HN2302 for adults with refractory generalized myasthenia gravis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label, single-arm interventional protocol that gives HN2302 injections to adults with antibody-positive generalized refractory myasthenia gravis. After up to a 4-week screening period, eligible participants enter a treatment period followed by a one-year safety and outcome follow-up. Key eligibility requires AChR or MuSK antibody positivity, MGFA class IIa–IVb, and an MG-ADL score ≥6 with inadequate response to standard therapies. The trial focuses on safety, tolerability, and preliminary signals of clinical benefit using standard MG outcome measures.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age: 18-80 years, no gender restriction;
* Confirmed diagnosis of generalized myasthenia gravis (MG) with positive AchR or MuSK antibodies, meeting at least one of the following conditions：(1) Repetitive nerve stimulation suggesting neuromuscular transmission defect; (2) Positive response to neostigmine test; (3) Clinically judged improvement of --MG symptoms after oral cholinesterase inhibitor therapy;
* Clinical classification of MG according to MGFA types IIa-IVb (including IIa, IIb, IIIa, IIIb, IVa, IVb);
* Baseline MG-ADL score ≥6, ocular-related score \<50%;
* Poor response and/or lack of efficacy under standard therapies;
* Minimum life expectancy \> 12 weeks;
* Adequate bone marrow, coagulation, cardiopulmonary, liver, and renal function.

Exclusion Criteria:

* Subjects positive for hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb) with detectable or quantifiable HBV DNA, positive for hepatitis C antibody (HCV Ab) with detectable or quantifiable HCV RNA, positive for HIV antibody, positive CMV DNA, or CMV DNA above the lower limit of detection; positive for syphilis antigen or antibody;
* Presence of other uncontrolled active infections;
* History of major organ transplantation (e.g., heart, lung, liver, kidney) or bone marrow/hematopoietic stem cell transplantation;
* Pregnant or breastfeeding women;
* Receipt of any mRNA-LNP products or other LNP-based drugs within the past two years;
* History of any of the following cardiovascular conditions within 6 months prior to screening: New York Heart Association (NYHA) Class III or IV heart failure, myocardial infarction, unstable angina, uncontrolled or symptomatic atrial arrhythmias, any ventricular arrhythmias, or other clinically significant cardiac disease;
* History of ≥Grade 2 bleeding events within 30 days prior to screening, or requiring long-term continuous anticoagulation therapy (e.g., warfarin, low molecular weight heparin, Xa factor inhibitors);
* History of live vaccination within 30 days prior to screening;
* Severe central nervous system diseases or pathological changes, including but not limited to: cerebrovascular accident, aneurysm, epilepsy, seizures/convulsions, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disorders, organic brain syndromes, or psychosis;
* History of asthma or severe allergies;
* Any condition that, in the investigator's opinion, may increase the patient's risk or interfere with study assessments.

Where it's running

• The Affiliated Hospital of Xuzhou Medical University
  Xuzhou, Jiangsu, China Recruiting

Study contacts

• Principal investigator: Guiyun Cui — The Affiliated Hospital of Xuzhou Medical University
• Study coordinator: Yong Zhang
• Email: zy20037416@163.com
• Phone: 86-0516-85802193

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.