Generalized Myasthenia GravisPhase 1NCT07714798
Universal STAR-T Cell Injection in Generalized Myasthenia Gravis
A Phase 1 study testing Universal STAR-T Cell in people with Generalized Myasthenia Gravis, 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. This is an exploratory clinical study of universal STAR-T cell injection in patients with refractory generalized myasthenia gravis (GMG). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Generalized Myasthenia Gravis
- What is being tested?
- Universal STAR-T Cell
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 6 Jul 2026to 6 Jul 2028
- 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
- Subjects must meet all the following inclusion criteria to be enrolled in this study:
- Age 18-65 years (inclusive), gender (no gender restriction);
- Previously diagnosed with Generalized Myasthenia Gravis (GMG), meeting the 2020 MGFA diagnostic criteria, with MG-ADL total score ≥6 and ocular-related subscore <50% of the total score, positive relevant antibodies, MGFA classification Grade II-IV, and having received at least 2 kinds of immunosuppressants or biological agents for standardized treatment;
- Have received MG treatment for at least 3 months and present with any of the following conditions:
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- MG-ADL total score increased by ≥2 points, and no single ocular item increased by >1 point;
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- QMGS total score increased by ≥3 points, or ≥2 non-ocular items each increased by ≥1 point;
- Increased dose of MG-related drugs, hospitalization, or emergency intervention required due to MG exacerbation; 4. Function of important organs meets the following requirements:
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- Bone marrow function:
- Absolute neutrophil count ≥1×10⁹/L (no colony-stimulating factor treatment within 2 weeks before testing);
- Hemoglobin ≥80 g/L (excluding neutropenia caused by disease);
- Liver function: ALT ≤3×ULN (elevated ALT due to disease is excluded); AST ≤3×ULN (elevated AST due to disease is excluded); TBIL ≤1.5×ULN (elevated TBIL due to disease is excluded);
- Renal function: Serum creatinine (CrCl) ≥45 mL/min (calculated by Cockcroft-Gault formula; acute CrCl decrease due to disease is excluded);
- Coagulation function: International Normalized Ratio (INR) ≤1.5×ULN; Prothrombin Time (PT) ≤1.5×ULN;
- Cardiac function: Systolic blood pressure >90 mmHg, no need for vasoactive drug maintenance; 5. Female subjects of childbearing potential and their male partners (of childbearing age) must use medically recognized contraceptive measures or abstain from sex during the study treatment period and for at least 12 months after the end of study treatment; female subjects of childbearing age must have a negative serum HCG test within 7 days before enrollment and not be in lactation; 6. Voluntarily participate in this clinical study, sign the informed consent form, be compliant, and cooperate with follow-up.
Who cannot join
- Subjects who meet any of the following exclusion criteria will be excluded from this study:
- Have used immunomodulatory or immunosuppressive drugs with therapeutic effects on the disease within 5 half-lives before enrollment, or biologics within 4 weeks (except for those who have received rituximab, with the last use of rituximab <3 months prior [B-cell reconstitution is excluded]);
- Have a history of severe drug allergy or allergic constitution;
- Have uncontrolled or requiring treatment for fungal, bacterial, or viral infections;
- Have active tumor lesions at screening;
- Have cardiac insufficiency (New York Heart Association [NYHA] functional class >II), and cannot tolerate platelet and cellular transfusions;
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- Have congenital immunodeficiency;
- Have a history of malignant tumor (except for cured cutaneous basal cell carcinoma or cervical carcinoma in situ);
- Have end-stage renal failure;
- Positive for Hepatitis B surface Antigen (HBsAg), or positive for Hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA level or titer above the cutoff value for positive specimens; positive for Hepatitis C virus (HCV) antibody with peripheral blood HCV RNA positive; positive for Human Immunodeficiency Virus (HIV) antibody; positive for syphilis testing;
- Pregnant or planning to become pregnant during the study or within 2 years after the end of study treatment (for both male and female subjects);
- Investigators consider there are other reasons that should not be 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
Daishi Tian, 13607178809, tiands@tjh.tjmu.edu.cn
About this study
Official title: An Exploratory Clinical Study of Universal STAR-T Cell Injection in Subjects With Generalized Myasthenia Gravis
This is a Phase I, single-arm, open-label, dose-escalation and dose-expansion study.
This is an exploratory clinical study of universal STAR-T cell injection in patients with refractory generalized myasthenia gravis (GMG). Approximately 10-24 participants aged 18-65 years (inclusive) with the condition are planned to be enrolled.
