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

Starting soon · Phase 2

Conditions studied: Lupus Nephritis (LN), Systemic Lupus Erythematosus (SLE)

In brief

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.

Key facts

Study ID

NCT07729826

Run by

AbelZeta Inc.

People needed

50

Starts

2026-09-30

Expected to finish

2029-09-01

Last updated by the study team

2026-07-28

Who can join

Age: 14 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Full record on ClinicalTrials.gov

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