Long title
A Phase 3, Randomized, Open-Label, Multicenter Study to Compare the efficacy and Safety of BMS-986393, a GPRC5D-directed CAR-T Cell Therapy, Versus Standard Regimens in Adult Participants with Relapsed or Refractory and Lenalidomide-refractory Multiple Myeloma
Date receipt dossier
EudraCT number
2024-515279-37-00
Company / Sponsor
Celgene
Phase
III
Treated organism
Humans
Indication category
Cancer therapy
Disease
Multiple myeloma
Therapeutic approach
Immunotherapy
Genetic modification
GPRC5D CAR
Method of transfer of nucleic acid of interest
Lentiviral vector
Administered biological material
Autologous T cells transduced with lentiviral vectors expressing a CAR specific for G protein-coupled receptor class C, group 5, member D (GPRC5D)
Route of administration
Intravenous
Locations in Belgium
UZ Gent, CHU UCL Namur Site Godinne
Nr of subjects
440
Foreseen duration
5/2025-6/2032
Type of procedure
Contained use only
Current status
Authorized
Pharmaceutical study code
BMS-986393