporting and 
Analysis Plan (RAP).
10. Active HIV, HBV, HCV or HTLV 1 or 2 infection as defined below (due to increased risk 
of complications during the lymphodepleting regimen and confounding effects on the 
immune system):

Positive serology for HIV.

Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test 
result at screening or within 3 months prior to first dose of study treatment.  For 
potent immunosuppressive agents, subjects with presence of hepatitis B core 
antibody (HBcAb) should also be excluded.

Active hepatitis C subjects as demonstrated by test for hepatitis C RNA.  Subjects 
who are HCV antibody positive will be screened for HCV RNA by any RT PCR or 
bDNA assay.  Eligibility will be determined based on a negative screening value. 

Positive serology for HTLV 1 or 2.
11. Subject has history of active, chronic or recurrent (within the last year prior to enrolment) 
severe autoimmune or immune mediated disease requiring steroids or other 
immunosuppressive treatments.
2.3
Prohibited Concomitant Medication and Treatment
Investigational anti-cancer therapies are prohibited on the study. 
Following administration of cells, progression of disease should be confirmed prior to initiating 
any cancer directed therapy, including chemotherapy, immune therapy, radiation, or surgery.
The use of systemic steroids may abrogate the effects of the T cell therapy and therefore use is 
discouraged unless required to manage CRS (see Section 4.4 for CRS treatment recommendations) 
or other significant immune-mediated adverse events.  According to local standard of care or 
ASCO guidelines (Smith 2015), steroids may be used as antiemetics with cyclophosphamide but 
must be discontinued no later than 24 hours prior to infusion of NY-ESO-1c259T.  Topical steroids
for cutaneous application and inhaled steroidal treatments are permitted.
2.3.1
Contraception
NY-ESO-1c259T may have adverse effects on a fetus in utero.  Furthermore, it is not known if NY-
ESO-1c259T has transient adverse effects on the composition of sperm.


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Definitions:
Woman of Childbearing Potential (WOCBP)
A woman is considered fertile following menarche and until becoming post-menopausal unless 
permanently sterile (see below).
If fertility is unclear (e.g., amenorrhea in adolescents or athletes) and a menstrual cycle cannot be 
confirmed before first dose of study intervention, additional evaluation should be considered.
Women in the following categories are not considered WOCBP
1. Premenarchal
2. Premenopausal female with 1 of the following:

Documented hysterectomy

Documented bilateral salpingectomy

Documented bilateral oophorectomy
For individuals with permanent infertility due to an alternate medical cause other than the 
above, (e.g., mullerian agenesis, androgen insensitivity), investigator discretion should be 
applied to determining study entry.
Note: Documentation can come from the site personnel’s: review of the participant’s medical 
records, medical examination, or medical history interview.
3. Postmenopausal female

A postmenopausal state is defined as no menses for 12 months without an alternative 
medical cause. 

A high follicle stimulating hormone (FSH) level in the postmenopausal range (as per 
laboratory parameters for postmenopausal range) may be used to confirm a
postmenopausal state in women not using hormonal contraception or hormonal 
replacement therapy (HRT) when postmenopausal status is in doubt.  However, in the 
absence of 12 months of amenorrhea, confirmation with more than one FSH 
measurement is required. 

Females on HRT and whose menopausal status is in doubt will be required to use one 
of the non-estrogen hormonal highly effective contraception methods if they wish to 
continue their HRT during the study.  Otherwise, they must discontinue HRT to allow 
confirmation of postmenopausal status before study enrollment.
Contraception:
Male Participants:
Male participants must agree to the following during the intervention period starting at the first 
dose of chemotherapy for at least 12 months after receiving the T-cell infusion, or 4 months after 
there is no evidence of persistence/ gene modified cells in the subject’s blood, whichever is longer. 

Refrain from donating sperm
Plus either: 


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
Be abstinent from heterosexual or homosexual intercourse as their preferred and usual 
lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent 
OR

Must agree to use contraception/barrier as detailed below:
o
Agree to use a male condom and should also be advised of the benefit for a 
female partner to use a highly effective method of contraception as a condom 
may break or leak when having sexual intercourse with a WOCBP who is not 
currently pregnant.
o
Agree to use male condom when engaging in any activity that allows for 
passage of ejaculate to another person.
Female Participants:
WOCBP must agree to the following during the intervention period starting at the first dose of 
chemotherapy for at least 12 months after receiving the T-cell infusion, or 4 months after there is 
no evidence of persistence/ gene modified cells in the subject’s blood, whichever is longer.  If 
randomized to Arm 2 WOCBP must use effective contraception for at least 4 months after the last 
dose of pembrolizumab if this time frame is longer than the duration of contraception required in 
the context of chemotherapy and gene modified cells.
For contraception, subjects who are WOCBP must use a barrier method (male condom) and should 
comply with one of the following:
CONTRACEPTIVESa ALLOWED DURING THE STUDY INCLUDE:
Highly Effective Methodsb That Have Low User Dependency Failure rate of <1% per year 
when used consistently and correctly.
Implantable progestogen-only hormone contraception associated with inhibition of ovulationc
Intrauterine device (IUD)
Intrauterine hormone-releasing system (IUS)c
Bilateral tubal occlusion
Vasectomized partner
Note: Vasectomized partner is a highly effective contraceptive method provided that the 
partner is the sole sexual partner of the woman of childbearing potential and the 
absence of sperm has been confirmed.  If not, an additional highly effective method of 
contraception should be used.  Spermatogenesis cycle is approximately 90 days.
Highly Effective Methods b That Are User Dependent Failure rate of <1% per year when 
used consistently and correctly.


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Combined (estrogen- and progestogen-containing) hormonal contraception associated with 
inhibition of ovulationc
oral
intravaginal
transdermal
injectable
Progestogen-only hormone contraception associated with inhibition of ovulationc
oral
injectable
Sexual abstinence
Note: Sexual abstinence is considered a highly effective method only if defined as refraining 
from heterosexual intercourse during the entire period of risk associated with the study 
intervention.  The reliability of sexual abstinence needs to be evaluated in relation to 
the duration of the study and the preferred and usual lifestyle of the participant
a.
Contraceptive use by men or women should be consistent with local regulations regarding the use of 
contraceptive methods for those participating in clinical studies.

Failure rate of <1% per year when used consistently and correctly.  Typical use failure rates differ from those 
when used consistently and correctly.

Male condoms must be used in addition to hormonal contraception.  If locally required, in accordance with 
Clinical Trial Facilitation Group guidelines, acceptable contraceptive methods are limited to those which 
inhibit ovulation as the primary mode of action.
Note: Periodic abstinence (calendar, sympto-thermal, post-ovulation methods), withdrawal (coitus interruptus), 
spermicides only, and lactational amenorrhoea method are not acceptable methods of contraception.  Male condom 
and female condom should not be used together (due to risk of failure with friction)
Subjects should be informed that taking the study medication may involve unknown risks to the 
fetus (unborn baby) if pregnancy were to occur during the study.  In order to participate in the 
study, WOCBP must adhere to the contraception requirement (described above) from the day of 
study medication initiation (or 14 days prior to the initiation of study medication for oral 
contraception) throughout the study period up to 12 months after receiving T-cell infusion, or up 
to 4 months after there is no evidence of persistence/gene modified cells in the subjects’ blood, 
whichever is longer.  If there is any question that a WOCBP will not reliably comply with the 
requirements for contraception, that subject should not be entered into the study.
The IB and Informed consent also contain language describing the risks and contraceptive 
guidelines described above.
2.4
Patient Enrollment 
2.4.1
Screening
Patients that are identified by the Investigator as possible candidates for the trial must consent to 
screening activities that will first confirm that the patient is HLA and NY-ESO-1 positive prior to 


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conducting the remaining screening procedures as shown in the Schedule of Procedures in 
Appendix 2. 
2.4.2
Screening Number
The screening period will begin on the day that the patient signs the Informed Consent.  When the 
patient signs the Informed Consent, the patient will be assigned a screening number.  Each site 
will be required to enter the patient information into the Electronic Data Capture (EDC) system 
and the EDC system will generate the screening number.  Once assigned, a screening number 
cannot be used for another patient.  If a screen failed patient later meets study eligibility and is re-
screened, the patient will retain the original screening number. 
2.4.3
Study Identification Number
After completion of all screening and
baseline procedures and requirements for 
inclusion/exclusion are met, site personnel will complete the Subject Enrollment Form and send 
to the Sponsor for confirmation of eligibility prior to apheresis.  Study procedures performed as 
part of standard of care prior to signing Informed Consent can be used for screening if they were 
performed within a medically reasonable period of time prior to signing the Informed Consent. 
There are no restrictions on the timing of HLA typing for screening and data can be taken from 
patients’ records.  
NOTE: The Study Identification Number will not be provided until the patient is assigned a 
screening number and registered in the EDC system.  The Study Identification Number is a unique 
number assigned to each patient on the trial.  A single patient cannot be assigned more than one 
Study Identification Number.
2.4.4
Screen Failures
A screen failure log documenting the investigators assessment of each screened patient with regard 
to the protocol’s inclusion and exclusion criteria should be maintained by the investigator, or 
tracked according to institutional guidelines.
2.5
Data Collection
All patients must have signed an Informed Consent Form and have filled out an eligibility checklist 
before entering the study.  All toxicity and event data must be entered by the participating 
institution as stipulated in the Institutional contract with the Sponsor.  In addition, complete records 
will be maintained on each patient at the participating institutions.  These will consist of the 
hospital chart with any supplementary information obtained from outside laboratories, radiology 
reports, or physician’s records.  These records will serve as the primary source of material that 
forms the basis for the research record and will be available for monitoring purposes.  
The Investigators at each site will be responsible for the collection, maintenance, and quality 
control of the study data.  The Investigator at each site is responsible for maintaining any source 
documentation related to the study, including any films, tracings, computer discs or tapes.  The 
anonymity of participating subjects must be maintained in strict confidence by the Investigator, 
except to the extent necessary to allow auditing by the regulatory authority, study monitor, or 
sponsor representatives.  The Investigators will allow GSK, and/or the Competent Authority to 
inspect study documents (e.g. consent forms, drug distribution forms, IRB/IEC approval) and 


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pertinent hospital or clinical records for confirmation of data throughout the study period.
An EDC system will be used to collect data for Cohorts 2, 3 and 4.  Trial data will be captured 
through an electronic Case Report Form (eCRF).  Within the EDC system the eCRF data will be 
entered by the site staff and all source document verification and data cleaning will be performed 
by the Sponsor or designee (e.g. CRO).
The specifications for the EDC system will be documented and approved before the development 
is completed and the EDC system is released for live use.  The validation of the eCRF data will be 
defined.  As data are entered into the eCRF, the validation checks will be performed and where 
necessary, queries will be raised.  All queries raised will be held in the EDC database.
The EDC system is a validated software program that has been designed to comply with CFR21 
Part 11 requirements.  All users will access the system using their user name and password.  A full 
audit history of all actions performed within the system is maintained.  User accounts ensure that 
each user can only perform the tasks applicable to their role and only have access to the data 
applicable to their role.
Medications and AEs will be coded using dictionaries specified by the Sponsor.
When all data have been entered and all data cleaning is complete the data will be locked and made 
available for analysis and reporting.
Upon completion of the study, all pertinent eCRF data, including all associated queries and audit 
history, will be made available in PDF format to the sites.
2.5.1
Source Documents
Source documents are original documents, data and records which include hospital records, clinic 
and office charts, laboratory data/information, patient diaries or evaluation checklists, pharmacy 
dispensing and other records, recorded data from automated instruments, microfiches, 
photographic negatives, microfilm or magnetic media, x-rays.  The Investigators/Institutions will 
permit trial-related monitoring, audits, IRB/IEC review, and regulatory inspections, providing 
direct access to source data documents. 
2.5.2
Protocol Violations
Any protocol violations and/or deviations should be directly reported to the Sponsor and the 
appropriate documentation obtained.  The Investigator will in turn report them to the institution’s 
IRB/IEC. 
3
Study Implementation
3.1
Study Design  
This trial was originally designed as a single arm pilot study to determine whether T cells 
genetically engineered to recognize an HLA-A2 binding peptide from NY-ESO-1 induce 
antitumor responses in patients with synovial sarcoma.  The goal of this pilot study was to assess 
whether this approach also induces a substantial rate of objective antitumor responses as a first 
step toward a larger randomized study of this therapy in synovial sarcoma using the same platform.  
Exploratory biologic studies are included to look for correlations between biologic endpoints and 
clinical response.  


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This trial expansion is based on favorable results from the single arm pilot study of Cohort 1 and 
will enroll additional patients into three cohorts designated as Cohorts 2, 3 and 4.  
3.2
Treatment Plan
All eligible patients will be treated with lymphodepleting chemotherapy and NY-ESO-1c259T.  The 
final patient of Cohort 1 was treated on 15 June 2015.  Newly enrolled patients will be allocated 
to subsequent available cohorts as eligible based on NY-ESO-1 expression and slot availability for
each cohort.  The Sponsor may choose to terminate the study at any point.  All drugs administered 
will be open label.  Cohorts 3 and 4 will accrue sequentially.
Patient characteristics and lymphodepleting chemotherapy for Cohorts 1, 2, 3 and 4 are described 
below.  The dose of NY-ESO-1c259T is described in Section 3.2.7.  Patients may become eligible 
for a second infusion of NY-ESO-1c259T, depending on allocated cohort and response to the first 
infusion, as defined in Section 3.5.3.
3.2.1
Cohort 1
Up to 20 patients with high tumor expression of NY-ESO-1 will be enrolled into Cohort 1 and will 
receive Regimen A as described in Section 3.3.3.  High tumor NY-ESO-1 expression is defined as 
2+ or 3+ by immunohistochemistry (IHC) in ≥ 50% cells.  Enrollment into this cohort is now 
complete.
3.2.2
Cohort 2
Up to 15 patients with low tumor expression of NY-ESO-1 will be treated in Cohort 2 and receive 
Regimen A, as described in Section 3.3.3, and NY-ESO-1c259T.  Low tumor NY-ESO-1 expression 
is defined as ≥ 1+ by IHC in ≥ 1% cells but not to exceed 2+ or 3+ in ≥ 50% cells. 
Stopping criteria for Cohort 2 are based on responses to treatment using Regimen A.  Based on 
the observed response rate in Cohort 1 of 50% in the mITT population (see Section 6.2), if 0 or 1 
responses are seen in the first 5 patients receiving Regimen A in Cohort 2 then the clinical effect 
will be reviewed in the context of the expression level to determine if the Cohort should close.  If 
3 or more responses are seen in the first 5 patients then the Cohort will recruit until completion.  
If 2 responses are observed in the first 5 patients, the Cohort will continue to enroll additional 
patients to further characterize the activity of the regimen.  Refer to Section 6.3 for information 
on the rationale for stopping the cohort at this point. 
Up to 5 additional patients considered unsuitable for Regimen A may also be enrolled in Cohort 2 
and will receive Regimen C.  Patients may be considered unsuitable for Regimen A for reasons 
that include, but are not limited to, advanced age, extent of prior therapies, or presence of co-
morbidities.  The assessment of whether a patient is suitable for Regimen A will be at the discretion 
of the Investigator.
3.2.3
Cohort 3 
Up to 15 patients with high tumor expression of NY-ESO-1 will be enrolled into Cohort 3 to obtain 
at least 10 patients who receive Regimen B, as described in Section 3.3.3, and NY-ESO-1c259T.  
High tumor NY-ESO-1 expression is defined as 2+ or 3+ by IHC in ≥ 50% cells. 


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Patients in Cohort 3 who do not experience an adequate response following Regimen B may be 
eligible for retreatment using Regimen A, as defined in Section 3.5.3
If 0 or 1 responses are seen in the first 5 patients in Cohort 3 then the clinical effect will be deemed 
insufficient to proceed with this approach and Cohort 3 will close due to inadequate activity.  If 3 
or more responses are seen in the first 5 patients in Cohort 3 then the Cohort will recruit until 
completion.  If 2 responses are observed in the first 5 patients in Cohort 3, the Cohort will continue 
to enroll additional patients to further characterize the activity of the regimen.  Refer to Section 
6.3 for information on the rationale for stopping the cohort at this point.  Enrollment into this 
cohort is now closed.
3.2.4
Cohort 4
On either completion of recruitment or closure of Cohort 3 up to 15 patients with high tumor 
expression of NY-ESO-1 will be treated in Cohort 4.  Cohort 4 will receive Regimen C 
lymphodepletion, as described in Section 3.3.3, and NY-ESO-1c259T.  High tumor NY-ESO-1 
expression is defined as 2+ or 3+ by IHC in ≥ 50% cells.
If 0 or 1 responses are seen in the first 5 patients in Cohort 4 then the clinical effect will be deemed 
insufficient to proceed with this approach and Cohort 4 will close due to inadequate activity.  If 3
or more responses are seen in the first 5 patients then the Cohort will recruit until completion.  If 
2 responses are observed in the first 5 patients, the Cohort will continue to enroll additional patients 
to further characterize the activity of the regimen.  The study may continue to enroll beyond 5 
subjects based on clinical judgement to evaluate anti-tumor activity more comprehensively in the
context of the totality of the data.  Refer to Section 6.3 for information on the rationale for stopping 
the cohort at this point.  If the anti-tumor activity with Regimen C is determined to be suboptimal, 
then future subjects enrolled in Cohort 4 will receive Regimen A.  
3.2.5
Apheresis 
A non-mobilized PBMC collection should be performed by apheresis at the enrolling institution 
according to the Hospital policies and procedures.  Bilateral peripheral venous access should be 
used whenever possible but a temporary central venous catheter (CVC) may be placed for 
collection if peripheral venous access is inadequate.  Standard clinical procedures for apheresis 
should be followed.  Prior to apheresis, platelets should be >75 x109/Land hemoglobin >8.0 gm/dl.  
A large volume leukapheresis should be performed.  For patients who are >50 kg, 10 to 15 liters
should be processed per procedure; in patients ≤50kg, 2-3 blood-volumes should be processed per 
procedure with a goal of the procedure being collection of 1.0 x 108 PBMC/kg, and a minimum of 
1.5x107 PBMC/kg.  Prior to leukapheresis, an absolute lymphocyte count of >0.5 x 109/L and the 
CD3 count >200/µL is recommended.  In cases where the minimum number of PBMC is not 
collected or the T cells cannot be administered (e.g. release criteria not met), a second apheresis 
may be performed.  Citrate anticoagulant should be used.  Prophylactic intravenous CaCl2 and 
MgSO4 infusions should be administered at the discretion of the apheresis physician.  
3.2.6
T cell Transduction and Expansion  
Leukapheresis product will be sent via designated express courier to a central manufacturer for 
transduction and expansion.  Apheresis product will be labelled according to regulatory 
requirements and the Study Procedures Manual to ensure identification and traceability.


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Current experience with NY-ESO-1c259T is with total cell doses in the range of ~1 – 15×109 cells 
with a transduction level of ~20 – 75%.  Thus, the target dose of 5×109 transduced cells with a 
minimum dose of 1×109 transduced cells and a maximum of 6 x 109 transduced cells is within a 
range that has been effective and safe for cell therapies (Section 3.2.7).
The final cell product, NY-ESO-1c259T, is tested using pre-established release criteria.  Expanded 
cells meeting the certificate of analysis will be cryopreserved then shipped back via designated 
express courier to the participating site where they will be thawed and infused on Day 0. 
A Certificate of Analysis sample for the release criteria for the T cell product shown is in Table 1
below.
Table 1: Sample Certificate of Analysis Release Criteria
Test
Method
Criteria
Cell viability on sentinel tube
Trypan blue exclusion
≥70%
% CD3 positive T cells
Flow cytometry
≥80%
Endotoxin
(LAL Kinetic Method)
≤0.5 EU/mL
Mycoplasma
PCR
Negative
VSV-G DNA(RCL)
PCR
Negative
Transduction efficiency (NY-ESO-1 TCR)
Flow Cytometry Dextramer Positive
≥10%
Transduction efficiency (copy number)
PCR
0.1≤x≤5 average copies/cell
Bovine Serum Albumin (BSA)
ELISA
≤1 mcg/ml
Bacterial culture
Culture
No growth
Fungal culture
Culture
No growth
3.2.7
Cell Dose
Patients who are ≥40kg will receive the target cell dose of 5×109 transduced cells with a minimum 
1×109 transduced cells and a maximum of 6×109 transduced cells.  Patients <40 kg, however, will 
be dosed per body weight with a minimum 0.025×109 transduced cells/kg, and a target dose of 
0.125×109 transduced cells/kg.  For cohorts 2, 3 and 4, where at the end of manufacture there are 
insufficient transduced cells to meet the minimum required cell dose, additional NY-ESO-1c259T 
will be manufactured using unused apheresis product.  This will increase the likelihood that a 
patient enrolled onto a cohort is ultimately treated. 
3.3
Drug Administration
Dosages of cyclophosphamide will be adjusted for obese patients and the dose of fludarabine for 
renal dysfunction as described below.  Institutions are permitted to use their standard guidelines 
for administration, hydration, and monitoring parameters pertaining to chemotherapy agents 


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utilized in this protocol.  In the absence of institutional standards, suggested guidelines are detailed 
below.
3.3.1
Timing
Apheresis and subsequent chemotherapy should be conducted following the required washout 
periods after the previous dose of treatment.  Preceding anti-neoplastic treatment will need to be 
completed at an appropriate time prior to lymphodepleting chemotherapy (see Section 2.1)
Patients will initiate lymphodepleting therapy upon receipt by the Sponsor of satisfactory 
documentation of in-process testing demonstrating that the product has achieved release criteria 
(Table 1).  In the unlikely event that lymphodepleting therapy has been initiated, but final cell 
product release criteria are not met, discussions between the manufacturing site, Principal 
Investigator, and Sponsor Study Physician will be conducted to evaluate the safety and feasibility 
of cell administration.  The Competent Authority and IRB/IEC will be notified as necessary.  
Should the cell product be unable to be administered, the Investigator’s clinical team will provide 
standard supportive care, e.g. G-CSF, and monitoring until full recovery.
3.3.2
Lymphodepleting Chemotherapy and Cell Infusion 
Patients will begin infectious prophylaxis for pneumocystis carinii, herpes zoster and herpes 
simplex the day prior to commencing lymphodepletion, or as clinically indicated.  Patients may be 
admitted to the hospital for chemotherapy administration.  Chemotherapy conditioning may also 
be performed as an outpatient procedure at the discretion of the PI.  Antiemetics and hydration for 
administration of chemotherapy will be given according to standard institutional practice. 
3.3.3
Lymphodepleting Regimens
Regimen A
Recommended supportive medication
Day
Drug
Dose
Route
Administration
Hydration: Ensure adequate hydration and 
antiemetic provision prior to commencing 
cyclophosphamide infusions
Mesna: may be given per institutional 
guidelines or as recommended in Section 
3.4
Cell therapy premedication: 
premedication should be given 
approximately 30-60 minutes prior to the 
NY-ESO1c259T infusion as described in 
Section 3.5.1
G-CSF: first dose on Day +2 or as 
described in Section 4.6.1
-5
Fludarabine1
30 mg/m2
IV
in 50 – 100ml (concentration 
of 1mg/mL or less) 0.9% 
NaCl over 30 mins*
-4
Fludarabine1
30 mg/m2
IV
in 50 – 100ml (concentration 
of 1mg/mL or less) 0.9% 
NaCl over 30 mins*
-3
Fludarabine1
30 mg/m2
IV
in 50 – 100ml (concentration 
of 1mg/mL or less) 0.9% 
NaCl over 30 mins*
Cyclophosphamide2
1800 mg/m2
IV
in 200 – 500 0.9% NaCl over 
2 hours* 
-2
Fludarabine1
30 mg/m2
IV
in 50 – 100ml (concentration 
of 1mg/mL or less) 0.9% 
NaCl over 30 mins*
Cyclophosphamide2
1800 mg/m2
IV
in 200 – 500 0.9% NaCl over 
2 hours*
-1
0
NY-ESO1c259T infusion3


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+1
+2
start G-CSF4
Notes:
1 
Fludarabine dose will be adjusted in renal impairment as described in Section 3.3.4
2 
Cyclophosphamide dose will be adjusted in obese patients as described in Section 3.3.5
3 
Administration of NY-ESO1c259T infusion is described in Section 3.5
4 
Pegylated G-CSF may be given instead of short acting G-CSF according to institutional standard practice.  Recommendations 
for G-CSF administration are listed in Section 4.6.1.
*    Or per institutional standards
Regimen C
Recommended supportive medication
Day
Drug
Dose
Route
Administration
Hydration: Ensure adequate hydration and 
antiemetic provision prior to commencing 
cyclophosphamide infusions
Mesna: may be given per institutional 
guidelines or as recommended in Section 
3.4
G-CSF: given as 24 hours post the final 
dose of cyclophosphamide or as described 
in Section 4
-7
Fludarabine1
30 mg/m2
IV
in 50 – 100ml (concentration 
of 1mg/mL or less) 0.9% 
NaCl over 30 mins*
Cyclophosphamide2
600 mg/m2
IV
in 100 – 250 ml 0.9% NaCl 
over 30 mins*
-6
Fludarabine1
30 mg/m2
IV
in 50 – 100ml (concentration 
of 1mg/mL or less) 0.9% 
NaCl over 30 mins*
Regimen B
Recommended supportive medication
Day
Drug
Dose
Route
Administration
Hydration: Ensure adequate hydration and 
antiemetic provision prior to commencing 
cyclophosphamide infusions
Mesna: may be given per institutional 
guidelines or as recommended in Section 
3.4
Cell therapy premedication: 
premedication should be given 
approximately 30-60 minutes prior to the 
NY-ESO1c259T infusion as described in 
Section 3.5.1
G-CSF: first dose on Day +2 or as 
described in Section 4
-5
-4
-3
Cyclophosphamide1
1800 mg/m2
IV
in 200 – 500 0.9% NaCl over 
2 hours*
-2
Cyclophosphamide1
1800 mg/m2
IV
in 200 – 500 0.9% NaCl over 
2 hours*
-1
0
NY-ESO1c259T infusion2
+1
+2
start G-CSF3
Notes:
1 
Cyclophosphamide dose will be adjusted in obese patients as described in Section 3.3.5
2 
Administration of NY-ESO1c259T infusion is described in Section 3.5
3 
Pegylated G-CSF may be given instead of short acting G-CSF according to institutional standard practice.  Recommendations 
for G-CSF administration are listed in Section 4
*      Or per institutional standards


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Cyclophosphamide2
600 mg/m2
IV
in 100 – 250 ml 0.9% NaCl 
over 30 mins*
Cell therapy premedication: 
premedication should be given 
approximately 30-60 minutes prior to the 
NY-ESO1c259T infusion as described in 
Section 3.5.1
-5
Fludarabine1
30 mg/m2
IV
in 50 – 100ml (concentration 
of 1mg/mL or less) 0.9% 
NaCl over 30 mins*
Cyclophosphamide2
600 mg/m2
IV
in 100 – 250 ml 0.9% NaCl 
over 30 mins*
-4
start G-CSF3
-3
-2
-1
0
NY-ESO1c259T infusion4
Notes:
1 
Fludarabine dose will be adjusted in renal impairment as described in Section 3.3.4
2 
Long-acting (pegylated) G-CSF may be given instead of short acting G-CSF according to institutional standard practice. 
Recommendations for G-CSF administration are listed in Section 4
3 
Administration of NY-ESO1c259T infusion is described in Section 3.5
*     Or per institutional standards
3.3.4
Dose Adjustments for Fludarabine
Dose of fludarabine will be adjusted for patients with renal dysfunction as follows:
Creatinine clearance
Fludarabine dose
>80 mL/min
30 mg/m2
40 – 79 mL/min
20 mg/m2
3.3.5
Dose Adjustments for Cyclophosphamide
If the subject’s weight is greater than 175% Ideal Body Weight (IBW) then calculate 
cyclophosphamide dose based on Adjusted Body Weight (ABW).
No dose adjustments will be made for obese subjects receiving 600 mg/m2 because the adjustment 
is not necessary with the lower dose of cyclophosphamide.
3.3.5.1 Calculating Ideal Body Weight
Estimated ideal body weight (IBW) in kg
Males
IBW = (0.9 × height in cm) −88
Females
IBW = (0.9 × height in cm) −92
3.3.5.2 Calculating Adjusted Body Weight 
If the actual body weight is greater than 175% of the calculated IBW, calculate the ABW: 


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ABW = IBW + 0.4 × (actual weight −IBW)
The IBW and ABW are used to calculate medication dosages when the patient is obese.  This 
formula only applies to persons 152 cm or taller.
3.3.5.3 Cyclophosphamide Dose Adjustment for Pediatric Subjects
For pediatric subjects, where subject weight is >175% of the calculated IBW use the following 
formula to calculate cyclophosphamide dose:
ABW = IBW + 0.25 × (actual weight −IBW)
3.4
Mesna Administration
Mesna will be given to cover the duration of cyclophosphamide chemotherapy according to local 
practice.  The London Cancer 2014 guideline for high dose cyclophosphamide is provided as an 
example and recommends:
(50% cyclophosphamide dose) as an IV bolus pre infusion, 3hr, 6hr and 9-hr post on each day of 
cyclophosphamide administration.
http://www.londoncancer.org/media/75898/140214-London-Cancer-Mesna-Guideline-v1.pdf
3.5
NY-ESO-1c259T Cell Administration 
On Day 0, the subject will receive thawed NY-ESO-1c259T by intravenous infusion. The infusion 
bag will be labeled according to applicable regulatory requirements including batch number, 
protocol number, number of transduced cells and the subject’s study identification number.  Prior 
to infusion, two clinical personnel will independently verify all the information in the presence of 
the subject and to confirm that the information is correctly matched to the subject, as per 
institutional blood bank procedures.
3.5.1
Premedication
Subjects will be premedicated with antihistamines and acetaminophen according to institutional 
practice 30-60 minutes prior to cell infusion.  Steroids must not be given as premedication.
3.5.2
Cell Infusion
NY-ESO-1c259T must not be thawed until immediately prior to infusion.  The cells can be thawed 
either in a water bath at the patient’s bedside or in a centralized facility, according to institutional 
standard procedures.  The cells must be infused without delay and, if thawed centrally, must be 
transported to the patient by appropriately trained clinical staff, to preserve the chain of custody.  
The cell product must not be washed or otherwise processed.  It is expected that the infusion will 
Regimen
Mesna dose
%age Cy dose
Dose schedule
A
900 mg/m2
50%
0hr, 3hr, 6hr, 9hr on each day of Cy administration
B
900 mg/m2
50%
0hr, 3hr, 6hr, 9hr on each day of Cy administration
C
120 mg/m2
20%
0hr, 3hr, 6hr, 9hr on each day of Cy administration


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commence within approximately 10 minutes of thawing and complete within 45 minutes of 
thawing to minimize exposure of the cell product to cryoprotectant.  If the cells are provided in 
multiple bags, the second bag must not be thawed until half the first has been infused without 
reaction. 
If after thawing the inner infusion bag is damaged or leaking, the PI and Sponsor should be notified 
and the cells should not be infused.
NY-ESO-1c259T will be administered using a dual spike infusion set by gravity over 15-45 minutes 
in the absence of reaction.  It is recommended that the cells are infused without a filter, however 
if a filter is required by institutional practice the pore size must not be smaller than 170 µm.  
Infusion pumps must not be used.  For administration of the cells, 100 - 250 ml of 0.9% sodium 
chloride should be connected to the second lumen of the infusion set, used to prime the line, and 
then the lumen closed.  On completion of the infusion of a bag of NY-ESO-1c259T, the main line 
should be closed and approximately 50ml saline transferred into the cell bag, and then infused to 
minimize the loss of cells.  This process should be repeated for each cell bag if multiple bags are 
provided.  On completion of the cell infusion the set should be flushed using additional saline from 
the attached bag. 
In the event of adverse reaction to the cell infusion the infusion rate should be reduced and the 
reaction managed according to institutional standard procedures.  Steroid treatment should be 
avoided unless medically required.
The day of T cell infusion may be delayed in patients with significant complications of 
chemotherapy if according to the Investigator it is in the best interest of the patient. The timing of 
all assessments post-infusion will be calculated with reference to the T-cell infusion date.  Subjects 
who have undergone leukapheresis but do not receive the T-cell infusion will be replaced.  
Cytopenias alone should not be a reason to delay T-cell infusion unless complications are present.
3.5.3
Second T Cell Infusions
Second infusions can occur in two settings:
1. Patients enrolled onto any cohort who have a confirmed response, or have stable disease 
for >3 months, then progress, are eligible for a second infusion of NY-ESO-1c259T.  Patients 
with confirmed responses or stable disease that qualify for a second infusion will receive 
lymphodepleting chemotherapy and T cell infusion as received for the first infusion.  A 
second infusion of NY-ESO-1c259T may only be given to these patients if their tumors 
continue to express the appropriate antigen target.  Eligible patients must provide fresh 
tumor biopsies at confirmation of progression of disease.  The biopsy collected at the time 
of progression is required for determination of NY-ESO-1 positivity prior to a second 
infusion.
2. Patients in Cohort 3 and 4 who have progressive disease or stable disease ≤3 months as 
best response, may receive a 2nd treatment of NY-ESO-1c259T using the Regimen A 
lymphodepletion to determine if more intense lymphodepletion can result in an improved 
best response.  Biopsies are not required for retreatment of these patients.  It is assumed 
that the antigen expression would not have changed, whereas a patient who responded and 
progressed may have progressed due to loss of antigen.  


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Where available, previously manufactured cell product will be used; otherwise any residual 
apheresis product from collections prior to receipt of the gene modified T cells will be utilized for 
a new product manufacture.  Patients will not be re-apheresed for cells unless there are no gene 
modified cells detectable by QPCR and approval to do so has been received by the Safety 
Monitoring Team consisting of the Sponsor and Investigators prior to the procedure.  
Patients may receive a maximum of two treatments with NY-ESO-1c259T.  The second cycle (i.e. 
re-treatment) can be given no sooner than 60 Days from the first infusion and no later than 2 years 
after the first infusion.  Decisions to retreat with a second infusion will be discussed with the 
Sponsor and Investigators.
3.5.3.1 Additional Eligibility Criteria (Prior to Second T-Cell Infusion)
Prior to receipt of a second infusion of NY-ESO-1c259T, all patients must remain eligible to 
receive manufactured T-cell product as defined in Section 2.1 and Section 2.2 and meet the 
following inclusion criteria:
1. Patient has had a documented confirmed response (PR or CR) or stable disease >3 months 
followed by confirmed PD after the first T-cell infusion.  In addition, patients in Cohort 3 
and 4 who have progressive disease or stable disease ≤3 months as best response may be 
eligible for second infusion (see Section 3.5.3).
2. A second T cell infusion is recommended by the Investigator.
3. Patients in any cohort with a confirmed response (PR or CR) or stable disease must have a
new tumor biopsy confirming NY-ESO-1 expression by immunohistochemistry. 
4. Patient has voluntarily agreed to receive a second T-cell infusion by giving written 
informed consent.
5. Patient has toxicity from first T-cell infusion that resolved to Grade ≤1. 
6. Manufactured T-cell product must be available.  

In cases where previously manufactured T-cell product is not available, any residual 
leukapheresis product from collections prior to receipt of the gene modified T cells will 
be utilized for a new product manufacture.  

In cases where residual leukapheresed product is not available, patients can agree to be 
re-leukapheresed for cells only in circumstances where there are no detectable gene 
modified cells.
Furthermore and prior to receipt of a second T-cell infusion, a patient meeting the following 
criterion is not eligible for a second T-cell infusion:
7. Patient with any Grade 4 CRS or clinically life-threatening (Grade 4) AEs deemed at least 
possibly related to the NY-ESO-1c259T cell product by the principal investigator and study 
sponsor reported during the first T-cell infusion.


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3.6
Safety Considerations
3.6.1
Early Stopping Rule
Throughout the conduct of the study, safety data will be reviewed for each subject on an ongoing 
basis.  Additionally, periodic safety reviews will be undertaken by the Sponsor. 
If the following events occur, further enrolment to the study will be suspended and the regulatory 
authorities informed.  
Any death occurs that is deemed to be probably or definitely related to the investigational 
medication/cell product by the principal investigator and study sponsor;
Or
Two (2) or more grade 4 autoimmune events deemed probably or definitely related to the 
investigational medication/cell product by the principal investigator and study sponsor;
Or
An apheresis confirmed positive biological replication competent lentivirus (RCL) occurs (see 
Section 3.9.4) or confirmed positive peripheral blood mononuclear cell (PBMC) RCL and no other 
vector lot is available
Following assessment by the Sponsor, enrollment and dosing may resume if agreed upon by the 
Sponsor, and regulatory authorities, if applicable.
3.7
Study Withdrawal
A subject may withdraw from the study at any time for any reason without prejudice to their future 
medical care by the physician or institution.  However, the Investigator must make every 
reasonable effort to keep each subject on study for the whole duration of the trial.  In cases where 
the subject is deemed ‘lost to follow-up’, the Investigator or designee must make every effort to 
regain contact with the subject (where possible, 3 telephone calls and, if necessary, a certified letter 
to the subject’s last known mailing address or local equivalent methods).  These contact attempts 
should be documented in the subject’s medical records.  Should the subject continue to be 
unreachable, only then will he/she be considered to have withdrawn from the study with the 
primary reason as ‘Lost to Follow-up’.
If the subject withdraws consent for further participation in the study, all final End-of-Study 
assessments should be performed, if possible on the day the decision is made to take the subject 
off-study or as soon as possible thereafter.  All of the results of the evaluations and observations, 
together with a description of the reasons for study withdrawal, must be recorded in the medical 
records and electronic Case Report Form (eCRF). 
The following are some of the justifiable reasons for the Investigator to withdraw a subject from 
study:

Withdrawal of consent.

Did not receive any T cells (refer to Section 8.3 and Section 8.4) for continued 
monitoring of AEs/SAEs following study procedures.


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If a subject who has consented to participate in pharmacogenetics research withdraws from the 
clinical study for any reason other than lost to follow-up, the subject will be given the following 
options concerning the pharmacogenetics sample, if already collected:

Pharmacogenetics research continues as per the subject’s consent; or,

Any remaining sample is destroyed.
If a subject withdraws consent from the pharmacogenetics research or requests sample destruction, 
the Investigator must complete the appropriate documentation to request sample destruction within 
the timeframe specified by GSK and maintain the documentation in the site study records.  In 
either case, GSK will only keep study information collected/generated up and until that point.
Once a subject has permanently discontinued from study treatment, the subject will not be allowed 
to be retreated.
All subjects who discontinue from study treatment will have safety assessments at the time of 
discontinuation and during post-study treatment follow-up as specified in the Schedule of 
Assessments Table (see Appendix 2).
3.8
On-Study Protocol Evaluations
3.8.1
Screening Studies 
Note: to be performed ≤7 days prior to apheresis, unless otherwise stated

Disease staging evaluation (CT or MRI within one month of apheresis)

History and complete physical examination, including height, weight, ECOG/Lansky and 
vital signs.

HLA screening (any time prior to apheresis)

NY-ESO-1 screening (any time prior to apheresis)

Labs: hematology, PT, PTT, chemistry (includes LDH, SGPT (ALT), SGOT (AST), 
alkaline phosphatase, bilirubin (total and direct), BUN/urea, creatinine, electrolytes, 
calcium, magnesium, phosphate, albumin), 

Urine or serum pregnancy test: required for females of childbearing potential

Urinalysis

Infectious disease markers: HIV, HBV, HCV, HTLV 1+2, CMV, EBV, and syphilis 
(spirochaete bacterium) (within one month prior to apheresis)

An ECHO or MUGA scan will be performed at screening to determine eligibility.  
Additional scans will be performed only if clinically indicated.  NOTE: the same method 
of cardiac evaluation must be used consistently for any follow-up scans.

ECG.
3.8.2
Baseline Studies 
Note: to be performed within 7 days prior to initiating chemotherapy, unless otherwise 
stated


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
Disease staging evaluation (CT or MRI) 

History and complete physical examination, including height, weight, ECOG/Lansky and 
vital signs.

Labs: hematology, PT, PTT, chemistry (includes LDH, SGPT (ALT), SGOT (AST), 
alkaline phosphatase, bilirubin (total and direct), BUN/urea, creatinine, electrolytes, 
calcium, magnesium, phosphate, albumin), uric acid, CRP, amylase, lipase, ferritin, 
rheumatoid factor, ANA, thyroid function.

Blood CMV DNA PCR

RCL

Urinalysis

Patients ≥65 yrs of age must have renal function measured either by 24-hour urine 
creatinine collection or by nuclear medicine EDTA GFR measurement, according to 
standard practice at the treating institution.
Note: Estimates of creatinine clearance decrease in accuracy with increasing subject age, 
tending to underestimate renal function in older patients (Raj 2006).  Accurate information 
on renal function is needed to evaluate eligibility for the study and to determine 
chemotherapy dose, therefore older patients will have renal function measured by the above 
methods to ensure accuracy.

Urine or serum pregnancy test: required for females of childbearing potential.

ECG

For subjects with cardiac or pericardial disease at baseline, inpatient telemetry monitoring 
will be carried out for a minimum of three and up to seven days post [TCR] infusion. 

Reports of cardiac events in subjects with cardiac or pericardial masses following treatment 
with NY-ESO-1c259T will continue to be monitored through normal proactive 
Pharmacovigilance.

Re-screening for infectious disease markers is not required at baseline (prior to 
lymphodepletion)
Note: Patients must meet eligibility criteria identified in Section 2 for those tests repeated at re-
staging (Baseline) prior to T cell infusion (see Appendix 2).
3.8.3
Baseline Research Studies

Serum cytokine levels

Persistence/Expansion of NY-ESO-1 specific T cells

Flow cytometry (includes lymphocyte subset phenotyping, including Tregs)

Tumor biopsy: when possible, patients with safely accessible tumor will be asked to 
undergo core needle tumor biopsies


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3.8.4
Monitoring During Chemotherapy (Daily from first day of chemotherapy)

Daily laboratory evaluation: hematology, chemistry (includes LDH, SGPT (ALT), SGOT 
(AST), alkaline phosphatase, bilirubin (total and direct), BUN/urea, creatinine, 
electrolytes, calcium, magnesium, phosphate, uric acid, albumin, CRP)
Note: institutions must follow their local procedures for clinical care of patients receiving 
cyclophosphamide and/or fludarabine
3.8.5
Day 0: Clinical Monitoring During and After Cell Infusion

Symptom-directed physical examination prior to cell infusion

Monitoring will include vital signs and oxygen saturation prior to and approximately every 
15 minutes until one hour after completion of infusion or until stable for two consecutive 
measures, whichever is later.  Once stable, vital signs will be monitored routinely
Note: Supplemental oxygen should be available at the bedside  

If an allergic or other acute reaction occurs, studies appropriate for investigation of a 
transfusion reaction will be performed (urinalysis, hematology, Coomb’s test)

Clinical labs:
Hematology, chemistry, (includes LDH, SGPT (ALT),
SGOT (AST), alkaline 
phosphatase, bilirubin (total and direct), BUN/urea, creatinine, electrolytes, calcium, 
magnesium, phosphate, CRP, uric acid, albumin)

CMV PCR

Research studies:
Serum cytokine levels
3.8.6
Monitoring Day 1 to Week 4
Note: days 1, 3, 4, 7 time-points may be performed ± 1 days

Physical exam: Day 1, 3, 4 and 7 obtain on at least 3 separate days. From Day 8 to Week 
4, perform once weekly  

Hematology: days 1, 3, 4 and 7 obtain on at least 3 separate days.  From Day 8 to Week 4, 
obtain once weekly

Chemistry (includes LDH, SGPT (ALT), SGOT (AST), alkaline phosphatase, bilirubin 
(total and direct), BUN/urea, creatinine, electrolytes, calcium, magnesium, phosphate, 
LDH, CRP, uric acid and albumin.  Day 1, 3, 4 and 7.  From Day 8 to Week 4, obtain once 
weekly

CMV PCR: Week 2 and 4

Radiographic imaging for response assessment at Week 4 (may be performed ± 4 days)

Research Studies:
Serum Cytokine Levels: days 1, 4 and weekly to Week 4


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Persistence/Expansion of NY-ESO-1 specific T cells: days 4, 7, Week 2, Week 4
Flow cytometry (includes lymphocyte subset phenotyping including Tregs) day 7 and 
Week 4
3.8.7
On Treatment Evaluations After Week 4
Note: Evaluations from Week 4 through Month 6 may be performed ± 1 week; for visits
>9 months, evaluations may be performed ± 3 weeks

Radiographic imaging for response assessment with restaging: Week 8, Week 12, Month 
6, Month 9 and Month 12, then every 3 months for 2 years and then yearly until 5 years 
post-infusion.

Evaluations at Week 6, Week 8, Week 12, Month 4, Month 5, Month 6, Month 9, Month 
12, then every 3 months until 2 years post-infusion, then every 6 months until 5 years post-
infusion or until progression and at discontinuation will include the following (unless 
otherwise stated):
Physical examination, including vital signs.  Hematology, chemistry (electrolytes/ liver/
renal function)

Additional visits for hematology tests only (physical examination and review not required): 
Week 5, Week 10

CMV PCR: Week 6 and 8

Detection of RCL as described in Section 3.9.5 and Appendix 2

Research studies (Refer to Appendix 2):
Serum cytokine levels (Week 6, Week 8)
Persistence/expansion of NY-ESO-1 specific T cells: if the patient is in the interventional 
phase of the study, samples are collected at Week 8, Week 12, Month 12 and every 6 
months until 5 years post-infusion as per Appendix 2.  If the patient is in LTFU, samples 
for persistence are collected as per Appendix 4
Flow cytometry (Note: draw only when patient’s absolute leukocyte count (ALC) is
≥0.2x109/L) Week 8, Months 6, 12 and every 3 months until 2 years post-infusion, then 
every 6 months until 5 years post-infusion
Tissue biopsy at Month 2 and if possible at disease progression (see section 3.9)
3.9
Biologic studies
3.9.1
Monitoring Persistence/Expansion of NY-ESO-1c259T
The goal of the immune/biologic studies are to monitor the expansion/persistence of the adoptively 
transferred cells to test the hypothesis that clinical response correlates with the 1) degree of 
expansion and/or 2) persistence of the genetically modified cell in vivo.  
Due to nature of this study, it is possible that expansion of specific T-cell clones will be observed 
as tumor reactive T-cells proliferate.  Therefore, care will be taken to track NY-ESO-1c259T 
persistence.  Genetically modified cells will be measured in blood samples collected periodically 


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according to the schedule in Appendix 2.  Persistence of genetically modified cells will be 
measured using PCR to transgene specific sequences.  Additionally for specific cutoff values such 
as transduction efficiency of the infused product (which requires 10% NY-ESO-1 reactive T cells)
the value obtained with antibodies to the BV13.1 chain of the T cell receptor will be used.
In addition to correlating persistence with response outcomes, monitoring persistence is important 
due to the theoretical risk of insertional mutagenesis in cells transduced with a lentiviral vector.  
While this risk has been realized in stem cell gene transfer studies, T cells appear resistant to 
transformation by integrating viruses (Cattoglio 2010; Newrzela 2008).  Monitoring for insertional 
oncogenesis follows the recommendations set forth in the FDA guidance (Guidance for Industry, 
Gene Therapy Clinical Trials-Observing Subjects for Delayed Adverse Events 2006; EMA CHMP 
Guideline on follow-up of patients administered with gene therapy medicinal products 2009).
Peripheral blood mononuclear cells (PBMCs) samples will be collected and used as the “surrogate 
sample” for monitoring persistence of gene modified cells in patients at baseline, 3, 6, and 12 
months post-infusion, every 6 months until 5 years post-infusion and every year until 15 years post 
infusion.  The samples will be tested to detect the presence of the WPRE or the Psi gene, both of 
which are part of the lentiviral vector used to transduce T cells.  Detection of WPRE or Psi DNA 
copies reflects persistence of the transduced T cells.  If at 1 year or beyond post-infusion greater 
than 1% PBMCs test positive for vector sequences, then the patient’s PBMCs will be evaluated 
for integration site analysis (see below).  If no gene modified cells are detected for three 
consecutive assessments and subject is 5 years post-infusion, no further monitoring of PBMCs is 
required and collection of samples for persistence may be stopped and the subject can be followed 
remotely for up to a total of 15 years post infusion.  Note that samples will still need to be collected 
until year 15 for RCL as described in Section 3.9.5.  
If persistence, as detected by the presence of vector sequences (WPRE or Psi DNA copies), is 
present in >1% of PBMC at 1 year or beyond post-infusion, DNA from the patient’s PBMCs will 
be sent for integration site analysis. 
If there is clonal dominance (either monoclonality or oligoclonality) the integration site analysis 
will be repeated within 3 months on a new sample.  If the retest demonstrates the same dominant 
clones, there will be a review by the Sponsor to develop a monitoring plan specific to the health 
care risk and/or strategies to inform appropriate subjects, investigators, and regulatory agencies of 
the findings.  If the integration site analysis indicates polyclonality of gene modified T cell 
population, then screening continues as scheduled. 
3.9.2
Monitoring Treg Depletion
In addition to studies on the expansion and persistence of genetically engineered T cells, we will 
also monitor for Treg populations using antibodies to FOXP3+ cells.  In this study, we will 
descriptively evaluate the relationship between FOXP3+ cells and tumor response.
3.9.3
Flow Cytometry
Flow cytometry will be conducted at a central laboratory designated by the Sponsor. (See 
Appendix 2)


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3.9.4
Monitoring and Management of Replication-Competent Lentivirus 
Replication Competent Lentivirus (RCL) is a theoretical risk associated with the use of lentiviral 
vectors; no RCL has ever been detected in vitro or in vivo.  The risk is derived from the detection 
of replication competent retrovirus (RCR) during the use of early γ-retroviral vector packaging 
systems which were inadequately designed to avoid recombination events between the vector and 
packaging components (Miller 1990).  RCR resulted in the onset of lymphoma in 3/10 monkeys 
after receiving cells transduced with an RCR contaminated vector lot (Donahue 1992).  Updated γ 
retroviral packaging systems have not been associated with RCR, however as a result of the 
Donahue study, RCR/L must continue to be rigorously evaluated in vector and cell lots, and in 
subjects post infusion with any product involving a retrovirus (FDA 2000).
A RCL may be generated during the production phase or subsequently after introduction of vector 
transduced cells into the subject.  RCL may be generated between homologous or non-homologous 
recombination between the transfer vector and packaging elements, or endogenous retroviral 
elements (Chong 1998; Garrett 2000).  A RCL resulting from the production phase of the lentivirus 
used in this trial is highly unlikely since elements are incorporated in the design of the vector 
system that minimize vector recombination and generation of RCL.  Nevertheless, generation of 
an RCL following infusion of the vector product remains a theoretical possibility.  The 
consequences of such recombination events could be neutral, could reduce the replication rate or 
pathogenicity of the subject's virus, or could increase the replication rate or pathogenicity of the 
subject's virus.  Since the development of a strain with increased pathogenicity would pose greater 
risk to both the subject and their close contact(s), periodic monitoring for RCL is conducted during 
the course of the trial.
Regulatory agencies and the gene therapy community have previously discussed measures to be 
taken should an RCL be confirmed in a subject (FDA 2000).  However, because the probability 
and characteristics of an RCL are unknown, no concrete plans have been put in place.  
Nevertheless, all agree that the subject must be isolated until an understanding of how to manage 
the subject becomes clear.
Approaches that have been discussed for managing the subject are the following:

Provide targeted antiretroviral therapies based on genotyping of the RCL.

