A Basket Study of Customized Autologous TCR-T Cell Therapies in Patients With Locally Advanced (Unresectable) or Metastatic Solid Tumors
NCT ID: NCT05973487
Last Updated: 2025-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
840 participants
INTERVENTIONAL
2024-05-06
2026-12-30
Brief Summary
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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.
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Detailed Description
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Depending on the genetic type, participants will be assigned to one of the following study groups:
Monotherapy:
* COHORT A: TSC-204-A0201 targeting MAGE-A1 on HLA-A\*02:01
* COHORT B: TSC-204-C0702 targeting MAGE-A1 on HLA-C\*07:02
* COHORT C: TSC-200-A0201 targeting HPV16 E7 on HLA-A\*02:01
* COHORT D: TSC-203-A0201 targeting PRAME on HLA-A\*02:01
* COHORT E: TSC-204-A0101 targeting MAGE-A1 on HLA-A\*01:01
* COHORT F: TSC-201-B0702 targeting MAGE-C2 on HLA-B\*07:02
* COHORT G: TSC-202-A0201 targeting MAGE-A4 on HLA-A\*02:01
T-Plex Combination:
* COHORT AB: TSC-204-A0201 + TSC-204-C0702
* COHORT AC: TSC-204-A0201 + TSC-200-A0201
* COHORT AD: TSC-204-A0201 + TSC-203-A0201
* COHORT AE: TSC-204-A0201 + TSC-204-A0101
* COHORT AF: TSC-204-A0201 + TSC-201-B0702
* COHORT BC: TSC-204-C0702 + TSC-200-A0201
* COHORT BD: TSC-204-C0702 + TSC-203-A0201
* COHORT BE: TSC-204-C0702 + TSC-204-A0101
* COHORT BF: TSC-204-C0702 + TSC-201-B0702
* COHORT CD: TSC-200-A0201 + TSC-203-A0201
* COHORT CE: TSC-200-A0201 + TSC-204-A0101
* COHORT CF: TSC-200-A0201 + TSC-201-B0702
* COHORT DE: TSC-203-A0201 + TSC-204-A0101
* COHORT DF: TSC-203-A0201 + TSC-201-B0702
* COHORT EF: TSC-204-A0101 + TSC-201-B0702
* COHORT AG: TSC-204-A0201 + TSC-202-A0201
* COHORT BG: TSC-204-C0702 + TSC-202-A0201
* COHORT CG: TSC-200-A0201 + TSC-202-A0201
* COHORT DG: TSC-203-A0201 + TSC-202-A0201
* COHORT EG: TSC-204-A0101 + TSC-202-A0201
* COHORT FG: TSC-201-B0702 + TSC-202-A0201
Participants will undergo leukapheresis to collect cells to manufacture the TCR-T products. They will then undergo lymphodepletion and receive one or two doses of the TCR-T cell therapy product as a monotherapy or part of a combination of TCR-Ts (referred to as T-Plex combinations in this study).
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Monotherapy Cohort A
TSC-204-A0201
TSC-204-A0201
Escalating doses of TSC-204-A0201 as a monotherapy
Monotherapy Cohort B
TSC-204-C0702
TSC-204-C0702
Escalating doses of TSC-204-C0702 as a monotherapy
Monotherapy Cohort C
TSC-200-A0201
TSC-200-A0201
Escalating doses of TSC-200-A0201 as a monotherapy
T-Plex Combination Cohort A + B
TSC-204-A0201 and TSC-204-C0702
TSC-204-A0201 + TSC-204-C0702
Escalating doses of TSC-204-A0201 in combination with TSC-204-C0702
T-Plex Combination Cohort B + C
TSC-204-C0702 and TSC-200-A0201
TSC-204-A0201 + TSC-200-A0201
Escalating doses of TSC-204-A0201 in combination with TSC-200-A0201
T-Plex Combination Cohort A + C
TSC-204-A0201 and TSC-200-A0201
TSC-204-C0702 + TSC-200-A0201
Escalating doses of TSC-204-C0702 in combination with TSC-200-A0201
Monotherapy Cohort D
TSC-203-A0201
TSC-203-A0201
Escalating doses of TSC-203-A0201 as a monotherapy
T-Plex Combination Cohort A + D
TSC-204-A0201 + TSC-203-A0201
TSC-204-A0201 + TSC-203-A0201
Escalating doses of TSC-204-A0201 in combination with TSC-203-A0201
T-Plex Combination Cohort B + D
TSC-204-C0702 + TSC-203-A0201
TSC-204-C0702 + TSC-203-A0201
Escalating doses of TSC-204-C0702 in combination with TSC-203-A0201
Monotherapy Cohort E
