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 avr 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