A phase 2, open-label, multi-cohort, single-arm, multi-center trial to determine the safety, feasibility, and efficacy of JCAR015 in adult subjects with B-cell acute lymphoblastic leukemia

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Study title: 
A phase 2, open-label, multi-cohort, single-arm, multi-center trial to determine the safety, feasibility, and efficacy of JCAR015 in adult subjects with B-cell acute lymphoblastic leukemia
Date receipt dossier: 
23 Nov 2016
EudraCT number: 
2016-001706-42
Company / Sponsor: 
Celgene
Phase: 
II
Treated organism: 
Humans
Indication category: 
Cancer therapy
Disease: 
Acute lymphoblastic leukemia
Therapeutic approach: 
Immunotherapy
Genetic modification: 
Chimeric antigen receptor against CD19
Method of transfer of nucleic acid of interest: 
Gamma-retroviral vectors
Administered biological material: 
T-cells transduced with gamma-retroviral vectors to express chimeric antigen receptor (CAR) against CD19
Route of administration: 
Intravenous
Locations in Belgium: 
UZ Gent
Nr of subjects: 
25 participants
Type of procedure: 
Contained use only
Current status: 
Authorized