[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100600965":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":23,"locations":29,"responsibleParty":47,"collaborators":11,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":11,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":11,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":11,"overallStatus":68,"whyStopped":11,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"Second Xiangya Hospital of Central South University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"CM355","EXPERIMENTAL",null,[13],"Biological: CM355",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":11},"BIOLOGICAL","CM355 injection",[9],[20],{"name":21,"affiliation":5,"role":22},"Hai Long","PRINCIPAL_INVESTIGATOR",[24],{"name":25,"role":26,"phone":27,"phoneExt":11,"email":28},"Qianjin Lu","CONTACT","+86 13787097676","qianlu5860@pumcderm.cams.cn",[30],{"facility":5,"status":11,"city":31,"state":32,"zip":11,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Changsha","Hunan","China","CN",{"type":36,"coordinates":37},"Point",[38,39],112.97087,28.19874,{"lat":39,"lon":38},[42,43,44,45],{"name":25,"role":26,"phone":27,"phoneExt":11,"email":28},{"name":25,"role":22,"phone":11,"phoneExt":11,"email":11},{"name":21,"role":22,"phone":11,"phoneExt":11,"email":11},{"name":46,"role":22,"phone":11,"phoneExt":11,"email":11},"Fen Li",{"type":48,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100600965","study-of-cm355-in-patients-with-systemic-lupus-erythematosus-100600965",false,"NCT07104344","Study of CM355 in Patients With Systemic Lupus Erythematosus","A Single-center, Open-label, Single-arm Clinical Study to Observe the Safety and Efficacy of CM355 in the Treatment of Refractory Systemic Lupus Erythematosus","Inclusion Criteria:\n\n* Ability to understand the nature of the study and voluntarily sign the informed consent form (ICF);\n* Age ≥ 18 to ≤ 65 years old, male or female;\n* At screening, patients must meet the 2019 European League Against Rheumatism (EULAR)\u002F American college of Rheumatology (ACR)classification criteria for systemic lupus erythematosus (SLE) as assessed by a qualified doctor, and have a disease course of ≥ 12 months；\n* systemic lupus erythematosus disease activity index2000 (SLEDAI-2K)≥8 points at screening. If there is a low complement and\u002For anti-ds-DNA antibody score, the SLEDAI-2K) clinical symptoms (excluding low complement and\u002For anti-ds-DNA antibody) score ≥ 6 points or ≥ 1 organ system in BILAG score should be Class A at screening；\n* Definition of refractory SLE;\n* The treatment regimen for SLE was stable for more than 4 weeks before the first dose.\n\nExclusion Criteria:\n\n* Renal disease: patients with severe lupus nephritis;\n* Patients with central nervous system diseases;\n* Patients who have received monoclonal antibodies targeting Cluster of Differentiation 19(CD19) or Cluster of Differentiation 20(CD20) or other B-cell depleting agents within 6months prior to the first dose ;\n* Any other condition assessed by investigator as unsuitable for participation in the study.","ALL","18 Years","64 Years",{"count":60,"type":61},5,"ESTIMATED","INTERVENTIONAL",[64],"NA","This study was designed to investigate the safety and efficacy of CM355 in patients with refractory SLE.",[67],"Systemic Lupus Erythematosus","NOT_YET_RECRUITING","2025-07-29",{"date":71,"type":72},"2025-08-05","ACTUAL",{"date":74,"type":61},"2025-09-25",{"date":76,"type":61},"2026-10",{"name":5,"class":6},1]