The Affiliated Hospital of Xuzhou Medical University
Phase
Not applicable
Started
2026-03-17
Last updated
2026-03-18
Condition(s) studied
Refractory Myasthenia Gravis
Investigational drug(s) / intervention(s)
HN2302 Injection
HN2302 Injection: Patients will be administrated with specified dose on specified days at a lower dose level and escalated to safe and effective dose levels.
Study summary
This is an open label, single arm study, to evaluate the safety , tolerability and preliminary efficacy of HN2302 for refractory myasthenia gravis.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Incidence of Treatment-Emergent Adverse Events — Up to 3 months Proportion and severity of adverse events (AEs)
Trial sites (1)
Facility
City
Region
Status
The Affiliated Hospital of Xuzhou Medical University
Xuzhou
Jiangsu
Recruiting
More The Affiliated Hospital of Xuzhou Medical University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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