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

Lead Sponsor

USWM CT, LLC

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

No

•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.

•Subjects must have ≥ 90% room air oxygen saturation at rest at Screening (within 7 days of leukapheresis) and at Baseline.
•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

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