A Basket Study of Customized Autologous TCR-T Cell Therapies in Patients With Locally Advanced (Unresectable) or Metastatic 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
1 other identifier
interventional
840
1 country
21
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 head-and-neck-cancer
Started May 2024
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 25, 2023
CompletedFirst Posted
Study publicly available on registry
August 3, 2023
CompletedStudy Start
First participant enrolled
May 6, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2026
November 17, 2025
November 1, 2025
2.7 years
July 25, 2023
November 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Evaluate the safety of monotherapy and T- Plex combination TCR-Ts
Number of subjects with dose limiting toxicities (DLT)
28 days
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 Outcomes (2)
Investigate preliminary anti-tumor activity of monotherapy and T- Plex combination TCR-Ts
Up to 12 months
Investigate the feasibility of repeat dosing of monotherapy and T- Plex combination TCR-Ts
Up to 12 months
Other Outcomes (3)
To measure the persistence of T-Plex TCR-T cells in the peripheral blood with single and repeat doses
Up to 24 months
To measure the infiltration of T-Plex TCR-T cells into tumors in post-treatment biopsies
Up to 24 months
To measure the immune activation markers in the tumor after single and repeated doses
Up to 24 months
Study Arms (28)
Monotherapy Cohort A
EXPERIMENTALTSC-204-A0201
Monotherapy Cohort B
EXPERIMENTALTSC-204-C0702
Monotherapy Cohort C
EXPERIMENTALTSC-200-A0201
T-Plex Combination Cohort A + B
EXPERIMENTALTSC-204-A0201 and TSC-204-C0702
T-Plex Combination Cohort B + C
EXPERIMENTALTSC-204-C0702 and TSC-200-A0201
T-Plex Combination Cohort A + C
EXPERIMENTALTSC-204-A0201 and TSC-200-A0201
Monotherapy Cohort D
EXPERIMENTALTSC-203-A0201
T-Plex Combination Cohort A + D
EXPERIMENTALTSC-204-A0201 + TSC-203-A0201
T-Plex Combination Cohort B + D
EXPERIMENTALTSC-204-C0702 + TSC-203-A0201
Monotherapy Cohort E
EXPERIMENTALTSC-204-A0101
Monotherapy Cohort F
EXPERIMENTALTSC-201-B0702
T-Plex Combination Cohort A + E
EXPERIMENTALTSC-204-A0201 + TSC-204-A0101
T-Plex Combination Cohort A + F
EXPERIMENTALTSC-204-A0201 + TSC-201-B0702
T-Plex Combination Cohort B + E
EXPERIMENTALTSC-204-C0702 + TSC-204-A0101
T-Plex Combination Cohort B + F
EXPERIMENTALTSC-204-C0702 + TSC-201B0702
T-Plex Combination Cohort C + D
EXPERIMENTALTSC-200-A0201 + TSC-203-A0201
T-Plex Combination Cohort C + E
EXPERIMENTALTSC-200-A0201 + TSC-204-A0101
T-Plex Combination Cohort C + F
EXPERIMENTALTSC-200-A0201 + TSC-201B0702
T-Plex Combination Cohort D + E
EXPERIMENTALTSC-203-A0201 + TSC-204A0101
T-Plex Combination Cohort D + F
EXPERIMENTALTSC-203-A0201 + TSC-201B0702
T-Plex Combination Cohort E + F
EXPERIMENTALTSC-204-A0101 + TSC-201-B0702
Monotherapy Cohort G
EXPERIMENTALTSC-202-A0201
T-Plex Combination Cohort A + G
EXPERIMENTALTSC-204-A0201 + TSC-202-A0201
T-Plex Combination Cohort B + G
EXPERIMENTALTSC-204-C0702 + TSC-202-A0201
T-Plex Combination Cohort C+ G
EXPERIMENTALTSC-200-A0201 + TSC-202-A0201
T-Plex Combination Cohort D + G
EXPERIMENTALTSC-203-A0201 + TSC-202-A0201
T-Plex Combination Cohort E + G
EXPERIMENTALTSC-204-A0101 + TSC-202-A0201
T-Plex Combination Cohort F + G
EXPERIMENTALTSC-201-B0702 + TSC-202-A0201
Interventions
Escalating doses of TSC-204-A0201 in combination with TSC-204-C0702
Escalating doses of TSC-204-A0201 in combination with TSC-200-A0201
Escalating doses of TSC-204-C0702 in combination with TSC-200-A0201
Escalating doses of TSC-204-A0201 in combination with TSC-203-A0201
Escalating doses of TSC-204-C0702 in combination with TSC-203-A0201
Escalating doses of TSC-200-A0201 in combination with TSC-203-A0201
Escalating doses of TSC-204-A0101 as a monotherapy
Escalating doses of TSC-201-B0702 as a monotherapy
Escalating doses of TSC-204-A0201 in combination with TSC-204-A0101
Escalating doses of TSC-204-A0201 in combination with TSC-201-B0702
Escalating doses of TSC-204-C0702 in combination with TSC-204-A0101
Escalating doses of TSC-204-C0702 in combination with TSC-201-B0702
Escalating doses of TSC-200-A0201 in combination with TSC-204-A0101
Escalating doses of TSC-200-A0201 in combination with TSC-201-B0702
Escalating doses of TSC-203-A0201 in combination with TSC-204-A0101
Escalating doses of TSC-203-A0201 in combination with TSC-201-B0702
Escalating doses of TSC-204-A0201 in combination with TSC-202-A0201
Escalating doses of TSC-204-C0702 in combination with TSC-202-A0201
Escalating doses of TSC-200-A0201 in combination with TSC-202-A0201
Escalating doses of TSC-203-A0201 in combination with TSC-202-A0201
Escalating doses of TSC-204-A0101 in combination with TSC-202-A0201
Escalating doses of TSC-201-B0702 in combination with TSC-202-A0201
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
HonorHealth Research and Innovation Institute
Scottsdale, Arizona, 85258, United States
University of California San Diego
San Diego, California, 92037, United States
Yale Cancer Center
New Haven, Connecticut, 06510, United States
Memorial Healthcare System
Hollywood, Florida, 33021, United States
University of Miami, Sylvester Comprehensive Cancer Center
Miami, Florida, 33136, United States
Orlando Health
Orlando, Florida, 32806, United States
University of South Florida
Tampa, Florida, 33606, United States
University of Chicago
Chicago, Illinois, 60637, United States
Norton Cancer Institute
Louisville, Kentucky, 40202, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
University of Minnesota Masonic Cancer Center
Minneapolis, Minnesota, 55455, United States
Columbia University Herbert Irving Comprehensive Cancer Center
New York, New York, 10032, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Oncology Hematology Care
Cincinnati, Ohio, 45242, United States
The Cleveland Clinic
Cleveland, Ohio, 44195, United States
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104, United States
Providence Cancer Institute Franz Clinic
Portland, Oregon, 97213, United States
Allegheny Hospitals Network
Pittsburgh, Pennsylvania, 15224, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232, United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Dawn Pinchasik, MD
TScan Therapeutics
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 25, 2023
First Posted
August 3, 2023
Study Start
May 6, 2024
Primary Completion (Estimated)
December 30, 2026
Study Completion (Estimated)
December 30, 2026
Last Updated
November 17, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share