Study title:
An open-label, phase I study to assess the safety of NKR-2 treatment administrated concurrently with 5-azacytidine in tretment-naïve acute myeloid leukemia or myelodysplastic syndrome patients not candidates for intensive therapy (EPITHINK - EPIgenetic dr
Long title:
An open-label, phase I study to assess the safety of NKR-2 treatment administrated concurrently with 5-azacytidine in tretment-naïve acute myeloid leukemia or myelodysplastic syndrome patients not candidates for intensive therapy (EPITHINK - EPIgenetic drug tretment and THerapeutic Immunotherapy with NKR-2)
Date receipt dossier:
10 jul 2018
EU record number:
CYAD-N2T-006
EudraCT number:
2018-000745-39
Pharmaceutical study code:
NKR-2
Company / Sponsor:
Celyad
Phase:
I
Treated organism:
Humans
Indication category:
Cancer therapy
Disease:
Myelodysplasic syndrome or acute myeloid leukemia
Therapeutic approach:
Immunotherapy
Genetic modification:
NKG2D-chimeric antigen receptor
Method of transfer of nucleic acid of interest:
Moloney Murine Leukemia Virus
Administered biological material:
Autologous T cells retrovirally transduced with a chimeric antigen receptor based on the NKG2D receptor
Route of administration:
Intravenous
Locations in Belgium:
CHU Liège, Universitair ziekenhuis Antwerpen, Cliniques Universitaires Saint-Luc, AZ Sint-Jan Brugge Oostende
Type of procedure:
Contained use only
Current status:
Authorized