Intensive follow up of subject in consultation with gene therapy experts, study 
investigators, HIV physicians, FDA and NIH.

Inform local public health officials and CDC.

Identify sexual partners and provide appropriate counseling and intervention.
3.9.5
Testing for RCL in Clinical Studies
RCL will be monitored using a PCR-based assay that detects and measures copies of the gene 
coding for the vector’s envelope protein, namely Vesicular Stomatitis Virus G protein (VSV-G) 
that is necessary for the assembly of pseudotyped infectious lentiviral particles but absent from the 
vector’s backbone.  RCL testing and monitoring will take place on:

cell product, whereby RCL testing will be performed by or under the direction of the 
manufacturing facility responsible for the manufacturing and release of the vector


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
patient PBMCs which will be collected prior to infusion of transduced T cells and then at 
3, 6, and 12 months post treatment.  If these tests are negative at all time points during the 
first year, PBMC samples will be collected and archived for up to 15 years post infusion; 
however, if VSV-G DNA copies are detected at any time point during the first 12 months 
after infusion, then patient samples will be tested until lentiviral gene copies are no longer 
detected in the subject.
3.9.6
RCL Safety Monitoring - Results
If a positive VSV-G DNA signal is obtained, following review by the Sponsor, the study PI will 
be informed and the subject scheduled as soon as possible for a retest and within one month after 
the initial positive result was reported to the Sponsor. 
If the second test is positive, infusions for all subjects receiving cells modified with the same vector 
lot will be postponed.  The subject with the confirmed positive VSV-G signal will be scheduled 
for leukapheresis and a biological RCL test measuring replication and infectivity of viral particles 
will be performed on the leukapheresis product. 
If the biological RCL test is positive, all infusions using the vector lot will be stopped.  If the test 
is negative, infusions for all subjects can resume.
3.9.7
Blood Volume Restrictions for Research Samples:
Blood sample volume for the research purposes of this study will be restricted.  The amount of 
blood drawn from adults (those 18 years of age or older, or relative country-specific guidelines) 
for research purposes shall not exceed 10.5 mL/kg or 550 mL, whichever is smaller, in an 8 week 
period.  The amount of blood drawn for research purposes from pediatric patient subjects (those 
under 18 years of age or relative country-specific guidelines) will not exceed 5 mL/kg in a single 
day, and no more than 9.5 mL/kg over an 8 week period.
In the event that blood draws are limited due to these restrictions, research studies will be 
performed in order of priority in discussion with the Investigator and Sponsor.
3.10
Tumor Biopsy for Research
The assessment of biopsy material is essential for the development of the NY-ESO-1c259T product; 
the information learned will build understanding of tumor immune escape mechanisms, as well as 
the ability of the cell product to induce or recover a broader anti-tumor immune response within 
each patient.  Correlating this data with patient responses will be essential to understanding the 
mechanism of action of the NY-ESO-1c259T product and mechanism(s) of tumor escape. The data 
will support late phase clinical development and in parallel will inform potential improvements 
that could be made to NY-ESO-1c259T to enhance response and durability.
3.10.1 Tumor Biopsy at Baseline, Month 2, and Disease Progression
When possible, patients with safely accessible tumor will be asked to undergo core needle tumor 
biopsies at baseline and Month 2 (the biopsy may be taken ±4 weeks of the Month 2 visit).  If 
possible, biopsies should consist of multiple cores taken from more than one lesion.  Since lung 
lesions are common in synovial sarcoma and may not be amenable to core needle biopsy, fine 
needle aspirates from one lesion may be obtained based on interventional radiology 
recommendations.  The baseline biopsy material may be collected anytime between two months 


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and 2 weeks (+1 week) prior to the start of chemotherapy, with a preference for the biopsy to be 
taken closer to the chemotherapy.  The tumor tissue should be taken from non-target lesions, or 
from target lesions provided they are greater than 2cm.  When possible the same lesion(s) should 
be biopsied at both baseline and Month 2.  If it is not possible to biopsy the same non-target 
lesion(s) at Month 2, then (an) other non-target lesion(s) preferably in the same anatomical region 
should be biopsied.  The apparent clinical or scan status of the lesion(s) biopsied at Month 2 should 
be noted at the time (e.g. decreased, stable, increased size or activity). 
Patient will not be excluded from the study if tumor is not safely accessible or if patient does not 
opt for biopsy.
The investigational plan for the biopsies and the collection and sample preparation methods can 
be found in the Study Procedures Manual. 
If feasible, biopsy material should also be collected when disease progression has been confirmed 
and documented, ideally on lesions that have progressed.  If progression is identified in the same 
lesion(s) biopsied at Month 2, then this lesion would be preferred for repeat biopsy.  A biopsy may
be obtained any time post-progression during resection, if possible.  
As stated in section 2.3, patients should not receive anticancer therapy, including surgical 
resections, prior to disease progression.  In the event that a resection of target or non-target lesions 
is performed for disease progression, or prior to progression for medically justified reasons, a 
portion of the tissue must be made available to GSK for translational research studies to understand 
mechanisms of response or resistance to the therapy.
In patients who have an accumulation of pleural effusion, if there is a clinical requirement for 
removal of the effusion fluid at any time on study we request that samples be collected for GSK 
for translational research studies.  If available, pleural effusion fluid should be collected in addition 
to and not in place of the requested tumor biopsies.  We request that every attempt is made to 
collect both tumor biopsies and effusion fluid when it is possible and for each of the requested on-
study time points.
3.11
Criteria for Completion of Interventional Phase, Transition to Long-Term Follow-up 
or Discontinuation
3.11.1 Interventional Phase:
All patients who receive one or more infusions of genetically engineered T cells will be followed 
as per Appendix 2 until they complete the interventional phase for one or more of the following 
events:

If patient does not meet eligibility for additional cell therapy cycles(s) or had unacceptable 
toxicity precluding additional cell therapy cycle(s), AND develops progressive disease that 
requires treatment with tumor directed therapy. 

if they are unable to comply with study requirements, or 

Patient, parent or guardian choice (elective withdrawal). 
The tests and procedures at discontinuation described in Appendix 3 should be performed, if 
possible, at the time a patient comes off regular study assessments, prior to entering long term 


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follow up, regardless of the reason, unless the test or procedure has been performed in the last 4 
weeks (2 weeks for physical examination and laboratory assessment).
Subjects who remain progression free will continue to be assessed under the interventional phase 
of the protocol until 2 years post infusion as described in Appendix 2.  After 2 years post the last 
T cell infusion all patients will transfer to the long term follow up schedule.  Subjects who receive 
a second T cell infusion will be followed for 6 months post infusion as described in Appendix 2 
before transferring to the long term follow up schedule.
3.11.2 Long-Term Follow-Up
All subjects will be followed for 15 years from the time of their last T cell infusion for observation 
of delayed adverse events in accordance with regulatory guidance. 
If a subject receives a second T cell infusion, observation for long-term follow up restarts with the 
second infusion, and subjects will be followed for 15 years from the time of second T cell infusion.  
All subjects will continue to be followed for overall survival during the Long Term Follow Up 
(LTFU).  LTFU will occur either as part of this study, or subjects will be rolled-over into a separate 
LTFU protocol (GSK208750 [ADP-0000-002]) when available.  The LTFU protocol will undergo 
regulatory, institutional and ethics committee approval and subjects will be consented to this 
specific LTFU study for continued collection of LTFU data. Please refer to Appendix 4 for LTFU
assessments.
Subjects who have progressive disease prior to one year will be assessed at 3 months for required 
persistence, RCL, hematology, chemistry, and physical exam but then should be monitored every 
6 months post cell infusion until the end of year 5 post T cell infusion as described in Appendix 4.
The physical exam (including concomitant medications and adverse events) will be conducted with 
careful attention to features possibly related to oncoretroviral diseases including: (1) New 
malignancies, (2) New incidence or exacerbation of a pre-existing neurologic disorder, (3) New 
incidence of exacerbation of a prior rheumatologic or other autoimmune disorder, and (4) New 
incidence of a hematologic disorder.  (5) Unexpected illness and hospitalization deemed related to 
gene therapy.
From year 6 to 15, subjects will be asked to return for testing only if vector modified cells were 
detected in the previous visit.  If so, then blood for persistence of vector modified cells will be 
performed and an annual RCL testing (archive) collected.  If no vector modified cells were detected 
in the previous visit, annual follow-up will be conducted by means of a clinical questionnaire 
completed via phone or through the mail by the study coordinator.  A draft letter to the patient and 
the patient’s primary doctor (if different than the study Investigator listed on this protocol) is 
provided in Appendix 5.
For as long as female patients have detectable gene modified cells, they will be advised to avoid 
pregnancy.  Persistence data will be performed in real time and this data will be used to properly 
advise patients in a timely manner.


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4
Supportive Care
4.1
Infection 
Patients should receive prophylaxis against Pneumocystis pneumonia, herpes simplex, and 
varicella zoster and according to the hospital guidelines for at least 1 year after completing this 
therapy.  In addition, measures to treat and prevent infection may be provided in accordance with 
hospital guidelines.  In particular, fever and neutropenia should be aggressively managed as well 
as preemptive influenza therapy and other standard therapies for immunocompromised hosts. 
4.1.1
Cytomegalovirus 
Subjects will be screened for cytomegalovirus (CMV) seropositivity at study entry.  CMV IgG 
positive subjects should be measured at baseline and monitored 2-weekly for CMV viremia by 
CMV DNA PCR from the start of lymphodepletion until 8 weeks post infusion of NY-ESO-1c259T
as shown in Appendix 2.  In the event CMV viremia is observed a specialist in infectious disease 
should be consulted and treatment initiated if necessary according to institutional practice. 
If a subject experiences prolonged or recurrent pancytopenia or lymphopenia additional 
monitoring for viral reactivation should be considered and treatment for viral infection initiated if 
necessary.  A strategy for management of pancytopenia or bone marrow failure is described in
Section 4.6.2.
4.1.2
Syphilis
Subjects will be screened for syphilis at study entry.  Subjects with positive screening results 
should be evaluated by an infectious diseases consultant.  If determined to have syphilis 
infection, the subject should be treated before lymphodepleting chemotherapy.
4.2
Hematologic and Blood Product Support
Blood product support should be provided to maintain platelets > 10 x109/L, Hb > 8.0 g/dL and as 
clinically indicated (AABB guideline, Kaufman 2015).  
4.2.1
Blood Product Irradiation
Bone marrow suppression can be a consequence of transfusion associated GvHD.  To minimize 
the possibility of transfusion associated GvHD, all blood products transfused within 4 weeks prior 
to leukapheresis, within 4 weeks prior to initiation of conditioning chemotherapy and following 
conditioning chemotherapy until at least 6 months following study T cell infusion or until 
lymphocyte count returns to ≥1.0 x109/L (whichever is longer) must be irradiated.  Patients who 
have received fludarabine as part of the conditioning chemotherapy must continue to receive 
irradiated blood products for at least 6 months post study treatment.  Patients receiving steroids or 
other immunosuppressive therapies should also receive irradiated blood products regardless of 
above time intervals. 
4.2.2
CMV Screened Blood Products
Subjects will be screened for CMV seropositivity on study entry.  In order to reduce the risk of 
primary CMV infection all subjects should receive leukoreduced blood products where possible 
(excluding the study T cell infusion).  Where leukoreduced blood is not available, CMV negative 


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patients must only receive blood products from CMV-seronegative donors from study entry to 
study discontinuation. 
4.3
Treatment of Autoimmunity
Patients should be monitored throughout the trial for potential autoimmune reactions in response 
to the genetically engineered T cells that could include skin toxicity, liver toxicity, colitis, eye 
toxicity etc.  If autoimmunity is suspected, the PI should be contacted and every attempt should be 
made to biopsy the affected organ to clarify whether the symptoms are related to the NY-ESO-1 
T cell therapy.  If the patient sustains persistent Grade 2, or Grade 3 or 4 autoimmunity, 
consideration should be given to administration corticosteroid therapy, either topically (e.g. skin, 
eyes) or systemically, as clinically indicated. 
4.4
Treatment of Cytokine Release Syndrome 
Cytokine release syndrome (CRS) is a potentially life-threatening toxicity that has been observed 
following administration of antibodies and adoptive T-cell therapies for cancer.  It is defined 
clinically by symptoms many of which mimic infection including pyrexia, nausea, diarrhea, 
headache, fatigue, tachycardia, hypotension, transaminitis, rash and dyspnea.  It is important to 
evaluate the subject for concurrent infections.  Potentially life-threatening complications of CRS 
include cardiac dysfunction, adult respiratory distress syndrome, neurologic toxicity, renal and/or 
hepatic failure and disseminated intravascular coagulation.  CRS may also be associated with 
findings of macrophage activation syndrome or occur coincident with tumor lysis syndrome.
CRS causes a rapid rise in serum cytokine levels under conditions of immune activation and 
although cytokines will be assayed serially throughout the study, results of the assays will not be 
available in real time; therefore CRS, should be graded and managed with supportive and 
immunosuppressive interventions according to the severity of symptoms (Lee 2014).  
Table 3 provides the recommended management of CRS according to grade, which has been 
further adapted from CTCAE for use with immunotherapy and should be implemented in 
accordance with institutional guidelines.
Symptoms typical of CRS are listed in the table below according to severity.  Symptoms can mimic 
those seen with infection.  The diagnosis of CRS is clinical, and is supported by the exclusion of 
infection as well as the presence of increased cytokine levels and other biomarkers.  Assessment 
and treatment guidelines are provided below.  If CRS is suspected, in addition to assessment for 
infection, cytokine levels as described as well CRP and Ferritin levels should be measured 
approximately every other day until symptoms are improving or an alternative diagnosis is 
confirmed. 
Table 2  Management Guidelines for Cytokine Release Syndrome
Grade
Clinical Presentation for Grading 
Assessment
Management Guidelines
1
Constitutional symptoms not life-threatening 
(e.g., fever, nausea, fatigue, headache, 
myalgias, malaise)

Vigilant supportive care1

Assess for infection and treat2
2
Symptoms require and respond to moderate 
intervention (Hypotension responds to fluids or 

Monitor cardiac and other organ 
function

Vigilant supportive care1.


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one low dose pressor, hypoxia responds to 
<40% O2, and/or Grade 2 organ toxicity)

Assess for infection and treat2

Treat hypotension with fluid and 
pressors.  

Administer O2 for hypoxia.

Administer tocilizumab ± 
corticosteroids3 in subjects with 
extensive co-morbidities or of older 
age.
3
Symptoms require and respond to aggressive 
intervention
hypotension requires multiple pressors or high 
dose pressors
hypoxia requires ≥40% O2
Grade 3 organ toxicity or Grade 4 transaminitis

Monitor subject very closely for 
cardiac and other organ dysfunction. 
Most likely will require monitoring in 
an intensive care unit (ICU).

Vigilant supportive care1

Assess for infection and treat2

Treat hypotension with fluid and 
pressors.  Administer O2 for hypoxia.

Administer tocilizumab ± 
corticosteroids3
4
Life-threatening symptoms
Grade 4 organ toxicity (excluding 
transaminitis)

Manage subject in ICU 

Intensive supportive care including 
mechanical ventilation, fluids, 
pressors, antibiotics and other 
measures as required

Administer tocilizumab ± 
corticosteroids3
5
Death
1.
Supportive care includes:  monitor fluid balance, maintain adequate hydration and blood pressure 
2.
Assessment and treatment to include history and physical, blood and urine cultures, imaging studies, 
administration of antimicrobial agents for concurrent bacterial infections, and for treatment of fever and 
neutropenia as per institutional practice; and antipyretics, analgesics as needed. 
3.
Other immunosuppressive agents may be used, including TNFα  and IL-1R inhibitors 
Source:  Lee 2014
Subjects requiring immunosuppressive intervention may receive tocilizumab, steroids, or both 
(Davila 2014; Lee 2014).  Tocilizumab is a humanized anti-IL-6 receptor antibody that has been 
used to manage severe CRS (although it is not approved for this indication).  Anecdotally, 
tocilizumab has produced rapid and complete correction of CRS with single doses (Maude 2014).  
Lee et al., recommend administration of tocilizumab 4 mg/kg administered over 1 hour in adult 
subjects as the first-line treatment of severe CRS (Lee 2014).  Subjects may receive a repeat dose 
if clinical signs and symptoms do not improve within 24-48 hours. 
Side effects attributed to chronic use of tocilizumab in rheumatologic disease include transaminitis, 
thrombocytopenia, elevated cholesterol and low-density lipoproteins, neutropenia and increased 
infections but acute infusional toxicities have not been reported in CRS use (Lee 2014).
Subjects unresponsive to tocilizumab or experiencing severe neurological symptoms (e.g. 
confusion, delirium, seizure, etc.) may require treatment with steroids.  Lee et al., recommend 
steroids as second-line therapy for CRS as the response to tocilizumab may be more rapid and 
owing to the potential of steroids to attenuate the anti-tumor effects of the adoptive T-cell therapy.  
However, in subjects with grade 3 or 4 CRS associated with neurologic dysfunction without 


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significant hemodynamic instability or other life-threatening symptomatology, consideration may 
be given to the use of corticosteroids as a preferred first-line immunosuppressive therapy.  High 
doses (e.g. 2 mg/kg/day prednisone equivalent) may be required.
If cytokine release syndrome is suspected, a physician with expertise in the management of 
subjects following bone marrow transplant should be consulted.  If high dose corticosteroids are 
required, treatment should generally be continued for at least 5 days followed by tapering doses 
over several weeks. 
Please review to the most recent version of the product label for tocilizumab.
4.5
Monitoring and management for Demyelinating Neuropathy and other Neurological 
events
Obtain a neurological consultation for participants with Grade 2 or higher neurologic events of a 
≥ 7 day duration.  Participants who develop signs and symptoms consistent with GBS must be 
evaluated by a neurologist to provide expert recommendations to guide appropriate diagnostic 
workup such as EMG, lumbar puncture, infectious panel to guide management and follow up.
4.6
Management of Graft-versus-Host Disease 
Autologous graft-versus-host disease (GvHD) has been described in association with adoptive 
transfer of ex-vivo expanded/co-stimulated autologous T-cells (Rapoport 2009), as well as 
infusion of T-cells with engineered specificity for NY-ESO-1 and LAGE-1a (Garfall 2013), 
following high-dose chemotherapy and autologous stem cell transplant (ASCT) in patients with 
multiple myeloma.  There is the potential for subjects who receive cytoreductive therapy followed 
by engineered autologous T-Cell infusion to experience GVHD and/or autoimmune GVHD-like 
symptomatology.  Autologous GvHD is typically milder than classic (allogeneic) GvHD (Kline 
2008), and is usually manageable with treatment.  However, severe cases (including fatalities) 
have been reported (Fidler 2012).  There are no published guidelines for the management of 
autologous GvHD.  However, lessons can be drawn from published cases reports and guidelines 
for the diagnosis and management of acute GvHD following allogeneic transplant (Dignan 2012).
4.6.1
Diagnosis of GvHD
The diagnosis of GvHD is predominantly based on clinical findings and is often one of exclusion.  
Many of these symptoms can also occur in the setting of the lymphodepleting regimen as well as 
with cytokine release syndrome.  Any of these conditions including GvHD can be associated with 
fever.  The skin is the most commonly involved organ, followed by the gastrointestinal (GI) tract 
and liver.  A constellation of symptoms involving these organ systems may be helpful in 
establishing the diagnosis of GvHD.  Diarrhea, rash, fever, and pancytopenia are common 
toxicities in the NY-ESO-1c259T program where we have the most clinical experience.  Mild (Grade 
1 or 2) transient transaminitis without cholestasis has been observed.
Organ
Findings/Symptoms
Differential Diagnosis
Histopathology
Skin
Maculopapular rash involving 
the neck and shoulders as well as 
the palms and soles that spreads 
to include the rest of the body.
Drug reactions, viral 
exanthems, cytokine release 
syndrome, and effects of 
chemotherapy or radiation
Apoptosis at base of epidermal 
rete pegs, dyskeratosis, 
exocytosis of lymphocytes, 
satellite lymphocytes adjacent to 
dyskeratotic epidermal 


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keratinocytes and perivascular 
lymphocytic infiltration in the 
dermis.
GI
Secretory diarrhea is most 
common but nausea, vomiting, 
anorexia, weight loss and 
abdominal pain can also occur. 
Diarrhea can be copious. 
Bleeding may result from 
mucosal ulceration and ileus 
may ensue.
Side effects of chemotherapy 
or other drugs and infection of 
the GI tract
Patchy ulcerations, apoptotic 
bodies at crypt bases, crypt 
ulceration and flattening of 
surface epithelium
Liver
Cholestatic pattern of liver injury 
including elevated conjugated 
bilirubin, alkaline phosphatase 
and GGTP.  Subjects may 
present with jaundice, with 
pruritus in more severe cases.
Veno-occlusive disease of the 
liver, viral infections, drug 
toxicity and sepsis.
Endothelialitis, lymphocytic 
infiltration of the portal areas, 
pericholangitis and bile-duct 
destruction.
Of Note: Bone marrow suppression and related cytopenias have been described in the setting of 
acute GvHD.  Management of this complication is challenging, with no clearly established 
guidelines regarding immunosuppression.  Treatment may be largely supportive, including 
transfusions and treatment of infections. 
Management should include consultation with a physician with expertise in the management of 
patients following bone marrow transplant.
Bone marrow suppression is also a feature of transfusion-related GvHD.  To minimize the 
possibility of transfusion-related GvHD, all blood products transfused within 4 weeks prior to 
leukapheresis, within 4 weeks prior to initiation of conditioning chemotherapy and following 
conditioning chemotherapy until at least 4 weeks following T-cell infusion or  until bone marrow 
recovery (whichever is longer) must be irradiated.  Patients receiving steroids or other 
immunosuppressive therapies should also receive irradiated blood products regardless of above 
time intervals.
4.6.2
Grading of GvHD
Grading of GvHD is based on the stage of dermal, gastrointestinal, and hepatic involvement as 
described in the Table below.  Careful measurement of stool volume and assessment of percentage 
of body area covered by rash are important for proper grading and treatment.
Stage
Skin
Gut
Liver
1
Maculopapular rash <25% of body area
Diarrhea >500 ml/day
Bilirubin 2-3 mg/dl
2
Maculopapular rash 25%-50% of body area
Diarrhea >1,000 ml/day
Bilirubin 3-6 mg/dl
3
Generalized erythroderma
Diarrhea>1,500 ml/day
Bilirubin 6-15 mg/dl
4
Desquamation and bullae
Diarrhea>2,000 ml/day or 
pain or ileus
Bilirubin >15 mg/dl
With the addition of assessment of functional impairment, grading can be determined using the 
table below (Glucksberg 1974).  


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Grade
Skina
Guta
Livera
Functional statusb
I
1-2
0
0
0
II
1-3
1
1
1
III
2-3
2-3
2-3
2
IV
1-4
2-4
2-4
3
a Staging is described above
b Mild, moderate, or severe decrease in performance status
4.6.3
Management of GvHD
Although the diagnosis of GvHD is predominantly based on clinical grounds, biopsy of affected 
organs can be helpful in excluding other causes and supporting the diagnosis of GvHD with 
consistent histopathologic findings.  However, awaiting biopsy results should not delay the 
institution of appropriate therapy. 
If GvHD is suspected:

A physician with expertise in the management of subjects following bone marrow 
transplant should be consulted.

Consider biopsy of the affected organ(s)
Corticosteroids have been used as the standard first line treatment for GvHD for several decades.  
Their effect is likely to be due to lympholytic effects and anti-inflammatory properties.  In general, 
intestinal and liver GvHD require more prolonged steroid therapy than skin disease although 
response times vary. 
Diarrhea should be managed with volume replacement, dietary restriction, and anti-diarrheal 
agents including the consideration of somatostatin for secretory diarrhea.  Agents that slow 
motility should be used cautiously, ensuring that there is no evidence of ileus or toxic megacolon, 
and infectious causes of diarrhea should be excluded.
General guidelines for first-line treatment based on grade are provided below, and should be 
considered in conjunction with input from the consulting physician with bone marrow transplant 
expertise.
Grade
Management Strategy
I
Subjects with grade I disease are not likely to require systemic treatment.  Cutaneous 
GvHD may respond to topical steroid creams.  Antihistamines may be helpful in 
subjects with pruritus.  Subjects should be reviewed frequently for other organ 
manifestations of GvHD.
II
Treat skin symptoms with topical steroids.  For GI symptoms - optimize anti-diarrheal 
regimen, dietary restrictions, volume replacement and consider initiation of non-
absorbable steroids.  For refractory or progressive symptoms consider systemic steroids 
as outlined below.


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III
For more severe or progressive symptoms consider systemic corticosteroids (e.g., 
methylprednisolone one (1) mg/kg per day*)
IV
Methylprednisolone two (2) mg/kg per day*
* The use of ‘nonabsorbable’ steroids (Budesonide and beclomethasone) can be considered for acute intestinal GvHD in 
order to reduce the dose of systemic steroids
If high dose corticosteroids are required, treatment should generally be continued for at least 5 
days followed by tapering doses over several weeks.  A physician with expertise in infectious 
diseases in immunocompromised hosts should be consulted, and prophylactic antimicrobials 
should be considered.
Second line treatment can be considered for subjects who have failed to respond for 5 days or have 
progressive symptoms after 3 days.  There is no clear second-line agent that is preferred for steroid 
refractory GvHD.  General guidelines for second-line treatment based on grade are provided 
below, and should be considered in conjunction with input from the consulting physician with 
bone marrow transplant expertise.
For steroid refractory skin rash, topical tacrolimus may also be useful.
Most allogeneic transplant subjects concurrently receive calcineurin inhibitors in part as 
prophylaxis against GvHD.  Therefore, for grade II-IV disease refractory to high dose steroids, the 
addition of a calcineurin inhibitor can be considered.
Otherwise, there are several additional second line treatment options for which there is currently 
limited and/or evolving supporting data.  Treating physicians can refer to the Haemato-oncology 
Task Force of the British Committee for Standards in Haematology and the British Society for 
Blood and Marrow Transplantation guideline for diagnosis and management of acute graft-versus-
host disease (Dignan 2012).
4.7
Chemotherapy Symptom Management
Cyclophosphamide and fludarabine are used as pre-conditioning lymphodepleting chemotherapy 
in this study.  Symptoms associated with the use of cyclophosphamide and fludarabine are included 
in the respective product labels.  Refer to the most current product label for each drug.
4.7.1
Management of Neutropenia
The pre-conditioning chemotherapy is intended to cause lymphodepletion.  However, neutropenia 
is also common.  Prophylactic use of G-CSF should be administered to all subjects.  G-CSF should 
be used for management of neutropenia according to ASCO guidelines.  G-CSF should be given
daily from day +2 (RIB/regimens A and B) or 24 hours post the final dose of cyclophosphamide 
(Regimen C) and continued until reaching an absolute neutrophil count (ANC) of at least 1 × 109/L
or per institutional practice.
According to institutional standard practice, long-acting (pegylated) G-CSF may be given in 
preference to short acting daily G-CSF.  Pegylated G-CSF will be given as one dose on day +2 
(Regimens A and B) or 24 hours post the final dose of cyclophosphamide (Regimen C).


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4.7.2
Management of Pancytopenia with Bone Marrow Failure
Recurrent pancytopenia/aplastic anemia has been reported after initial bone marrow recovery from 
chemotherapy followed by infusion of NY-ESO-1c259T cells.  Bone marrow recovery following 
lymphodepletion will be defined as:

Absolute neutrophil count ≥ 1 x109/L for 2 consecutive measurements and

Platelet count ≥20 x109/L without transfusion support
Aplastic anemia is a rare hematological disorder characterized by pancytopenia and a hypocellular 
marrow.  Patients are usually symptomatic on presentation but some are detected incidentally when 
unexpected cytopenias are found on a routine blood count.  The diagnosis of severe aplastic anemia 
is made in the setting of a hypocellular bone marrow when 2 of the following 3 blood counts are 
met: absolute neutrophil count < 0.5 x109/L, absolute reticulocyte count < 60 x109/L, and platelet 
count < 20 x109/L, and myelodysplastic syndrome is ruled out.  The clinical consequences of 
aplastic anemia are life-threatening bleeding from thrombocytopenia, and infection as a result of 
neutropenia.  Bacterial and fungal infections are common and a significant cause of morbidity and 
mortality.
Management of bone marrow suppression and related cytopenias in aplastic anemia is challenging, 
with no clearly established guidelines regarding immunosuppression.  Treatment is largely 
supportive, including transfusions and treatment of infections.  If there is evidence of, or concern 
for the development of pancytopenia (decreasing hemoglobin, platelets or neutrophils, or 
increasing transfusion requirements) following initial bone marrow recovery the following 
measures should be implemented:
1. Consult a physician with expertise in the management of aplastic anemia
2. Increase the frequency of CBCs as clinically indicated.
3. Exclude other alternative etiologies such as other drugs, viral causes, etc.
4. An early bone marrow biopsy is recommended for clinical diagnosis, with a sample to be 
provided to the sponsor for study
5. A matched peripheral blood sample should be collected in parallel with the bone marrow 
sample and provided to the sponsor
6. Initiate treatment with GCSF
7. Consult an Infectious Diseases expert
8. Once alternative etiologies have been excluded, strongly consider immunosuppression 
(e.g. methylprednisolone 2mg/kg initial dose) or more aggressive regimens (e.g. 
antithymocyte globulin (ATG), cyclosporine, eltrombopag) as well as antimicrobial 
prophylaxis/therapy with the advice of your hematology/ID consultant(s).  If high dose 
corticosteroids are initiated, continue for a minimum of 5 days and taper gradually with 
advice from expert consultants.
Please refer to Section 4.5 (Management of Graft-versus-Host Disease) regarding bone marrow 
suppression as a feature of GvHD.


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5
Response Criteria 
Objective response and progression will be primarily evaluated in this study using the new 
international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST 
v1.1) Committee (Eisenhauer 2009).  Although criteria for progression may be reached at the Day 
28 evaluation, determination of progression will not be made prior to confirmation by evaluation 
at Week 8, due to the potential for initial swelling and delayed tumor response in cell therapy 
regimens.  
All imaging scans (CT or MRI) will also be collected and stored at a central imaging laboratory 
for independent review.  Imaging scans of all areas affected by disease including, at minimum, the 
chest, abdomen and pelvis should be performed at Baseline and all subsequent visits.  Acceptable 
imaging modalities for this study include:

Diagnostic-quality CT scan with oral and/or i.v. iodinated contrast of the chest and 
abdomen/pelvis (CT is the preferred modality for tumor assessments)

MRI of the abdomen/pelvis acquired before and after gadolinium contrast agent 
administration and a non-contrast enhanced CT of the chest, if a subject is contraindicated 
for contrast enhanced CT.
The same imaging modality and image-acquisition protocol (including the use of IV contrast) 
should be used consistently across all timepoints for individual subjects to allow uniform 
comparison of lesions.  Prior to starting the study, a detailed imaging acquisition protocol will be 
provided to the sites.
5.1
Response Criteria for Radiographic Studies
In accordance with RECIST v1.1, at the baseline tumor assessment, a maximum of five (up to two 
per organ) reproducibly measurable lesions (≥10mm in longest diameter or, for lymph nodes, 
≥15mm in the shortest diameter) will be determined as Target lesions and other tumor lesions or 
disease manifestations (e.g. ascites, effusions) recorded as Non-Target lesions.  At each subsequent 
tumor assessment, changes in the sum of the diameters (unidimensional measurement) of all 
designated Target tumor lesions is used to assess outcome according to RECIST v1.1 criteria.  In 
addition, perpendicular bi-dimensional measurements of Target lesions should also be made 
(where possible) and the sum of the products of the 2 largest perpendicular diameters are to be 
used to evaluate tumor burden in accordance with the principles of the immune related response 
criteria (irRC, Wolchok 2009).  
5.2
Tumor Response Evaluation – RECIST v1.1
a.
Evaluation of Target Lesions 
Complete Response (CR) 
Disappearance of all target lesions.  Any pathological lymph nodes (whether target or 
non-target) must have reduction in short axis to <10 mm
Partial Response (PR) 
At least a 30% decrease in the sum of the diameters of target lesions, taking as reference 
the baseline sum diameters
Progressive Disease (PD) 


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At least a 20% increase in the sum of the diameters of target lesions, taking as reference 
the smallest sum on study (this includes the baseline sum if that is the smallest on 
study).  In addition to the relative increase of 20%, the sum must also demonstrate an 
absolute increase of at least 5 mm.  Note: determination of PD will require confirmation 
by an additional scan 4 weeks later unless the patient requires anti-cancer therapy 
sooner.
Stable Disease (SD) 
Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, 
taking as reference the smallest sum diameters while on study
b. Evaluation of Non-Target Lesions 
Complete Response (CR) 
Disappearance of all non-target lesions and normalization of tumor marker level.  All 
lymph nodes must be non-pathological in size (<10 mm short axis)
Note:  If tumor markers are initially above the upper normal limit, they must normalize 
for a patient to be considered in complete clinical response.
Non-CR/Non-PD (Stable Disease, SD)
Persistence of one or more non-target lesion(s) and/or maintenance of tumor marker 
level above the normal limits.
Progressive Disease (PD) 
Unequivocal progression of existing non-target lesions may be considered PD for non-
target lesions. 
Unequivocal progression should not normally trump target lesion status.  It must be 
representative of overall disease status change, not a single lesion increase.    
Although a clear progression of “non-target” lesions only is exceptional, the opinion 
of the treating physician should prevail in such circumstances, and the progression 
status should be confirmed at a later time by the review panel (or Principal 
Investigator).
Evaluation of New lesions
New lesions should be unequivocal and not attributable to differences in scanning 
technique or findings which may not be a tumor.  Unequivocal new lesions constitute 
Progressive Disease, however, determination of PD will require confirmation by an 
additional scan 4 weeks later unless the patient requires anti-cancer therapy sooner.
Evaluation of Best Overall Response
The best overall response is the best response recorded from the start of the treatment 
until disease progression/recurrence (taking as reference for progressive disease the 
smallest measurements recorded since the treatment started) or subject discontinuation 
from the study assessments (if the subject discontinued without evidence of radiologic 
progression).  The patient's best response assignment will depend on the achievement 
of both measurement and confirmation criteria.  The investigator’s assessment of Best 


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Overall Response is performed according to the table below.  Additional details of the 
evaluation of response according to RECIST v1.1 will be provided in the RAP.
Target Lesions
Non-Target 
Lesions
New Lesions
Overall 
Response
Best Overall Response when 
Confirmation is Required*
CR
CR
No
CR
>4 wks. Confirmation
CR
Non-CR
Non-PD
No
PR
>4 wks. Confirmation
CR
Not evaluated
No
PR
PR
Non-PD
Not evaluated
No
PR
SD
Non-PD
Not evaluated
No
SD
Documented at least once >4 wks. 
from baseline
PD
Any
Yes or No
PD
>4 wks. Confirmation
Any
PD**
Yes or No
PD
Any
Any
Yes
PD
* See RECIST 1.1 manuscript for further details on what is evidence of a new lesion.
** In exceptional circumstances, unequivocal progression in non-target lesions may be accepted as disease 
progression
c.
Patients with a global deterioration of health status requiring additional anti-cancer 
therapy without objective evidence of disease progression at that time should be 
reported as “symptomatic deterioration.”  Every effort should be made to document 
the objective progression even after discontinuation of treatment.
d. In some circumstances, it may be difficult to distinguish residual disease from normal 
tissue.  When the evaluation of complete response depends on this determination, it is 
recommended that the residual lesions be investigated (fine needle aspirate/biopsy, 
PET scan) before confirming the complete response status.
5.3
Confirmatory Measurement/Duration of Response
a.
Confirmation
To be assigned a status of a CR, PR or PD, changes in tumor measurements must be 
confirmed by repeat assessments that should be performed at least 4 weeks after the 
criteria for response are first met.  
b. Duration of Overall Response
The duration of overall response is measured from the time measurement criteria are 
met for CR or PR (whichever is first recorded) until the first date that progressive 


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disease is objectively documented (taking as reference for progressive disease the 
smallest measurements recorded since the treatment started).
5.4
Measurable Disease
Measurable lesions are defined as those that can be accurately measured in at least one dimension 
(longest diameter to be recorded), as >10 mm (or twice the slice thickness, if a slice thickness >5 
mm is used) with CT scan, or >10 mm with calipers by clinical exam.  All tumor measurements 
must be recorded in millimeters (or decimal fractions of centimeters).
5.5
Malignant Lymph Nodes 
To be considered pathologically enlarged and measurable, a lymph node must be >15 mm in short 
axis when assessed by CT scan (CT scan slice thickness recommended to be no greater than 5 
mm).  At baseline and in follow-up, only the short axis will be measured and followed.
5.6
Non-Measurable Disease
All other lesions (or sites of disease), including small lesions (longest diameter <10 mm or 
pathological lymph nodes with ≥ 10 to <15 mm short axis), are considered non-measurable disease.  
Bone lesions, leptomeningeal disease, ascites, pleural/pericardial effusions, lymphangitis 
cutis/pulmonitis, inflammatory breast disease, and abdominal masses (not followed by CT or 
MRI), are considered as non-measurable.
Note:  Cystic lesions that meet the criteria for radiographically defined simple cysts should not be 
considered as malignant lesions (neither measurable nor non-measurable) since they are, by 
definition, simple cysts.
‘Cystic lesions’ thought to represent cystic metastases can be considered as measurable lesions, if 
they meet the definition of measurability described above.  However, if non-cystic lesions are 
present in the same patient, these are preferred for selection as target lesions.
5.7
Target Lesions
Measurable lesions up to a maximum of 2 lesions per organ and 5 lesions in total, representative 
of all involved organs, should be identified as target lesions and measured and recorded at 
baseline.  Target lesions should be selected on the basis of their size (lesions with the longest 
diameters), be representative of all involved organs, but in addition should be those that lend 
themselves to reproducible repeated measurements.  It may be the case that, on occasion, the 
largest lesion does not lend itself to reproducible measurement in which circumstance the next 
largest lesion which can be measured reproducibly should be selected.  A sum of the diameters 
(longest for non-nodal lesions, short axis for nodal lesions) for all target lesions will be calculated 
and reported as the baseline sum diameters.  If lymph nodes are to be included in the sum, then 
only the short axis is added into the sum.  The baseline sum diameters will be used as reference to 
further characterize any objective tumor regression in the measurable dimension of the disease.
Progressive disease by RECIST v1.1 criteria (Eisenhauer 2009) noted after the first re-staging scan 
may represent disease that was not detected on the pre-study scan, and a confirmatory scan will be 
required at the next scheduled re-staging evaluation unless clinically not indicated.  If confirmed, 
progression should be dated by the initial time when the lesions are first detected. 


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5.8
Non-Target Lesions 
All other lesions (or sites of disease) including any measurable lesions over and above the 5 target 
lesions should be identified as non-target lesions and should also be recorded at baseline.  
Measurements of these lesions are not required but the presence, absence, or in rare cases 
unequivocal progression of each should be noted throughout follow-up. 
5.9
Metastatic Bone Lesions
Disease progression is considered if a minimum of two new lesions is observed on bone scan.  
New lesions seen with the first re-staging bone scan may represent disease that was not detected 
on the pre-study scan, and a confirmatory scan will be required at the next scheduled re-staging 
bone scan unless clinically not indicated.  If confirmed, progression should be dated by the initial 
time when the lesions are first detected.
5.10
Clinical Lesions 
Clinical lesions will only be considered measurable when they are superficial (e.g., skin nodules 
and palpable lymph nodes) and 10 mm diameter as assessed using calipers (e.g., skin nodules).  
In the case of skin lesions, documentation by color photography, including a ruler to estimate the 
size of the lesion, is recommended. 
5.11
Guidelines for Evaluation of Measurable Disease
All measurements should be taken and recorded in metric notation using a ruler or calipers.  All 
baseline evaluations should be performed as closely as possible to the beginning of treatment and 
never more than 4 weeks before the beginning of the treatment.
The same method of assessment and the same technique should be used to characterize each 
identified and reported lesion at baseline and during follow-up.  Imaging-based evaluation is 
preferred to evaluation by clinical examination unless the lesion(s) being followed cannot be 
imaged but are assessable by clinical exam.
5.12
Methods of Measurement
Chest X-ray - Lesions on chest x-ray are acceptable as measurable lesions when they are clearly 
defined and surrounded by aerated lung.  However, CT is preferable. 
CT and MRI - CT and MRI are the best currently available and reproducible methods to measure 
target lesions selected for response assessment.  Recommended slice thickness is 5 mm for chest, 
abdomen and pelvis lesions and 2-3 mm thickness for head and neck lesions.  PET (alone) is 
currently not an acceptable method of assessment but may be used to confirm progression.
5.13
Toxicity Criteria
The following adverse event management guidelines are intended to ensure the safety of each 
patient while on the study.  The descriptions and grading scales found in the revised NCI Common 
Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE 
reporting. All appropriate treatment areas have access to a copy of the CTCAE version 4.0. A 
copy of the CTCAE version 4.0 can be downloaded from the CTEP web site 
(http://ctep.cancer.gov).


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6
Statistical Considerations
6.1
Overview Statistical Methods
The primary objectives of this pilot trial are to evaluate (1) efficacy and (2) the safety of treatment 
with adoptively transferred NY-ESO-1c259T cells.  The data will be summarized by cohort and 
overall. No specific statistical hypotheses will be evaluated.  All analyses will be descriptive and 
exploratory.  
6.2
Study Populations and Subgroups
Intent-to-Treat (ITT) population: all subjects who were enrolled in the trial. 
Modified Intent-to-Treat (mITT) population: all subjects who received at least one NY-ESO-
1c259T cell infusion.  The mITT population is the primary analysis population for efficacy and 
safety evaluations.  
If several subjects within a cohort are deemed major protocol violators, for example receiving a 
dose outside the range defined in Section 3.2.7, a per-protocol population may be evaluated.  
Decisions regarding subject eligibility for inclusion in the per-protocol population will be made 
prior to data analysis and reporting.
The following subgroups may be evaluated: (1) Subjects who receive a dose of at least 1 billion 
cells, (2) Subjects in Cohort 2 who receive Regimen A or C, (3) Subjects receiving a second 
infusion.  Other subgroups may be defined in the RAP.
For cohorts where N≤5, for example Cohort 2 subjects receiving regimen C, the data may be listed 
only.
6.3
Statistical Assumptions 
The sample size for each cohort is based on clinical judgment.  The study is not statistically 
powered to conduct hypothesis testing between cohorts.
6.3.1
Cohorts 1, 3 and 4
Data from protocol 08-C-0121 0121 at the NCI, Phase II Study of Metastatic Cancer that 
Expresses NY-ESO-1 Using Lymphodepleting Conditioning Followed by Infusion of Anti-NY ESO-
1 TCR-Gene Engineered Lymphocytes demonstrated that NY-ESO-1 specific T cells mediated 
objective responses (CR or PR by RECIST) in 4 of 6 (67%) patients with synovial sarcoma.  The 
following table shows the probability of observing 5+ or 6+ responses in 10 patients as a function 
of the true underlying probability of a response:
True Response Probability 
Number of patients 
achieving clinical response, 
assuming N=10 
Probability of responding (as 
noted)
30% response rate
5 or more
0.15 probability
30% response rate
6 or more
0.05 probability
40% response rate
5 or more
0.37 probability
40% response rate
6 or more
0.17 probability
57% response rate
5 or more
0.78 probability


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True Response Probability 
Number of patients 
achieving clinical response, 
assuming N=10 
Probability of responding (as 
noted)
67% response rate
5 or more
0.93 probability
67% response rate
6 or more
0.79 probability
Thus, if the true probability of a response were 0.67, there is a 79% probability of observing 6 or 
more responses and 93% probability of observing 5 or more responses.  If the true probability were 
0.30, these probabilities are 5% and 15% respectively.  This would indicate that observing 5 or 
more responses out of 10 provides reasonable evidence that the true response rate could be 
consistent with 67%.  
A lower response rate for example of 57% would also be clinically meaningful.  The probability 
of observing 5 or more responders out of 10 subjects would be 78% given a true response rate of 
0.57.  
Should the trial dynamics result in >10 subjects in a cohort, holding all other variables constant, 
this would result in greater confidence.  The table below illustrates this for the probability of 
observing 10+ or 12+ responses in 20 subjects as a function of the true underlying probability of 
a response. For example, the probability of observing 10 or more responders out of 20 subjects 
would be 0.80 given a true response rate of 0.57.  
Therefore, even if the true response rate is lower than 0.57, clinically meaningful conclusions may 
be drawn from 10 subjects if five or more responses are observed and there is even more 
confidence with 20 subjects, holding all other variables constant.
True Response Probability 
Number of patients achieving RECIST 
response, assuming N=20 in a cohort
Probability of 
responding 
57% response rate
10 or more
0.80 probability
67% response rate
10 or more
0.96 probability
67% response rate
12 or more
0.82 probability
6.3.2
Cohort 2
A true response rate of 0.40 would be clinically meaningful in this cohort.  The following table 
shows the probability of observing 3+ or 4+ responses in 10 patients as a function of the true 
underlying probability of a response equaling 40%:
True Response Probability 
Number of patients achieving clinical 
response, assuming N=10 
Probability of 
responding 
40% response rate
3 or more
0.83 probability
40% response rate
4 or more
0.62 probability
Thus, if the true probability of a response were 0.40, there is a 62% probability of observing 4 or 
more responses and 83% probability of observing 3 or more responses.  This would indicate that 
observing 3 or more responses out of 10 provides reasonable evidence that the true response rate 
could be consistent with 40%.  


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6.3.3
Stopping Criteria for Cohorts 2, 3 and 4
As discussed in Section 3.2, the decision to stop or continue enrolment to Cohorts 2, 3 and 4 after 
first 5 subjects is based on responses seen with these 5 subjects.  Futility evaluations using 
predictive probability in a Bayesian framework coupled with clinical judgment will aid in this 
decision making.  The advantages of a Bayesian framework in an early phase study with smaller 
sample size is that it allows one to make decisions without relying on large sample theory in 
addition to being able to incorporate prior information.  The cohorts under study are not powered 
to test hypotheses and therefore, type II error has not been controlled.
The predictive probability is the probability of exceeding a response rate of interest at the end of 
the trial with the maximum planned sample size Nmax (up to 10), given the results from the initial 
group (i.e., n=5).  Assuming a historical control rate of 0.18, one-sided futility assessments are 
planned for cohorts 2 to 4 based on response rates of interest ranging from 0.18, 0.25, 0.5. 
Therefore 0.18 represents the response rate for the historical control whereas, 0.5 is the projected 
clinically meaningful response rate for TCR as seen in cohort 1 with 12 subjects.  The 95% 
(Wilson) confidence interval for the response rate of 6/12 = 0.5, seen in cohort 1 is (0.25, 0.75).  
This implies that repeated clinical trials would result in ORR estimates ranging from 0.25 up to 
0.75.  As such the lower bound of 0.25 is considered clinically relevant to evaluate for futility. 
To compute the predictive probability (PP), we assume a fairly non-informative prior distribution, 
i.e., a beta (0.18, 0.82) for the ORR.  This prior was chosen as it may be viewed as somewhat 
pessimistic and supportive of the historical control rate.  Under the assumption that the number of 
responses X in n=5 subjects follows a binary distribution B(n, p), the posterior distribution of the 
ORR follows a beta(0.18+x, 0.82+n-x) distribution.  This then means that the future number of 
responses, Y in m = Nmax - n follows a beta-binomial (m, 0.18+x, 0.82+n-x) distribution.  Using 
methods described in Lee and Liu (2008), the predictive probability is derived for Nmax =10 as 
shown in the table below.
A threshold of 0.2 is used to declare futility, i.e. if PP < 0.2 then the cohort has met the futility 
criterion. 
Table 3: Predictive Probability that ORR Exceeds Pre-identified Rate at Nmax =10, Having 
Observed X responses in 5 Subjects
ORR of interest
X=0/5
X=1/5 *
X=2/5
X=3/5
Futility (PP < 0.2)
0.18
0.0016
0.109
0.548
0.932
Yes X=0,1
0.25 
0.0002
0.033
0.302
0.773
Yes X=0,1
0.50  
0
0
0.031
0.299
Yes X=0,1,2
* if 1/ 5 responses are observed the PP that ORR > 0.25 is 0.033, which is < 0.2 (the futility 
threshold), so the futility criterion has been met.

When X = 0 or 1 the PP meets the futility threshold for all the scenarios of ORR of interest 
considered above. 

Likewise when X > 2, the PP does not meet the futility criterion and hence the cohort will 
continue to Nmax subjects. 
When X = 2/5 (i.e., p=0.4), the PP ranges from 0.031 to 0.548 depending on whether the rate is 
0.50, 0.25 or 0.18 and hence futility is declared for the probability that ORR exceeds 0.50 but not 


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for the other two scenarios.  Note that in this case the ORR of 0.4 leads to a 95 % (Wilson) CI of 
(0.12, 0.77).  The small sample size leads to a high degree of imprecision and therefore a high 
chance of a type II error (even if this trial is not powered to test the hypothesis).  Thus, clinical 
judgment will also be employed in the decision to stop a cohort as indicated earlier.
6.4
Statistical Methods for Efficacy Endpoints
To determine the effect of the treatment, the following efficacy parameters will be summarized:  
overall response rate (ORR); time to response (TTR), duration of response (DoR), best overall 
response (BOR); progression free survival rate (PFS); and the overall survival rate (OS).
Primary Analyses – The primary efficacy endpoint is ORR.  ORR is defined as the proportion of 
subjects with a confirmed CR or PR per RECIST v1.1 relative to the total number of subjects in 
the corresponding analysis population.  The ORR will be based on confirmed responses from the 
investigator assessment of overall response.  Subjects with unknown or missing response will be 
treated as non-responders (i.e., they will be included in the denominator when calculating the 
proportion).  90% and 95% Wilson confidence intervals will be computed for ORR in each cohort.  
Secondary Analyses – The key secondary endpoints are DoR, PFS and OS.  
Duration of overall response is defined as the time between confirmed response until the first date 
of progressive disease per RECIST v1.1 (see Section 5.2).  DoR will be summarized descriptively 
for subjects for each cohort using Kaplan-Meier quartile estimates.  
Overall Survival is defined as the interval between date of T-cell infusion and death due to any 
cause.  If the subject does not have a documented date of death, OS will be censored at the date of 
the last adequate assessment.
PFS is defined as the interval between the date of first dose and the earliest date of disease 
progression or death due to any cause.  PFS will be summarized by cohort sing Kaplan-Meier 
quartile estimates.  If the subject does not have a documented date of progression or death, PFS 
will be censored at the date of the last adequate assessment.
OS and PFS will be summarized graphically for each cohort using Kaplan-Meier plots.
Further details about the primary and other secondary efficacy/exploratory analyses will be 
outlined in the RAP, for example, sensitivity analyses, details for rules for censoring, etc. 
6.5
Statistical Methods for Safety and Demographic Endpoints
The safety profile will be based on adverse events reported, vital signs measurements, clinical 
laboratory measurements, ECG recordings, and physical examination results.  
Adverse Events – All adverse events will be listed and coded by MedDRA.  The number and 
percent of patients reporting any treatment emergent adverse events will be tabulated by system 
organ class and preferred term.  Adverse events with missing date of onset will be considered 
treatment emergent. Adverse events will be further summarized by severity, relationship to 
treatment and seriousness. Tables and/or narratives of any on study death, or serious or significant 
adverse event, including early withdrawals from the interventional period because of adverse 
events, will be provided should they occur.
Vital Signs – Vital signs will be listed for each patient.  Summaries of vital signs data over time 
may be provided.


