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.

Trial Details

NCT ID
NCT07174427
Phase
PHASE3
Sponsor
Takara Bio Inc.
Status
RECRUITING
Cancer Type
Sarcoma
Interventions
  • TBI-1301
  • Cyclophosphamide
  • Fludarabine
Locations (sample)
  • Osaka, Osaka, Japan|34.69379,135.50107
  • Fukuoka, Japan|33.6,130.41667
  • Kashiwa, Japan|35.86224,139.97732

Key Eligibility 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

For full eligibility, visit ClinicalTrials.gov.

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