A single arm Phase I/II study of the safety and efficacy of gene-modified WT1 TCR therapy in patients with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML)

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Study title: 
A single arm Phase I/II study of the safety and efficacy of gene-modified WT1 TCR therapy in patients with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML)
Date receipt dossier: 
20 Aug 2015
EudraCT number: 
2014-003111-10
Company / Sponsor: 
Catapult Cell Therapy
Phase: 
I/II
Treated organism: 
Humans
Indication category: 
Cancer therapy
Disease: 
Acute myeloid leukemia and myelodysplastic syndromes in adults
Therapeutic approach: 
Immunotherapy
Genetic modification: 
Expression of the Wilms' tumour antigen 1 (WT1)- specific T cell receptor (TCR)
Method of transfer of nucleic acid of interest: 
Retroviral vectors
Administered biological material: 
Autologous T-cells transduced with retroviral vectors expressing WT1-specific TCR
Route of administration: 
Intravenous
Locations in Belgium: 
UZ Leuven, AZ Sint-Jan Brugge-Oostende
Type of procedure: 
Contained use only
Current status: 
Authorized