Ovarian Cancer Clinical Trial
Official title:
A Phase 1 Basket Study Evaluating the Safety and Feasibility of T-Plex, Autologous Customized T Cell Receptor-Engineered T Cells Targeting Multiple Peptide/HLA Antigens in Participants With Antigen-positive Locally Advanced (Unresectable) or Metastatic Solid Tumors
TScan Therapeutics is developing cellular therapies across multiple solid tumors in which autologous participant-derived T cells are engineered to express a T cell receptor that recognizes cancer-associated antigens presented on specific Human Leukocyte Antigen (HLA) molecules. This is a multi-center, non-randomized, multi-arm, open-label, basket study evaluating the safety and preliminary efficacy of single and repeat dose regimens of TCR'Ts as monotherapies and as T-Plex combinations after lymphodepleting chemotherapy in participants with locally advanced, metastatic solid tumors disease.
Participants will be screened in a separate screening study, TSCAN-003 (NCT05812027), to assess their HLA type, tumor-associated antigen (TAA) expression and loss of heterozygosity (LOH) status. The results of these tests will be used to determine initial eligibility in this study. Depending on the genetic type, participants will be assigned to one of the following study groups: Monotherapy: - COHORT A: TSC-204-A0201 targeting MAGE-A1 on HLA-A*02:01 - COHORT B: TSC-204-C0702 targeting MAGE-A1 on HLA-C*07:02 - COHORT C: TSC-200-A0201 targeting HPV16 E7 on HLA-A*02:01 - COHORT D: TSC-203-A0201 targeting PRAME on HLA-A*02:01 - COHORT E: TSC-204-A0101 targeting MAGE-A1 on HLA-A*01:01 - COHORT F: TSC-201-B0702 targeting MAGE-C2 on HLA-B*07:02 T-Plex Combination: - COHORT AB: TSC-204-A0201 + TSC-204-C0702 - COHORT AC: TSC-204-A0201 + TSC-200-A0201 - COHORT AD: TSC-204-A0201 + TSC-203-A0201 - COHORT AE: TSC-204-A0201 + TSC-204-A0101 - COHORT AF: TSC-204-A0201 + TSC-201-B0702 - COHORT BC: TSC-204-C0702 + TSC-200-A0201 - COHORT BD: TSC-204-C0702 + TSC-203-A0201 - COHORT BE: TSC-204-C0702 + TSC-204-A0101 - COHORT BF: TSC-204-C0702 + TSC-201-B0702 - COHORT CD: TSC-200-A0201 + TSC-203-A0201 - COHORT CE: TSC-200-A0201 + TSC-204-A0101 - COHORT CF: TSC-200-A0201 + TSC-201-B0702 - COHORT DE: TSC-203-A0201 + TSC-204-A0101 - COHORT DF: TSC-203-A0201 + TSC-201-B0702 - COHORT EF: TSC-204-A0101 + TSC-201-B0702 Participants will undergo leukapheresis to collect cells to manufacture the TCR-T products. They will then undergo lymphodepletion and receive one or two doses of the TCR-T cell therapy product as a monotherapy or part of a combination of TCR-Ts (referred to as T-Plex combinations in this study). ;
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