Engineered immune cells take aim at debilitating muscle weakness
NCT ID NCT07714798
First seen Jul 20, 2026 · Last updated Jul 21, 2026 · Updated 1 time
Summary
This early-phase trial tests a single infusion of universal STAR-T cells—engineered immune cells—in adults aged 18 to 65 with refractory generalized myasthenia gravis, a condition causing severe muscle weakness. The study aims to assess safety, tolerability, and signs of effectiveness, with participants followed for up to two years. It is conducted at a single hospital in China.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a cell therapy called universal STAR-T cells
- What this could lead to
- If successful, this could point toward a new treatment option for people with hard-to-treat generalized myasthenia gravis.
- What could go wrong
- This is an early, small phase 1 trial focused on safety, so it may not show clear benefit. Cell therapies can cause serious side effects like cytokine release syndrome.
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 10 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2028
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: * Subjects must meet all the following inclusion criteria to be enrolled in this study: 1. Age 18-65 years (inclusive), gender (no gender restriction); 2. 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; 3. Have received MG treatment for at least 3 months and present with any of the following conditions: <!-- --> 1. MG-ADL total score increased by ≥2 points, and no single ocular item increased by \>1 point; 2. QMGS total score increased by ≥3 points, or ≥2 non-ocular items each increased by ≥1 point; 3. Increased dose of MG-related drugs, hospitalization, or emergency intervention required due to MG exacerbation; 4. Function of important organs meets the following requirements: <!-- --> 1. Bone marrow function: 1. Absolute neutrophil count ≥1×10⁹/L (no colony-stimulating factor treatment within 2 weeks before testing); 2. Hemoglobin ≥80 g/L (excluding neutropenia caused by disease); 2. 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); 3. Renal function: Serum creatinine (CrCl) ≥45 mL/min (calculated by Cockcroft-Gault formula; acute CrCl decrease due to disease is excluded); 4. Coagulation function: International Normalized Ratio (INR) ≤1.5×ULN; Prothrombin Time (PT) ≤1.5×ULN; 5. 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. Exclusion Criteria: * Subjects who meet any of the following exclusion criteria will be excluded from this study: 1. 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 \[B-cell reconstitution is excluded\]); 2. Have a history of severe drug allergy or allergic constitution; 3. Have uncontrolled or requiring treatment for fungal, bacterial, or viral infections; 4. Have active tumor lesions at screening; 5. Have cardiac insufficiency (New York Heart Association \[NYHA\] functional class \>II), and cannot tolerate platelet and cellular transfusions; 6. Have congenital immunodeficiency; 7. Have a history of malignant tumor (except for cured cutaneous basal cell carcinoma or cervical carcinoma in situ); 8. Have end-stage renal failure; 9. 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; 10. 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); 11. Investigators consider there are other reasons that should not be 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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