[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100568446":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":17,"centralContacts":18,"locations":17,"responsibleParty":24,"collaborators":26,"id":30,"slug":31,"hasResults":32,"nctId":33,"briefTitle":34,"officialTitle":35,"acronym":17,"eligibilityCriteria":36,"healthyVolunteers":32,"sex":37,"minAge":38,"maxAge":39,"enrollmentInfo":40,"targetDuration":17,"studyType":43,"phases":44,"briefSummary":46,"conditions":47,"keywords":17,"overallStatus":49,"whyStopped":17,"lastUpdateSubmitDate":50,"lastUpdatePostDateStruct":51,"startDateStruct":54,"completionDateStruct":56,"leadSponsor":58,"locationsCount":17},{"fullName":5,"class":6},"Bioray Laboratories","INDUSTRY",[8],{"label":9,"type":10,"description":9,"interventionNames":11},"BCMA CART + CD19 CART","EXPERIMENTAL",[12],"Biological: BCMA CART + CD19 CART",[14],{"type":15,"name":9,"description":9,"armGroupLabels":16,"otherNames":17},"BIOLOGICAL",[9],null,[19],{"name":20,"role":21,"phone":22,"phoneExt":17,"email":23},"Dandan Wang, PhD","CONTACT","15850515316","dangdangwang2007@163.com",{"type":25,"investigatorFullName":17,"investigatorTitle":17,"investigatorAffiliation":17,"oldNameTitle":17,"oldOrganization":17},"SPONSOR",[27],{"name":28,"class":29},"The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School","OTHER","100568446","early-phase-1-universal-car-t-cell-therapy-for-refractory-lupus-nephritis-100568446",false,"NCT06681337","Universal CAR-T Cell Therapy for Refractory Lupus Nephritis","A Clinical Study of the Safety and Efficacy of Universal CAR-T Cells Targeting BCMA and CD19 for the Treatment of Refractory Lupus Nephritis","Inclusion Criteria:\n\n* Aged 18-65 years; both genders eligible.\n* Subjects diagnosed with lupus nephritis.\n* Previous treatment outcomes were unsatisfactory.\n* Diagnosis of active nephritis type III or IV with or without type V according to 2018 International Society of Nephrology and Society of Renal Pathology (ISN\u002FRPS) criteria.\n* NIH Activity Index \\> 2 and elevated chronicity index.\n* Urine protein: creatinine ratio (UPCR) ≥ 1.0 g\u002Fg, or 24-hour urine protein ≥ 1.0 g, with or without active urine sediment with red blood cell casts.\n* Receiving hormones with or without antimalarials.\n* SLEDAI-2K score ≥ 6.\n* Antinuclear antibody positive, and\u002For anti-ds-DNA antibody positive, and\u002For anti-Smith antibody positive.\n* Positive expression of CD19 on B cells in peripheral blood.\n* Agrees to use double barrier methods, condoms, oral or injectable contraceptives, or intrauterine devices during the study period and for one year after taking the study medication.\n* Provides written informed consent.\n\nExclusion Criteria:\n\n* History of solid organ transplantation.\n* Malignant tumor within the last two years.\n* Positive for Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb), with peripheral blood Hepatitis B virus (HBV) DNA detected as positive; positive for Hepatitis C virus antibodies, with peripheral blood Hepatitis C virus RNA detected as positive; positive for Human Immunodeficiency Virus (HIV) antibodies; positive for Cytomegalovirus (CMV) DNA; positive for syphilis.\n* Primary immunodeficiency (congenital or acquired).\n* Severe cardiac disease.\n* History of psychiatric disorders or history of psychotropic drug abuse, with no history of withdrawal.\n* Allergic constitution or a history of severe allergies.\n* Pregnant or breastfeeding women.","ALL","18 Years","65 Years",{"count":41,"type":42},10,"ESTIMATED","INTERVENTIONAL",[45],"EARLY_PHASE1","This investigator-initiated trial aims to assess the efficacy and safety of combination therapy using universal CAR-T cells targeting BCMA and CD19 in refractory lupus nephritis.",[48],"Lupus Nephritis","NOT_YET_RECRUITING","2024-11-07",{"date":52,"type":53},"2024-11-08","ACTUAL",{"date":55,"type":42},"2024-11-25",{"date":57,"type":42},"2025-12",{"name":5,"class":6}]