Efficacy and Safety of HN2302 in Refractory Myasthenia Gravis(MG) (NCT07413835) | Clinical Trial Compass
RecruitingNot Applicable
Efficacy and Safety of HN2302 in Refractory Myasthenia Gravis(MG)
China6 participantsStarted 2026-03-17
Plain-language summary
This is an open label, single arm study, to evaluate the safety , tolerability and preliminary efficacy of HN2302 for refractory myasthenia gravis.
Who can participate
Age range18 Years – 80 Years
SexALL
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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 followi…
What they're measuring
1
Incidence of Treatment-Emergent Adverse Events
Timeframe: Up to 3 months
Trial details
NCT IDNCT07413835
SponsorThe Affiliated Hospital of Xuzhou Medical University