Spots Global Cancer Trial Database for Study of TBI-1301 (NY-ESO-1 T Cell Receptor Gene Transduced Autologous T Lymphocytes) in Patients With Synovial Sarcoma
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Trial Identification
Brief Title: Study of TBI-1301 (NY-ESO-1 T Cell Receptor Gene Transduced Autologous T Lymphocytes) in Patients With Synovial Sarcoma
Official Title: Multi-center Phase I/II Study of NY-ESO-1 T Cell Receptor Gene Transferred T Lymphocytes in Patients With Synovial Sarcoma
Study ID: NCT03250325
Conditions
Study Description
Brief Summary: 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.
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Sapporo Medical University Hospital, Sapporo, Hokkaido, Japan
Mie University Hospital, Tsu, Mie, Japan
National Cancer Center Hospital, Chuo-ku, Tokyo, Japan
Kyushu University Hospital, Fukuoka, , Japan
National Hospital Organization Osaka National Hospital, Osaka, , Japan
Contact Details
Name: Masanobu Kimura
Affiliation: Takara Bio Inc.
Role: STUDY_DIRECTOR
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