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Split dose of 5x10\^9 TBI-1301 will be administered intravenously for 2 days following cyclophosphamide pre-treatment 750 mg/m2/d for 2 days.

Split dose of TBI-1301 is administered intravenously for 2 days following cyclophosphamide pre-treatment.

TBI-1301

Cyclophosphamide (750mg/m2/day x 2 days Intravenous (IV)) is administered as pre-treatment medication of TBI-1301.

Masanobu Kimura

The purpose of this study is to evaluate the safety and the efficacy of TBI-1301 for NY-ESO-1 expressing synovial sarcoma when administered following cyclophosphamide pre-treatment.

Following pre-treatment with cyclophosphamide, NY-ESO-1-specific T cell receptor (TCR) gene transduced T lymphocytes are transferred to human leukocyte antigen (HLA)-A\*02:01 or HLA-A\*02:06 positive patients with synovial sarcoma expressing NY-ESO-1, which are surgically unresectable and refractory to anthracycline therapy. The primary objective is to evaluate the safety in the phase 1 and the efficacy in the phase 2.

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

Multi-center Phase I/II Study of NY-ESO-1 T Cell Receptor Gene Transferred T Lymphocytes in Patients With Synovial Sarcoma

Confirm the toxicity profile, which is measured by the degree of grade and seriousness, duration, causality, classification, etc. of the adverse events.

Confirm that no replication competent retrovirus observed.

Evaluate persistence and expansion of transferred TBI-1301.

Evaluate response rate by measuring response using RECIST v1.1 and irRECIST

Evaluate progression free rate by measuring response using RECIST v1.1 and irRECIST

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of TBI-1301 (NY-ESO-1 T Cell Receptor Gene Transduced Autologous T Lymphocytes) in Patients With Synovial Sarcoma	NCT03250325	Synovial Sarcom...	TBI-1301 Cyclophosphamid...	18 Years -	Takara Bio Inc.
Study of TBI-1301 (NY-ESO-1 T Cell Receptor Gene Transduced Autologous T Lymphocytes) in Patients With Synovial Sarcoma	NCT03250325	Synovial Sarcom...	TBI-1301 Cyclophosphamid...	18 Years -	Takara Bio Inc.

Spots Global Cancer Trial Database for t cell receptor gene therapy