An open-label, phase I, multi-center study to determine in relapsed/refractory acute myeloid leukemia or myelodysplasic syndrome patients the recommended dose of CYAD-02 after a non-myeloablative preconditioning chemotherapy followed by a potential CYAD-0

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Study title: 
An open-label, phase I, multi-center study to determine in relapsed/refractory acute myeloid leukemia or myelodysplasic syndrome patients the recommended dose of CYAD-02 after a non-myeloablative preconditioning chemotherapy followed by a potential CYAD-0
Long title: 
An open-label, phase I, multi-center study to determine in relapsed/refractory acute myeloid leukemia or myelodysplasic syndrome patients the recommended dose of CYAD-02 after a non-myeloablative preconditioning chemotherapy followed by a potential CYAD-02 consolidation cycle for non-progressive patients.
Date receipt dossier: 
1 Oct 2019
EU record number: 
CYAD-02-001
EudraCT number: 
2019-001816-46
Pharmaceutical study code: 
CYAD-02
Company / Sponsor: 
Celyad
Phase: 
I
Treated organism: 
Humans
Indication category: 
Cancer therapy
Disease: 
Multiple myeloma
Therapeutic approach: 
Immunotherapy
Genetic modification: 
NKG2D-chimeric antigen receptor, ShRNA targeting the endogenous RNA of NKG2D ligands MICA and MICB and truncated CD19 reporter protein
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, a ShRNA targeting the endogenous RNA of NKG2D ligands MICA and MICB and a truncated CD19 reporter protein
Route of administration: 
Intravenous
Locations in Belgium: 
AZ Delta, CHU Liège, UZ Leuven
Nr of subjects: 
27
Type of procedure: 
Contained use only
Current status: 
Authorized