TK cell therapy for acute leukaemia patients who are candidate to haematopoietic stem cell transplantation – adjunct therapy
TK cell therapy is intended to be used as an adjunct therapy for the treatment of acute leukaemia patients who are candidates for haematopoietic stem cell transplantation (HSCT) and missing a suitable human leukocyte antigen matched donor. If licensed, it has the potential to reduce transplant related mortality, leukemic relapse and reduce the need for post-transplant immune-suppression. TK cell therapy is an immunostimulant product based on T cells from a donor, potentially enabling safer HSCT from haplo-identical donors.
In the UK, approximately 2,600 adults are diagnosed with acute leukaemia, either myeloid (AML) or lymphoblastic (ALL), every year. In Europe, 8,752 leukaemia-related HSCT operations were conducted in 2009, 8,022 (92%) allogeneic and 730 (8%) autologous. According to information provided by the company, up to 50% of HSCT patients would be eligible and could potentially benefit from TK cell therapy. In the UK, 749 unrelated donor HSCT were performed in 2009 compared to 301 in 2001.
Acute leukaemia can be treated with a range of chemotherapies, radiation therapies, or chemotherapy with stem cell transplantation. TK cell therapy is currently in a phase III clinical trial comparing its effect on acute leukaemia combined with haploidentical HCT against haploidentical HCT alone. This trial is expected to report in June 2016.