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

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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