Safety and Efficacy of CT103A Cells for Relapsed/Refractory Antibody-associated Inflammatory Diseases of the Nervous System
Summary
Antibody-mediated inflammatory diseases of the nervous system (also known as autoimmune diseases of the nervous system) are autoimmune diseases in which autoimmune cells and immune molecules attack the nervous system as the main pathogenic mechanism. In the immune response, pathogenic antibodies acting on autoantigens of the nervous system are collectively referred to as autoantibodies of the nervous system, and antibody-mediated inflammatory diseases of the nervous system can occur in the central nervous system, peripheral nervous system, and neuromuscular junctions, and muscles. In this study, we will recruit eight kinds of autoimmune diseases of nervous system including Neuromyelitis Optica Spectrum Disorder (NMOSD), Myasthenia Gravis (MG), Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP), idiopathic inflammatory myopathyand (IIM), multiple sclerosis (MS), autoimmune encephalitis (AE), Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD) and POEMS Syndrome. B-cell maturation antigen (BCMA) is expressed on the surface of plasma cells, thus making it an ideal target for targeted therapies. Chimeric antigen receptor (CAR) T cells against BCMA offers another potential therapeutic option to eliminate plasma cells in patients with neurological autoimmune diseases driven by abnormal antibody who still suffer recurrent attacks from conventional treatments. In the current study, the safety and efficacy of a novel CAR-T cell therapy using CT103A cells, are evaluated in patients with relapsed/refractory antibody-mediated idiopathic inflammatory diseases.
Timeline
- Start
- 2020-09-22
- Primary completion
- 2027-02-22
- Completion
- 2027-05-31
Publications
- Qin C, Dong MH, Zhou LQ, Chu YH, Pang XW, He JY, Shang K, Xiao J, Zhu L, Ye H, Cai SB, Wang D, Bu BT, Meyer Zu Horste G, Li CR, Tian DS, Wang W. Anti-BCMA CAR-T therapy in patients with progressive multiple sclerosis. Cell. 2025 Nov 13;188(23):6414-6423.e11. doi: 10.1016/j.cell.2025.09.020. Epub 2025 Oct 15.
- Dong MH, Mei ZC, Zhou LQ, Heming M, Xu LL, Liu YX, Pang XW, Chu YH, Cai SB, Ye H, Shang K, Xiao J, Meyer Zu Horste G, Wang W, Qin C, Tian DS. Anti-BCMA CAR-T cell therapy in relapsed/refractory chronic inflammatory demyelinating polyneuropathy. Med. 2025 Sep 12;6(9):100704. doi: 10.1016/j.medj.2025.100704. Epub 2025 May 26.
- Keam SJ. Equecabtagene Autoleucel: First Approval. Mol Diagn Ther. 2023 Nov;27(6):781-787. doi: 10.1007/s40291-023-00673-y. Epub 2023 Sep 2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CT103A | Cell therapy | 250000 cells/kg | Intravenous |
| Subject | CT103A | Cell therapy | 500000 cells/kg | Intravenous |
| Subject | CT103A | Cell therapy | 1e+06 cells/kg | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | 300 mg/m2 | Intravenous |
| Background | Fludarabine | Small molecule | 30 mg/m2 | Intravenous |