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Electrocardiogram – Electrocardiogram data will be listed for each patient.  Fridericia’s and 
Bazett’s correction will be used to adjust QT for RR. Summaries of ECG intervals and/or the 
change from baseline will be provided.
Anti-NY-ESO-1 Antibodies – The patient incidence of Anti- NY-ESO-1 antibody formation will 
be computed and the anti- NY-ESO-1 Antibodies results will be listed.
T cell Phenotype and Cytokines – Exploratory correlations with clinical outcomes may be 
performed.  
Clinical Laboratory Tests – Clinical chemistry, hematology, and urinalysis data will be listed for 
each patient. Values outside the normal laboratory reference ranges will be flagged as high or low 
on the listings. Summaries of clinical laboratory tests over time may be provided.  Laboratory 
abnormalities will be graded using CTCAE version 4. Each patient’s maximum post-baseline 
grade will be computed for each laboratory parameter and referred to as their worst grade for that 
laboratory parameter. For each parameter shift tables from baseline to worst grade may be 
presented.
Descriptive statistics will be provided for selected demographic assessments such as age, gender, 
prior chemotherapy, etc.  
For descriptive statistics, continuous data will be summarized using means, medians, standard 
deviations, and/or ranges.  Categorical data will be summarized using frequency counts and 
percentages.  Graphical summaries of the data may be presented.  
7
Human Subjects Protections
7.1
Participation of Children
The age range of patients eligible for this trial is ages ≥4 and up.  All patients <18 years of age (or 
relative country-specific guidelines) will be enrolled at participating sites.  Physicians, nurses, and 
multidisciplinary support teams for these subjects must have expertise in the management of 
children.  
7.2
Evaluation of Benefits and Risks/Discomforts
7.2.1
Potential Benefit of Adoptive Immunotherapy
Survival for the population of patients eligible for this trial is limited.  Although the overall 
treatment plan is experimental, preliminary data from a study conducted in adults demonstrated 
significant antitumor effects, therefore, there is reason to believe that patients enrolled on this study 
will derive benefit.  Patients participating in this trial will be treated with therapeutic intent, and 
the response to therapy will be monitored.  The potential benefits from adoptive immunotherapy 
for synovial sarcoma are disease remission and/or reduction in cancer-related symptoms.  This 
protocol involves greater than minimal risk, but presents the potential for direct benefit to 
individual subjects according to 21CFR50.52, 46.405.
7.2.2
Potential Risks of Adoptive Immunotherapy
The primary risks to patients participating in this research study include toxicity of the 
chemotherapy, as described in Section 7.2.3, and the potential risks associated with infusion of 
autologous modified T cells engineered to express antigen receptors to a known tumor antigen.  


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Toxicities relating to the infused gene modified T cells potentially include infusion reactions, 
cytokine release syndrome, and effects of the cells themselves including autoimmunity and graft-
versus-host disease.  The full safety profile for NY-ESO-1c259T has not yet been established.  See 
Section 4 for recommendations on supportive care of patients on this study including strategies for 
management of the above possible toxicities. 
7.2.3
Potential Risks of Lymphodepleting Chemotherapy
Lymphodepleting drugs used in this protocol are standard chemotherapy agents with the expected 
toxicities of myelosuppression.  Grade 3 or 4 hematological toxicity may occur and are expected.  
There is an increased risk of infection during the neutropenic period, so patients will be supported 
using G-CSF as well as transfusions.  The agents are also immunosuppressive (hence their use as 
lymphodepleting therapy).  Patients may receive prophylaxis against PCP pneumonia, invasive 
fungal infection, herpes simplex and herpes zoster according to institutional practice.
7.2.4
Potential Risk of Tumor biopsy 
In the event a patient has a readily accessible tumor, adult patients will be asked to undergo biopsy 
in order to obtain tissue for research evaluation.  Standard techniques will be used for percutaneous 
biopsies and may include CT and / or ultrasound guidance.  Although direct benefit from research 
conducted on this tumor biopsy is unlikely, participation in this research may allow patients some 
benefit in knowing their contribution may lead to a greater understanding of their cancer and 
potential benefit to others in the future.  Patients enrolled on this protocol suffer from extremely 
rare malignancies with very low survival rates and often have a strong desire to participate in 
research that may lead to a better understanding of their disease.
7.2.5
Potential Risk of Acute inflammatory demyelinating polyneuropathy / Guillain Barré 
Syndrome (GBS)
Acute demyelinating peripheral neuropathy / Guillain Barré Syndrome (GBS) developed in two 
subjects who received the NY-ESO-1C259T cells following infusion. Therefore, subjects with prior 
or active demyelinating disease will be excluded from the study. Neurologic consultation is 
required for patients with Grade 2 or higher neurologic events of a ≥7 day duration. Additionally, 
any potential future recurrence of GBS will lead to a pause in study enrolment until further 
investigation.
7.3
Consent and Assent Processes and Documentation
7.3.1
Screening Sample Consent
Telephone consent may be employed in order to screen outside samples for prospective subjects 
for NY-ESO-1, if not previously conducted by the outside institution.  In such cases, a protocol 
investigator will review the Screening Consent form by telephone.  The consent/assent signatures 
will be witnessed and a copy will be faxed and the original sent by mail to the PI.  Prospective 
subjects who consent to send such samples for outside testing will NOT be registered with the 
Sponsor unless they are subsequently enrolled on protocol.  Subjects and their referring medical 
team will be notified of the results and records will be maintained with the protocol research files.


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7.3.2
Protocol Consent
A signed informed consent document will be obtained prior to entry onto the study.  The PI or an 
associate investigator on the trial will obtain consent.  The PI, an Associate Investigator, or their 
designee will be available to answer all questions from patients and their parents or guardians.  The 
investigational nature and research objectives of this trial, the procedures and treatments involved 
and their attendant risks and discomforts and potential benefits, and alternative therapies will be 
carefully explained to the patient and/or the patient’s parents or guardian if he/she is of minor age.  
Pediatric patients will be included in age appropriate discussion.  Verbal assent will be obtained 
for those > 7 years of age when deemed appropriate by the clinician and the child’s parents or 
guardian.  In such cases, the parent or guardian will sign the designated line on the informed 
consent attesting to the fact that the child has given assent.  The attached informed consent 
documents contain all elements required for consent. 
8
Data Reporting
8.1
Safety Reporting
Timely, accurate and complete reporting and analysis of safety information from clinical studies 
are crucial for the protection of subjects and is mandated by regulatory agencies worldwide.  The 
Sponsor has established standard operating procedures in conformity with regulatory requirements 
worldwide to ensure appropriate reporting of all safety information; all clinical studies conducted 
by the Sponsor or its affiliates will be conducted in accordance with those procedures.  Individual 
AEs should be evaluated by the Investigator and should be reported to the Sponsor as appropriate.  
This includes the evaluation of its intensity, the causality between the investigational medicinal 
product and/or concomitant therapy and the adverse event and seriousness. 
The Sponsor has to keep detailed records of all AEs reported by the investigator(s) and to perform 
an evaluation with respect to causality, seriousness, and expectedness.  The Sponsor has 
obligations for expedited reporting of certain events to Regulatory Authorities, IRBs/ Research 
Committees and other study participants.  On request of a competent authority in whose territory 
the clinical trial is being conducted, the Sponsor will submit detailed records of all adverse events 
which are reported to him by the relevant Investigator(s).  Case report processing concerns 
evaluation of data in individual cases, identification of individual cases requiring specific handling, 
recognition and processing of alerts, and any other data processing of aggregated cases
8.2
Definition of Adverse Event
In accordance with the International Conference of Harmonization (ICH), an AE is any untoward 
medical occurrence in a subject or clinical investigation subject who receives a pharmaceutical 
product.  The event does not necessarily have a causal relationship with study treatment to be an 
AE.  An AE can therefore be any unfavorable and unintended sign (including an abnormal 
laboratory finding), symptom, or disease temporally associated with the use of a medicinal 
(investigational) product, whether or not considered related to the medicinal (investigational) 
product.  Disease progression will not be reported as an AE, however other pre-existing conditions 
which worsen during the study are to be reported as AEs.
Additionally for this study, all laboratory abnormalities with a CTCAE grading of grade 3 or above 
must be reported as an adverse event.


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8.3
Reporting of Adverse Events
Subjects will be monitored for the duration of the protocol, including intervals required as part of 
long-term follow-up.  The AE reporting period begins at the start of lymphodepletion and 
continues until the subject has confirmed disease progression following the subject’s last cell 
product infusion.  During the period between leukapheresis and lymphodepletion, only serious 
adverse events (SAEs) related to the study procedure which occur within 2 weeks of leukapheresis 
will be reported.  During long term follow-up (15 years), subjects will only be monitored for 
delayed adverse events related to the gene transfer aspect of the protocol (see Section 3.11.2 for 
LTFU). 
Adverse events will be graded according to the NCI Common Toxicity Criteria for Adverse Events 
(CTCAE) v 4.0. 
All reported adverse events, signs or symptoms or abnormal laboratory findings should be 
recorded at every visit according to the appropriate diagnosis and rated for intensity, causality and 
seriousness.  In the absence of a diagnosis, individual symptoms or findings should be recorded 
and rated.  If photographs are requested by the sponsor of e.g. a rash AE, the subject will sign a 
Medical Photograph Release prior to any photographs being taken. 
All AEs should be followed until: 

Resolved or improved to baseline.

Investigator confirms no further improvement can be expected.

Death
On discontinuation of the subject from the interventional portion of the study, or withdrawal from 
the study, serious or severe adverse events will be followed until one of the above criteria is met 
for up to 4 weeks.  Serious adverse events related to investigational product will continue to be 
recorded and monitored into long-term follow-up at any time (Section 10.4).
8.3.1
Assessment of Intensity
The investigator will assess intensity of all AEs will be graded according to the NCI Common 
Toxicity Criteria for Adverse Events (CTCAE) v 4.0 on a five point scale (grade 1-5) and reported 
in detail on the eCRF.
AEs not specifically listed on the CTCAE should be graded according to Table 4:
Table 4: Grading of AEs not specified in CTCAE v4.0
CTCAE 
Grade
Equivalent to
Definition
Grade 1
Mild
Discomfort noticed but no disruption of normal 
daily activity
Grade 2
Moderate
Discomfort sufficient to reduce or affect daily 
activity; minimal medical intervention is indicated.
Grade 3
Severe
Incapacitating with inability to work or perform 
normal daily activity; treatment or medical 
intervention is indicated in order to improve the 


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overall well-being or symptoms; delaying the onset 
of treatment is not putting the survival of the 
subject at direct risk.
Grade 4
Life threatening/ 
disabling
An immediate threat to life that requires urgent 
medical intervention
Grade 5
Death
AE resulting in death.
8.3.2
Assessment of Causality
The investigator will assess the causal relationship between the adverse event and investigational 
product according to his/her best clinical judgement.  
8.4
Reporting Serious Adverse Events (SAEs)
An SAE is any adverse event that:

Is fatal (results in death; NOTE: death is the outcome, not the event).

Is life-threatening; (NOTE: the term “life-threatening” refers to an event in which the 
subject was at immediate risk of death at the time of the event; it does not refer to an event 
which could hypothetically have caused a death had it been more severe).

Requires in-subject hospitalization or prolongation of existing hospitalization.

Results in a persistent or significant disability or substantial disruption of the ability to 
conduct normal life functions.

Is a congenital anomaly/birth defect.

Is clinically significant or requires intervention or prevent one or the outcomes listed above.
Medical and scientific judgment should be exercised in deciding if an adverse event is of 
significant enough medical importance to be classified as serious outside the above definitions.  
Important medical events are those that may not be immediately life threatening, but are clearly of 
major clinical significance.  They may jeopardize the subject, and may require intervention to 
prevent one of the other serious outcomes noted above.  For example, drug overdose or abuse, a 
seizure that did not result in in-subject hospitalization or intensive treatment of bronchospasm in 
an emergency department would typically be considered serious.  In this case event will be reported 
using the serious criteria of clinically significant or requires intervention.
Additional protocol-defined criteria

Any Grade ≥3 cytokine release syndrome or GvHD, and all cases of Guillain Barré 
syndrome or other demyelinating neuropathies must be reported as an SAE within 24 hours.
The study will comply with all local regulatory requirements and adhere to the full requirements 
of the ICH Guideline for Clinical Safety Data Management, Definitions and Standards for 
Expedited Reporting, Topic E2. 
An SAE must be recorded by completing the SAE eCRF form within the electronic data capture 
(EDC) system.  In addition, an SAE Worksheet must be completed and submitted to GSK within 
24 hours by e-mail to
and
(or fax:
). 
PPD
PPD
PPD
PPD


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Details pertaining to the SAE must be completed by the Investigator with as much available 
information about the event.  The minimum reporting criteria for an SAE include:

Identifiable subject (Subject ID)

Event that is identified as serious (SAE term)

Severity and grading  

Suspect medicinal product

Relationship to suspect medication

Identifiable reporting source (PI acknowledgment of the report and his/her signature is 
required)
The investigator will assess the causal relationship between the SAE and investigational product 
according to his/her best clinical judgement.  Further details can be found in the Study Procedures
Manual.
8.5
Reporting Criteria during Long Term Follow-Up (Years 1-15)
Due to the nature of the treatment, subjects are required to be followed for up to 15 years after 
treatment with genetically modified T cells according to FDA guidance (Guidance for Industry, 
Gene Therapy Clinical Trials-Observing Subjects for Delayed Adverse Events; November 2006).  
Subjects will be followed according to the schedule outlined in Section 3.11.2.  Emergence of any 
of the following new clinical conditions reported or observed and the action taken will be reported 
to the Sponsor: 

New malignancies.

New incidence of exacerbation of a pre-existing neurological disorder.

New incidence of exacerbation of a prior rheumatologic or other autoimmune disorder.

New incidence of immune-related hematologic disorder.

Serious infections (including opportunistic).

Unexpected illness or hospitalization deemed related to gene modified cell therapy.
A detailed narrative description of the event should include the date of diagnosis and the nature of 
the diagnosis for all AEs.  If the diagnosis is cancer, record the type and stage of the cancer.  If the 
cancer is metastatic, list the metastatic sites.  If a new malignancy is recorded in a vector target 
cell type, tumor cells will be evaluated for vector sequences.  If the tumor is positive for vector 
sequences or the surrogate sample is positive for vector sequences and is confirmed in accordance 
to this protocol, clonality analysis will be performed.  If no evidence of oligo-or monoclonality is 
observed, a summary report of any and all analysis for the pattern of vector integration will be 
assembled, and submitted within the annual report of the INDs listed on this protocol under which 
the subject(s) evaluated originally received their treatment.  If evidence of oligo- or monoclonality 
is observed, an information amendment will be submitted within 30 days to the INDs listed on this 
protocol under which the subject(s) evaluated originally received their treatment. Adverse events 
should be recorded in the eCRF using a diagnosis or possible diagnosis, and rated for intensity, 
causality and seriousness.  If photographs are requested by the Sponsor of e.g. a rash AE, the 


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subject will sign a Medical Photograph Release prior to any photographs being taken.  Suspected 
unexpected serious adverse reactions (SUSARs) deemed related to the gene modified cells will be 
reported to the Regulatory Agencies and shared with Investigators as necessary in the form of 
Investigational new drug safety reports (INDSRs).
All AEs should be followed until:

Resolved or improved to baseline.

Investigator confirms no further improvement can be expected.

Death.
8.6
Cardiovascular and Death Events
For any cardiovascular events detailed below and all deaths, whether or not they are considered 
SAEs, specific Cardiovascular (CV) and Death sections of the CRF will be required to be 
completed. These sections include questions regarding cardiovascular (including sudden cardiac 
death) and non-CV death. 
The CV CRFs are presented as queries in response to reporting of certain CV Medical Dictionary 
for Regulatory Activities (MedDRA) terms. The CV information should be recorded in the 
specific cardiovascular section of the CRF within one week of receipt of a CV Event data query 
prompting its completion. 
The Death CRF is provided immediately after the occurrence or outcome of death is reported.  
Initial and follow-up reports regarding death must be completed within one week of when the 
death is reported.
Definition of Cardiovascular Events
Cardiovascular Events (CV) Definition:
Investigators will be required to fill out the specific CV event page of the CRF for the 
following AEs and SAEs:

Myocardial infarction/unstable angina

Congestive heart failure

Arrhythmias

Valvulopathy

Pulmonary hypertension

Cerebrovascular events/stroke and transient ischemic attack

Peripheral arterial thromboembolism

Deep venous thrombosis/pulmonary embolism

Revascularization


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8.7
Management of Encephalopathy Syndrome
Encephalopathy has been described in association with chimeric antigen receptor (CAR) T 
therapy, and termed (CAR) T cell related encephalopathy syndrome, or CRES (Neelapu et al, 
2018).  CRES typically manifests as a toxic encephalopathy which is generally reversible.  Early 
signs include diminished attention, language disturbance and impaired handwriting.  Other 
signs/symptoms include confusion, disorientation, agitation, aphasia, somnolence, and tremors.  In 
severe cases of CRES (defined as grade >2), seizures, motor weakness, incontinence, mental 
obtundation, increased intracranial pressure, papilledema, and cerebral edema may also occur.
CRES occurring within the first 5 days after immunotherapy may be concurrent with high fever 
and CRS symptoms.  This form of CRES tends to be of shorter duration, lower grade (grade 1–2, 
see Table 6), and is generally reversible with anti-IL-6 therapy.  CRES presenting as delayed 
neurotoxicity with seizures or episodes of confusion can occur three or four weeks after CART 
cell therapy, after the initial fever and CRS subside.
Encephalopathy syndrome (ES) may occur with other cancer immunotherapies, including TCRs.  
Cancer patients may also be at risk for encephalopathic symptoms due to other causes ranging 
from mild to moderate somnolence and confusion as a result of sedating medications, to seizures 
in relation to brain metastases.  The possible contribution of other medications, underlying disease 
and/or co-morbidities should be evaluated when considering a diagnosis of encephalopathy 
syndrome in relation to T cell therapy.
8.7.1
Grading of ES
Neelapu et al (2018) have developed a new grading system for ES which incorporates the 
CARTOX 10 point neurological assessment (CARTOX 10) tool, see Table 5.  Points are assigned 
for each of the tasks in Table 1 which are performed correctly.  Normal cognitive function is 
defined by an overall score of 10.
The CARTOX-10 should be used to monitor all subjects for ES.
Table 5:
CARTOX 10-point neurological assessment (CARTOX-10)
Task
CARTOX Points
Orientation to: year, month, city, hospital, and 
President/Prime Minister of country of residence
Total of 5 points (one point for each)
Name three objects, for example point to: clock, 
pen, button
Total of 3 points (one point for each)
Write a standard sentence, eg. ‘our national bird is 
the bald eagle’
1 point
Count backwards from 100 in tens
1 point
The CARTOX-10 score is used in grading of ES as presented in Table 6.


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Table 6:
Grading of Encephalopathy Syndrome (ES), based on Neelapu et al. 2018
Symptom or sign
Grade 1
Grade 2
Grade 3
Grade 4
Neurological 
assessment score
(by CARTOX-101)
7–9 (mild
impairment) 
if 
different 
from 
baseline
3–6 (moderate
Impairment)
0–2 
(severe 
impairment)
Patient in critical 
condition, 
and/or 
obtunded and cannot 
perform assessment 
of tasks
Raised intracranial 
pressure
NA
NA
Stage 
1–2 
papilloedema2, 
or 
CSF
opening 
pressure 
<20 mmHg
Stage 
3–5 
papilloedema2, 
or 
CSF 
opening 
pressure 
≥20 
mmHg, or cerebral 
oedema
Seizures or motor 
weakness
NA
NA
Partial seizure, or 
non-convulsive 
seizures 
on 
EEG 
with 
response 
to 
benzodiazepine
Generalized 
seizures, 
or 
convulsive or non-
convulsive 
status 
epilepticus, or new 
motor weakness
1 See Table 1 for CARTOX-10.
2 Papilloedema grading is performed according to the modified Frisén scale.
8.7.2
Monitoring for ES
Brain MRI (or CT Scan if MRI not feasible) should be obtained in all subjects at the time of 
screening.  Baseline brain MRI should be repeated if more than 4 months have elapsed prior to 
lymphodepletion.
CARTOX-10 should be measured on the day of NY-ESO-1c259T infusion prior to receiving 
treatment and then at least through Day 8 according to the schedule of procedures.  Subjects with 
known brain metastases should be monitored at least twice per day for the first 5 days following 
MAGE-A4c1032T infusion.  If a subject is found to have ES, the CARTOX-10 should be used at 
least twice per day until resolution or stable.  It can also be used at later visits if indicated.
8.7.3
Management of ES
The recommended management of ES should be based on toxicity grade.  Table 7 provides 
guidance on the management of ES, and should be implemented in accordance with institutional 
guidelines.  
Grade 1 ES is primarily managed with supportive care as outlined below.  For subjects requiring 
intervention beyond supportive measures, anti-IL-6 therapy should be the first line treatment of 
for ES in the setting of CRS.  In the setting of concurrent CRS, for Grades 1-3 ES additional doses 
of anti-IL-6 therapy should be considered before instituting corticosteroids since the use of 
systemic steroids may abrogate the effects of the T cell therapy.  For subjects with neurologic 
symptoms refractory to an initial dose of anti-IL-6 therapy, consider siltuximab for the second 
dose based on its mechanism of action directly against IL-6.  
A neurology consultation should be obtained for all subjects with ES for thorough neurological 
evaluation, and recommendations for further testing such as EEG and neuroimaging as indicated.


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Table 7 Management of encephalopathy syndrome (CRES)
Grade
Treatment
1
• Vigilant supportive care; aspiration precautions; intravenous (IV) hydration
• Withhold oral intake of food, medicines, and fluids, and assess swallowing
• Convert all oral medications and/or nutrition to IV or enteral tube if swallowing is impaired
• Avoid medications that cause central nervous system depression
• Evaluate for other contributing causes and treat accordingly
• Neurology consultation including fundoscopic exam to assess for papilloedema
• MRI of the brain with and without contrast (CT scan of the brain if MRI is not feasible).  Further 
testing if indicated such as diagnostic lumbar puncture with measurement of opening pressure if 
increased intracranial pressure is suspected, or MRI spine if the subject has focal peripheral neurological 
deficits
• Institute levetiracetam therapy and consider EEG if seizure activity is suspected
• Consider anti-IL-6 therapy with tocilizumab 8 mg/kg1 IV or siltuximab 11 mg/kg IV, if Grade 1 
persists beyond 24 hours, or worsening and associated with concurrent cytokine-release syndrome 
(CRS)
2
• Supportive care and neurological work-up as described for grade 1 ES
• Anti-IL-6 therapy if associated with concurrent CRS
• Consider Dexamethasone 10 mg IV every 6 h or methylprednisolone 1 mg/kg IV every 12 h if 
refractory to anti-IL-6 therapy, or for ES without concurrent CRS; Once initiated continue 
corticosteroids until improvement to grade 1 ES and then taper
• Consider transferring patient to intensive-care unit (ICU) if ES associated with grade ≥2 CRS
3
• Supportive care and neurological work-up as indicated for grade 1 ES
• ICU transfer is recommended
• Anti-IL-6 therapy if associated with concurrent CRS if not administered previously
• Corticosteroids as outlined for grade 2 ES if symptoms worsen despite anti-IL-6 therapy, or for ES 
without concurrent CRS; continue corticosteroids until improvement to grade 1 ES and then taper
• Stage 1 or 2 papilloedema with cerebrospinal fluid (CSF) opening pressure <20 mmHg should be 
treated corticosteroid regimen as per Grade 4 below.
• Consider repeat neuroimaging (CT or MRI) every 2–3 days if patient has persistent grade ≥3 ES
4
• Supportive care and neurological work-up as indicated for grade 1 ES
• Consider neurosurgical consultation for patients with evidence of increased intracranial pressure
• ICU monitoring; consider mechanical ventilation for airway protection
• Anti-IL-6 therapy and repeat neuroimaging as described for grade 3 ES
• High-dose corticosteroids continued until improvement to grade 1 ES and then taper; for example, 
methylprednisolone IV 1 g/day for 3 days, followed by rapid taper at 250 mg every 12 h for 2 days, 125 
mg every 12 h for 2 days, and 60 mg every 12 h for 2 days
1 Maximum amount of tocilizumab per dose is 800 mg.
8.8
Pregnancy
There is no preclinical or clinical trial data of NY-ESO-1c259T in pregnant women; however, 
there is a reasonable but unproven likelihood that this intervention may be significantly 
embryotoxic or even an abortifacient given the underlying biology of the target.  The effects on 
breast milk are unknown; therefore, breastfeeding should be discontinued for the duration of the 


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study, starting at the first dose of chemotherapy and for at least 12 months after receiving the T-
cell infusion, or 4 months after there is no evidence of persistence/gene modified cells in the 
subject’s blood, whichever is longer.
Pregnancy (or pregnancy of a male subject’s partner) is not considered an AE/SAE unless there is 
reason to believe that the pregnancy may be the result of failure of the contraceptive being used 
due to interaction with any of the IPs.  However, the Investigator shall report all pregnancies 
immediately to the Sponsor.  A woman who becomes and remains pregnant during the study will 
be discontinued from the treatment phase as exposure to radiation from imaging studies would be 
contraindicated in this setting.  The subject would enter into LTFU.  The outcome of the pregnancy 
must also be reported to the Sponsor.  The contraception and pregnancy guidelines in Section 2.3.1
should continue to be followed during LTFU.
If a pregnancy is reported, the investigator should inform GSK within 24 hours of learning of the
pregnancy.
8.9
Timelines for Safety Reporting
Initial Reports
Follow-up Information on a Previous 
Report
Type of Event
Time Frame
Documents
Time Frame
Documents
All SAEs
24 hours
SAE data 
collection tool
24 hours
Updated SAE data 
collection tool 
“CV events” and/or 
“death”
Initial and 
follow up 
reports to be 
completed 
within one 
week of when 
the CV event or 
death is 
reported
“CV events” and/or 
“death” data 
collection tool(s) if 
applicable
Initial and follow 
up reports to be 
completed within 
one week of when 
the CV event or 
death is reported
Updated “CV 
events” and/or 
“death” data 
collection tool(s) if 
applicable
Pregnancy
24 Hours
Pregnancy 
Notification Form
2 Weeks
Pregnancy 
Follow up- Form
9
Data Safety Monitoring Plan
The Sponsor is responsible for review of all adverse events and the Principal Investigators will be 
responsible for reporting all adverse events.  The Sponsor, Principal Investigators, and research 
teams can meet or teleconference at frequent or regularly scheduled intervals, to determine 
treatment modifications and treatment based toxicities, to monitor trends in adverse events, and 
determine if trends are noted, as needed.
The Sponsor is responsible for monitoring toxicity trends on this study. The Sponsor will report 
to the site IRB/IEC on at least an annual basis according to the institutions policy on continuing 
reviews.


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This study will be monitored by the Sponsor or their designee.
9.1 Safety Review Team
A SRT will be implemented in this study. In line with routine pharmacovigilance, a GSK SRT will 
review blinded safety data, including clinical laboratory parameters and AEs, at appropriate 
intervals during the period of study conduct. Recommendations on study modification, halting the 
study and/or pausing enrollment will be provided by the SRT. A SRT charter, defining roles and 
accountabilities and the process for safety review and meeting frequency, will be available.
9.1.1
Mandated Study Pause Due to GBS
The occurrence of any event of GBS will mandate a pause in enrollment and stopping treatment 
for all participants within the GSK3377794 studies.
9.2
Regulatory and Ethical Considerations, Including the Informed Consent Process 
Prior to initiation of a site, the Sponsor will obtain favorable opinion/approval from the appropriate 
regulatory agency to conduct the study in accordance with ICH Good Clinical Practice (GCP) and 
applicable country-specific regulatory requirements.
The study will also be conducted in accordance with ICH Good Clinical Practice (GCP), all 
applicable subject privacy requirements, and the guiding principles of the current version of the 
Declaration of Helsinki.  This includes, but is not limited to, the following:

IRB/IEC review and favorable opinion/approval of the study protocol and amendments as 
applicable

Obtaining signed informed consent

Investigator reporting requirements (e.g. reporting of AEs/SAEs/protocol deviations to 
IRB/IEC)

Sponsor will provide full details of the above procedures, either verbally, in writing, or 
both.

Optional assessments (including those in a separate protocol and/or under separate 
informed consent) and the clinical protocol should be concurrently submitted for approval 
unless regulation requires separate submission.  Approval of the optional assessments may 
occur after approval is granted for the clinical protocol where required by regulatory 
authorities.  In this situation, written approval of the clinical protocol should state that 
approval of optional assessments is being deferred and the study, with the exception of the 
optional assessments, can be initiated.  


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10
Appendices
10.1
Appendix 1: Performance Status 
PERFORMANCE STATUS CRITERIA Karnofsky and Lansky performance scores are intended to be multiples of 10.
ECOG (Zubrod)
Karnofsky
Lansky
Score
Description
Score
Description
Score
Description
0
Fully active, able to carry on all pre-disease 
performance without restriction. 
100%
Normal, no complaints, no 
evidence of disease. 
100%
Fully active, normal.
90%
Able to carry on normal activity; 
minor signs or symptoms of 
disease.
90%
Minor restrictions in physically 
strenuous activity.
1
Restricted in physically strenuous activity but 
ambulatory, able to carry out light or sedentary 
work, e.g., light housework, office work.
80%
Able to carry on normal activity 
with effort; some signs or 
symptoms of disease.
80%
Active, but tires more quickly.
70%
Cares for self, unable to carry on 
normal activity or do active work.
70%
Both greater restriction of, and less time 
spent in, play activities.
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. 
60%
Requires occasional assistance but 
is able to care for most of own 
needs.
60%
Up and around, but minimal active play; 
keeps busy with quieter activities.
50%
Requires considerable assistance 
and frequent medical care.
50%
Gets dressed, but lies around much of 
the day; no active play; able to 
participate in quiet play and activities. 
3
Capable of only limited self-care, confined to bed or 
chair more than 50% of waking hours
40%
Disabled; requires special care and 
assistance. 
40%
Mostly in bed; participates in quiet 
activities.
30%
Severely disabled; hospitalization 
indicated, although death not 
imminent.
30%
In bed; needs assistance even for quiet 
play.
4
Completely disabled.  Cannot carry on any self-
care.  Totally confined to a bed or chair
20%
Very ill; hospitalization necessary; 
active supportive treatment 
required.
20%
Often sleeping; play entirely limited to 
very passive activities.
10%
Moribund, fatal process 
progressing rapidly
10%
No play; does not get out of bed
5
Dead
0%
Patient expired
0%
Unresponsive; Dead


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10.2
Appendix 2: Schedule of Procedures
Screening and Baseline
Interventional Phase
Screening
Baseline
Days
Weeks
Months
Every 3 months 
until 2 years, 
every 6 months 
until 5 years, 
until progression/ 
discontinuation(n)
Labs, Tests, Procedures
Within 7 
days of 
apheresis
Apheresis
Within 7 
days 
prior to 
chemo
-7
-6
-5
-4
-3
-2
-1
0(b
1(b
3(b
4(b
7(b
2
3
4
5
6
8
10
12
4
5
6
9
12
Tests and Procedures
Informed Consent
X(a
History
X
X
Physical Exam
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Adverse Events/ConMeds (m
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
CARTOX-10 neurological 
assessment tool
X
X
X
X
X
X
HLA-A2
X(c
NY-ESO-1 Expression 
X(c
Drug Administration
Regimen A chemotherapy(d,e
X
X
X
X
Regimen B chemotherapy(d,e
X
X
Regimen C chemotherapy(d,e
X
X
X
NY-ESO-1c259T
X
Lab Tests & Procedures
Large Volume Apheresis
X
Disease Staging-CT / MRI 
X
X
X
X
X
X
X
X
X
Urinalysis
X
X
Hematology
X
X
X(o) X(o) X(o)
X(o) X(o)
X(o)
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Chemistry
X
X
X(o) X(o) X(o)
X(o) X(o)
X(o)
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
CMV PCR
X
X
X
X
X
X
PT, PTT
X
X
Amylase/Lipase
X
Ferritin
X
GFR / creatinine clearance(p)
X


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Screening and Baseline
Interventional Phase
Screening
Baseline
Days
Weeks
Months
Every 3 months 
until 2 years, 
every 6 months 
until 5 years, 
until progression/ 
discontinuation(n)
Labs, Tests, Procedures
Within 7 
days of 
apheresis
Apheresis
Within 7 
days 
prior to 
chemo
-7
-6
-5
-4
-3
-2
-1
0(b
1(b
3(b
4(b
7(b
2
3
4
5
6
8
10
12
4
5
6
9
12
Virology
X(f
Thyroid Panel
X(g
ANA
X(g
Rheumatoid Factor
X(g
Lab Tests & Procedures
Pregnancy(q)
X
X
Echo or MUGA
X
ECG
X
X
Brain MRI
X
Vector Copies (Persistence 
for Safety) (l)
X
X
X
X
X
VSV-G DNA (RCL) for 
safety
X
X
X
X
X
Research Studies:
Tumor biopsy
Xh
Xi
Xj
Serum Cytokines
X
X(k
X
X
X
X
X
X
X
X
Vector Copies (Persistence 
for Research)
X
X
X
X
X
X
Flow Cytometry
X
X
X
X
X
X
X
Notes:
a
Written subject informed consent must be obtained prior to performing any protocol procedures.  The Tissue/Screening Informed Consent Form will be signed prior to tumor 
sample collection during screening, and the Treatment Informed Consent will be signed prior to all other remaining screening procedures
b
Days 1 to 7 obtain physical examination, adverse events, concomitant medications, hematology, chemistry on at least 3 separate days
c
Any time prior to apheresis 
d
Patients may be admitted to the hospital for administration of chemotherapy and remain hospitalized until recovery of ANC to >0.5x109/L.  Chemotherapy conditioning may 
also be performed as an outpatient procedure at the discretion of the PI.  Chemotherapy will be given with supporting therapy as described in Section 3.3
e
G-CSF should be given daily from Day +2 (Regimens A and B) or from 24 hours post chemotherapy (Regimen C) until ANC >1.0x109/L, or per institutional guidelines as 
described in Section 4.  Long-acting (pegyated) G-CSF may be substituted according to institutional practice as described in Section 4


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f
Within 1 month of apheresis 
g
Within 8 weeks of initiating chemotherapy, unless clinically indicated to be repeated prior to chemotherapy initiation
h
The baseline biopsy material may be collected anytime between two months and two weeks (+1 week) prior to the start of chemotherapy, with a preference for the biopsy to be 
taken closer to the time of infusion
i
The biopsy scheduled post therapy may be taken ±4 weeks of the week 8 visit
j
The tumor biopsy at this time point is for disease progression/study discontinuation only, not every 3 months
k
Pre-infusion and any time from 1 hour post-infusion or later at the discretion of the investigator or if clinically indicated.  Levels should also be obtained if clinical symptoms 
of cytokine release syndrome develop
l
Persistence will be taken at Baseline (any time prior to cell infusion), Month 3, 6, 12, then every 6 months until 5 years post-infusion and until no gene modified cells are 
detected (i.e. not required at every visit).  If no gene modified cells are detected at 5 years, patients may be followed by postcard or phone call
m
Refer to Section 8.3 for reporting of adverse events
n
Subjects who remain in the interventional phase of the study at 5 years post treatment will then be assessed according to the Long Term Follow Up schedule in Appendix 4
o
Hematology and serum chemistry are required only on the days the patient receives chemotherapy during conditioning
p
Required for patients ≥65 yrs age
q
Pregnancy test for WOCBP only.  Urine or serum pregnancy test is to be performed and confirmed negative at screening and at baseline.  Pregnancy test (urine or serum per 
local requirements) is required within 24 hours before first dose of study intervention.


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10.3
Appendix 3: Off-Treatment Procedures
(One time only; at discontinuation)
History & Physical, vital signs & weight
X
Laboratory

Hematology
X

Chemistry*
X

Flow cytometry 
X
Disease Restaging
X
* LDH, ALT, AST, alk phos, bilirubin (total and direct), BUN/urea, creatinine, electrolytes, Ca, Mg, PO4, uric acid, albumin.
10.4
Appendix 4: Long-Term Follow-Up Schedule
Time post-infusion
Year 1
Year 2
Year 3
Year 4
Year 5
Years Post-infusion(b)
3 mo 6 mo 1 yr
1yr 
6 mo 2 yr 
2 yr 
6 mo 3 yr 3 yr 
6 mo
4 yr 4 yr 
6 mo
5 yr 
6
7
8
9
10
11
12
13
14
15
Clinical Assessments
Medical History(a)
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Physical Exam
X
X
X
X
X
X
X
X
X
X
Concomitant Medications
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Chemotherapies
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Adverse Events(c)
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Hematology
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Serum chemistry
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
VSV-G DNA (RCL) for 
safety(d)
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Vector Copies 
(Persistence) for safety(e)
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Overall Survival
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
a Including any changes in medical history since last visit
b Subjects who do not have persistence of gene modified cells may be followed remotely during years 6-15.  In this case, 
physical exam, vector copied, and RCL will not be collected.
c Adverse event collection is limited to:

New malignancies.

New incidence or exacerbation of a pre-existing neurologic disorder.

New incidence or exacerbation of a prior rheumatologic or other autoimmune disorder.

New incidence of immune-related hematologic disorder.

Serious infections (including opportunistic).

Unexpected illness and hospitalization deemed related to gene therapy.


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d RCL samples collected annually after the first year post infusion
e Month 3, 6, 12, and annually until year 5 and until no gene modified cells are detected. 
f Only concomitant medications for the treatment of AEs related to NY-ESO-1c259T will be collected


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10.5
Appendix 5: Draft letter to patients and physicians for long term follow-up for delayed 
adverse events 
10.5.1 Draft Patient Letter
[date]
[name and address]
Dear [patient name],
You have participated in a clinical research study that requires the study doctors and nurses to monitor 
your health for 15 years.  In addition to the semi-annual and annual visits you will be attending, we would 
like for you to report certain events listed below to your study doctor or nurse if they occur:
1. Your doctor tells you that you have been diagnosed with any new type of cancer, including blood 
disorders such as leukemia or lymphoma (this would be separate from your diagnosis of multiple 
myeloma).
2. You develop loss of feeling in any part of your body, especially hands and feet; you develop a loss 
of control of any body part (arms, legs…); you have a seizure; you experience memory loss.  In 
addition, if you experience a worsening of any of the symptoms listed, please contact your study 
nurse or doctor.  These types of symptoms are called neurological disorders.  If your primary doctor 
or specialist tells you that you have developed neurological symptoms, contact your study doctor or 
nurse.
3. You develop arthritis or autoimmune disease, or worsening of any previously experienced arthritis 
or autoimmune disease which you were experiencing prior to participation in the study.  If you are 
experiencing symptoms of arthritis or have been told by your doctor that you have an autoimmune 
disease, contact your study doctor or nurse.
If you experience any of these events, please contact your study physician or the study nurse listed 
below as soon as you can.  They may ask you questions about your health and will record your 
symptoms/disease and then monitor your health if they decide that it is necessary.  When you call, please 
mention the protocol number of your study which is #( XXXXXX), or the brief study title which is “A 
pilot study of genetically engineered NY-ESO-1 specific (c259) T cells in HLA-A2+ patients with 
synovial sarcoma”.  Your patient identification number under this protocol is (#XXX).
Study Coordinator:
Name
Address
Phone
Email
If you have any questions about this letter or the follow up procedures for the study itself, please do not 
hesitate to contact the above study nurse or doctor.
Thank you for your continued participation in our clinical research study.  Best regards,
[study coordinator]


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10.5.2 Draft Physician Letter
[date]
[name and address]
Dear [physician name],
Your patient [patient name] has participated in a clinical research study that requires 15 year monitoring 
for adverse events.  To aid in reporting of adverse events that are possible related to the clinical research 
study, we are asking the patients on our research study to designate a primary care or infectious disease 
physician that may help in the monitoring and reporting of adverse events.  Your patient has designated 
you.  If upon any of your visits with your patient, any of the following events are reported or 
discovered, please contact the study nurse or physician as soon as possible: 
New malignancies
New incidence of exacerbation of a pre-existing neurologic disorder
New incidence or exacerbation of a prior rheumatologic or other autoimmune disorder
New incidence of a hematologic disorder.
Unexpected illness and hospitalization deemed related to gene therapy
If your patient experiences any of these events, please contact the study coordinator below as soon 
as you can so that they can record the event and then monitor your patient’s health if necessary.  When 
you call, remember to mention the protocol number of the study which is #(
), 
patient ID (#           ) and the study title which is “A pilot study of genetically engineered NY-ESO-1 
specific (c259) T cells in HLA-A2+ patients with synovial sarcoma”.
Study Coordinator 
Name
Address
Phone
Email
If you have any questions about this letter or the study itself, please do not hesitate to contact the above 
study nurse or physician.
Thank you for your support in helping us to monitor for delayed adverse events.  Best regards,
[study coordinator]


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10.6
Appendix 6: Liver Safety Required Actions and Follow up Assessments
Level 1 Monitoring
In the event that the subject develops elevations in LFT parameters as defined below, an increase to liver 
chemistry monitoring i.e. at weekly intervals, will apply.
Liver Chemistry Monitoring Criteria Level 1
Criteria
Actions
ALT ≥3x ULN but ALT <5x ULN and bilirubin 
<2xULN, without symptoms believed to be related 
to liver injury, or hypersensitivity.
Notify the GSK medical monitor within
24 hours of learning of the abnormality to 
discuss participant safety. 
Participant must return weekly for repeat liver 
chemistries (ALT, AST, alkaline phosphatase, 
bilirubin) until they resolve, stabilise or return 
to within baseline.
If, during monitoring, ALT increases to ≥5x
ULN, or remains ≥3x ULN for ≥4 weeks, or if 
total bilirubin increases to ≥2x ULN, refer to 
Level 2 monitoring guidance below.
If, after 4 weeks of monitoring, ALT <3x ULN 
and bilirubin <2x ULN, monitor participants 
twice 
monthly 
until 
liver 
chemistries 
normalize or return to within baseline.
Level 2 Monitoring
In the event that the subject develops elevations in LFT parameters as defined below, an increase to liver 
chemistry monitoring at more frequent intervals i.e. twice weekly, will apply.
Liver Chemistry Monitoring Criteria Level 2
ALT-absolute
ALT 5x ULN 
ALT Increase
ALT 3x ULN that persists for 4 weeks
Bilirubin1, 2
ALT 3x ULN and bilirubin 2x ULN (>35% direct bilirubin) 
INR2 
ALT 3x ULN and INR>1.5


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Symptomatic3
ALT 3x ULN and associated with symptoms (new or 
worsening) believed to be related to liver injury or 
hypersensitivity.
Required Actions and Follow up Assessments
Actions
Follow Up Assessments

Report the event to GSK within 
24 hours

Complete the CRF and complete 
an SAE data collection tool if the 
event also meets the criteria for 
an SAE2

Perform liver event follow up 
assessments 

Monitor the participant until liver 
chemistries resolve, stabilize, or 
return to within baseline (pre-
Gene Therapy) (see 
MONITORING below)
MONITORING:
For bilirubin or INR criteria: 

Repeat liver chemistries (include 
ALT, AST, alkaline phosphatase, 
bilirubin, INR) and perform liver 
event follow up assessments 
within 24 hrs

Monitor participants twice 
weekly until liver chemistries 
resolve, stabilize or return to 
within baseline (pre-Gene 
Therapy)

A specialist or hepatology 
consultation is recommended
For All other criteria: 

Viral hepatitis serology4

Obtain INR and recheck with each liver chemistry 
assessment until the transaminases values show downward 
trend

Serum creatine phosphokinase (CPK) and lactate 
dehydrogenase (LDH).

Fractionate bilirubin, if total bilirubin2x ULN

If possible, obtain peripheral blood for persistence of 
genetically modified cells.

Obtain complete blood count with differential to assess 
eosinophilia

Record the appearance or worsening of clinical symptoms 
of liver injury, or hypersensitivity, on the AE report form

Record use of concomitant medications on the 
concomitant medications report form including 
acetaminophen, herbal remedies, other over the counter 
medications.

Record alcohol use on the liver event alcohol intake case 
report form
For bilirubin or INR criteria:

Anti-nuclear antibody, anti-smooth muscle antibody, 
Type 1 anti-liver kidney microsomal antibodies, and 
quantitative total immunoglobulin G (IgG) or gamma 
globulins.

Liver imaging (ultrasound, magnetic resonance, or 
computerised tomography) and /or liver biopsy to 
evaluate liver disease; complete Liver Imaging and/or 
Liver Biopsy CRF forms.


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
Repeat liver chemistries (include 
ALT, AST, alkaline phosphatase, 
bilirubin, INR) and perform liver 
event follow up assessments 
within 24-72 hrs
Monitor participants at least weekly 
until 
liver
chemistries 
resolve, 
stabilize or return to within baseline 
(pre-Gene Therapy)
1.
Serum bilirubin fractionation should be performed if testing is available.  Additionally, if serum bilirubin fractionation 
testing is unavailable, record presence of detectable urinary bilirubin on dipstick, indicating direct bilirubin 
elevations and suggesting liver injury. 
2.
All events of ALT 3x ULN and bilirubin 2x ULN (>35% direct bilirubin) or ALT 3x ULN and INR>1.5, which 
may indicate severe liver injury (possible ‘Hy’s Law’), must be reported as an SAE (excluding studies of hepatic 
impairment or cirrhosis); The INR threshold value stated will not apply to participants receiving anticoagulants.
3.
New or worsening symptoms believed to be related to liver injury (such as fatigue, nausea, vomiting, right upper 
quadrant pain or tenderness, or jaundice) or believed to be related to hypersensitivity (such as fever, rash or 
eosinophilia).
4.
Includes: Hepatitis A IgM antibody; Hepatitis B surface antigen (HbsAg) and Hepatitis B Core Antibody (IgM); 
Hepatitis C RNA; Cytomegalovirus IgM antibody; Epstein-Barr viral capsid antigen IgM antibody (or if unavailable, 
obtain heterophile antibody or monospot testing); Hepatitis E IgM antibody.


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10.7
Appendix 7: Summary of Changes from Amendment 14 to Amendment 15
Primary reason for this amendment:
Changes made to the protocol were requested by the FDA as a result of safety events which included 2 
reports of Guillain-Barré syndrome in subjects who have received chemotherapy and GSK3377794 during 
clinical trials..
Section of Amendment 15
Change
2.2
Addition of Prior or active demyelinating disease as an exclusion 
criterion.
4.5
Addition of Monitoring and Management for Demyelinating 
Neuropathy and other Neurological events
7.2.5
Update to risk assessment to add additional risk of Guillain-Barré
syndrome and other demyelinating neuropathies.
8.4
Addition of all cases of Guillain-Barré syndrome or acute 
demyelinating neuropathy as a reportable SAE within 24 hours.
9.1
Addition of GSK SRT
9.1.1
Addition of Mandated Study Pause due to GBS


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11
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associated with novel T cell-engaging therapies. Cancer J, 2014, 20(2), 119-122. doi: 
10.1097/PPO.0000000000000035.
Miller AD. Retrovirus packaging cells. Human Gene Therapy, 1990, 1(1), 5-14. doi: 
10.1089/hum.1990.1.1-5.
Neelapu SS, Tummala S, Kebriaei P, Wierda W, Gutierrez C, et al. Chimeric antigen receptor 
T-cell therapy - assessment and management of toxicities. Nat Rev Clin Oncol. 2018 
Jan;15(1):47-62.
Newrzela S, Cornils K, Li Z, Baum C, Brugman MH, Hartmann M, et al. Resistance of mature 
T cells to oncogene transformation. Blood. 2008 Sep 15;112(6):2278-86. doi: 10.1182/blood-
2007-12-128751.
Okcu MF, Despa S, Choroszy M, et al. Synovial sarcoma in children and adolescents: thirty 
three years of experience with multimodal therapy. Med Pediatr Oncol. 2001;37(2):90-96.
Okcu MF, Munsell M, Treuner J, et al. Synovial sarcoma of childhood and adolescence: a 
multicenter, multivariate analysis of outcome. J Clin Oncol. 2003;21(8):1602-1611.
Old LJ. Cancer vaccines: an overview. Cancer Immun. 2008;8 Suppl 1:1.
Palmerini E, Staals EL, Alberghini M, et al. Synovial sarcoma: retrospective analysis of 250 
patients treated at a single institution. Cancer. 2009;115(13):2988-2998.
Paplham P, Hahn T, Dubel K, et al. Fludarabine and cyclophosphamide provides a 
nonmyeloablative alternative conditioning regimen with low transplant-related mortality and 
control of high risk disease. Leukemia Research Reports 2014; 3: 28–31


PROTOCOL NUMBER: GSK208466 (ADP-04511)
INVESTIGATIONAL PRODUCT: NY-ESO-1C259T
Protocol: GSK208466 (ADP-04511)
Version: 15
CONFIDENTIAL:  DO NOT PHOTOCOPY
Date 17October 2018
Page 99 of 100
Pappo AS, Devidas M, Jenkins J, et al. Phase II trial of neoadjuvant vincristine, ifosfamide, 
and doxorubicin with granulocyte colony-stimulating factor support in children and 
adolescents with advanced-stage nonrhabdomyosarcomatous soft tissue sarcomas: a Pediatric 
Oncology Group Study. J Clin Oncol. 2005;23(18):4031-4038.
Prado-Garcia H, Romero-Garcia S, Aguilar-Cazares D, Meneses-Flores M, Lopez-Gonzalez 
J. Tumor-Induced CD8+ T-Cell Dysfunction in Lung Cancer Patients. Clinical and 
Developmental Immunology 2012, Article ID 741741.
Raj GV, Iasonos A, Herr H, Donat SM. Formulas Calculating Creatinine Clearance Are
Inadequate for Determining Eligibility for Cisplatin-Based Chemotherapy in Bladder Cancer. 
Journal of Clinical Oncology 2006; 24:3095-3100
Rapoport, A.P., et al. Rapid immune recovery and graft-versus-host disease-like engraftment 
syndrome following adoptive transfer of costimulated autologous T cells. Clin Cancer Res.
2009; 15:4499-507.
Robbins PF, Li YF, El-Gamil M, et al. Single and dual amino acid substitutions in TCR CDRs 
can enhance antigen-specific T cell functions. J Immunol. 2008;180(9):6116-6131.
Robbins PF, Morgan RA, Feldman SA, et al. Tumor Regression in Patients With Metastatic 
Synovial Cell Sarcoma and Melanoma Using Genetically Engineered Lymphocytes Reactive 
With 
NY-ESO-1. 
Journal 
of 
Clinical 
Oncology. 
2011;29(7):917-924. 
10.1200/jco.2010.32.2537.
Robbins PF, Kassim SH, Tran, TLN, 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. Clinical Cancer Research 2015;21(5):1019-27.
Scanlan MJ, Gure AO, Jungbluth AA, Old LJ, Chen YT. Cancer/testis antigens: an expanding 
family of targets for cancer immunotherapy. Immunol Rev. 2002;188:22-32.
Smith TJ, Bohlke K, Lyman GH, Carson KR, Crawford J, Cross SJ, Recommendations for the
Use of WBC Growth Factors: American Society of Clinical Oncology Clinical Practice
Guideline Update. Journal of Clinical Oncology 2015; 62.3488
Sultan I, Rodriguez-Galindo C, Saab R, Yasir S, Casanova M, Ferrari A. Comparing children 
and adults with synovial sarcoma in the Surveillance, Epidemiology, and End Results 
program, 1983 to 2005: an analysis of 1268 patients. Cancer. 2009.
Tunn PU, Andreou D, Illing H, Fleige B, Dresel S, Schlag PM. Sentinel node biopsy in 
synovial sarcoma. Eur J Surg Oncol. 2008;34(6):704-707. Prepublished on 2007/09/18 as DOI 
S0748-7983(07)00286-7 [pii] 10.1016/j.ejso.2007.07.014.
Turtle CJ, Berger C, Sommermeyer D, Hanafi L, Pender B, Robinson E, et al., Anti-CD19 
Chimeric Antigen Receptor-Modified T Cell Therapy for B Cell Non-Hodgkin Lymphoma 
and Chronic Lymphocytic Leukemia: Fludarabine and Cyclophosphamide Lymphodepletion 
Improves In Vivo Expansion and Persistence of CAR-T Cells and Clinical Outcomes. Oral 
presentation, Session: 624 American Society of Hematology, 57th Annual Meeting and 
Exposition December 6, 2015.


