Synovial SarcomasPhase 3NCT07174427
Multi-center Study of TBI-1301 (INN: Mipetresgene Autoleucel; Mip-cel) in Patients With NY-ESO-1 Positive Synovial Sarcoma
A Phase 3 study testing TBI-1301, Cyclophosphamide and Fludarabine in people with Synovial Sarcomas, run by Takara Bio Inc. at 3 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Synovial Sarcomas
- What is being tested?
- TBI-1301, Cyclophosphamide and Fludarabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 3 sitesJapan
- Study dates
- 5 Jan 2026to Mar 2032
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Japan3 sites, 3 recruiting
- Recruiting
Kyusyu University Hospital
Fukuoka
Takara Bio, +81(0)77 565 6976, takara-clinical@takara-bio.co.jp
- Recruiting
National Cancer Center Hospital East
Kashiwa
Takara Bio, +81(0)77 565 6976, takara-clinical@takara-bio.co.jp
- Recruiting
Osaka International Cancer Institute
Osaka, Osaka, 541-8567
Takara Bio, +81(0)77 565 6976, takara-clinical@takara-bio.co.jp
About this study
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
- Being tested
- TBI-1301, Cyclophosphamide, Fludarabine
- Keywords
- adoptive cell transfer, NY-ESO-1, T cell receptor, ex vivo gene therapy, synovial sarcoma
- Medical subject headings
- Sarcoma, Synovial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TBI-1301Biological
Split dose of TBI-1301 is administered intravenously for 2 days following cyclophosphamide/fludarabine pre-treatment.
CyclophosphamideDrug
Cyclophosphamide (750mg/m2/day x 2 days Intravenous (IV)) is administered as pre-treatment medication of TBI-1301.
FludarabineDrug
Fludarabine (30mg/m2/day x 2 days Intravenous (IV)) is administered as pre-treatment medication of TBI-1301.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: TBI-1301; Drug: Cyclophosphamide; Drug: Fludarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Evaluate response rate by measuring response using RECIST v1.1
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start5 Jan 2026
- Primary completionMar 2032 (estimated)
- Study completionMar 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Synovial SarcomasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Takara Bio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07174427
- Sponsor's protocol ID
- 1301-04
- Status last verified
- Sep 2025
- First submitted
- 12 Sep 2025
- Last updated
- 28 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center Study of TBI-1301 (INN: Mipetresgene Autoleucel; Mip-cel) in Patients With NY-ESO-1 Positive Synovial Sarcoma
- ClinicalTrials.gov ID
- NCT07174427
- Acronym / sponsor ID
- 1301-04
- Conditions
- Synovial Sarcomas
- Keywords
- adoptive cell transfer, NY-ESO-1, T cell receptor, ex vivo gene therapy, synovial sarcoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Takara Bio Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Jan 2026 (actual)
- Primary completion
- Mar 2032 (estimated)
- Study completion
- Mar 2032 (estimated)
- First posted
- 16 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Split dose of 5x10^9 TBI-1301 | Experimental | Biological: TBI-1301, Drug: Cyclophosphamide, Drug: FludarabineSplit dose of 5x10^9 TBI-1301 will be administered intravenously for 2 days following pre-treatment for 2 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- ≥ 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TBI-1301Split dose of TBI-1301 is administered intravenously for 2 days following cyclophosphamide/fludarabine pre-treatment. | Biological | Split dose of 5x10^9 TBI-1301 |
| CyclophosphamideCyclophosphamide (750mg/m2/day x 2 days Intravenous (IV)) is administered as pre-treatment medication of TBI-1301. | Drug | Split dose of 5x10^9 TBI-1301 |
| FludarabineFludarabine (30mg/m2/day x 2 days Intravenous (IV)) is administered as pre-treatment medication of TBI-1301. | Drug | Split dose of 5x10^9 TBI-1301 |
Primary outcome
Objective response rate
Time frame: 52 weeks
Evaluate response rate by measuring response using RECIST v1.1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TBI-1301, Cyclophosphamide and Fludarabine in people with Synovial Sarcomas, run by Takara Bio Inc. at 3 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.