Study on Cytokine-Induced Memory-Like Natural Killer Cells for Treating Relapsed or Hard-to-Treat Acute Myeloid Leukemia

Sponsor: Children's Hospital Medical Center, Cincinnati

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05580601

Provider View

This clinical trial is testing a new treatment using special immune cells called cytokine-induced memory-like natural killer cells to help patients with acute myeloid leukemia (AML) that has returned or is not responding to standard treatments.

Patient Parameters

Program Overview

The aim of this study is to see if a new type of immune cell treatment, called cytokine-induced memory-like natural killer cells, can be safely given to patients with relapsed or hard-to-treat acute myeloid leukemia (AML). Researchers also want to find out if these cells can effectively treat AML.

Description

This study focuses on patients with acute myeloid leukemia (AML) that has come back or is not responding to usual treatments. The goal is to help these patients achieve remission and potentially move on to a stem cell transplant. Standard treatments often don't work well for these patients, so this study is exploring a new approach.

In this trial, patients will receive a special type of immune cell treatment. These cells, called natural killer (NK) cells, are taken from a related donor and modified in the lab to become 'memory-like' using cytokines, which are substances that help cells communicate and grow. Before receiving these modified NK cells, patients will undergo a chemotherapy regimen to prepare their bodies.

The main goal of the study is to ensure that the infusion of these memory-like NK cells is safe and feasible. Researchers will also look at how well the treatment works by checking if the cancer responds and if patients can later have a stem cell transplant. They will also monitor how long these NK cells stay active in the body.

Eligibility Criteria

Inclusion Criteria

  • Must be 2 years or older.
  • Diagnosed with acute myeloid leukemia (AML) according to specific medical criteria.
  • Have AML that has returned or is not responding to treatment, with certain levels of cancer cells in the bone marrow.
  • Have a related donor who can provide the necessary cells for treatment.
  • Have a performance status of 50% or higher on specific health scales, depending on age.

Exclusion Criteria

  • Have only central nervous system (CNS) disease or other specific types of leukemia.
  • Have an active, uncontrolled infection.
  • Have poor kidney function.
  • Have a heart function below a certain level.
  • Have low oxygen levels in the blood.
  • Have liver function tests above certain levels.
  • Are taking high doses of steroids or other investigational treatments.
  • Have an allergy to IL-2 injections.
  • Are pregnant or breastfeeding, due to potential risks to the baby. Women must take a pregnancy test before joining the study. Participants must agree to use effective birth control during the study and for six months after.

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