PROTOCOL NUMBER: GSK208466 (ADP-04511)
INVESTIGATIONAL PRODUCT: NY-ESO-1C259T
Protocol: GSK208466 (ADP-04511)
Version: 15
CONFIDENTIAL:  DO NOT PHOTOCOPY
Date 17October 2018
Page 100 of 100
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Zeng G, Li Y, El-Gamil M, et al. Generation of NY-ESO-1-specific CD4+ and CD8+ T cells 
by a single peptide with dual MHC class I and class II specificities: a new strategy for vaccine 
design. Cancer Res. 2002;62(13):3630-3635.

SAP_001.pdf: 
CONFIDENTIAL
The GlaxoSmithKline group of companies
208466/ADP-04511
1
Division
:
Worldwide Development
Information Type
:
Reporting and Analysis Plan (RAP)
Title
:
A Pilot Study of Genetically Engineered NY-ESO-1 Specific 
NY-ESO 1c259T in HLA-A2+ Patients with Synovial 
Sarcoma
Compound Number 
:
GSK3377794
Effective Date 
:
07-NOV-2019
Description:

The purpose of this RAP is to describe the planned analyses and output to be 
included in the Clinical Study Report for Protocol 208466/ADP-04511.

This RAP is intended to describe the planned efficacy and safety analyses required 
for the study. 

This RAP will be provided to the study team members to convey the content of the 
Statistical Analysis Complete (SAC) deliverable.
RAP Author(s):
Author
Date
28-Oct.-2019
Principal Biostatistician (Oncology, Clinical Statistics)
Copyright 2019 the GlaxoSmithKline group of companies. All rights reserved.  
Unauthorized copying or use of this information is prohibited.
PPD


CONFIDENTIAL
The GlaxoSmithKline group of companies
208466/ADP-04511
2
Reviewer (Method: Email)
Date
02-Nov.-2019
Global Medical Director (Oncology, Clinical Development)
01-Nov.-2019
Principal Programmer (Oncology, Clinical Programming)
04-Nov.-2019
Clinical Development Head (Oncology, Clinical Development)
01-Nov.-2019
Clinical Development Lead (Oncology, Clinical Development)
Clinical Statistics and Clinical Programming Line Approvals: (Method: Pharma 
TMF eSignature)
Approver
Date
07-Nov.-2019
Statistics Director (Oncology Clinical Statistics)
On behalf of
(Senior Statistics Director, Clinical 
Statistics)
07-Nov.-2019
Programming Manager (Oncology Clinical Programming)
PPD
PPD
PPD
PPD
PPD
PPD
PPD


CONFIDENTIAL
208466/ADP-04511
3
1.
TABLE OF CONTENTS
PAGE
1.
TABLE OF CONTENTS ...........................................................................................3
2.
LIST OF TABLES.....................................................................................................5
3.
LIST OF ABBREVIATIONS & TRADE MARKS ........................................................6
4.
INTRODUCTION......................................................................................................8
5.
OVERALL STUDY DESIGN AND OBJECTIVES......................................................8
5.1.
Study Objectives...........................................................................................8
5.1.1.
Primary Objectives.........................................................................8
5.1.2.
Secondary Objectives....................................................................8
5.1.3.
Exploratory Objectives...................................................................8
5.2.
Trial Design and Study Procedures...............................................................9
5.2.1.
Study Design .................................................................................9
5.2.2.
Treatments and Assignment to Treatment .....................................9
5.3.
Sample Size .................................................................................................9
6.
GENERAL ANALYSIS CONVENTIONS.................................................................10
6.1.
Study Periods .............................................................................................11
6.2.
Visit Windows .............................................................................................12
7.
ANALYSIS POPULATIONS ...................................................................................12
7.1.
Intent-to-Treat Population ...........................................................................12
7.2.
Modified Intent-to-Treat Population.............................................................12
7.3.
Per-Protocol Population..............................................................................13
8.
SUBJECT DISPOSITION.......................................................................................13
9.
PROTOCOL DEVIATIONS.....................................................................................13
10. DEMOGRAPHIC AND BASELINE CHARACTERISTICS .......................................14
10.1.
Demographic Characteristics......................................................................14
10.2.
Medical History ...........................................................................................14
10.3.
Prior Cancer Therapy..................................................................................14
11. STATISTICAL METHODS FOR EFFICACY...........................................................15
11.1.
Primary Efficacy Analysis............................................................................15
11.2.
Secondary Efficacy Analyses......................................................................16
12. STATISTICAL/ANALYTICAL ISSUES....................................................................21
12.1.
Handling of Dropouts or Missing Data.........................................................21
12.2.
Pooling of Centers in Multi-Center Studies..................................................21
12.3.
Multiple Comparisons/Multiplicity ................................................................21
12.4.
Examination of Subgroups..........................................................................21
12.5.
Interim Analysis and Data Monitoring..........................................................22
13. STATISTICAL METHODS FOR SAFETY ENDPOINTS .........................................22
13.1.
Study Drug Exposure..................................................................................22


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208466/ADP-04511
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13.2.
Adverse Events...........................................................................................22
13.2.1.
Adverse Events............................................................................23
13.3.
Adverse Events of Special Interest (AESI)..................................................25
13.4.
Laboratory Tests.........................................................................................25
13.4.1.
Clinical Laboratory Tests .............................................................25
13.4.2.
Persistence of NY-ESO-1 c259T and Replication 
Competent Lentivirus (RCL).........................................................26
13.4.3.
Cytokines.....................................................................................28
13.5.
Vital Signs...................................................................................................28
13.6.
Physical Exams ..........................................................................................29
13.7.
Electrocardiograms.....................................................................................29
13.8.
Eastern Cooperative Oncology Group (ECOG) Performance Status...........29
13.9.
Concomitant Medications............................................................................29
14. QUALITY CONTROL .............................................................................................30
15. TABLES AND LISTINGS CONVENTIONS.............................................................30
16. REFERENCES.......................................................................................................32
17. PRELIMINARY LIST OF TABLES, LISTINGS, AND FIGURES TO BE 
PROGRAMMED.....................................................................................................33
17.1.
Statistical Tables.........................................................................................33
17.2.
Data Listings...............................................................................................38
17.3.
Figures .......................................................................................................41
18. APPENDICES........................................................................................................43
18.1.
Appendix 1 Safety Laboratory Tests by Category .......................................43
18.2.
Appendix 2 List of PTs to Be Combined......................................................45
18.3.
Appendix 3 Specification for Collapsing Adverse Event Segments .............48
1.
COLLAPSING AE SEGMENTS WITH A COMMON AE PREFERRED 
TERM (PT) INTO UNIQUE EVENTS BASED ON THE START AND END 
DATES...................................................................................................................48
1.1
Multiple AE Segments with Overlapped or Continuous Start/End 
Dates..........................................................................................................48
1.2
Sort Adverse Events (AE)...........................................................................48
1.3
Create Derived Variables in ADAE ADaM SAS Dataset..............................49
2.
ADDITIONAL NOTES ............................................................................................52
3.
DATA EXAMPLES .................................................................................................53
3.1
Case #1: Previous AE End Date is Same as Next AE Start Date................53
3.2
Case #2: Previous AE Start Date is Same as Next AE Start Date...............54
3.3
Case #3: Next AE Start Date is One Day after Previous AE End 
Date............................................................................................................55
3.4
Case #4: Previous AE End Date is Greater Than Next AE Start 
Date............................................................................................................55


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208466/ADP-04511
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2.
LIST OF TABLES
Table 1
Definition of Baseline............................................................................... 10
Table 2
Partial or Missing Date Algorithms.......................................................... 11
Table 3
Best Overall Response per RECIST v1.1. ................................................ 19
Table 4
Sensitivity Analyses for NE Responses.................................................... 21
Table 5
Potentially Clinically Significant Elevations in Hepatic Parameters........ 26
Table 6
Potentially Clinically Significant Vital Signs Values............................... 29


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208466/ADP-04511
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3.
LIST OF ABBREVIATIONS & TRADE MARKS
Abbreviation
Description
AE
Adverse Event
ATC-2
Anatomical Therapeutic Chemical 2nd level
ATC-3
Anatomical Therapeutic Chemical 3rd level
BMI
Body Mass Index
BOR
Best Overall Response
BSA
Body Surface Area
CDISC
Clinical Data Interchange Standards Consortium
CI
Confidence Interval
CMV
Cytomegalovirus
CR
Complete Response
CRP
C-reactive protein 
CRS
Cytokine Release Syndrome
CTCAE
Common Toxicity Criteria for Adverse Events
DOR
Duration of Respond
DOSD
Duration of Stable Disease
ECG
Electrocardiogram
ECOG
Eastern Cooperative Oncology Group 
eCRF
Electronic Case Report Form
eCTD
Electronic Common Technical Document
GVHD
Graft Versus Host Disease
ICH
International Conference on Harmonisation
ITT
Intent-to-treat
KM
Kaplan-Meier
LTFU
Long-Term Follow-Up
MedDRA
Medical Dictionary for Regulatory Activities
mITT
Modified Intent-to-Treat
NCI
National Cancer Institute
NE
Not Evaluable
ORR
Overall Response Rate
OS
Overall Survival
PCR
Polymerase Chain Reaction
PD
Progression of Disease
PFS
Progression-Free Survival
PP
Per-protocol
PR
Partial Response
PT
Preferred Term
QTc
QT Interval Corrected for Heart Rate
RECIST
Response Evaluation Criteria in Solid Tumors
RCL
Replication Competent Lentovirus
SAE
Serious Adverse Event
SAP
Statistical Analysis Plan
SD
Stable Disease
SOC
System Organ Class


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208466/ADP-04511
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Abbreviation
Description
TTR
Time to Complete Response
ULN
Upper Limit of Normal
WHO
World Health Organization
Trademarks of the GlaxoSmithKline 
Group of Companies
Trademarks not owned by the 
GlaxoSmithKline Group of Companies
None
SAS


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208466/ADP-04511
8
4.
INTRODUCTION
This statistical analysis plan (SAP) describes the efficacy and safety analyses that will be 
performed for Study 208466/ADP-04511, based on the study protocol Version 15, dated 
15OCT2018. The SAP should be used in conjunction with the protocol and electronic 
case report form (eCRF).
5.
OVERALL STUDY DESIGN AND OBJECTIVES
5.1.
Study Objectives
5.1.1.
Primary Objectives

Determine the response rate in subjects with unresectable, metastatic or recurrent 
synovial sarcoma treated with lymphodepletion and Treg depletion followed by 
adoptive immunotherapy with T cells engineered to recognize an HLA-A2 
restricted NY-ESO-1 derived peptide (Cohort 1).

Determine the response rate and duration of response of adoptive immunotherapy 
with NY-ESO-1c259T cells in subjects with synovial sarcoma and low-level 
expression of NY-ESO-1 (Cohort 2).

Determine the response rate and duration of response of adoptive immunotherapy 
with NY-ESO-1c259T cells in subjects with synovial sarcoma treated with a 
lymphodepleting conditioning regimen containing cyclophosphamide as a single 
cytotoxic agent (Cohort 3).

Determine the response rate and duration of response of adoptive immunotherapy 
with NY-ESO-1c259T cells in subjects with synovial sarcoma treated with a 
lymphodepleting regimen containing cyclophosphamide and fludarabine cytotoxic 
agents at reduced total doses (Cohort 4).
5.1.2.
Secondary Objectives

Determine the safety of treatment with adoptively transferred NY-ESO-1c259T 
cells.

When possible, assess whether subjects with progressive disease following NY-
ESO-1c259T cell infusion or who do not respond experience a response following a 
second dose.
5.1.3.
Exploratory Objectives

Evaluate persistence, phenotype, and functionality of adoptively transferred NY-
ESO-1c259T cells and correlate with clinical response. 

Evaluate mechanisms of resistance and sensitivity to NY-ESO-1c259T cells. 

Evaluate antigen spreading as a mechanism of response.


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208466/ADP-04511
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5.2.
Trial Design and Study Procedures
5.2.1.
Study Design
This open-label trial was designed as a four Cohort study as of Protocol Amendment 15.
Study implementation (including study design) is described in detail in Section 3 of the 
protocol.
Subjects are eligible for the study if they test positive for HLA-A*02:01, HLA-A*02:05, 
and/or HLA-A*02:06; are ≥4 years of age; and have NY-ESO-1 expressing unresectable, 
metastatic or recurrent synovial sarcoma.
Efficacy, safety, and biomarker assessments to be conducted as each visit are outlined in 
the Schedule of Procedures in Section 10.2 (Appendix 2) of the protocol.
5.2.2.
Treatments and Assignment to Treatment
Drug administration details for each of the four cohorts are described in Section 3.3. of 
the protocol. Subjects in each cohort received lymphodepletion followed by infusion of 
transduced NY-ESO-1c259T cells, then were followed for toxicity, antitumor effects, and 
immune endpoints. The target dose administered was 5x109 with a minimum of 1x109 to 
a maximum of 6x109 transduced NY-ESO-1c259T cells for subjects ≥40 kg. Subjects <40
kg were dosed per body weight with a minimum 0.025x109 transduced cells/kg, with a 
target dose of 0.125x109 transduced cells/kg. 
Second infusions can occur in two settings:
1. Patients enrolled onto any cohort who have a confirmed response, or have stable 
disease for >3 months, then progress, were eligible for a second infusion of NY-ESO-
1c259T, provided eligibility criteria are met. Patients with confirmed responses or stable 
disease that qualify for a second infusion will receive lymphodepleting chemotherapy and 
T cell infusion as received for the first infusion. 
2. Patients in Cohort 3 and 4 who have progressive disease or stable disease ≤3 months 
as best response, may receive a 2nd treatment of NY-ESO-1c259T using the Regimen A 
lymphodepletion to determine if more intense lymphodepletion can result in an improved 
best response. 
Patients may receive a maximum of two treatments with NY-ESO-1c259T. The second 
cycle (i.e. re-treatment) can be given no sooner than 60 Days from the first infusion and 
no later than 2 years after the first infusion. Decisions to retreat with a second infusion 
will be discussed with the Sponsor and Investigators.
5.3.
Sample Size
The sample size for each cohort is based on clinical judgment. The study is not statistically 
powered to conduct hypothesis testing between cohorts.


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208466/ADP-04511
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6.
GENERAL ANALYSIS CONVENTIONS
With respect to the primary objectives and endpoints, no specific statistical hypotheses 
will be evaluated. All analyses will be descriptive and exploratory. 
In the protocol and eCRF, the date of the first T cell infusion is referred to as Day 0.For 
the tables, listings, and figures, the date of the first T cell infusion will be referred to as
Day 1 to be consistent with CDISC data standards.
Data collected in this study will be documented using summary tables and subject data 
listings. Continuous variables will be summarized using descriptive statistics (number of 
subjects, mean, median, standard deviation, minimum, and maximum). Categorical 
variables will be summarized using frequencies and proportions. Time-to-event data will 
be summarized via Kaplan-Meier (KM) methodology using the 25th, 50th (median), and 
75th percentiles with associated 2-sided 95% confidence intervals (CIs) using the 
complementary log-log transformation, as well as the proportion of censored 
observations. The 95% CIs for proportions will be calculated using Wilson and exact 
confidence limits. 
Because of the small number of expected subjects receiving a second infusion, only select 
adverse events tables will be prepared for data on subjects who receive a second infusion.
Efficacy data will be summarized in tables and listings.
Assessments will be displayed for each Cohort and for all Cohorts combined (i.e., 
overall).
Unless specified otherwise, baseline measurements should be the most recent value prior 
to initiating lymphodepletion and should occur within 7 days prior to initiating 
lymphodepletion (Table 1). If an assessment is not available, then the last assessment 
prior to that visit would be used. 
Table 1
Definition of Baseline
Assessment/Test
Visit
Target and Non-target Lesions
Baseline within 7 days prior to initiating 
lymphodepletion
Demography 
Date of Screening Informed Consent  
Hematology, Chemistry, C-reactive 
protein (CRP), CMV PCR, Additional 
Lab
Baseline within 7 days prior to initiating 
lymphodepletion
Vital Signs, Physical Exam, ECOG
Baseline within 7 days prior to initiating 
lymphodepletion
Electrocardiograms
Baseline within 7 days prior to initiating 
lymphodepletion
Cytokines
Baseline within 7 days prior to initiating 
lymphodepletion


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208466/ADP-04511
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Algorithms for imputing partial or missing dates are shown in Table 2. If a period 
determination cannot be made for an adverse event, it will be attributed to the post-
lymphodepletion period (described in Section 6.1), with missing dates imputed as 
explained in Table 2. AE end dates are imputed to facilitate calculation of AE duration. 
Note: Only SAEs are collected prior to leukapheresis.
Table 2
Partial or Missing Date Algorithms
Variable
Missing Day
Missing Day, Month
Missing Day, Month, 
Year
Date of Last Systemic 
Therapy/Date of Initial 
Diagnosis
Assign 1
Assign January 1 if prior 
to date of informed 
consent, otherwise use 
date of informed consent
Missing (do not impute)
Adverse Event Start 
Date
Assign first day of 
month unless it is the 
month of start of 
lymphodepletion.
Otherwise, assign date 
lymphodepletion started.
Assign January 1 unless 
the year is year of start 
of lymphodepletion
Otherwise, assign date 
lymphodepletion started.
Assign date 
lymphodepletion started.
Adverse Event End Date
Assign the last day of 
the month or end of 
study date, whichever is 
earlier. 
Assign December 31 or 
end of study date, 
whichever is earlier.
If ongoing, end date is 
missing. Otherwise, 
assign end of study date.
Missing date information for concomitant medication will not be imputed. 
Medical history, adverse events and concurrent procedures will be coded using Medical 
Dictionary for Regulatory Activities (MedDRA), Version 22.0 or higher. Prior and 
concomitant medications will be coded using the World Health Organization (WHO) 
Drug Dictionary (December 2015 or later).
Data for all subjects in the clinical database will be included in the data listings. 
Calculated (derived) variables will be listed as appropriate. All tables, listings, and 
figures will be programmed using SAS Version 9.3 or higher. 
A list of proposed statistical tables, data listings, and figures is provided in Section 17. 
BSA (m^2) will be presented as reported on the eCRF. 
BMI will be computed as weight in kg/height in m^2
6.1.
Study Periods
Subjects undergo leukapheresis within 7 days of the screening visit. Following 
leukapheresis, cells are transduced. A baseline visit occurs within 7 days prior to
initiating chemotherapy for lymphodepletion. The T cell infusion occurs at most 7 days 


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208466/ADP-04511
12
following chemotherapy depending on the Cohort. The interventional phase is the period 
from initiation of chemotherapy for lymphodepletion through the date of discontinuation 
or up to 5 years after the last T cell infusion, whichever is earlier Subjects are followed 
for 15 years after infusion, or until death, lost to follow-up, or withdrawal of consent, 
whichever comes first.
For the purposes of adverse event reporting, the following visit intervals will apply:

Pre-leukapheresis Period: Date screening ICF signed to the date before 
leukapheresis – only serious adverse events (SAEs) will be reported for screened 
subjects

Date informed consent signed (Screening) to end of study (Period 1)

Day 1 of lymphodepletion to end of study (Period 2)
Period 1 adverse events will be summarized for the intent-to-treat population unless 
otherwise specified. Period 2 adverse events will be summarized for the modified intent-
to-treat population. 
Period 2 is clinically relevant for summarizing safety in the context of lymphodepletion 
and T-cell therapy because Period 1 includes safety results prior to lymphodepletion and 
T-cell therapy.
6.2.
Visit Windows
Study visits are expected to occur according to the protocol schedule. All data will be 
tabulated per the evaluation visit as recorded on the eCRF even if the assessment is 
outside of the visit window. In data listings, dates and study day relative to T cell infusion
(Study Day 1) will be presented. Note: for time-to-event analyses, evaluations will be 
based on the actual date of the event rather than on the visit on which the event was 
reported.
7.
ANALYSIS POPULATIONS
The number of subjects in each study population will be summarized. 
7.1.
Intent-to-Treat Population
The intent-to-treat (ITT) population will include all subjects who were enrolled in the 
trial (i.e., underwent leukapheresis). The ITT population will be used to assess the 
efficacy and safety of the T cell therapy regimen.
7.2.
Modified Intent-to-Treat Population
The modified intent-to-treat (mITT) population will include all subjects who receive NY-
ESO-1c259T cell infusion. The mITT population is the primary analysis population for 
both safety and efficacy. If the ITT and mITT populations are the same, only analyses 
associated to the ITT population will be reported.


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208466/ADP-04511
13
7.3.
Per-Protocol Population
A per-protocol population (PP) may be included if there are subjects in the mITT 
population who have protocol deviations that are expected to affect efficacy assessments 
(e.g., subjects enrolled who do not meet key eligibility criteria) during the trial.  
Exclusions from the per protocol population will be identified and documented prior to 
database lock. 
8.
SUBJECT DISPOSITION
Subject disposition will be summarized by Cohort, Cohorts 2-4 combined and overall for 
all subjects who entered the study (i.e., signed the informed consent for the study) and 
will include the number of subjects in each population (ITT, mITT, PP if applicable) and 
reasons subjects were removed from a population. The number of subjects receiving 
lymphodepleting chemotherapy will also be summarized. The number and proportion of 
subjects who complete the trial, as well as those exiting the interventional phase for each 
reason specified on the eCRFs will also be summarized. A subject will be considered to 
have completed the trial when he/she has confirmed progression of disease or death, or 
when the subject is in the trial for 5 years after the last T cell infusion. Reasons for early 
termination from the study are: 

Disease Progression

Unacceptable toxicity and other safety reasons 

Death 

Investigator discretion 

Subject withdrew consent 

Protocol deviation

Lost to follow-up

Termination by Sponsor 

Failed manufacture of cell product

Pregnancy

Failed to meet eligibility criteria for the second infusion.
Leukapharesed or T-cell infused subjects excluded from analysis populations will be 
presented in a data listing.
9.
PROTOCOL DEVIATIONS
Subjects will be excluded from the per protocol population if they have protocol 
deviations expected to affect efficacy assessments, these may include the following, and 
possibly others not listed here:

Did not meet key inclusions criteria (e.g., did not meet disease requirements)

Received less than 1 billion transduced NY-ESO-1c259T cells (or less than 
0.025x109 cells/kg if <40kg).

Had a post baseline tumor resection

Took prohibited medication


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
Developed withdrawal criteria during the study but were not withdrawn

Did not have at least one post-treatment tumor assessment

Had different imaging methods for baseline and post-baseline assessments
Protocol deviations will be presented by Cohort and subject in a data listing.
10.
DEMOGRAPHIC AND BASELINE CHARACTERISTICS
10.1.
Demographic Characteristics
Demographic and baseline characteristics at study entry will be summarized by Cohort 
and overall for the ITT and mITT populations. Variables to be summarized are:

Continuous variables
-
Age (years) at time of screening informed consent
-
Weight (kg, converted from pounds if necessary)
-
Height (cm, converted from inches if necessary)
-
Body surface area (BSA) (m2) 
-
BMI [(weight in kg)/(height in m)2]

Categorical variables
-
Sex
-
Race
-
Ethnicity
-
NY-ESO status
-
HLA status (HLA-A*0201, HLA-A*0205, HLA-A*0206, Other)
-
ECOG performance status at baseline
-
Primary disease site at enrollment
-
Disease stage at enrollment
-
Histology grade at enrollment 
Demographic and baseline characteristics will be presented by Cohort and subject in data 
listings.
10.2.
Medical History
Medical history will be summarized by Cohort and overall for the ITT population. 
Medical history information will be presented by Cohort and subject in a data listing. 
10.3.
Prior Cancer Therapy
All prior cancer therapies should have an end date prior to screening Informed Consent 
date. Additionally, all prior cancer therapies taken from after apheresis and before 
lymphodepletion (i.e., bridging therapies) will be summarized.
Prior systemic therapy, radiotherapy, surgery history, and bridging therapies will be 
summarized for the ITT and mITT populations by Cohort and overall. The following 
variables will be summarized:

Prior systemic therapy (yes/no)


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
Type of systemic therapy

Time since last systemic therapy (days)

Time since initial diagnosis (days)

Best response to last systemic therapy

Prior radiotherapy (yes/no)

Prior cancer-related surgery (yes/no)

Bridging therapy (yes/no)

Type of bridging therapy (chemotherapy, radiation, other)
Bridging therapy is therapy administered on or after apheresis and before 
lymphodepletion.
Time since last systemic therapy is calculated as the date the informed consent was 
signed minus the latest therapy end date, expressed in days, and will be summarized 
using descriptive statistics. Time since initial diagnosis is calculated as the date the 
informed consent was signed minus the date of initial diagnosis, expressed in days, and 
will be summarized using descriptive statistics. Partial dates for date of last systemic 
therapy and time since initial diagnosis will be imputed as described in Section 6. Only 
positive values will be summarized for time since last systemic therapy and time since 
initial diagnosis. Number of lines of prior systemic therapy will be summarized using 
descriptive statistics and will also be categorized and summarized using counts and 
percentages. All other variables listed above will be summarized using counts and 
percentages.
Yes/no variables for prior systemic therapy, prior radiotherapy, and prior cancer-related 
surgery will be derived from the presence or absence of this information in the raw 
datasets, as there is no specific question on the eCRF for these variables. 
Prior systemic therapy, radiotherapy, and surgery history information will be presented 
by Cohort and subject in a data listing.
11.
STATISTICAL METHODS FOR EFFICACY
The study objectives are described in Section 5.1.
11.1.
Primary Efficacy Analysis
The primary analysis population for primary and secondary efficacy endpoints will be the 
mITT population. ITT will be used as the secondary population for analysis of the 
primary endpoint. The primary efficacy endpoint is the overall response rate (ORR).
ORR is defined as the proportion of subjects with a confirmed complete response (CR) or 
partial response (PR) relative to the total number of subjects in the corresponding 
analysis population per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) as 
determined by the local investigators. To be assigned a status of a CR or PR, changes in 
tumor measurements must be confirmed by repeat assessments that should be performed 


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at least 4 weeks after the criteria for response are first met. Subjects with unknown or 
missing response will be treated as non-responders, that is, they will be included in the 
denominator when calculating the proportion.
Response categories are confirmed CR, confirmed PR, stable disease (SD), and 
progressive disease (PD). Response confirmation will be handled according to Table 3
(RECIST v1.1) in the next section.
Sensitivity analyses to be performed for ORR defined by RECIST v1.1 include:

Two-sided 95% CIs for ORR will be calculated using both the Wilson and 
Clopper-Pearson methods

ORR analyses repeated for the PP population (if a PP population is defined)

Investigator assessed response
Listings of response data and lesion measurements per RECIST v1.1 will also be 
provided.
11.2.
Secondary Efficacy Analyses
The key secondary efficacy endpoints are

Time to confirmed response (TTR)

Duration of response (DOR)

Progression-free survival (PFS)

Overall survival (OS)
Additional clinically relevant endpoints include best overall response (BOR) duration of 
stable disease (DOSD), and time on study (defined as date of last visit in study – date of 
informed consent +1).
The secondary efficacy analyses will be performed for the mITT population, that is, 
subjects who received T-cell infusion, which is the primary population for efficacy 
analysis. Efficacy endpoints will be based on RECIST v1.1. 
Time to confirmed response (CR or PR) (reported in weeks) is defined as the interval 
between the date of first T-cell infusion and the earliest date of first documented
confirmed CR or confirmed PR among participants with a confirmed PR or CR.
Duration of response (reported in weeks) is defined as the time from first documented 
evidence of confirmed CR or confirmed PR until first documented date of disease 
progression or death due to any cause or surgical resection or start of prohibited 
medications. For responders who are still alive and who do not have documented disease 
progression, surgical resection, or prohibited medication the date of the last disease 
assessment is used.
PFS (reported in weeks) is defined as the interval between the date of first T cell infusion 
and the earliest documented evidence of disease progression or death due to any cause or 
surgical resection or start of prohibited medications. Subjects who do not have a 


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documented date of progression, death, surgical resection, or prohibited medication will 
be censored at the date of the last disease assessment.
Subject will be censored for PFS and DOSD at the day 1 for the situation the censoring 
algorithm calls for the subject to be censored at the date of the last disease assessment but 
no such assessment exists.
Extended Loss to Follow-up
For the analysis of PFS, if there are two or more consecutive scheduled disease 
assessments which are missing and are then followed by an assessment demonstrating 
disease progression or death (due to any cause) or surgical resection or start of prohibited 
medications, PFS will be censored at the last adequate disease assessment prior to 
progression or death or surgical resection or start of prohibited medications. For this type 
of censoring due to extended loss to follow-up, the ‘last adequate disease assessment’ 
will be defined as the date of the last radiological assessment prior to the missing 
assessments that shows no disease progression.
As the assessment schedule changes through the course of the study (i.e. every 4 weeks 
during the first 12 weeks and then every 3 months until month 24 and then every 6 
months after month 24), the following rules will be used for identifying extended loss to 
follow up.

If PFS event is on or prior to week 12, then a subject will be identified as an 
extended loss to follow up if the subject did not have an adequate disease 
assessment during the time period of 56 days (8 weeks) prior to PFS event;

Else if PFS event is after week 12 and on or prior to the first scheduled disease 
assessment date (month 6, day 183) during week 12 to month 24, then a subject 
will be identified as an extended loss to follow up if the subject missed both week 
8 and week 12 disease assessments:
o
If PFS event is after week 12 and on or prior to day 122 (month 4), then a 
subject will be identified as an extended loss to follow up if the subject did 
not have an adequate disease assessment during the time period of 56 days 
(8 weeks);
o
Else if PFS event is after week 12 and on or prior to day 153 (month 5), 
then a subject will be identified as an extended loss to follow up if the 
subject did not have an adequate disease assessment during the time 
period of 84 days (12 weeks);
o
Else if PFS event is after week 12 and on or prior to day 183 (month 6), 
then a subject will be identified as an extended loss to follow up if the 
subject did not have an adequate disease assessment during the time 
period of 112 days (16 weeks);

Else if PFS event is after day 183 (month 6) and on or prior to the second 
scheduled disease assessment date (month 9, day 274) during week 12 to month 


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24, then a subject will be identified as an extended loss to follow up if the subject 
missed both week 12 and month 6 disease assessments:
o
If PFS event is after day 183 (month 6) and on or prior to day 214 (month 
7), then a subject will be identified as an extended loss to follow up if the 
subject did not have an adequate disease assessment during the time 
period of 120 days (4 weeks + 3 months);
o
Else if PFS event is after day 183 (month 6) and on or prior to day 244 
(month 8), then a subject will be identified as an extended loss to follow 
up if the subject did not have an adequate disease assessment during the 
time period of 150 days (4 weeks + 4 months);
o
Else if PFS event is after day 183 (month 6) and on or prior to day 274 
(month 9), then a subject will be identified as an extended loss to follow 
up if the subject did not have an adequate disease assessment during the 
time period of 181 days (4 weeks + 5 months);

Else if PFS event is after day 274 (month 9) and on or prior to day 731 (month 
24), then a subject will be identified as an extended loss to follow up if the subject 
did not have an adequate disease assessment during the time period of 183 days (6 
months);

Else if PFS event is after day 731 (month 24) and on or prior to day 914 (24 
months + 6 months), then a subject will be identified as an extended loss to follow 
up if the subject missed both month 21 and month 24 disease assessments;
o
If PFS event is after day 731 (month 24) and on or prior to day 822 (month 
27), then a subject will be identified as an extended loss to follow up if the 
subject did not have an adequate disease assessment during the time 
period of 183 days (6 months);
o
Else if PFS event is after day 822 (month 27) and on or prior to day 914 
(month 30), then a subject will be identified as an extended loss to follow 
up if the subject did not have an adequate disease assessment during the 
time period of 274 days (6 months + 3 months);

Else if PFS event is after day 914 (month 30) and on or prior to day 1096 (month 
36), then a subject will be identified as an extended loss to follow up if the subject 
missed both month 24 and month 30 disease assessments;
o
If PFS event is after day 914 (month 30) and on or prior to day 1005 
(month 33), then a subject will be identified as an extended loss to follow 
up if the subject did not have an adequate disease assessment during the 
time period of 274 days (6 months + 3 months);
o
Else if PFS event is after day 1005 (month 33) and on or prior to day 1096 
(month 36), then a subject will be identified as an extended loss to follow 


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up if the subject did not have an adequate disease assessment during the 
time period of 366 days (12 months);

Else if PFS event is after day 1096 (month 36), then a subject will be identified as 
an extended loss to follow up if the subject did not have an adequate disease 
assessment during the time period of 366 days (12 months);
Overall survival (reported in weeks) is defined as the interval between the date of the first 
T-cell infusion and date of death from any cause. Subjects who are still alive or who are 
lost to follow-up will be censored at the date of last contact.
Best overall response is the best response recorded from the start of treatment (first T cell 
infusion) until disease progression/recurrence. Response categories from best to worst 
are: confirmed CR, confirmed PR, SD and confirmed PD. The handling of response 
confirmation will be handled according Table 3 (RECIST v1.1). Duration of stable 
disease must be at least 4 weeks to qualify SD as the BOR. If a subject did not have 
confirmed CR or PR and had stable disease for less than 4 weeks, BOR will be PD. 
Table 3
Best Overall Response per RECIST v1.1.
Overall Response
First time point
Overall Response
Subsequent Time Point
Best Overall Response
CR
CR
CR
CR
PR
SD, PD, or PR*
CR
SD
SD provided minimum criteria for SD duration  met**, 
otherwise PD
CR
PD
SD provided minimum criteria for SD duration  met**, 
otherwise PD
CR
NE
SD provided minimum criteria for SD duration  met**, 
otherwise NE
PR
CR
PR
PR
PR
PR
PR
SD
SD
PR
PD
SD provided minimum criteria for SD duration  met**, 
otherwise PD
PR
NE
SD provided minimum criteria for SD duration  met**, 
otherwise NE
NE
NE
NE
*If CR is truly met at first time point, then any disease seen at a subsequent time point, even disease meeting PR 
criteria relative to baseline, makes the disease PD at that point (since disease must have reappeared after CR). Best 
response would depend on whether minimum duration for SD was met. However, sometimes ‘CR’ may be claimed 
when subsequent scans suggest small lesions were likely still present and in fact the patient had PR, not CR at the first 
time point. Under these circumstances, the original CR should be changed to PR and the best response is PR. 
** Minimum criteria for SD disease duration is at least 4 weeks to qualify SD as BOR.
Note: If Best Overall Response is CR or PR, the subject is classified as a responder for the ORR analysis.
Duration of stable disease (reported in weeks) is defined as the interval between the date 
of first T cell infusion and the earliest documented evidence of PD. Subjects who do not 
have documented evidence of PD will be censored at the date of the last assessment.                                       
No hypothesis testing is planned for these secondary endpoints. Time to event endpoints 
will be summarized and displayed graphically using KM methodology to estimate the 
median, and the 25th and 75th percentiles and associated 2-sided 95% CIs using the 
complementary log-log transform.  Overall survival may be assessed at fixed time points 


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such as 1 year and 2 years using KM methods. The proportion of censored observations 
will be summarized.
Sensitivity analyses will be performed for BOR, DOR, and PFS as follows: 

Summaries based on the PP population (if a PP population is defined) 

In cases where a tumor assessment has a value of NE (missing or unknown), 
sensitivity analyses will be performed assigning values of PD and SD (PFS only)

For PFS, subjects who received surgical resection or prohibited medications prior 
to documented disease progression then PFS will be censored at the date of the 
last adequate disease assessment 

Based on investigator assessment

In cases where a tumor assessment has a value of NE (missing or unknown), 
sensitivity analyses will be performed ignoring the assessment with a value of NE 

In cases where a tumor assessment has a value of not evaluable (NE) (i.e., missing 
or unknown), sensitivity analyses will be performed assigning values of SD if the 
assessments before and after the NE assessment are CR, PR, or SD. and will 
assign PD otherwise, except for PR NE CR where the assessment is improving, as 
shown in Table 4. (per RECIST v1.1.)


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Table 4
Sensitivity Analyses for NE Responses
Responses at Time Points 1, 2, 3
Sensitivity Analysis 1: SD Replaces NE at the second 
time point
CR-NE-CR 
SD
CR-NE-PR
SD
CR-NE-SD
SD
CR-NE-PD
PD
CR-NE-NE
PD
PR-NE-CR 
SD
PR-NE-PR
SD
PR-NE-SD
SD
PR-NE-PD
PD
PR-NE-NE
PD
Other sensitivity analyses may be performed as appropriate.
Subject response characteristics and time on study will be shown on a swim lane plot. 
Time on study will be calculated as (date of last assessment for ongoing subjects or 
discontinuation date) – date of first T cell infusion).
Maximal change in target lesions from baseline will be shown in a waterfall plot. Change 
in target lesions from baseline over time will be shown in a spider plot.
Listings of response data and derivations for secondary endpoints will be provided, along 
with other relevant data collected on the eCRF.
12.
STATISTICAL/ANALYTICAL ISSUES
12.1.
Handling of Dropouts or Missing Data
Missing dates will be imputed as described in Section 4. Sensitivity analyses for missing
data are described in Section 11.1 and Section 11.2.
12.2.
Pooling of Centers in Multi-Center Studies
Data will not be summarized by study center or for groupings of study centers. 
12.3.
Multiple Comparisons/Multiplicity
No formal statistical testing will be performed; therefore, no adjustments for multiple 
comparisons or multiplicity are planned. 
12.4.
Examination of Subgroups
No subgroup analyses are planned.


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12.5.
Interim Analysis and Data Monitoring 
Futility evaluation was conducted by Adaptimmune for cohorts 2, 3, and 4 after enrolling 
5 subjects using stopping criteria described in Section 3.2 of the protocol.
13.
STATISTICAL METHODS FOR SAFETY ENDPOINTS
Safety endpoints are:

Adverse events (AEs), including serious AEs (SAEs) and adverse events of 
special events (AESI)

Laboratory assessments, including chemistry, hematology and anti-infused cell 
(NY-ESO-1c259T) antibodies

Correlation of circulating cytokines with CRS
Other safety assessments include physical exams, vital signs, and concomitant 
medications.
All safety data will be included in data listings.
13.1.
Study Drug Exposure
The total number of transduced T cells and a summary of lymphodepleting chemotherapy 
administration will be summarized for the mITT population by Cohort and overall using 
descriptive statistics. The number of transduced cells will be summarized overall for 
subjects with a second T cell infusion.
All dose administration data for lymphodepletion, including cyclophosphamide and 
fludarabine, and for T cell infusion will be presented by subject in a data listing.
13.2.
Adverse Events
Adverse events (AEs) will be summarized separately for each analysis population and 
Period (as appropriate) as described in Section 6 and as described below.  AEs with 
partial start or end dates will be imputed as described in Section 6.
Adverse events (AEs) will be summarized by Cohort and overall for:

Period 1: Date informed consent signed (Screening) to end of study for ITT and 
mITT populations

Period 2: Day 1 of lymphodepletion to end of study for mITT population only

Pre-leukapheresis Period: SAEs only for screened subjects.


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Adverse events will be summarized by MedDRA (version 22.0) system organ class 
(SOC) and preferred term (PT) in alphabetic order for SOC and PT within a SOC. AEs 
will be graded according to the National Cancer Institute (NCI) Common Toxicity 
Criteria for Adverse Events (CTCAE) version 4.0. Per the request of the clinical team, 
various Preferred Terms were combined and will be reported together as one term. The 
combined terms are listed in Appendix 2. Of note, tables that summarize AEs by SOC 
and PT and fatal AEs will use MedDRA preferred terms. All other AE tables will 
summarize AEs by the combined terms in Appendix 2.
Only SAEs occurring prior to leukapheresis for screened subjects will be reported for the 
pre-leukapheresis period. 
AEs with partial start or end dates will be imputed as described in Section 4.
An overview summary table of Period 1 (ITT) and Period 2 (mITT) AEs will be 
presented by Cohort and overall, including the number and proportion of subjects 
reporting an AE for the following categories:

Subjects reporting at least one AE

Subjects reporting at least one treatment-related AE

Subjects with ≥Grade 3 AE

Subjects with ≥Grade 3 related AEs

Subjects with ≥Grade 3 SAE

Subjects with ≥Grade 3 related SAEs

Subjects reporting at least one SAE

Subjects reporting at least one treatment-related SAE

Subjects with SAEs with fatal outcome
For subjects who have a second T cell infusion, an overview summary table of post-
lymphodepletion AEs associated with the second infusion will be presented, including the 
number and proportion of subjects reporting an AE for the following categories: 

Subjects reporting at least one AE

Subjects reporting at least one treatment-related AE

Subjects reporting at least one SAE

Subjects reporting at least one treatment-related SAE

Subjects with SAEs with fatal outcome
The second infusion AE summaries will be summarized across cohorts.
13.2.1.
Adverse Events
The number and proportion of subjects by Cohort and overall with the following 
categories of AEs will be summarized in tables by system organ class and preferred term
for Period 1 (ITT and mITT) and Period 2 (mITT):

Any AE

Any AE by toxicity grade

Any AE by relationship to study treatment 


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
Any AE ≥ Grade 3 

Any treatment-related AE ≥ Grade 3 

Any SAE ≥ Grade 3 SAE

Any treatment-related SAE ≥ Grade 3 

Any SAE 

Any treatment-related SAE 

Any SAE with fatal outcome AEs by descending order of PTs (ordered by overall 
incidence)

SAEs by descending order of PTs (ordered by overall incidence)
In addition, the following summaries will be provided for the pre-leukapheresis period 
(all screened subjects):

Any SAE 

Any SAE with fatal outcome 

Any SAE ≥Grade 3 
The number and percentage of subjects who experienced at least one AE will be 
summarized overall and for each SOC and each PT. The proportion will be based on the 
number of subjects in the relevant population by Cohort and overall. Each subject will 
contribute at most one count per summarization category. In other words, if a subject has 
more than one AE with the same PT, the subject will be counted only once for that PT. 
Similarly, if a subject has more than one AE for a SOC, the subject will be counted only 
once in that SOC, listing out all the PTs. 
AE toxicity grade will be classified using NCI CTCAE version 4 criteria into 5 
categories: Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life 
threatening and Grade 5 = fatal. If a subject has multiple occurrences of the same SOC or 
PT, then only the most severe event will be summarized in the tables for that SOC and 
PT. AEs of grade 3 or higher will also be summarized. A missing toxicity grade will not 
be imputed.
The relationship of the AE to T cell infusion will be classified into 5 categories: 
definitely related, probably related, possibly related, unlikely (Cohort 1 only), and not 
related. AEs will be summarized in the tables as ‘related’ or ‘not related’ and listings will 
display all categories. Treatment-related AEs include definitely related, probably related, 
unlikely, and possibly related. If a subject has multiple occurrences of the same SOC or 
PT, only the most related event will be summarized in the tables for that SOC and PT. 
For subjects who have a second T cell infusion, the number and proportion of subjects 
with the following categories of AEs will be summarized in tables by system organ class 
and preferred term for AEs associated with the second infusion for the post-
lymphodepletion period.

Any AE

Any AE by toxicity grade

Any AE by relationship to study treatment 


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
Any SAE 
No formal hypothesis-testing analysis of AE incidence rates will be performed. All 
reported AEs will be listed in data listings, with a separate listing for AEs associated with 
a second T cell infusion. By-subject listings also will be provided for all subjects for the 
following: all AEs, serious AEs, and AEs with intensity grade 3 or above; the listings will 
identify which AEs are associated with the first T cell infusion and which are associated 
with the second T cell infusion. In addition, deaths and cause of death will be presented 
in a data listing.
13.3.
Adverse Events of Special Interest (AESI)
An adverse event of special interest is a grouping of adverse events that are of scientific 
and medical concern specific to NY-ESO-1c259T cell infusion. As changes to the MeDRA 
dictionary may occur between the time of the start of the study and the time of the final 
reporting, the list of terms to be used for each event of interested will be based on the 
latest listing provided by safety team.
Summaries of the number and percentage of subjects with these events will be provided 
for each type of events separately. The summary of event characteristics will also be 
provided, including number of subjects with any event, number of events, number of 
subjects with any event that is serious, the outcome of the event, maximum grade. The 
worst-case approach will be applied at subject level for the event outcome, maximum 
graded, i.e. a subject will only be conted once as the worst case from all the events that 
subject had. In addition, onset and duration of the first/last occurences for each type of 
events will be summarized. AE preferred terms will be ‘collapsed’ (refer to Appendix 3
for the specific rules) when reporting the onset and duration. Of note, if the AE start date 
is before the lymphodepletion date and the end date is on or after the lymphodepletion 
date then the start date for calculating the onset of the AE is still the start date of the AE 
but the start date for calculating the duration of the AE is the lymphodepletion start date.
Additionally, by-subject listings for subjects experiencing AESIs of CRS, GVHD, GBS, 
Encephalopathy syndrome and Recurrent pancytopenia with bone marrow 
failure/Aplastic anemia will be provided (MEdDRA preferred terms are listed in 
Appendix 2). The time course of CRS and Recurrent pancytopenia with bone marrow 
failure/Aplastic anemia indicating the severity will be graphically displayed.
Boxplots of select cytokines may also be provided for subjects with and without CRS. A 
timeline plot of CRS indicating the severity of CRS will be created. 
13.4.
Laboratory Tests
13.4.1.
Clinical Laboratory Tests
Quantitative clinical laboratory results for hematology and clinical chemistry will be 
summarized at baseline (as defined in Table 1), each scheduled post-baseline visit, and 
change from baseline to each scheduled visit using descriptive statistics (number of 
subjects, mean, median, standard deviation, and minimum and maximum values) for each 
Cohort and overall. Refer to Appendix 1 for a list of safety laboratory tests by category.


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Laboratory data will be summarized for the post-lymphodepletion period (mITT 
population).
Shift tables that present changes from baseline to worst post-baseline values relative to 
NCI CTCAE version 4 classification ranges will be produced for each Cohort and overall 
for laboratory parameters with quantitative CTCAE criteria
The number and percentage of subjects with potentially clinically significant post-
baseline elevations in hepatic parameters (Table 5) will be summarized by Cohort and 
overall.
A listing of the subjects with clinically significant post-baseline hepatic elevations will be 
provided. The listing will contain all of a subject’s values for parameters meeting the 
criteria.
Table 5
Potentially Clinically Significant Elevations in Hepatic 
Parameters
Parameter*
Criterion
ALT, AST and Total Bilirubin Elevations
≥3 xULN AST and/or ALT and ≥2 xULN total BIL
≥3 xULN AST and/or ALT and ≥1.5 xULN total BIL
ALT Elevations
≥20 xULN
≥10 xULN
≥5 xULN
≥3 xULN
Total Bilirubin Elevations
>2 xULN
>1.5 xULN
  *ALT = Alanine aminotransferase, ALK = Alkaline Phosphatase, AST = Aspartate aminotransferase, BIL = Total 
bilirubin, ULN = upper limit of normal. 
All laboratory parameters will be included in data listings, and values outside of the 
reference range will be flagged as high or low on the listings.
13.4.2.
Persistence of NY-ESO-1 c259T and Replication Competent 
Lentivirus (RCL)
Persistence of gene-modified cells is an indicator of exposure and expansion of T cell 
therapy. Persistence will be monitored in peripheral blood mononuclear cell (PBMC) 
samples using a PCR-based method for the presence of the specific WPRE or Psi 
sequences, which are part of the lentiviral vector used to transduce the T cells. Note,  
vector with WPRE sequence utilized for subjects dosed before 12-Dec-2016 with 
exception of Subject
, who was dosed with Psi vector. 
Persistence data is reported from the analysis vendor as:

Copies/well

Copies/ug DNA

Copies/cell
PPD


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27
Copies/ug DNA and copies/cell are calculated by analysis vendor as follows:

copies/µg DNA=copies per well/µg DNA per well

copies/cell=(copies/µg)x(0.0000063 µg DNA/cell)
In addition, the following calculations will be performed, where Psi is the persistence 
result from the eCRF:
Cell Persistence = Absolute peripheral gene-marked cell number / µL = (Psi result 
number / 151515) x (lymphocyte count + monocyte count) x 1000
Percent of gene marked cells per total lymphocyte compartment = 
((Absolute peripheral gene marked cell number / µL) / (Lymphocyte count x 1000)) x 
100
OF note, for the data directly from vendor post GSK-Adaptimmune transition, the 
following calculation will be performed: Cell persistence=Absolute peripheral gene-
marked cell number/μL= copies/cell × (lymphocyte count + monocyte count) × 1000, 
where copies/cell is reported by analysis vendor.
For persistence value below LLOQ, the following rules will be applied:
Reported Copies 
per cell Result
Reported Copies per 
ug DNA Result
Reported Result
Set Value for 
Copies per cell
Set Value for 
Copies per ug 
DNA
<0.0003
<50.0
Negative
0
0
<0.0003
<50.0
Detectable, <LLOQ 0.0003
50
Note, sometimes values for copies per cell and copies per ug DNA might be different 
than above as it depends on the input of DNA, but rule would be the same:

If interpretive reported result is negative, set values at 0.

If interpretive reported result is “Detectable, <LLOQ”, set values at LLOQ 
(If <XXX, set at XXX)
Spider plots of persistence (copies/ug DNA) will be used to graphically summarize 
persistence over time for each subject by responders and non-responders.  Maximum 
persistence during the study and time to maximum persistence will be summarized 
overall and for responders and non-responders using descriptive statistics and boxplots. 
A listing of persistence will be provided and will include coefficient of variation, number 
of positive replicates, copies/DNA,  interpretive result, duration of detectible persistence 
and time to loss of 25%/50%/75% peak persistence.
Duration of detectable persistence is defined as time from T-cell infusion until 
persistence is no longer detectable. Persistence above the assay limit of detection but 
below the lower limit of quantitation is considered for the duration determination, i.e. the 
time window from infusion until the first instance persistence falls below the detection 
limit and the interpretive reported result is “Negative.” If persistence for a given subject 


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remains detectable at their last sample collection timepoint, the last observed time is 
reported and considered as right-censored with a “+” appended to the numerical result. 
Note, transduced T-cells frequently persist beyond the follow-up period, and hence, the 
reported duration is directly influenced by length of time the patient is on-study.
Time to loss of 25% of peak persistence will be calculated as the time since T-cell 
infusion corresponding to observing at least 25% loss of peak persistence. If time to 25% 
loss of peak persistence is not observed, the last observed time will be reported with a 
“+”. The same procedure will be followed for 50% and 75%.
The proportion of subjects who are RCL positive will be summarized for the mITT 
population. RCL is reported as “Negative” if copies of VSV-G are <50 copies/ugDNA
RCL and persistence results (raw and derived) will be presented by Cohort and subject in 
a data listing. 
13.4.3.
Cytokines
Boxplots of the maximum post-baseline value for select cytokines including IFN gamma 
IL6, IL8, IL12, IL13, and TNF alpha will be provided for subjects with none or non-
serious CRS vs. serious CRS for the mITT population and for responders vs. non-
responders. One spider plot and boxplot will be presented per cytokine. 
Cytokine results will be presented by subject in a data listing. Subjects with an adverse 
event of cytokine release symptom (CRS) will be flagged in the listing. If the reported 
result is “Fail QC” or “CV>25%”, then the value will be set to missing. For values 
deemed < lower limit of quantitation, a value of the laboratory specified lower limit of 
quantitation divided by 3 will be used. Laboratory specified upper limit of quantitation
values will be used for values > upper limit of quantitation. If there are multiple baseline 
values, the earliest value will be used as baseline.
The missing data rules for cytokines are as follows:
Reported Result
                     Set Value
Fail QC
Missing
CV>25%
Missing
<LLOQ (ex. <0.25)
LLOQ/3 (ex: 0.0833 calculated from 0.25/3)
13.5.
Vital Signs
A listing of the subjects with potentially clinically significant post-baseline vital signs 
will be provided. The listing will contain all of a subject’s values for parameters meeting 
the criteria (Table 6).


