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

StatusActive, Not Recruiting
PhasePhase 1
Started2024-05-06
View on ClinicalTrials.gov ↗

Amendment history

2025-11-14
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v16
Trial statusRecruiting→Active, Not Recruiting
Study sitesdetails revised at 21 of 21 sites
2025-09-02
Study Status, Contacts/Locations v15
Study sites20→21
2025-03-28
Study Status, Study Description, Conditions, Study Design, Arms and Interventions, Eligibility, Contacts/Locations v14
Enrollment target100→840
Study sites15→20
Study arms21→28
InterventionsTSC-200-A0201 (Biological), TSC-200-A0201 + TSC-201-B0702 (Biological), TSC-200-A0201 + TSC-203-A0201 (Biological), TSC-200-A0201 +…→TSC-200-A0201 (Biological), TSC-200-A0201 + TSC-201-B0702 (Biological), TSC-200-A0201 + TSC-202-A0201 (Biological), TSC-200-A0201 +…
Eligibility criteria+546 characters
[...] ied 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-E7 assessed in the last 8 months in screening study TSCAN-003 [...] 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) wi [...] [...]
Study description+303 characters
[...] 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 [...] 01 + 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 [...]
2024-08-22
Study Status, Contacts/Locations v13
Study sites14→15
2024-08-12
Study Status, Contacts/Locations v12
Re-verified, no change to tracked fields
Show 11 earlier versions
2024-08-07
Study Status, Contacts/Locations v11
Study sitesdetails revised at 1 of 14 sites
2024-07-03
2 amendments v9-v10
2 re-verifications since 2024-06-12, no change to tracked fields
2024-05-09
Study Status v8
Start dateestimated 2024-04-30→confirmed 2024-05-06
2024-04-24
Study Status, Contacts/Locations v7
Study sitescontacts updated at 1 of 14 sites
2024-04-19
Study Status, Study Description, Arms and Interventions, Eligibility, Contacts/Locations v6
Study sites13→14
Study arms10→21
InterventionsTSC-200-A0201 (Biological), TSC-200-A0201 + TSC-203-A0201 (Biological), TSC-204-A0201 (Biological), TSC-204-A0201 + TSC-200-A0201…→TSC-200-A0201 (Biological), TSC-200-A0201 + TSC-201-B0702 (Biological), TSC-200-A0201 + TSC-203-A0201 (Biological), TSC-200-A0201 +…
Eligibility criteria+31 characters
[...] of care systemic therapies for that particular indication. AnySolid solid tumortumors, including but not limited to non-nasopharyngeal head and n [...] al 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 [...] by a qualified genomics assay in screening study TSCAN-003: HLA-B*07:02 HLA-A*01:01 HLA-C*07:02, HLA-A*02:01 and HLA-C*07:02 plus HLA-A*02:01 Tumor must express one or more of the following: MAGE-A1, and/orMAGE-C2, PRAME and/or HPV16-E7 as assessed by a qualified IHC or RNA-I [...] [...]
Study description+483 characters
[...] assigned to one of the following study groups: Monotherapy: CohortCOHORT A: TSC-204-A0201 targeting MAGE-A1 on HLA-A*02:01 CohortCOHORT B: TSC-204-C0702 targeting MAGE-A1 on HLA-C*07:02 CohortCOHORT C: TSC-200-A0201 targeting HPV16 E7 on HLA-A*02:01 CohortCOHORT 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 T-Plex Combination: COHORT AB: TSC-204-A0201 + TSC-204-C0702 COHORT AC: TSC-204-A0201 + TSC-200-A0201 ⇅ moved COHORT AD: TSC-204-A0201 + TSC-203-A0201 COHORT AE: TSC-204-A0201 + TSC-2 [...] [...]
2024-04-05
Study Status, Contacts/Locations v5
Start date2024-02-29→2024-04-30
Study sites12→13
2024-01-09
Study Status, Contacts/Locations v4
Start date2023-11-30→2024-02-29
Study sites5→12
2023-10-26
Not Yet Recruiting→Recruiting Study Status, Study Description, Conditions, Arms and Interventions, Eligibility, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Start date2023-09-30→2023-11-30
Study sites4→5
Study arms6→10
InterventionsTSC-200-A0201 (Biological), TSC-204-A0201 (Biological), TSC-204-A0201 + TSC-200-A0201 (Biological), TSC-204-A0201 + TSC-200-A0201…→TSC-200-A0201 (Biological), TSC-200-A0201 + TSC-203-A0201 (Biological), TSC-204-A0201 (Biological), TSC-204-A0201 + TSC-200-A0201…
Eligibility criteria+13 characters
[...] and HLA-C*07:02 plus HLA-A*02:01 Tumor must express MAGE-A1 and/or PRAME and/or HPV16-E7 as assessed by a qualified IHC or RNA-ISH p [...]
Study description+178 characters
[...] 2 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 T-Plex Combination: CohortCOHORT AB: TSC-204-A0201 + TSC-204-C0702 CohortCOHORT BCAC: TSC-204-A0201 + TSC-200-A0201 CohortCOHORT ACBC: TSC-204-C0702 + TSC-200-A0201 COHORT AD: TSC-204-A0201 + TSC-203-A0201 COHORT BD: TSC-204-C0702 + TSC-203-A0201 COHORT CD: TSC-200-A0201 + TSC-203-A0201 Participants will undergo leukapheresis to collect cells to [...]
2023-09-07
Study Status, Contacts/Locations v2
Start date2023-08-31→2023-09-30
Study sites2→4
2023-08-03
Study Status, Conditions v1
Re-verified, no change to tracked fields
2023-08-01
Original filing
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 Details
NCT Number NCT05973487
Lead Sponsor TScan Therapeutics, Inc.
Conditions 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 +13 more
Enrollment 840 participants
Start Date 2024-05-06
Primary Completion 2026-12-30 (estimated)
Study Completion 2026-12-30 (estimated)
Updated on ClinicalTrials.gov 2025-11-17