Tests HN2302 injection in adults with hard-to-treat myasthenia gravis
Tests the HN2302 injection for safety in adults with refractory myasthenia gravis.
Plain-language title generated from the registry record
Registry title: Efficacy and Safety of HN2302 in Refractory Myasthenia Gravis(MG)
Key facts
- Where
- Xuzhou, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07413835, who can take part
Where in China
- The affiliated hospital of xuzhou medical universityXuzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- The Affiliated Hospital of Xuzhou Medical University
- Trial code
- NCT07413835
- Record updated
- 18 March 2026
- Original description
This is an open label, single arm study, to evaluate the safety , tolerability and preliminary efficacy of HN2302 for refractory myasthenia gravis.Read full original descriptionShow less
A Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of HN2302 in Patients With Refractory Myasthenia Gravis
This is an open label, single arm study, to evaluate the safety , tolerability and preliminary efficacy of HN2302 for refractory myasthenia gravis.
Inclusion: 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: 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; 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; 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; Pregnant or breastfeeding women.