Universal STAR-T Cell Injection in Generalized Myasthenia Gravis
China10 participantsStarted 2026-07-06
Plain-language 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). 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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:
. MG-ADL total score increased by ≥2 points, and no single ocular item increased by \>1 point;
. 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:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Type, severity, and frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs).
Timeframe: AEs observation will be follow-up for 24 weeks. The observation period is extended to 104 weeks.
. Absolute neutrophil count ≥1×10⁹/L (no colony-stimulating factor treatment within 2 weeks before testing);
Exclusion criteria
. 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;
. Have congenital immunodeficiency;
. Have a history of malignant tumor (except for cured cutaneous basal cell carcinoma or cervical carcinoma in situ);