[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"AbelZeta Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":50},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":4},"100649219","phase-2-c-car168-car-t-cell-therapy-for-the-treatment-of-lupus-nephritis-refractory-to-standard-therapy-100649219",false,"NCT07729826","C-CAR168 CAR T-Cell Therapy for the Treatment of Lupus Nephritis Refractory to Standard Therapy","Multi-center, Phase 2 Clinical Study of an Autologous Anti-CD20\u002FBCMA Chimeric Antigen Receptor T Cell Therapy (C-CAR168) for the Treatment of Lupus Nephritis Refractory to Standard Therapy","Inclusion Criteria:\n\n* Able to provide informed consent or assent where applicable.\n* Male or female aged 14-70 years, weighing at least 40 kg.\n* Diagnosis of systemic lupus erythematosus according to the 2019 EULAR\u002FACR classification criteria.\n* Biopsy-confirmed ISN\u002FRPS Class III or IV lupus nephritis, with or without Class V, within 6 months before screening.\n* Proteinuria meeting protocol-defined thresholds.\n* Refractory to standard therapy.\n* Meets corticosteroid taper requirements.\n* Positive ANA and\u002For anti-dsDNA and\u002For anti-Smith antibody.\n* Meets all protocol eligibility requirements.\n\nExclusion Criteria:\n\n* Active uncontrolled infection\n* Active hepatitis B, hepatitis C, or HIV infection\n* Active tuberculosis\n* Pregnancy or breastfeeding\n* Prior gene therapy or CAR T-cell therapy\n* Active malignancy\n* Severe cardiovascular disease\n* Significant pulmonary disease\n* CNS disease precluding participation\n* Any condition that would interfere with study participation or safety","ALL","14 Years","70 Years",{"count":20,"type":21},50,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This Phase 2, multicenter, open-label study will evaluate the safety and efficacy of a single infusion of autologous anti-CD20\u002FBCMA chimeric antigen receptor T cells (C-CAR168) following lymphodepleting chemotherapy in participants with refractory lupus nephritis who are not responding to standard therapy.\n\nApproximately 50 participants will undergo leukapheresis, lymphodepletion with fludarabine and cyclophosphamide, and infusion of C-CAR168. Participants will be followed for 104 weeks (approximately 2 years) to evaluate renal response, safety, CAR T-cell persistence, pharmacokinetics\u002Fpharmacodynamics, and biomarkers. Long-term safety follow-up for gene therapy-related events will continue for up to 15 years following CAR T-cell infusion.",[27,28],"Lupus Nephritis (LN)","Systemic Lupus Erythematosus (SLE)",[30,31,32,33,34,35,36,37],"Lupus Nephritis","Systemic Lupus Erythematosus","CAR T","CAR-T Cell Therapy","CD20","BCMA","Autoimmune Disease","Cell Therapy","NOT_YET_RECRUITING","2026-07-22",{"date":41,"type":42},"2026-07-28","ACTUAL",{"date":44,"type":21},"2026-09-30",{"date":46,"type":21},"2029-09-01",{"name":48,"class":49},"AbelZeta Inc.","INDUSTRY",""]