Read more
The primary objective is to evaluate the safety, tolerability, preliminary efficacy, pharmacokinetic/pharmacodynamic (PK/PD) profile, and immunogenicity of universal STAR-T cell injection. The starting dose is 1.5E6 STAR+ T cells/kg, administered as a single intravenous infusion.Based on safety, PK results, and preliminary efficacy data obtained from the initial dose cohorts, a recommended dose will be selected for subsequent dose-expansion studies to further systematically evaluate the safety and efficacy of universal STAR-T cell injection.
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).
The study is being conducted at Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology.
- Conditions
- Generalized Myasthenia Gravis
- Being tested
- Universal STAR-T Cell
- Keywords
- Generalized Myasthenia Gravis
- Medical subject headings
- Myasthenia Gravis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Universal STAR-T CellDrug
Subjects will receive infusion of Universal STAR-T Cells at the starting dose of 1.5E6 STAR+T cells/kg.
| Study group | Role | What they receive |
|---|---|---|
| Universal STAR-T Cell | Experimental | Subjects will receive infusion of Universal STAR-T Cells at the starting dose of 1.5E6 STAR+T cells/kg. Receives: Drug: Universal STAR-T Cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
Type, severity, and frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs).
Characterization of treatment-emergent adverse events (TEAEs) graded by NCI-CTCAE v6.0, including laboratory abnormalities, vital sign changes, and infusion-related reactions.
Measured: AEs observation will be follow-up for 24 weeks. The observation period is extended to 104 weeks.
Incidence of Dose-Limiting Toxicities (DLTs).
To assess the safety and tolerability of [Drug Name] and determine the Maximum Tolerated Dose (MTD) or Recommended Phase 2 Dose (RP2D). DLTs are defined according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v6.0.
Measured: Within 28 days after infusion
Secondary outcomes (8)
Change in Myasthenia Gravis Quantitative Scale (QMG) or Myasthenia Gravis Activities of Daily Living (MG-ADL) Scores.
Evaluation of preliminary efficacy based on the Myasthenia Gravis Quantitative Scale (QMG) and Myasthenia Gravis Activities of Daily Living (MG-ADL) scale. Response is defined as a ≥5-point reduction from baseline in either the QMG score or the MG-ADL score. Both scales are standardized patient-reported outcome measures.
Measured: The efficacy endpoint evaluation for 104 weeks.
Maximum Plasma Concentration of Universal STAR-T Cells (Cmax)
To evaluate the maximum observed plasma concentration of Universal STAR-T Cells .
Measured: Up to 24 weeks (Core Analysis Period); Extended observation up to 104 weeks.
Time to Reach Maximum Plasma Concentration (Tmax) of Universal STAR-T Cells.
To evaluate the time to reach the maximum observed plasma concentration of Universal STAR-T Cells.
Measured: Up to 24 weeks (Core Analysis Period); Extended observation up to 104 weeks.
Area Under the Plasma Concentration-Time Curve (AUC) of Universal STAR-T Cells.
To evaluate the total systemic exposure to Universal STAR-T Cells over time.
Measured: Up to 24 weeks (Core Analysis Period); Extended observation up to 104 weeks.
Change in Serum Cytokine Concentrations (IL-1β, IL-6, etc.) as a PD Biomarker.
Evaluation of pharmacodynamic (PD) effects via serial measurement of serum cytokine concentrations, including IL-1β, IL-2R, IL-6, IL-8, TNF-α, and IFN-γ, using validated ELISA kits.
Measured: Up to 24 weeks (Core Analysis Period); Extended observation up to 104 weeks.
PD Biomarker Level Change (B cells Quantification and Phenotypic).
Evaluation of Pharmacodynamic (PD) effects of Universal STAR-T Cells via serial quantification of CD19-positive B cells in peripheral blood, expressed as cells per microliter (cells/μL). Measurement will be performed using flow cytometry according to standardized laboratory protocols.
Measured: Up to 24 weeks (Core Analysis Period); Extended observation up to 104 weeks.
Immunogenicity: Anti-Drug Antibodies (ADA) against universal STAR-T cells.
To evaluate the development of anti-drug antibodies (ADA) against allogeneic universal STAR-T cells in peripheral blood.
Measured: Up to 24 weeks (Core Analysis Period); Extended observation up to 104 weeks.
Change in Replication-Competent Adeno-Associated Virus (RCA) Concentration in Peripheral Blood.
To quantitatively detect replication-competent adeno-associated virus (RCA) in peripheral blood using droplet digital PCR (ddPCR). Results will be reported as copies/mL. RCA detection serves as a safety biomarker to assess potential vector shedding or replication in vivo.
