Date receipt dossier
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