[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100576455":3},{"organization":4,"outcomesModule":7,"designInfo":23,"detailedDescription":29,"studyPopulation":22,"armGroups":30,"interventions":37,"overallOfficials":43,"centralContacts":47,"locations":55,"responsibleParty":73,"collaborators":77,"id":81,"slug":22,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":22,"eligibilityCriteria":86,"healthyVolunteers":82,"sex":87,"minAge":88,"maxAge":22,"enrollmentInfo":89,"targetDuration":22,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":97,"overallStatus":58,"whyStopped":22,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Zhejiang University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":22},[9,13],{"measure":10,"description":11,"timeFrame":12},"Dose-limiting toxicity (DLT)","Adverse events assessed according to NCI-CTCAE v5.0 criteria","Up to 28 years after Treatment",{"measure":14,"description":15,"timeFrame":16},"Incidence of treatment-emergent adverse events (TEAEs)","Incidence of treatment-emergent adverse events \\[Safety and Tolerability\\]","Up to 2 years after Treatment",[18],{"measure":19,"description":20,"timeFrame":21},"Urinary protein index","Urinary protein index（24h urinary protein、Urinary protein\u002Fcreatinine ratio）","Up to 24 hours after Treatment",null,{"allocation":24,"interventionModel":25,"interventionModelDescription":22,"primaryPurpose":26,"observationalModel":22,"timePerspective":22,"maskingInfo":27},"NA","SINGLE_GROUP","TREATMENT",{"masking":28,"maskingDescription":22,"whoMasked":22},"NONE","In this study, 9 patients with relapsed refractory Lupus Nephritis were proposed to undergo CD19\u002FBCMA CAR-T Cells therapy. Under the premise that its safety has been clarified in previous studies, further observation and evaluation of the effectiveness of CD19\u002FBCMA CAR-T Cells therapy for relapsed refractory Lupus Nephritis; At the same time, on the basis of expanding the sample size, more safety data on CD19\u002FBCMA CAR-T Cells treatment for relapsed refractory Lupus Nephritis were accumulated.",[31],{"label":32,"type":33,"description":34,"interventionNames":35},"Lupus Nephritis","EXPERIMENTAL","Administration of CD19\u002FBCMA Lupus Nephritis Targeted CAR T-cells",[36],"Biological: CD19\u002FBCMA Lupus Nephritis Targeted CAR T-cells injection",[38],{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":22},"BIOLOGICAL","CD19\u002FBCMA Lupus Nephritis Targeted CAR T-cells injection","Each subject receive CD19\u002FBCMA Lupus Nephritis Targeted CAR T-cells by intravenous infusion",[32],[44],{"name":45,"affiliation":5,"role":46},"He Huang, MD","PRINCIPAL_INVESTIGATOR",[48,52],{"name":45,"role":49,"phone":50,"phoneExt":22,"email":51},"CONTACT","0571-87233772","hehuangyu@126.com",{"name":53,"role":49,"phone":50,"phoneExt":22,"email":54},"Yongxian Hu, MD","huyongxian2000@aliyun.com",[56],{"facility":57,"status":58,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"The first affiliated hospital of medical college of zhejiang university","RECRUITING","Hangzhou","Zhejiang","310003","China","CN",{"type":65,"coordinates":66},"Point",[67,68],120.16142,30.29365,{"lat":68,"lon":67},[71,72],{"name":45,"role":49,"phone":50,"phoneExt":22,"email":51},{"name":53,"role":49,"phone":50,"phoneExt":22,"email":54},{"type":74,"investigatorFullName":75,"investigatorTitle":76,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"SPONSOR_INVESTIGATOR","He Huang","Clinical Professor",[78],{"name":79,"class":80},"Yake Biotechnology Ltd.","INDUSTRY","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":90,"type":91},9,"ESTIMATED","INTERVENTIONAL",[94],"EARLY_PHASE1","A Clinical Study of the Safety and Efficacy of CD19\u002FBCMA CAR-T Cell Therapy for Refractory\u002FRelapsed Lupus Nephritis.",[32],[98],"CD19\u002FBCMA CAR-T","2025-01-20",{"date":101,"type":102},"2025-01-21","ACTUAL",{"date":104,"type":91},"2025-01-31",{"date":106,"type":91},"2027-10-31",{"name":75,"class":6},1]