Study of Second-generation CD19BCMA CAR NK Cells for Treating Childrens B Cell-related Autoimmune Diseases

What this Trial Is About

Researchers are evaluating the safety and effectiveness of second-generation anti-CD19BCMA CAR-NK cell injections for treating children with B cell-related autoimmune diseases. This early-phase clinical trial focuses on pediatric patients and aims to better understand how these engineered immune cells perform in managing conditions such as systemic lupus erythematosus SLE, steroid-resistant nephrotic syndrome, IgA nephropathy, systemic sclerosis, and ANCA-associated vasculitis. Participants will receive a treatment regimen starting with lymphodepletion using fludarabine and cyclophosphamide, followed by infusion of the anti-CD19BCMA CAR NK cells. The study follows a dose-escalation and expansion design to carefully assess safety and response. All participants undergo the same treatment process without placebo comparison. Throughout the study, participants will be closely monitored for adverse effects and treatment response using measures like dose-limiting toxicity, treatment-emergent adverse events, response rates, and CRISS scores over one to six months. Researchers will evaluate cardiac, liver, kidney, and lung function before and during treatment. The total study duration allows for detailed safety and efficacy assessments under medical supervision.

Exploratory Clinical Study of Second-generation CD19/BCMA Chimeric Antigen Receptor NK Cell Injection in Treating Paediatric B Cell-related Autoimmune Diseases