Multiple Sclerosis (MS)Phase 1NCT07523100
A Study on the Safety and Tolerability of Universal STAR-T Cell Therapy for Multiple Sclerosis.
A Phase 1 study testing Universal STAR-T Cell Injection in people with Multiple Sclerosis (MS), run by Daishi Tian at 1 site in China.
Trial summary
This is a Phase I, single-arm, open-label, dose-escalation and dose-expansion study. The main objective is to explore the safety and tolerability of the universal STAR-T cell injection in patients with progressive or relapsing-remitting multiple sclerosis (MS).The secondary objectives are to evaluate the efficacy of… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis (MS)
- What is being tested?
- Universal STAR-T Cell Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 7 Apr 2026to 1 Apr 2029
- Phase
- Phase 1
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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).
- 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:
- 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;
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- 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);
- Kidney function: Creatinine clearance rate (CrCl) ≥ 30 ml/minute (Cockcroft/Gault formula, acute CrCl decline caused by the disease is excluded);
- Coagulation function: International normalized ratio (INR) ≤ 1.5×ULN, prothrombin time (PT) ≤ 1.5×ULN;
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science & Technology
Wuhan, Hubei, 430030
About this study
Official title: A Clinical Study on the Safety and Tolerability of Universal STAR-T Cell Injection in Patients With Multiple Sclerosis.
This is a Phase I, single-arm, open-label, dose-escalation and dose-expansion study.
The main objective is to explore the safety and tolerability of the universal STAR-T cell injection in patients with progressive or relapsing-remitting multiple sclerosis (MS).The secondary objectives are to evaluate the efficacy of the universal STAR-T cell injection in treating patients with progressive or relapsing-remitting MS; and to assess the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of the universal STAR-T cell injection.
Read more
The primary endpoint of this study is the incidence rate of dose-limiting toxicity (DLT), as well as the types, severity and frequency of adverse events (AE).The secondary research endpoints of this study are the efficacy endpoints as well as the expansion and persistence of the universal STAR-T cells in the body.
This study is an exploratory clinical trial of the universal STAR-T cell injection for the treatment of progressive or relapsed-remitting MS. The study will be conducted in two phases: dose escalation and dose expansion. The dose escalation group 1 (1.5E6 STAR-T cells) begins, followed by dose escalation group 2 (3E6 STAR-T cells), and dose escalation group 3 (4.5E6 STAR-T cells).
Expansion study phase: After the dose escalation stage is completed, based on the safety, PK results and preliminary efficacy data of each dose group during the escalation stage, the recommended dose will be determined for the dose expansion study. It is planned to include 3 to 6 subjects to further systematically evaluate the safety and efficacy of the universal STAR-T cell.
This study includes the screening period (from D-28 to D-6), the pre-clearance treatment and rest observation period (from D-5 to D-1), the cell infusion and main study endpoint observation period (from D0 to W12 after infusion), and the follow-up period (from W12 after infusion to W104).
- Conditions
- Multiple Sclerosis (MS)
- Being tested
- Universal STAR-T Cell Injection
- Keywords
- Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Universal STAR-T Cell InjectionDrug
Subjects will receive Universal STAR-T Cell Injection, and dose escalation will commence at 1.5E6 cells/kg or the starting dose may be adjusted based on accumulated data.
| Study group | Role | What they receive |
|---|---|---|
| Universal STAR-T Cell Injection | Experimental | Not described Receives: Drug: Universal STAR-T Cell Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicity
Measured: Within 28 days after infusion
The types, severity and frequency of adverse events (AE)
Measured: Within 6 months after infusion
Secondary outcomes (2)
Efficacy endpoint
Definition of treatment effectiveness: An increase in the EDSS score (an increase of 1 point for scores below 5 and 0.5 points for scores of 5 and above) is defined as deterioration. If no deterioration occurs, it is considered effective; or a reduction in the Annualized Relapse Rate (ARR).
Measured: Within 12 weeks after infusion
The in vivo expansion and persistence of universal STAR-T cells.
Key PK parameters: peak amplification (Cmax), time to peak (Tmax), area under the blood concentration-time curve (AUC), as well as studies on cell subtypes and dominant clones, etc.
