Long title
A Phase 1b-2, open-label study of JNJ-68284528, a Chimeric Antigen Receptor T cell (CAR-T) therapy directed against BCMA in subjets with relapsed or refractory multiple myeloma. Protocol 68284528MMY2001
Date receipt dossier
EU record number
68284528MMY2001
EudraCT number
2018-000121-32
Company / Sponsor
Janssen-Cilag International NV
Phase
Ib/II
Treated organism
Humans
Indication category
Cancer therapy
Disease
Relapsed or refractory multiple myeloma
Therapeutic approach
Immunotherapy
Genetic modification
B-cell maturation antigen (BCMA)-chimeric antigen receptor
Method of transfer of nucleic acid of interest
lentiviral vector
Administered biological material
Autologous T-cells transduced with lentiviral vector expressing BCMA-CAR
Route of administration
Intravenous
Locations in Belgium
UZ Leuven, Universitair Ziekenhuis Antwerpen, Universitair Ziekenhuis Gent
Type of procedure
Contained use only
Current status
Authorized
Pharmaceutical study code
JNJ-68284528