Acute Myeloid Leukaemia Clinical Trial
Official title:
WT1 TCR Gene Therapy for Leukaemia: A Phase I/II Safety and Toxicity Study
WT1 TCR gene therapy is a new treatment for acute myeloid leukaemia and chronic myeloid
leukaemia.
Patient's white blood cells (T cells) are modified to specifically fight the leukaemia cells
by transferring a gene into the T cells, which allows them to recognize fragments of a
protein called WT1. This protein is present on the surface of leukaemia cells at very high
levels. The gene transferred to the T cells enables them to make a new T cell receptor (TCR),
which will allow them to attack leukaemia cells with high levels of WT1 on their surface.
Using this form of gene therapy the investigators can convert some of the patient's immune
system's own T cells into T cells that the investigators hope will be much more effective at
recognizing and killing leukaemia cells.
This trial concerns a novel approach to generating leukaemia antigen-specific T cells for
adoptive cellular therapy in HLA-A*0201 patients with acute myeloid leukaemia (AML) and
chronic myeloid leukaemia (CML)
In this study, patient T cells will be gene-modified using a GMP grade retroviral vector
containing the genes for a WT1-specific, HLA-A2-restricted T cell receptor. This ex vivo gene
therapy will generate T cells expressing the WT1-specific TCR and thus able to recognise
WT1-expressing target cells.
The autologous Cys1 WT1 TCR-transduced T cells will be re-infused back into adult leukaemia
patients following lymphodepleting conditioning.
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