Back to resultsADP-A2M4CD8 in HLA-A2+ Subjects With MAGE-A4 Positive Esophageal or Esophagogastric Junction Cancers (SURPASS-2)
Primary Purpose
Esophageal Cancer, Esophagogastric Junction Cancer
Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Autologous genetically modified ADP-A2M4CD8 cells
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Cancer focused on measuring Cell Therapy, T Cell Therapy, SPEAR T Cell, MAGE-A4, Immuno-oncology, Metastatic, Esophagogastric Junction, Esophageal Cancer
Eligibility Criteria
Key Inclusion Criteria:
- Age ≥18 and <75 years
- Diagnosis of Esophageal cancer or Esophagogastric junction cancer.
- Previously received for advanced or metastatic disease.
- Measurable disease according to RECIST v1.1.
- HLA-A*02 positive
- Tumor shows MAGE-A4 expression confirmed by central laboratory.
- ECOG Performance Status of 0 or1.
- Left ventricular ejection fraction (LVEF) ≥50%.
Note: other protocol defined Inclusion criteria may apply
Key exclusion criteria
- Positive for any HLA-A*02 allele other than: one of the inclusion alleles
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to fludarabine, cyclophosphamide or other agents used in the study
- Active autoimmune or immune mediated disease
- Leptomeningeal disease, carcinomatous meningitis or symptomatic CNS metastases
- Other prior malignancy that is not considered by the Investigator to be in complete remission. Clinically significant cardiovascular disease
- Uncontrolled intercurrent illness
- Active infection with human immunodeficiency virus, hepatitis B virus, hepatitis C virus, or human T cell leukemia virus
- Pregnant or breastfeeding
Note: other protocol defined Inclusion/Exclusion criteria may apply.
Sites / Locations
- City of Hope National Medical Center
- Mayo Clinic
- Northwestern Medical Faculty Foundation
- University of Chicago Medicine
- Simon Cancer Center-Indiana University
- Mayo Clinic
- Washington University School of Medicine- Siteman Cancer Center
- Memorial Sloan Kettering Cancer Center
- Duke University Medical Center
- OU Health Stephenson Cancer Center
- Providence Cancer Institute Franz Clinic
- UT Southwestern Medical Center
- University Of Texas, MD Anderson Cancer Center
- University Of Wisconsin Clinical Science Center
- Froedtert Hospital and Medical College of Wisconsin
- Princess Margaret Cancer Centre
- McGill University Health Centre Glen Site
- Hopital Huriez
- Centre Leon-Berard (CLB) - Centre de Recherche en Cancerologie Lyon-Est (CRCL)
- Centre Eugene Marquis
- Institut Gustave Roussy
- Hospital Universitari Vall d'Hebron
- Hospital Universitario 12 de Octubre
- Hospital Clinico Universitario de Valencia
- Hospital Fundacion Jimenez Diaz
- Hospital Universitario Madrid Sanchinarro (CIOCC)
- Clinica Universidad de Navarra
- Hospital Universitario Virgen del Rocio
- The Christie NHS Foundation Trust
- Beatson West of Scotland Cancer Centre
- University College Hospital
- Guy's Hospital-Guy's and St Thomas NHS Foundation Trust
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Autologous genetically modified ADP-A2M4CD8 cells
Arm Description
Outcomes
Primary Outcome Measures
Efficacy: Overall Response Rate (ORR)
ORR is defined as incidence of complete responses or partial responses as assessed by RECIST v1.1
Secondary Outcome Measures
Number of subjects with treatment -related adverse events (AEs), including serious adverse events (SAEs) as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Determine if treatment with ADP-A2M4CD8 is safe and tolerable through assessment of adverse events (AEs) including Serious Adverse Events (SAEs)
Efficacy: Best overall response (BOR)
Best Overall Response (BOR) is per RECIST V1.1.
Time to response (TTR)
For patients who are observed to respond to ADP-A2M4CD8, the time taken from date of infusion to achieve a partial response or complete response (TTR) is assessed.
Duration of Response (DoR)
For patients who are observed to respond to ADP-A2M4CD8, the DoR is the date of initial response (including confirmation) from date of infusion up until disease progression per RECIST v 1.1 or death.
Progression Free Survival (PFS)
PFS is assessed from date of infusion of ADP-A2M4CD8 up until the date of disease progression per RECIST v1.1 or death.
Overall Survival (OS)
OS is assessed from date of infusion of ADP-A2M4CD8 up until the date of patient death.
