[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100592965":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":30,"responsibleParty":45,"collaborators":20,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":9,"eligibilityCriteria":54,"healthyVolunteers":50,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":20,"studyType":61,"phases":62,"briefSummary":65,"conditions":66,"keywords":69,"overallStatus":71,"whyStopped":20,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Shanghai Changzheng Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"MSC303","EXPERIMENTAL","MSC303 is an asymmetric trivalent bispecific antibody targeting both CD20 and CD3 (with a ratio of CD20:CD3 at 2:1). By binding to the CD20 antigen on the surface of B cells with one end and the CD3 on the surface of T cells with the other, MSC303 recruits activated T cells around B cells, thereby enhancing the killing effect on B cells.",[13],"Drug: Injection of MSC303",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Injection of MSC303","Dose Group 1: D1, D8, D15, and D36 were respectively given 1, 5, 15, and 15 mg of MSC303 for injection; The second dose group: D1, D8, D15 and D36 were respectively given for injection MSC303 1, 5, 20, 20 mg.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Huji Xu, Ph.D, MD","PRINCIPAL_INVESTIGATOR",[26],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":29},"CONTACT","+862181885516","xuhuji@smmu.edu.cn",[31],{"facility":5,"status":20,"city":32,"state":33,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Shanghai","Shanghai Municipality","200003","China","CN",{"type":38,"coordinates":39},"Point",[40,41],121.45806,31.22222,{"lat":41,"lon":40},[44],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":29},{"type":24,"investigatorFullName":46,"investigatorTitle":47,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Xu huji","Professor and Chief Physician, Head of the Department of Rheumatology and Immunology, Shanghai Changzheng Hospital.","100592965","phase-1-msc303-subcutaneous-injection-for-the-treatment-of-immunologic-glomerular-disease-100592965",false,"NCT07000292","MSC303 Subcutaneous Injection for the Treatment of Immunologic Glomerular Disease.","A Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics and Efficacy of Subcutaneous Injection of MSC303 for the Treatment of Immune Glomerular Diseases","Inclusion Criteria:\n\n1. Aged 18 to 65 years (including boundary values), gender unspecified；\n2. Willing to participate voluntarily in this clinical study and with good compliance；\n3. Regarding the criteria for the study diseases, meet the diagnostic criteria for any of the following diseases:\n\n   1. Diagnosed with lupus nephritis(LN);\n   2. diagnosed with ANCA-associated glomerulonephritis (ANCA-GN);\n4. Sufficient organ function;\n\nExclusion Criteria:\n\n1. History of severe allergic reaction to humanized monoclonal antibodies, or known allergy to any component of MSC303；\n2. Active infection requiring antibiotic treatment；\n3. Concomitant with other serious diseases；\n4. Patients with congenital immunoglobulin deficiency；\n5. Infection with human immunodeficiency virus (Human immunodeficiency virus (HIV)), hepatitis B or hepatitis C (including HBsAg, HBcAb positive with abnormal Hepatitis B Virus DNA (HBV DNA) or Hepatitis C virus RNA (HCV RNA ));\n6. Other exclusion criteria may apply.","ALL","18 Years","65 Years",{"count":59,"type":60},12,"ESTIMATED","INTERVENTIONAL",[63,64],"PHASE1","PHASE2","This study will evaluate the safety and efficacy of MSC303 in patients with Immune glomerular diseases.",[67,68],"Lupus Nephritis (LN)","ANCA-Associated Glomerulonephritis",[9,70],"Immune glomerular diseases","NOT_YET_RECRUITING","2025-06-05",{"date":74,"type":75},"2025-06-11","ACTUAL",{"date":77,"type":60},"2025-06-20",{"date":79,"type":60},"2027-02-20",{"name":5,"class":6},1]