[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shenzhen MagicRNA Biotechnology Co., Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":95},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,44,71],{"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},"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":20,"type":21},6,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This is an open label, single arm study, to evaluate safety, tolerability and preliminary efficacy of HN2301 in patients with Generalized Myasthenia Gravis.",[27],"Generalized Myasthenia Gravis",[29,30],"MG","in vivo CART","NOT_YET_RECRUITING","2026-04-26",{"date":34,"type":35},"2026-04-29","ACTUAL",{"date":37,"type":21},"2026-05-05",{"date":39,"type":21},"2027-12-31",{"name":41,"class":42},"Shenzhen MagicRNA Biotechnology Co., Ltd","INDUSTRY",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":61,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":43},"100577655","phase-1-efficacy-and-safety-of-hn2301-in-autoimmune-diseasesaids-100577655","NCT06801119","Efficacy and Safety of HN2301 in Autoimmune Diseases（AIDs）","Dose-escalation Study to Assess the Safety, Tolerability, and Preliminary Efficacy of HN2301 in Patients With Autoimmune Diseases Including Systemic Lupus Erythematosus（SLE）, Systemic Sclerosis (SSc) and Rheumatoid Arthritis （RA）","SLE，SSc，RA","Inclusion Criteria:\n\n* Patients aged between 18 and 69 (inclusive), of any gender;\n* Appropriate bone marrow, coagulation, cardiopulmonary, liver, and kidney functions. Bone marrow function: ANC ≥1.5×10\\^9\u002FL, ALC ≥0.8×10\\^9\u002FL, Hb ≥80g\u002FL. No use of transfusions and growth factors allowed within 7 days prior to screening to meet these requirements. Coagulation function: INR or APTT ≤1.5×ULN. Cardiac function: Echocardiography (ECHO) assessment of left ventricular ejection fraction (LVEF) ≥40%. Lung function: ≤CTCAE grade 1 dyspnea and SpO2 ≥92% (measured by pulse oximetry) while breathing indoor air. Liver function: ALT and AST ≤2.5×ULN, total bilirubin \\\u003C2.0mg\u002FdL (Gilbert syndrome subjects total bilirubin \\\u003C3.0mg\u002FdL). Kidney function: defined as creatinine clearance rate (Cockcroft-Gault) ≥50mL\u002Fmin without need for fluid assistance;\n* Non-pregnant\u002Fnon-lactating participants, willing to adopt contraceptive measures within 12 months after drug infusion;\n* Diagnosed with SLE according to the 2019 EULAR\u002FACR SLE diagnostic criteria; A history of SLE for at least 6 months, having used a stable standard treatment regimen for at least 8 weeks; Oral corticosteroids are prednisone (or equivalent drug) ≥7.5mg\u002Fday and ≤30mg\u002Fday. At least two immunosuppressants have been used in a standardized manner (including hydroxychloroquine); Screening period tests meet: positive blood antinuclear antibody (ANA), and\u002For positive anti-ds-DNA antibodies, and\u002For hypocomplementemia;\n* SSc-meets the classification criteria of ACR and EULAR, 10-35 in mRSS score;\n* RA-meets the classification criteria of ACR and EULAR, DAS28-ESR\\>3.2, ACPA possitive.\n\nExclusion Criteria:\n\n* Individuals with positive Hepatitis B surface antigen (HBsAg) and\u002For Hepatitis B core antibody (HBcAb), and Hepatitis B virus (HBV) DNA positivity or titers above the detection threshold; those with positive Hepatitis C virus (HCV) antibodies and HCV RNA positivity or titers above the detection threshold; individuals with Human Immunodeficiency Virus (HIV) antibodies positivity, CMV DNA positivity or above the detection limit; those with positive syphilis antigen or antibodies;\n* Presence of other uncontrolled active infections;\n* History of major organ transplantation (such as heart, lung, liver, kidney) or bone marrow\u002Fhematopoietic stem cell transplantation;\n* Pregnant or breastfeeding women;\n* Receiving any mRNA-LNP product or other LNP medications within the past two years;\n* History of any of the following cardiovascular diseases within the last 6 months before screening: Class III