Cytokine-induced Memory-like NK Cells in Patients With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)

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Amendment 16: Based on the data indicating that ALT-803/IL-15 result in more modulation of the NK cells in vivo, the investigators performed a lead in cohort with ALT-803 replacing IL-2 at a dose of 10 mcg/kg SQ administered q5 days starting on the date of NK cell infusion. The first two patients tr...

Amendment 16: Based on the data indicating that ALT-803/IL-15 result in more modulation of the NK cells in vivo, the investigators performed a lead in cohort with ALT-803 replacing IL-2 at a dose of 10 mcg/kg SQ administered q5 days starting on the date of NK cell infusion. The first two patients treated in the ALT-803 lead in cohort experienced a set of symptoms consistent with cytokine release syndrome (CRS) including fevers, elevated markers of inflammation between days 10-14 after ML NK cell infusion. Based on the evidence of increased CD8 T cell activation, the in vitro data indicating that ALT-803 promoted recipient CD8 T cell expansion and killing of donor ML NK cells, and the lack of clinical responses using ALT-803, the lead in cohort was closed, and a decision was made to return to rhIL-2 support, mimicking the cytokine support utilized in the phase 2 portion of the trial. PLEASE NOTE: THE PEDIATRIC PORTION OF THE STUDY IS CLOSED TO FURTHER ENROLLMENT.

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