C-CAR168 CAR T Cell Therapy for Refractory Autoimmune Disease (NCT06935474) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
C-CAR168 CAR T Cell Therapy for Refractory Autoimmune Disease
United States24 participantsStarted 2026-07
Plain-language summary
This multi-center, open-label, Phase 1/2 study aims to evaluate the safety, tolerability, and preliminary efficacy of C-CAR168, an autologous anti-CD20/BCMA CAR-T therapy, in patients with autoimmune diseases refractory to standard treatments. The study includes both dose escalation and dose expansion phases, with participants grouped into condition-specific cohorts.
The purpose of this study is to:
1. Test the safety and ability for subjects with autoimmune refractory to standard treatment to tolerate the C-CAR168.
2. Determine the recommended Phase 2 dose of C-CAR168 in subjects with autoimmune disease refractory to standard treatment.
Participants will be asked to:
* Undergo screening to determine eligibility based on entry criteria.
* Taper steroid use before leukapheresis.
* Undergo leukapheresis for the manufacturing of C-CAR168.
* Temporarily discontinue immunosuppressive therapy at least 7 days prior to leukapheresis.
* Receive bridging therapy (steroids) if necessary to maintain disease stability during C-CAR168 manufacturing.
* Undergo lymphodepletion therapy with fludarabine and cyclophosphamide.
* Receive a single intravenous infusion of C-CAR168 at the assigned dose level on Day 0.
* Attend regular safety and efficacy assessments for up to 24 months post-infusion.
* Undergo dose-limiting toxicity evaluation during the first 28 days post-infusion (for those in the dose escalation phase).
* Follow withdrawal procedures if necessary, including a discharge visit within 14 days if their condition deteriorates, unacceptable toxicity occurs, they no longer meet criteria, or they choose to withdraw.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Informed Consent: Voluntary signed consent required.
✓. Age \& Gender: Males and females, 18-70 years old.
✓. Diagnosis: Clinical diagnosis of SLE per EULAR/ACR criteria for at least 6 months.
✓. Lupus Nephritis (LN): Biopsy-confirmed active proliferative LN (Class III/IV ± V) within the past 12 months.
✓. Refractory Disease:
✓. Disease Activity at Screening:
✓. Autoantibody Status:
✓. Infection Status: No active infection within 2 weeks before leukapheresis.
Exclusion criteria
✕. Any other concomitant diseases requiring long term systemic steroids (oral or intravenously) treatment that may confound the interpretation of study results or have interference with background steroid tapering for the subjects.
✕
What they're measuring
1
Incidence of Adverse Events or Dose Limiting Toxicities
✕. History of major organ transplantation (such as heart, lung, liver, kidney) or history of bone marrow/hematopoietic stem cell transplantation.
✕. History of any of stroke, unstable angina, myocardial infarction, congestive heart failure (NYHA Class III or IV), severe cardiomyopathy or ventricular arrhythmia requiring medication or mechanical control within 6 months of screening.
✕. History of ≥ Grade 2 bleeding within the past 30 days.
✕. Received a live vaccine within 4 weeks prior to signing the ICF.