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.
| Status | Recruiting |
| Enrollment | 100 |
| Est. completion date | December 30, 2026 |
| Est. primary completion date | December 30, 2026 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: 1. Must be at least 18 years. 2. Locally advanced (unresectable) or metastatic solid tumor for which there are no available curative treatment options, after failure of the standard of care systemic therapies for that particular indication. 3. Solid tumors, including but not limited to non-nasopharyngeal head and neck cancer, non-small cell lung cancer, cutaneous melanoma, cervical cancer, ovarian cancer, anal cancer and genital cancers. Other tumor types may be permitted if approved by TScan. 4. Participants must express one of the following HLA types, as assessed by a qualified genomics assay in screening study TSCAN-003: HLA-B*07:02 HLA-A*01:01 HLA-C*07:02 HLA-A*02:01 5. Tumor must express one or more of the following: MAGE-A1, MAGE-C2, PRAME and HPV16-E7 assessed in the last 8 months in screening study TSCAN-003 (NCT05812027). 6. Eastern Cooperative Oncology Group (ECOG) Performance status 0-1 at screening. 7. Participants must be able to understand and be willing to give informed consent; decision-impaired adults may consent with their legally authorized representative. 8. At least 1 measurable lesion per modified Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. 9. Adequate bone marrow and organ function. Exclusion Criteria: 1. Medical or psychological conditions that would make the participant unsuitable candidate for cell therapy at the discretion of the PI. 2. History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, cardiac arrhythmia requiring antiarrhythmic or procedure, or other clinically significant cardiac disease within 12 months of enrollment 3. History of stroke or transient ischemic attack (TIA) within 12 months of enrollment 4. Systemic corticosteroid therapy >10 mg of prednisone daily or equivalent within 7 days of enrollment 5. History of severe hypersensitivity to fludarabine or cyclophosphamide or study product excipients including human serum albumin, Cryostor (DMSO or Dextran 40), or Plasma-Lyte. 6. Untreated or symptomatic central nervous system (CNS) metastases or cytology proven carcinomatous meningitis. 7. Concurrent receipt of another anti-cancer therapy. 8. Presence of fungal, bacterial, viral, or other infection requiring anti-microbials for management. 9. Tumors that have HLA LOH using a central lab clinical trial assay of HLAs addressed by the monotherapy and/or T-Plex combination TCR-Ts in the protocol and have no available TCR-T options for intact HLAs in the participant's tumor. 10. Participants who regularly require supplemental oxygen. |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of North Carolina at Chapel Hill | Chapel Hill | North Carolina |
| United States | The Cleveland Clinic | Cleveland | Ohio |
| United States | Karmanos Cancer Institute | Detroit | Michigan |
| United States | Memorial Healthcare System | Hollywood | Florida |
| United States | Norton Cancer Institute | Louisville | Kentucky |
| United States | University of Miami, Sylvester Comprehensive Cancer Center | Miami | Florida |
| United States | University of Minnesota Masonic Cancer Center | Minneapolis | Minnesota |
| United States | Yale Cancer Center | New Haven | Connecticut |
| United States | Columbia University Herbert Irving Comprehensive Cancer Center | New York | New York |
| United States | Orlando Health | Orlando | Florida |
| United States | Allegheny Hospitals Network | Pittsburgh | Pennsylvania |
| United States | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania |
| United States | Providence Cancer Institute Franz Clinic | Portland | Oregon |
| United States | HonorHealth Research and Innovation Institute | Scottsdale | Arizona |
| Lead Sponsor | Collaborator |
|---|---|
| TScan Therapeutics, Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | To measure the persistence of T-Plex TCR-T cells in the peripheral blood with single and repeat doses | Percentage of TCR-T cells in the peripheral blood after single and repeat doses | Up to 24 months | |
| Other | To measure the infiltration of T-Plex TCR-T cells into tumors in post-treatment biopsies | Percentage of TCR-T cells in the tumor after single and repeat doses | Up to 24 months | |
| Other | To measure the immune activation markers in the tumor after single and repeated doses | Status of immune activation markers in the tumor after single and repeat doses | Up to 24 months | |
| Primary | Evaluate the safety of monotherapy and T- Plex combination TCR-Ts | Number of subjects with dose limiting toxicities (DLT) | 28 days | |
| Primary | Determine the recommended phase 2 dose of monotherapy and T- Plex combination TCR-Ts | Frequency and severity of DLTs, AEs and SAEs | Up to 12 months | |
| Secondary | Investigate preliminary anti-tumor activity of monotherapy and T- Plex combination TCR-Ts | Response Evaluation Criteria In Solid Tumors RECIST 1.1 | Up to 12 months | |
| Secondary | Investigate the feasibility of repeat dosing of monotherapy and T- Plex combination TCR-Ts | Frequency and severity of DLTs, AEs and SAEs | Up to 12 months |
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