Long title
A Phase 1, Multicenter, Open-Label Study Of CC-97540 (BMS 986353), CD19-Targeted NEX-T Chimeric Antigen Receptor (CAR) T Cells, in Participants with Severe, Refractory Systemic Lupus Erythematosus (SLE)
Date receipt dossier
EudraCT number
2023-503823-24
Company / Sponsor
Celgene
Phase
I
Treated organism
Humans
Indication category
Auto-immune disease
Disease
Refractory Systemic Lupus Erythematosus (SLE)
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
Type of procedure
Contained use only
Current status
Authorized
Pharmaceutical study code
CC-97540