Study title:
Administration of genetically engineered T cells (KTE-X19) in Pediatric and Adolescent Subjects with Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia or Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
Long title:
Administration of genetically engineered T cells (KTE-X19) in Pediatric and Adolescent Subjects with Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia or Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
Date receipt dossier:
3 mei 2021
EudraCT number:
2015-005010-30
Pharmaceutical study code:
KTE-X19
Company / Sponsor:
Kite Pharma
Phase:
I/II
Treated organism:
Humans
Indication category:
Cancer therapy
Disease:
Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia or Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
Therapeutic approach:
Immunotherapy
Genetic modification:
CD19-CAR
Method of transfer of nucleic acid of interest:
Retroviral vector
Administered biological material:
Autologous T-cells retrovirally transduced with CD19-CAR
Route of administration:
Intravenous
Locations in Belgium:
UZ Gent
Type of procedure:
Contained use only
Current status:
Authorized