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Clinical Trials in the USA / NCT05973487
Active, not recruiting Phase 1

A Basket Study of Customized Autologous TCR-T Cell Therapies in Patients With Locally Advanced (Unresectable) or Metastatic Solid Tumors

NCT05973487 · tracked via the Priya Life Science USA tracker
Sponsor
TScan Therapeutics, Inc
Phase
Phase 1
Started
2024-05-06
Last updated
2025-11-17

Condition(s) studied

Head and Neck CancerCervical CancerNon-small Cell CarcinomaMelanomaOvarian CancerAnogenital CancersHPV - Anogenital Human Papilloma Virus InfectionHPV-Related Cervical CarcinomaHPV-Related CarcinomaHPV-Related Squamous Cell CarcinomaHPV-Related MalignancyHPV-Related AdenocarcinomaHPV Positive Oropharyngeal Squamous Cell CarcinomaHPV-Related Adenosquamous CarcinomaHPV-Associated Vaginal AdenocarcinomaHPV-Related Endocervical AdenocarcinomaHPV-Related Anal Squamous Cell CarcinomaHPV-Related Verrucous CarcinomaHPV-Related Penile Squamous Cell CarcinomaHPV-Related Vulvar Squamous Cell CarcinomaHPV Positive Rectal Squamous Cell Carcinoma

Investigational drug(s) / intervention(s)

TSC-204-A0201TSC-204-C0702TSC-200-A0201TSC-204-A0201 + TSC-204-C0702TSC-204-A0201 + TSC-200-A0201TSC-204-C0702 + TSC-200-A0201TSC-204-A0201 + TSC-203-A0201TSC-204-C0702 + TSC-203-A0201TSC-200-A0201 + TSC-203-A0201TSC-203-A0201TSC-204-A0101TSC-201-B0702TSC-204-A0201 + TSC-204-A0101TSC-204-A0201 + TSC-201-B0702TSC-204-C0702 + TSC-204-A0101TSC-204-C0702 + TSC-201-B0702TSC-200-A0201 + TSC-204-A0101TSC-200-A0201 + TSC-201-B0702TSC-203-A0201 + TSC-204-A0101TSC-203-A0201 + TSC-201-B0702TSC-202-A0201TSC-204-A0201 + TSC-202-A0201TSC-204-C0702 + TSC-202-A0201TSC-200-A0201 + TSC-202-A0201TSC-203-A0201 + TSC-202-A0201TSC-204-A0101 + TSC-202-A0201TSC-201-B0702 + TSC-202-A0201

TSC-204-A0201: Escalating doses of TSC-204-A0201 as a monotherapy

TSC-204-C0702: Escalating doses of TSC-204-C0702 as a monotherapy

TSC-200-A0201: Escalating doses of TSC-200-A0201 as a monotherapy

TSC-204-A0201 + TSC-204-C0702: Escalating doses of TSC-204-A0201 in combination with TSC-204-C0702

TSC-204-A0201 + TSC-200-A0201: Escalating doses of TSC-204-A0201 in combination with TSC-200-A0201

TSC-204-C0702 + TSC-200-A0201: Escalating doses of TSC-204-C0702 in combination with TSC-200-A0201

TSC-204-A0201 + TSC-203-A0201: Escalating doses of TSC-204-A0201 in combination with TSC-203-A0201

TSC-204-C0702 + TSC-203-A0201: Escalating doses of TSC-204-C0702 in combination with TSC-203-A0201

TSC-200-A0201 + TSC-203-A0201: Escalating doses of TSC-200-A0201 in combination with TSC-203-A0201

TSC-203-A0201: Escalating doses of TSC-203-A0201 as a monotherapy

TSC-204-A0101: Escalating doses of TSC-204-A0101 as a monotherapy

TSC-201-B0702: Escalating doses of TSC-201-B0702 as a monotherapy

TSC-204-A0201 + TSC-204-A0101: Escalating doses of TSC-204-A0201 in combination with TSC-204-A0101

TSC-204-A0201 + TSC-201-B0702: Escalating doses of TSC-204-A0201 in combination with TSC-201-B0702

TSC-204-C0702 + TSC-204-A0101: Escalating doses of TSC-204-C0702 in combination with TSC-204-A0101

TSC-204-C0702 + TSC-201-B0702: Escalating doses of TSC-204-C0702 in combination with TSC-201-B0702

TSC-200-A0201 + TSC-204-A0101: Escalating doses of TSC-200-A0201 in combination with TSC-204-A0101

TSC-200-A0201 + TSC-201-B0702: Escalating doses of TSC-200-A0201 in combination with TSC-201-B0702

TSC-203-A0201 + TSC-204-A0101: Escalating doses of TSC-203-A0201 in combination with TSC-204-A0101

TSC-203-A0201 + TSC-201-B0702: Escalating doses of TSC-203-A0201 in combination with TSC-201-B0702

TSC-202-A0201: Escalating doses of TSC-202-A0201 as a monotherapy

TSC-204-A0201 + TSC-202-A0201: Escalating doses of TSC-204-A0201 in combination with TSC-202-A0201

