NCT07413835 Efficacy and Safety of HN2302 in Refractory Myasthenia Gravis(MG)
| NCT ID | NCT07413835 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Affiliated Hospital of Xuzhou Medical University |
| Condition | Refractory Myasthenia Gravis |
| Study Type | INTERVENTIONAL |
| Enrollment | 6 participants |
| Start Date | 2026-03-17 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 6 participants in total. It began in 2026-03-17 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is an open label, single arm study, to evaluate the safety , tolerability and preliminary efficacy of HN2302 for refractory myasthenia gravis.
Eligibility Criteria
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.
Contact & Investigator
Guiyun Cui
PRINCIPAL INVESTIGATOR
The Affiliated Hospital of Xuzhou Medical University
Frequently Asked Questions
Who can join the NCT07413835 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Refractory Myasthenia Gravis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07413835 currently recruiting?
Yes, NCT07413835 is actively recruiting participants. Contact the research team at zy20037416@163.com for enrollment information.
Where is the NCT07413835 trial being conducted?
This trial is being conducted at Xuzhou, China.
Who is sponsoring the NCT07413835 clinical trial?
NCT07413835 is sponsored by The Affiliated Hospital of Xuzhou Medical University. The principal investigator is Guiyun Cui at The Affiliated Hospital of Xuzhou Medical University. The trial plans to enroll 6 participants.