[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624761":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":28,"locations":34,"responsibleParty":50,"collaborators":52,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":32,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":32,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":75,"overallStatus":36,"whyStopped":32,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"The Affiliated Hospital of Xuzhou Medical University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"HN2302 treatment group","EXPERIMENTAL","Started at a lower dose level",[13],"Drug: HN2302 Injection",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","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.",[9],[21],"in vivo CAR-T",[23,26],{"name":24,"affiliation":5,"role":25},"Guiyun Cui","PRINCIPAL_INVESTIGATOR",{"name":27,"affiliation":5,"role":25},"Yong Zhang",[29],{"name":27,"role":30,"phone":31,"phoneExt":32,"email":33},"CONTACT","86-0516-85802193",null,"zy20037416@163.com",[35],{"facility":5,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"RECRUITING","Xuzhou","Jiangsu","221000","China","CN",{"type":43,"coordinates":44},"Point",[45,46],117.28386,34.20442,{"lat":46,"lon":45},[49],{"name":27,"role":30,"phone":31,"phoneExt":32,"email":33},{"type":51,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR",[53],{"name":54,"class":55},"Shenzhen MagicRNA Biotechnology Co., Ltd","INDUSTRY","100624761","efficacy-and-safety-of-hn2302-in-refractory-myasthenia-gravismg-100624761",false,"NCT07413835","Efficacy and Safety of HN2302 in Refractory Myasthenia Gravis(MG)","A Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of HN2302 in Patients With Refractory Myasthenia Gravis","Inclusion Criteria:\n\n* Age: 18-80 years, no gender restriction;\n* 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;\n* Clinical classification of MG according to MGFA types IIa-IVb (including IIa, IIb, IIIa, IIIb, IVa, IVb);\n* Baseline MG-ADL score ≥6, ocular-related score \\\u003C50%;\n* Poor response and\u002For lack of efficacy under standard therapies;\n* Minimum life expectancy \\> 12 weeks;\n* Adequate bone marrow, coagulation, cardiopulmonary, liver, and renal function.\n\nExclusion Criteria:\n\n* Subjects positive for hepatitis B surface antigen (HBsAg) and\u002For 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;\n* Presence of other uncontrolled active infections;\n* History of major organ transplantation (e.g., heart, lung, liver, kidney) or bone marrow\u002Fhematopoietic stem cell transplantation;\n* Pregnant or breastfeeding women;\n* Receipt of any mRNA-LNP products or other LNP-based drugs within the past two years;\n* 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;\n* 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);\n* History of live vaccination within 30 days prior to screening;\n* Severe central nervous system diseases or pathological changes, including but not limited to: cerebrovascular accident, aneurysm, epilepsy, seizures\u002Fconvulsions, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disorders, organic brain syndromes, or psychosis;\n* History of asthma or severe allergies;\n* Any condition that, in the investigator's opinion, may increase the patient's risk or interfere with study assessments.","ALL","18 Years","80 Years",{"count":67,"type":68},6,"ESTIMATED","INTERVENTIONAL",[71],"NA","This is an open label, single arm study, to evaluate the safety , tolerability and preliminary efficacy of HN2302 for refractory myasthenia gravis.",[74],"Refractory Myasthenia Gravis",[76,77],"MG","HN2302","2026-03-16",{"date":80,"type":81},"2026-03-18","ACTUAL",{"date":83,"type":81},"2026-03-17",{"date":85,"type":68},"2027-12",{"name":5,"class":6},1]