MAGE-A4ᶜ¹º³²T for Multi-Tumor

This study will investigate the safety and tolerability of MAGE-A4ᶜ¹º³²T cell therapy in subjects who have the appropriate HLA-A2 tissue marker and whose urinary bladder, melanoma, head and neck, ovarian, non-small cell lung, esophageal, gastric, synovial sarcoma, or myxoid / round call liposarcoma (MRCLS) tumor has the MAGE-A4 protein expressed. This study will take a subject's T cells and give them a T cell receptor protein that recognizes and attacks the tumors. This study has a substudy component that will investigate the safety and tolerability of MAGE-A4c1032T cell therapy in combination with low dose radiation in up to 10 subjects.

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
• 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.

Trial Phase Phase I

Trial Type Treatment

Lead Organization
Adaptimmune Limited

• Primary ID ADP-0044-001
• Secondary IDs NCI-2017-01505
• Clinicaltrials.gov ID NCT03132922