Shiga, Japan – May 29, 2023 - Takara Bio Inc., an innovative biotechnology company, announced that the results from the clinical trial of NY-ESO-1・siTCR~{TM} gene therapy in Japan (Development Code: TBI-1301, INN: mipetresgene autoleucel) will be presented at the 2023 Annual Meeting of the American Society of Clinical Oncology (ASCO) on June 2-6, 2023 in Chicago, Illinois US.

Name of Conference

2023 ASCO Annual Meeting


McCormick Place (Chicago, Illinois, U.S.)


June 3, 1:15 pm – 4:15 pm (Local time)


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.


Synovial sarcoma is one of malignant soft tissue tumors with a poor prognosis. A cancer-testis antigen NY-ESO-1 is expressed in the tumors of 50-80 % synovial sarcoma patients. The purpose of this study was to evaluate the safety and the efficacy of gene engineered autologous T cell product with NY-ESO-1 siTCR retroviral vector which expressed affinity-enhanced NY-ESO-1-specific TCR and siRNA to silence endogenous TCR (TBI-1301).
- This was an open label phase I/II study.
- Subjects in this study was HLA-A*02:01 or HLA-A*02:06 positive synovial sarcoma, which were surgically unresectable and refractory to anthracycline therapy.
- TBI-1301 was infused for two days following cyclophosphamide treatment.
- Eight subjects were enrolled and treated with TBI-1301.
- The objective response rate was 50.0% and the median overall survival was 650 days.
- Cytokine release syndrome (CRS) occurred in 50.0% and consisted of 1 subject with grade 1 CRS and 3 subjects with grade 2 CRS. All subjects who developed CRS recovered with prespecified treatment.
Adoptive immunotherapy with TBI-1301 to selectively target NY-ESO-1 positive tumors will become a promising treatment for advanced or recurrent synovial sarcoma with acceptable toxicity.

click here for the poster

Throughout its leading biotechnology, Takara Bio is proceeding with the preparation for the New Drug Application of TBI-1301 in Japan along with the establishment of its post marketing supply chain system.