Cytokine-induced Memory-like NK Cells in Patients With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)
Status:
Recruiting
Trial end date:
2028-09-13
Target enrollment:
Participant gender:
Summary
This phase I/2 trial studies the side effects and best dose of activated natural killer cells
in treating patients with relapsed or refractory acute myeloid leukemia and myeloid
dysplastic syndromes. Giving chemotherapy before a donor natural killer cell infusion helps
stop the growth of cancer cells. It may also stop the patient's immune system from rejecting
the donor's natural killer cells. Modified natural killer cells may help the body build an
immune response to kill cancer cells. Aldesleukin (interleukin-2) may stimulate the white
blood cells (including natural killer cells) to kill leukemia cells.
In the phase II and pediatric portion of the study, the investigators intend to use maximal
tolerated or tested (MT/TD) CIML NK cell dose as determined from the phase I part of this
study. The phase II portion of the study also replaces IL-2 with ALT-803. The rationale for
this change is to support the donor derived NK cells in vivo after adoptive transfer.
PLEASE NOTE: THE PEDIATRIC PORTION OF THE STUDY IS CLOSED TO FURTHER ENROLLMENT.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Washington University School of Medicine
Collaborators:
American Society of Clinical Oncology American Society of Hematology Gabrielle's Angel Foundation ImmunityBio, Inc. National Cancer Institute (NCI) The Leukemia and Lymphoma Society