Brief Title: Surpass: ADP-A2M4CD8 in HLA-A2+ Subjects With MAGE-A4 Positive Tumors

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: To evaluate safety and tolerability of ADP-A2M4CD8 as monotherapy or in combination with either nivolumab or pembrolizumab

Primary Outcome 1 - Timeframe: 2.5 years

Primary Outcome 2 - Measure: To evaluate safety of ADP-A2M4CD8 as monotherapy or in combination with either nivolumab or pembrolizumab

Primary Outcome 2 - Timeframe: Up to 15 years

CONDITION

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ELIGIBILITY

* 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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: D

Role: P

Affiliation: M

Overall Contact

Name: D

Phone: 7

Email: d

LOCATION