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
Patients with the following conditions are excluded from the study; Unstable angina, cardiac infarction, or heart failure; Uncontrolled diabetes or hypertension; Active infection; Obvious interstitial pneumonia or lung fibrosis by chest X-ray; Active autoimmune disease requiring steroids or immunosuppressive therapy.
Active metastatic tumor cell invasion into CNS
Active multiple cancer
Positive for HBs antigen or HBV-DNA observed in serum
Sequential
TBI-1301
Biological/VaccineSplit dose of TBI-1301 is administered intravenously for 2 days following cyclophosphamide/fludarabine pre-treatment.
Cyclophosphamide
DrugCyclophosphamide (750mg/m2/day x 2 days Intravenous (IV)) is administered as pre-treatment medication of TBI-1301.
Fludarabine
DrugFludarabine (30mg/m2/day x 2 days Intravenous (IV)) is administered as pre-treatment medication of TBI-1301.
Objective response rate
Evaluate response rate by measuring response using RECIST v1.1
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