Invitro diagnostic (IVD) assay for screening
Development and validation of the MAGE-A4 antigen expression companion diagnostic assay
Time taken to achieve peak expansion of genetically engineered T-cells in PBMCs
Time taken to achieve peak expansion of genetically engineered T-cells in PBMCs by flow cytometry
Full Information
NCT ID
NCT04752358
First Posted
February 8, 2021
Last Updated
June 28, 2023
Sponsor
Adaptimmune
Collaborators
ICON plc
1. Study Identification
Unique Protocol Identification Number
NCT04752358
Brief Title
ADP-A2M4CD8 in HLA-A2+ Subjects With MAGE-A4 Positive Esophageal or Esophagogastric Junction Cancers (SURPASS-2)
Official Title
A Phase 2 Open-Label Clinical Trial of ADP-A2M4CD8 in Subjects With Advanced Esophageal or Esophagogastric Junction Cancers
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 15, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Adaptimmune
Collaborators
ICON plc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study will investigate the efficacy of ADP-A2M4CD8 T-cell therapy in subjects who have the appropriate human leukocyte antigen (HLA) and tumor antigen status and whose esophageal or esophagogastric junction (EGJ) cancer expresses the MAGE-A4 protein.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer, Esophagogastric Junction Cancer
Keywords
Cell Therapy, T Cell Therapy, SPEAR T Cell, MAGE-A4, Immuno-oncology, Metastatic, Esophagogastric Junction, Esophageal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Autologous genetically modified ADP-A2M4CD8 cells
Arm Type
Experimental
Intervention Type
Genetic
Intervention Name(s)
Autologous genetically modified ADP-A2M4CD8 cells
Intervention Description
Infusion of autologous genetically modified ADP-A2M4CD8 on Day 1
Primary Outcome Measure Information:
Title
Efficacy: Overall Response Rate (ORR)
Description
ORR is defined as incidence of complete responses or partial responses as assessed by RECIST v1.1
Time Frame
2.5 Years
Secondary Outcome Measure Information:
Title
Number of subjects with treatment -related adverse events (AEs), including serious adverse events (SAEs) as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Description
Determine if treatment with ADP-A2M4CD8 is safe and tolerable through assessment of adverse events (AEs) including Serious Adverse Events (SAEs)
Time Frame
2.5 years
Title
Efficacy: Best overall response (BOR)
Description
Best Overall Response (BOR) is per RECIST V1.1.
Time Frame
2.5 Years
Title
Time to response (TTR)
Description
For patients who are observed to respond to ADP-A2M4CD8, the time taken from date of infusion to achieve a partial response or complete response (TTR) is assessed.
Time Frame
2.5 years
Title
Duration of Response (DoR)
Description
For patients who are observed to respond to ADP-A2M4CD8, the DoR is the date of initial response (including confirmation) from date of infusion up until disease progression per RECIST v 1.1 or death.
Time Frame
2.5 years
Title
Progression Free Survival (PFS)
Description
PFS is assessed from date of infusion of ADP-A2M4CD8 up until the date of disease progression per RECIST v1.1 or death.
Time Frame
2.5 years
Title
Overall Survival (OS)
Description
OS is assessed from date of infusion of ADP-A2M4CD8 up until the date of patient death.
Time Frame
15 years
Title
Invitro diagnostic (IVD) assay for screening
Description
Development and validation of the MAGE-A4 antigen expression companion diagnostic assay
Time Frame
2.5 years
Title
Time taken to achieve peak expansion of genetically engineered T-cells in PBMCs
Description
Time taken to achieve peak expansion of genetically engineered T-cells in PBMCs by flow cytometry
Time Frame
2.5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Age ≥18 and <75 years
Diagnosis of Esophageal cancer or Esophagogastric junction cancer.
Previously received treatment for advanced or metastatic disease.
Measurable disease according to RECIST v1.1.
HLA-A*02 positive
Tumor shows MAGE-A4 expression confirmed by central laboratory.
ECOG Performance Status of 0 or1.
Left ventricular ejection fraction (LVEF) ≥50%.
Note: other protocol defined Inclusion criteria may apply
Key exclusion criteria
Positive for any HLA-A*02 allele other than: one of the inclusion alleles
History of allergic reactions attributed to compounds of similar chemical or biologic composition to fludarabine, cyclophosphamide or other agents used in the study
Active autoimmune or immune mediated disease
Leptomeningeal disease, carcinomatous meningitis or symptomatic CNS metastases
Other prior malignancy that is not considered by the Investigator to be in complete remission. Clinically significant cardiovascular disease
Uncontrolled intercurrent illness
Active infection with human immunodeficiency virus, hepatitis B virus, hepatitis C virus, or human T cell leukemia virus
Pregnant or breastfeeding
Note: other protocol defined Inclusion/Exclusion criteria may apply.
Facility Information:
Facility Name
City of Hope National Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Northwestern Medical Faculty Foundation
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Chicago Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Simon Cancer Center-Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Washington University School of Medicine- Siteman Cancer Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
OU Health Stephenson Cancer Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Providence Cancer Institute Franz Clinic
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
University Of Texas, MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University Of Wisconsin Clinical Science Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Froedtert Hospital and Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
McGill University Health Centre Glen Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
Hopital Huriez
City
Lille
State/Province
Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Centre Leon-Berard (CLB) - Centre de Recherche en Cancerologie Lyon-Est (CRCL)
City
Lyon
State/Province
Cedex
ZIP/Postal Code
69008
Country
France
Facility Name
Centre Eugene Marquis
City
Rennes
State/Province
Cedex
ZIP/Postal Code
35062
Country
France
Facility Name
Institut Gustave Roussy
City
Vaillant
State/Province
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
Hospital Universitari Vall d'Hebron
City
la Vall d'Hebron
State/Province
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Córdoba
State/Province
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Clinico Universitario de Valencia
City
Ibáñez
State/Province
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Hospital Fundacion Jimenez Diaz
City
Madrid
ZIP/Postal Code
228040
Country
Spain
Facility Name
Hospital Universitario Madrid Sanchinarro (CIOCC)
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Clinica Universidad de Navarra
City
Navarro
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
The Christie NHS Foundation Trust
City
Withington
State/Province
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Beatson West of Scotland Cancer Centre
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
University College Hospital
City
London
ZIP/Postal Code
NW2 1PG
Country
United Kingdom
Facility Name
Guy's Hospital-Guy's and St Thomas NHS Foundation Trust
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
ADP-A2M4CD8 in HLA-A2+ Subjects With MAGE-A4 Positive Esophageal or Esophagogastric Junction Cancers (SURPASS-2)
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