[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635702":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":29,"locations":39,"responsibleParty":54,"collaborators":56,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":33,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":33,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":81,"whyStopped":33,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Shenzhen MagicRNA Biotechnology Co., Ltd","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"HN2301 treatment group","EXPERIMENTAL","Participants will receive HN2301 Injection at the specified dose level and on the specified study days.",[13],"Drug: HN2301 injection",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","HN2301 injection","Dosing will begin at a lower dose level and may be escalated to dose levels considered safe and potentially effective according to the study protocol.",[9],[21],"in vivo CAR-T",[23,27],{"name":24,"affiliation":25,"role":26},"Wen Xu","The First Affiliated Hospital of University of Science and Technology of China","PRINCIPAL_INVESTIGATOR",{"name":28,"affiliation":25,"role":26},"Yan Jiang",[30,35],{"name":24,"role":31,"phone":32,"phoneExt":33,"email":34},"CONTACT","+86055162284920",null,"Xuwen6779@ustc.edu.cn",{"name":36,"role":31,"phone":37,"phoneExt":33,"email":38},"Zexiu Xiao","+86075527109036","xiaozexiu@magicrna.com",[40],{"facility":25,"status":33,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Hefei","Anhui","230036","China","CN",{"type":47,"coordinates":48},"Point",[49,50],117.28083,31.86389,{"lat":50,"lon":49},[53],{"name":24,"role":31,"phone":32,"phoneExt":33,"email":34},{"type":55,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR",[57],{"name":25,"class":58},"OTHER","100635702","phase-1-efficacy-and-safety-of-hn2301-in-patients-with-generalized-myasthenia-gravis-mg-100635702",false,"NCT07556120","Efficacy and Safety of HN2301 in Patients With Generalized Myasthenia Gravis (MG)","An Exploratory Study to Evaluate Safety, Tolerability and Preliminary Efficacy of HN2301 in Patients With Generalized 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* Patients combined with other malignant tumors;\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":70,"type":71},6,"ESTIMATED","INTERVENTIONAL",[74],"PHASE1","This is an open label, single arm study, to evaluate safety, tolerability and preliminary efficacy of HN2301 in patients with Generalized Myasthenia Gravis.",[77],"Generalized Myasthenia Gravis",[79,80],"MG","in vivo CART","NOT_YET_RECRUITING","2026-04-26",{"date":84,"type":85},"2026-04-29","ACTUAL",{"date":87,"type":71},"2026-05-05",{"date":89,"type":71},"2027-12-31",{"name":5,"class":6},1]