Study of Universal Allogeneic CAR T-Cell Therapy Targeting CD19 and BCMA for Adults with Relapsed or Refractory Neurological Autoimmune Diseases

What this Trial Is About

Researchers are evaluating the safety and initial effectiveness of universal CD19BCMA CAR T-cell therapy in adults with relapsed or refractory neurological autoimmune diseases. These diseases include neuromyelitis optica spectrum disorders, myasthenia gravis, multiple sclerosis, autoimmune encephalitis, and chronic inflammatory demyelinating polyradiculoneuropathy. The study is an early phase 1, open-label trial conducted at a single site, focusing on patients whose disease has not responded to previous treatments. The treatment involves a single intravenous infusion of universal CAR T-cells targeting CD19 and BCMA after patients receive a lymphodepleting regimen with fludarabine and cyclophosphamide. The study plans to enroll up to 12 participants and will perform an interim analysis 90 days after the CAR T-cell infusion to evaluate safety and response. Participants will be closely monitored for adverse events and dose-limiting toxicities within 28 and 90 days after infusion. Disability and disease activity will be assessed up to 24 months using various clinical scales depending on the specific neurological condition. Participants must provide informed consent, comply with study procedures, and agree to contraception requirements if applicable. Overall involvement lasts at least two years for ongoing evaluations.

Universal Chimeric Antigen Receptor T-Cell （UCAR T-cell） Therapy Targeting CD19/B Cell Maturation Antigen （CD19/BCMA） in Patients With r/r Neurological Autoimmune Diseases