Study title:
A phase II, single-arm, multi-center trial to determine the efficacy and safety of CTL019 in pediatric patients with relapsed and refractory B-cell acute lymphoblastic leukemia
Date receipt dossier:
14 oct 2015
EudraCT number:
2014-003060-20
Company / Sponsor:
Novartis Pharma Services AG
Phase:
II
Treated organism:
Humans
Indication category:
Cancer therapy
Disease:
Leukemia
Therapeutic approach:
Immunotherapy
Genetic modification:
Chimeric antigen receptor against CD19
Method of transfer of nucleic acid of interest:
Lentiviral vector
Administered biological material:
T-cells transduced with lentiviral vector expressing anti-CD19 CAR
Route of administration:
Intravenous
Locations in Belgium:
UZ Gent
Type of procedure:
Contained use only
Current status:
Authorized