Study title:
An open-label phase I, multi-center study to determine the recommended dose of the chimeric antigen receptor T-cell treatment CYAD-211 after a non-myeloablative preconditioning chemotherapy in multiple myeloma patients with relapsed or refractory disease.
Long title:
An open-label phase I, multi-center study to determine the recommended dose of the chimeric antigen receptor T-cell treatment CYAD-211 after a non-myeloablative preconditioning chemotherapy in multiple myeloma patients with relapsed or refractory disease.
Date receipt dossier:
2 Sep 2020
EU record number:
CYAD-211-001
EudraCT number:
2020-001414-38
Pharmaceutical study code:
CYAD-211
Company / Sponsor:
Celyad
Phase:
I
Treated organism:
Humans
Indication category:
Cancer therapy
Disease:
Multiple myeloma
Therapeutic approach:
Immunotherapy
Genetic modification:
BCMA-CAR and ShRNA CD3ζ
Method of transfer of nucleic acid of interest:
Moloney murine leukemia virus
Administered biological material:
Autologous T-cells retrovirally transduced with BCMA-CAR and ShRNA CD3ζ
Route of administration:
Intravenous
Locations in Belgium:
UZA, AZ Delta
Type of procedure:
Contained use only
Current status:
Authorized