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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, ...
Autologous genetically modified MAGE A10ᶜ⁷⁹⁶T cells are an investigational gene therapy being studied in urothelial carcinoma, along with melanoma and head and neck cancers. The product consists of a patient's own T cells that have been genetically modified and then returned to the patient. Adaptimmune Therapeutics PLC is developing it.
Autologous genetically modified MAGE A10ᶜ⁷⁹⁶T cells are being studied for urothelial carcinoma, including bladder urothelial carcinoma. The clinical program also enrolled patients with melanoma and head and neck cancer. The approach is biomarker selected, meaning patients are chosen based on a biomarker rather than treated unselected.
The therapy targets ADA, an exogenous gene introduced into the patient's T cells through genetic modification. The target class is an exogenous gene rather than a native human protein. The modified cells are autologous, meaning they are derived from the patient's own T cells before being administered back.
Adaptimmune Therapeutics PLC, which trades under the ticker ADAPY, is the developer of autologous genetically modified MAGE A10ᶜ⁷⁹⁶T cells. The company is running the program in oncology as a gene therapy approach, with urothelial carcinoma as the lead indication listed for the asset.
Autologous genetically modified MAGE A10ᶜ⁷⁹⁶T cells are in Phase 1 development and remain investigational. The single registered trial, NCT02989064, has a completed status. It was an uncontrolled, non-randomized study without double blinding, and it enrolled 10 patients across the United States, Canada, and Spain.
Autologous genetically modified MAGE A10ᶜ⁷⁹⁶T cells were studied in NCT02989064, titled MAGE-A10ᶜ⁷⁹⁶T for Urothelial Cancer, Melanoma or Head and Neck Cancers. The Phase 1 trial enrolled 10 patients aged 18 years and older of all sexes, with no healthy volunteers, and it has completed.