Long title
A Phase 2, randomized, open-label, controlled study to evaluate the efficacy and safety of rapcabtagene autoleucel versus comparator in participants with severe refractory idiopathic inflammatory myopathies.
Date receipt dossier
EudraCT number
2024-514137-38
Company / Sponsor
Novartis Pharma Services AG
Phase
II
Treated organism
Humans
Indication category
Immune disease
Disease
Myositis
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 D-domain BCMA-CAR
Route of administration
Intravenous
Locations in Belgium
UZ Gent
Nr of subjects
10
Foreseen duration
8/2025-3/2030
Type of procedure
Contained use only
Current status
Authorized
Pharmaceutical study code
YTB323