Actively Recruiting
Efficacy and Safety of HN2302 in Refractory Myasthenia Gravis(MG)
Led by The Affiliated Hospital of Xuzhou Medical University · Updated on 2026-03-18
6
Participants Needed
1
Research Sites
89 weeks
Total Duration
On this page
Sponsors
T
The Affiliated Hospital of Xuzhou Medical University
Lead Sponsor
S
Shenzhen MagicRNA Biotechnology Co., Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is an open label, single arm study, to evaluate the safety , tolerability and preliminary efficacy of HN2302 for refractory myasthenia gravis.
CONDITIONS
Official Title
Efficacy and Safety of HN2302 in Refractory Myasthenia Gravis(MG)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years, any gender
- Confirmed diagnosis of generalized myasthenia gravis (MG) with positive AchR or MuSK antibodies and one of the following: repetitive nerve stimulation showing neuromuscular transmission defect, positive neostigmine test, or clinical improvement after cholinesterase inhibitor therapy
- Clinical MG classification according to MGFA types IIa to IVb
- Baseline MG-ADL score of 6 or higher with ocular-related score less than 50%
- Poor response or lack of efficacy with standard therapies
- Minimum life expectancy greater than 12 weeks
- Adequate bone marrow, coagulation, cardiopulmonary, liver, and renal function
You will not qualify if you...
- Positive for hepatitis B surface antigen or core antibody with detectable HBV DNA, hepatitis C antibody with detectable HCV RNA, HIV antibody positive, positive CMV DNA, or positive syphilis antigen or antibody
- Presence of other uncontrolled active infections
- History of major organ transplantation or bone marrow/hematopoietic stem cell transplantation
- Pregnant or breastfeeding women
- Received any mRNA-LNP or other LNP-based drugs within the past two years
- History of significant cardiovascular conditions within 6 months before screening, including severe heart failure, myocardial infarction, unstable angina, or serious arrhythmias
- History of grade 2 or higher bleeding events within 30 days before screening or needing long-term anticoagulation therapy
- History of live vaccination within 30 days before screening
- Severe central nervous system diseases or pathological changes like stroke, epilepsy, dementia, Parkinson's disease, or psychosis
- History of asthma or severe allergies
- Any condition that may increase risk or interfere with study evaluations as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China, 221000
Actively Recruiting
Research Team
Y
Yong Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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