Spots Global Cancer Trial Database for Investigator Initiated Phase 1 Study of TBI-1301
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Trial Identification
Brief Title: Investigator Initiated Phase 1 Study of TBI-1301
Official Title: Multi-center, Investigator Initiated Phase 1 Study of NY-ESO-1 Specific TCR Gene Transferred T Lymphocytes With Solid Tumors
Study ID: NCT02366546
Conditions
Study Description
Brief Summary: Following pre-treatment with cyclophosphamide and/or fludarabine, NY-ESO-1-specific TCR gene transduced T lymphocytes are transferred to the patients with NY-ESO-1-expressing solid tumors.
Detailed Description: Following pre-treatment with cyclophosphamide alone or in combination with fludarabine, NY-ESO-1-specific TCR gene transduced T lymphocytes are transferred to HLA-A\*02:01 or HLA-A\*02:06 positive patients with solid tumors which are 1) unresectable, refractory to standard therapy (chemotherapy, radiotherapy, etc), and 2) NY-ESO-1-expressing. The primary objective is to evaluate the safety and in vivo kinetics, and the secondary is to evaluate clinical effect.
Eligibility
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mie University Hospital, Tsu, Mie, Japan
Contact Details
Name: Hiroshi Shiku, M.D., Ph.D.
Affiliation: Department of Immuno-Gene Therapy, Mie University, Graduate School of Medicine Mie University Hospital
Role: STUDY_CHAIR
Name: Shinichi Kageyama, M.D., Ph.D.
Affiliation: Department of Immuno-Gene Therapy, Mie University, Graduate School of Medicine Mie University Hospital
Role: PRINCIPAL_INVESTIGATOR
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