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

NCT ID: NCT07174427

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-05
• Study Completion Date: 2032-03-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Split dose of 5x10^9 TBI-1301

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

Group Type: EXPERIMENTAL

TBI-1301

Intervention Type: BIOLOGICAL

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

Cyclophosphamide

Intervention Type: DRUG

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

Fludarabine

Intervention Type: DRUG

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

Interventions

TBI-1301

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

Intervention Type: BIOLOGICAL

Cyclophosphamide

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

Intervention Type: DRUG

Fludarabine

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. ≥ 18 years of age

2. Histologically confirmed synovial sarcoma

3. Surgically unresectable tumor

4. Progressing or recurrent synovial sarcoma which has been treated with 1-4 regimens of systemic chemotherapies including anthracycline

5. HLA-A*02:01 or HLA-A*02:06 positive

6. Tumor that express NY-ESO-1 by immunohistochemistry

7. Measurable lesions that are evaluable by the RECIST ver1.1

8. ECOG Performance Status of 0, 1 or 2

9. No treatment such as chemotherapy and be expected to recover fully from the previous treatment at the time of the lymphocytes collection for manufacturing

10. Life expectancy ≥ 16 weeks after consent

11. 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

12. Patients must be able to understand the study contents and to give a written consent at his/her free will.

Exclusion Criteria

1. 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.

2. Active metastatic tumor cell invasion into CNS

3. Active multiple cancer

4. Positive for HBs antigen or HBV-DNA observed in serum

5. Positive for HCV antibody and HCV-RNA observed in serum

6. Positive for antibodies against HIV or HTLV-1

7. History of serious hypersensitivity reactions to bovine or murine derived substances.

8. History of hypersensitivity reaction to ingredients or excipients of investigational drugs used in this study

9. History of hypersensitivity reaction to antibiotics used in manufacturing for the investigational drug used in this study.

10. History of treatment with cell therapy or gene therapy

11. Alcohol or drug dependence that may interfere with study participation

12. 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.

13. 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takara Bio Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Kyusyu University Hospital

Fukuoka, , Japan

Site Status: RECRUITING

Countries

Japan

Facility Contacts

Takara Bio

Role: primary

takara-clinical@takara-bio.co.jp

+81(0)77 565 6976

Other Identifiers

1301-04

Identifier Type: -

Identifier Source: org_study_id