C-CAR168 CAR T-Cell Therapy for the Treatment of Lupus Nephritis Refractory to Standard Therapy | NCT07729826

NCT07729826

Overview

NCT ID: NCT07729826
Lead Sponsor: AbelZeta Inc.INDUSTRY
Official Title: Multi-center, Phase 2 Clinical Study of an Autologous Anti-CD20/BCMA Chimeric Antigen Receptor T Cell Therapy (C-CAR168) for the Treatment of Lupus Nephritis Refractory to Standard Therapy
Brief Summary: 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.
Conditions

Ages Eligible for Study: Child (0-17)Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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

Central Contacts: Kirstin LiechtyContact
kirstin.liechty@abelzeta.com240-552-5870