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

NCT07174427 | Recruiting Phase 3

• 1 other identifier: 1301-04
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Synovial Sarcomas

Keywords

adoptive cell transfer; NY-ESO-1; T cell receptor; ex vivo gene therapy; synovial sarcoma

Outcome Measures

Primary Outcomes (1)

• Objective response rate

  Evaluate response rate by measuring response using RECIST v1.1

  52 weeks

Study Arms (1)

Split dose of 5x10^9 TBI-1301

EXPERIMENTAL

Split dose of 5x10\^9 TBI-1301 will be administered intravenously for 2 days following pre-treatment for 2 days.

Biological: TBI-1301; Drug: Cyclophosphamide; Drug: Fludarabine

Interventions

TBI-1301 BIOLOGICAL

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

Split dose of 5x10^9 TBI-1301

Cyclophosphamide DRUG

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

Split dose of 5x10^9 TBI-1301

Fludarabine DRUG

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

Split dose of 5x10^9 TBI-1301

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 years of age
• Histologically confirmed synovial sarcoma
• Surgically unresectable tumor
• Progressing or recurrent synovial sarcoma which has been treated with 1-4 regimens of systemic chemotherapies including anthracycline
• HLA-A\*02:01 or HLA-A\*02:06 positive
• Tumor that express NY-ESO-1 by immunohistochemistry
• Measurable lesions that are evaluable by the RECIST ver1.1
• ECOG Performance Status of 0, 1 or 2
• No treatment such as chemotherapy and be expected to recover fully from the previous treatment at the time of the lymphocytes collection for manufacturing
• Life expectancy ≥ 16 weeks after consent
• 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
• Patients must be able to understand the study contents and to give a written consent at his/her free will.

You may not qualify if:

• Patients with the following conditions are excluded from the study; Unstable angina, cardiac infarction, or heart failure; Uncontrolled diabetes or hypertension; Active infection; Obvious interstitial pneumonia or lung fibrosis by chest X-ray; Active autoimmune disease requiring steroids or immunosuppressive therapy.
• Active metastatic tumor cell invasion into CNS
• Active multiple cancer
• Positive for HBs antigen or HBV-DNA observed in serum
• Positive for HCV antibody and HCV-RNA observed in serum
• Positive for antibodies against HIV or HTLV-1
• History of serious hypersensitivity reactions to bovine or murine derived substances.
• History of hypersensitivity reaction to ingredients or excipients of investigational drugs used in this study
• History of hypersensitivity reaction to antibiotics used in manufacturing for the investigational drug used in this study.
• History of treatment with cell therapy or gene therapy
• Alcohol or drug dependence that may interfere with study participation
• Pregnant females, lactating females (except when they cease and do not resume lactation) or female and male patients who cannot agree to practice the adequate birth control from the consent to 6 months after infusion of the investigational drug.
• Clinically significant systemic illness that in the judgment of the PI or sub-investigator would compromise the patient's ability to tolerate protocol therapy or significantly increase the risk of complications.

Sponsors & Collaborators

• Takara Bio Inc.: lead

Study Sites (2)

Osaka International Cancer Institute

Osaka, Osaka, 541-8567, Japan

RECRUITING

Kyusyu University Hospital

Fukuoka, Japan

RECRUITING

MeSH Terms

Conditions

Sarcoma, Synovial

Interventions

Cyclophosphamide; fludarabine

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: September 16, 2025
• Study Start: January 5, 2026
• Primary Completion (Estimated): March 1, 2032
• Study Completion (Estimated): March 1, 2032
• Last Updated: February 18, 2026

Record last verified: 2025-09

Locations

JP (2)