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

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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