Pilot Study of Memory-like Natural Killer Cells After Half-Matched Family Stem Cell Transplant in High-Risk Acute Myeloid Leukemia

Sponsor: Washington University School of Medicine

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06158828

This study is testing a new approach to improve stem cell transplants for children and young adults with high-risk acute myeloid leukemia (AML). It involves using a half-matched family donor and adding special immune cells to help fight the cancer.

Patient Parameters

Program Overview

This study aims to improve the success of stem cell transplants for children and young adults with high-risk acute myeloid leukemia (AML). Participants will receive a stem cell transplant from a half-matched family member. One week after the transplant, they will get an infusion of special immune cells called memory-like natural killer (ML NK) cells, along with a drug called interleukin-2. This approach is designed to reduce complications and enhance the effectiveness of the transplant by preventing graft-versus-host disease (GvHD) while boosting the body's ability to fight cancer.

Eligibility Criteria

Inclusion Criteria

  • Have high-risk acute myeloid leukemia (AML) in complete remission or a leukemia-free state.
  • Meet specific high-risk features if newly diagnosed with AML in first remission.
  • Have AML in second remission or therapy-related AML in first remission.
  • AML that developed from myelodysplastic syndrome (MDS).
  • Previous stem cell transplant is allowed if in remission.
  • Be 30 years old or younger.
  • Have a performance status score above 60%.
  • Have adequate organ function, including liver, kidney, heart, and lungs.
  • Agree to use effective birth control during and after the study.
  • Be able to understand and sign a consent form, or have a guardian who can.
  • Have a family donor who is a half-match and willing to donate cells.

Exclusion Criteria

  • Have active graft-versus-host disease (GvHD).
  • Have another active cancer.
  • Be on other experimental treatments.
  • Have active disease in the central nervous system or outside the bone marrow.
  • Have allergies to study drugs.
  • Cannot stop medications that interfere with ML NK cells.
  • Have significant antibodies against donor cells.
  • Have another major health condition that prevents transplant.
  • Have Fanconi Anemia or Down Syndrome.
  • Have uncontrolled illness or infection.
  • Be pregnant or breastfeeding.

Donor Eligibility Criteria:

  • Must be at least 18 years old.
  • Must be a half-match family member.
  • Must meet specific health criteria.
  • Must be willing to donate cells twice.
  • Must not be pregnant or breastfeeding.
  • Must be able to understand and sign a consent form.

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