CD19/BCMA-Targeted UCAR-T for Patients With Neurological Autoimmune Diseases
Status:
RECRUITING
Trial end date:
2028-11-01
Target enrollment:
Participant gender:
Summary
This single-arm, open-label investigator-initiated trial (IIT) evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of RD06-05 in patients with autoimmune neurological diseases, including Multiple Sclerosis (MS), Myasthenia Gravis (MG), Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), and other B-cell-mediated neuroautoimmune disorders.
In this study, the dose of CAR-T cells administered is 1010 CART cells per kilogram of body weight. Investigators may decide whether to add other dose groups based on the subjects' safety data, pharmacokinetic (PK) data, pharmacodynamic (PD) data, and preliminary efficacy data.
For each indication, 6 to 9 subjects will be enrolled, with a total of 18 to 27 subjects planned for enrollment in the entire study.