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Infusion of autologous genetically modified MAGE A10ᶜ⁷⁹⁶T on Day 1

Autologous genetically modified MAGE A10ᶜ⁷⁹⁶T cells

David Hong, MD

This Phase 1 study is designed as a cell dose escalation trial in HLA-A\*02:01 and HLA-A\*02:06 subjects with MAGE-A10 positive urothelial, melanoma or head and neck tumors. The study will enroll subjects between the ages of 18 and 75 using a modified 3+3 cell dose escalation design, to evaluate dose limiting toxicities and determine the target cell dose range. Following the dose escalation phase, additional subjects will be enrolled at the target cell dose range to further characterize safety and the effects at this cell dose.

The study will take the subject's T cells, which are a natural type of immune cell in the blood, and send them to a laboratory to be modified. The changed T cells used in this study will be the subject's own T cells that have been genetically changed with the aim of attacking and destroying cancer cells. When the MAGE-A10ᶜ⁷⁹⁶T cells are available, subjects will undergo lymphodepleting chemotherapy with cyclophosphamide and fludarabine, followed by T cell infusion. The purpose of this study is to test the safety of genetically changed T cells and find out what effects, if any, they have in subjects with urothelial, melanoma or head and neck cancer.

Subjects will be seen frequently by the Study Physician after receiving their T cells for the next 6 months. After that, subjects will be seen every 3, 6, or 12 months according to the Schedule of Procedures. All subjects completing or withdrawing from the interventional portion of the study will enter a long term follow-up phase for observation of delayed adverse events and overall survival for 15 years post-infusion.

MAGE-A10ᶜ⁷⁹⁶T for Urothelial Cancer, Melanoma or Head and Neck Cancers

Phase 1 Cell Dose Escalation Study to Assess the Safety and Tolerability of Genetically Engineered MAGE-A10ᶜ⁷⁹⁶T in HLA-A2+ Subjects With MAGE-A10 Positive Urothelial, Melanoma or Head and Neck Tumors

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
MAGE-A10ᶜ⁷⁹⁶T for Urothelial Cancer, Melanoma or Head and Neck Cancers	NCT02989064	Urothelial Carc... Head and Neck C... Melanoma Bladder Urothel...	Autologous gene...	18 Years - 75 Years	Adaptimmune
MAGE-A10ᶜ⁷⁹⁶T for Urothelial Cancer, Melanoma or Head and Neck Cancers	NCT02989064	Urothelial Carc... Head and Neck C... Melanoma Bladder Urothel...	Autologous gene...	18 Years - 75 Years	Adaptimmune

Spots Global Cancer Trial Database for autologous genetically modified mage a10ᶜ⁷⁹⁶t cells