[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624761":3},{"organization":4,"outcomesModule":7,"designInfo":44,"detailedDescription":50,"studyPopulation":43,"armGroups":51,"interventions":58,"overallOfficials":66,"centralContacts":72,"locations":77,"responsibleParty":93,"collaborators":95,"id":99,"slug":43,"hasResults":100,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":43,"eligibilityCriteria":104,"healthyVolunteers":100,"sex":105,"minAge":106,"maxAge":107,"enrollmentInfo":108,"targetDuration":43,"studyType":111,"phases":112,"briefSummary":113,"conditions":114,"keywords":116,"overallStatus":79,"whyStopped":43,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"The Affiliated Hospital of Xuzhou Medical University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":43},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence of Treatment-Emergent Adverse Events","Proportion and severity of adverse events (AEs)","Up to 3 months",[14,18,21,24,27,30,34,37,40],{"measure":15,"description":16,"timeFrame":17},"Changes from baseline in Myasthenia Gravis Activities of Daily Living（MG-ADL） score","Proportion of patients ≥2 points. A total score can fall between 0 and 24, with a higher score representing a more significant degree of disease activity","Up to 12 months",{"measure":19,"description":20,"timeFrame":17},"Changes from baseline in Myasthenia Gravis Composite （MGC） score","Proportion of patients ≥3-point reduction.The total score is 50 points. The higher the score, the more severe the condition is indicated.",{"measure":22,"description":23,"timeFrame":17},"Changes from baseline in Quantitative Myasthenia Gravis (QMG) score","Proportion of patients ≥3-point reduction. To assess the muscle strength and endurance of the affected muscles in patients with myasthenia gravis, thereby reflecting the severity of the disease.",{"measure":25,"description":26,"timeFrame":17},"Changes from baseline in 15-item quality of life (MG-QOL15r) score","To assess important aspects of the patient's experience related to MG, scores each of 15 items 0-2 (max score 30).",{"measure":28,"description":29,"timeFrame":17},"Percentage of patients with symptom changes after treatment","Proportion of patients without symptom worsening or relapse",{"measure":31,"description":32,"timeFrame":33},"in vivo CAR T cell production","Assessment of CAR T production (CAR expression ratio in T cells) in the peripheral blood of MG patients by flow cytometry (FACS)","Day-28 to14 days",{"measure":35,"description":36,"timeFrame":17},"B cell ratio and counts in peripheral blood","Assessment of B cell ratio and counts (B cell counts per μl peripheral blood) and B cell subsets(naive B cell, memory B cell) by flow cytometry (FACS) in peripheral blood",{"measure":38,"description":39,"timeFrame":17},"Dynamic changes in cytokine levels after treatment","Differences in cytokine post-administration vs. baseline",{"measure":41,"description":42,"timeFrame":17},"Changes in acetylcholine receptor (AchR) antibody levels after treatment","Differences in AchR antibody post-administration vs. baseline",null,{"allocation":45,"interventionModel":46,"interventionModelDescription":43,"primaryPurpose":47,"observationalModel":43,"timePerspective":43,"maskingInfo":48},"NA","SINGLE_GROUP","TREATMENT",{"masking":49,"maskingDescription":43,"whoMasked":43},"NONE","The study will consist of an up to 4-week Screening Period, Treatment Period and one year Follow-up Period.",[52],{"label":53,"type":54,"description":55,"interventionNames":56},"HN2302 treatment group","EXPERIMENTAL","Started at a lower dose level",[57],"Drug: HN2302 Injection",[59],{"type":60,"name":61,"description":62,"armGroupLabels":63,"otherNames":64},"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.",[53],[65],"in vivo CAR-T",[67,70],{"name":68,"affiliation":5,"role":69},"Guiyun Cui","PRINCIPAL_INVESTIGATOR",{"name":71,"affiliation":5,"role":69},"Yong Zhang",[73],{"name":71,"role":74,"phone":75,"phoneExt":43,"email":76},"CONTACT","86-0516-85802193","zy20037416@163.com",[78],{"facility":5,"status":79,"city":80,"state":81,"zip":82,"country":83,"countryCode":84,"cosmosGeoPoint":85,"geoPoint":90,"contacts":91},"RECRUITING","Xuzhou","Jiangsu","221000","China","CN",{"type":86,"coordinates":87},"Point",[88,89],117.28386,34.20442,{"lat":89,"lon":88},[92],{"name":71,"role":74,"phone":75,"phoneExt":43,"email":76},{"type":94,"investigatorFullName":43,"investigatorTitle":43,"investigatorAffiliation":43,"oldNameTitle":43,"oldOrganization":43},"SPONSOR",[96],{"name":97,"class":98},"Shenzhen MagicRNA Biotechnology Co., Ltd","INDUSTRY","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":109,"type":110},6,"ESTIMATED","INTERVENTIONAL",[45],"This is an open label, single arm study, to evaluate the safety , tolerability and preliminary efficacy of HN2302 for refractory myasthenia gravis.",[115],"Refractory Myasthenia Gravis",[117,118],"MG","HN2302","2026-03-16",{"date":121,"type":122},"2026-03-18","ACTUAL",{"date":124,"type":122},"2026-03-17",{"date":126,"type":110},"2027-12",{"name":5,"class":6},1]