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Autologous genetically modified MAGE A10ᶜ⁷⁹⁶T cells · 1 trial · 4 indications
Determine if treatment with autologous genetically modified T cells, (MAGE A10ᶜ⁷⁹⁶T ) is safe and tolerable through laboratory assessments including chemistry, hematology and coagulation; and cardiac assessments, including ECG/troponin.
Evaluation of the persistence of the infused T cells in the periphery.
Evaluation of RCL in Subject PBMCs using PCR-based assay.
Evaluation of dose limiting toxicities will be performed using the CTCAE Version 4.0
Evaluation of the efficacy of the treatment by assessment of the Overall Response Rate according to RECIST v1.1
Evaluation of the efficacy of the treatment by assessment of time to first response.
Evaluation of the efficacy of the treatment by assessment of duration of response.
Evaluation of the efficacy of the treatment by assessment of duration of stable disease.
Evaluation of the efficacy of the treatment by assessment of progression-free survival.
Evaluation of the efficacy of the treatment by assessment of overall survival.
* New occurrence of any malignancy * New occurrence or exacerbation of a pre-existing neurologic disorder * New occurrence or exacerbation of a prior rheumatologic or other autoimmune disorder * New occurrence of a hematologic disorder * New occurrence of any opportunistic and/or serious infections * New occurrence of any unanticipated illness and/or hospitalization deemed related to gene modified cell therapy
| Arm | Type | Description |
|---|---|---|
| Autologous genetically modified MAGE A10ᶜ⁷⁹⁶T cells | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Autologous genetically modified MAGE A10ᶜ⁷⁹⁶T cells | GENETIC | Infusion of autologous genetically modified MAGE A10ᶜ⁷⁹⁶T on Day 1 |
Inclusion Criteria: 1. Subject is ≥18 to ≤75 years of age at the time of signing the study informed consent. 2. Subject has histologically confirmed diagnosis of any one of the following cancers: (A) urothelial cancer (transitional cell cancer of the bladder, ureter or renal pelvis), (B) melanoma, ...
It is an investigational gene therapy being studied for urothelial carcinoma, a type of bladder cancer. It has also been evaluated in clinical trials for melanoma and head and neck cancers. It is not approved for any indication and remains in clinical development.
It is an autologous T cell therapy genetically modified to express a T cell receptor targeting MAGE-A10, a cancer-testis antigen. The target class is an exogenous gene, and the molecular target is ADA. The modified T cells are designed to recognize and attack MAGE-A10 expressing tumor cells.
Adaptimmune Therapeutics PLC Sponsored ADR (ticker: ADAP) is the developer. The company is responsible for the research and clinical development of this autologous genetically modified T cell therapy.
It is in Phase 1 clinical development. The only trial, NCT02989064, is completed. It is an investigational therapy and has not been approved by the FDA for any indication.
It has been studied in one Phase 1 trial, NCT02989064, titled MAGE-A10ᶜ⁷⁹⁶T for Urothelial Cancer, Melanoma or Head and Neck Cancers. The trial enrolled 10 participants across the United States, Canada, and Spain and is now completed.
Yes, it is a biomarker-selected therapy. The trial required patients to have MAGE-A10 expressing tumors. This means only patients whose tumors express the MAGE-A10 antigen were eligible for treatment.