Status:
TERMINATED
ADP-A2M4CD8 in HLA-A2+ Subjects With MAGE-A4 Positive Esophageal or Esophagogastric Junction Cancers (SURPASS-2)
Lead Sponsor:
Adaptimmune
Collaborating Sponsors:
ICON plc
Conditions:
Esophageal Cancer
Esophagogastric Junction Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 esophagogastr...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
September 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2023
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT04752358
Start Date
September 15 2021
End Date
December 15 2023
Last Update
September 4 2024
Active Locations (17)
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1
City of Hope National Medical Center
Duarte, California, United States, 91010
2
University of Chicago Medicine
Chicago, Illinois, United States, 60637
3
Washington University School of Medicine- Siteman Cancer Center
St Louis, Missouri, United States, 63110
4
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065