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