In collaboration with the Department of Hematology of the Radboud Medical Centre in Nijmegen (The Netherlands) a first in man study has been conducted using oNKord®. This HOVON-associated study was designed for elderly acute myeloid leukemia (AML) patients who were not eligible for allogeneic stem cell transplantation. Patients who had successfully achieved complete remission after chemotherapy were treated with oNKord®, comprising natural killer cells (NK-cells) generated ex vivo from umbilical cord blood progenitor cells. Previous studies suggest that NK cells can have an anti-leukemic effect.
This phase I dose escalation study investigated safety of ex vivo generated NK-cells - oNKord®. Secondary objectives were in vivo lifespan and expansion of infused NK-cells, and the effect on residual disease.
First interim data have been presented at ASH 2015.
Summary of oNKord® Phase 1 study in AML patients
- Ten elderly AML patients ineligible to receive allogeneic stem-cell transplantation (Allo-SCT) were treated with oNKord® following chemotherapy and fludarabine cyclophosphamide (Flu-Cy) conditioning Study: EudraCT number 2010-018988-41
- Confirmed that 100 billion NK cells can be produced from one cord blood under GMP
- Demonstrated no T-cell impurity
- No dose limiting toxicities or Graft-versus-Host Disease (GVHD) observed in the study
- oNKord® cells show in vivo survival, expansion and further maturation
- oNKord® cells home to the bone marrow and target leukemia cells
- Treatment with oNKord® resulted in strong reduction of residual disease as well as prolonged Progression-free Survival and Overall Survival as compared to historical data (1).
(1) Source: The Netherlands Cancer Registry www.dutchcancerfigures.nl). Based on historical controls (yearly survival rates after diagnosis) in AML patients between 65-74 years of age.