[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633176":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":27,"locations":37,"responsibleParty":50,"collaborators":52,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":57,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":31,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":77,"overallStatus":80,"whyStopped":31,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"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,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":31},"Hefei","Anhui","230036","China","CN",{"type":45,"coordinates":46},"Point",[47,48],117.28083,31.86389,{"lat":48,"lon":47},{"type":51,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR",[53],{"name":25,"class":54},"OTHER","100633176","phase-1-safety-and-preliminary-efficacy-of-hn2302-in-patients-with-autoimmune-diseases-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":67,"type":68},12,"ESTIMATED","INTERVENTIONAL",[71],"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).",[74,75,76],"Autoimmune Disease","Systemic Lupus Erythematosus","Systemic Sclerosis (SSc)",[78,79],"SLE","SSc","NOT_YET_RECRUITING","2026-04-09",{"date":83,"type":84},"2026-04-14","ACTUAL",{"date":86,"type":68},"2026-04-28",{"date":88,"type":68},"2028-06-30",{"name":5,"class":6},1]