Key PD parameters: changes in cytokines, levels and characteristics of immune cell reconstitution such as CD19-positive B cells, etc.
Research on immunogenicity and other aspects: Studies on the production of anti-drug antibodies (ADA) in peripheral blood against the universal STAR-T cell injection solution and the generation of replication-type adeno-associated viruses (RCA).
Measured: Within 12 months after infusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start7 Apr 2026 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis (MS)Studies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daishi Tian
- Sponsor type
- University, hospital or other
- Collaborators
- China Immunotech (Beijing) Biotechnology Co., Ltd.
- Responsible party
- Sponsor-investigator, Daishi Tian, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07523100
- Sponsor's protocol ID
- YTS209-001
- Status last verified
- Apr 2026
- First submitted
- 4 Apr 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study on the Safety and Tolerability of Universal STAR-T Cell Injection in Patients With Multiple Sclerosis.
- ClinicalTrials.gov ID
- NCT07523100
- Acronym / sponsor ID
- YTS209-001
- Conditions
- Multiple Sclerosis (MS)
- Keywords
- Multiple Sclerosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Daishi TianUniversity, hospital or other
- Collaborators
- China Immunotech (Beijing) Biotechnology Co., Ltd.
- Study start
- 7 Apr 2026 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2029 (estimated)
- First posted
- 13 Apr 2026 (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.
This is a Phase I, single-arm, open-label, dose-escalation and dose-expansion study.
The main objective is to explore the safety and tolerability of the universal STAR-T cell injection in patients with progressive or relapsing-remitting multiple sclerosis (MS).The secondary objectives are to evaluate the efficacy of the universal STAR-T cell injection in treating patients with progressive or relapsing-remitting MS; and to assess the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of the universal STAR-T cell injection.
The primary endpoint of this study is the incidence rate of dose-limiting toxicity (DLT), as well as the types, severity and frequency of adverse events (AE).The secondary research endpoints of this study are the efficacy endpoints as well as the expansion and persistence of the universal STAR-T cells in the body.
This study is an exploratory clinical trial of the universal STAR-T cell injection for the treatment of progressive or relapsed-remitting MS. The study will be conducted in two phases: dose escalation and dose expansion. The dose escalation group 1 (1.5E6 STAR-T cells) begins, followed by dose escalation group 2 (3E6 STAR-T cells), and dose escalation group 3 (4.5E6 STAR-T cells).
Expansion study phase: After the dose escalation stage is completed, based on the safety, PK results and preliminary efficacy data of each dose group during the escalation stage, the recommended dose will be determined for the dose expansion study. It is planned to include 3 to 6 subjects to further systematically evaluate the safety and efficacy of the universal STAR-T cell.
This study includes the screening period (from D-28 to D-6), the pre-clearance treatment and rest observation period (from D-5 to D-1), the cell infusion and main study endpoint observation period (from D0 to W12 after infusion), and the follow-up period (from W12 after infusion to W104).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Universal STAR-T Cell Injection | Experimental | Drug: Universal STAR-T Cell Injection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
- 3. The functions of important organs should meet the following requirements:
- 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.
Key exclusion criteria (12 listed)
- 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;
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 |
|---|---|---|
| Universal STAR-T Cell InjectionSubjects will receive Universal STAR-T Cell Injection, and dose escalation will commence at 1.5E6 cells/kg or the starting dose may be adjusted based on accumulated data. | Drug | Universal STAR-T Cell Injection |
Primary outcome
Dose Limiting Toxicity
Time frame: Within 28 days after infusion
The types, severity and frequency of adverse events (AE)
Time frame: Within 6 months after infusion
2 secondary outcomes
Efficacy endpoint
Time frame: Within 12 weeks after infusion
The in vivo expansion and persistence of universal STAR-T cells.
Time frame: Within 12 months after infusion.
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 13 Apr 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Universal STAR-T Cell Injection in people with Multiple Sclerosis (MS), run by Daishi Tian at 1 site in China.
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 12 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: opening soon, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Contact Daishi Tian (13607178809, tiands@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limiting Toxicity (time frame: Within 28 days after infusion). The study lists 2 primary outcomes in all. 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 13 Apr 2026.