Experimental STAR-T cell therapy aims to tame multiple sclerosis
NCT ID NCT07523100
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage trial will test the safety of a new immune cell therapy called universal STAR-T cells in 24 adults with multiple sclerosis (MS) who have no other treatment options. The therapy involves infusing specially engineered cells that may help control the disease. The study will first find the safest dose, then expand to confirm safety and look for early signs of effectiveness.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Universal STAR-T cell injection (a type of immune cell therapy)
- What this could lead to
- If this early trial shows the therapy is safe, it could point toward a new way to control multiple sclerosis by targeting the immune system.
- What could go wrong
- This is a very early Phase 1 study with only 24 participants, so it is too soon to know if it works. There may be serious side effects from the cell therapy, and it is not a cure.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 1\. Aged from 18 to 65 years (inclusive), with no gender restriction. * 2\. Patients with MS who have been diagnosed according to the specified diagnostic criteria in the past and currently have no effective treatment options need to meet the following requirements, including: 1. According to the revised 2024 McDonald diagnostic criteria, they are clinically diagnosed with progressive MS (including primary progressive PPMS or secondary progressive SPMS) or relapsing-remitting MS (RRMS), and their disability status at the time of screening meets an EDSS score of 2-7 (inclusive). 2. For RRMS patients, they need to meet any of the following conditions: a) They have failed treatment with ≥1 effective DMT (fenogomide, cinemodide, ozamod, and anti-CD20 monoclonal antibody therapy, etc.); b) They have had at least 2 clinical relapses in the past 2 years, or they have had 1 clinical relapse in the past 2 years and MRI shows ≥1 new Gd-enhanced lesion, or they have had ≥1 new Gd-enhanced lesion on MRI within the past 6 months; c) There are ≥2 active Gd-enhanced lesions on T1-weighted brain MRI at the time of screening. * 3\. The functions of important organs should meet the following requirements: 1. Bone marrow function should satisfy: a. Neutrophil count ≥ 1×109/L (no colony-stimulating factor treatment within 2 weeks before the examination, and neutrophil reduction caused by the disease is excluded); b. Hemoglobin ≥ 60g/L; 2. Liver function: ALT ≤ 3×ULN (ALT elevation caused by the disease can be excluded); AST ≤ 3×ULN (AST elevation caused by the disease can be excluded); TBIL ≤ 1.5×ULN (TBIL elevation caused by the disease can be excluded); 3. Kidney function: Creatinine clearance rate (CrCl) ≥ 30 ml/minute (Cockcroft/Gault formula, acute CrCl decline caused by the disease is excluded); 4. Coagulation function: International normalized ratio (INR) ≤ 1.5×ULN, prothrombin time (PT) ≤ 1.5×ULN; 5. Cardiac function: Good hemodynamic stability; * 4\. For female subjects with reproductive capacity and their male partners, as well as male subjects whose female partners are of childbearing age, they are required to adopt medically approved contraceptive measures or abstain from sexual activity during the study treatment period and for at least 12 months after the end of the study treatment; female subjects of childbearing age must have a negative serum HCG test result within 7 days before study enrollment and must not be in the lactation period. * 5\. Voluntarily participated in this clinical study, signed the informed consent form, had good compliance, and cooperated with the follow-up. Exclusion Criteria: If the subjects meet any of the following exclusion criteria, they will not be included in this study: * 1\. The period of using immunosuppressants with therapeutic effects on the disease before enrollment is within five half-lives or the biological agents have been used for 4 weeks. For subjects who have received rituximab treatment, the time since the last use of rituximab is less than 3 months (except for those with B-cell reconstitution); * 2\. Have a severe history of drug allergy or are allergic constitution; * 3\. Have uncontrollable or require treatment infections such as fungi, bacteria, viruses, etc.; * 4\. Have active tuberculosis at the time of screening; * 5\. Have heart dysfunction (NYHA cardiac function classification \> grade II) and cannot tolerate the study's lymphocyte purification and cell reinfusion. * 6.Subjects with congenital immunoglobulin deficiencies; * 7\. Subjects with a history of unremitting malignant tumors within the past five years; * 8\. Subjects with end-stage renal failure; * 9\. Subjects with positive hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), and peripheral blood HBV DNA titer higher than the detection limit; subjects with positive hepatitis C virus (HCV) antibody and positive HCV RNA in peripheral blood; subjects with positive human immunodeficiency virus (HIV) antibody; subjects with positive syphilis test results; * 10\. Male and female subjects who are pregnant or have a fertility plan during the participation in this study or within 2 years after receiving study treatment; * 11\. Subjects that the researchers consider have other reasons that prevent them from being included in this study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science & Technology
Wuhan, Hubei, 430030, China
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Other studies related to the condition(s) this trial covers.
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