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

Official Title

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 Tumours

Summary:

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 tumours. The study will enroll subjects at least 18 years of age 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.

Trial Description

Primary Outcome:

  • Number of subjects with adverse events (AE), including serious adverse events (SAE).
  • Evaluation of the persistence of genetically modified T cells
  • Measurement of RCL in genetically modified T cells.
  • Assessment of dose limiting toxicities to determine optimally tolerated dose range
  • Proportion of subjects with a confirmed Complete Response (CR) and/or Partial Response (PR).
  • Interval between the date of first T cell infusion dose and first documented evidence of CR or PR.
  • Interval between the date of first documented evidence of CR or PR until first documented disease progression or death due to any cause.
  • Interval between the date of first documented evidence of SD until first documented disease progression or death due to any cause.
  • Interval between the date of first T cell infusion and the earliest date of disease progression or death due to any cause
  • Interval between the date of first T cell infusion and date of death due to any cause.
  • Number and % of subjects having any Long Term Follow Up Adverse Events (AEs)

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society