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

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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 mai 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