Study title:
An open-label, Phase I/II study to assess the safety and clinical activity of NKR-2 treatment administration after non-myeloablative preconditioning chemotherapy in relapse/refractory acute myeloid leukemia or myelodysplasic syndrome patient (DEPLETHINK -
Long title:
An open-label, Phase I/II study to assess the safety and clinical activity of NKR-2 treatment administration after non-myeloablative preconditioning chemotherapy in relapse/refractory acute myeloid leukemia or myelodysplasic syndrome patient (DEPLETHINK - LymphoDEPLEtion and THerapeutic Immunotherapy with NKR-2).
Date receipt dossier:
18 Nov 2019
EU record number:
CYAD-N2T-005
EudraCT number:
2018-000205-22
Pharmaceutical study code:
NKR-2
Company / Sponsor:
Celyad
Phase:
I/II
Treated organism:
Humans
Indication category:
Cancer therapy
Disease:
Different metastatic tumor type
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:
AZ Sint-Jan Brugge-Oostende AV, UZ Antwerpen, Institut Jules Bordet
Type of procedure:
Contained use only
Current status:
Authorized