[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100576455":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":33,"responsibleParty":51,"collaborators":55,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":20,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":20,"enrollmentInfo":68,"targetDuration":20,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":76,"overallStatus":36,"whyStopped":20,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Zhejiang University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Lupus Nephritis","EXPERIMENTAL","Administration of CD19\u002FBCMA Lupus Nephritis Targeted CAR T-cells",[13],"Biological: CD19\u002FBCMA Lupus Nephritis Targeted CAR T-cells injection",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","CD19\u002FBCMA Lupus Nephritis Targeted CAR T-cells injection","Each subject receive CD19\u002FBCMA Lupus Nephritis Targeted CAR T-cells by intravenous infusion",[9],null,[22],{"name":23,"affiliation":5,"role":24},"He Huang, MD","PRINCIPAL_INVESTIGATOR",[26,30],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":29},"CONTACT","0571-87233772","hehuangyu@126.com",{"name":31,"role":27,"phone":28,"phoneExt":20,"email":32},"Yongxian Hu, MD","huyongxian2000@aliyun.com",[34],{"facility":35,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"The first affiliated hospital of medical college of zhejiang university","RECRUITING","Hangzhou","Zhejiang","310003","China","CN",{"type":43,"coordinates":44},"Point",[45,46],120.16142,30.29365,{"lat":46,"lon":45},[49,50],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":29},{"name":31,"role":27,"phone":28,"phoneExt":20,"email":32},{"type":52,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"SPONSOR_INVESTIGATOR","He Huang","Clinical Professor",[56],{"name":57,"class":58},"Yake Biotechnology Ltd.","INDUSTRY","100576455","early-phase-1-cd19bcma-car-t-cell-therapy-for-refractoryrelapsed-lupus-nephritis-100576455",false,"NCT06785519","CD19\u002FBCMA CAR-T Cell Therapy for Refractory\u002FRelapsed Lupus Nephritis","A Clinical Study of the Safety and Efficacy of CD19\u002FBCMA CAR-T Cell Therapy for Refractory\u002FRelapsed Lupus Nephritis","Inclusion Criteria:\n\n* 1\\. Age ≥18 years old;\n* 2\\. A clinical diagnosis of systemic lupus erythematosus (SLE) according to the 2019 American College of Rheumatology (ACR) and European Federation of Rheumatology Societies (EULAR) \u002FACR classification criteria. Grade III, IV, or V lupus nephritis was confirmed by biopsy according to the 2003 ISN\u002FRPS standard.\n* 3\\. SLEDAI-2K ≥8 during screening\n* 4\\. failure to respond to two or more standard immunosuppressive therapies, or relapse (increased disease activity index and need to adjust drug dose or type);\n* 5\\. Expected survival \\>12 weeks;\n* 6\\. Fertile women and men agree to use appropriate contraceptive methods before entering the study, during study participation, and for 6 months after transfusion (the safety of this therapy for the unborn child is not known);\n* 7\\. Volunteer to participate in this experiment and sign the informed consent.\n\nExclusion Criteria:\n\n* 1\\. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases;\n* 2\\. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;\n* 3\\. Active infected persons who are not cured:\n* 4\\. Active hepatitis B or C virus infection;\n* 5\\. Patients who have taken more than 20mg\u002Fd of prednisone or equivalent systemic steroid drugs within 1 week prior to treatment (except those who have recently or currently taken inhaled steroids);\n* 6\\. Have used any gene therapy products before;\n* 7\\. Insufficient amplification ability (\\\u003C5 times) in response to CD3 \u002F CD28 costimulation signals;\n* 8\\. ALT\u002FAST\\>3 times the normal amount or bilirubin \\>2.0 mg\u002Fdl;\n* 9\\. Those who have other uncontrolled diseases that the researcher deems unsuitable for enrollment;\n* 10\\. HIV-infected people;\n* 11\\. Any situation that the investigator believes may increase the risk to the subject or interfere with the test results.","ALL","18 Years",{"count":69,"type":70},9,"ESTIMATED","INTERVENTIONAL",[73],"EARLY_PHASE1","A Clinical Study of the Safety and Efficacy of CD19\u002FBCMA CAR-T Cell Therapy for Refractory\u002FRelapsed Lupus Nephritis.",[9],[77],"CD19\u002FBCMA CAR-T","2025-01-20",{"date":80,"type":81},"2025-01-21","ACTUAL",{"date":83,"type":70},"2025-01-31",{"date":85,"type":70},"2027-10-31",{"name":53,"class":6},1]