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

EU record number

CYAD-02-001

EudraCT number

2019-001816-46

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

Pharmaceutical study code

CYAD-02

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