Date: 2016-04-12
Type of information: Interim results
phase: 1-2
Announcement: interim results
Company: Cell and Gene Therapy Catapult (UK) Imperial Innovations (UK) University College London Business (UK)
Product: WT1-TCR T cell therapy
Action
mechanism: cell therapy/gene therapy. The therapy uses TCR gene-modified T cells to target WT1-overexpressing cells. It involves modification by gene therapy of the patient's own T cells, so that they may recognise and destroy WT1-expressing cells when infused back into the body.
Disease: myelodysplastic syndrome (MDS), acute myeloid leukaemia (AML)
Therapeutic area: Cancer - Oncology
Country: UK
Trial
details: This Phase I/II study is evaluating the safety and efficacy of the WT1 TCR therapy in patients with myelodysplastic syndrome (MDS) or acute myeloid leukaemia (AML) following azacitidine therapy. Patient's white blood cells (T cells) will be modified by transferring a gene which enables them to make a new T cell receptor (TCR) that can recognize fragments of a protein called WT1 which is present at abnormally high levels on the surface of myelodysplastic and leukaemic cells. In this trial, approximately 30 participants with an Human Leukocyte Antigen A2(HLAA2) tissue type who have low blast count, stable MDS or AML but failed to reach an IWG response following Azacitidine therapy will be recruited. (NCT02550535)
Latest
news: * On April 12, 2016, the Cell and Gene Therapy Catapult, the UK organisation dedicated to the growth of the UK cell and gene therapy industry, alongside UCL Business PLC (UCLB) and Imperial Innovations, announced a positive interim review in the phase I/II trial conducted by Catapult Therapy TCR using a T cell therapy to target acute myeloid leukaemia. The review has been conducted by the Data Safety Monitoring Board (DSMB), an independent panel of specialists in the field. The reviewed data shows that in the first cohort comprising 3 patients treated, there was a good safety profile with no serious adverse events (SAEs) related to the WT1-TCR T cell therapy. Importantly, the therapy also met the protocol specified requirements for cell persistence, showing that the WT1 targeted T cells can survive and expand in patients. Passing this first interim review has enabled the clinical trial to enter its second phase. Dosing has now successfully started in the second cohort of patients in the trial which allows patients to receive a higher dose of the gene modified WT1 TCR T cells. The trial is operated by Catapult Therapy TCR Limited, a company formed by the Cell and Gene Therapy Catapult with UCLB and Imperial Innovations to develop the T cell therapy, and is supported by the NIHR Biomedical Research Centre (BRC) at University College London Hospitals. Pre-clinical development of the TCR gene therapy programme was supported by Bloodwise, previously Leukaemia and Lymphoma Research. In August 2015 the Cell and Gene Therapy Catapult appointed Cellular Therapeutics Limited (CTL), as a manufacturer for the clinical trial.
