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

Running, not enrolling · Phase 1

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT05973487

Run by

TScan Therapeutics, Inc.

People needed

840

Starts

2024-05-06

Expected to finish

2026-12-30

Last updated by the study team

2025-11-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Must be at least 18 years.
• 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.
• 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.
• 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
• 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).
• Eastern Cooperative Oncology Group (ECOG) Performance status 0-1 at screening.
• Participants must be able to understand and be willing to give informed consent; decision-impaired adults may consent with their legally authorized representative.
• At least 1 measurable lesion per modified Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
• Adequate bone marrow and organ function.

You may not qualify if…

• Medical or psychological conditions that would make the participant unsuitable candidate for cell therapy at the discretion of the PI.
• 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
• 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.
• History of stroke or transient ischemic attack (TIA) within 6 months of enrollment
• Systemic corticosteroid therapy >10 mg of prednisone daily or equivalent within 7 days of enrollment.
• History of severe hypersensitivity to fludarabine or cyclophosphamide or study product excipients including human serum albumin, Cryostor (DMSO or Dextran 40), or Plasma-Lyte.
• Untreated or symptomatic central nervous system (CNS) metastases or cytology proven carcinomatous meningitis.
• 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.
• Presence of fungal, bacterial, viral, or other infection requiring anti-microbials for management.
• 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.
• Participants who regularly require supplemental oxygen.

Where it is running

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

Full record on ClinicalTrials.gov

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