Measured: Up to 24 weeks (Core Analysis Period); Extended observation up to 104 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start6 Jul 2026 (estimated)
- Primary completion6 Jul 2027 (estimated)
- Study completion6 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Myasthenia GravisStudies 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
- 10 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
- Investigators
- Daishi Tian, Study director, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07714798
- Sponsor's protocol ID
- YTS209-002
- Status last verified
- Jul 2026
- First submitted
- 9 Jul 2026
- Last updated
- 20 Jul 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 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Study of Universal STAR-T Cell Injection in Subjects With Generalized Myasthenia Gravis
- ClinicalTrials.gov ID
- NCT07714798
- Acronym / sponsor ID
- YTS209-002
- Conditions
- Generalized Myasthenia Gravis
- Keywords
- Generalized Myasthenia Gravis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Daishi TianUniversity, hospital or other
- Collaborators
- China Immunotech (Beijing) Biotechnology Co., Ltd.
- Study start
- 6 Jul 2026 (estimated)
- Primary completion
- 6 Jul 2027 (estimated)
- Study completion
- 6 Jul 2028 (estimated)
- First posted
- 20 Jul 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.
This is an exploratory clinical study of universal STAR-T cell injection in patients with refractory generalized myasthenia gravis (GMG). Approximately 10-24 participants aged 18-65 years (inclusive) with the condition are planned to be enrolled.
The primary objective is to evaluate the safety, tolerability, preliminary efficacy, pharmacokinetic/pharmacodynamic (PK/PD) profile, and immunogenicity of universal STAR-T cell injection. The starting dose is 1.5E6 STAR+ T cells/kg, administered as a single intravenous infusion.Based on safety, PK results, and preliminary efficacy data obtained from the initial dose cohorts, a recommended dose will be selected for subsequent dose-expansion studies to further systematically evaluate the safety and efficacy of universal STAR-T cell injection.
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).
The study is being conducted at Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology.
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 | Experimental | Drug: Universal STAR-T CellSubjects will receive infusion of Universal STAR-T Cells at the starting dose of 1.5E6 STAR+T cells/kg. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Subjects must meet all the following inclusion criteria to be enrolled in this study:
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Key exclusion criteria (12 listed)
- Subjects who meet any of the following exclusion criteria will be excluded from this study:
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 CellSubjects will receive infusion of Universal STAR-T Cells at the starting dose of 1.5E6 STAR+T cells/kg. | Drug | Universal STAR-T Cell |
Primary outcome
Type, severity, and frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs).
Time frame: AEs observation will be follow-up for 24 weeks. The observation period is extended to 104 weeks.
Characterization of treatment-emergent adverse events (TEAEs) graded by NCI-CTCAE v6.0, including laboratory abnormalities, vital sign changes, and infusion-related reactions.
Incidence of Dose-Limiting Toxicities (DLTs).
Time frame: Within 28 days after infusion
To assess the safety and tolerability of [Drug Name] and determine the Maximum Tolerated Dose (MTD) or Recommended Phase 2 Dose (RP2D). DLTs are defined according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v6.0.
8 secondary outcomes
Change in Myasthenia Gravis Quantitative Scale (QMG) or Myasthenia Gravis Activities of Daily Living (MG-ADL) Scores.
Time frame: The efficacy endpoint evaluation for 104 weeks.
Maximum Plasma Concentration of Universal STAR-T Cells (Cmax)
Time frame: Up to 24 weeks (Core Analysis Period); Extended observation up to 104 weeks.
Time to Reach Maximum Plasma Concentration (Tmax) of Universal STAR-T Cells.
Time frame: Up to 24 weeks (Core Analysis Period); Extended observation up to 104 weeks.
Area Under the Plasma Concentration-Time Curve (AUC) of Universal STAR-T Cells.
Time frame: Up to 24 weeks (Core Analysis Period); Extended observation up to 104 weeks.
Change in Serum Cytokine Concentrations (IL-1β, IL-6, etc.) as a PD Biomarker.
Time frame: Up to 24 weeks (Core Analysis Period); Extended observation up to 104 weeks.
PD Biomarker Level Change (B cells Quantification and Phenotypic).
Time frame: Up to 24 weeks (Core Analysis Period); Extended observation up to 104 weeks.
Immunogenicity: Anti-Drug Antibodies (ADA) against universal STAR-T cells.
Time frame: Up to 24 weeks (Core Analysis Period); Extended observation up to 104 weeks.
Change in Replication-Competent Adeno-Associated Virus (RCA) Concentration in Peripheral Blood.
Time frame: Up to 24 weeks (Core Analysis Period); Extended observation up to 104 weeks.
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 20 Jul 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.
Daishi Tian study director
Tongji Hospital
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 in people with Generalized Myasthenia Gravis, 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 16 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 20 Jul 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?
Type, severity, and frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs). (time frame: AEs observation will be follow-up for 24 weeks. The observation period is extended to 104 weeks.). 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 20 Jul 2026.