TBI-1301

BIOLOGICAL4 trials

Sponsors

Mie University, University Health Network, Toronto, Takara Bio Inc.

Conditions

Bladder CancerEsophageal CancerLiver CancerLung CancerMelanomaNY-ESO-1 Expressing Solid Tumors in HLA-A2 Positive PatientsOvarian CancerSolid Tumors

Phase 1

Investigator Initiated Phase 1 Study of TBI-1301

Mie UniversitySolid Tumors

Start: 2015-03-31Updated: 2018-10-24

Study of TBI-1301 (NY-ESO-1 Specific TCR Gene Transduced Autologous T Lymphocytes) in Patients With Solid Tumors

Active, not recruitingNCT02869217

University Health Network, TorontoBladder Cancer, Esophageal Cancer, Liver Cancer +5

Start: 2016-09-30End: 2026-11-30Target: 22Updated: 2025-12-03

Study of TBI-1301 (NY-ESO-1 T Cell Receptor Gene Transduced Autologous T Lymphocytes) in Patients with Synovial Sarcoma

CompletedNCT03250325

Takara Bio Inc.Synovial Sarcoma

Start: 2017-09-20End: 2022-03-09Updated: 2024-11-20

Phase 3

Multi-center Study of TBI-1301 (INN: Mipetresgene Autoleucel; Mip-cel) in Patients With NY-ESO-1 Positive Synovial Sarcoma

RecruitingNCT07174427

Takara Bio Inc.Synovial Sarcomas

Start: 2026-01-05End: 2032-03-01Target: 5Updated: 2026-02-18

Related Papers

Recent Advancements in Cell-Based Therapies in Melanoma.

2024-09-124 citations

Results from phase I/II study of NY-ESO-1-specific TCR gene-transduced T cell therapy (TBI-1301, mipetresgene autoleucel) in patients with advanced synovial sarcoma.

Journal of Clinical Oncology2023-06-013 citations

NY-ESO-1-specific redirected T cells with endogenous TCR knockdown mediate tumor response and cytokine release syndrome

Journal for ImmunoTherapy of Cancer2022-06-0156 citations

The addition of fludarabine to cyclophosphamide for lymphodepleting chemotherapy enhances the persistence of infused NY-ESO-1 TCR anticancer therapy TBI-1301.

Journal of Clinical Oncology2022-06-012 citations

Tumor responses and early onset cytokine release syndrome in synovial sarcoma patients treated with a novel affinity-enhanced NY-ESO-1-targeting TCR-redirected T cell transfer.

Journal of Clinical Oncology2019-05-207 citations

Effect of minimal lymphodepletion prior to ACT with TBI-1301, NY-ESO-1 specific gene-engineered TCR-T cells, on clinical responses and CRS.

Journal of Clinical Oncology2019-05-204 citations

Study of TBI-1301 (NY-ESO-1 specific TCR gene transduced autologous T lymphocytes) in patients with solid tumors

Annals of Oncology2018-10-012 citations