Long title
A phase 2, Multicenter, Open-Label Study Of CC-97540 (BMS-986353), CD-19-Targeted NEXT-T Chimeric Antigen Receptor (CAR) T Cells, in Participants with Active Systemic Lupus Erythematosus (SLE) (Including Lupus Nephritis) with Inadequate Response to Glucocorticoids and at Least 2 Immunosuppressants (Brekfree-SLE)
Date receipt dossier
EudraCT number
2024-519278-37
Company / Sponsor
Celgene
Phase
II
Treated organism
Humans
Indication category
Immune disease
Disease
Active Systemic Lupus Erythematosus (SLE) (Including Lupus Nephritis)
Therapeutic approach
Immunotherapy
Genetic modification
CD19 CAR
Method of transfer of nucleic acid of interest
Lentiviral vector
Administered biological material
Autologous T cells transduced with lentiviral vectors expressing CD19-CAR
Route of administration
Intravenous
Locations in Belgium
UZ Leuven; UZ Antwerpen
Nr of subjects
89 subjects (2 participants in Belgium)
Foreseen duration
7/2025 - 6/2032
Type of procedure
Contained use only
Current status
Authorized
Pharmaceutical study code
CC-97540 (BMS-986353)