[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"refractory-myasthenia-gravis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:refractory-myasthenia-gravis":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"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":20,"type":21},6,"ESTIMATED","INTERVENTIONAL",[24],"NA","This is an open label, single arm study, to evaluate the safety , tolerability and preliminary efficacy of HN2302 for refractory myasthenia gravis.",[27],"Refractory Myasthenia Gravis",[29,30],"MG","HN2302","RECRUITING","2026-03-16",{"date":34,"type":35},"2026-03-18","ACTUAL",{"date":37,"type":35},"2026-03-17",{"date":39,"type":21},"2027-12",{"name":41,"class":42},"The Affiliated Hospital of Xuzhou Medical University","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":4},"100611652","early-phase-1-allogeneic-cd19-car-nk-cells-in-patients-with-refractory-myasthenia-gravis-100611652","NCT07243366","Allogeneic CD19-CAR-NK Cells in Patients With Refractory Myasthenia Gravis","Exploratory Clinical Trial of Allogeneic CD19-CAR-NK Cells in Patients With Refractory Myasthenia Gravis","Inclusion Criteria:\n\n* Aged 18-65 years old, including the boundary value, no gender restriction;\n* MGFA clinical class II-IV;\n* Anti-acetylcholine-receptor antibody (AChR-Ab) shows positive;\n* Willing to participate in the study, understand and sign the informed consent form (ICF).\n* Baseline characteristics - all must be fulfilled:\n\n  1. Refractory MG patients: Meet the diagnostic criteria in the Chinese Guidelines for the Diagnosis and Treatment of MG (2020 edition). On the basis of typical MG clinical features (fluctuating muscle weakness), a diagnosis can be made if any of the following three points are met, including pharmacological examination, electrophysiological characteristics, and serum anti-AChR antibody testing. Other diseases must also be excluded.\n  2. Myasthenia Gravis Activities of Daily Living (MG-ADL) score ≥ 6, with ocular sub-score \\\u003C 50 % of total.\n* Diagnostic Criteria: Meeting any one of the following four conditions:\n\n  1. Following an adequate dose and full course of at least two conventional immunotherapies (including both corticosteroids and non-steroidal immunosuppressants), and at least one complete treatment cycle with a biologic agent (efgartigimod, eculizumab, rituximab, or telitacicept), the post-intervention status (PIS) remains unchanged or worsens.\n  2. Following an adequate dose and full course of at least two conventional immunotherapies (including both corticosteroids and non-steroidal immunosuppressants) and at least one complete treatment cycle with a biologic agent, the PIS improves, yet the MG-ADL score is still ≥6 and persists for at least six months.\n  3. Following an adequate dose and full course of at least two conventional immunotherapies (including both corticosteroids and non-steroidal immunosuppressants) and at least one complete treatment cycle with a biologic agent, the PIS shows remission or improvement; however, during the regular tapering of immunotherapy drugs, the patient experiences ≥2 exacerbations per year with an MG-ADL score ≥6.\n  4. Despite treatment with multiple immunotherapies-including intravenous immunoglobulin (IVIG), plasma exchange, and high-dose intravenous methylprednisolone (IVMP)-as well as aggressive infection control after a myasthenic crisis, the patient remains unable to be weaned from mechanical ventilation for more than 14 days due to respiratory muscle weakness caused by MG.\n* Within 30 days before enrollment: glucocorticoids unchanged for 1 month, immunosuppressants for 3 months, pyridostigmine for 2 weeks, and stable MG-ADL score for 1 month.\n\nNote: 1. \"Two conventional immunotherapies\" consist of one corticosteroid plus one non-steroidal immunosuppressant. 2. \"Adequate dose for a full course\" is defined as follows: 1) Corticosteroid: 0.5-1.0 mg · kg-¹ · d-¹ for ≥ 8 weeks. 2) One of the following non-steroidal immunosuppressants taken for the specified minimum duration: A. Azathioprine: 1.5-2.5 mg · kg-¹ · d-¹ in 2-3 divided doses for ≥ 24 weeks. B. Methotrexate: 15 mg once weekly for ≥ 24 weeks. C. Mycophenolate mofetil: 0.75-1.00 g twice daily for ≥ 24 weeks. D. Cyclophosphamide: 400-800 mg intravenously every week OR 100 mg\u002Fday orally in two divided doses, with a cumulative dose ≥ 15 g. E. Tacrolimus: 2-3 mg\u002Fday with at least one trough level ≥ 4.8 ng\u002FmL for ≥ 12 weeks. F. Cyclosporine: 2-4 mg · kg-¹ · d-¹ in two divided doses, with at least one fasting trough level ≥ 100 ng\u002FmL for ≥ 24 weeks. 3. Failure to complete the full dose and course of any one conventional immunotherapy due to contraindications, comorbidities, or inability to tolerate drug adverse effects is considered equivalent to having an inadequate response after completing a full dose and course of that conventional immunotherapy. 4. Biologic agents include efgartigimod, eculizumab, rituximab, and telitacicept.\n\nExclusion Criteria:\n\n* Received IVMP, IVIG, or TPE within the 2 months before the current visit;\n* Unable to cooperate in completing the MG-ADL, or QMG, or Quantitative QMG questionnaire.\n* Judged by a senior clinician to have any of the following: 1)Severe or chronic urinary-tract infection; 2)History of recurrent infections; 3)Previous allergy to any human-derived biologic drug; 4)Depression, suicidal ideation, or other psychiatric disorder;\n* Patients with active infection, such as herpes zoster, HIV, active tuberculosis, or active hepatitis.\n* Rituximab within 6 months, eculizumab within 3 months, or efgartigimod within 1 month before enrollment.\n* Receipt of any live vaccine within 3 months before screening or planned vaccination during the study.\n* Subjects deemed unsuitable for participation in this trial by the investigator (e.g., severe psychiatric illness).","65 Years",{"count":53,"type":21},15,[55],"EARLY_PHASE1","This study is a single-center, prospective, nonrandom, single-arm trial.",[27],"NOT_YET_RECRUITING","2025-11-19",{"date":61,"type":35},"2025-11-21",{"date":63,"type":21},"2025-11-25",{"date":65,"type":21},"2027-11-30",{"name":67,"class":68},"Guangdong ProCapZoom Biosciences Co., Ltd.","INDUSTRY"]