haploidentical NK cells in cancer patients Successful adoptive transfer and in vivo expansion of human

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Abstract We previously demonstrated that autologous NK cell therapy after hematopoietic cell transplantion (HCT) is safe but does not provide an anti-tumor effect. We hypothesize that this is due to a lack of NK cell inhibitory receptor mismatching with autologous tumor cells which may be overcome by allogeneic NK cell infusions. Here, we test haploidentical, related donor NK cell infusions in a non-transplant setting to determine safety and in vivo NK cell expansion. Two lower intensity outpatient immune suppressive regimens were tested: 1) low-dose cyclophophamide and methylprednisolone and 2) fludarabine. A higher intensity inpatient regimen of high-dose cyclophosphamide and fludarabine (Hi-Cy/Flu) was tested in patients with poor prognosis AML. All patients received subcutaneous IL-2 after infusions. Patients who received lower intensity regimens showed transient persistence but no in vivo expansion of donor cells. In contrast, infusions after the more intense Hi-Cy/Flu resulted in a marked rise in endogenous IL-15, expansion of donor NK cells and induction of complete hematologic remission in five of nineteen poor prognosis AML patients. These findings suggest that haploidentical NK cells can persist and expand

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