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.

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 following cancers: urothelial cancer (transitional cell cancer of the bladder, ureter, urethra or renal pelvis), melanoma, squamous cell carcinoma of the head and neck, ovarian cancer, NSCLC (squamous, adenosquamous, adenocarcinoma or large cell), esophageal (squamous and adenocarcinoma) or gastric cancer, synovial sarcoma or MRCLS.
• Subject is HLA-A*02 positive and subject's tumor shows expression of the MAGE-A4 RNA or protein.
• 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 is HLA-A*02:05 positive in either allele; Subject has HLA-A*02:07 as the sole HLA-A*02 allele (e.g., a subject with HLA alleles A*02:04 and A*02:07 is eligible); or Subject has any A*02 null allele (designated with an "N", e.g., A*02:32N) as the sole HLA-A*02 allele
• 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.

Lead Organization
Adaptimmune Limited

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