[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649219":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":19,"responsibleParty":34,"collaborators":19,"id":36,"slug":37,"hasResults":38,"nctId":39,"briefTitle":40,"officialTitle":41,"acronym":19,"eligibilityCriteria":42,"healthyVolunteers":38,"sex":43,"minAge":44,"maxAge":45,"enrollmentInfo":46,"targetDuration":19,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":56,"overallStatus":65,"whyStopped":19,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":19},{"fullName":5,"class":6},"AbelZeta Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"C-CAR168","EXPERIMENTAL","Participants will receive:\n\n* Leukapheresis\n* Fludarabine\n* Cyclophosphamide\n* Single intravenous infusion of C-CAR168",[13],"Drug: C-CAR168",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Autologous anti-CD20\u002FBCMA chimeric antigen receptor T-cell therapy administered as a single intravenous infusion at a target dose of 1 × 10\\^6 CAR-positive T cells\u002Fkg (maximum dose 100 × 10\\^6 CAR-positive T cells).",[9],null,[21],{"name":22,"affiliation":23,"role":24},"Scott Antonia, MD, PhD","Duke University","PRINCIPAL_INVESTIGATOR",[26,31],{"name":27,"role":28,"phone":29,"phoneExt":19,"email":30},"Kirstin Liechty","CONTACT","240-552-5870","kirstin.liechty@abelzeta.com",{"name":32,"role":28,"phone":29,"phoneExt":19,"email":33},"Nurat Quadri","clinicaltrials@abelzeta.com",{"type":35,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","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":47,"type":48},50,"ESTIMATED","INTERVENTIONAL",[51],"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.",[54,55],"Lupus Nephritis (LN)","Systemic Lupus Erythematosus (SLE)",[57,58,59,60,61,62,63,64],"Lupus Nephritis","Systemic Lupus Erythematosus","CAR T","CAR-T Cell Therapy","CD20","BCMA","Autoimmune Disease","Cell Therapy","NOT_YET_RECRUITING","2026-07-22",{"date":68,"type":69},"2026-07-28","ACTUAL",{"date":71,"type":48},"2026-09-30",{"date":73,"type":48},"2029-09-01",{"name":5,"class":6}]