C-CAR168 CAR T-Cell Therapy for the Treatment of Lupus Nephritis Refractory to Standard Therapy

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.

Inclusion Criteria: * Able to provide informed consent or assent where applicable. * Male or female aged 14-70 years, weighing at least 40 kg. * Diagnosis of systemic lupus erythematosus according to the 2019 EULAR/ACR classification criteria. * Biopsy-confirmed ISN/RPS Class III or IV lupus nephritis, with or without Class V, within 6 months before screening. * Proteinuria meeting protocol-defined thresholds. * Refractory to standard therapy. * Meets corticosteroid taper requirements. * Positive ANA and/or anti-dsDNA and/or anti-Smith antibody. * Meets all protocol eligibility requirements. Exclusion Criteria: * Active uncontrolled infection * Active hepatitis B, hepatitis C, or HIV infection * Active tuberculosis * Pregnancy or breastfeeding * Prior gene therapy or CAR T-cell therapy * Active malignancy * Severe cardiovascular disease * Significant pulmonary disease * CNS disease precluding participation * Any condition that would interfere with study participation or safety