NCT07174427

Multi-center Study of TBI-1301 (INN: Mipetresgene Autoleucel; Mip-cel) in Patients With NY-ESO-1 Positive Synovial Sarcoma

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 5 (estimated)
• Sponsor: Takara Bio Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Synovial Sarcomas

Interventions

Type	Name	Description
BIOLOGICAL	TBI-1301	Split dose of TBI-1301 is administered intravenously for 2 days following cyclophosphamide/fludarabine pre-treatment.
DRUG	Cyclophosphamide	Cyclophosphamide (750mg/m2/day x 2 days Intravenous (IV)) is administered as pre-treatment medication of TBI-1301.
DRUG	Fludarabine	Fludarabine (30mg/m2/day x 2 days Intravenous (IV)) is administered as pre-treatment medication of TBI-1301.

Timeline

• Start date: 2026-01-05
• Primary completion: 2032-03-01
• Completion: 2032-03-01
• First posted: 2025-09-16
• Last updated: 2026-02-18

Locations

2 sites across 1 country: Japan