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.
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.
Active uncontrolled infection
Active hepatitis B, hepatitis C, or HIV infection
Active tuberculosis
Pregnancy or breastfeeding
Single group
C-CAR168
DrugAutologous anti-CD20/BCMA chimeric antigen receptor T-cell therapy administered as a single intravenous infusion at a target dose of 1 × 10\^6 CAR-positive T cells/kg (maximum dose 100 × 10\^6 CAR-positive T cells).
Complete Renal Response (CRR)
Proportion of participants achieving Complete Renal Response according to protocol-defined criteria.
Incidence and severity of adverse events (AEs)
Evaluate the incidence, severity, and relationship of adverse events following C-CAR168 infusion, graded according to NCI CTCAE Version 6.0.
incidence of serious adverse events (SAEs)
Evaluate the incidence of serious adverse events following treatment.
Incidence and severity of cytokine release syndrome (CRS)
Assess CRS according to American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading criteria.
Incidence and severity of immune effector cell-associated neurotoxicity syndrome (ICANS)
Assess ICANS according to ASTCT consensus grading criteria.
Exploratory Biomarker Assessments
Evaluate exploratory biomarkers associated with treatment with C-CAR168 and their relationship to efficacy and safety. Biomarkers include C-CAR168-related and disease-related markers in blood, urine, and optional tissue specimens, including immune cell populations, gene expression, cytokines, and urinary biomarkers.
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