or IV heart failure defined by the New York Heart Association (NYHA), myocardial infarction, unstable angina, uncontrolled or symptomatic atrial arrhythmias, any ventricular arrhythmias, or other clinically significant cardiac diseases;\n* History of live vaccine administration within the last 30 days;\n* Individuals with asthma, severe allergies;\n* Other conditions deemed inappropriate for participation in this clinical study by the investigator.","69 Years",{"count":54,"type":21},30,[24],"This is an open lable and single arm study, is designed to evaluate the safety and preliminary efficacy of HN2301 in Autoimmune Disease（AID）",[58,59,60],"Systemic Lupus Erythematosus","Scleroderma","Rheumatoid Arthritis",[62],"SLE, SSc,RA","RECRUITING",{"date":65,"type":35},"2026-04-28",{"date":67,"type":35},"2025-03-16",{"date":69,"type":21},"2028-06-30",{"name":41,"class":42},{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":52,"enrollmentInfo":79,"targetDuration":4,"studyType":22,"phases":81,"briefSummary":82,"conditions":83,"keywords":86,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":93,"leadSponsor":94,"locationsCount":43},"100633176","phase-1-safety-and-preliminary-efficacy-of-hn2302-in-patients-with-autoimmune-diseases-100633176","NCT07523282","Safety and Preliminary Efficacy of HN2302 in Patients With Autoimmune Diseases","A Study to Assess the Safety and Preliminary Efficacy of HN2302 in Patients With Autoimmune Diseases","AID","Inclusion Criteria:\n\n* Adults aged 18 to 69 years, regardless of gender.\n* Adequate bone marrow, coagulation, cardiopulmonary, hepatic, and renal function.\n* Participants who are not pregnant or breastfeeding and who agree to use effective contraception for 12 months after drug infusion, if applicable.\n* Diagnosis of systemic lupus erythematosus (SLE) according to the 2019 EULAR\u002FACR classification criteria, with a history of SLE for at least 6 months; during screening, participants must have positive antinuclear antibody (ANA), and\u002For positive anti-double-stranded DNA antibody, and\u002For hypocomplementemia.\n* Diagnosis of systemic sclerosis (SSc) according to the 2013 ACR\u002FEULAR classification criteria, including limited cutaneous or diffuse cutaneous systemic sclerosis, with new or progressive skin manifestations within 6 months before screening.\n\nExclusion Criteria:\n\n* Positive hepatitis B surface antigen (HBsAg), or positive hepatitis B core antibody (HBcAb) with detectable or quantifiable HBV DNA; positive hepatitis C antibody with detectable or quantifiable HCV RNA; positive HIV antibody; positive CMV DNA; or positive syphilis antigen or antibody.\n* Presence of any other uncontrolled active infection.\n* History of major solid organ transplantation (for example, heart, lung, liver, or kidney transplantation) or bone marrow\u002Fhematopoietic stem cell transplantation.\n* Pregnant or breastfeeding women.\n* Receipt of any mRNA-LNP product or other LNP-based drug within the past 2 years.\n* History, within 6 months before screening, of any of the following cardiovascular conditions: NYHA Class III or IV heart failure, myocardial infarction, unstable angina, uncontrolled or symptomatic atrial arrhythmia, ventricular arrhythmia, or other clinically significant cardiac disease.\n* Receipt of a live vaccine within 30 days before screening.\n* History of asthma or severe allergy, if considered clinically significant by the investigator.\n* Any condition that, in the investigator's opinion, would increase risk to the participant or interfere with study assessments.",{"count":80,"type":21},12,[24],"This is an open-label, single-arm study designed to evaluate the safety and preliminary efficacy of HN2302 in patients with autoimmune diseases, including systemic lupus erythematosus (SLE) and systemic sclerosis (SSc).",[84,58,85],"Autoimmune Disease","Systemic Sclerosis (SSc)",[87,88],"SLE","SSc","2026-04-09",{"date":91,"type":35},"2026-04-14",{"date":65,"type":21},{"date":69,"type":21},{"name":41,"class":42},""]