Multi-center Study of TBI-1301 (INN: Mipetresgene Autoleucel; Mip-cel) in Patients With NY-ESO-1 … (NCT07174427) | Clinical Trial Compass
RecruitingPhase 3
Multi-center Study of TBI-1301 (INN: Mipetresgene Autoleucel; Mip-cel) in Patients With NY-ESO-1 Positive Synovial Sarcoma
Japan5 participantsStarted 2026-01-05
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. ≥ 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
Exclusion criteria
✕. 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
✕. Positive for HCV antibody and HCV-RNA observed in serum