WT1 TCR Gene Therapy for Leukaemia: A Phase I/II Safety and Toxicity Study (WT1 TCR-001)
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.
General
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Identify organ toxicities and other side effects
Up to 12 months per patient
Yes
Emma Morris, Dr
Principal Investigator
Royal Free and University College London
United Kingdom: Medicines and Healthcare Products Regulatory Agency
UCL 06/154
NCT01621724
April 2012
April 2016
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