Status:
ACTIVE_NOT_RECRUITING
A Basket Study of Customized Autologous TCR-T Cell Therapies in Patients With Locally Advanced (Unresectable) or Metastatic Solid Tumors
Lead Sponsor:
TScan Therapeutics, Inc.
Conditions:
Head and Neck Cancer
Cervical Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 ...
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 r...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
May 6 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2026
Estimated Enrollment :
840 Patients enrolled
Trial Details
Trial ID
NCT05973487
Start Date
May 6 2024
End Date
December 30 2026
Last Update
November 17 2025
Active Locations (21)
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1
HonorHealth Research and Innovation Institute
Scottsdale, Arizona, United States, 85258
2
University of California San Diego
San Diego, California, United States, 92037
3
Yale Cancer Center
New Haven, Connecticut, United States, 06510
4
Memorial Healthcare System
Hollywood, Florida, United States, 33021