A Basket Study of Customized Autologous TCR-T Cell Therapies in Patients With Locally Advanced (Unresectable) or Metastatic Solid Tumors
NCT05973487 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 840
Last updated 2025-11-17
Summary
TScan Therapeutics is developing cellular therapies across multiple solid tumors in which autologous participant-derived engeneered 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.
Conditions
- Head and Neck Cancer
- Cervical Cancer
- Non-small Cell Carcinoma
- Melanoma
- Ovarian Cancer
- Anogenital Cancers
- HPV - Anogenital Human Papilloma Virus Infection
- HPV-Related Cervical Carcinoma
- HPV-Related Carcinoma
- HPV-Related Squamous Cell Carcinoma
- HPV-Related Malignancy
- HPV-Related Adenocarcinoma
- HPV Positive Oropharyngeal Squamous Cell Carcinoma
- HPV-Related Adenosquamous Carcinoma
- HPV-Associated Vaginal Adenocarcinoma
- HPV-Related Endocervical Adenocarcinoma
- HPV-Related Anal Squamous Cell Carcinoma
- HPV-Related Verrucous Carcinoma
- HPV-Related Penile Squamous Cell Carcinoma
- HPV-Related Vulvar Squamous Cell Carcinoma
- HPV Positive Rectal Squamous Cell Carcinoma
Interventions
- BIOLOGICAL
-
TSC-204-A0201
Escalating doses of TSC-204-A0201 as a monotherapy
- BIOLOGICAL
-
TSC-204-C0702
Escalating doses of TSC-204-C0702 as a monotherapy
- BIOLOGICAL
-
TSC-200-A0201
Escalating doses of TSC-200-A0201 as a monotherapy
- BIOLOGICAL
-
TSC-204-A0201 + TSC-204-C0702
Escalating doses of TSC-204-A0201 in combination with TSC-204-C0702
- BIOLOGICAL
-
TSC-204-A0201 + TSC-200-A0201
Escalating doses of TSC-204-A0201 in combination with TSC-200-A0201
- BIOLOGICAL
-
TSC-204-C0702 + TSC-200-A0201
Escalating doses of TSC-204-C0702 in combination with TSC-200-A0201
- BIOLOGICAL
-
TSC-204-A0201 + TSC-203-A0201
Escalating doses of TSC-204-A0201 in combination with TSC-203-A0201
- BIOLOGICAL
-
TSC-204-C0702 + TSC-203-A0201
Escalating doses of TSC-204-C0702 in combination with TSC-203-A0201
- BIOLOGICAL
-
TSC-200-A0201 + TSC-203-A0201
Escalating doses of TSC-200-A0201 in combination with TSC-203-A0201
- BIOLOGICAL
-
TSC-203-A0201
Escalating doses of TSC-203-A0201 as a monotherapy
- BIOLOGICAL
-
TSC-204-A0101
Escalating doses of TSC-204-A0101 as a monotherapy
- BIOLOGICAL
-
TSC-201-B0702
Escalating doses of TSC-201-B0702 as a monotherapy
- BIOLOGICAL
-
TSC-204-A0201 + TSC-204-A0101
Escalating doses of TSC-204-A0201 in combination with TSC-204-A0101
- BIOLOGICAL
-
TSC-204-A0201 + TSC-201-B0702
Escalating doses of TSC-204-A0201 in combination with TSC-201-B0702
- BIOLOGICAL
-
TSC-204-C0702 + TSC-204-A0101
Escalating doses of TSC-204-C0702 in combination with TSC-204-A0101
- BIOLOGICAL
-
TSC-204-C0702 + TSC-201-B0702
Escalating doses of TSC-204-C0702 in combination with TSC-201-B0702
- BIOLOGICAL
-
TSC-200-A0201 + TSC-204-A0101
Escalating doses of TSC-200-A0201 in combination with TSC-204-A0101
- BIOLOGICAL
-
TSC-200-A0201 + TSC-201-B0702
Escalating doses of TSC-200-A0201 in combination with TSC-201-B0702
- BIOLOGICAL
-
TSC-203-A0201 + TSC-204-A0101
Escalating doses of TSC-203-A0201 in combination with TSC-204-A0101
- BIOLOGICAL
-
TSC-203-A0201 + TSC-201-B0702
Escalating doses of TSC-203-A0201 in combination with TSC-201-B0702
- BIOLOGICAL
-
TSC-202-A0201
Escalating doses of TSC-202-A0201 as a monotherapy
- BIOLOGICAL
-
TSC-204-A0201 + TSC-202-A0201
Escalating doses of TSC-204-A0201 in combination with TSC-202-A0201
- BIOLOGICAL
-
TSC-204-C0702 + TSC-202-A0201
Escalating doses of TSC-204-C0702 in combination with TSC-202-A0201
- BIOLOGICAL
-
TSC-200-A0201 + TSC-202-A0201
Escalating doses of TSC-200-A0201 in combination with TSC-202-A0201
- BIOLOGICAL
-
TSC-203-A0201 + TSC-202-A0201
Escalating doses of TSC-203-A0201 in combination with TSC-202-A0201
- BIOLOGICAL
-
TSC-204-A0101 + TSC-202-A0201
Escalating doses of TSC-204-A0101 in combination with TSC-202-A0201
- BIOLOGICAL
-
TSC-201-B0702 + TSC-202-A0201
Escalating doses of TSC-201-B0702 in combination with TSC-202-A0201
Sponsors & Collaborators
-
TScan Therapeutics, Inc.
lead INDUSTRY
Principal Investigators
-
Dawn Pinchasik, MD · TScan Therapeutics
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-05-06
- Primary Completion
- 2026-12-30
- Completion
- 2026-12-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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