TSC-204-C0702 + TSC-202-A0201: Escalating doses of TSC-204-C0702 in combination with TSC-202-A0201

TSC-200-A0201 + TSC-202-A0201: Escalating doses of TSC-200-A0201 in combination with TSC-202-A0201

TSC-203-A0201 + TSC-202-A0201: Escalating doses of TSC-203-A0201 in combination with TSC-202-A0201

TSC-204-A0101 + TSC-202-A0201: Escalating doses of TSC-204-A0101 in combination with TSC-202-A0201

TSC-201-B0702 + TSC-202-A0201: Escalating doses of TSC-201-B0702 in combination with TSC-202-A0201

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 and/or HLA-A\*02:01 5. Tumor must express one or more of the following: MAGE-A1, MAGE-A4, MAGE-C2, PRAME and HPV16 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. Have a history of ASTCT Grade 4 CRS, Grade 3 or greater ICANS, or Grade 3 or greater IECHS. Participants with a history of lower grade CRS, ICANS, or IECHS may be eligible, pending review and approval by the Medical Monitor. 4. History of stroke or transient ischemic attack (TIA) within 6 months of enrollment 5. Systemic corticosteroid therapy \>10 mg of prednisone daily or equivalent within 7 days of enrollment. 6. History of severe hypersensitivity to fludarabine or cyclophosphamide or study product excipients including human serum albumin, Cryostor (DMSO or Dextran 40), or Plasma-Lyte. 7. Untreated or symptomatic central nervous system (CNS) metastases or cytology proven carcinomatous meningitis. 8. Concurrent receipt of another anti-cancer therapy. Have a history of acute mental status changes of unknown etiology within 6 months prior to enrollment, or any neurological or neurodegenerative disorder (e.g., Parkinson disease, Huntington disease, uncontrolled seizure disorder) that may increase the risk for or confound the assessment of neurotoxicity. 9. Presence of fungal, bacterial, viral, or other infection requiring anti-microbials for management. 10. 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. 11. Participants who regularly require supplemental oxygen.

Primary outcome measure(s)

  • Evaluate the safety of monotherapy and T- Plex combination TCR-Ts — 28 days
    Number of subjects with dose limiting toxicities (DLT)
  • Determine the recommended phase 2 dose of monotherapy and T- Plex combination TCR-Ts — Up to 12 months
    Frequency and severity of DLTs, AEs and SAEs

Trial sites (21)

FacilityCityRegionStatus
HonorHealth Research and Innovation Institute Scottsdale Arizona
University of California San Diego San Diego California
Yale Cancer Center New Haven Connecticut
Memorial Healthcare System Hollywood Florida
University of Miami, Sylvester Comprehensive Cancer Center Miami Florida
Orlando Health Orlando Florida
University of South Florida Tampa Florida
University of Chicago Chicago Illinois
Norton Cancer Institute Louisville Kentucky
Karmanos Cancer Institute Detroit Michigan
University of Minnesota Masonic Cancer Center Minneapolis Minnesota
Columbia University Herbert Irving Comprehensive Cancer Center New York New York
University of North Carolina at Chapel Hill Chapel Hill North Carolina
Oncology Hematology Care Cincinnati Ohio
The Cleveland Clinic Cleveland Ohio
OU Health Stephenson Cancer Center Oklahoma City Oklahoma
Providence Cancer Institute Franz Clinic Portland Oregon
Allegheny Hospitals Network Pittsburgh Pennsylvania
University of Pittsburgh Medical Center Pittsburgh Pennsylvania
Sarah Cannon Research Institute Nashville Tennessee
Baylor College of Medicine Houston Texas

More TScan Therapeutics, Inc. trials in the USA

A Study of T-Cell Receptor Engineered Donor T Cells in Subjects Undergoing Allogeneic Peripheral Blood Stem Cell Transplantation (ALLOHA) Active, not recruiting
A Screening Study to Collect Samples for TAA, HLA & HLA Loss of Heterozygosity in Patients With Metastatic Solid Tumors Active, not recruiting
A Study of T-Cell Receptor Engineered Donor T Cells in Subjects Undergoing Allogeneic Peripheral Blood Stem Cell Transplantation Active, not recruiting
A Long Term Follow-up Study of TScan TCR-T Products Recruiting

Other trials for the same condition

A First-In Human (FIH) Study to Find Out How Well REGN10597 Medicine Given Alone or in Combination With Cemiplimab Works in Adult Participants Who Have Cancer With Tumors That Have Spread in Their Body Recruiting
Relacorilant in Combination With Different Treatment Regimens in Patients With Gynecological Cancers Recruiting
In Vivo Liquid Biopsy of Melanoma (Cytophone) Recruiting
A Study of CUSP06 in Patients With Platinum-Refractory/Resistant Ovarian Cancer and Other Advanced Solid Tumors Recruiting
MAGE-A4ᶜ¹º³²T for Multi-Tumor Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05973487 on ClinicalTrials.gov ↗ ← All trials in the USA