Study of RD06-05 CAR-T Cell Treatment Targeting CD19BCMA in Adults With Neurological Autoimmune Diseases

What this Trial Is About

Researchers are evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and effectiveness of RD06-05, a universal CAR-T cell therapy targeting CD19BCMA, in patients with autoimmune neurological diseases. These conditions include Multiple Sclerosis MS, Myasthenia Gravis MG, Chronic Inflammatory Demyelinating Polyneuropathy CIDP, Autoimmune Encephalitis AE, and other B-cell-mediated neuroautoimmune disorders. This early phase 1, open-label, single-arm trial plans to enroll 24 to 36 participants, with 6 to 9 subjects per disease group. Participants undergo lymphodepleting chemotherapy with fludarabine and cyclophosphamide for three days before receiving a single intravenous infusion of RD06-05 CAR-T cells dosed at 1 x 107 CAR-positive T cells per kilogram of body weight. The investigators may adjust dosing or add groups based on safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy data. The study includes only one treatment group receiving this CAR-T cell therapy following conditioning chemotherapy. During the study, participants will be monitored from the day of infusion up to 24 months to assess safety by tracking adverse events, including serious and special interest events. Researchers will measure disease-specific outcomes such as relapse rates and MRI changes in MS, symptom scores in MG, disability scales in CIDP, and cognitive and functional assessments in AE. Blood samples will be collected at multiple time points to study the therapys behavior in the body. The total participation duration spans up to two years after infusion, during which safety and effectiveness data will be gathered.

CD19/BCMA-Targeted UCAR-T for Patients With Neurological Autoimmune Diseases