Study to Evaluate the Safety and Preliminary Efficacy of CD19 CAR-T Cell Therapy (TranspoCART19) in Patients With Refractory Lupus Nephritis
Sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz • ClinicalTrials.gov ID: NCT07799116
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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.
Interventions
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TranspoCART19
(Biological)
Autologous CD19-directed CAR-T cell therapy administered following lymphodepleting chemotherapy. After leukapheresis and manufacturing, participants receive TranspoCART19 as a fractionated intravenous infusion (10%, 30%, and 60% of the target dose) at a total target dose of 1 × 10\^6 CAR-T cells/kg body weight. The product is manufactured using Sleeping Beauty transposon technology and consists of genetically modified T lymphocytes expressing an anti-CD19 chimeric antigen receptor.
Eligibility criteria
Conditions
Locations
- Hospital Germans Trias i Pujol — Badalona, Barcelona, Spain
- Hospital Clínico Universitario de Santiago — Santiago de Compostela, Galicia, Spain
- Clinica Universidad de Navarra — Pamplona, Navarre, Spain
- Hospital Universitario de León — León, Spain
- Hospital Universitario Fundación Jiménez Diaz — Madrid, Spain
- Hospital Clínico Universitario Virgen de la Arrixaca — Murcia, Spain
- Hospital Universitario de Salamanca — Salamanca, Spain
- Hospital Universitario Virgen del Rocio — Seville, Spain
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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