Study of Anti-CD19BCMA CAR-NK Cell Therapy for Children Aged 3 and Older With B Cell Autoimmune Diseases

What this Trial Is About

Researchers are evaluating the safety and effectiveness of anti-CD19BCMA CAR-NK cells in patients with B cell mediated autoimmune diseases, including systemic lupus erythematosus SLE, multi-drug resistant nephrotic syndrome MDR-SRNS, and immunoglobulin A nephropathy IgAN. These autoimmune conditions cause the immune system to attack the bodys own tissues, leading to serious organ damage, especially in children with SLE who face severe disease progression. The study addresses the urgent need for new treatments as current therapies often fail to achieve remission or prevent kidney failure in these patients. Participants will receive a combination treatment starting with fludarabine and cyclophosphamide to prepare the body for the infusion of anti-CD19BCMA CAR-NK cells. The treatment uses a dose-escalation strategy, meaning the doses of the CAR-NK cells will be increased gradually to assess safety and effectiveness. This investigational therapy modifies natural killer cells to target disease-related cells, offering potential advantages over existing CAR T-cell therapies, including fewer severe side effects and lower costs. During the study, participants will be monitored closely with assessments focusing on the safety of the CAR-NK cell therapy within the first month and its effectiveness after three months. Additional follow-up visits will evaluate longer-term effects over six months. Researchers will track organ function, disease activity, and any side effects through laboratory tests and clinical evaluations. The total duration of participation and detailed monitoring plans are designed to ensure thorough evaluation of this new treatment approach.

Anti-CD19/BCMA CAR-NK Cells in Patients With B Cell Mediated Autoimmune Disease