Study to Evaluate the Safety and Preliminary Efficacy of CD19 CAR-T Cell Therapy (TranspoCART19) in Patients With Refractory Lupus Nephritis

Study acronym: CART-NEL
StatusRecruiting
PhasePhase 1/2
Started

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Record History

  1. Recruitment opened
    • Start date changed from estimate of Sep 2026 to Sep 23, 2026
    • Site details revised at 8 of 8 sites
  2. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
The goal of this clinical trial is to evaluate the safety and preliminary efficacy of CD19 CAR-T cell therapy (TranspoCART19) in adults with refractory lupus nephritis. Lupus nephritis is a serious kidney complication of systemic lupus erythematosus that may not respond adequately to standard treatments. The main questions this study aims to answer are: * Is TranspoCART19 safe and tolerable in patients with refractory lupus nephritis? * Can TranspoCART19 induce complete or partial clinical and immunological remission? Participants will: * Undergo leukapheresis to collect immune cells for manufacturing TranspoCART19. * Receive lymphodepleting chemotherapy before treatment. * Receive a single fractionated infusion of TranspoCART19. * Attend regular follow-up visits for safety, disease activity, kidney function, immune response, and quality-of-life assessments for up to 24 months, with long-term safety follow-up after study completion.
Trial Details
NCT Number NCT07799116
Lead Sponsor Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Conditions
(from sponsor)		 Lupus Nephritis, Lupus Nephritis (LN)
Related terms Autoimmune Diseases, Lupus Erythematosus, Systemic, Lupus Nephritis
Enrollment 10 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov