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