OncoMatch/Clinical Trials/NCT07174427
Multi-center Study of TBI-1301 (INN: Mipetresgene Autoleucel; Mip-cel) in Patients With NY-ESO-1 Positive Synovial Sarcoma
Is NCT07174427 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies multiple treatments including TBI-1301 and Cyclophosphamide for synovial sarcomas.
Treatment: TBI-1301 · Cyclophosphamide · Fludarabine — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Other
Biomarker criteria
Required: CTAG1B NY-ESO-1 expression by immunohistochemistry
Tumor that express NY-ESO-1 by immunohistochemistry
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: anthracycline
Cannot have received: cell therapy
Cannot have received: gene therapy
Lab requirements
Blood counts
2,500/μL < WBC ≤ ULN; Hemoglobin ≥ 8.0g/dL; Platelets ≥ 75,000/μL
Kidney function
Creatinine < 1.5 x ULN
Liver function
Total bilirubin ≤ 1.5 x ULN; AST(GOT), ALT(GPT) < 3.0 x ULN
Cardiac function
No severe damage on the major organs (bone marrow, heart, lung, liver, kidney, etc)
No severe damage on the major organs (bone marrow, heart, lung, liver, kidney, etc) and meet the following lab value criteria; Total bilirubin ≤ 1.5 x upper limit of normal (ULN); AST(GOT), ALT(GPT) < 3.0 x ULN; Creatinine < 1.5 x ULN; 2,500/μL < WBC ≤ULN; Hemoglobin ≥ 8.0g/dL; Platelets ≥ 75,000/μL
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07174427 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior cell therapy, gene therapy disqualifies patients from enrollment.
Does this trial require CTAG1B?
Yes, CTAG1B NY-ESO-1 expression by immunohistochemistry is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify