Condition: Lupus Nephritis (LN) · Systemic Lupus Erythematosus (SLE) · Sponsor: AbelZeta Inc.
This Phase 2, multicenter, open-label study will evaluate the safety and efficacy of a single infusion of autologous anti-CD20/BCMA chimeric antigen receptor T cells (C-CAR168) following lymphodepleting chemotherapy in participants with refractory lupus nephritis who are not responding to standard therapy. Approximately 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/pharmacodynamics, and biomarkers. Long-term safety follow-up for gene therapy-related events will continue for up to 15 years following CAR T-cell infusion.
This description comes directly from the study's public registry record.
Kirstin Liechty · 240-552-5870 · kirstin.liechty@abelzeta.com
Nurat Quadri · 240-552-5870 · clinicaltrials@abelzeta.com
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Source record: clinicaltrials.gov/study/NCT07729826