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Clinical Trial Summary

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.


Clinical Trial Description

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). ;


Study Design


Related Conditions & MeSH terms

  • Adenocarcinoma
  • Carcinoma
  • Carcinoma, Adenosquamous
  • Carcinoma, Squamous Cell
  • Cervical Cancer
  • Head and Neck Cancer
  • HPV - Anogenital Human Papilloma Virus Infection
  • HPV Positive Oropharyngeal Squamous Cell Carcinoma
  • HPV-Related Anal Squamous Cell Carcinoma
  • HPV-Related Carcinoma
  • HPV-Related Cervical Carcinoma
  • HPV-Related Malignancy
  • HPV-Related Penile Squamous Cell Carcinoma
  • HPV-Related Squamous Cell Carcinoma
  • HPV-Related Vulvar Squamous Cell Carcinoma
  • Melanoma
  • Non-small Cell Carcinoma
  • Ovarian Cancer
  • Papilloma
  • Papillomavirus Infections
  • Squamous Cell Carcinoma of Head and Neck

NCT number NCT05973487
Study type Interventional
Source TScan Therapeutics, Inc.
Contact Marlyane Motta, BS
Phone 857-399-9887
Email mmotta@tscan.com
Status Recruiting
Phase Phase 1
Start date May 6, 2024
Completion date December 30, 2026

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