A Phase 1, Open Label, Non-comparative Study to Evaluate the Safety and the Ability of UCART19 to Induce Molecular Remission in Paediatric Patients With Relapsed/Refractory B Acute Lymphoblastic Leukaemia

Study title: 
A Phase 1, Open Label, Non-comparative Study to Evaluate the Safety and the Ability of UCART19 to Induce Molecular Remission in Paediatric Patients With Relapsed/Refractory B Acute Lymphoblastic Leukaemia
Date receipt dossier: 
24 Apr 2017
EudraCT number: 
2015-004293-15
Company / Sponsor: 
Institut de Recherches Internationales Servier
Phase: 
I
Treated organism: 
Humans
Indication category: 
Cancer therapy
Disease: 
Refractory B-cell Acute Lymphoblastic Leukemia
Therapeutic approach: 
Immunotherapy
Genetic modification: 
chimeric antigen receptor and suicide-ligand (RQR8)
Method of transfer of nucleic acid of interest: 
Lentiviral vector
Administered biological material: 
T-cells transduced with lentiviral vectors to express a chimeric antigen receptor (CAR) and a suicide-ligand (RQR8)
Route of administration: 
Intravenous
Locations in Belgium: 
UZ Gent
Nr of subjects: 
10 participants
Foreseen duration: 
3 years
Type of procedure: 
Contained use only
Current status: 
Authorized