C-CAR168 CAR T-Cell Therapy for the Treatment of Lupus Nephritis Refractory to Standard Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: C-CAR168.
- Who it may be relevant to
- Registry conditions: Lupus Nephritis (LN), Systemic Lupus Erythematosus (SLE). Basic parameters: 14 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Detailed description
This is a global, multicenter, single-arm, open-label Phase 2 study evaluating C-CAR168, an autologous dual-targeted anti-CD20/BCMA CAR T-cell therapy, in participants with biopsy-confirmed refractory lupus nephritis who are not responding to standard therapy.
Participants will undergo screening, leukapheresis, manufacture of autologous C-CAR168, lymphodepleting chemotherapy consisting of fludarabine and cyclophosphamide, followed by a single intravenous infusion of C-CAR168.
The study begins with a safety run-in involving the first five participants. Following review by the Safety Monitoring Committee (SMC), enrollment of the remaining participants may proceed if predefined safety criteria are met.
Participants will be followed for 104 weeks after infusion for evaluation of efficacy, safety, pharmacokinetics, pharmacodynamics, immunologic biomarkers, and patient-reported outcomes. Participants will subsequently be invited to enroll in a separate long-term follow-up study for continued safety monitoring consistent with FDA recommendations for gene-modified cellular therapies.
Interventions
- Drug C-CAR168
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).
Primary outcome measures
- Complete Renal Response (CRR) [Time frame: Week 65 (Month 15)]
Secondary outcome measures (12)
- Incidence and severity of adverse events (AEs) [Time frame: Through Week 104 (Month 24)]
- incidence of serious adverse events (SAEs) [Time frame: Through Week 104 (Month 24)]
- Incidence and severity of cytokine release syndrome (CRS) [Time frame: Through Week 104 (Month 24)]
- Incidence and severity of immune effector cell-associated neurotoxicity syndrome (ICANS) [Time frame: Through Week 104 (Month 24)]
- Duration of Complete Renal Response (CRR) [Time frame: Through Week 104 (Month 24)]
- Partial Renal Response (PRR) [Time frame: Through Week 104 (Month 24)]
- Primary Efficacy Renal Response (PERR) [Time frame: Through Week 104 (Month 24)]
- Reduction in proteinuria [Time frame: Through Week 104 (Month 24)]
- Time to renal response [Time frame: Through Week 104 (Month 24)]
- Pharmacokinetics of C-CAR168 measuring quantitative polymerase chain reaction (qPCR) [Time frame: Through Week 104 (Month 24)]
- Pharmacokinetics of C-CAR168 utilizing flow cytometry [Time frame: Through Week 104 (Month 24)]
- Change in patient-reported outcomes (PROs) [Time frame: Through Week 104 (Month 24)]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07729826 · ABZT-421 · IND 30283 · C-CAR168