[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100568446":3},{"organization":4,"outcomesModule":7,"designInfo":23,"detailedDescription":30,"studyPopulation":26,"armGroups":31,"interventions":37,"overallOfficials":26,"centralContacts":41,"locations":26,"responsibleParty":47,"collaborators":49,"id":53,"slug":26,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":26,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":26,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":26,"overallStatus":71,"whyStopped":26,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":26},{"fullName":5,"class":6},"Bioray Laboratories","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"AEs","The total number, incidence, and severity of AE","Within 6 months after BCMA CART and CD19 CART infusion",[14],{"measure":15,"description":16,"timeFrame":17},"ORR (CR and PR)","Complete response (CR) was defined as serum creatinine ≤ 1.2 mg\u002Fdl or ≤ 125% of baseline value, and urine protein\u002Fcreatinine ratio \\\u003C 0.5 or 24-hour urine protein quantification \\\u003C 0.5 g, and prednisone dose reduction to ≤ 10 mg\u002Fd (or equivalent dose). Partial response (PR) was defined as if both serum creatinine and urine protein\u002Fcreatinine ratio (or 24-hour urine protein quantification) were abnormal before treatment, both items improved by \\> 30% after treatment, without other indicators of deterioration; if only urine protein\u002Fcreatinine ratio (or 24-hour urine protein quantification) was abnormal before treatment, the improvement was \\> 50% after treatment.","At 6 months after BCMA CART and CD19 CART infusion",[19],{"measure":20,"description":21,"timeFrame":22},"PK\u002FPD","Changes and duration of CAR gene copy number and CAR-T cell number in peripheral blood after BCMA CART and CD19 CART infusion","Within 3 months after BCMA CART and CD19 CART infusion",{"allocation":24,"interventionModel":25,"interventionModelDescription":26,"primaryPurpose":27,"observationalModel":26,"timePerspective":26,"maskingInfo":28},"NA","SINGLE_GROUP",null,"TREATMENT",{"masking":29,"maskingDescription":26,"whoMasked":26},"NONE","This study is a non-randomized, open-label, single-arm clinical trial designed to assess the efficacy and safety of combination therapy for refractory lupus nephritis using universal CAR-T cells targeting BCMA and CD19.",[32],{"label":33,"type":34,"description":33,"interventionNames":35},"BCMA CART + CD19 CART","EXPERIMENTAL",[36],"Biological: BCMA CART + CD19 CART",[38],{"type":39,"name":33,"description":33,"armGroupLabels":40,"otherNames":26},"BIOLOGICAL",[33],[42],{"name":43,"role":44,"phone":45,"phoneExt":26,"email":46},"Dandan Wang, PhD","CONTACT","15850515316","dangdangwang2007@163.com",{"type":48,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[50],{"name":51,"class":52},"The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School","OTHER","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":63,"type":64},10,"ESTIMATED","INTERVENTIONAL",[67],"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.",[70],"Lupus Nephritis","NOT_YET_RECRUITING","2024-11-07",{"date":74,"type":75},"2024-11-08","ACTUAL",{"date":77,"type":64},"2024-11-25",{"date":79,"type":64},"2025-12",{"name":5,"class":6}]