ADP-A2M4CD8 in HLA-A2+ Subjects With MAGE-A4 Positive Esophageal or Esophagogastric Junction Cancers (SURPASS-2)
Reason given: Study was terminated due to difficulty recruiting subjects and lack of efficacy
Key facts
- Where
- Chicago, Duarte, Houston, Madison, New York, Oklahoma City, Portland, and St Louis, United StatesSee the 8 sites
- Phase
- Phase 2
Where in United States
- University of Chicago MedicineChicago, United StatesNo longer taking part
- City of Hope National Medical CenterDuarte, United StatesNo longer taking part
- University of Texas - MD Anderson Cancer CenterHouston, United StatesNo longer taking part
- University of Wisconsin Clinical Science CenterMadison, United StatesNo longer taking part
- Memorial Sloan-Kettering Cancer CenterNew York, United StatesNo longer taking part
- OU Health Stephenson Cancer CenterOklahoma City, United StatesNo longer taking part
- Providence Cancer Institute Franz ClinicPortland, United StatesNo longer taking part
- Washington University School of Medicine - Siteman Cancer CenterSt Louis, United StatesNo longer taking part
Trial details
- Who runs it
- Adaptimmune
- Trial code
- NCT04752358
- Record updated
- 4 September 2024
- Original description
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.Read full original descriptionShow less
A Phase 2 Open-Label Clinical Trial of ADP-A2M4CD8 in Subjects With Advanced Esophageal or Esophagogastric Junction Cancers
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.
Inclusion: 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.
Exclusion: 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; Positive for any HLA-A*02 allele other than: one of the inclusion alleles; Pregnant or breastfeeding; Note: other protocol defined Inclusion/Exclusion criteria may apply.