RecruitingPhase 3NCT07174427

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


Sponsor

Takara Bio Inc.

Enrollment

5 participants

Start Date

Jan 5, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a specialized cell therapy called mipetresgene autoleucel (Mip-cel) — engineered immune cells that are trained to recognize and attack a protein called NY-ESO-1 found on synovial sarcoma cells — in patients whose cancer has returned or stopped responding to chemotherapy. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of synovial sarcoma (a type of soft tissue cancer) - Your tumor cannot be surgically removed - Your cancer is recurring or progressing after 1 to 4 prior chemotherapy regimens (including anthracycline-based chemotherapy) - Your tumor tests positive for NY-ESO-1 protein and you have a specific immune marker (HLA-A*02:01 or HLA-A*02:06) - Your organ function is in an acceptable range **You may NOT be eligible if...** - You have active heart problems (e.g., recent heart attack or unstable angina) - You have serious infections or active autoimmune disease - You have received another investigational treatment recently Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALTBI-1301

Split dose of TBI-1301 is administered intravenously for 2 days following cyclophosphamide/fludarabine pre-treatment.

DRUGCyclophosphamide

Cyclophosphamide (750mg/m2/day x 2 days Intravenous (IV)) is administered as pre-treatment medication of TBI-1301.

DRUGFludarabine

Fludarabine (30mg/m2/day x 2 days Intravenous (IV)) is administered as pre-treatment medication of TBI-1301.


Locations(2)

Osaka International Cancer Institute

Osaka, Osaka, Japan

Kyusyu University Hospital

Fukuoka, Japan

View Full Details on ClinicalTrials.gov

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NCT07174427


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