Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT07174427

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

Led by Takara Bio Inc. · Updated on 2026-02-18

5

Participants Needed

2

Research Sites

321 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years of age or older
  • Histologically confirmed synovial sarcoma
  • Surgically unresectable tumor
  • Progressing or recurrent synovial sarcoma treated with 1-4 systemic chemotherapy regimens including anthracycline
  • HLA-A02:01 or HLA-A02:06 positive
  • Tumor expresses NY-ESO-1 by immunohistochemistry
  • Measurable lesions evaluable by RECIST ver1.1
  • ECOG Performance Status of 0, 1, or 2
  • No chemotherapy or expected full recovery from previous treatment at lymphocyte collection
  • Life expectancy of at least 16 weeks after consent
  • No severe damage to major organs and meet specific laboratory value criteria
  • Able to understand study and provide written informed consent
Not Eligible

You will not qualify if you...

  • Unstable angina, heart attack, or heart failure
  • Uncontrolled diabetes or hypertension
  • Active infection
  • Obvious interstitial pneumonia or lung fibrosis on chest X-ray
  • Active autoimmune disease requiring steroids or immunosuppressive therapy
  • Active metastatic tumor invasion into the central nervous system
  • Active multiple cancers
  • Positive for hepatitis B surface antigen or HBV-DNA in serum
  • Positive for hepatitis C antibody and HCV-RNA in serum
  • Positive for antibodies against HIV or HTLV-1
  • History of serious allergic reactions to bovine or murine substances
  • History of allergic reaction to ingredients of investigational drugs in this study
  • History of allergic reaction to antibiotics used in manufacturing investigational drugs
  • Previous treatment with cell or gene therapy
  • Alcohol or drug dependence interfering with participation
  • Pregnant or lactating females, or patients unable to agree to birth control from consent to 6 months after infusion
  • Clinically significant systemic illness that may compromise ability to tolerate treatment or increase risk

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Osaka International Cancer Institute

Osaka, Osaka, Japan, 541-8567

Actively Recruiting

2

Kyusyu University Hospital

Fukuoka, Japan

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

1

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