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

NCT07729826 | Not Yet Recruiting Phase 2 FDA Drug

• 3 other identifiers: ABZT-421IND 30283C-CAR168
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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

Lupus Nephritis (LN); Systemic Lupus Erythematosus (SLE)

Keywords

Lupus Nephritis; Systemic Lupus Erythematosus; CAR T; CAR-T Cell Therapy; CD20; BCMA; Autoimmune Disease; Cell Therapy

Outcome Measures

Primary Outcomes (1)

• Complete Renal Response (CRR)

  Proportion of participants achieving Complete Renal Response according to protocol-defined criteria.

  Week 65 (Month 15)

Secondary Outcomes (17)

• Incidence and severity of adverse events (AEs)

  Through Week 104 (Month 24)

• incidence of serious adverse events (SAEs)

  Through Week 104 (Month 24)

• Incidence and severity of cytokine release syndrome (CRS)

  Through Week 104 (Month 24)

• Incidence and severity of immune effector cell-associated neurotoxicity syndrome (ICANS)

  Through Week 104 (Month 24)

• Duration of Complete Renal Response (CRR)

  Through Week 104 (Month 24)

Other Outcomes (1)

• Exploratory Biomarker Assessments

  Through Week 104 (Month 24)

Study Arms (1)

C-CAR168

EXPERIMENTAL

Participants will receive: * Leukapheresis * Fludarabine * Cyclophosphamide * Single intravenous infusion of C-CAR168

Drug: C-CAR168

Interventions

C-CAR168 DRUG

Autologous 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).

C-CAR168

Eligibility Criteria

• Age: 14 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• AbelZeta Inc.: lead

Related Links

• AbelZeta Presents New Data on C-CAR168 for the Treatment of Autoimmune Diseases at LUPUS 2025

MeSH Terms

Conditions

Lupus Nephritis; Lupus Erythematosus, Systemic; Autoimmune Diseases

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Immune System Diseases

Study Officials

• Scott Antonia, MD, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kirstin Liechty

CONTACT

240-552-5870; kirstin.liechty@abelzeta.com

Nurat Quadri

CONTACT

240-552-5870; clinicaltrials@abelzeta.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All enrolled participants receive lymphodepleting chemotherapy followed by a single infusion of C-CAR168.

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: July 28, 2026
• Study Start (Estimated): September 30, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): September 1, 2029
• Last Updated: July 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share