Esophageal Cancer Clinical Trial
ADP-A2M4CD8 in HLA-A2+ Subjects With MAGE-A4 Positive Esophageal or Esophagogastric Junction Cancers (SURPASS-2)
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.
Key Inclusion Criteria:
Age â‰¥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.
Tumor shows MAGE-A4 expression confirmed by central laboratory.
ECOG Performance Status of 0 or1.
Left ventricular ejection fraction (LVEF) â‰¥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.
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There are 32 Locations for this study
Duarte California, 91010, United States
Jacksonville Florida, 32224, United States
Chicago Illinois, 60611, United States
Chicago Illinois, 60637, United States
Indianapolis Indiana, 46202, United States
Rochester Minnesota, 55905, United States
Saint Louis Missouri, 63110, United States
New York New York, 10065, United States
Durham North Carolina, 27710, United States
Oklahoma City Oklahoma, 73104, United States
Portland Oregon, 97213, United States
Dallas Texas, 75390, United States
Houston Texas, 77030, United States
Madison Wisconsin, 53792, United States
Milwaukee Wisconsin, 53226, United States
Toronto Ontario, M5G 2, Canada
Montreal Quebec, H4A 3, Canada
Lille Cedex, 59037, France
Lyon Cedex, 69008, France
Rennes Cedex, 35062, France
Vaillant Villejuif, 94805, France
la Vall d'Hebron Barcelona, 08035, Spain
CÃ³rdoba Madrid, 28041, Spain
IbÃ¡Ã±ez Valencia, 46010, Spain
Madrid , 22804, Spain
Madrid , 28050, Spain
Navarro , 31008, Spain
Sevilla , 41013, Spain
Withington Manchester, M20 4, United Kingdom
Glasgow Scotland, G12 0, United Kingdom
London , NW2 1, United Kingdom
London , SE1 9, United Kingdom
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