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Table 6
Potentially Clinically Significant Vital Signs Values
Parameter
Criterion
Heart Rate
< 60 bpm
  > 100 bmp
Systolic blood pressure
≥ 140 mmHg
Diastolic
≥ 90 mmHg
Vital signs will be presented by Cohort and subject in a data listing.
13.6.
Physical Exams
Physical exam results will be presented by Cohort and subject in a data listing.
13.7.
Electrocardiograms
All ECG, ECHO, MUGA results will be presented by Cohort and subject in data listings.
13.8.
Eastern Cooperative Oncology Group (ECOG) Performance 
Status
ECOG performance status results will be summarized by Cohort and overall at baseline, 
each scheduled post-baseline visit with counts and proportion of subjects with each score
for the mITT population. For subjects less than 10 years of age, Lansky scores will be 
listed instead of ECOG. 
If there are multiple assessments on the same visit the worst ECOG status will be used.
13.9.
Concomitant Medications
Concomitant medications will be summarized by the WHO Drug Dictionary Anatomical 
Therapeutic Chemical 3rd level (ATC-3) and preferred name by Cohort and overall for 
the mITT population. If the 3rd level term is not available, the next available level (e.g.,
ATC-2) will be used.  
The number and proportion of the subjects who took each medication will be tabulated by 
the ATC-3 level and preferred name for concomitant medications. A subject will only be 
counted once within each ATC-3 code and within each preferred name.
All concomitant medication data will be listed by subject.


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14.
QUALITY CONTROL
All data displays and analyses will adhere to the International Conference on 
Harmonisation (ICH) Harmonized Tripartite Guideline: Structure and Content of 
Clinical Study Reports (ICH Topic E3).
GSK will review all tables, listings, and figures prior to final database lock. Final SAS 
datasets, programs and outputs will be transferred to GSK at project completion.
15.
TABLES AND LISTINGS CONVENTIONS
Mock-ups for statistical tables and listings will be provided. Final formats for the 
statistical tables and listings may deviate from these mock-ups upon agreement with 
GSK.. Footnotes will be used as needed to clarify the information that is presented in the 
tables and listings. Unless otherwise requested by GSK the term ‘subject’ will be used in 
all tables and listings, in accordance with CDISC standards.
The general layout of tables and listings will be as follows:
All tables and listings will use landscape orientation. Margins will be at least 2.0 cm at 
the top and bottom and at least 0.8 cm on the left and right, excluding headers and 
GlaxoSmithKline
Page x of y
Protocol: GSK208466/ADP-04511 
Run Date: DDMMMYY-HH:MM
<Population>
Listing 16.2_x (or Table 14.x_x)
<Title>
___________________________________________________________________________________________________
 
Col 1
Col 2
Col 3
etc
___________________________________________________________________________________________________
<Any footnotes>
File Name:   <pathname for SAS program>


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31
footers, in accordance with electronic Common Technical Document (eCTD) guidelines. 
Font will be Courier New, unless otherwise specified, with an 8-point font size in most 
cases. Page numbering will be sequential within each table, listing, and figure. Column 
headers should be in initial capital letters. Units for numeric data will be included when 
appropriate.
Tables and data listings will be created from different SAS programs. A single program 
may produce multiple tables or multiple data listings from the same dataset (e.g., all 
clinical chemistry data listings may be generated by a single program).
Statistical Table Conventions
Mock-ups for statistical tables will include headers, title numbers, titles, column headers 
and footers, and a proposed layout for the display of data. The final decision on the 
precision (i.e., number of decimal places) for presentation of descriptive statistics will be 
made by GSK after review of draft statistical tables and before database freeze.  
Data Listing Conventions
Mock-ups for data listings will include headers, title numbers, titles, column headers, and 
footers. Data listings will provide all data collected on the corresponding eCRF page or 
provided by external vendors, unless otherwise indicated. If there are too many fields to 
be fit into a single page, data should be grouped logically and the listings will be 
generated as Part I, Part II, etc.
In general, data listings should include all subjects with data. However, if only subjects 
who meet a certain condition are listed (e.g., subjects with SAEs) and no subjects meet 
the condition, the data listing will so indicate.
The sort order for data presented in data listings will be Cohort and subject ID, unless 
otherwise requested by Updated... Within a subject, data will be listed in chronological 
order. Whenever possible, formatted values will be displayed (i.e., decoded). Where 
applicable, calendar date and study day of evaluations/events will be provided in the data 
listings.


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16.
REFERENCES
Eisenhauer EA, et al. New response evaluation criteria in solid tumors: Revised RECIST 
guideline (version 1.1) 2009; Eur J Ca 45:228-247.
Wolchok JD, Hoos A, O'Day S, Weber JS, Hamid O, Lebbé C et al. Guidelines for the 
Evaluation of Immune Therapy Activity in Solid Tumors: Immune-Related Response Criteria 
Clin Cancer Res 2009;15:7412-7420.


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17.
PRELIMINARY LIST OF TABLES, LISTINGS, AND 
FIGURES TO BE PROGRAMMED
17.1.
Statistical Tables
Table Number 
Table Title 
Analysis 
Population 
6.1001
Subject Enrollment and Disposition
ITT
6.2001
Demographic and Baseline Characteristics
ITT
6.2002
Demographic and Baseline Characteristics
mITT
6.3001
Summary of Medical History
ITT  
6.4001
Summary of Prior Cancer Therapy
ITT
6.4002
Summary of Prior Cancer Therapy
mITT
7.1001
Summary of Overall Response Rate and Best 
Overall Response for the First Infusion
mITT
7.1002
Summary of Overall Response Rate and Best 
Overall Response for the Second Infusion
Subjects with a 
Second T Cell 
Infusion
7.2001
Time in Study, Time to Response, Duration of 
Response, and Kaplan-Meier Estimate of 
Duration of Stable Disease
mITT
7.2002
Kaplan-Meier Estimate of Progression-Free 
Survival and Overall Survival
mITT
7.2101
Sensitivity Analyses for Best Overall Response
for the First Infusion
mITT
7.2103
Sensitivity Analyses for Progression-Free 
Survival
mITT
8.0001
Summary of Lymphodepleting Chemotherapy 
Administration for the First Infusion
mITT
8.0002
Summary of the First T Cell Infusion 
mITT 
8.0003
Summary of the Second T Cell Infusion
Subjects with a 
Second T Cell 
Infusion
8.1001
Overall Summary of Adverse Events for Period 
1
ITT
8.1003
Overall Summary of Adverse Events for Period 
2
mITT
8.1101
Incidence of Adverse Events by System Organ 
Class and Preferred Term for Period 1
ITT
8.1103
Incidence of Adverse Events by System Organ 
Class and Preferred Term for Period 2
mITT
8.1104
Summary of Adverse Events Grouped by 
Similarity of Preferred Terms for Period 1
ITT
8.1106
Summary of Adverse Events Grouped by 
Similarity of Preferred Terms for Period 2
mITT


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208466/ADP-04511
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Table Number 
Table Title 
Analysis 
Population 
8.1201
Incidence of Adverse Events by Toxicity Grade  
and Preferred Term for Period 1
ITT
8.1203
Incidence of Adverse Events by Toxicity Grade  
and Preferred Term for Period 2
mITT
8.1204
Incidence of Treatment Related Adverse Events 
by Toxicity Grade and Preferred Term for 
Period 2
mITT
8.1205
Incidence of Treatment Related Adverse Events 
by System Organ Class and Preferred Term for 
Period 1
mITT
8.1206
Incidence of Treatment Related Adverse Events 
by System Organ Class and Preferred Term for 
Period 2
mITT
8.1301
Incidence of Adverse Events with Toxicity 
Grade >=3  by System Organ Class and 
Preferred Term for Period 1
ITT
8.1303
Incidence of Adverse Events with Toxicity 
Grade >=3 by System Organ Class and 
Preferred Term for Period 2
mITT
8.1305
Incidence of Treatment Related Adverse Events 
with Toxicity Grade >=3 by System Organ 
Class and Preferred Term for Period 1
mITT
8.1306
Incidence of Treatment Related Adverse 
Eventswith Toxicity Grade >=3 by System 
Organ Class and Preferred Term for Period 2
mITT
8.1401
Incidence of Serious Adverse Events by System 
Organ Class and Preferred Term for the Pre-
leukapheresis Period
ITT
8.1402
Incidence of Serious Adverse Events by System 
Organ Class and Preferred Term for Period 1
ITT 
8.1404
Incidence of Serious Adverse Events by System 
Organ Class and Preferred Term for Period 2
mITT
8.1502
Incidence of Treatment Related Serious 
Adverse Events by System Organ Class and 
Preferred Term for Period 1
mITT 
8.1503
Incidence of Treatment Related Serious 
Adverse Events by System Organ Class and 
Preferred Term for Period 2
mITT 
8.1504
Incidence of Serious Adverse Events by 
Toxicity Grade and Preferred Term for Period 1
ITT
8.1505
Incidence of Serious Adverse Events by 
Toxicity Grade and Preferred Term for Period 2
mITT
8.1506
Incidence of Treatment Related Serious 
Adverse Events by Toxicity Grade and 
mITT


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208466/ADP-04511
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Table Number 
Table Title 
Analysis 
Population 
Preferred Term for Period 2
8.1601
Incidence of Serious Adverse Events with 
Toxicity Grade >=3 by System Organ Class and 
Preferred Term for the Pre-leukapheresis Period
ITT
8.1602
Incidence of Serious Adverse Events with 
Toxicity Grade >=3 by System Organ Class and 
Preferred Term for Period 1
ITT
8.1604
Incidence of Serious Adverse Events with 
Toxicity Grade >=3 by System Organ Class and 
Preferred Term for Period 2
mITT 
8.1606
Incidence of Treatment Related Serious 
Adverse Events with Toxicity Grade >=3 by 
System Organ Class and Preferred Term for the 
Period 1
mITT 
8.1607
Incidence of Treatment Related Serious 
Adverse Events with Toxicity Grade >=3 by 
System Organ Class and Preferred Term for the 
Period 2
mITT 
8.1608
Incidence of Serious Adverse Events Resulting 
in Death by System Organ Class and Preferred 
Term for the Pre-leukapheresis Period
ITT
8.2101
Incidence of Serious Adverse Events Resulting 
in Death by System Organ Class and Preferred 
Term for Period 1
ITT
8.2103
Incidence of Serious Adverse Events Resulting 
in Death by System Organ Class and Preferred 
Term for Period 2
mITT
8.3001
Overall Summary of Adverse Events for the 
Post-lymphodepletion Period for the Second T 
Cell Infusion
Subjects with a 
Second T Cell 
Infusion
8.3002
Incidence of Adverse Events by System Organ 
Class and Preferred Term for the Post-
lymphodepletion Period for the Second T Cell 
Infusion
Subjects with a 
Second T Cell 
Infusion
8.3003
Incidence of Adverse Events by Toxicity Grade  
and Preferred Term for the Post-
lymphodepletion Period for the Second T-Cell 
Infusion
Subjects with a 
Second T-Cell 
Infusion
8.3004
Incidence of Treatment Related Adverse Events 
by System Organ Class and Preferred Term for 
the Post- lymphodepletion Period for the 
Second T-Cell Infusion
Subjects with a 
Second T-Cell 
Infusion
8.3005
Incidence of Serious Adverse Events by System 
Organ Class and Preferred Term for the Post-
Subjects with a 
Second T-Cell 


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208466/ADP-04511
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Table Number 
Table Title 
Analysis 
Population 
lymphodepletion Period for the Second T-Cell 
Infusion
Infusion
8.3006
Incidence of Treatment Related Adverse Events 
by Toxicity Grade and Preferred Term for the 
Post- lymphodepletion Period for the Second T-
Cell Infusion
Subjects with a 
Second T-Cell 
Infusion
8.3007
Incidence of Serious Adverse Events by 
Toxicity Grade and Preferred Term for the 
Post- lymphodepletion Period for the Second T-
Cell Infusion
Subjects with a 
Second T-Cell 
Infusion
8.3008
Incidence of Treatment Related Serious 
Adverse Events by Toxicity Grade and 
Preferred Term for the Post- lymphodepletion 
Period for the Second T-Cell Infusion
Subjects with a 
Second T-Cell 
Infusion
8.3101
Summary of Adverse Events of Special Interest 
by Cohort (All Infusions)
mITT
8.3102
Summary of Adverse Events of Special Interest 
for the First Infusion 
mITT
8.3103
Summary of Adverse Events of Special Interest 
by Cohort for the Second Infusion 
Subjects with a 
Second T-Cell 
Infusion
8.3104
Summary of Characteristics of Guillain-Barre 
Syndrome (All Infusions)
mITT
8.3105
Summary of Characteristics of Graft versus 
Host Disease (All Infusions)
mITT
8.3106
Summary of Characteristics of Cytokine 
Release Syndrome (All Infusions)
mITT
8.3107
Summary of Characteristics of Recurrent 
Pancytopenia/Aplastic Anaemia (All Infusions)
mITT
8.3108
Summary of Characteristics of Encephalopathy 
(All Infusions)
mITT
8.3109
Summary of Characterisics of Guillain-Barre 
Syndrome (Second Infusion)
Subjects with a 
Second T-Cell 
Infusion
8.3110
Summary of Characteristics of Graft versus 
Host Disease (Second Infusion)
Subjects with a 
Second T-Cell 
Infusion
8.3111
Summary of Characteristics of Cytokine 
Release Syndrome (Second Infusion)
Subjects with a 
Second T-Cell 
Infusion
8.3112
Summary of Characteristics of Recurrent 
Pancytopenia/Aplastic Anaemia (Second 
Infusion)
Subjects with a 
Second T-Cell 
Infusion
8.3113
Summary of Characteristics of Encephalopathy 
Subjects with a 


CONFIDENTIAL
208466/ADP-04511
37
Table Number 
Table Title 
Analysis 
Population 
(Second Infusion)
Second T-Cell 
Infusion
8.3114
Summary of Onset and Duration of the First 
Occurrence of Guillain-Barre Syndrome
mITT
8.3115
Summary of Onset and Duration of the First 
Occurrence of Graft versus Host Disease
mITT
8.3116
Summary of Onset and Duration of the First 
Occurrence of Cytokine Release Syndrome
mITT
8.3117
Summary of Onset and Duration of the First 
Occurrence of Recurrent Pancytopenia/Aplastic 
Anaemia
mITT
8.3118
Summary of Onset and Duration of the Last 
Occurrence of Encephalopathy
mITT
8.3119
Summary of Onset and Duration of the Last 
Occurrence of Guillain-Barre Syndrome
mITT
8.3120
Summary of Onset and Duration of the Last 
Occurrence of Graft versus Host Disease
mITT
8.3121
Summary of Onset and Duration of the Last 
Occurrence of Cytokine Release Syndrome
mITT
8.3122
Summary of Onset and Duration of the Last 
Occurrence of Recurrent Pancytopenia/Aplastic 
Anaemia
mITT
8.3123
Summary of Onset and Duration of the Last 
Occurrence of Encephalopathy
mITT
8.3124
Summary of Adverse Events of Special Interest 
by Cohort (Comprehensive List - All Infusions)
mITT
8.3125
Summary of Adverse Events of Special Interest 
for the First Infusion (Comprehensive List)
mITT
8.3126
Summary of Adverse Events of Special Interest 
by Cohort for the Second Infusion 
(Comprehensive List)
Subjects with a 
Second T-Cell 
Infusion
8.3127
Summary of Characteristics of Haematopoietic 
Cytopenias (Comprehensive List-All Infusions)
mITT
8.3128
Summary of Characteristics of Haematopoietic 
Cytopenias (Comprehensive List-Second 
Infusion)
Subjects with a 
Second T-Cell 
Infusion
8.3129
Summary of Onset and Duration of the First 
Occurrence of Haematopoietic Cytopenias 
(Comprehensive List)
mITT
8.3201
Time to Resolution of Grade >= 3 
Haematopoietic Cytopenias (Comprehensive 
List)
mITT
8.3202
Time to Resolution of Grade >=3 Recurrent 
Pancytopenia/Aplastic Anaemia
mITT


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208466/ADP-04511
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Table Number 
Table Title 
Analysis 
Population 
8.3203
Time to Resolution of Grade >=3 Graft versus 
Host Disease
mITT
8.3204
Time to Resolution of Grade >=3 Cytokine 
Release Syndrome
mITT
8.4101
Change from Baseline to Each Scheduled Visit 
for Hematology Parameters for the Post-
lymphodepletion Period
mITT
8.4102
Change from Baseline to Each Scheduled Visit 
for Chemistry Parameters for the Post-
lymphodepletion Period
mITT
8.4201
Shifts from Baseline to Worst Post-Baseline 
NCI-CTCAE Grade for Hematology 
Parameters for the Post-lymphodepletion 
Period
mITT
8.4202
Shifts from Baseline to Worst Post-Baseline 
NCI-CTCAE Grade for Chemistry Parameters 
for the Post-lymphodepletion Period
mITT 
8.4301
Number and Proportion of Subjects with 
Potentially Clinically Significant Hepatic Post-
Baseline Results for the Post-lymphodepletion 
Period
mITT
8.5001
Maximum Persistence and Time to Maximum 
Persistence for Responders, Non-responders, 
and Overall
mITT
8.5002
Number and Proportion of RCL Positive 
Subjects
mITT
8.5003
Number and Percentage of Subjects with 
Potentially Clinically Significant Post-Baseline 
Vital Signs Results
mITT
8.6101
Summary of ECOG Performance Status at Each 
Visit 
mITT 
17.2.
Data Listings
Number 
Title 
26.0001
Subject Disposition
26.0002
Study Visits
Protocol Deviations 
26.1401
Inclusion and Exclusion Criteria Not Met Prior to Leukapheresis
26.1403
Protocol Deviations


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208466/ADP-04511
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Number 
Title 
Demographic Data 
26.1101
Demographics and Baseline Characteristics
26.3101
Medical History 
26.3102
HLA and NY-ESO Antigen
26.2101
Disease Characteristics
26.4001
Prior Cancer Surgery
26.4002
Prior Oncology Treatment
Study Drug Administration 
28.0001
Dates of Leukapheresis, Lymphodepleting Chemotherapy, and T-
Cell Infusion  
28.0002
Lymphodepleting Chemotherapy
28.0003
T Cell Infusion
Individual Efficacy Response Data 
27.0001
Lesion Measurements and Assessments by RECIST 1.1
27.0003
Response Assessments and Overall Response by RECIST v1.1 for
the First Infusion
27.0004
Response Assessments and Overall Response by RECIST v1.1 
Following a Second T Cell Infusion
27.0005
Investigator RECIST v1.1 Response Assessments and Overall 
Response for the First Infusion
27.00051
Investigator RECIST v1.1 Response Assessments and Overall 
Response Following a Second T Cell Infusion
27.0007
Progression-Free Survival and Overall Survival
27.0008
Time to Confirmed Response, Duration of Response, and Duration 
of Stable Disease, and Best Overall Response
Adverse Event Listings 
28.1001 
Adverse Events for First T-Cell Infusion  
28.1002
Adverse Events for Second T-Cell Infusion
28.1003
Adverse Events with CTCAE Grade 3 or Higher
28.2001
Serious Adverse Events 
28.3001
Cytokine Release Syndrome (CRS)
28.3002
Graft Versus Host Disease (GVHD)
28.3003
Recurrent pancytopenia with bone marrow failure/Aplastic anemia
28.3004
Guillain-Barre syndrome
28.3005
Encephalopathy syndrome
Listings of Individual Laboratory Measurements 
28.3101
Hematology Evaluations - Part 1
28.3111
Hematology Evaluations - Part 2


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208466/ADP-04511
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Number 
Title 
28.3121
Hematology Evaluations - Part 3
28.3131
Clinically Significant Hematology Findings
28.3132
Listing of Subjects with Potentially Clinically Significant Hepatic 
Post-Baseline Results the Post-lymphodepletion Period
28.3201 
Clinical Chemistry Evaluations - Part 1
28.3211
Clinical Chemistry Evaluations – Part 2
28.3221 
Clinical Chemistry Evaluations – Part 3
28.3231
Clinically Significant Clinical Chemistry Findings
28.3301
Urinalysis Evaluations – Part 1
28.3311
Urinalysis Evaluations – Part 2
28.3321
Urinalysis Evaluations – Part 3
28.3331
Clinically Significant Urinalysis Findings
28.3341
Additional Laboratory Assessments
28.3342
Clinically Significant Additional Laboratory Findings
28.3343
Renal Function Findings
28.4001
Replication Competent Lentivirus (RCL)
28.4002
Persistence
28.4101
Cytokines – Part 1
28.4102
Cytokines – Part2
28.4201
Biopsy – Tumor Antigen Results
28.4301
Flow Cytometry
28.5001
Pregnancy Test Results
28.5101
Vital Signs
28.5102
Listing of Subjects with Potentially Clinically Significant Post-
Baseline Vital Signs Results
28.5201
ECOG Performance Status, Karnofsky Score, and Lansky Score
28.6101
Electrocardiogram
28.6201
Physical Examination 
28.6301
Concomitant Medications
28.6401
Bridging Therapies
28.6402
On-study Surgery
28.6403
On-study Oncology Treatment
28.6404
Echocardiogram or Multigated Acquisition Scan (MUGA)
28.6502
EBV and Anti-CMV Status
28.6503
Infectious Disease Testing


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208466/ADP-04511
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17.3.
Figures
Number
Figure Title 
Analysis 
Population 
17.0001
Maximal Reduction in Sum of Diameters of Target Lesions 
from Baseline through Progression or Prior to Subsequent 
Anti-Cancer Therapy for the First Infusion
mITT
17.0002
Maximal Reduction in Sum of Diameters of Target Lesions 
from the Second Infusion through Progression or Subsequent 
Anti-Cancer Therapy
mITT
17.1001
Kaplan-Meier Plot of Progression-Free Survival
mITT
17.1002
Kaplan-Meier Plot of Overall Survival
mITT
17.2001
Response Characteristics via RECIST 1.1 and Follow-up
mITT
17.3001
Boxplots for Peak Expansion by Responders vs. Non-
Responders for the First Infusion
mITT
17.4001
Spider Plots for Persistence Results over Time (Truncated at 
60 Days) for Responders vs. Non-Responders for the First 
Infusion
mITT
17.4002
Spider Plots for Persistence Results over Time (Truncated at 
100 Days) by Responders vs. Non-Responders for the First 
Infusion 
mITT
17.4003
Spider Plots for Persistence Results over Time by 
Responders vs. Non-Responders for the First Infusion 
mITT
17.4004
Spider Plots of Change from Baseline in Target Lesion 
through Progression and Prior to Subsequent Anti-Cancer 
Therapy Over Time by Response Status for the First Infusion
mITT
17.4005
Spider Plots for Persistence Results over Time (Truncated at 
60 Days) by Responders vs. Non-Responders for the Second 
Infusion
mITT
17.4006
Spider Plots for Persistence Results over Time (Truncated at 
100 Days) by Responders vs. Non-Responders for the 
Second Infusion
mITT
17.4007
Spider Plots for Persistence Results over Time by 
Responders vs. Non-Responders for the Second Infusion
mITT
17.4008
Spider Plots of Change from Baseline in Target Lesion 
through Progression and Prior to Subsequent Anti-Cancer 
Therapy Over Time by Response Status for the Second 
Infusion
mITT
18.5003
Characteristics of CRS Plot for the First Infusion
mITT
18.5004
Characteristics of CRS Plot for the Second Infusion
Subjects with 
a Second T-
Cell Infusion
18.5005
Characteristics of Recurrent Pancytopenia with Bone 
Marrow Failure/Aplastic Anemia Plot for the First Infusion
mITT
18.5006
Characteristics of Recurrent Pancytopenia with Bone 
Marrow Failure/Aplastic Anemia Plot for the Second 
Subjects with 
a Second T-


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208466/ADP-04511
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Number
Figure Title 
Analysis 
Population 
Infusion
Cell Infusion
18.5101
Profile of INF-Gamma by CRS Status and Subject (First 
Infusion)
mITT
18.5102
Profile of IL-6 by CRS Status and Subject (First Infusion)
mITT
18.5103
Profile of IL-8 by CRS Status and Subject (First Infusion)
mITT
18.5104
Profile of IL-12 by CRS Status and Subject (First Infusion)
mITT
18.5105
Profile of IL-13 by CRS Status and Subject (First Infusion)
mITT
18.5106
Profile of TNF-Alpha by CRS Status and Subject (First 
Infusion)
mITT
18.5107
Profile of INF-Gamma by Response and Subject (First 
Infusion)
mITT
18.5108
Profile of IL-6 by Response and Subject (First Infusion)
mITT
18.5109
Profile of IL-8 by Response and Subject (First Infusion)
mITT
18.5110
Profile of IL-12 by Response and Subject (First Infusion)
mITT
18.5111
Profile of IL-13 by Response and Subject (First Infusion)
mITT
18.5112
Profile of TNF-Alpha by Response and Subject (First 
Infusion)
mITT
18.5113
Peak Cytokine Expression of INF-Gamma by CRS Status 
(First Infusion)
mITT
18.5114
Peak Cytokine Expression of IL-6 by CRS Status (First 
Infusion)
mITT
18.5115
Peak Cytokine Expression of IL-8 by CRS Status (First 
Infusion)
mITT
18.5116
Peak Cytokine Expression of IL-12 by CRS Status (First 
Infusion)
mITT
18.5117
Peak Cytokine Expression of IL-13 by CRS Status (First 
Infusion)
mITT
18.5118
Peak Cytokine Expression of TNF-Alpha by CRS Status 
(First Infusion)
mITT
18.5119
Peak Cytokine Expression of INF-Gamma by Response 
(First Infusion)
mITT
18.5120
Peak Cytokine Expression of IL-6 by Response (First 
Infusion)
mITT
18.5121
Peak Cytokine Expression of IL-8 by Response (First
Infusion)
mITT
18.5122
Peak Cytokine Expression of IL-12 by Response (First 
Infusion)
mITT
18.5123
Peak Cytokine Expression of IL-13 by Response (First 
Infusion)
mITT
18.5124
Peak Cytokine Expression of TNF-Alpha by Response (First 
Infusion)
mITT


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18.
APPENDICES
18.1.
Appendix 1
Safety Laboratory Tests by Category
Urinalysis

Specific gravity

Urine glucose

Urine protein

Urine biliburin

Urine ketones

Urine blood

PH

Urine leukocytes
Hematology

WBC

RBC

Hemaglobin

Hematocrit

Platelet count

Absolute neturophil count

Absolute lymphocyte count

Absolute monocyte count

Absolute eosinophil count

Reticulocyte count
Chemistry

Creatinine clearance

BUN

Creatinine

Sodium

Potassium

Chloride

CO2

Calcium

Magnesium

Albumin

Total Bilirubin

Alkaline Phosphatase

AST

ALT

LDH

Phosphorus


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
Ferritin

C-reactive protein

Direct Bilirubin

Uric Acid

Amylase

Lipase
Coagulation

PT

PTT
Pregnancy Test

Urine pregnancy test

serum pregnancy test
Additional Lab

TSH

T3

T4


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18.2.
Appendix 2
List of PTs to Be Combined
The following synonyms will be combined under the PT as shown below. The combined 
term will be used when reporting AE data in tables by PT.
Synonymous terms will be combined regardless of body system.
Synonym
MedDRA Preferred terms (System Organ 
Class)
Anaemia/Red blood cell count decreased
Anaemia (Blood and lymphatic system disorders)
Cytokine Release Syndrome (CRS)
Cytokine Release Syndrome (Immune System 
Disorders)
Cytokine Storm (Immune System Disorders)
Acute GVHD – Skin
Acute graft versus host disease in skin
Acute GVHD - Gut (Liver and Intestine)
Acute graft versus host disease in liver
Acute graft versus host disease in intestine
Acute GVHD  - Other (Lung, Bone Marrow, not 
specified)
Acute graft versus host disease
Chronic GVHD -  Skin
Chronic graft versus host disease in skin
Acute GVHD - Gut (Liver and Intestine)
Acute graft versus host disease in liver
Acute graft versus host disease in intestine
Acute GVHD  - Other (Lung, Bone Marrow, not 
specified)
Acute graft versus host disease
Chronic GVHD -  Skin
Chronic graft versus host disease in skin
Chronic GVHD - Gut (Liver and Intestine)
Chronic graft versus host disease in liver


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Synonym
MedDRA Preferred terms (System Organ 
Class)
Chronic graft versus host disease in intestine
Chronic GVHD Other -  (Lung, Bone Marrow, not 
specified)
Chronic graft versus host disease
Unspecified GVHD - Skin
Graft versus host disease in skin
Unspecified GVHD - Gut (Liver and Intestine)
Graft versus host disease in liver
Graft versus host disease in gastrointestinal tract
Unspecified GVHD - Other (Lung, Bone Marrow, 
not specified)
Graft versus host disease
Graft versus host disease in eye
Graft versus host disease in lung
Prophylaxis against graft versus host disease
Transfusion associated graft versus host disease
Engraftment syndrome 
Leukopenia/WBC decreased
White blood cell count decreased (Investigations)
Leukopenia (Blood and lymphatic system 
disorders)
Lymphopenia/Lymphocyte count decreased
Lymphopenia (Investigations)
Lymphocyte count decreased (Investigations)
CD4 lymphocytes decreased (Investigations)
CD8 lymphocytes decreased 
Neutropenia/Neutrophil count decreased
Neutrophil count decreased (Investigations)
Neutropenia (Blood and lymphatic system
disorders)


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Synonym
MedDRA Preferred terms (System Organ 
Class)
Rash/Rash maculo-papular
Rash maculo-papular
Rash
Rash erythematous
Thrombocytopenia/Platelet count decreased
Platelet count decreased (Investigations)
Thrombocytopenia (Blood and lymphatic system 
disorders)
MedDRA Version 22
The AE listing will not combine these PTs but list them out as they are reported.


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18.3.
Appendix 3
Specification for Collapsing Adverse Event 
Segments
This section provides the specification for collapsing the segments of adverse 
events with common preferred term and with either overlapped/or continuous 
start/end dates into unique adverse events (AEs) based on ADAE ADaM SAS 
dataset.
1.
COLLAPSING AE SEGMENTS WITH A COMMON AE PREFERRED 
TERM (PT) INTO UNIQUE EVENTS BASED ON THE START AND END 
DATES 
For each unique subject, the AE records (segments) with the same AE preferred term 
will be collapsed into one unique AE event based on the start and end dates below.
1.1
Multiple AE Segments with Overlapped or Continuous Start/End 
Dates
Multiple AE segments with a common preferred term (PT, 
variable=ADAE.AEDECOD) that occurred around the same time; defined as:
If a segment starts no more than one day (i.e., ≤ 1 day) prior, on, or after 
the previous segment’s end date, it is considered as an ‘event’.  
If the gap between the start date of a segment and the end date of previous 
segment is greater than one complete day (i.e., > 1 day), then consider 
these segments as different events. 
If partial start or end dates for any AE segments, then consider these 
segments as separate events.
*** NOTE: Handling of partial dates or completely missing dates
Partial dates or completely missing dates will not be imputed. 
The reason for not using imputed dates is due to the small number of partial / or 
completely missing dates.  Furthermore, using imputed dates might create 
additional error of up to 30 days off for the AE start or AE end dates, and can be 
up to 60 days off for the duration of AE.
1.2
Sort Adverse Events (AE) 
For any AE event identified above:
o
Sort the AEs segments by study ID (ADAE.STUDYID), unique subject ID 
(ADAE.USUBJID), AE preferred term (ADAE.AEDECOD), AE start 
date (ADAE.AESTDTC), and AE end date (ADAE.AEENDTC). The 


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sorting will include all AE segments with complete or partial start / end 
dates.
1.3
Create Derived Variables in ADAE ADaM SAS Dataset
Based on the ADAE dataset sorted above under Section 1.2, for each unique 
subject, create the following derived variables in the ADAE ADaM SAS data set:
1) ANL01FL: Flag for the unique AE
a) Collapsed AE Segments
For collapsed AE segments. based on the ADAE data set sorted above 
under Section 1.2: 
o
derive the flag variable: ANL01FL=”Y” on the first record for each 
collapsed AE (i.e. the earliest segment within each collapsed AE 
with the same ADAE.AEDECOD) .
o
Otherwise ANL01FL=”” (Missing).
b) AE Events Comprised of a Single Row (No Collapsing Needed)
o
derive the flag variable: ANL01FL=”Y” for each single segment AE 
event.
2) EVTSEQ: Sequence number of each unique AE with the same PT
Create a sequence number, EVTSEQ, for each unique AE within the same 
ADAE.AEDECOD.
For each unique subject within each unique AE preferred term, this variable 
will be recorded as the sequential number to identify all unique adverse 
events (including both single segment events (i.e., no collapsing needed) 
and collapsed events from multiple segments) based on the sorting order 
chronologically addressed above under Section 1.2. 
a) Collapsed AE Segments
Each collapsed AE and its corresponding composed segments will have 
the same sequence numbers (i.e., if multiple segments/records are 
qualified for being collapsed into one unique AE (i.e, all those records will 
have same value for the derived variable EVTSEQ for that corresponding 
subject within the same collapsed AE).


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b) Single Segment AE Records
Each single segment AE event (i.e., un-collapsed event) will have 
different unique sequence number separately
       c)  AE Segments with partial start or end dates 
Each AE segment with partial start or end dates will have different 
unique   sequence number starting from 99XXX, where 
             XXX=001, 002, ... .
  * NOTE:
     For those subjects who received 2 T-cell infusions, the sequential number 
will be based on both infusion periods combined 
     (i.e., the assigned sequential number will be independent of T-cell infusion 
periods).
-
Example:
Original ADAE Dataset:
SUBJID
ADECODE
APERIOD
ASTDT
AENDT
Cytokine Release 
Syndrome
1
Cytokine Release 
Syndrome
1
Cytokine Release 
Syndrome
1
Cytokine Release 
Syndrome
2
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD


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Derived ADAE Dataset:
3) EVTENDT: End Date for each unique AE 
a) Collapsed AE Segments
o
=ADAE.AENDT (end date) of the last segment of the collapsed 
event (i.e., the segment with the latest ADAE.AENDT within the same 
collapsed AE for each unique subject) 
o
This should be populated on the segment with ANL01FL=’Y’ only 
(i.e., the segment with earliest ADAE.ASTDT of each collapsed 
AE). .
o
Note:
       If any of the segments have missing end date (i.e., unresolved) 
then the derived EVTENDT will be missing, and hence 
       cannot calculate duration of event (please see derived variable: 
EVTDUR under item 4) below).
b) Single Segment AE Records
=ADAE.AENDT (end date) of each single segment event (i.e. un-
collapsed record).
SUBJID
ADECODE
APERIOD
ASTDT
AENDT
ANL01FL
EVTSEQ
Cytokine 
Release 
Syndrome
1
Y
1
Cytokine 
Release 
Syndrome
1
1
Cytokine 
Release 
Syndrome
1
1
Cytokine 
Release 
Syndrome
2
Y
2
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD


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4) EVTDUR: Duration of each unique AE
a) Collapsed AE Segments
o
Where ANL01FL=’Y’ then EVTDUR = AESTDT-EVTENDT+ 1
o
= Missing, if missing end date for the derived variable EVTENDT 
(i.e., AEOUT=unresolved with missing AEENDTC for any of the 
segments within the same collapsed AE)
b) Single Segment AE records
o
EVTDUR = AESTDT-EVTENDT (i.e., = AEENDT) + 1
o
= Missing, if missing end date (i.e., missing AEENDT and hence 
EVTENDT due to AEOUT=unresolved for the corresponding, single 
segment record (i.e., un-collapsed AE record).
2. ADDITIONAL NOTES

For any collapsed AEs and single segment records with missing or partial 
start and/or end dates, 
o
EVTDUR= missing and will be excluded from the calculation for the 
summary statistics of AE duration.

AOCCPFL: Flag for the first occurrence of preferred term 
o
This variable is a GSK standard variable in the ADAE ADaM SAS data 
set, which can be used to capture the first AE onset date for each unique 
AE preferred term.


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3. DATA EXAMPLES
3.1
Case #1: Previous AE End Date is Same as Next AE Start Date
Original ADAE Dataset
USUBJID
AEDECO
D
ASTD
T
AEND
T
APERIO
D
ATOXGR
N
AREL
1
AEOUT
AEACN
Cytokine 
release 
syndrome
1
1
Y
RECOVERED/RESOLV
ED
NOT 
APPLICABL
E
Cytokine 
release 
syndrome
1
2
Y
RECOVERED/RESOLV
ED
NOT 
APPLICABL
E
Cytokine 
release 
syndrome
2
2
N
Y
RECOVERED/RESOLV
ED
NOT 
APPLICABL
E
Cytokine 
release 
syndrome
2
3
Y
RECOVERED/RESOLV
ED
NOT 
APPLICABL
E
In the above example, this subject had 4 CRS records with the first two occurred after the 
1st T-cell infusion, and the last two  occurred after the 2nd T-cell infusion. The first two 
segments can be collapsed into one single CRS event since the 2nd segment started on the 
same date as the end date of the 1st segment. Similarly, the 3rd and 4th segment post the 
2nd T-cell infusion can be collapsed into one other CRS event due to the same reason.  
Below please see the derived variables added into ADAE ADaM SAS dataset.
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD


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Derived ADAE Dataset
USUB
JID
AED
ECO
D
AS
TD
T
AE
ND
T
APE
RIO
D
ATO
XGR
N
AR
EL
1
AEOUT
AEAC
N
ANL
01FL
EVT
SEQ
EVT
END
T
EVT
DUR
AOC
CPF
L
Cytok
ine 
releas
e 
syndr
ome
1
1
Y
RECOVERE
D/RESOLVE
D
NOT 
APPLI
CABL
E
Y
1
3
Cytok
ine 
releas
e 
syndr
ome
1
2
Y
RECOVERE
D/RESOLVE
D
NOT 
APPLI
CABL
E
1
Cytok
ine 
releas
e 
syndr
ome
2
2
N
RECOVERE
D/RESOLVE
D
NOT 
APPLI
CABL
E
Y
2
14
Cytok
ine 
releas
e 
syndr
ome
2
3
Y
RECOVERE
D/RESOLVE
D
NOT 
APPLI
CABL
E
2
3.2
Case #2: Previous AE Start Date is Same as Next AE Start Date
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD


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3.3
Case #3: Next AE Start Date is One Day after Previous AE End 
Date 
3.4
Case #4: Previous AE End Date is Greater Than Next AE Start 
Date.
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD


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Protocol: GSK208466/ADP-04511          
    
                                                                     Page 1 of 2
Population: Intent-To-Treat   
                                                               
      
(Data as of: 24APR2018)
Table 6.1001
Subject Enrollment and Disposition
ITT Population 
Cohort 1
Cohort 2
Cohort 3
Cohort 4
Cohort 2-4 
Total
Overall
ITT Population
xx
xx
xx
xx
xx
xx
MITT Population
xx
xx
xx
xx
xx
xx
Lymphodepleted
xx
xx
xx
xx
xx
xx
Subject Status at the End of the First Infusion
  Disease progression
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
  Unacceptable toxicity and other safety reasons
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
  death
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
  INVESTIGATOR DISCRETION
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
  subject withdrew consent
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
  protocol violation
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
  lost to follow-up
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
  termination by sponsor
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
  failed manufacture of cell product
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
  pregnancy
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
  FAILED TO MEET ELIGIBILITY CRITERIA FOR THE SECOND INFUSION
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
ITT = Intent-to-treat, mITT = Modified ITT. 
ITT Population = all subjects who were enrolled in the trial (i.e., underwent leukapheresis).
MITT Population = all subjects in the ITT population who received at least one T cell infusion.
Note 1: Denominator for percentages is based on the ITT Population.
Note 2: Subjects who have disease progression are considered to have completed the interventional phase.
Note 3: If withdrawn less than or equal to 60 days since the first infusion, the subject cannot be re-enrolled into the 2nd infusion and only required to provide 
the status at the end of the study.  
File Name: S:\...... \&prog_name


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Protocol: GSK208466/ADP-04511          
    
                                                                     Page 2 of 2
Population: Intent-To-Treat   
                                                               
(Data as of: 24APR2018)
Table 6.1001
Subject Enrollment and Disposition 
ITT Population
Cohort 1
Cohort 2
Cohort 3
Cohort 4
Cohort 2-4 
Total
Overall
Subject Status at the End of the Study
  Disease progression
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
  Unacceptable toxicity and other safety reasons
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
  death
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
  INVESTIGATOR DISCRETION
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
  subject withdrew consent
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
  protocol violation
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
  lost to follow-up
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
  termination by sponsor
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
  failed manufacture of cell product
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
  pregnancy
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
  FAILED TO MEET ELIGIBILITY CRITERIA FOR THE SECOND INFUSION
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
ITT = Intent-to-treat, mITT = Modified ITT. 
ITT Population = all subjects who were enrolled in the trial (i.e., underwent leukapheresis).
MITT Population = all subjects in the ITT population who received at least one T cell infusion.
Note 1: Denominator for percentages is based on the ITT Population.
Note 2: Subjects who have disease progression are considered to have completed the interventional phase.
Note 3: If withdrawn less than or equal to 60 days since the first infusion, the subject cannot be re-enrolled into the 2nd infusion and only required to 
provide the status at the end of the study.  
File Name: S:\...... \&prog_name


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Protocol: GSK208466/ADP-04511                     
                                                                    Page 1 of 3
Population: Intent-To-Treat                                         
                                   
(Data as of: 24APR2018)
Table 6.2001
Demographic and Baseline Characteristics
ITT Population
Parameter
Category
Statistic
Cohort 1
(N=xx)
Cohort 2
(N=xx)
Cohort 3
(N=xx)
Cohort 4
(N=xx)
Cohort 2-4 
Total
(N=xx)
Overall
(N=xx)
Sex
FEMALE
n(%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
MALE
n(%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
Age (years)
N
x
x
x
x
x
x
Mean 
xx.x
xx.x
xx.x
xx.x
xx.x
xx.x
SD
xx.xx
xx.xx
xx.xx
xx.xx
xx.xx
xx.xx
Median
xx.x
xx.x
xx.x
xx.x
xx.x
xx.x
Min,Max
xx, xx
xx, xx
xx, xx
xx, xx
xx, xx
xx, xx
Race
BLACK OR AFRICAN AMERICAN
n(%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
AMERICAN INDIAN OR ALASKA 
NATIVE
n(%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
ASIAN
n(%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
NATIVE HAWAIIAN OR OTHER 
PACIFIC ISLANDER
n(%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
WHITE
n(%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
OTHER
n(%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
Ethnicity
HISPANIC OR LATINO
n(%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
NOT HISPANIC OR LATINO
n(%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
Screening 
Height (cm)
N
x
x
x
x
x
x
Mean 
xx.xx
xx.xx
xx.xx
xx.xx
xx.xx
xx.xx
SD
xx.xxx
xx.xxx
xx.xxx
xx.xxx
xx.xxx
xx.xxx
Median
xx.xx
xx.xx
xx.xx
xx.xx
xx.xx
xx.xx
Min,Max
xx.x,xx.x
xx.x,xx.x
xx.x,xx.x
xx.x,xx.x
xx.x,xx.x
xx.x,xx.x
BMI = Body Mass Index, BSA = Body Surface Area, ECOG = Eastern Cooperative Oncology Group, SD = Standard Deviation.
Note 1: Age is the age at informed consent, baseline weight is within 7 days prior to lymnphodepletion, and BMI is calculated using the baseline weight and the 
height at the Screening visit. 
Note 2: ECOG Score: 0 – Fully active and able to carry on all pre-disease activities without restriction, 1 – Restricted in physically strenuous activity but 
ambulatory and able to carry out work of a light sedentary nature, 2 – Ambulatory and capable of all self-care but unable to carry out any work activities, 3 –
Capable of only limited self-care, 4 – Completely disabled, 5 – Dead. Subjects had to have an ECOG score of 0 or 1 to be enrolled in the study.
File Name: S:\...... \&prog_name


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Protocol: GSK208466/ADP-04511              
                                            
Page 2 
Population: Intent-To-Treat                                                                  
(Data as of: 24APR2018)
Table 6.2001
Demographic and Baseline Characteristics
ITT Population
Parameter
Category
Statistic
Cohort 1
(N=xx)
Cohort 2
(N=xx)
Cohort 3
(N=xx)
Cohort 4
(N=xx)
Cohort 2-4 
Total 
(N=xx)
Overall
(N=xx)
Weight (kg)
N
x
x
x
x
x
X
Mean 
xx.xx
xx.xx
xx.xx
xx.xx
xx.xx
xx.xx
SD
xx.xxx
xx.xxx
xx.xxx
xx.xxx
xx.xxx
xx.xxx
Median
xx.xx
xx.xx
xx.xx
xx.xx
xx.xx
xx.xx
Min,Max
xx.x,xx.x
xx.x,xx.x
xx.x,xx.x
xx.x,xx.x
xx.x,xx.x
xx.x,xx.x
BMI(kg/m^2)
N
x
x
X
X
X
X
Mean 
xx.xx
xx.xx
xx.xx
xx.xx
xx.xx
xx.xx
SD
xx.xxx
xx.xxx
xx.xxx
xx.xxx
xx.xxx
xx.xxx
Median
xx.xx
xx.xx
xx.xx
xx.xx
xx.xx
xx.xx
Min,Max
xx.x,xx.x
xx.x,xx.x
xx.x,xx.x
xx.x,xx.x
xx.x,xx.x
xx.x,xx.x
BSA (m^2)
N
x
x
X
X
X
X
Mean 
xx.xx
xx.xx
xx.xx
xx.xx
xx.xx
xx.xx
SD
xx.xxx
xx.xxx
xx.xxx
xx.xxx
xx.xxx
xx.xxx
Median
xx.xx
xx.xx
xx.xx
xx.xx
xx.xx
xx.xx
Min,Max
xx.x,xx.x
xx.x,xx.x
xx.x,xx.x
xx.x,xx.x
xx.x,xx.x
xx.x,xx.x
HLA Status
HLA-A*0201
n(%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
HLA-A*0205
n(%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
HLA-A*0206
n(%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
Other
n(%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
NY-ESO Status
Positive High 
n(%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
Positive Low
n(%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
Negative
n(%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
Not Evaluable
n(%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
BMI = Body Mass Index, BSA = Body Surface Area, ECOG = Eastern Cooperative Oncology Group, SD = Standard Deviation.
Note 1: Age is the age at informed consent, baseline weight is within 7 days prior to T-cell infusion, and BMI is calculated using the baseline weight and the 
height at the Screening visit. 
Note 2: ECOG Score: 0 – Fully active and able to carry on all pre-disease activities without restriction, 1 – Restricted in physically strenuous activity but
ambulatory and able to carry out work of a light sedentary nature, 2 – Ambulatory and capable of all self-care but unable to carry out any work activities, 3 –
Capable of only limited self-care, 4 – Completely disabled, 5 – Dead. Subjects had to have an ECOG score of 0 or 1 to be enrolled in the study.
File Name: S:\...... \&prog_name


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Protocol: GSK208466/ADP-04511  
            
                         Page 3 of 3
Population: Intent-To-Treat  
                                                                
(Data as of: 24APR2018)
Table 6.2001
Demographic and Baseline Characteristics
ITT Population
Parameter
Category
Statistic
Cohort 1
(N=xx)
Cohort 2
(N=xx)
Cohort 3
(N=xx)
Cohort 4
(N=xx)
Cohort 2-4 
Total 
(N=xx)
Overall
(N=xx)
Disease Stage at 
Enrollment
Stage I
Stage II
Stage III
n(%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
Stage IV
n(%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
OTHER
MISSING
n(%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
Type of Histology
MONOPHASIC
n(%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
BIPHASIC
n(%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
OTHER
n(%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
Screening ECOG Performance 
Status
0
n(%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
1
n(%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
BMI = Body Mass Index, BSA = Body Surface Area, ECOG = Eastern Cooperative Oncology Group, SD = Standard Deviation.
Note 1: Age is the age at informed consent, baseline weight is within 7 days prior to T-cell infusion, and BMI is calculated using the baseline weight and the 
height at the Screening visit. 
Note 2: ECOG Score: 0 – Fully active and able to carry on all pre-disease activities without restriction, 1 – Restricted in physically strenuous activity but 
ambulatory and able to carry out work of a light sedentary nature, 2 – Ambulatory and capable of all self-care but unable to carry out any work activities, 3 –
Capable of only limited self-care, 4 – Completely disabled, 5 – Dead. Subjects had to have an ECOG score of 0 or 1 to be enrolled in the study.
File Name: S:\...... \&prog_name


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208466/ADP-04511
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Repeat 6.2001 format for:
Table 6.2002
Demographic and Baseline Characteristics
mITT Population 
Note: mITT tables will be provided only if mITT and ITT populations differ.


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Protocol: GSK208466/ADP-04511              
                                             
Page 1 of 1
Population: Intent-To-Treat                                                                  
      (Data as of: 24APR2018)
Table 6.3001
Summary of Medical History
ITT Population
System Organ Class/
  Preferred Term
Cohort 1
(N=xx)
Cohort 2
(N=xx)
Cohort 3
(N=xx)
Cohort 4
(N=xx)
Cohort 2-4 
Total
(N=xx)
Overall
(N=xx)
Any Medical History
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
  
SOC 1
  Preferred Term 1
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
  Preferred Term 2
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
  Etc. 
SOC 2
  Preferred Term 1
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
  Preferred Term 2
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
  Etc. 
Etc.
File Name: S:\...... \&prog_name
Programming note: sort by descending overall SOC and descending overall PT. 


