Study 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
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:
27 Nov 2018
EU record number:
68284528MMY2001
EudraCT number:
2018-000121-32
Pharmaceutical study code:
JNJ-68284528
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