Brief Title: MAGE-A4ᶜ¹º³²T for Multi-Tumor

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Number of subjects with adverse events (AE), including serious adverse events (SAEs).

Primary Outcome 1 - Timeframe: 3.5 years

Primary Outcome 2 - Measure: Determining dose limiting toxicities (DLT) and optimally tolerated dose range

Primary Outcome 2 - Timeframe: 3.5 years

Primary Outcome 3 - Measure: Evaluation of persistence of genetically modified T cells.

Primary Outcome 3 - Timeframe: 3.5 years

Primary Outcome 4 - Measure: Measurement of RCL in genetically modified T cells.

Primary Outcome 4 - Timeframe: 3.5 years

CONDITION

• Urinary Bladder Cancer
• Melanoma
• Head and Neck Cancer
• Ovarian Cancer
• Non-Small Cell Lung Cancer
• Esophageal Cancer
• Gastric Cancer
• Synovial Sarcoma
• Myxoid Round Cell Liposarcoma
• Gastroesophageal Junction

ELIGIBILITY

Inclusion Criteria:
Subject is ≥18 years of age at the time of signing the study informed consent.

- Subject has histologically confirmed diagnosis of any one of the indicated tumor types

- Subject is HLA-A*02 positive. (This determination will be made under screening protocol ADP-0000-001).

- Subject's tumor shows expression of the MAGE-A4 RNA or protein. (This determination will be made under screening protocol ADP-0000-001).

- Adequate organ function as indicated in the study protocol

- Subject has measurable disease according to RECIST v1.1 criteria prior to lymphodepletion

- Subject meets disease-specific requirements per protocol
7. Subject has anticipated life expectancy > 6 months prior to leukapheresis and >3 months prior to lymphodepletion.
Exclusion Criteria:
Subject does not express appropriate HLA-A genotype

- Subject is receiving excluded therapy/treatment per protocol

- Subject has symptomatic CNS metastases.

- Subject has any other active malignancy besides the tumor under study within 3 years prior to Screening. Subject has uncontrolled intercurrent illness.

- Subject has active infection with HIV, HBV, HCV or HTLV

- Subject is pregnant or breastfeeding.
Additional Exclusion Criteria for the Radiation Substudy:
Subject does not meet eligibility criteria for the main study (ADP-0044-001).

- Subject does not have at least one target lesion amenable to radiation.

- Certain radiation therapy within 6 months of clinical trial are an exclusion.

- Metastatic disease impinging on the spinal cord or threatening spinal cord compression.

Gender: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: David Hong, MD

Role: Principal Investigator

Affiliation: M.D. Anderson Cancer Center

Overall Contact

Name: David Hong, MD

Phone: 713-563-5844

Email: dshong@madanderson.org

LOCATION