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Protocol: GSK208466/ADP-04511              
                                        
Page 1 of 2
Population: Intent-To-Treat                                                                  
(Data as of: 24APR2018)
Table 6.4001
Summary of Prior Cancer Therapy
ITT Population
Characteristic/
  Category
Statistic
Cohort 1
(N=xx)
Cohort 2
(N=xx)
Cohort 3
(N=xx)
Cohort 4
(N=xx)
Cohort 2-4
Total
(N=xx)
Overall
(N=xx)
Prior Systemic Therapy
  YES
n(%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
  NO
n(%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
Number of Prior Systemic 
Therapy Regimens 
  1
n(%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
  2
n(%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
  Etc.
Type of Systemic Therapy $
  CHEMOTHERAPY
n(%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
  IMMUNOTHERAPY
n(%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
  HORMONAL
n(%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
  VACCINE
n(%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
  OTHER
n(%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
Time Since Last Systemic 
Therapy (Days) @
n
x
x
x
x
x
x
Mean 
xx.xx
xx.xx
xx.xx
xx.xx
xx.xx
xx.xx
SD
xx.xxx
xx.xxx
xx.xxx
xx.xxx
xx.xxx
xx.xxx
Median
xx.xx
xx.xx
xx.xx
xx.xx
xx.xx
xx.xx
Min,Max
xx.x,xx.x
xx.x,xx.x
xx.x,xx.x
xx.x,xx.x
xx.x,xx.x
xx.x,xx.x
Best Response to Last Systemic 
Therapy
  COMPLETE RESPONSE
n(%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
  PARTIAL RESPONSE
n(%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
  STABLE DISEASE
n(%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
  DISEASE PROGRESSION
n(%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
  UNKNOWN
n(%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
  NOT DONE
n(%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
$ A subject may have more than one response.
@ Time Since Last Systemic Therapy is calculated as the date the informed consent was signed minus the latest therapy end date. Time Since Initial Diagnosis is 
calculated as the date the informed consent was signed minus the date of initial diagnosis. 
# Bridging therapy is therapy administered on or after apheresis and before lymphodepletion.
File Name: S:\...... \&prog_name


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         Page 2 of 2
Population: Intent-To-Treat                                                                  
(Data as of: 24APR2018)
Table 6.4001
Summary of Prior Cancer Therapy
ITT Population
Characteristic/
  Category
Statistic
Cohort 1
(N=xx)
Cohort 2
(N=xx)
Cohort 3
(N=xx)
Cohort 4
(N=xx)
Cohort 2-4
Total
(N=xx)
Overall
(N=xx)
Prior Radiotherapy
  YES
n(%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
  NO
n(%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
Prior Cancer-Related Surgery
  YES
n(%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
  NO
n(%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
Bridging Therapy #
  YES
n(%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
  NO
n(%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
Type of Bridging Therapy #
  CHEMOTHERAPY
n(%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
  RADIATION
n(%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
  OTHER
n(%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
Time Since Initial 
Diagnosis(Days) @
n
x
x
x
x
x
x
Mean 
xx.xx
xx.xx
xx.xx
xx.xx
xx.xx
xx.xx
SD
xx.xxx
xx.xxx
xx.xxx
xx.xxx
xx.xxx
xx.xxx
Median
xx.xx
xx.xx
xx.xx
xx.xx
xx.xx
xx.xx
Min,Max
xx.x,xx.x
xx.x,xx.x
xx.x,xx.x
xx.x,xx.x
xx.x,xx.x
xx.x,xx.x
$ A subject may have more than one response.
@ Time Since Last Systemic Therapy is calculated as the date the informed consent was signed minus the latest therapy end date. Time Since Initial Diagnosis is 
calculated as the date the informed consent was signed minus the date of initial diagnosis. 
# Bridging therapy is therapy administered on or after apheresis and before lymphodepletion.
File Name: S:\...... \&prog_name


CONFIDENTIAL
208466/ADP-04511
65
Repeat 6.4001 format for: 
Table 6.4002
Summary of Prior Cancer Therapy
mITT Population


CONFIDENTIAL
208466/ADP-04511
66
Protocol: GSK208466/ADP-04511 
                 
                              Page 1 of 1
Population: Modified Intent-To-Treat                            
                              
(Data as of: 24APR2018)
Table 7.1001
Summary of Overall Response Rate and Best Overall Response for the First Infusion
mITT Population
Parameter/
Cohort 1
Cohort 2
Cohort 3
Cohort 4
  Category or Criterion
Statistic
(N=xx)
(N=xx)
(N=xx)
(N=xx)
Overall Response Rate 
(ORR) $
  
  Derived Response 
derived based on RECIST 
V1.1
n (%) 
95% Clopper Pearson 
CI 
95% Wilson CI
x (xx.x%) 
(xx.x, xx.x)
(xx.x, xx.x)
x (xx.x%) 
(xx.x, xx.x)
(xx.x, xx.x)
x (xx.x%) 
(xx.x, xx.x)
(xx.x, xx.x)
x (xx.x%) 
(xx.x, 
xx.x)
(xx.x, 
xx.x)
  Investigator-assessed 
based on RECIST V1.1
n (%) 
95% CI 
x (xx.x%) 
(xx.x, xx.x)
x (xx.x%) 
(xx.x, xx.x)
x (xx.x%) 
(xx.x, xx.x)
x (xx.x%) 
(xx.x, 
xx.x)
Best Overall Response 
(BOR) derived based on 
RECIST V1.1 &
  Complete Response
n (%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
  Partial Response
n (%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
  Stable Disease
n (%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
  Progressive
    Disease
n (%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
  Unknown or Missing
n (%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
BOR = Best Overall Response, CI = Confidence Interval, ORR = Overall Response Rate. 
$ Overall response rate is defined as the proportion of subjects with a confirmed complete response or partial response relative to the total number of subjects 
in the population.
& Best overall response is the best response recorded from the time of first T cell infusion until disease progression, use of prohibited medications, or 
surgical resection. If unconfirmed complete or partial response, then the best overall response is stable disease.
Note 1: Subject
 had a day 3 assessment of PD that is not included in this summary because assessments prior to week 4 were not used in determination of PD.
Note 2: In cohort 2 subject
’s derived BOR based on RECIST 1.1 is SD but PD per investigator-assessed.
File Name: S:\...... \&prog_name
PPD
PPD


CONFIDENTIAL
208466/ADP-04511
67
Repeat Table 7.1001 template for:
Table 7.1002
Summary of Overall Response Rate and Best Overall Response for the Second Infusion
Subjects Who Received Second Infusion


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Protocol: GSK208466/ADP-04511              
                               
Page 1 of 2
Population: Modified Intent-To-Treat                                                                  
      (Data as of: 24APR2018)
Table 7.2001
Time in Study, Time to Response, Duration of Response, and Kaplan-Meier Estimate of Duration of Stable Disease
mITT Population
Parameter/
Cohort 1
Cohort 2
Cohort 3
Cohort 4
  Category
Statistic
(N=xx)
(N=xx)
(N=xx)
(N=xx)
Time to Response 
(weeks)&
n
x
x
x
x
   
Mean
x.x
x.x
x.x
x.x
SD
x.xx
x.xx
x.xx
x.xx
Median
x.x
x.x
x.x
x.x
  
Min, Max
x, x
x, x
x, x
x, x
Duration of Response 
(weeks) @
n
x
x
x
x
  
Mean
x.x
x.x
x.x
x.x
  
SD
x.xx
x.xx
x.xx
x.xx
Median
x.x
x.x
x.x
x.x
  
Min, Max
x, x
x, x
x, x
x, x
CI = Confidence interval, DOR = Duration of Response, TTR = Time to Response, DOSD = Duration of Stable Disease, Q1=25th percentile, Q3=75th percentile, CR = 
Complete Response, PR = Confirmed Response, PD = Progressive Disease.  
Note: Quartiles and 95% CI are from Kaplan-Meier estimate. CIs are from complementary log-log transformation.
& TTR is defined as the interval between the date of first T cell infusion and the earliest date of confirmed complete response (CR) or partial response (PR), 
and is summarized for those subjects with a confirmed CR or PR.
@ DOR is defined as the time from first documented confirmed CR or PR until first documented disease progression or death due to any cause or surgical resection 
or start of prohibited medications from any cause. For responders without these events, date of the last study assessment is used.
# DOSD is defined as the interval between the date of first T cell infusion and the first documented disease progression. Subjects who do not have documented 
disease progression are censored at the date of last disease assessment.
File Name: S:\...... \&prog_name


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                                                             Page 2 of 2
Population: Modified Intent-To-Treat                                                                  
                 (Data as of: 24APR2018)
Table 7.2001
Time in Study, Time to Response, Duration of Response, and Kaplan-Meier Estimate of Duration of Stable Disease
mITT Population
Parameter/
Cohort 1
Cohort 2
Cohort 3
Cohort 4
  Category
Statistic
(N=xx)
(N=xx)
(N=xx)
(N=xx)
Duration of Stable 
Disease (DOSD) #
  Subjects with Event 
n (%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
  Number Censored 
n (%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
  Duration of Stable
  Disease (weeks)
N
X
X
X
X
Q1 (95% CI)
xx.x (xx.x, xx.x)
xx.x (xx.x, xx.x)
xx.x (xx.x, xx.x)
xx.x (xx.x, xx.x)
Median 
(95% CI)
xx.x (xx.x, xx.x)
xx.x (xx.x, xx.x)
xx.x (xx.x, xx.x)
xx.x (xx.x, xx.x)
Q3 (95% CI)
xx.x (xx.x, xx.x)
xx.x (xx.x, xx.x)
xx.x (xx.x, xx.x)
xx.x (xx.x, xx.x)
Time in Study(Days) 
n
x
x
x
x
Mean 
xx.xx
xx.xx
xx.xx
xx.xx
SD
xx.xxx
xx.xxx
xx.xxx
xx.xxx
Median
xx.xx
xx.xx
xx.xx
xx.xx
Min,Max
xx.x,xx.x
xx.x,xx.x
xx.x,xx.x
xx.x,xx.x
CI = Confidence interval, DOR = Duration of Response, TTR = Time to Response, DOSD = Duration of Stable Disease, Q1=25th percentile, Q3=75th percentile, CR = 
Complete Response, PR = Confirmed Response, PD = Progressive Disease.  
Note: Quartiles and 95% CI are from Kaplan-Meier estimate. CIs are from complementary log-log transformation.
& TTR is defined as the interval between the date of first T cell infusion and the earliest date of confirmed complete response (CR) or partial response (PR), 
and is summarized for those subjects with a confirmed CR or PR.
@ DOR is defined as the time from first documented confirmed CR or PR until first documented disease progression or death due to any cause or surgical resection 
or start of prohibited medications from any cause. For responders without these events, date of the last study assessment is used.
# DOSD is defined as the interval between the date of first T cell infusion and the first documented disease progression. Subjects who do not have documented 
disease progression are censored at the date of last disease assessment.
File Name: S:\...... \&prog_name


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Population: Modified Intent-To-Treat                                                                  
               
(Data as of: 24APR2018)
Table 7.2002
Kaplan-Meier Estimate of Progression-Free Survival and Overall Survival
mITT Population
Parameter/
Cohort 1
Cohort 2
Cohort 3
Cohort 4
  Category
Statistic
(N=xx)
(N=xx)
(N=xx)
(N=xx)
Progression-Free 
Survival (PFS) &
  Subjects with Event 
n (%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
  Number Censored 
n (%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
  PFS (weeks)
N
X
X
X
X
Q1 (95% 
CI)
xx.x (xx.x, xx.x)
xx.x (xx.x, 
xx.x)
xx.x (xx.x, 
xx.x)
xx.x (xx.x, xx.x)
Median 
(95% CI)
xx.x (xx.x, xx.x)
xx.x (xx.x, 
xx.x)
xx.x (xx.x, 
xx.x)
xx.x (xx.x, xx.x)
Q3 (95% 
CI)
xx.x (xx.x, xx.x)
xx.x (xx.x, 
xx.x)
xx.x (xx.x, 
xx.x)
xx.x (xx.x, xx.x)
Reason for PD/Death 
  Increased Tumor Burden 
n (%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
  Death 
n (%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
  Surgical Resection 
n (%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
  Prohibited Medication 
n (%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
Overall Survival (OS) @
  Subjects with Event 
n (%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
  Number Censored 
n (%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
  OS (weeks)
N
X
X
X
X
Q1 (95% 
CI)
xx.x (xx.x, xx.x)
xx.x (xx.x, 
xx.x)
xx.x (xx.x, 
xx.x)
xx.x (xx.x, xx.x)
Median 
(95% CI)
xx.x (xx.x, xx.x)
xx.x (xx.x, 
xx.x)
xx.x (xx.x, 
xx.x)
xx.x (xx.x, xx.x)
Q3 (95% 
CI)
xx.x (xx.x, xx.x)
xx.x (xx.x, 
xx.x)
xx.x (xx.x, xx.x)
xx.x (xx.x, 
xx.x)
CI = Confidence interval, OS = Overall Survival, PFS = Progression-Free Survival, Q1=25th percentile, Q3=75th percentile.  
Note: Quartiles and 95% CI are from Kaplan-Meier estimate. CIs are from complementary log-log transformation.
& PFS is defined as the interval between the date of first T cell infusion and first documented disease progression or death due to any cause or surgical 
resection or start of prohibited medication. Subjects without any of the aforementioned events are censored at the date of last adequate assessment.


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@ OS is defined as the interval between the date of first T cell infusion and date of death due to any cause. Subjects who are still alive or lost to follow-up 
are censored at the date of last contact.
File Name: S:\...... \&prog_name
Note to programmer: Denominator for each reason is number fo subjects with event.


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Protocol: GSK208466/ADP-04511              
                                                                 
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Population: Modified Intent-To-Treat                                                         
(Data as of: 24APR2018)
Table 7.2101 
Sensitivity Analyses for Best Overall Response for the First Infusion
mITT Population
Sensitivity Analysis/
Cohort 1
Cohort 2
Cohort 3
Cohort 4
  Response Category 
Statistic
(N=xx)
(N=xx)
(N=xx)
(N=xx)
Progressive Disease
Based on Last Tumor 
Assessment $
  Complete Response
n (%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
  Partial Response
n (%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
  Stable Disease
n (%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
  Progressive
    Disease
n (%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
  Unknown or Missing
n (%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
Investigator Assessment 
of Response
  Complete Response
n (%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
  Partial Response
n (%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
  Stable Disease
n (%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
  Progressive
    Disease
n (%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
  Unknown or Missing
n (%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
BOR = Best Overall Response, CR = Complete Response, PR = Partial Response, SD = Stable Disease, PD = Progressive Disease, NE = Not Evaluable (Unknown or 
Missing), N/A = Not Applicable. 
Note: Best overall response is the best response recorded from the time of first T cell infusion until disease progression, use of prohibited medications, or 
surgical resection, whichever came first, except as noted in $ footnote.
$ Date of last assessment is used as date of progressive disease in place of start date of prohibited medications or surgical resection.
@ Assign values of SD if the assessments before and after the NE assessment are CR, PR, or SD. Assign PD otherwise, except for PR NE CR where the assessment is 
improving.
Note: Subject
 had a day 3 assessment of PD that is not included in this summary because assessments prior to week 4 were not used in determination of PD.
File Name: S:\...... \&prog_name
PPD


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Protocol: GSK208466/ADP-04511              
                            
                                Page 2 of 2
Population: Modified Intent-To-Treat                                                         
(Data as of: 24APR2018)
Table 7.2101 
Sensitivity Analyses for Best Overall Response for the First Infusion
mITT Population
Sensitivity Analysis/
Cohort 1
Cohort 2
Cohort 3
Cohort 4
  Response Category 
Statistic
(N=xx)
(N=xx)
(N=xx)
(N=xx)
Replace NE with SD 
or PD @
  Complete Response
n (%)
N/A
x (xx.x%)
x (xx.x%)
x (xx.x%)
  Partial Response
n (%)
N/A
x (xx.x%)
x (xx.x%)
x (xx.x%)
  Stable Disease
n (%)
N/A
x (xx.x%)
x (xx.x%)
x (xx.x%)
  Progressive
    Disease
n (%)
N/A
x (xx.x%)
x (xx.x%)
x (xx.x%)
  Unknown or Missing
n (%)
N/A
x (xx.x%)
x (xx.x%)
x (xx.x%)
BOR = Best Overall Response, CR = Complete Response, PR = Partial Response, SD = Stable Disease, PD = Progressive Disease, NE = Not Evaluable (Unknown or 
Missing), N/A = Not Applicable. 
Note: Best overall response is the best response recorded from the time of first T cell infusion until disease progression, use of prohibited medications, or 
surgical resection, whichever came first, except as noted in $ footnote.
$ Date of last assessment is used as date of progressive disease in place of start date of prohibited medications or surgical resection.
@ Assign values of SD if the assessments before and after the NE assessment are CR, PR, or SD. Assign PD otherwise, except for PR NE CR where the assessment is 
improving.
Note: Subject
 had a day 3 assessment of PD that is not included in this summary because assessments prior to week 4 were not used in determination of PD.
File Name: S:\...... \&prog_name
PPD


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Protocol: GSK208466/ADP-04511              
                                                            
        Page 1 of 4
Population: Modified Intent-To-Treat                                                         
(Data as of: 24APR2018)
Table 7.2103 
Sensitivity Analyses for Progression-Free Survival
mITT Population
Sensitivity Analysis/
Cohort 1
Cohort 2
Cohort 3
Cohort 4
  Response Category 
Statistic
(N=xx)
(N=xx)
(N=xx)
(N=xx)
Progressive Disease
Based on Last Tumor 
Assessment $
  Subjects with Event 
n (%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
  Number Censored 
n (%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
  Progression-Free 
  Survival(weeks)
N
X
X
X
X
Q1 (95% CI)
xx.x (xx.x, xx.x)
xx.x (xx.x, xx.x)
xx.x (xx.x, xx.x)
xx.x (xx.x, xx.x)
Median 
(95% CI)
xx.x (xx.x, xx.x)
xx.x (xx.x, xx.x)
xx.x (xx.x, xx.x)
xx.x (xx.x, xx.x)
Q3 (95% CI)
xx.x (xx.x, xx.x)
xx.x (xx.x, xx.x)
xx.x (xx.x, xx.x)
xx.x (xx.x, xx.x)
CR = Complete Response, PR = Partial Response, SD = Stable Disease, PD = Progressive Disease, NE = Not Evaluable (Unknown or Missing). 
& PFS is defined as the interval between the date of first T cell infusion and first disease progression, death due to any cause, surgical resection, or start 
of prohibited medication, except as noted in $ footnote. Subjects without any of the aforementioned events are censored at the date of last study assessment.
$ Subjects are censored at first surgical resection or start of prohibited medications, whichever came first.
@ Assign values of SD if the assessments before and after the NE assessment are CR, PR, or SD. Assign PD otherwise, except for PR NE CR where the assessment is 
improving.
^ Subjects who discontinued for disease progression but did not meet RECIST criteria for PD are classified as PD at the date of discontinuation.
File Name: S:\...... \&prog_name


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Protocol: GSK208466/ADP-04511              
  
                                         Page 2 of 4
Population: Modified Intent-To-Treat                                                         
(Data as of: 24APR2018)
Table 7.2103 
Sensitivity Analyses for Progression-Free Survival
mITT Population
Sensitivity Analysis/
Cohort 1
Cohort 2
Cohort 3
Cohort 4
  Response Category 
Statistic
(N=xx)
(N=xx)
(N=xx)
(N=xx)
Investigator Assessment of 
Response
  Subjects with Event 
n (%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
  Number Censored 
n (%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
  Progression-Free  
  Survival(weeks)
N
X
X
X
X
Q1 (95% CI)
xx.x (xx.x, xx.x)
xx.x (xx.x, xx.x)
xx.x (xx.x, xx.x)
xx.x (xx.x, xx.x)
Median 
(95% CI)
xx.x (xx.x, xx.x)
xx.x (xx.x, xx.x)
xx.x (xx.x, xx.x)
xx.x (xx.x, xx.x)
Q3 (95% CI)
xx.x (xx.x, xx.x)
xx.x (xx.x, xx.x)
xx.x (xx.x, xx.x)
xx.x (xx.x, xx.x)
Ignore Assessments of NE 
  Subjects with Event 
n (%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
  Number Censored 
n (%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
  Progression-Free  
  Survival(weeks)
N
X
X
X
X
Q1 (95% CI)
xx.x (xx.x, xx.x)
xx.x (xx.x, xx.x)
xx.x (xx.x, xx.x)
xx.x (xx.x, xx.x)
Median 
(95% CI)
xx.x (xx.x, xx.x)
xx.x (xx.x, xx.x)
xx.x (xx.x, xx.x)
xx.x (xx.x, xx.x)
Q3 (95% CI)
xx.x (xx.x, xx.x)
xx.x (xx.x, xx.x)
xx.x (xx.x, xx.x)
xx.x (xx.x, xx.x)
CR = Complete Response, PR = Partial Response, SD = Stable Disease, PD = Progressive Disease, NE = Not Evaluable (Unknown or Missing). 
& PFS is defined as the interval between the date of first T cell infusion and first disease progression, death due to any cause, surgical resection, or start 
of prohibited medication, except as noted in $ footnote. Subjects without any of the aforementioned events are censored at the date of last study assessment.
$ Subjects are censored at first surgical resection or start of prohibited medications, whichever came first.
@ Assign values of SD if the assessments before and after the NE assessment are CR, PR, or SD. Assign PD otherwise, except for PR NE CR where the assessment is 
improving.
^ Subjects who discontinued for disease progression but did not meet RECIST criteria for PD are classified as PD at the date of discontinuation.
File Name: S:\...... \&prog_name


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         Page 3 of 4
Population: Modified Intent-To-Treat                                                         
(Data as of: 24APR2018)
Table 7.2103 
Sensitivity Analyses for Progression-Free Survival
mITT Population
Sensitivity Analysis/
Cohort 1
Cohort 2
Cohort 3
Cohort 4
  Response Category 
Statistic
(N=xx)
(N=xx)
(N=xx)
(N=xx)
Replace NE with SD or 
PD @
  Subjects with Event 
n (%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
  Number Censored 
n (%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
  Progression-Free  
  Survival(weeks)
N
X
X
X
X
Q1 (95% CI)
xx.x (xx.x, xx.x)
xx.x (xx.x, xx.x)
xx.x (xx.x, xx.x)
xx.x (xx.x, xx.x)
Median 
(95% CI)
xx.x (xx.x, xx.x)
xx.x (xx.x, xx.x)
xx.x (xx.x, xx.x)
xx.x (xx.x, xx.x)
Q3 (95% CI)
xx.x (xx.x, xx.x)
xx.x (xx.x, xx.x)
xx.x (xx.x, xx.x)
xx.x (xx.x, xx.x)
Replace NE with SD 
  Subjects with Event 
n (%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
  Number Censored 
n (%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
  Progression-Free  
  Survival(weeks)
N
X
X
X
X
Q1 (95% CI)
xx.x (xx.x, xx.x)
xx.x (xx.x, xx.x)
xx.x (xx.x, xx.x)
xx.x (xx.x, xx.x)
Median 
(95% CI)
xx.x (xx.x, xx.x)
xx.x (xx.x, xx.x)
xx.x (xx.x, xx.x)
xx.x (xx.x, xx.x)
Q3 (95% CI)
xx.x (xx.x, xx.x)
xx.x (xx.x, xx.x)
xx.x (xx.x, xx.x)
xx.x (xx.x, xx.x)
CR = Complete Response, PR = Partial Response, SD = Stable Disease, PD = Progressive Disease, NE = Not Evaluable (Unknown or Missing). 
& PFS is defined as the interval between the date of first T cell infusion and first disease progression, death due to any cause, surgical resection, or start 
of prohibited medication, except as noted in $ footnote. Subjects without any of the aforementioned events are censored at the date of last study assessment.
$ Subjects are censored at first surgical resection or start of prohibited medications, whichever came first.
@ Assign values of SD if the assessments before and after the NE assessment are CR, PR, or SD. Assign PD otherwise, except for PR NE CR where the assessment is 
improving.
^ Subjects who discontinued for disease progression but did not meet RECIST criteria for PD are classified as PD at the date of discontinuation.
File Name: S:\...... \&prog_name


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         Page 4 of 4
Population: Modified Intent-To-Treat                                                         
(Data as of: 24APR2018)
Table 7.2103
Sensitivity Analyses for Progression-Free Survival
mITT Population
Sensitivity Analysis/
Cohort 1
Cohort 2
Cohort 3
Cohort 4
  Response Category 
Statistic
(N=xx)
(N=xx)
(N=xx)
(N=xx)
Replace NE with PD
  Subjects with Event 
n (%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
  Number Censored 
n (%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
  Progression-Free  
  Survival(weeks)
N
X
X
X
X
Q1 (95% CI)
xx.x (xx.x, xx.x)
xx.x (xx.x, xx.x)
xx.x (xx.x, xx.x)
xx.x (xx.x, xx.x)
Median 
(95% CI)
xx.x (xx.x, xx.x)
xx.x (xx.x, xx.x)
xx.x (xx.x, xx.x)
xx.x (xx.x, xx.x)
Q3 (95% CI)
xx.x (xx.x, xx.x)
xx.x (xx.x, xx.x)
xx.x (xx.x, xx.x)
xx.x (xx.x, xx.x)
Progressive Disease
Based on Discontinuation Date 
for Unconfirmed 
PD ^
  Subjects with Event 
n (%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
  Number Censored 
n (%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
  Progression-Free  
  Survival(weeks)
N
X
X
X
X
Q1 (95% CI)
xx.x (xx.x, xx.x)
xx.x (xx.x, xx.x)
xx.x (xx.x, xx.x)
xx.x (xx.x, xx.x)
Median 
(95% CI)
xx.x (xx.x, xx.x)
xx.x (xx.x, xx.x)
xx.x (xx.x, xx.x)
xx.x (xx.x, xx.x)
Q3 (95% CI)
xx.x (xx.x, xx.x)
xx.x (xx.x, xx.x)
xx.x (xx.x, xx.x)
xx.x (xx.x, xx.x)
CR = Complete Response, PR = Partial Response, SD = Stable Disease, PD = Progressive Disease, NE = Not Evaluable (Unknown or Missing). 
& PFS is defined as the interval between the date of first T cell infusion and first disease progression, death due to any cause, surgical resection, or start 
of prohibited medication, except as noted in $ footnote. Subjects without any of the aforementioned events are censored at the date of last study assessment.
$ Subjects are censored at first surgical resection or start of prohibited medications, whichever came first.
@ Assign values of SD if the assessments before and after the NE assessment are CR, PR, or SD. Assign PD otherwise, except for PR NE CR where the assessment is 
improving.
^ Subjects who discontinued for disease progression but did not meet RECIST criteria for PD are classified as PD at the date of discontinuation.
File Name: S:\...... \&prog_name


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                            Page 1 of 1
Population: Modified Intent-To-Treat                                                         
(Data as of: 24APR2018)
Table 8.0001 
Summary Lymphodepleting Chemotherapy Administration for the First Infusion
mITT Population
Cohort 1
Cohort 2
Cohort 3
Cohort 4
Cohort 2-4
Total
Overall
Regimen
Statistic
(N=xx)
(N=xx)
(N=xx)
(N=xx)
(N=xx)
(N=xx)
Initial 
Treatment @
Regimen A
n/N
xx/XX
xx/XX
xx/XX
xx/XX
xx/XX
xx/XX
Regimen B
n/N
xx/XX
xx/XX
xx/XX
xx/XX
xx/XX
xx/XX
Regimen C
n/N
xx/XX
xx/XX
xx/XX
xx/XX
xx/XX
xx/XX
Note 1: n = number of subjects with the regimen, N = total number of subjects receiving treatment.
Note 2: Regimen A = Fludarabine 30 mg/m^2 on Days -5 to -2 and Cyclophosphamide 1800 mg/m^2 on Days -5 and -3. Regimen B = Cyclophosphamide 1800 mg/m^2 on Days 
-3 and -2. Regimen C = Fludarabine 30 mg/m^2 and Cyclophosphamide 600 mg/m^2 on Days -7 to -5.
@ Subjects in Cohort 1 received Regimen A, subjects in Cohort 2 received Regimen A or C, subjects in Cohort 3 received Regimen B, and subjects in Cohort 4 
received Regimen C. 
File Name: S:\...... \&prog_name


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         Page 1 of 1
Population: Modified Intent-To-Treat                                                         
(Data as of: 24APR2018)
Table 8.0002 
Summary of the First T Cell Infusion
mITT Population
Cohort 1
Cohort 2
Cohort 3
Cohort 4
Cohort 2-4
Total
Overall
Parameter
Statistic
(N=xx)
(N=xx)
(N=xx)
(N=xx)
(N=xx)
(N=xx)
Total Number of 
Transduced Cells 
(x 10^9)
N
x
X
x
x
x
x
Mean 
xxx.x
xxx.x
xxx.x
xxx.x
xxx.x
xxx.x
SD
xx.xx
xx.xx
xx.xx
xx.xx
xx.xx
xx.xx
Median
xxx
Xxx
xxx
xxx
xxx
xxx
Min,Max
xxx,xxx
xxx,xxx
xxx,xxx
xxx,xxx
xxx,xxx
xxx,xxx
File Name: S:\...... \&prog_name


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Protocol: GSK208466/ADP-04511              
         Page 1 of 1
Population: Modified Intent-To-Treat                                                         
(Data as of: 24APR2018)
Table 8.0003 
Summary of Second T Cell Infusion
(Subjects with a Second T Cell Infusion)
Cohort 1
Cohort 2
Cohort 3
Cohort 4
Cohort 2-4
Total
Overall
Parameter
Statistic
(N=xx)
(N=xx)
(N=xx)
(N=xx)
(N=xx)
(N=xx)
Total Number of 
Transduced Cells 
(x 10^9)
N
x
X
x
x
x
x
Mean 
xxx.x
xxx.x
xxx.x
xxx.x
xxx.x
xxx.x
SD
xx.xx
xx.xx
xx.xx
xx.xx
xx.xx
xx.xx
Median
xxx
Xxx
xxx
xxx
xxx
xxx
Min,Max
xxx,xxx
xxx,xxx
xxx,xxx
xxx,xxx
xxx,xxx
xxx,xxx
File Name: S:\...... \&prog_name


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Protocol: GSK208466/ADP-04511              
                                                
         Page 1 of 1
Population: Intent-To-Treat                                                                  
      (Data as of: 24APR2018)
Table 8.1001
Overall Summary of Adverse Events for Period 1 
ITT Population
ADAE.PER01FL = 'Y’
ITTFL = ‘Y’
Do not use treatment-emergent flag.
Use ARM
Cohort 1
Cohort 2
Cohort 3
Cohort 4
Cohort 2-4
Total
Overall
Category
(N=xx)
(N=xx)
(N=xx)
(N=xx)
(N=xx)
(N=xx)
Subjects with Any AEs 
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
Subjects with Any AEs Related& to T Cell 
Therapy RELGR1 = ‘Related’
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
Subjects with Any AEs >= Grade 3
TOXGGR1 = ‘Grade 3 or Higher’
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
Subjects with Any AEs Related& T Cell Therapy 
and Grade >= 3 RELGR1 = ‘Related’, 
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
TOXGGR1 = ‘Grade 3 or Higher’
Subjects with Any AEs Related& T Cell Therapy 
and 
Fatal Outcome 
Subjects with Any Serious AEs (SAE) 
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
AESER = ‘Y’
Subjects with Any SAEs Related& to T Cell 
Therapy AESER = ‘Y’, RELGR1 = ‘Related’
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
Subjects with Any SAEs >= Grade 3
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
AESER = ‘Y’, TOXGGR1 = ‘Grade 3 or Higher’
Subjects with Any SAEs Related& to T Cell 
Therapy and Grade >= 3 AESER = ‘Y’,
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
RELGR1=‘Related’,TOXGGR1=‘Grade 3 or Higher’
Subjects with Any SAEs with Fatal Outcome
AESER = ‘Y’, AEOUT = ‘FATAL’
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)
x (xx.x%)


CONFIDENTIAL
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SAE = serious adverse event.
Period 1 = from date of informed consent through end of study.
& Treatment-related: definitely related, probably related, possibly related, or unlikely related to T cell infusion.
File Name: S:\...... \&prog_name
Repeat Table 8.1001 template for:
Table 8.1003
Overall Summary of Adverse Events for Period 2.
mITT Population
(replace Period 1 footnote with: Period 2 = from start date of lymphodepletion through end of study.)
ADAE.PER02FL = 'Y’
MITTFL = ‘Y’
Do not use treatment-emergent flag.
Use ARM.


CONFIDENTIAL
208466/ADP-04511
83
Protocol: GSK208466/ADP-04511              
Page 1 of 1
Population: Intent-To-Treat                                                                  
(Data as of: 24APR2018)
Table 8.1101
Incidence of Adverse Events by System Organ Class and Preferred Term for Period 1
ITT Population
ADAE.PER01FL = 'Y’
ITTFL = ‘Y’
Do not use treatment-emergent flag for any tables.
Use ARM for all tables
System Organ Class/ 
ADAE.AEBODSYS
Cohort 2-4
Total
(N=xx)
  Preferred Term 
ADAE.AEDECOD
Cohort 1
(N=xx)
Cohort 2
(N=xx)
Cohort 3
(N=xx)
Cohort 4
(N=xx)
Overall
(N=xx)
Any Adverse Event
xx(xx.x %)
xx(xx.x %)
xx(xx.x %)
xx(xx.x %)
xx(xx.x %)
xx(xx.x %)
SOC1
xx(xx.x %)
xx(xx.x %)
xx(xx.x %)
xx(xx.x %)
xx(xx.x %)
xx(xx.x %)
  Term 1
xx(xx.x %)
xx(xx.x %)
xx(xx.x %)
xx(xx.x %)
xx(xx.x %)
xx(xx.x %)
  Term 2
xx(xx.x %)
xx(xx.x %)
xx(xx.x %)
xx(xx.x %)
xx(xx.x %)
xx(xx.x %)
SOC2
xx(xx.x %)
xx(xx.x %)
xx(xx.x %)
xx(xx.x %)
xx(xx.x %)
xx(xx.x %)
  Term 1
xx(xx.x %)
xx(xx.x %)
xx(xx.x %)
xx(xx.x %)
xx(xx.x %)
xx(xx.x %)
  Term 2
xx(xx.x %)
xx(xx.x %)
xx(xx.x %)
xx(xx.x %)
xx(xx.x %)
xx(xx.x %)
Etc.
Programming Note: Sort SOCs by descending frequency of subjects in Overall column, then alphabetically.  Within each SOC, sort PTs by 
descending frequency of subjects Overall column, then alphabetically.
Period 1 = from date of informed consent through end of study.
Note 1: Subjects are counted once for each system organ class and once for each preferred term. 
Note 2: System organ classes (and preferred terms within each) are sorted by descending frequency according to the Overall group.
File Name: S:\...... \&prog_name


CONFIDENTIAL
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Repeat Table 8.1101 template for:
Table 8.1103
Incidence of Adverse Events by System Organ Class and Preferred Term for Period 2 
mITT Population
(replace Period 1 footnote with: Period 2 = from start date of lymphodepletion through end of study.)
ADAE.PER02FL = 'Y’
MITTFL = ‘Y’
Use ARM
Table 8.1104
Summary of Adverse Events Grouped by Similarity of Preferred Terms for Period 1 
ITT
ADAE.PER01FL = 'Y’
ITTFL = ‘Y’
Use ARM
Table 8.1106
Summary of Adverse Events Grouped by Similarity of Preferred Terms for Period 2 
mITT
(replace Period 1 footnote with: Period 2 = from start date of lymphodepletion through end of study.)
ADAE.PER02FL = 'Y’
MITTFL = ‘Y’
Use ARM
Footnotes for 8.1104, 8.1101:
Period 1 = from date of informed consent through end of study.
Note 1: Subjects are counted once for each synonym and once for each preferred term 
Note 2: Synonyms (and preferred terms within each) are sorted by descending frequency according to the Overall group.
File Name: S:\...... \&prog_name


CONFIDENTIAL
208466/ADP-04511
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Protocol: GSK208466/ADP-04511              
Page 1 of n
Population: Intent-To-Treat                                                                  
(Data as of: 24APR2018)
Table 8.1201
Incidence of Adverse Events by Toxicity Grade and Preferred Term for Period 1 
ITT Population
Cohort 1 (N=xxx)
                                                          Maximum Grade
Preferred Term
1
2
3
4
5
3+4+5
   Unknown
Total
Any Adverse Event
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
   Term 1
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
   Term 2
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
   Term 3
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
   Term 4
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
   Term 5
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
   …
Period 1 = from date of informed consent through end of study.
Note 1: Subjects are counted once for each system organ class and once for each preferred term under the most severe toxicity grade.
Note 2: System organ classes (and preferred terms within each) are sorted by descending frequency in the Overall group.
Note 3: Synonymous preferred terms are combined.
Note to programmer: Include only Grades with frequency > 0 for Overall columns. Please only present synonym terms as described in appendix 2.
File Name: S:\...... \&prog_name


CONFIDENTIAL
208466/ADP-04511
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Protocol: GSK208466/ADP-04511              
Page 1 of n
Population: Intent-To-Treat                                                                  
(Data as of: 24APR2018)
Table 8.1201
Incidence of Adverse Events by Toxicity Grade Preferred Term for Period 1 
ITT Population
Cohort 2 (N=xxx)
                                                          Maximum Grade
Preferred Term
1
2
3
4
5
3+4+5
   Unknown
Total
Any Adverse Event
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
   Term 1
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
   Term 2
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
   Term 3
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
   Term 4
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
   Term 5
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
   …
Period 1 = from date of informed consent through end of study.
Note 1: Subjects are counted once for each system organ class and once for each preferred term under the most severe toxicity grade.
Note 2: System organ classes (and preferred terms within each) are sorted by descending frequency in the Overall group.
Note 3: Synonymous preferred terms are combined.
Note to programmer: Include only Grades with frequency > 0 for Overall columns. Please only present synonym terms as described in appendix 2.
File Name: S:\...... \&prog_name


CONFIDENTIAL
208466/ADP-04511
87
Protocol: GSK208466/ADP-04511              
Page 1 of n
Population: Intent-To-Treat                                                                  
(Data as of: 24APR2018)
Table 8.1201
Incidence of Adverse Events by Toxicity Grade Preferred Term for Period 1 
ITT Population
Cohort 3 (N=xxx)
                                                          Maximum Grade
Preferred Term
1
2
3
4
5
3+4+5
   Unknown
Total
Any Adverse Event
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
   Term 1
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
   Term 2
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
   Term 3
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
   Term 4
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
   Term 5
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
   …
Period 1 = from date of informed consent through end of study.
Note 1: Subjects are counted once for each system organ class and once for each preferred term under the most severe toxicity grade.
Note 2: System organ classes (and preferred terms within each) are sorted by descending frequency in the Overall group.
Note 3: Synonymous preferred terms are combined.
Note to programmer: Include only Grades with frequency > 0 for Overall columns. Please only present synonym terms as described in appendix 2.
File Name: S:\...... \&prog_name


CONFIDENTIAL
208466/ADP-04511
88
Protocol: GSK208466/ADP-04511              
Page 1 of n
Population: Intent-To-Treat                                                                  
(Data as of: 24APR2018)
Table 8.1201
Incidence of Adverse Events by Toxicity Grade and Preferred Term for Period 1 
ITT Population
Cohort 4 (N=xxx)
                                                          Maximum Grade
Preferred Term
1
2
3
4
5
3+4+5
   Unknown
Total
Any Adverse Event
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
   Term 1
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
   Term 2
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
   Term 3
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
   Term 4
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
   Term 5
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
   …
Period 1 = from date of informed consent through end of study.
Note 1: Subjects are counted once for each system organ class and once for each preferred term under the most severe toxicity grade.
Note 2: System organ classes (and preferred terms within each) are sorted by descending frequency in the Overall group.
Note 3: Synonymous preferred terms are combined.
Note to programmer: Include only Grades with frequency > 0 for Overall columns. Please only present synonym terms as described in appendix 2.


CONFIDENTIAL
208466/ADP-04511
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Protocol: GSK208466/ADP-04511              
                                                                
Page 1 of n
Population: Intent-To-Treat                                                                  
(Data as of: 24APR2018)
Table 8.1201
Incidence of Adverse Events by Toxicity Grade and Preferred Term for Period 1 
ITT Population
Cohort 2-4 (N=xxx)
                                                          Maximum Grade
Preferred Term
1
2
3
4
5
3+4+5
   Unknown
Total
Any Adverse Event
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
   Term 1
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
   Term 2
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
   Term 3
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
   Term 4
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
   Term 5
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
   …
Period 1 = from date of informed consent through end of study.
Note 1: Subjects are counted once for each system organ class and once for each preferred term under the most severe toxicity grade.
Note 2: System organ classes (and preferred terms within each) are sorted by descending frequency in the Overall group.
Note 3: Synonymous preferred terms are combined.
Note to programmer: Include only Grades with frequency > 0 for Overall columns. Please only present synonym terms as described in appendix 2.
File Name: S:\...... \&prog_name


CONFIDENTIAL
208466/ADP-04511
90
Protocol: GSK208466/ADP-04511              
                                                                
Page 1 of n
Population: Intent-To-Treat                                                                  
(Data as of: 24APR2018)
Table 8.1201
Incidence of Adverse Events by Toxicity Grade and Preferred Term for Period 1 
ITT Population
Cohort 1-4 (N=xxx)
                                                          Maximum Grade
Preferred Term
1
2
3
4
5
3+4+5
   Unknown
Total
Any Adverse Event
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
   Term 1
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
   Term 2
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
   Term 3
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
   Term 4
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
   Term 5
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
   …
Period 1 = from date of informed consent through end of study.
Note 1: Subjects are counted once for each system organ class and once for each preferred term under the most severe toxicity grade.
Note 2: System organ classes (and preferred terms within each) are sorted by descending frequency in the Overall group.
Note 3: Synonymous preferred terms are combined.
Note to programmer: Include only Grades with frequency > 0 for Overall columns. Please only present synonym terms as described in appendix 2.
File Name: S:\...... \&prog_name
Repeat Table 8.1201 template for:
Table 8.1203
Incidence of Adverse Events by Toxicity Grade Class and Preferred Term for Period 2 
mITT Population
(replace Period 1 footnote with: Period 2 = from start date of lymphodepletion through end of study.)
ADAE.PER02FL = 'Y’
MITTFL = ‘Y’
Use ARM
Include only Grades with frequency > 0 for Overall columns.
Table 8.1204
Incidence of Treatment Adverse Events by Toxicity Grade Class and Preferred Term for Period 2 
mITT Population
(replace Period 1 footnote with: Period 2 = from start date of lymphodepletion through end of study.)


CONFIDENTIAL
208466/ADP-04511
91
Protocol: GSK208466/ADP-04511              
                                                                
Page 1 of 1
Population: Modified Intent-To-Treat                                                          
(Data as of: 24APR2018)
Table 8.1205
Incidence of Treatment Related Adverse Events by System Organ Class and Preferred Term for Period 1 
mITT Population
ADAE.PER01FL = 'Y’
MITTFL = ‘Y’
Use ARM
Include only related AEs (RELGR1 = ‘Related’). 
System Organ 
Class/ADAE.AEBODSYS
Cohort 2-4
Total
(N=xx)
  Preferred Term ADAE.AEDECOD
Cohort 1
(N=xx)
Cohort 2
(N=xx)
Cohort 3
(N=xx)
Cohort 4
(N=xx)
Overall
(N=xx)
Any Adverse Event
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
SOC1
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
  Term 1
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
  Term 2
  
Etc.
Period 1 = from date of informed consent through end of study.
Note 1: Subjects are counted once for each system organ class and once for each preferred term under the strongest relationship.
Note 2: Related adverse events have a relationship of definitely related, probably related, possibly related, or unlikely related to T cell infusion or 
lymphodepletion chemotherapy (cyclophosphamide and/or Mesna).
Note 3: System organ classes (and preferred terms within each) are sorted by descending frequency in the Overall group.
File Name: S:\...... \&prog_name


CONFIDENTIAL
208466/ADP-04511
92
Use 8.1205 as a template for the following Tables:
Table 8.1206
Incidence of Treatment Related Adverse Events by System Organ Class and Preferred Term for Period 2
mITT Population
(replace Period 1 footnote with: Period 2 = from start date of lymphodepletion through end of study.)
ADAE.PER02FL = 'Y’
MITTFL = ‘Y’
Use ARM
Include only related AEs (RELGR1 = ‘Related’).
Use 8.1101 as a template for the following Tables:
Table 8.1301
Incidence of Adverse Events with Toxicity Grade >=3 by System Organ Class and Preferred Term for Period 1
ITT Population
ADAE.PER01FL = 'Y’
ITTFL = ‘Y’
TOXGGR1 = ‘Grade 3 or Higher’
Use ARM
Table 8.1303
Incidence of Adverse Events with Toxicity Grade >=3 by System Organ Class and Preferred Term for Period 2
mITT Population
(replace Period 1 footnote with: Period 2 = from start date of lymphodepletion through end of study.)
ADAE.PER02FL = 'Y’
MITTFL = ‘Y’
TOXGGR1 = ‘Grade 3 or Higher’
Use ARM


CONFIDENTIAL
208466/ADP-04511
93
Use 8.1205 as a template for the following Tables:
Table 8.1305
Incidence of Treatment Related Adverse Events with Toxicity Grade >=3 by System Organ Class and Preferred Term for Period 1
mITT Population
ADAE.PER01FL = 'Y’
MITTFL = ‘Y’
Use Include only related AEs (RELGR1 = ‘Related’).  
TOXGGR1 = ‘Grade 3 or Higher’
Use ARM
Table 8.1306
Incidence of Treatment Related Adverse Events with Toxicity Grade >=3 by System Organ Class and Preferred Term for Period 2
mITT Population
(replace Period 1 footnote with: Period 2 = from start date of lymphodepletion through end of study.)
ADAE.PER02FL = 'Y’
MITTFL = ‘Y’
Use Include only related AEs (RELGR1 = ‘Related’).  
TOXGGR1 = ‘Grade 3 or Higher’
Use ARM


CONFIDENTIAL
208466/ADP-04511
94
Use Table 8.1101 as a template for the following Tables:
Table 8.1401
Incidence of Serious Adverse Events by System Organ Class and Preferred Term for the Pre-leukapheresis Period
ITT Population
ADAE.PRELEUFL = 'Y’
(no pop specified)
AESER = ‘Y’
Use ARM [it looks like there are no AEs meeting criteria at this point]
Programming note: Change the “Population: Modified Intent-To-Treat” in the upper left to “Population: Intent-to-Treat”.
Footnotes for Table 8.1401:
Note 1: Subjects are counted once for each system organ class and once for each preferred term. 
Note 2: Serious adverse events that occur after the date of informed consent and prior to date of leukapheresis are included.
Note 3: System organ classes (and preferred terms within each) are sorted by descending frequency in the Overall group.
Table 8.1402
Incidence of Serious Adverse Events by System Organ Class and Preferred Term for Period 1
ITT Population
ADAE.PER01FL = 'Y’
ITTFL = ‘Y’
AESER = ‘Y’
Use ARM
Table 8.1404
Incidence of Serious Adverse Events by System Organ Class and Preferred Term for the Period 2
mITT Population
(replace Period 1 footnote with: Period 2 = from start date of lymphodepletion through end of study.)
ADAE.PER02FL = 'Y’
MITTFL = ‘Y’
AESER = ‘Y’
Use ARM


CONFIDENTIAL
208466/ADP-04511
95
Use 8.1205 as a template for the following Tables:
Table 8.1502
Incidence of Treatment Related Serious Adverse Events by System Organ Class and Preferred Term for Period 1
mITT Population
ADAE.PER01FL = 'Y’
MITTFL = ‘Y’
AESER = ‘Y’
RELGR1 = ‘Related’
Use ARM
Table 8.1503
Incidence of Treatment Related Serious Adverse Events by System Organ Class and Preferred Term for Period 2
mITT Population
(replace Period 1 footnote with: Period 2 = from start date of lymphodepletion through end of study.)
ADAE.PER02FL = 'Y’
MITTFL = ‘Y’
AESER = ‘Y’
RELGR1 = ‘Related’
Use ARM


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Repeat Table 8.1201 template for:
Table 8.1504 
Incidence of Serious Adverse Events by Toxicity Grade and Preferred Term for Period 1
ITT population
Table 8.1505
Incidence of Serious Adverse Events by Toxicity Grade and Preferred Term for Period 2
mITT population
(replace Period 1 footnote with: Period 2 = from start date of lymphodepletion through end of study.)
Table 8.1506
Incidence of Treatment Related Serious Adverse Events by Toxicity Grade and Preferred Term for Period 2
mITT population
(replace Period 1 footnote with: Period 2 = from start date of lymphodepletion through end of study.)
Use 8.1101 as a template for the following Tables:
Table 8.1601
Incidence of Serious Adverse Events with Toxicity Grade >=3 by System Organ Class and Preferred Term for the Pre-leukapheresis Period 
ITT Population
Footnotes:
Note 1: Subjects are counted once for each system organ class and once for each preferred term. 
Note 2: Serious adverse events that occur after the date of informed consent and prior to date of leukapheresis are included.
Note 3: System organ classes (and preferred terms within each) are sorted by descending frequency in the Overall group.
ADAE.PRELEUFL = 'Y’
(no pop specified)
AESER = ‘Y’
TOXGGR1 = ‘Grade 3 or Higher’
Use ARM [it looks like there are no AEs meeting criteria at this point]
Programming note: Change the “Population: Modified Intent-To-Treat” in the upper left to “Population: Intent-to-Treat”.
Table 8.1602
Incidence of Serious Adverse Events with Toxicity Grade >=3 by System Organ Class and Preferred Term for Period 1
ITT Population
ADAE.PER01FL = 'Y’
ITTFL = ‘Y’
AESER = ‘Y’
TOXGGR1 = ‘Grade 3 or Higher’
Use ARM 
Table 8.1604


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Incidence of Serious Adverse Events with Toxicity Grade >=3 by System Organ Class and Preferred Term for Period 2
mITT Population
(replace Period 1 footnote with: Period 2 = from start date of lymphodepletion through end of study.)
ADAE.PER02FL = 'Y’
MITTFL = ‘Y’
AESER = ‘Y’
TOXGGR1 = ‘Grade 3 or Higher’
Use ARM


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Use 8.1205 as a template for the following Tables:
Table 8.1606
Incidence of Treatment Related Serious Adverse Events with Toxicity Grade >=3 by System Organ Class and Preferred Term for Period 1
mITT Population
ADAE.PER01FL = 'Y’
MITTFL = ‘Y’
AESER = ‘Y’
RELGR1 = ‘Related’
TOXGGR1 = ‘Grade 3 or Higher’
Use ARM 
Table 8.1607
Incidence of Treatment Related Serious Adverse Events with Toxicity Grade >=3 by System Organ Class and Preferred Term for Period 2
mITT Population
(replace Period 1 footnote with: Period 2 = from start date of lymphodepletion through end of study.)
ADAE.PER02FL = 'Y’
MITTFL = ‘Y’
AESER = ‘Y’
RELGR1 = ‘Related’
TOXGGR1 = ‘Grade 3 or Higher’
Use ARM 


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Use 8.1101 as a template for the following Tables:
Table 8.1608
Incidence of Serious Adverse Events Resulting in Death by System Organ Class and Preferred Term for the Pre-leukapheresis Period 
ITT Population
ADAE.PRELEUFL = 'Y’
(no pop specified)
AESER = ‘Y’
AEOUT = ‘FATAL’
Use ARM [it looks like there are no AEs meeting criteria at this point]
Footnotes:
Note 1: Subjects are counted once for each system organ class and once for each preferred term. 
Note 2: Serious adverse events that occur after the date of informed consent and prior to date of leukapheresis are included.
Note 3: System organ classes (and preferred terms within each) are sorted by descending frequency in the Overall group.
Programming note: Change the “Population: Modified Intent-To-Treat” in the upper left to “Population: Intent-to-Treat”.
AESER = ‘Y’
AEOUT = ‘FATAL’
Table 8.2101
Incidence of Serious Adverse Events Resulting in Death by System Organ Class and Preferred Term for Period 1
ITT Population
ADAE.PER01FL = 'Y’
MITTFL = ‘Y’
AESER = ‘Y’
AEOUT = ‘FATAL’
Table 8.2103
Incidence of Serious Adverse Events Resulting in Death by System Organ Class and Preferred Term for Period 2
mITT Population
(replace Period 1 footnote with: Period 2 = from start date of lymphodepletion through end of study.)
ADAE.PER02FL = 'Y’
MITTFL = ‘Y’
AESER = ‘Y’
AEOUT = ‘FATAL’


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Protocol: GSK208466/ADP-04511              
   
                                            Page 1 of 1
Population: Modified Intent-To-Treat                                                        
(Data as of: 24APR2018)
Table 8.3001
Overall Summary of Adverse Events for the Post-lymphodepletion Period for the Second T Cell Infusion
Subjects with a Second T Cell Infusion
ADAE.INF2FL = ‘Y’
TRT02A = ‘T-CELL’ (denominator)
Overall
Category
(N=xx)
Subjects with Any AEs 
x (xx.x%)
Subjects with Any AEs Related& to T Cell Therapy RELGR1 = ‘Related’
x (xx.x%)
Subjects with Any AEs >= Grade 3 TOXGGR1 = ‘Grade 3 or Higher’
x (xx.x%)
Subjects with Any Serious AEs (SAE) AESER = ‘Y’
x (xx.x%)
Subjects with Any SAEs with Fatal Outcome AESER = ‘Y’, AEOUT = ‘FATAL’
x (xx.x%)
SAE = serious adverse event.
& Treatment-related: definitely related, probably related, or possibly related to T cell infusion.
File Name: S:\...... \&prog_name


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Protocol: GSK208466/ADP-04511              
                                                 
Page 1 of 1
Population: Modified Intent-To-Treat                                                       
(Data as of: 24APR2018)
Table 8.3002
Incidence of Adverse Events by System Organ Class and Preferred Term for the Post-lymphodepletion Period for the Second T Cell Infusion
Subjects with a Second T Cell Infusion
ADAE.INF2FL = ‘Y’
TRT02A = ‘T-CELL’ (denominator)
System Organ Class/ ADAE.AEBODSYS
  Preferred Term ADAE.AEDECOD
Overall
(N=xx)
Any Adverse Event
xx(xx.x %)
SOC1
xx(xx.x %)
  Term 1
xx(xx.x %)
  Term 2
xx(xx.x %)
SOC2
xx(xx.x %)
  Term 1
xx(xx.x %)
  Term 2
xx(xx.x %)
Etc.
Note 1: Subjects are counted once for each system organ class and once for each preferred term. 
Note 2: System organ classes (and preferred terms within each) are sorted by descending frequency according to the Overall group.
File Name: S:\...... \&prog_name


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Protocol: GSK208466/ADP-04511              
                                                               
Page 1 of 1
Population: Modified Intent-To-Treat                                                        
(Data as of: 24APR2018)
Table 8.3003
Incidence of Adverse Events by Toxicity Grade and Preferred Term for the Post-lymphodepletion Period for the Second T-Cell Infusion Period 
Subjects with a Second T-Cell Infusion
Total (N=xxx)
                                                             Maximum Grade
Preferred Term
1
2
3
4
5
3+4+5
   Unknown
Total
Any Adverse Event
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
   Term 1
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
   Term 2
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
   Term 3
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
   Term 4
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
   Term 5
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
xx(xx.x%)
   …
Note 1: Subjects are counted once for each system organ class and once for each preferred term under the most severe toxicity grade.
Note 2: System organ classes (and preferred terms within each) are sorted by descending frequency in the Overall group.
Note 3: Synonymous preferred terms are combined.
Note to programmer: Include only Grades with frequency > 0 for Overall columns. Please only present synonym terms as described in appendix 2.
File Name: S:\...... \&prog_name


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Use 8.3002 as a template for the following Tables:
Table 8.3004
Incidence of Treatment Related Adverse Events by System Organ Class and Preferred Term for the Post-lymphodepletion Period for the Second T-Cell Infusion 
Subjects with a Second T Cell Infusion
Add footnote: Note 2: Related adverse events have a relationship of definitely related, probably related, or possibly related to T cell infusion or 
lymphodepletion chemotherapy (cyclophosphamide and/or Mesna).
ADAE.INF2FL = ‘Y’
TRT02A = ‘T-CELL’ (denominator)
RELGR1 = ‘Related’
Table 8.3005
Incidence of Serious Adverse Events by System Organ Class and Preferred Term for the Post-lymphodepletion Period for the Second T Cell Infusion
Subjects with a Second T Cell Infusion
ADAE.INF2FL = ‘Y’
TRT02A = ‘T-CELL’ (denominator)
AESER = ‘Y’


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Use 8.3003 as a template for the following Tables:
Table 8.3006 
Incidence of Treatment Related Adverse Events by Toxicity Grade and Preferred Term for the Post-lymphodepletion Period for the Second T-Cell Infusion
Population: Subjects with a Second T-Cell Infusion
Table 8.3007 
Incidence of Serious Adverse Events by Toxicity Grade and Preferred Term for the Post-lymphodepletion Period for the Second T-Cell Infusion
Population: Subjects with a Second T-Cell Infusion
Table 8.3008 
Incidence of Treatment Related Serious Adverse Events by Toxicity Grade and Preferred Term for the Post-lymphodepletion Period for the Second T-Cell Infusion
Population: Subjects with a Second T-Cell Infusion


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Protocol: GSK208466/ADP-04511              
                                                              
Page 1 of 4
Population: Modified Intent-To-Treat                                                          
(Data as of: 24APR2018)
Table 8.3101
Summary of Adverse Events of Special Interest by Cohort (All Infusions)
                 
               Cohort 1 (N=xx)
Maximum Grade
AESI Category
   Preferred Term
1
2
3
4
5
3+4+5
Unknown
Total
ANY EVENT
  1  (1%)
  4  (5%)
  6  (7%)
71 (86%)
  0
77 (93%)
  0
82 (99%)
Potential symptoms of GVHD
   Any Event
24 (29%)
31 (37%)
26 (31%)
  0
  0
26 (31%)
  0
81 (98%)
   Nausea
40 (48%)
26 (31%)
  5  (6%)
  0
  0
  5  (6%)
  0
71 (86%)
   Diarrhoea
23 (28%)
14 (17%)
11 (13%)
  0
  0
11 (13%)
  0
48 (58%)
   Rash maculo-papular
17 (20%)
  8 (10%)
  6  (7%)
  0
  0
  6  (7%)
  0
31 (37%)
   Abdominal pain
15 (18%)
  6  (7%)
  4  (5%)
  0
  0
  4  (5%)
  0
25 (30%)
Note 1: Subjects are counted once for each preferred term under the most severe grade.
Note 2: Preferred terms are sorted by descending frequency of 'Total' AEs.
Note 3: Adverse events with missing grade are only included in 'Unknown' and 'Total' columns.
Note 4: Synonymous preferred terms are combined.
Programming note: AESI list will be provided by GSK. Please use the AESI list and report the synonym terms as described in appendix 2.
.


