INTERNATIONAL: Multi-center Study of TBI-1301 (Mipetresgene Autoleucel; Mip-cel) in Patients With NY-ESO-1 Positive Synovial Sarcoma
Trial ID: NCT07174427
Phase: Phase 3
Status: Recruiting
Last Update Posted: September 2026
Eligibility: Adults aged 18 and older with histologically confirmed, surgically unresectable synovial sarcoma that is progressing or recurrent after 1 to 4 prior chemotherapy regimens, including an anthracycline. Patients must be HLA-A02:01 or HLA-A02:06 positive, have tumors expressing NY-ESO-1, have measurable disease per RECIST v1.1, and have an ECOG performance status of 0, 1, or 2.
Overview: This Phase 3 multi-center trial evaluates TBI-1301 (mipetresgene autoleucel, or mip-cel), a TCR gene therapy in which a patient’s own T-cells are genetically modified to recognize and attack NY-ESO-1-expressing synovial sarcoma cells. Patients first receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine, followed by a split-dose intravenous infusion of TBI-1301 administered over two days. The trial aims to confirm the safety and efficacy of this approach, building on earlier-phase studies of the same therapy.
Preliminary Effectiveness: As an ongoing Phase 3 trial, no results have been posted to ClinicalTrials.gov at this time. The study’s primary measure is objective response rate at 52 weeks, assessed using RECIST v1.1. Enrollment is estimated at 5 participants, with primary completion estimated for March 2032.

Study Contact: Takara Bio Inc.

Treatment Centers:
Japan

  • Kyushu University Hospital, Fukuoka
  • National Cancer Center Hospital East, Kashiwa
  • Osaka International Cancer Institute, Osaka

More Information: clinicaltrials.gov/study/NCT07174427