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.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Number of subjects with adverse events (AE), including serious adverse events (SAE).
Timeframe: 3 years
Evaluation of the persistence of genetically modified T cells
Timeframe: 3 years
Measurement of RCL in genetically modified T cells.
Timeframe: 3 years
Assessment of dose limiting toxicities to determine optimally tolerated dose range
Timeframe: 3 years
Proportion of subjects with a confirmed Complete Response (CR) and/or Partial Response (PR).
Timeframe: 3 years
Interval between the date of first T cell infusion dose and first documented evidence of CR or PR.
Timeframe: 3 years
Interval between the date of first documented evidence of CR or PR until first documented disease progression or death due to any cause.
Timeframe: 3 years
Interval between the date of first documented evidence of SD until first documented disease progression or death due to any cause.
Timeframe: 3 years
Interval between the date of first T cell infusion and the earliest date of disease progression or death due to any cause
Timeframe: 3 years
Interval between the date of first T cell infusion and date of death due to any cause.
Timeframe: 3 years
Number and % of subjects having any Long Term Follow Up Adverse Events (AEs)
Timeframe: 15 years post last treatment (infusion)