TSC-204-A0101
TSC-204-A0101
Escalating doses of TSC-204-A0101 as a monotherapy
Monotherapy Cohort F
TSC-201-B0702
TSC-201-B0702
Escalating doses of TSC-201-B0702 as a monotherapy
T-Plex Combination Cohort A + E
TSC-204-A0201 + TSC-204-A0101
TSC-204-A0201 + TSC-204-A0101
Escalating doses of TSC-204-A0201 in combination with TSC-204-A0101
T-Plex Combination Cohort A + F
TSC-204-A0201 + TSC-201-B0702
TSC-204-A0201 + TSC-201-B0702
Escalating doses of TSC-204-A0201 in combination with TSC-201-B0702
T-Plex Combination Cohort B + E
TSC-204-C0702 + TSC-204-A0101
TSC-204-C0702 + TSC-204-A0101
Escalating doses of TSC-204-C0702 in combination with TSC-204-A0101
T-Plex Combination Cohort B + F
TSC-204-C0702 + TSC-201B0702
TSC-204-C0702 + TSC-201-B0702
Escalating doses of TSC-204-C0702 in combination with TSC-201-B0702
T-Plex Combination Cohort C + D
TSC-200-A0201 + TSC-203-A0201
TSC-200-A0201 + TSC-203-A0201
Escalating doses of TSC-200-A0201 in combination with TSC-203-A0201
T-Plex Combination Cohort C + E
TSC-200-A0201 + TSC-204-A0101
TSC-200-A0201 + TSC-204-A0101
Escalating doses of TSC-200-A0201 in combination with TSC-204-A0101
T-Plex Combination Cohort C + F
TSC-200-A0201 + TSC-201B0702
TSC-200-A0201 + TSC-201-B0702
Escalating doses of TSC-200-A0201 in combination with TSC-201-B0702
T-Plex Combination Cohort D + E
TSC-203-A0201 + TSC-204A0101
TSC-203-A0201 + TSC-204-A0101
Escalating doses of TSC-203-A0201 in combination with TSC-204-A0101
T-Plex Combination Cohort D + F
TSC-203-A0201 + TSC-201B0702
TSC-203-A0201 + TSC-201-B0702
Escalating doses of TSC-203-A0201 in combination with TSC-201-B0702
T-Plex Combination Cohort E + F
TSC-204-A0101 + TSC-201-B0702
TSC-204-A0101
Escalating doses of TSC-204-A0101 as a monotherapy
TSC-201-B0702
Escalating doses of TSC-201-B0702 as a monotherapy
Monotherapy Cohort G
TSC-202-A0201
TSC-202-A0201
Escalating doses of TSC-202-A0201 as a monotherapy
T-Plex Combination Cohort A + G
TSC-204-A0201 + TSC-202-A0201
TSC-204-A0201 + TSC-202-A0201
Escalating doses of TSC-204-A0201 in combination with TSC-202-A0201
T-Plex Combination Cohort B + G
TSC-204-C0702 + TSC-202-A0201
TSC-204-C0702 + TSC-202-A0201
Escalating doses of TSC-204-C0702 in combination with TSC-202-A0201
T-Plex Combination Cohort C+ G
TSC-200-A0201 + TSC-202-A0201
TSC-200-A0201 + TSC-202-A0201
Escalating doses of TSC-200-A0201 in combination with TSC-202-A0201
T-Plex Combination Cohort D + G
TSC-203-A0201 + TSC-202-A0201
TSC-203-A0201 + TSC-202-A0201
Escalating doses of TSC-203-A0201 in combination with TSC-202-A0201
T-Plex Combination Cohort E + G
TSC-204-A0101 + TSC-202-A0201
TSC-204-A0101 + TSC-202-A0201
Escalating doses of TSC-204-A0101 in combination with TSC-202-A0201
T-Plex Combination Cohort F + G
TSC-201-B0702 + TSC-202-A0201
TSC-201-B0702 + TSC-202-A0201
Escalating doses of TSC-201-B0702 in combination with TSC-202-A0201
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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TScan Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Dawn Pinchasik, MD
Role: STUDY_DIRECTOR
TScan Therapeutics
Locations
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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
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Baylor College of Medicine
Houston, Texas, United States
Countries
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Other Identifiers
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TSCAN-002
Identifier Type: -
Identifier Source: org_study_id
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