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

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

5

Participants

Timeline

Start Date

November 30, 2025

Primary Completion Date

March 31, 2032

Study Completion Date

March 31, 2032

Conditions
Synovial Sarcomas
Interventions
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.

All Listed Sponsors
lead

Takara Bio Inc.

INDUSTRY