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Protocol: GSK208466/ADP-04511              
                                                              
Page 2 of 4
Population: Modified Intent-To-Treat                                                          
(Data as of: 24APR2018)
Table 8.3101
Summary of Adverse Events of Special Interest by Cohort (All Infusions)
                 
               Cohort 2 (N=xx)
Maximum Grade
AESI Category
   Preferred Term
1
2
3
4
5
3+4+5
Unknown
Total
ANY EVENT
  1  (1%)
  4  (5%)
  6  (7%)
71 (86%)
  0
77 (93%)
  0
82 (99%)
Potential symptoms of GVHD
   Any Event
24 (29%)
31 (37%)
26 (31%)
  0
  0
26 (31%)
  0
81 (98%)
   Nausea
40 (48%)
26 (31%)
  5  (6%)
  0
  0
  5  (6%)
  0
71 (86%)
   Diarrhoea
23 (28%)
14 (17%)
11 (13%)
  0
  0
11 (13%)
  0
48 (58%)
   Rash maculo-papular
17 (20%)
  8 (10%)
  6  (7%)
  0
  0
  6  (7%)
  0
31 (37%)
   Abdominal pain
15 (18%)
  6  (7%)
  4  (5%)
  0
  0
  4  (5%)
  0
25 (30%)
Note 1: Subjects are counted once for each preferred term under the most severe grade.
Note 2: Preferred terms are sorted by descending frequency of 'Total' AEs.
Note 3: Adverse events with missing grade are only included in 'Unknown' and 'Total' columns.
Note 4: Synonymous preferred terms are combined.
Programming note: AESI list will be provided by GSK. Please use the AESI list and report the synonym terms as described in appendix 2.


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Protocol: GSK208466/ADP-04511              
                                                              Page 3 of 4
Population: Modified Intent-To-Treat                                                          
(Data as of: 24APR2018)
Table 8.3101
Summary of Adverse Events of Special Interest by Cohort (All Infusions)
                 
               Cohort 3 (N=xx)
Maximum Grade
AESI Category
   Preferred Term
1
2
3
4
5
3+4+5
Unknown
Total
ANY EVENT
  1  (1%)
  4  (5%)
  6  (7%)
71 (86%)
  0
77 (93%)
  0
82 (99%)
Potential symptoms of GVHD
   Any Event
24 (29%)
31 (37%)
26 (31%)
  0
  0
26 (31%)
  0
81 (98%)
   Nausea
40 (48%)
26 (31%)
  5  (6%)
  0
  0
  5  (6%)
  0
71 (86%)
   Diarrhoea
23 (28%)
14 (17%)
11 (13%)
  0
  0
11 (13%)
  0
48 (58%)
   Rash maculo-papular
17 (20%)
  8 (10%)
  6  (7%)
  0
  0
  6  (7%)
  0
31 (37%)
   Abdominal pain
15 (18%)
  6  (7%)
  4  (5%)
  0
  0
  4  (5%)
  0
25 (30%)
Note 1: Subjects are counted once for each preferred term under the most severe grade.
Note 2: Preferred terms are sorted by descending frequency of 'Total' AEs.
Note 3: Adverse events with missing grade are only included in 'Unknown' and 'Total' columns.
Note 4: Synonymous preferred terms are combined.
Programming note: AESI list will be provided by GSK. Please use the AESI list and report the synonym terms as described in appendix 2.


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Protocol: GSK208466/ADP-04511              
                                                            Page 4 of 4
Population: Modified Intent-To-Treat                                                          
(Data as of: 24APR2018)
Table 8.3101
Summary of Adverse Events of Special Interest by Cohort (All Infusions)
                 
               Cohort 4 (N=xx)
Maximum Grade
AESI Category
   Preferred Term
1
2
3
4
5
3+4+5
Unknown
Total
ANY EVENT
  1  (1%)
  4  (5%)
  6  (7%)
71 (86%)
  0
77 (93%)
  0
82 (99%)
Potential symptoms of GVHD
   Any Event
24 (29%)
31 (37%)
26 (31%)
  0
  0
26 (31%)
  0
81 (98%)
   Nausea
40 (48%)
26 (31%)
  5  (6%)
  0
  0
  5  (6%)
  0
71 (86%)
   Diarrhoea
23 (28%)
14 (17%)
11 (13%)
  0
  0
11 (13%)
  0
48 (58%)
   Rash maculo-papular
17 (20%)
  8 (10%)
  6  (7%)
  0
  0
  6  (7%)
  0
31 (37%)
   Abdominal pain
15 (18%)
  6  (7%)
  4  (5%)
  0
  0
  4  (5%)
  0
25 (30%)
Note 1: Subjects are counted once for each preferred term under the most severe grade.
Note 2: Preferred terms are sorted by descending frequency of 'Total' AEs.
Note 3: Adverse events with missing grade are only included in 'Unknown' and 'Total' columns.
Note 4: Synonymous preferred terms are combined.
Programming note: AESI list will be provided by GSK. Please use the AESI list and report the synonym terms as described in appendix 2.


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Protocol: GSK208466/ADP-04511              
                                                              
Page 1 of n
Population: Modified Intent-To-Treat                                                          
(Data as of: 24APR2018)
Table 8.3101
Summary of Adverse Events of Special Interest by Cohort (All Infusions)
              Overall (N=xx)
Maximum Grade
AESI Category
   Preferred Term
1
2
3
4
5
3+4+5
Unknown
Total
ANY EVENT
  1  (1%)
  4  (5%)
  6  (7%)
71 (86%)
  0
77 (93%)
  0
82 (99%)
Potential symptoms of GVHD
   Any Event
24 (29%)
31 (37%)
26 (31%)
  0
  0
26 (31%)
  0
81 (98%)
   Nausea
40 (48%)
26 (31%)
  5  (6%)
  0
  0
  5  (6%)
  0
71 (86%)
   Diarrhoea
23 (28%)
14 (17%)
11 (13%)
  0
  0
11 (13%)
  0
48 (58%)
   Rash maculo-papular
17 (20%)
  8 (10%)
  6  (7%)
  0
  0
  6  (7%)
  0
31 (37%)
   Abdominal pain
15 (18%)
  6  (7%)
  4  (5%)
  0
  0
  4  (5%)
  0
25 (30%)
Note 1: Subjects are counted once for each preferred term under the most severe grade.
Note 2: Preferred terms are sorted by descending frequency of 'Total' AEs.
Note 3: Adverse events with missing grade are only included in 'Unknown' and 'Total' columns.
Note 4: Synonymous preferred terms are combined.
Programming note: AESI list will be provided by GSK. Please use the AESI list and report the synonym terms as described in appendix 2.
Use 8.3101 as a template for the following Table:
Table 8.3102
Summary of Adverse Events of Special Interest for the First Infusion 
Programming note: Please use the AESI list and report the synonym terms as described in appendix 2.
Use 8.3101 as a template for the following Table:
Table 8.3103
Overall Summary of Adverse Events of Special Interest by Cohort for the Second Infusion 
Programming note: Please use the AESI list and report the synonym terms as described in appendix 2.
Protocol: GSK208466/ADP-04511              
                                               
         Page 1 of 1
Population: Modified Intent-To-Treat                                   
      (Data as of: 24APR2018)
Table 8.3104


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Summary of Characterisics of Guillain-Barre Syndrome (All Infusions)
Cohort 1
(N=xx)
Cohort 2
(N=xx)
Cohort 3
(N=xx)
Cohort 4
(N=xx)
Cohort 2 -4
Total
  (N=xx)
Overall
(N=xx)
Number of Subjects with Events
   50 (50%)
   40 (40%)
   50 (50%)
   40 (40%)
   50 (50%)
   40 (40%)
Number of Events
   60
   40
   60
   40
   60
   40
Event Characteristics [1]
    
    
    
n
   50
   40
   50
   40
   50
   40
Serious
   10/50 (20%)
    4/40 (10%)
   10/50 (20%)
    4/40 (10%)
   10/50 (20%)
    4/40 (10%)
Drug-related
    5/50 (10%)
    3/40  (8%)
    5/50 (10%)
    3/40  (8%)
    5/50 (10%)
    3/40  (8%)
Fatal
    0
    0
    0
    0
    0
    0
Number of occurrences 
n
   50
   40
   50
   40
   50
   40
One
   40/50 (80%)
   40/40 (100%)
   40/50 (80%)
   40/40 (100%)
   40/50 (80%)
   40/40 (100%)
Two
   10/50 (20%)
    0
   10/50 (20%)
    0
   10/50 (20%)
    0
Three or more
    0
    0
    0
    0
    0
    0
Outcome [2] 
n
   50
   40
   50
   40
   50
   40
Recovered/Resolved
   50/50 (100%)
   30/40 (75%)
   50/50 
(100%)
   30/40 (75%)
   50/50 (100%)
   30/40 (75%)
Recovering/Resolving
    0
    6/40 (15%)
    0
    6/40 (15%)
    0
    6/40 (15%)
Not Recovered/Not Resolved
    0
    0
    0
    0
    0
    0
Recovered/Resolved w/sequelae
   10/50 (20%)
    4/40 (10%)
   10/50 (20%)
    4/40 (10%)
   10/50 (20%)
    4/40 (10%)
Fatal
    0
    0
    0
    0
    0
    0
[1] Subjects may be included in more than one category for ‘Event Characteristics’.
[2] Outcome worst case hierarchy: Fatal > Not Recovered/Not Resolved > Recovered/Resolved with sequelae > Recovering/Resolving > Recovered/Resolved
Programming note: Please use the AESI list of Guillain-Barre Syndrome; for No. of Events, n, No. of occurrences, outcome and grade counts please follow the AE 
collapsing rule in the RAP AESI section.
Protocol: GSK208466/ADP-04511              
                                                    
       Page 1 of 1
Population: Modified Intent-To-Treat                                                             
      (Data as of: 24APR2018)
Table 8.3104
PPD


CONFIDENTIAL
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Summary of Characterisics of Guillain-Barre Syndrome (All Infusions)
Cohort 1
(N=200)
Cohort 2
(N=100)
Cohort 3
(N=200)
Cohort 4
(N=100)
Cohort 2 – 4
Total
(N=200)
Overall
(N=100)
Maximum Grade 
n
   50
   40
   50
   40
   50
   40
Grade 1
    5/50 (10%)
    4/40 (10%)
    5/50 (10%)
    4/40 (10%)
    5/50 (10%)
    4/40 (10%)
Grade 2
    2/50  (4%)
    0   
    2/50  (4%)
    0   
    2/50  (4%)
    0   
Grade 3
    0
    0
    0
    0
    0
    0
Grade 4
   40/50 (80%)
   35/40 (88%)
   40/50 (80%)
   35/40 (88%)
   40/50 (80%)
   35/40 (88%)
Grade 5
    3/50  (6%)
    1/40  (3%)
    3/50  (6%)
    1/40  (3%)
    3/50  (6%)
    1/40  (3%)
[1] Subjects may be included in more than one category for ‘Event Characteristics’.
[2] Outcome worst case hierarchy: Fatal > Not Recovered/Not Resolved > Recovered/Resolved with sequelae > Recovering/Resolving > Recovered/Resolved
Programming note: Please use the AESI list of Guillain-Barre Syndrome; for No. of Events, n, No. of occurrences, outcome and grade counts please follow the AE 
collapsing rule in the RAP AESI section.
Use 8.3104 as a template for the following Table:
Table 8.3105
Summary of Characteristics of Cytokine Release Syndrome (All Infusions)
Table 8.3106
Summary of Characteristics of Cytokine Release Syndrome (All Infusions)
Table 8.3107
PPD


CONFIDENTIAL
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Summary of Characteristics of Recurrent Pancytopenia/Aplastic Anaemia (All Infusions)
Table 8.3108
Summary of Characteristics of Encephalopathy (All Infusions)
Table 8.3109
Summary of Characterisics of Guillain-Barre Syndrome (Second Infusions)
Programming note: population: subjects with a second T-cell infusion
Table 8.3110
Summary of Characteristics of Graft versus Host Disease (Second Infusions)
Programming note: population: subjects with a second T-cell infusion
Table 8.3111
Summary of Characteristics of Cytokine Release Syndrome (Second Infusions)
Programming note: population: subjects with a second T-cell infusion
Table 8.3112
Summary of Characteristics of Recurrent Pancytopenia/Aplastic Anaemia (Second Infusions)
Programming note: population: subjects with a second T-cell infusion
Table 8.3113
Summary of Characteristics of Encephalopathy (Second Infusions)
Programming note: population: subjects with a second T-cell infusion


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Population: Modified Intent-To-Treat                                                          
(Data as of: 24APR2018)
Table 8.3114
Summary of Onset and Duration of the First Occurrence of Guillain-Barre Syndrome
Cohort 1
(N=100)
Cohort 2
(N=100)
Cohort 3
(N=100)
Cohort 4
(N=100)
Cohort 2 – 4
   Total
(N=100)
Overall
(N=100)
Number of Subjects with Events
   50 (50%)
   40 (40%)
   50 (50%)
   40 (40%)
   50 (50%)
   40 (40%)
Time of onset, days
Subjects with event 
1-14
   40  
   40  
   40  
   40  
   40  
   40 
  15-28
   10   
    0  
   10   
   0  
   10   
    0  
>28
    0  
    0 
    0   
    0  
    0   
    0  
Mean
    2.5 
    2.1 
    2.5 
    2.1 
    2.5 
    2.1 
SD
    1.44
    1.24
    1.44
    1.24
    1.44
    1.24
Median
    4
    3
    4
    3
    4
    3
Min.
    1
    1
    1
    1
    1
    1
Max.
    8
    5
    8
    5
    8
    5
Duration, days
n
   50
   40
   50
   40
   50
   40
1-5
   40  (80%)
   40 (100%)
   40  (80%)
   40 (100%)
   40  (80%)
   40 (100%)
  6-10
   10  (20%)
    0
   10  (20%)
    0
   10  (20%)
    0
>10
    0
    0
    0
    0
    0
    0
  Mean
    2.5 
    2.1 
    2.5 
    2.1 
    2.5 
    2.1 
  SD
    1.44
    1.24
    1.44
    1.24
    1.44
    1.24
  Median
    4
    3
    4
    3
    4
    3
  Min.
    1
    1
    1
    1
    1
    1
  Max.
    8
    5
    8
    5
    8
    5
Note: Subjects at risk is calculated as the number at risk at the start of the interval.
Programming note: Please use the AESI list of Guillain-Barre Syndrome; for duration please follow the AE collapsing rule in the RAP AESI section.
Use 8.3114 as a template for the following Table:
Table 8.3115, Table 8.3116, Table 8.3117, Table 8.3118, Table 8.3119, Table 8.3120, Table 8.3121, Table 8.3122 and Table 8.3123
Use 8.3101 as a template for the table 8.3124 (programming note: please use the Comprehensive AESI flag)
Use 8.3102 as a template for the table 8.3125 (programming note: please use the Comprehensive AESI flag)
Use 8.3103 as a template for the table 8.3126 (programming note: please use the Comprehensive AESI flag)
PPD


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Use 8.3104 as template for the table:
Table 8.3127 Summary of Characteristics of Haematopoietic Cytopenias (Comprehensive List-All Infusions)
Population: mITT
Programming note: please use AESI comprehensive AESI list and use the AESI term “Haematopoietic cytopenias” to report this table.
Use 8.3104 as template for the table:
Table 8.3128 Summary of Characteristics of Haematopoietic Cytopenias (Comprehensive List-Second Infusions)
Population: Subjects with a Second T-Cell Infusion
Programming note: please use AESI comprehensive AESI list and use the AESI term “Haematopoietic cytopenias” to report this table.
Use 8.3114 as a template for the table:
Table 8.3129 Summary of Onset and Duration of the First Occurrence of Haematopoietic Cytopenias (Comprehensive List)
Population: mITT
Programming note: please use AESI comprehensive AESI list and use the AESI term “Haematopoietic cytopenias” to report this table.


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Population: Modified Intent-To-Treat                                                          
(Data as of: 24APR2018)
Table 8.3201
Time to Resolution of Grade >= 3 Haematopoietic Cytopenias (Comprehensive List)
Cohort 1
(N=100)
Cohort 2
(N=100)
Cohort 3
(N=100)
Cohort 4
(N=100)
Cohort 2 – 4
   Total
(N=100)
Overall
(N=100)
Number of Subjects with Events
   50 (50%)
   40 (40%)
   50 (50%)
   40 (40%)
   50 (50%)
   40 (40%)
Time to Resolution
Subjects with event 
≤ 28 days
   40  
   40  
   40  
   40  
   40  
   40 
  29 days – 3 months
   10   
    0  
   10   
    0  
10
0
  > 3 months
    0  
    0 
    0   
    0  
    0   
    0  
Note: Time to resolution is defined as time from T-cell infusion to the last date of end dates of AESI preferred terms. 
Programming note: Please use the comprehensive list AESI term Haematopoietic cytopenias.
Use table 8.3201 as a template for the following tables:
Table 8.3202 Time to Resolution of Grade >=3 Recurrent Pancytopenia/Aplastic Anaemia
Population: mITT
Programming note: Please use the focused list AESI term ‘Recurrent Pancytopenia/Aplastic Anaemia’
Table 8.3203 Time to Resolution of Grade >=3 Graft versus Host Disease
Population: mITT
Programming note: Please use the focused list AESI term GVHD.
Table 8.3204 Time to Resolution of Grade >=3 Cytokine Release Syndrome
Population: mITT
Programming note: Please use the focused list AESI term CRS.


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Population: Modified Intent-To-Treat                                                          
(Data as of: 24APR2018)
Table 8.4101
Change from Baseline to Each Scheduled Visit for Hematology Parameters for the Post-lymphodepletion Period
mITT Population
MITTFL = ‘Y’ and ADLB.PARCAT1 = ‘HEMATOLOGY’ and ADLB.ANLXXFL = ‘Y’ (if analysis flag for mean change tables)
Parameter
  Study Visit
    Timepoint
Statistic
Cohort 1
(N=xx)
Cohort 2
(N=xx)
Cohort 3
(N=xx)
Cohort 4
(N=xx)
Cohort 2-4
Total
(N=xx)
Overall
(N=xx)
Parameter 1 (units)
  Day 1
    Baseline
N
x
x
x
x
x
X
Mean 
xx.xx
xx.xx
xx.xx
xx.xx
xx.xx
xx.xx
SD
xx.xxx
xx.xxx
xx.xxx
xx.xxx
xx.xxx
xx.xxx
Median
xx.xx
xx.xx
xx.xx
xx.xx
xx.xx
xx.xx
Min,Max
xx.x,xx.x
xx.x,xx.x
xx.x,xx.x
xx.x,xx.x
xx.x,xx.x
xx.x,xx.x
    Visit
N
x
x
X
X
X
X
Mean 
xx.xx
xx.xx
xx.xx
xx.xx
xx.xx
xx.xx
SD
xx.xxx
xx.xxx
xx.xxx
xx.xxx
xx.xxx
xx.xxx
Median
xx.xx
xx.xx
xx.xx
xx.xx
xx.xx
xx.xx
Min,Max
xx.x,xx.x
xx.x,xx.x
xx.x,xx.x
xx.x,xx.x
xx.x,xx.x
xx.x,xx.x
    Change from Baseline
N
x
x
X
X
X
X
Mean 
xx.xx
xx.xx
xx.xx
xx.xx
xx.xx
xx.xx
SD
xx.xxx
xx.xxx
xx.xxx
xx.xxx
xx.xxx
xx.xxx
Median
xx.xx
xx.xx
xx.xx
xx.xx
xx.xx
xx.xx
Min,Max
xx.x,xx.x
xx.x,xx.x
xx.x,xx.x
xx.x,xx.x
xx.x,xx.x
xx.x,xx.x
Etc.
Continue for remaining scheduled visits
SD = Standard Deviation.
Note: Baseline is within 7 days prior to intitiating lymphodepletion.
File Name: S:\...... \&prog_name
Use 8.4101 as a template for the following Table:
Table 8.4102
Change from Baseline to Each Scheduled Visit for Chemistry Parameters for the Post-lymphodepletion Period
mITT Population


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Population: Modified Intent-To-Treat                                                          
(Data as of: 24APR2018)
Table 8.4201
Shifts from Baseline to Worst Post-Baseline NCI-CTCAE Grade for Hematology Parameters for the Post-lymphodepletion Period
mITT Population
SAFFL = ‘Y’ and ADLB.PARCAT1 = ‘HEMATOLOGY’ and ADLB.ANLXXFL = ‘Y’ (if analysis flag for shift tables)
Use ADLB.SHIFT1 for record with LVOTFL = ‘Y’.  If SHIFT1 is not in dataset, use ADLB.ANRIND and ADLB.BNRIND.
BNRIND contains baseline value, and ANRIND contains End of Treatment Value.
Worst On-Study Grade
Parameter/
  Cohort
Baseline
Grade
0
n/N (%)
1
n/N (%)
2
n/N (%)
3
n/N (%)
4
n/N (%)
Parameter 1
  Cohort 1 (N=xx)
0
1
2
3
4
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
  Cohort 2 (N=xx)
0
1
2
3
4
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
  Cohort 3 (N=xx)
0
1
2
3
4
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
  Cohort 4 (N=xx)
0
1
2
3
4
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
  Cohort 2-4 combined (N=xx)
0
1
2
3
4
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
x/x (xx.x)
  Cohort 1-4 conbined (N=xx)
    ………..
NCI-CTCAE = National Cancer Institute - Common Terminology Criteria for Adverse Events.
Note 1: For n/N, n=number of subjects who meet the criterion, N=number of subjects with both baseline and post-baseline results.
Note 2: Baseline is within 7 days prior to intitiating lymphodepletion.


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Use 8.4201 as a template for the following Table:
Table 8.4202
Shifts from Baseline to Worst Post-Baseline NCI-CTCAE Grade for Chemistry Parameters for the Post-lymphodepletion Period
mITT Population


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Population: Modified Intent-To-Treat                                                          
(Data as of: 24APR2018)
Table 8.4301
Number and Proportion of Subjects with Potentially Clinically Significant Hepatic Post-Baseline Results for the Post-lymphodepletion Period
mITT Population
Select records with ADLB.CRITXXFL = ‘Y’
Parameter ADLB.PARAM
Criterion
Statistic
Cohort 1
(N=xx)
Cohort 2
(N=xx)
Cohort 3
(N=xx)
Cohort 4
(N=xx)
Cohort 2-4
Total
(N=xx)
Overall
(N=xx)
ALT, AST and BIL 
Elevations
(≥3xULN AST and/or ALT) and ≥2xULN BIL
n/N (%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
(≥3xULN AST and/or ALT) and 
≥1.5xULN BIL
n/N (%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
ALT Elevations
≥20xULN
n/N (%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
≥10xULN
n/N (%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
≥5xULN
n/N (%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
≥3xULN
n/N (%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
BIL Elevations
>2 xULN
n/N (%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
>1.5 xULN
n/N (%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
ALT = Alanine aminotransferase, AST = Aspartate aminotransferase, BIL = Total bilirubin.
Note 1: Baseline is within 7 days prior to initiating lymphodepletion.
Note 2: For n/N, n=number of subjects who meet the criterion at least once, N=number of subjects with post-baseline results.
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Population: Modified Intent-To-Treat                                                          
(Data as of: 24APR2018)
Table 8.5001
Maximum Persistence and Time to Maximum Persistence for Responders, Non-Responders, and Overall for the First Infusion
mITT Population
Parameter 
Statistic
Cohort 1
(N=xx)
Cohort 2
(N=xx)
Cohort 3
(N=xx)
Cohort 4
(N=xx)
   Cohort 2-4
Total
(N=xx)
Overall
(N=xx)
Responders
Maximum Persistence
N
x
x
x
x
x
x
Mean 
xx.xx
xx.xx
xx.xx
xx.xx
xx.xx
xx.xx
SD
xx.xxx
xx.xxx
xx.xxx
xx.xxx
xx.xxx
xx.xxx
Median
xx.xx
xx.xx
xx.xx
xx.xx
xx.xx
xx.xx
Min,Max
xx.x,xx.x
xx.x,xx.x
xx.x,xx.x
xx.x,xx.x
xx.x,xx.x
xx.x,xx.x
Time to Maximum Persistence
N
x
x
x
x
x
x
Mean 
xx.xx
xx.xx
xx.xx
xx.xx
xx.xx
xx.xx
SD
xx.xxx
xx.xxx
xx.xxx
xx.xxx
xx.xxx
xx.xxx
Median
xx.xx
xx.xx
xx.xx
xx.xx
xx.xx
xx.xx
Maximum Cell Persistence (/µL)                  
…
Time to Maximum Cell Persistence (Days)         
…
Maximum Gene marked cells per total lymphocyte 
(%)  …
Time to Maximum Gene marked cells per total 
lymphocyte (%) (Days)                           
Min,Max
xx.x,xx.x
xx.x,xx.x
xx.x,xx.x
xx.x,xx.x
xx.x,xx.x
xx.x,xx.x
Repeast for Non-Responders and Overall.
Note 1: Time to maximum persistence is defined as date of maximum persistence for Infusion 1 visits – date of T Cell infusion + 1. 
Note 2: Cell Persistence = Absolute peripheral gene-marked cell number/µL = (Psi result number/151515) X (lymphocyte count + monocyte count) X 1000, where Psi  
is value collected on eCRF.
Note 3: Percent of gene marked cells per total lymphocyte compartment = ((Absolute peripheral gene marked cell number/μL)/Lymphocyte count x 1000)) X 100.
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Population: Modified Intent-To-Treat                                                          
(Data as of: 24APR2018)
Table 8.5002
Number and Proportion of RCL Positive Subjects
mITT Population
Parameter 
Statistic
Cohort 1
(N=xx)
Cohort 2
(N=xx)
Cohort 3
(N=xx)
Cohort 4
(N=xx)
    Cohort 2-
4
Total
(N=xx)
Overall
(N=xx)
RCL Positive
n/N
xx/XX (xx.x%) xx/XX 
(xx.x%)
xx/XX 
(xx.x%)    
xx/XX (xx.x%) xx/XX (xx.x%) xx/XX (xx.x%)
Note: n = number of subjects who are RCL positive at any time after initial T Cell infusion, N = number of subjects tested for RCL 
at least once after initial T Cell infusion. 
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Population: Modified Intent-To-Treat                                                          
(Data as of: 24APR2018)
Table 8.5003
Number and Percentage of Subjects with Potentially Clinically Significant Post-Baseline Vital Signs Results
MITT Population
  Cohort 2-4
Total
(N=xx)
Parameter
Criterion
Statistic
Cohort 1
(N=xx)
Cohort 2
(N=xx)
Cohort 3
(N=xx)
Cohort 4
(N=xx)
Overall
(N=xx)
Heart Rate
< 60 bpm
n/N (%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
> 100 bpm
n/N (%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
Systolic Blood Pressure
>=140 mmHg
n/N (%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
Diastolic Blood Pressure
>=90mmHg
n/N (%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
Note 1: Baseline is within 7 days of initiating lymphodepletion. 
Note 2: For n/N, n=number of subjects who meet the criterion at least once, N=number of subjects with post-baseline results.
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Population: Modified Intent-To-Treat                                                          
(Data as of: 24APR2018)
Table 8.6101
Summary of ECOG Performance Status at Each Visit 
MITT Population
Visit/
Score
Statistic
Cohort 1
(N=xx)
Cohort 2
(N=xx)
Cohort 3
(N=xx)
Cohort 4
(N=xx)
    Cohort 2-4
Total
(N=xx)
Overall
(N=xx)
Screening
    0
n/N(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
    1
n/N(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
    2
n/N(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
    3
n/N(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
    4
n/N(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
    5
n/N(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
Baseline
0
n/N(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
    1
n/N(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
    2
n/N(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
    3
n/N(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
    4
n/N(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
    5
n/N(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
T-CELL INFUSION
0
n/N(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
    1
n/N(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
    2
n/N(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
    3
n/N(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
    4
n/N(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
    5
n/N(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
xx/xx(%)
Etc.    Programming note:  continue for each post-baseline visit. 
ECOG = Eastern Cooperative Oncology Group. 
Note 1: Baseline is within 7 days of initiating lymphodepletion.
Note 2: ECOG Score: 0 – Fully active and able to carry on all pre-disease activities without restriction, 1 – Restricted in physically strenuous activity but 
ambulatory and able to carry out work of a light sedimentary nature, 2 – Ambulatory and capable of all self-care but unable to carry out any work activities, 3 
– Capable of only limited self-care, 4 – Completely disabled, 5 – Dead. 
File Name: S:\...... \&prog_name
Protocol: GSK208466/ADP-04511              
                                                               
         
Page 1 of 4
Population: Modified Intent-To-Treat                                                          
      
(Data as of: 24APR2018)
Figure 17.0001


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Maximal Reduction in Sum of Diameters of Target Lesions from Baseline through Progression or Prior to Subsequent Anti-Cancer Therapy for the First Infusion
Cohort 1
Programming note: please also exclude recordes after anti-cancer treatment.
PPD


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Protocol: GSK208466/ADP-04511              
                                                               Page 2 of 4
Population: Modified Intent-To-Treat                                                          
(Data as of: 24APR2018)
Figure 17.0001
Maximal Reduction in Sum of Diameters of Target Lesions from Baseline through Progression or Prior to Subsequent Anti-Cancer Therapy for the First Infusion
Cohort 2
Programming note: please also exclude recordes after anti-cancer treatment.
PPD


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Protocol: GSK208466/ADP-04511              
                                                               Page 3 of 4
Population: Modified Intent-To-Treat                                                          
(Data as of: 24APR2018)
Figure 17.0001
Maximal Reduction in Sum of Diameters of Target Lesions from Baseline through Progression or Prior to Subsequent Anti-Cancer Therapy for the First Infusion
Cohort 3
Programming note: please also exclude recordes after anti-cancer treatment.
PPD


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Protocol: GSK208466/ADP-04511              
                                                               
Page 4 of 4
Population: Modified Intent-To-Treat                                                          
(Data as of: 24APR2018)
Figure 17.0001
Maximal Reduction in Sum of Diameters of Target Lesions from Baseline through Progression or Prior to Subsequent Anti-Cancer Therapy for the First Infusion 
Cohort 4
Programming note: please also exclude recordes after anti-cancer treatment.
PPD


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Protocol: GSK208466/ADP-04511              
                                                               
Page 1 of 4
Population: Modified Intent-To-Treat                                                          
(Data as of: 24APR2018)
Figure 17.0002
Maximal Reduction in Sum of Diameters of Target Lesions from the Second Infusion through Progression or Prior to Subsequent Anti-Cancer Therapy
Programming note: for subjects who received 2nd infusion report them all together in in graph and if possible mark the corresponding cohort under the subject ID.
Programming note: please also exclude recordes after anti-cancer treatment.
PPD


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Protocol: GSK208466/ADP-04511              
                                                               Page 1 of 4
Population: Modified Intent-To-Treat                                                          
(Data as of: 24APR2018)
Figure 17.1001
Kaplan-Meier Plot of Progression-Free Survival
Programming note: please plot all KM curves in on graph and provide legend.


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Protocol: GSK208466/ADP-04511              
                                                               
Page 1 of 4
Population: Modified Intent-To-Treat                                                          
(Data as of: 24APR2018)
Figure 17.1002
Kaplan-Meier Plot of Overall Survival
Programming note: please plot all KM curves in on graph and provide legend.


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Protocol: GSK208466/ADP-04511              
                                                               
Page 1 of 4
Population: Modified Intent-To-Treat                                                          
(Data as of: 24APR2018)
Figure 17.2001
Response Characteristics via RECIST 1.1 and Follow-up
Cohort 1
Programming note: please repeat for cohort 2-4 and add 2nd infusion info. (add a symbol for the start timepoint of the 2nd infusion.) And also change the X-axis 
label to Time from the First Tcell Infusion (Weeks); please change “x Surgical Resection” to “x Surgical Resection/Anti-Cancer Therapy” in the lengend and so 
please also mark the anti-cancer therapy in the plot.
PPD


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Protocol: GSK208466/ADP-04511              
                                                               
Page 1 of 4
Population: Modified Intent-To-Treat                                                          
(Data as of: 24APR2018)
Figure 17.3001
Boxplots for Peak Expansion by Responders vs. Non-Responders for the First Infusion
Cohort 1
Note: Within each boxplot, the horizontal line is the median and the diamond is the mean.
Programming note: please repeat for cohort 2-4.


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Protocol: GSK208466/ADP-04511              
                                                               
Page 1 of 4
Population: Modified Intent-To-Treat                                                          
(Data as of: 24APR2018)
Figure 14.4001
Spider Plots for Persistence Results over Time (Truncated at 60 Days) by Responders vs. Non-Responders for the First Infusion
Cohort 1
Note: Y-axis is log-transformed. Values below the lower limit of quantitation are set to 1.
The R and NR before the subject number indicate responders and non-responders, respectively.
Programming note: please repeat for cohort 2-4.
PPD
PPD
PPD
PPD
PPD
PPD


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Protocol: GSK208466/ADP-04511              
                                                               
Page 1 of 4
Population: Modified Intent-To-Treat                                                          
(Data as of: 24APR2018)
Figure 17.4002
Spider Plots for Persistence Results over Time (Truncated at 100 Days) by Responders vs. Non-Responders for the First Infusion 
Cohort 1
Note: Y-axis is log-transformed. Values below the lower limit of quantitation are set to 1.
The R and NR before the subject number indicate responders and non-responders, respectively.
Programming note: please repeat for cohort 2-4.
PPD
PPD
PPD
PPD
PPD
PPD


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Protocol: GSK208466/ADP-04511              
                                                               Page 1 of 4
Population: Modified Intent-To-Treat                                                          
(Data as of: 24APR2018)
Figure 17.4003
Spider Plots for Persistence Results over Time by Responders vs. Non-Responders for the First Infusion 
Cohort 1
Note: Y-axis is log-transformed. Values below the lower limit of quantitation are set to 1.
The R and NR before the subject number indicate responders and non-responders, respectively.
Programming note: please repeat for cohort 2-4.
PPD
PPD
PPD
PPD
PPD
PPD


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Protocol: GSK208466/ADP-04511              
                                                               
Page 1 of 4
Population: Modified Intent-To-Treat                                                          
(Data as of: 24APR2018)
Figure 17.4004
Spider Plots of Change from Baseline in Target Lesion through Progression and Prior to Subsequent Anti-Cancer Therapy  Over Time by Response Status for the 
First Infusion
Cohort 1
Note: The R and NR before the subject number indicate responders and non-responders, respectively.
Programming note: please repeat for cohort 2-4. Please also exclude data after anti-cancer therapy (including anti-cancer surgery)
Figure 17.4005: Spider Plots for Persistence Results over Time (Truncated at 60 Days) by Responders vs. Non-Responders for the Second Infusion
Programming note: Repeat Figure 17.4001 for subjects who had 2nd infusion. Please report all subjects who received the 2nd infusion from different cohorts in one 
plot. Responders/non-responders are only for the 2nd infusion period. please also mark the patient cohort in the legend.
PPD
PPD
PPD
PPD
PPD
PPD


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Figure 17.4006: Spider Plots for Persistence Results over Time (Truncated at 100 Days) by Responders vs. Non-Responders for the Second Infusion 
Programming note: Repeat Figure 17.4002 for subjects who had 2nd infusion. Please report all subjects who received the 2nd infusion from different cohorts in one 
plot. Responders/non-responders are only for the 2nd infusion period. please also mark the patient cohort in the legend.
Figure 17.4007: Spider Plots for Persistence Results over Time by Responders vs. Non-Responders for the Second Infusion 
Programming note: Repeat Figure 17.4003 for subjects who had 2nd infusion. Please report all subjects who received the 2nd infusion from different cohorts in one 
plot. Responders/non-responders are only for the 2nd infusion period. please also mark the patient cohort in the legend.
Figure 17.4008: Spider Plots of Change from Baseline in Target Lesion through Progression and Prior to Subsequent Anti-Cancer Therapy  Over Time by Response 
Status for the Second Infusion
Programming note: Repeat Figure 17.4004 for subjects who had 2nd infusion. Please report all subjects who received the 2nd infusion from different cohorts in one 
plot. Responders/non-responders are only for the 2nd infusion period. please also mark the patient cohort in the legend.


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Protocol: GSK208466/ADP-04511              
                                                               
Page 1 of 4
Population: Modified Intent-To-Treat                                                          
(Data as of: 24APR2018)
Figure 18.5003
Characteristics of CRS Plot for the First Infusion
Cohort 1
Programming note: please repeat for cohort 2-4. Please use the focused scope AESI list. Change the x-axis label to “Time from the First Tcell Infusion (Days)”
PPD


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Use Figure 18.5003 as a template for the following figures:
Figure 18.5004
Characteristics of CRS Plot for the Second Infusion
Population: Subjects with a Second T-Cell Infusion
Programming note: please repeat for cohort 2-4. Please use the focused AESI list. Change the x-axis label to “Time from the Second Tcell Infusion (Days)”
Figure 18.5005
Characteristics of Recurrent Pancytopenia with Bone Marrow Failure/Aplastic Anemia plot for the First Infusion
Population: MITT
Programming note: please repeat for cohort 2-4. Please use the focused AESI list of Recurrent Pancytopenia with Bone Marrow Failure/Aplastic Anemia.
Figure 18.5006
Characteristics of Recurrent Pancytopenia with Bone Marrow Failure/Aplastic Anemia plot for the Second Infusion
Population: MITT
Programming note: please repeat for cohort 2-4. Please use the focused AESI list of Recurrent Pancytopenia with Bone Marrow Failure/Aplastic Anemia. Change the 
x-axis label to “Time from the Second Tcell Infusion (Days)”
Protocol: GSK208466/ADP-04511              
                                                               
         
Page 1 of 4
Population: Modified Intent-To-Treat                                                          
      
(Data as of: 24APR2018)
Figure 18.5101
Profile of INF-Gamma by CRS Status and Subject (First Infusion)
Cohort 1


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Programming note: please repeat for cohort 2-4. Please use the focused scope AESI list. By CSR (None or Non-Serious CRS vs. Serious CRS) and add legend for 
start and stop of CRS event. Change color of label for end of event.
Use Figure 18.5101 as a template for the following figures:
Figure 18.5102
Profile of IL-6 by CRS Status and Subject (First Infusion)
Population: Modified Intent-To-Treat                                                          
Figure 18.5103
Profile of IL-8 by CRS Status and Subject (First Infusion)
Population: Modified Intent-To-Treat                                                          
PPD
PP
PPD
PPD
PPD


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Figure 18.5104
Profile of IL-12 by CRS Status and Subject (First Infusion)
Population: Modified Intent-To-Treat                                                          
Figure 18.5105
Profile of IL-13 by CRS Status and Subject (First Infusion)
Figure 18.5106
Profile of TNF-Alpha by CRS Status and Subject (First Infusion)
Population: Modified Intent-To-Treat                                                          
Figure 18.5107
Profile of TNF-Gamma by Response and Subject (First Infusion)
Population: Modified Intent-To-Treat                                                          
Programming note: Change the graph tile to “Responder” and “Non-Responder”
Figure 18.5108
Profile of IL-6 by Response and Subject (First Infusion)
Population: Modified Intent-To-Treat                                                          
Programming note: Change the graph tile to “Responder” and “Non-Responder”
Figure 18.5109
Profile of IL-8 by Response and Subject (First Infusion)
Population: Modified Intent-To-Treat                                                          
Programming note: Change the graph tile to “Responder” and “Non-Responder”
Figure 18.5110
Profile of IL-12 by Response and Subject (First Infusion)
Population: Modified Intent-To-Treat                                                          
Programming note: Change the graph tile to “Responder” and “Non-Responder”
Figure 18.5111
Profile of IL-13 by Response and Subject (First Infusion)
Population: Modified Intent-To-Treat                                                          
Programming note: Change the graph tile to “Responder” and “Non-Responder”
Figure 18.5112
Profile of TNF-Alpha by Response and Subject (First Infusion)
Population: Modified Intent-To-Treat                                                          
Programming note: Change the graph tile to “Responder” and “Non-Responder”


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Protocol: GSK208466/ADP-04511              
                                                               
Page 1 of 4
Population: Modified Intent-To-Treat                                                          
(Data as of: 24APR2018)
Figure 18.5113
Peak Cytokine Expression of INF-Gamma by CRS Status (First Infusion)
Cohort 1
Programming note: please repeat for cohort 2-4. By CSR (None or Non-Serious CRS vs. Serious CRS).
Use Figure 18.5113 as a template for the following figures:
Figure 18.5114
Peak Cytokine Expression of IL-6 by CRS Status (First Infusion)
Population: Modified Intent-To-Treat
Figure 18.5115


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Peak Cytokine Expression of IL-8 by CRS Status (First Infusion)
Population: Modified Intent-To-Treat
Figure 18.5116
Peak Cytokine Expression of IL-12 by CRS Status (First Infusion)
Population: Modified Intent-To-Treat
Figure 18.5117
Peak Cytokine Expression of IL-13 by CRS Status (First Infusion)
Population: Modified Intent-To-Treat
Figure 18.5118
Peak Cytokine Expression of TNF-Alpha by CRS Status (First Infusion)
Population: Modified Intent-To-Treat
Figure 18.5119
Peak Cytokine Expression of INF-Gamma by Response (First Infusion)
Population: Modified Intent-To-Treat
Programmingn note: by responder and non-responder. Please change the x-axis labels to “Responder” and “Non-Responder”
Figure 18.5120
Peak Cytokine Expression of IL-6 by Response (First Infusion)
Population: Modified Intent-To-Treat
Programmingn note: by responder and non-responder. Please change the x-axis labels to “Responder” and “Non-Responder”
Figure 18.5121
Peak Cytokine Expression of IL-8 by Response (First Infusion)
Population: Modified Intent-To-Treat
Programmingn note: by responder and non-responder. Please change the x-axis labels to “Responder” and “Non-Responder”
Figure 18.5122
Peak Cytokine Expression of IL-12 by Response (First Infusion)
Population: Modified Intent-To-Treat
Programmingn note: by responder and non-responder. Please change the x-axis labels to “Responder” and “Non-Responder”
Figure 18.5123
Peak Cytokine Expression of IL-13 by Response (First Infusion)
Population: Modified Intent-To-Treat
Programmingn note: by responder and non-responder. Please change the x-axis labels to “Responder” and “Non-Responder”
Figure 18.5124
Peak Cytokine Expression of TNF-Alpha by Response (First Infusion)
Population: Modified Intent-To-Treat
Programmingn note: by responder and non-responder. Please change the x-axis labels to “Responder” and “Non-Responder”
Protocol: GSK208466/ADP-04511           
                                                                       Page 1 of 1
Population: Intent-To-Treat                                                                  
      (Data as of: 24APR2018)
Listing 26.0001
Subject Disposition 


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Programmer: If reason for discontinuation is ‘Protocol Violation’ or ‘Failed manufacture of cell product’, report this as Reason (e.g. Protocol): <specify> 
where the specify is from SUPPDS.
There are up to 3 Informed Consent Dates: 1) at Screening visit for study, 2) for treatment, and for second infusion.
Patient Status will be ‘End of Infusion 1’ or= ‘Infusion 2’, depending on when the subject exited the study. 
_____________________________________________________________________________________________________________________________________________________
Y = Yes, N = No.
Note: Study Day is relative to the date of the first T cell infusion, which is Study Day 1.
$ Subject Status = ‘Infusion 1’ or ‘Infusion 2’, depending on when subject exited the study.
File Name: S:\...... \&prog_name
Subject
ADSL.SUBJID
Screening Treatment
Informed  Informed
Consent   Consent 
Date      Date
Protocol 
Version
Subject
Status $
Discontinu-
ation Date
Reason for 
Discontinuation
Second 
T-Cell 
Infusion?
Second 
Infusion
Consent Date
Date
of
Death
Cohort:
ADSL.ACTARM    


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Protocol: GSK208466/ADP-04511           
                                                                       Page 1 of 1
Population: Intent-To-Treat                                                                  
      (Data as of: 24APR2018)
Listing 26.0002
Study Visits 
_____________________________________________________________________________________________________________________________________________________
Cohort
ADSL.ACTARM
Subject
ADSL.SUBJID
Visit
    
Visit Date          Reason for
(Study Day)         Unscheduled Visit
_____________________________________________________________________________________________________________________________________________________
Note: Study Day is relative to the date of the first T cell infusion, which is Study Day 1.
File Name: S:\...... \&prog_name


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Protocol: GSK208466/ADP-04511           
                                                                       Page 1 of 1
Population: Intent-To-Treat                                                                  
      (Data as of: 24APR2018)
Listing 26.1401
Inclusion and Exclusion Criteria Not Met Prior to Leukapheresis 
_____________________________________________________________________________________________________________________________________________________
Note to programmer:  Criterion Type Violated = ‘Inclusion’ or ‘Exclusion’.
If all criteria were met, insert statement into listing: ‘All subjects met inclusion and exclusion criteria’  
_____________________________________________________________________________________________________________________________________________________
Note: Only subjects who did not meet all inclusion/exclusion criteria prior to leukapheresis are listed.
File Name: S:\...... \&prog_name
Cohort
ADSL.ACTARM
Subject
ADSL.SUBJID
Criterion Type    
Violated            
Criterion Number
Violated


