Chronic Myeloid Leukemia Clinical Trial
Official title:
Adoptive Immunotherapy in Patients With Chronic Myeloid Leukemia: Phase I/II Study to Test the Safety and Feasibility of Autologous Activated and Expanded Natural Killer Cells
The purpose of this study is to evaluate safety, feasibility and maximum tolerated dose of NK cells cultured in vitro as adjuvant treatment of patients with chronic myeloid leukemia candidates to allogenic bone marrow transplantation or refractory to conventional treatment.
Natural killer (NK) cells are one of the main type of immune cells that mediate the
graft-versus-leukemia (GVL) effect. They are a fundamental part of innate immunity, with a
major role in rapid response against infectious agents and activating immune system against
tumoral cells. Patients with chronic myelogenous leukemia (CML), however, seem to have lower
NK cell counts as disease progresses from chronic phase to blast crisis, as well as
diminished cytotoxicity in those NK cells remaining. Therapeutic role of the NK cell ability
to target certain specific cells is currently being studied, especially regarding their
action against tumoral cells. Chronic myeloid leukemia studies with NK cells have so far
demonstrated that autologous ex vivo activated NK cells are able to suppress in vitro the
presence of the breakpoint cluster region-abelson leukemia virus (BCR-ABL) oncogene. These
studies have demonstrated that adoptive NK cell therapy may have a potential role in
treatment of CML patients.
The purpose of this study is to evaluate safety, feasibility and maximum tolerated dose of NK
cells cultured in vitro as adjuvant treatment of patients with chronic myeloid leukemia
candidates to allogenic bone marrow transplantation or refractory to conventional treatment.
NK cells will be expanded from peripheral blood mononuclear cells after depletion of T cells.
They ar going to be co-cultured with clone 9 K562 artificial antigen presenting cell (aAPCs),
which are posteriorly modified to also express membrane interleukin-21 (mIL-21)
;
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