Study 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)
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:
18 Sep 2023
EudraCT number:
2023-503823-24
Pharmaceutical study code:
CC-97540
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