[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633176":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":27,"locations":37,"responsibleParty":49,"collaborators":51,"id":54,"slug":31,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":55,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":31,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":75,"overallStatus":78,"whyStopped":31,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Shenzhen MagicRNA Biotechnology Co., Ltd","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"HN2302 treatment group","EXPERIMENTAL","Participants will receive HN2302 Injection at the specified dose level and on the specified study days.",[13],"Drug: HN2302 Injection",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","HN2302 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],{"name":24,"affiliation":25,"role":26},"Zhu Chen","The First Affiliated Hospital of University of Science and Technology of China","PRINCIPAL_INVESTIGATOR",[28,33],{"name":24,"role":29,"phone":30,"phoneExt":31,"email":32},"CONTACT","+86055162284920",null,"doczchen@ustc.edu.cn",{"name":34,"role":29,"phone":35,"phoneExt":31,"email":36},"Zexiu Xiao","+86075527109036","xiaozexiu@magicrna.com",[38],{"facility":25,"status":31,"city":39,"state":40,"zip":41,"country":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":31},"Hefei","Anhui","230036","China",{"type":44,"coordinates":45},"Point",[46,47],117.28083,31.86389,{"lat":47,"lon":46},{"type":50,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR",[52],{"name":25,"class":53},"OTHER","100633176",false,"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.","ALL","18 Years","69 Years",{"count":65,"type":66},12,"ESTIMATED","INTERVENTIONAL",[69],"PHASE1","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).",[72,73,74],"Autoimmune Disease","Systemic Lupus Erythematosus","Systemic Sclerosis (SSc)",[76,77],"SLE","SSc","NOT_YET_RECRUITING","2026-04-09",{"date":81,"type":82},"2026-04-14","ACTUAL",{"date":84,"type":66},"2026-04-28",{"date":86,"type":66},"2028-06-30",{"name":5,"class":6},1]