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Customized T Cell Therapies for Advanced 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

Phase 1 Interventional TScan Therapeutics, Inc. · NCT05973487

This study is testing a new type of personalized T cell therapy to see if it can help people with advanced solid tumors when other treatments haven't worked.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment840 (estimated)
Ages18 Years and up
SexAll
SponsorTScan Therapeutics, Inc. Industry-sponsored
Drugs / interventionscyclophosphamide, fludarabine, prednisone, chemotherapy
Locations20 sites (Scottsdale, Arizona and 19 other locations)
Trial IDNCT05973487 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and preliminary efficacy of customized autologous T cell receptor (TCR) therapies in patients with locally advanced or metastatic solid tumors. Participants will undergo screening to determine their HLA type and tumor-associated antigen expression, which will guide their assignment to specific treatment cohorts. The study includes both monotherapy and combination therapy approaches, utilizing engineered T cells to target cancer-specific antigens after lymphodepleting chemotherapy. The trial aims to assess the potential of these therapies to improve outcomes for patients with limited treatment options.

Who should consider this trial

Good fit: Ideal candidates are adults with locally advanced or metastatic solid tumors who have failed standard treatments and express specific HLA types and tumor-associated antigens.

Not a fit: Patients with resectable tumors or those who do not express the required HLA types or tumor-associated antigens may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could provide a novel treatment option for patients with advanced solid tumors that currently have no curative options.

How similar studies have performed: Other studies utilizing TCR-T cell therapies have shown promise, indicating potential for success in this novel approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Scottsdale, Arizona and 19 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
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Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.