Multi-center Study of TBI-1301 (INN: Mipetresgene Autoleucel; Mip-cel) in Patients With NY-ESO-1 Positive Synovial Sarcoma
The purpose of this study is to verify the safety and the efficacy of TBI-1301 for NY-ESO-1 expressing synovial sarcoma when administered following cyclophosphamide/fludarabine pre-treatment.
• ≥ 18 years of age
• Histologically confirmed synovial sarcoma
• Surgically unresectable tumor
• Progressing or recurrent synovial sarcoma which has been treated with 1-4 regimens of systemic chemotherapies including anthracycline
• HLA-A\*02:01 or HLA-A\*02:06 positive
• Tumor that express NY-ESO-1 by immunohistochemistry
• Measurable lesions that are evaluable by the RECIST ver1.1
• ECOG Performance Status of 0, 1 or 2
• No treatment such as chemotherapy and be expected to recover fully from the previous treatment at the time of the lymphocytes collection for manufacturing
⁃ Life expectancy ≥ 16 weeks after consent
⁃ No severe damage on the major organs (bone marrow, heart, lung, liver, kidney, etc) and meet the following lab value criteria; Total bilirubin ≤ 1.5 x upper limit of normal (ULN); AST(GOT), ALT(GPT) \< 3.0 x ULN; Creatinine \< 1.5 x ULN; 2,500/μL \< WBC ≤ULN; Hemoglobin ≥ 8.0g/dL; Platelets ≥ 75,000/μL
⁃ Patients must be able to understand the study contents and to give a written consent at his/her free will.