ADP-A2M4CD8 As Monotherapy or in Combination with Either Nivolumab or Pembrolizumab in HLA-A2+ Subjects with MAGE-A4 Positive Tumors (SURPASS)

Inclusion Criteria

• - Key Inclusion criteria - Age ≥18 and ≤ 75 years - Subject is positive for at least 1 HLA-A*02 inclusion allele - Histologically or cytogenetically confirmed diagnosis of urothelial cancer, esophageal, esophagogastric junction (EGJ) cancer, gastric cancer, non-small cell lung carcinoma (NSCLC), head and neck or ovarian cancer, endometrial cancer, melanoma - Measurable disease according to RECIST v1.1 prior to leukapheresis and lymphodepletion. - Tumor shows MAGE-A4 expression as confirmed by central laboratory - ECOG Performance Status of 0 or 1. - Left ventricular ejection fraction (LVEF) ≥50% or the institutional lower limit of normal range, whichever is lower Note: other protocol defined Inclusion/Exclusion criteria may apply - Subjects must have ≥ 90% room air oxygen saturation at rest at Screening (within 7 days of leukapheresis) and at Baseline. 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.