A Phase I/II trial investigating a novel T-cell based immunotherapy for acute myeloid leukaemia (AML) being carried out by the UK’s Catapult Therapy TCR* has been given a green light following an independent interim safety review.

The therapy, which involves genetically modifying the patient's own T cells so that they can recognise and destroy WT1-expressing cells when infused back into the body, has shown promise in a variety of cancers including AML and myelodysplastic syndrome.

After reviewing data from the first cohort involving three treated patients, the Data Safety Monitoring Board (DSMB) concluded that WT1-TCR T cell therapy has a good safety profile with no related serious adverse events.

Crucially, the therapy also met the protocol specified requirements for cell persistence, showing that the WT1 targeted T cells can survive and expand in patients, the groups noted.

The positive review has opened the door to the second phase of the trial, which allows patients to receive a higher dose of the gene modified WT1 TCR T cells.

“The progress of the WT1 TCR clinical trials supported by the positive DSMB review, is encouraging and we look forward to expanding these trials across the UK and Europe. Further results are expected during 2017,” commented Keith Thompson, chief executive of the Cell and Gene Therapy Catapult.

*Catapult Therapy TCR is a company formed by the Cell and Gene Therapy Catapult with UCL Business and Imperial Innovations to develop the T cell therapy, with supported by the NIHR Biomedical Research Centre (BRC) at University College London Hospitals.