CD19/BCMA-Targeted UCAR-T for Patients With Neurological Autoimmune Diseases
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), Autoimmune Encephalitis (AE), and other B-cell-mediated neuroautoimmune disorders. In this study, the dose of CAR-T cells administered is 10×10⁶ CAR⁺T 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 24 to 36 subjects planned for enrollment in the entire study.
Timeline
- Start
- 2025-12-12
- Primary completion
- 2026-12-01
- Completion
- 2028-11-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | RD06-05 | Cell therapy | 1e+07 cells/kg | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | 300 mg/m2 | — |
| Background | Fludarabine | Small molecule | 30 mg/m2 | — |