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Protocol: GSK208466/ADP-04511           
                                                                       Page 1 of 1
Population: Intent-To-Treat                                                                  
      (Data as of: 24APR2018)
Listing 26.1403
Protocol Deviations
Cohort
Subject
Date Of
Deviation
(Study Day)
Description
ADSL.ACTARM
ADSL.SUBJID
DV.DVSTDTC
DV.DVTERM
Note to programmer: exact layout of the listing will not be known until later. Deviations not collected on eCRF.
Note 1: Study Day is relative to the date of the first T cell infusion, which is Study Day 1.
Note 2: Only subjects with protocol deviations are listed.
File Name: S:\...... \&prog_name


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Protocol: GSK208466/ADP-04511           
                                                                       Page 1 of 1
Population: Intent-To-Treat                                                                  
      (Data as of: 24APR2018)
Listing 26.1101
Demographics and Baseline Characteristics
_____________________________________________________________________________________________________________________________________________________
Note to programmer: If race is Other, report this as Other: <specify>. 
____________________________________________________________________________________________________________________________________________________
BMI = Body Mass Index (calculated from weight and height), BSA = Body Surface Area (from eCRF).
File Name: S:\...... \&prog_name
Cohort
ADSL.ACTARM   
Cohort 
Number
Subject 
ADSL.SUBJID
Date of 
Birth
Age
(Years)
Sex
Child-
Bearing
Potetnial? Race
Ethnicity
Weight
(kg)
Height
(cm)
BMI
(kg/m2)
BSA 
(m2)
Strip number 
from 
ADSL.ARCMD, 
this should 
match number 
in ACTARM 
except for 
subjects with 
treatment of 
‘Not 
Assigned’


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Protocol: GSK208466/ADP-04511           
                                                                       Page 1 of 1
Population: Intent-To-Treat                                                                  
      (Data as of: 24APR2018)
Listing 26.3101
Medical History
MHCAT = ‘GENERAL MEDICAL HISTORY’
Cohort
Subject 
S:System Organ Class
P:Preferred Term
V:Verbatim Term
Start Date
End Date
Or Ongoing
Treated?
ADSL.ACTARM
ADSL.SUBJID
S: MH.MHBODSYS
P: MH.MHDECOD
V: MH.MHTERM`
MH.MHSTDTC
MH.MHENDTC
Or ONGOING
Note to Programmer: medical history will be coded with MedDRA.
______________________________________________________________________________________________________________________________________
Y = Yes, N = No.
Note 1: Only subjects with medical history reported are listed.
File Name: S:\...... \&prog_name
Protocol: GSK208466/ADP-04511           
                                                                       Page 1 of 1


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Population: Intent-To-Treat                                                                  
      (Data as of: 24APR2018)
Listing 26.3102
HLA and NY-ESO-1 Antigen 
_____________________________________________________________________________________________________________________________________________________
Cohort
ADSL.ACTARM
Subject 
ADSL.SUBJID
Sample Date for
Cancer Testis 
Antigen Expression
HLA-A*0201
HLA-A*0205
HLA-A*0206
Other
HLA
Status
NY-ESO-1 Status
Note to programmer: The HLA and NY-ESO-1 status in this listing is from the Screening Enrollment CRF and the data is in S.SC. 
A subject may have more than one HLA status. If HLA Status is Other, report the <specify> in the Other column. A subject will have only one NY-ESO-1 status. 
_____________________________________________________________________________________________________________________________________________________
Y = Yes, N = No.
File Name: S:\...... \&prog_name


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Protocol: GSK208466/ADP-04511           
                                                                       Page 1 of 1
Population: Intent-To-Treat                                                                  
      (Data as of: 24APR2018)
Listing 26.2101
Disease Characteristics 
_____________________________________________________________________________________________________________________________________________________
Cohort
ADSL.ACTARM
Subject 
ADSL.SUBJID
Primary/Original
Diagnosis Date
Primary Disease 
Site at Screening
Disease Stage 
at Screening
Grade of 
Histology
Type of Histology
MHSTDTC when MHCAT = 
'PRIMARY DIAGNOSIS'
Note to programmer: if Disease Stage or Type of Histology is Other, report this as Other: <specify>. 
_____________________________________________________________________________________________________________________________________________________
File Name: S:\...... \&prog_name


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Protocol: GSK208466/ADP-04511           
                                                                       Page 1 of 1
Population: Intent-To-Treat                                                                  
      (Data as of: 24APR2018)
Listing 26.4001
Prior Cancer Surgery
_____________________________________________________________________________________________________________________________________________________
Cohort
Subject 
Organ – Site
of Surgery
Description of Surgery
Surgery
Date
ADSL.ACTARM
ADSL.SUBJID
_____________________________________________________________________________________________________________________________________________________
N = No, Y = Yes.
Note: Only subjects with prior cancer surgery are listed.
File Name: S:\...... \&prog_name


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Protocol: GSK208466/ADP-04511           
                                                                       Page 1 of 1
Population: Intent-To-Treat                                                                  
      (Data as of: 24APR2018)
Listing 26.4002
Prior Oncology Treatment
_____________________________________________________________________________________________________________________________________________________
Subject
ADSL.SUBJID 
Therapy
Class
Therapy Description
Dose
Ordered
Start 
Date
End 
Date
Best Response
Cohort:
ADSL.ACTARM
  
Note to programmer: All prior treatments from CM except for Radiation which is in S.PR
Note: Only subjects reporting prior oncology treatment are listed.
File Name: S:\...... \&prog_name


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Protocol: GSK208466/ADP-04511           
                                                                       Page 1 of 1
Population: Intent-To-Treat                                                                  
      (Data as of: 24APR2018)
Listing 28.0001
Dates of Leukapheresis, Lymphodepleting Chemotherapy, and T-Cell Infusion
______________________________________________________________________________________________________________________________________
Cohort
ADSL.ACTARM
Subject
ADSL.SUBJID
Visit
Treatment
Date of Treatment
(Study Day)
Note to programmer: Treatment will be Leukapheresis, Lymhodepleting Chemotherapy (list which med was given), or T-Cell 
______________________________________________________________________________________________________________________________________
Note: Study Day is relative to the date of the first T cell infusion, which is Study Day 1.
File Name: S:\...... \&prog_name


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Protocol: GSK208466/ADP-04511           
                                                                       Page 1 of 1
Population: Intent-To-Treat                                                                  
      (Data as of: 24APR2018)
Listing 28.0002
Lymphodepleting Chemotherapy 
______________________________________________________________________________________________________________________________________
Subject
ADSL.SUBJID
Medication 
Date of Med 
(Study Day)
Start
Time
End
Time
Time
Point
Hospital-
ized? #
Dose             Infusion
(mg/m^2)         Duration @
Cohort:
Note to Programmers: Include Fludarabine, Cyclophosphamide, and Mesna. Time Point is Pre-CTX or Post-CTX for Mesna.
______________________________________________________________________________________________________________________________________
Note: Study Day is relative to the date of the first T cell infusion, which is Study Day 1.
# For Cyclophosphamide treatment.
@ Duration follows ISO 8601 format. P indicates that the value is a duration, T = Time, H = Hours, M = Minutes, D = Days.
File Name: S:\...... \&prog_name


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Protocol: GSK208466/ADP-04511           
                                                                       Page 1 of 1
Population: Intent-To-Treat                                                                  
      (Data as of: 24APR2018)
Listing 28.0003
T Cell Infusion 
______________________________________________________________________________________________________________________________________
Subject
ADSL.SUBJID
T-Cell 
Infusion Date 
(Study Day)
Start Time/
End Time
Total Cell
Dose (x10^9)
Total
Cells
Transduced
(x10^9)
Percent of 
Cells 
Infused
(%) #
Reason
Whole Bag
Not Infused #
Duration 
of Infusion
Vector 
Copy 
Number 
(copies)
Lot Number 
(PCT Unit #)
Reaction
To
Infusion?
EXADJ       ECDUR or
Cohort:
EXDUR
______________________________________________________________________________________________________________________________________
Y = Yes, N = No.
Note 1: Only subjects who received T Cell Infusion are listed.
Note 2: Study Day is relative to the date of the first T cell infusion, which is Study Day 1.
# If whole bag was not infused.
File Name: S:\...... \&prog_name


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Protocol: GSK208466/ADP-04511           
                                                                       Page 1 of 1
Population: Intent-To-Treat                                                                  
      (Data as of: 24APR2018)
Listing 27.0001
Lesion Measurements and Assessments by RECIST v1.1
______________________________________________________________________________________________________________________________________
      ADTRREC. 
Subject 
TR.
TRVISIT
Visit
TR.TRDTC
Assessment
Date
(Study Day)
Method
Lesion
ID $
Organ
Site 
Tumor 
Type
Criterion
Longest 
Diameter
(mm)
Short 
Axis
(mm)
PARAMCD=
SDIAM
Sum of 
Longest 
Diameter
(mm) 
% Change
From Baseline
PCHG for SDIAM 
for BASETYPE = 
NADIR 1
% Change
from Nadir
Assessment @
     SUPPTU.SITE TRCAT      TRTESTCD=  
   TRTESTCD =
Cohort:
TRMETHOD TRLNKID
  TRGRPID           LDIAM    TRTESTCD=
PCHG for 
   TR.TUMSTATE
TULOC
     
       SAXIS
SDIAM for 
     
BASETYPE =
PRETREATMENT BASELINE 1
Note to programmer: If Site or Modality is Other, report this as Other: <specify>. If TRSTAT = ‘NOT DONE’, ‘ND:’<reason not done> under Assessment Date.
Organ, Site, Sum of Longest Diameter and Sum of Short Axis only occur for first row per subject per visit. Tumor Type is Index,Non-Index, Target, Target Nodal, 
Non-Target, and New. Criterion is IRRC or RECIST v1.1. Assessment is Tumor State. 
______________________________________________________________________________________________________________________________________
ND = Not Done.
Note 1: Study Day is relative to the date of the first T cell infusion, which is Study Day 1.
Note 2: Sum of Longest Diameter is sum of the longest diameter for non-nodal lesions and short axis for nodal lesions. Sum of Short Axis is sum of the short 
axis for all nodal lesions.
Note 3: Listing includes subjects who received at least one T cell infusion.
@ Assessment was performed by investigator and applies to Non-target lesions and New lesions.
$ T = Target lesion, NT = Non-target lesion, NEW = New lesion.
File Name: S:\...... \&prog_name


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Population: Intent-To-Treat                                                                  
      (Data as of: 24APR2018)
Listing 27.0003
Response Assessments and Overall Response by RECIST v1.1 for the First Infusion 
______________________________________________________________________________________________________________________________________
                            
Subject
Visit
Date of
T Cell
Infusion
Assessment 
Date 
(Study Day)
Target 
Lesion 
Evaluation
Non-Target 
Lesion 
Evaluation
New 
Lesions?
Visit       Best   
Overall    Overall  
Response  Response  
ADSL.SUBJID
TRTSDT
ADT
AVALC
AVALC
AVALC
AVALC
Cohort:
for
for
for
for
TRGRESP
NTRGRESP NEWLES VISRESP
Note to programmer:  Put ‘ND’ under Assessment Date if tumor was NOT assessed on a visit. 
______________________________________________________________________________________________________________________________________
N
Y = Yes, N = No, PD = Progressive Disease, SD = Stable Disease, NE = Not Evaluable, CR = Complete Response, PR = Partial Response.
RECIST = Response Evaluation Criteria in Solid Tumors.
Note 1: Study Day is relative to the date of the first T cell infusion, which is Study Day 1.
Note 2: Evaluation of target and non-target lesions does not take into account the presence of new lesions.
The overall response does take new lesions into account.
Note 3: Subject 
 had a Day 3 assessment of PD that was not used in derivation of Best Overall Response.
File Name: S:\...... \&prog_name
PPD


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Use Template for Listing 27.0003 for
Listing 27.0004
Response Assessments and Overall Response by RECIST v1.1 Following a Second T Cell Infusion
(Programming note: Please use the following footnotes:
Y = Yes, N = No, PD = Progressive Disease, SD = Stable Disease, NE = Not Evaluable, CR = Complete Response, PR = Partial Response.
RECIST = Response Evaluation Criteria in Solid Tumors.
Note 1: Listing includes only subjects who had a second T cell infusion.
Note 2: 1st Study Day is relative to the date of the first T cell infusion, 2nd study day is relative to date of the second T cell infusion.)


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Population: Intent-To-Treat                                                                  
      (Data as of: 24APR2018)
Listing 27.0005
Investigator RECIST v1.1 Response Assessments and Overall Response for the First Infusion 
______________________________________________________________________________________________________________________________________
                            
Subject Visit
Date of
T Cell
Infusion
Assessment 
Date 
(Study Day)
Target 
Lesions 
Evaluation
Non-Target 
Lesions
Evaluation
New 
Lesions?
Visit
Overall  
Response
Best
Overall
Response
ADSL.SUBJID
TRTSDT
ADT
AVALC
AVALC
AVALC
AVALC
Cohort:
for
for
for
for
TRGRESP
NTRGRESP NEWLES VISRESP
Note to programmer:  Put ‘ND’ under Assessment Date if tumor was NOT assessed on a visit. 
____________________________________________________________________________________________________________________________________              __
Y = Yes, N = No, PD = Progressive Disease, SD = Stable Disease, NE = Not Evaluable, CR = Complete Response, PR = Partial Response.
RECIST = Response Evaluation Criteria in Solid Tumors.
Note 1: Listing includes subjects who received at least one T cell infusion.Note 2: Study Day is relative to the date of the first T cell infusion, which is 
Study Day 1.
Note 3: Subjects
 received anti-cancer therapy on 
.
File Name: S:\...... \&prog_name
Use Template for Listing 27.0005 for
Listing 27.00051
Investigator RECIST v1.1 Response Assessments and Overall Response Following a Second T Cell Infusion
Programming note: Please using the following footnotes:
Y = Yes, N = No, PD = Progressive Disease, SD = Stable Disease, NE = Not Evaluable, CR = Complete Response, PR = Partial Response.
RECIST = Response Evaluation Criteria in Solid Tumors.
Note 1: Listing includes only subjects who had a second T cell infusion.
Note 2: 1st Study Day is relative to the date of the first T cell infusion, 2nd study day is relative to date of the second T cell infusion.
PPD
PPD


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Population: Intent-To-Treat                                                                  
      (Data as of: 24APR2018)
Listing 27.0007
Progression-Free Survival and Overall Survival
ADTTEREC.PARAMCD = ‘PFS’ for Reason for PD, Death, Date of PD/Death, Progression-Free Survival.
ADTTEREC.PARAMCD = ‘OS’ for Date of Death or Censoring and Overall Survival
From ADTTEREC
Note to programmer: there may be multiple reasons for PD. Each can go on a different row. These will be Increased Tumor Burden, Surgical Resection, Prohibited 
Medications
______________________________________________________________________________________________________________________________________
N = No, Y = Yes, OS = Overall Survival PFS = Progression-Free Survival, PD = Progressive Disease.
Note 1: PFS is defined as the interval between the date of first T cell infusion and the earliest documented evidence of disease progression or death due to any 
cause or surgical resection or start of prohibited medications. Subjects who do not have a documented date of progression, death, surgical resection, or 
prohibited medication are censored at the date of last assessment.
Note 2: OS is defined as the interval between the date of first T cell infusion and date of death from any cause. Subjects who are still alive or who are lost 
to follow-up are censored at the date of last contact.
Note 3: Study Day is relative to the date of the first T cell infusion, which is Study Day 1.
Note 4: Listing includes subjects who received at least one T cell infusion.
File Name: S:\...... \&prog_name
Cohort
Subject
Date of 
T cell 
Infusion 
PD?
Reason 
For 
PD
Date of PD/Death 
or Censoring 
(Study Day)
Progression-
Free Survival 
(Weeks)
Date of Death 
or Censoring 
(Study Day)
Overall 
Survival 
(Weeks)
TRTSDT
Y/N
ADT, ADY
AVAL
ADT, ADY
AVAL
                                 Y if CNSR = 0  
                                 N if CNSR = 1 


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Population: Intent-To-Treat                                                                  
      (Data as of: 24APR2018)
Listing 27.0008
Time to Confirmed Response, Duration of Response, and Duration of Stable Disease, and Best Overall Response 
Note: one row per subject. 
Programming Note: Subjects who do not have confirmed response of CR or PR will not have values for Date of Confirmed Response, Time to Response. Duration of 
Response.
From ADRSREC and ADTTEREC
______________________________________________________________________________________________________________________________________
BOR = Best Overall Response, CR = Complete Response, DOR = Duration of Response, PD = Progressive Disease, PR = Partial Response, NE = Not Evaluable, SD = 
Stable Disease, TTR = Time to Response.  
Note 1: TTR is defined as the interval between the date of first T-cell infusion and the earliest date of first documented confirmed CR or confirmed PR among 
participants with a confirmed PR or CR.
Note 2: Duration of response is defined as the time from first documented evidence of confirmed CR or PR until first documented date of disease progression or 
death due to any cause or surgical resection or start of prohibited medications. Responders who are still alive and who do not have documented disease 
progression, surgical resection, or prohibited medication are censored at the date of the last assessment.
Note 3: Listing includes subjects who received at least one T-cell infusion.
Note 4: Study Day is relative to the date of the first T cell infusion, which is Study Day 1.
Note 5: Duration of response or duration of stable disease with a “+” sign means the subject did not have documented disease progression. 
File Name: S:\...... \&prog_name
Cohort Subject
Date of T Cell 
Infusion
AVALC for
ADRSREC.
PARAMCD = 
‘BESTRESP’
And DTYPE = 
‘INFUSION 1
RESPONSE’
Best 
Overall Response 
(BOR)
ADT for ADRSREC.
PARAMCD = 
‘RSPSTUS’
When AVALC =
‘RESPONDER’
And DTYPE = 
‘INFUSION 1
RESPONSE’
Date of 
Confirmed
Response 
(CR or PR) 
(Study Day)
AVAL for 
ADTTEREC.PARAMCD
= ‘TTR’ and
CNSR = 0.
Time to 
Response 
(Weeks)
AVAL for 
ADTTEREC.PARAMCD
= ‘DOR’ and
CNSR = 0.
Duration of Response 
(DOR)
(Weeks)
AVAL for ADTTEREC.PARAMCD
= ‘DOSD’ and
CNSR = 0.
Duration of Stable Disease 
(Weeks)
TRTSDT
CR, PR, SD, PD, 
NE


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Population: Intent-To-Treat                                                                  
      (Data as of: 24APR2018)
Listing 28.1001
Adverse Events for First T Cell Infusion
Subject
ADSL.SUBJID
S:System Organ Class 
P:Preferred Term 
V:Verbatim Term 
Start Date 
(Study Day)
End Date 
(Study Day)
or Ongoing
Serious?/
Pre? #
Reason
Serious @ Toxicity Grade 
$
Relationship
to T Cell 
Infusion
Action Taken 
with T Cell
Infusion
Other 
Action
Taken
Outcome
ADAE.AEENDTC    
Cohort:
ADAE.AEBODSYS         
(ADAE.AEENDY)   ADAE.TRTEMFL
ADAE.AEREL
ADAE.AEOUT
ADSL.ACTARM
ADAE.AEDECOD          
ADAE.AESTDTC  
ADAE.AESER
ADAE.AEACN
ADAE.AETERM                (ADAE.AESTDY)
______________________________________________________________________________________________________________________________________
Note 1: Only subjects with adverse events are listed. Includes all adverse events from date of informed consent through end of study or start of lymphodepletion 
for second T cell infusion, whichever is earlier.
Note 2: Study Day is relative to the date of the first T cell infusion, which is Study Day 1.
Note 3: Adverse events are graded using NCI CTCAE Version 4.03.
# If Serious = ‘Y’ and the AE started prior to leukapheresis, response to Pre? = ‘Y’. Otherwise, response to Pre is missing.
@ DE = Death, DI = Disability, CA = Congenital Anomaly, LF = Life Threatening, HO = Hospitalization, MS = Medically Significant Event.
$ ‘C’ after the toxicity grade indicates a change in severity.
File Name: S:\...... \&prog_name


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Population: Intent-To-Treat                                                                  
      (Data as of: 24APR2018)
Listing 28.1002
Adverse Events for Second T-Cell Infusion 
Subject
ADSL.SUBJID
S:System Organ Class 
P:Preferred Term 
V:Verbatim Term 
Start Date 
(Study Day 1/
Study Day 2)
End Date 
(Study Day)
or Ongoing
Serious?
Reason
Serious 
@
Toxicity 
Grade $
Relationship
to T Cell 
Infusion
Action Taken 
with T Cell
Infusion
Other 
Action
Taken
Outcome
ADAE.AEENDTC    
Cohort:
ADAE.AEBODSYS       
(ADAE.AEENDY)   ADAE.TRTEMFL
ADAE.AEREL
ADAE.AEOUT
ADSL.ACTARM
ADAE.AEDECOD         ADAE.AESTDTC  
ADAE.AESER
ADAE.AEACN
ADAE.AETERM          (ADAE.AESTDY)
Note to Programmer:
______________________________________________________________________________________________________________________________________
Note 1: Only subjects with adverse events are listed. Includes all adverse events beginning with start of lymphodepletion for second T cell infusion.
Note 2: 1st Study Day is relative to the date of the first T cell infusion, 2nd study day is relative to date of the second T cell infusion.
Note 3: Adverse events are graded using NCI CTCAE Version 4.03.
@ DE = Death, DI = Disability, CA = Congenital Anomaly, LF = Life Threatening, HO = Hospitalization, MS = Medically Significant Event.
$ ‘C’ after the toxicity grade indicates a change in severity.
File Name: S:\...... \&prog_name
Protocol: GSK208466/ADP-04511           
                                                                       Page 1 of 1
Population: Intent-To-Treat                                                                  
      (Data as of: 24APR2018)
Listing 28.1003
Adverse Events with CTCAE Grade 3 or Higher


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Subject
ADSL.SUBJID
S:System Organ Class 
P:Preferred Term 
V:Verbatim Term 
Start Date 
(Study Day)/
Infusion
End Date 
(Study Day)
or Ongoing
Serious?/
Pre? #
Reason
Serious @ Toxicity Grade 
$
Relationship
to T Cell 
Infusion
Action Taken 
with T Cell
Infusion
Other 
Action
Taken
Outcome
ADAE.AEENDTC    
Cohort:
ADAE.AEBODSYS         
(ADAE.AEENDY)   ADAE.TRTEMFL
ADAE.AEREL
ADAE.AEOUT
ADSL.ACTARM
ADAE.AEDECOD          
ADAE.AESTDTC  
ADAE.AESER
ADAE.AEACN
ADAE.AETERM                (ADAE.AESTDY)
Note to programmers: Infusion is First or Second. If there are no values for a column, omit the column.
______________________________________________________________________________________________________________________________________
Note 1: Only subjects with adverse events with toxicity grade of 3 or more are listed. 
Note 2: Study Day is relative to the date of the first T cell infusion, which is Study Day 1.
Note 3: Adverse events are graded using NCI CTCAE Version 4.03.
# If Serious = ‘Y’ and the AE started prior to leukapheresis, response to Pre? = ‘Y’. Otherwise, response to Pre is missing.
@ DE = Death, DI = Disability, CA = Congenital Anomaly, LF = Life Threatening, HO = Hospitalization, MS = Medically Significant Event.
$ ‘C’ after the toxicity grade indicates a change in severity.
File Name: S:\...... \&prog_name


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Population: Intent-To-Treat                                                                  
      (Data as of: 24APR2018)
Listing 28.2001
Serious Adverse Events
Subject
ADSL.SUBJID
S:System Organ Class 
P:Preferred Term 
V:Verbatim Term 
Start Date 
(Study Day)
Infusion
End Date 
(Study Day)
or Ongoing
Serious?/
Pre? #
Reason
Serious @ Toxicity Grade 
$
Relationship
to T Cell 
Infusion
Action Taken 
with T Cell
Infusion
Other 
Action
Taken
Outcome
ADAE.AEENDTC    
Cohort:
ADAE.AEBODSYS         
(ADAE.AEENDY)   ADAE.TRTEMFL
ADAE.AEREL
ADAE.AEOUT
ADSL.ACTARM
ADAE.AEDECOD          
ADAE.AESTDTC  
ADAE.AESER
ADAE.AEACN
ADAE.AETERM                (ADAE.AESTDY)
Note to programmers: Infusion is First or Second.
______________________________________________________________________________________________________________________________________
Note 1: Only subjects with serious adverse events are listed. 
Note 2: Study Day is relative to the date of the first T cell infusion, which is Study Day 1.
Note 3: Adverse events are graded using NCI CTCAE Version 4.03.
# If the SAE started prior to leukapheresis, response to Pre? = ‘Y’. Otherwise, response to Pre is missing.
@ DE = Death, DI = Disability, CA = Congenital Anomaly, LF = Life Threatening, HO = Hospitalization, MS = Medically Significant Event.
$ ‘C’ after the toxicity grade indicates a change in severity.
File Name: S:\...... \&prog_name


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Population: Intent-To-Treat                                                                  
     (Data as of: 24APR2018)
Listing 28.3001
Cytokine Release Syndrome (CRS)
Subject
ADSL.SUBJID
S:System Organ Class 
P:Preferred Term 
V:Verbatim Term 
Start Date 
(Study Day)/
Infusion
End Date 
(Study Day)
or Ongoing
Serious?/
Pre? #
Reason
Serious @ Toxicity Grade 
$
Relationship
to T Cell 
Infusion
Action Taken 
with T Cell
Infusion
Other 
Action
Taken
Outcome
ADAE.AEENDTC    
Cohort:
ADAE.AEBODSYS         
(ADAE.AEENDY)   ADAE.TRTEMFL
ADAE.AEREL
ADAE.AEOUT
ADSL.ACTARM
ADAE.AEDECOD          
ADAE.AESTDTC  
ADAE.AESER
ADAE.AEACN
ADAE.AETERM                (ADAE.AESTDY)
Note to programmers: Infusion is First or Second. List of preferred terms to include is in Appendix 2 of SAP.
______________________________________________________________________________________________________________________________________
Note 1: Only subjects with adverse events coded to the MedDRA PT cytokine release syndrome or cytokine storm  are listed.
Note 2: Study Day is relative to the date of the first T cell infusion, which is Study Day 1.
Note 3: Adverse events are graded using NCI CTCAE Version 4.03.
# If Serious = ‘Y’ and the AE started prior to leukapheresis, response to Pre? = ‘Y’. Otherwise, response to Pre is missing.
@ DE = Death, DI = Disability, CA = Congenital Anomaly, LF = Life Threatening, HO = Hospitalization, MS = Medically Significant Event.
$ ‘C’ after the toxicity grade indicates a change in severity.
File Name: S:\...... \&prog_name


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Population: Intent-To-Treat                                                                  
      (Data as of: 24APR2018)
Listing 28.3002
       Graft Versus Host Disease (GVHD)
Subject
ADSL.SUBJID
S:System Organ Class 
P:Preferred Term 
V:Verbatim Term 
Start Date 
(Study Day)/
Infusion
End Date 
(Study Day)
or Ongoing
Serious?/
Pre? #
Reason
Serious @ Toxicity Grade 
$
Relationship
to T Cell 
Infusion
Action Taken 
with T Cell
Infusion
Other 
Action
Taken
Outcome
ADAE.AEENDTC    
Cohort:
ADAE.AEBODSYS         
(ADAE.AEENDY)   ADAE.TRTEMFL
ADAE.AEREL
ADAE.AEOUT
ADSL.ACTARM
ADAE.AEDECOD          
ADAE.AESTDTC  
ADAE.AESER
ADAE.AEACN
ADAE.AETERM                (ADAE.AESTDY)
Note to programmers: Infusion is First or Second. List of preferred terms to include is in Appendix 2 of SAP.
______________________________________________________________________________________________________________________________________
Note 1: Only subjects with adverse events coded to the MedDRA PT terms associated with GVHD are listed.
Note 2: Study Day is relative to the date of the first T cell infusion, which is Study Day 1.
Note 3: Adverse events are graded using NCI CTCAE Version 4.03.
# If Serious = ‘Y’ and the AE started prior to leukapheresis, response to Pre? = ‘Y’. Otherwise, response to Pre is missing.
@ DE = Death, DI = Disability, CA = Congenital Anomaly, LF = Life Threatening, HO = Hospitalization, MS = Medically Significant Event.
$ ‘C’ after the toxicity grade indicates a change in severity.
File Name: S:\...... \&prog_name
Programming note:
Use Listing 28.3001 template for:   
Listing 28.3003 Recurrent pancytopenia with bone marrow failure/Aplastic anemia
Listing 28.3004 Guillain-Barre syndrome 
Listing 28.3005 Encephalopathy syndrome


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Population: Intent-To-Treat                                                                  
      (Data as of: 24APR2018)
Listing 28.3101
Hematology Evaluations – Part 1
Subject 
ADSL.SUBJID
Visit
LB.VIIST
Collection Date
(Study Day)
LB.LBDTC (LB.LBDY)
Parameter1 (unit)
Parameter2 
(unit)
Parameter3 (unit)
Parameter4 (unit)
Parameter5 (unit)
Parameter6 (unit)
Cohort:                                           LB.LBSTRESC concatenated with LB.LBNRIND for ‘L’ or ‘H’ for each LBTESTCD
ADSL.ACTARM 
Notes to programmer: If sample not collected, put ND under Collection Date. If test is not done on a parameter on a certain visit put ND as result corresponding 
to that parameter on that visit. Listing includes Coagulation parameters
List L or H for values outside the reference range. LB.LBNRIND
Include as many parts as needed to accommodate all parameters. If multiple parts, numbering will be 28.3101, 28.3102, etc.
ND = Not Done.
L = Below lower limit of laboratory reference range, H = Above upper limit of laboratory reference range.
Note: Study Day is relative to the date of the first T cell infusion, which is Study Day 1.
File Name: S:\...... \&prog_name
Programming note:
Use Listing 28.3101 template for: Listings 28.3111, 28.3121.


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Population: Intent-To-Treat                                                                  
      (Data as of: 24APR2018)
Listing 28.3131
Clinically Significant Hematology Findings
Subject ADSL.SUBJID
Visit
Collection Date 
(Study Day)
Parameter 
(unit)
Result
Reference
Range
Cohort: 
ADSL.ACTARM
LB.VISIT
LB.LBDTC (LB.LBDY)
Note to programmer: Include only clinically significant values. 
_____________________________________________________________________________________________________________________________________________________
L = Below lower limit of laboratory reference range, H = Above upper limit of laboratory reference range.
Note: Study Day is relative to the date of the first T cell infusion, which is Study Day 1.
File Name: S:\...... \&prog_name
Protocol: GSK208466/ADP-04511              
                                                                
         
Page 1 of 1
Population: Modified Intent-To-Treat                                                          
      
(Data as of: 24APR2018)
Listing 28.3132
Listing of Subjects with Potentially Clinically Significant Hepatic Post-Baseline Results for the Post-lymphodepletion Period
mITT Population
Criterion
Cohort
Subject 
Visit
Collection 
Date/Time 
(Study Day)
Parameter
Value
(≥3xULN AST and/or ALT) and ≥2xULN BIL


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.
ALT = Alanine aminotransferase, AST = Aspartate aminotransferase, BIL = Total bilirubin.
Note 1: Baseline is within 7 days of initiating lymphodepletion. 
Note 2: Study Day is relative to the day of the first T Cell infusion (Day 1).
File Name: S:\...... \&prog_name
Programming Note: List all of a subject’s values for parameters listed in the criterion if a subject meets criterion for at least one visit.  


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Population: Intent-To-Treat                                                                  
      (Data as of: 24APR2018)
Listing 28.3201
Clinical Chemistry Evaluations – Part 1
___________________________________________________________________________________________________________________________________________________
Same template as Listing 28.3101
Note to Programmer: Include as many Parts as needed to accommodate all parameters. If multiple parts, numbering will be 28.3202, 28.3203 etc.
___________________________________________________________________________________________________________________________________________________
File Name: S:\...... \&prog_name
Programming note:  
Use Listing 28.3201 template for Listings 28.3211, 28.3221.


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Population: Intent-To-Treat                                                                  
      (Data as of: 24APR2018)
Listing 28.3231
Clinically Significant Clinical Chemistry Findings 
______________________________________________________________________________________________________________________________________
Same template as Listing 28.3131
______________________________________________________________________________________________________________________________________
File Name: S:\...... \&prog_name


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Protocol: GSK208466/ADP-04511           
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Population: Intent-To-Treat                                                                  
      (Data as of: 24APR2018)
Listing 28.3301
Urinalysis Evaluations – Part 1 
______________________________________________________________________________________________________________________________________
Same template as Listing 28.3101
Note to Programmer: Include as many Parts as needed to accommodate all parameters. If multiple parts, numbering will be 28.3302, 28.3303 etc.
______________________________________________________________________________________________________________________________________
File Name: S:\...... \&prog_name
Programming note:
Use Listing 28.3301 template for:  Listings28.3311, 28.3321.


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Protocol: GSK208466/ADP-04511           
                                                                       Page 1 of 1
Population: Intent-To-Treat                                                                  
      (Data as of: 24APR2018)
Listing 28.3331
Clinically Significant Urinalysis Findings 
______________________________________________________________________________________________________________________________________
Same template as Listing 28.3131
______________________________________________________________________________________________________________________________________
File Name: S:\...... \&prog_name


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Population: Intent-To-Treat                                                                  
      (Data as of: 24APR2018)
Listing 28.3341
Additional Laboratory Assessments
_____________________________________________________________________________________________________________________________________________________
Cohort
Subject
Visit
Collection Date 
(Study Day)
ANA
Rheumatoid
Factor
TSH
(units)
T3
(units)
T4
(units)
Notes to programmer: If all of the tests are not done on a visit, put ‘ND’ under Collection Date for that visit. If a particular test is not done on a visit, 
put ‘ND’ under that test for that visit. 
_____________________________________________________________________________________________________________________________________________________
ND = Not Done.
Note: Study Day is relative to the date of the first T cell infusion, which is Study Day 1.
File Name: S:\...... \&prog_name


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Population: Intent-To-Treat                                                                  
      (Data as of: 24APR2018)
Listing 28.3342
Clinically Significant Additional Laboratory Findings 
______________________________________________________________________________________________________________________________________
Same template as Listing 28.3131
______________________________________________________________________________________________________________________________________________
File Name: S:\...... \&prog_name


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Protocol: GSK208466/ADP-04511           
                                                                       Page 1 of 1
Population: Intent-To-Treat                                                                  
      (Data as of: 24APR2018)
Listing 28.3343
Renal Function Findings
______________________________________________________________________________________________________________________________________
Cohort
Subject
Visit
Collection Date 
(Study Day)
LBSP.TESTCD =
CREATCLR
Creatinine
Clearance
(mL/min)
LBSP.TESTCD =
CREATEXR
Creatinine
Clearance
Excretion 
Rate
(g/day)
LBSP.TESTCD =
EDTACLR
EDTA GFR
(mL/min)
LBSP.LBCAT = ‘RENAL FUNCTION TEST’ Notes to programmer: If all of the tests are not done on a visit, put ‘ND’ under Collection Date for that visit. If a 
particular test is not done on a visit, put ‘ND’ under that test for that visit. 
______________________________________________________________________________________________________________________________________
ND = Not Done.
Note: Study Day is relative to the date of the first T cell infusion, which is Study Day 1.
File Name: S:\...... \&prog_name


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Population: Intent-To-Treat                                                                  
      (Data as of: 24APR2018)
Listing 28.4001
Replication Competent Lentivirus (RCL)
_____________________________________________________________________________________________________________________________________________________
Cohort
Subject
Visit
Collection Date (Study 
Day)
Result
Notes to programmer: If test are not done on a visit, put ‘ND’ under Collection Date for that visit. Data to come from vendor.
_____________________________________________________________________________________________________________________________________________________
ND = Not Done.
Note: Study Day is relative to the date of the first T cell infusion, which is Study Day 1.
File Name: S:\...... \&prog_name


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Population: Modified Intent-To-Treat                                                             
      (Data as of: 24APR2018)
Listing 28.4002
Persistence
________________________________________________________________________________________________________________________________________________________________
Cohort Subject
Visit
Collection 
Date 
(Study Day)
Result #
(copies/mcg 
DNA)
Lymphocytes
(10^9/L)
Monocytes
(10^9/L)
Cell
Persistence $
% Gene Marked 
Cells per 
Lymphocyte &
Coefficient 
of 
Variation/
Number of 
Possitive 
Replicates
Interpretive 
Result
Peak 
Persistence/
Time to Peak 
Persistence 
(Days)
Time to 25% Loss of 
Peak Persistence 
(Days) / 50% / 75% 
/ Duration of 
Detectable 
Persistence
Cohort 1 200 Baseline 01OCT2012(-28)50.55      0.02         0.02       0.1234546      0.364748         N/A/        NEGATIVE     586978.1/     3/
                                                                                                        1                       2             14/
                                                                                                                                              14/
                                                                                                                                              28+ 
Notes to programmer: If test are not done on a visit, put ‘ND’ under Collection Date for that visit. There is a pre-infusion sample on Day 0. Need to map data
________________________________________________________________________________________________________________________________________________________________
ND = Not Done.
Note: Study Day is relative to the date of the first T cell infusion, which is Study Day 1.
# As collected on eCRF.
$ Cell Persistence = Absolute peripheral gene-marked cell number/µL = (Psi result number/151515) x (lymphocyte count + monocyte count) 
  x 1000, where Psi is value collected on eCRF.
& Percent of gene marked cells per total lymphocyte compartment = ((Absolute peripheral gene marked cell number/µL)/Lymphocyte count x 
  1000)) x 100.
File Name: S:\...... \&prog_name


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Protocol: GSK208466/ADP-04511           
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Population: Intent-To-Treat                                                                  
      (Data as of: 24APR2018)
Listing 28.4101 
Cytokines – Part 1
______________________________________________________________________________________________________________________________________
Cohort
Subject
Visit
Timepoint
T Cell
Infusion
Dates
Collection Date 
(Study Day)
Time
Point
Param 1
Param 2
Etc.
Notes to programmer: If test are not done on a visit, put ‘ND’ under Collection Date for that visit. There is a pre-infusion sample on Day 0. Subjects with an 
AE of CRS will have # after their subject number. 
Note to Programmer: Include as many Parts as needed to accommodate all parameters. If multiple parts, numbering will be 28.4102, 28.4103 etc. Data will come 
from vendor
______________________________________________________________________________________________________________________________________
ND = Not Done.
Note: Study Day is relative to the date of the first T cell infusion, which is Study Day 1.
# Subject has an adverse event of cytokine release syndrome (CRS).
File Name: S:\...... \&prog_name
Porgramming note:
Repeat Listing 28.4101 format for Listing 28.4102.


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Protocol: GSK208466/ADP-04511           
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Population: Intent-To-Treat                                                                  
     (Data as of: 24APR2018)
Listing 28.4201 
Biopsy-Tumor Antigen Results
______________________________________________________________________________________________________________________________________
Cohort
Subject
Visit
Collection Date (Study 
Day)
Type of
Sample
Media of 
Sample Storage
Any Antigen
Expression?
Date of Antigen
Expression
______________________________________________________________________________________________________________________________________
ND = Not Done.
Note: Study Day is relative to the date of the first T cell infusion, which is Study Day 1.
File Name: S:\...... \&prog_name


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Protocol: GSK208466/ADP-04511           
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Population: Intent-To-Treat                                                                  
      (Data as of: 24APR2018)
Listing 28.4301 
Flow Cytometry
______________________________________________________________________________________________________________________________________
Cohort
Subject
Visit
T Cell
Infusion
Dates
Collection Date 
(Study Day)
______________________________________________________________________________________________________________________________________
ND = Not Done.
Note: Study Day is relative to the date of the first T cell infusion, which is Study Day 1.
File Name: S:\...... \&prog_name


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Protocol: GSK208466/ADP-04511           
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Population: Intent-To-Treat                                                                  
      (Data as of: 24APR2018)
Listing 28.5001
Pregnancy Test Results
______________________________________________________________________________________________________________________________________
Cohort
Subject
Visit
Date Performed
(Study Day)
Specimen Type
Result
Notes to programmer: If pregnancy test not performed, put ND under Date Performed. 
Result = Positive or Negative.
______________________________________________________________________________________________________________________________________
ND = Not Done.
Note: Study Day is relative to the date of the first T cell infusion, which is Study Day 1.
File Name: S:\...... \&prog_name


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Protocol: GSK208466/ADP-04511           
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Population: Intent-To-Treat                                                                  
      (Data as of: 24APR2018)
Listing 28.5101
Vital Signs
Subject
ADSL.SUBJID
Visit
Date/Time 
Performed
(Study Day) Time-point
Blood Pressure
Systolic/Diastolic
(mmHg)
Pulse
Rate
(bpm)
Temperature
(C)
Respiratory Rate
(Breaths/min)
Weight 
(kg)
BSA
(m^2)
Oxygen 
Saturation
(%)
VS.VISIT
VS.VSDTC 
(VS.VSDY)
VS.VSTPT
VS.VSSTRESC for 
VS.VSTESTCD in 
‘SYSBP’/’DIABP’
VS.VSSTRESC 
for 
VS.VSTESTCD  = 
‘HR’
VS.VSSTRESC for 
VS.VSTESTCD  = 
‘RESP’
VS.VSSTRESC 
for 
VS.VSTESTCD  = 
‘BMI’
Cohort:
ADSL.ACTARM
VS.VSSTRESC 
for 
VS.VSTESTCD  = 
‘TEMP’
VS.VSSTRESC 
for 
VS.VSTESTCD  = 
‘WEIGHT’
VS.VSSTRESC 
for 
VS.VSTESTCD  = 
‘OXYSAT’
Notes to programmer: If all of the tests are not done on a visit, put ND under Date Performed for that visit. If all of the tests are not done on a time-point 
on a certain visit put ND under each test corresponding to that time-point. If a particular test is not done on a visit or on a time point, put ‘ND’ under that 
test for that visit or time point.  
______________________________________________________________________________________________________________________________________
ND = Not Done.
BSA = Body Surface Area.
Note: Study Day is relative to the date of the first T cell infusion, which is Study Day 1.
File Name: S:\...... \&prog_name


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Protocol: GSK208466/ADP-04511           
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Population: Modified Intent-To-Treat                                                                  
      (Data as of: 24APR2018)
Listing 28.5102
Listing of Subjects with Potentially Clinically Significant Post-Baseline Vital Signs
Subject
ADSL.SUBJID
Visit
Date/Time 
Performed
(Study Day) Time-point
Blood Pressure
Systolic/Diastolic
(mmHg)
Pulse
Rate
(bpm)
VS.VISIT
VS.VSDTC 
(VS.VSDY)
VS.VSTPT
VS.VSSTRESC for 
VS.VSTESTCD in 
‘SYSBP’/’DIABP’
VS.VSSTRESC 
for 
VS.VSTESTCD  = 
‘HR’
Cohort:
ADSL.ACTARM
Notes to programmer: If all of the tests are not done on a visit, put ND under Date Performed for that visit. If all of the tests are not done on a time-point 
on a certain visit put ND under each test corresponding to that time-point. If a particular test is not done on a visit or on a time point, put ‘ND’ under that 
test for that visit or time point. The listing will contain all of a subject’s values for parameters meeting the criteria.  
______________________________________________________________________________________________________________________________________
ND = Not Done.
BSA = Body Surface Area.
Note 1: Potentially clinically significant vital signs criteria: heart rate is either less than 60 bpm or greater than 100 bpm; systolic blood pressure ≥ 140 
mmHg; Diastolic ≥ 90 mmHg.  
Note 2: Study Day is relative to the date of the first T cell infusion, which is Study Day 1.


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Protocol: GSK208466/ADP-04511           
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Population: Intent-To-Treat                                                                  
      (Data as of: 24APR2018)
Listing 28.5201
ECOG Performance Status, Karnofsky Score, and Lansky Score 
______________________________________________________________________________________________________________________________________
Cohort      
Subject 
Visit
Date Performed 
(Study Day)
ECOG Score#
Karnofsky
Score (%)
Lansky 
Score (%)
______________________________________________________________________________________________________________________________________
ND = Not Done, ECOG = Eastern Cooperative Oncology Group.
Note 1: The Lansky Score was assessed for children <= 10 years of age. The Karnofsky Score was optional.
Note 2: Study Day is relative to the date of the first T cell infusion, which is Study Day 1
# ECOG Score
0 = Fully active and able to carry on all pre-disease activities without restriction, 
1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, 
2 = Ambulatory and capable of all self-care but unable to carry out any work activities, 
3 = Capable of only limited self-care, 
4 = Completely disabled, 
5 = Dead.
File Name: S:\...... \&prog_name 


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Protocol: GSK208466/ADP-04511           
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Population: Intent-To-Treat                                                                  
      (Data as of: 24APR2018)
Listing 28.6101
Electrocardiogram
______________________________________________________________________________________________________________________________________
Cohort
Subject
Visit
Date/Time 
Performed 
(Study Day)
Assessment
Abnormalities
Reason for
Unscheduled 
Assessment
Notes to programmer: If all of the tests are not done on a visit(EGTESTCD = ‘EGALL’), put ‘ND’ under Date Performed for that visit. If a particular test is not 
done on a visit, put ‘ND’ under that test for that visit.
______________________________________________________________________________________________________________________________________
ND = Not Done.
Note: Study Day is relative to the date of the first T cell infusion, which is Study Day 1.
File Name: S:\...... \&prog_name


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Protocol: GSK208466/ADP-04511           
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Population: Intent-To-Treat                                                                  
      (Data as of: 24APR2018)
Listing 28.6201
Physical Examination 
_____________________________________________________________________________________________________________________________________________________
Cohort
ADSL.ACTARM
Subject
ADSL.SUBJID
Visit
Date Performed
(Study Day)
Body System
Abnormality
Notes to programmer: If Physical Examination is not performed, put ND under Date Performed. If Body System result was not done, put ND under Abnormality.
____________________________________________________________________________________________________________________________________________________
ND = Not Done.
Note 1: Only abnormalities and body systems not assessed are listed.
Note: Study Day is relative to the date of the first T cell infusion, which is Study Day 1.
File Name: S:\...... \&prog_name


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Protocol: GSK208466/ADP-04511           
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Population: Intent-To-Treat                                                                  
      (Data as of: 24APR2018)
Listing 28.6301
Concomitant Medications
Subject 
ADSL.SUBJID
A:ATC-3     
P:Preferred Name    
V:Verbatim Name
Start Date
(Study Day)
End Date 
(Study Day) 
or Ongoing
Dose 
(units)
Frequency
Route
Indication
Cohort 
ADSL.ACTARM
A: QVAL when QNAM = 
ATC3
CM.CMSTDTC
CM.CMENDTC
CM.CMINDC
P: CM.CMDECOD
(CM.CMSTDY)
(CM.CMENDY)
V: CM.CMTRT
Or CM.CMENRF
Note to programmer: If Unit, Frequency, or Route is Other, report this as Other: <Specify>. 
______________________________________________________________________________________________________________________________________
Note 1: Only subjects reporting medications are listed.
Note 2: Medications are coded by WHO Drug Dictionary 2015-Dec. 
Note 3: Study Day is relative to the date of the first T cell infusion, which is Study Day 1.
Note 4: If the 3rd level term is not available, the next available level is used.
File Name: S:\...... \&prog_name


CONFIDENTIAL
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Protocol: GSK208466/ADP-04511           
                                                                       Page 1 of 1
Population: Intent-To-Treat                                                                  
      (Data as of: 24APR2018)
Listing 28.6401
Bridging Therapies
Cohort 
ADSL.ACTARM
Subject 
ADSL.SUBJID
Start Date
(Study Day)
Stop Date
(Study Day)
Hospitalized
for Therapy?
Therapy
Class
Therapy
Description
Dose
Ordered
Disease
Status
______________________________________________________________________________________________________________________________________
Note 1: Only subjects with cancer therapies given after apheresis and before lymphodepletion are listed.
Note 2: Study Day is relative to the date of the first T cell infusion, which is Study Day 1.
File Name: S:\...... \&prog_name


CONFIDENTIAL
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Protocol: GSK208466/ADP-04511           
                                                                       Page 1 of 1
Population: Intent-To-Treat                                                                  
      (Data as of: 24APR2018)
Listing 28.6402
On-Study Surgery
______________________________________________________________________________________________________________________________________
Cohort
Subject 
T-Cell 
Infusion
Dates
Organ – Site
of Surgery
Description of Surgery
Surgery
Date
ADSL.ACTARM
ADSL.SUBJID
______________________________________________________________________________________________________________________________________
N = No, Y = Yes.
Note: Only subjects with surgery following T-cell administration are listed.
File Name: S:\...... \&prog_name


CONFIDENTIAL
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Protocol: GSK208466/ADP-04511           
                                                                       Page 1 of 1
Population: Intent-To-Treat                                                                  
      (Data as of: 24APR2018)
Listing 28.6403
On-Study Oncology Treatment
CM.CMCAT = ‘ON STUDY ONCOLOGY TREATMENT’
PR.PRCAT = ‘ON STUDY ONCOLOGY TREATMENT’
______________________________________________________________________________________________________________________________________
Cohort
ADSL.ACTARM
Subject
ADSL.SUBJID 
T-Cell 
Infusion
Dates
Therapy
Class
Therapy 
Description
Dose
Ordered
Start Date 
(Study Day)
End Date
(Study Day)
‘RADIATION’           
If from PR
PRTRT
CMTRT
PRDOSTXT
CMDOSTXT
  
   CM.CMSCAT
Note to programmer: All prior treatments from CM except for Radiation which is in S.PR
______________________________________________________________________________________________________________________________________Note: Only subjects 
reporting prior oncology treatment are listed.
File Name: S:\...... \&prog_name


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Protocol: GSK208466/ADP-04511           
                                                                       Page 1 of 1
Population: Intent-To-Treat                                                                  
      (Data as of: 24APR2018)
Listing 28.6404
Echocardiogram or Multigated Acquisition Scan (MUGA)
Cohort ADSL.ACTARM
Subject 
ADSL.SUBJID
Visit
Date Performed
(Study Day)
Test 
Performed
Result
Details of 
CS Abnormality
LVEF 
(%)
ECHO
MUGA
______________________________________________________________________________________________________________________________________
CS = Clinically Significant, NCS = Not Clinically Significant, LVEF = Left Ventricular Ejection Fraction.
Note: Study Day is relative to the date of the first T cell infusion, which is Study Day 1.
File Name: S:\...... \&prog_name


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Protocol: GSK208466/ADP-04511           
                                                                       Page 1 of 1
Population: Intent-To-Treat                                                                  
      (Data as of: 24APR2018)
Listing 28.6502
EBV and Anti-CMV Status
______________________________________________________________________________________________________________________________________
Cohort
Subject
Visit
Collection
(Study Day)
EBV Status
Anti-CMV Status
ADLBSP
______________________________________________________________________________________________________________________________________
ND = Not Done.
Note: Study Day is relative to the date of the first T cell infusion, which is Study Day 1.
File Name: S:\...... \&prog_name


CONFIDENTIAL
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Protocol: GSK208466/ADP-04511           
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Population: Intent-To-Treat                                                                  
      (Data as of: 24APR2018)
Listing 28.6503
Infection Disease Testing
______________________________________________________________________________________________________________________________________
Cohort
Subject
Visit
Date of Testing
(Study Day)
______________________________________________________________________________________________________________________________________
ND = Not Done.
Note: Study Day is relative to the date of the first T cell infusion, which is Study Day 1.
File Name: S:\...... \&prog_name