CAR-T Cells in Systemic B Cell Mediated Autoimmune Disease

Summary

The investigational product is designed to effectively combat B cells in patients with autoimmune diseases. Autologous T cells enriched with CD4/CD8 are genetically engineered using a lentiviral vector to express chimeric antigen receptors (CARs) that target the CD19 antigen on the cell surface of B cells and their precursors. During treatment, patients undergo leukapheresis, lymophodepleting chemotherapy and administration of the expanded CD19-CAR-transduced T cells.

Timeline

Start

2023-07-17

Primary completion

2026-05-31

Completion

2026-05-31

Outcome

Met primary endpoint

paper Primary and secondary endpoints of CASTLE were met. PMID 41501497 ↗

Publications

• Rius Rigau A, Xu M, Liu Z, Chenguiti Fakhouri S, Auth J, Garantziotis P, Zoli A, Selvaraju MK, Raimondo MG, Tur C, Filla T, Gehringer P, Eckstein M, Muller F, Atzinger A, Ronicke M, Ekici A, Schmid R, Wirsching A, Hagen M, Boltz S, Krickau T, Horch RE, Berking C, Grieshaber-Bouyer R, Ramming A, Gupta P, Bozec A, Mackensen A, Distler JH, Schett G, Li YN, Bergmann C. Deep phenotyping of skin tissue remodeling in patients with systemic sclerosis treated with CD19-CAR T cells. Nat Commun. 2026 May 23;17(1):4640. doi: 10.1038/s41467-026-72817-7.
• Muller F, Hagen M, Wirsching A, Kharboutli S, Aigner M, Volkl S, Kretschmann S, Tascilar K, Taubmann J, Bucci L, Raimondo MG, Bergmann C, Rothe T, Corte G, Tur C, Munoz L, Boltz S, Schuster L, Hartmann F, Garantziotis P, Sporl S, Vasova I, Gerbitz A, Spriewald B, Kiener H, Giannarelli D, Locatelli F, D'Agostino MA, Hanssens L, Miltenyi S, Bozec A, Grieshaber-Bouyer R, Mackensen A, Schett G. CD19 CAR-T cells for treatment-refractory autoimmune diseases: the phase 1/2 CASTLE basket trial. Nat Med. 2026 Mar;32(3):1142-1151. doi: 10.1038/s41591-025-04185-6. Epub 2026 Jan 7.

Drugs

Indications