Trials / Active Not Recruiting
Active Not RecruitingNCT05973487
A Basket Study of Customized Autologous TCR-T Cell Therapies in Patients With Locally Advanced (Unresectable) or Metastatic Solid Tumors
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
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 840 (estimated)
- Sponsor
- TScan Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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 * COHORT G: TSC-202-A0201 targeting MAGE-A4 on HLA-A\*02:01 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 * COHORT AG: TSC-204-A0201 + TSC-202-A0201 * COHORT BG: TSC-204-C0702 + TSC-202-A0201 * COHORT CG: TSC-200-A0201 + TSC-202-A0201 * COHORT DG: TSC-203-A0201 + TSC-202-A0201 * COHORT EG: TSC-204-A0101 + TSC-202-A0201 * COHORT FG: TSC-201-B0702 + TSC-202-A0201 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).
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
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2024-05-06
- Primary completion
- 2026-12-30
- Completion
- 2026-12-30
- First posted
- 2023-08-03
- Last updated
- 2025-11-17
Locations
21 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05973487. Inclusion in this directory is not an endorsement.