Mipetresgene autoleucel (Mip-cel) for NY-ESO-1–positive synovial sarcoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter Phase 3 trial administers cyclophosphamide and fludarabine lymphodepletion followed by infusion of TBI-1301 (mipetresgene autoleucel), an autologous T‑cell receptor gene therapy targeting NY‑ESO‑1. Eligible adults have unresectable or recurrent synovial sarcoma that expresses NY‑ESO‑1 and are HLA‑A*02:01 or HLA‑A*02:06 positive, with 1–4 prior systemic chemotherapy regimens and measurable disease per RECIST 1.1. Patients undergo leukapheresis to collect T cells for ex vivo genetic modification and expansion before infusion. The study monitors safety and antitumor activity to determine whether this approach produces meaningful responses with an acceptable safety profile.

Why it matters

Who can join: the full rules

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.

Where it's running

• Osaka International Cancer Institute
  Osaka, Osaka, Japan Recruiting
• Kyusyu University Hospital
  Fukuoka, Japan Recruiting
• National Cancer Center Hospital East
  Kashiwa, Japan Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• TLN-499 plus venetoclax in relapsed or refractory solid tumors

  Doctors are testing whether TLN-499 added to venetoclax can help patients with relapsed or refractory solid tumors, including SCLC and certain neuroendocrine cancers.

  Recruiting Phase 1 Treeline Biosciences, Inc. · Camperdown, New South Wales and 2 other locations · NCT07713732

• ZI-MA4-1 cell therapy for hard-to-treat solid cancers

  This early-stage trial tests ZI-MA4-1, an allogeneic cell therapy, in patients with inoperable locally advanced or metastatic ovarian cancer, squamous NSCLC, synovial sarcoma, or head and neck cancer to see if it is safe and tolerable and to find a recommended dose.

  Recruiting at 2 sites Phase 1 Zelluna Immunotherapy AS · London and 1 other locations · NCT07613723

• Dose‑escalated, short‑course proton radiation for inoperable soft tissue sarcoma

  This will try higher-dose, shorter-course proton radiation to see if it controls tumors better in adults with inoperable soft tissue sarcoma.

  Recruiting Phase 2 Oslo University Hospital · Bergen and 1 other locations · NCT07173972

• Three-week preoperative proton versus X-ray radiotherapy for localized soft tissue sarcoma

  This trial tests whether selecting proton rather than standard X‑ray radiotherapy before surgery for adults with localized soft tissue sarcoma can lower long-term radiation side effects without increasing surgical complications.

  Recruiting Phase 2 Oslo University Hospital · Bergen and 3 other locations · NCT07169344

• Combining Lutathera® and Olaparib for treating recurrent solid tumors in children and adolescents

  This study is testing if combining Lutathera® with olaparib can help children and teenagers with hard-to-treat solid tumors that have certain receptors.

  Recruiting Phase 1/2 Fundación de investigación HM · Boadilla del Monte, Madrid · NCT06607692

• Zanzalintinib treatment for advanced leiomyosarcoma

  This study is testing if a new medication called zanzalintinib can help people with advanced leiomyosarcoma live longer without their cancer getting worse.

  Recruiting Phase 2 Northwestern University · Chicago, Illinois · NCT06571734

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.