NCT07729826Not yet recruitingPhase 2
C-CAR168, an Autologous Anti-CD20/BCMA Chimeric Antigen Receptor T-Cell Therapy, in Participants With Lupus Nephritis Refractory to Standard Therapy
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
Source: ClinicalTrials.gov · Last updated 13 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 16 Jul 2026
- Start date
- 30 Sept 2026
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- AbelZeta Inc.
- Diseases
- Lupus (SLE)
- NCT number
- NCT07729826
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 50
- From 30 Sept 2026 to the primary completion date, 31 Dec 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior gene therapy or CAR T-cell therapy
Other illness
- Active uncontrolled infection
- Active hepatitis B, hepatitis C, or HIV infection
- Active tuberculosis
- Active malignancy
- Severe cardiovascular disease
- Significant pulmonary disease
- CNS disease precluding participation
- Any condition that would interfere with study participation or safety
Other
- Pregnancy or breastfeeding
Who the study is looking for
- 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.
Age in the registry: 14 years to 70 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.