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Study of Natural Killer Cells and Aldesleukin for Patients with Acute Myeloid Leukemia

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of blood cancer called Acute Myeloid Leukemia (AML) and related conditions such as Myelodysplastic Syndromes (MDS) with excess blasts. The study involves a treatment using a combination of two therapies: RNK001, which is a type of cell therapy involving natural killer cells, and aldesleukin, also known as IL-2, which is given as an injection under the skin. The purpose of the study is to evaluate the safety and effects of these treatments on the disease.

Participants in the study will receive an infusion of RNK001 natural killer cells, which are specially prepared outside the body, and may also receive aldesleukin to help boost the immune response. The study will be conducted in two phases. In the first phase, the focus will be on assessing the safety and any side effects of the treatment. In the second phase, the study will look at how well the treatment works in controlling the disease.

The treatment involves a non-myeloablative immunosuppressive conditioning regimen, which means it is designed to suppress the immune system without completely destroying the bone marrow. This approach helps the body accept the new cells. The study will monitor participants closely to understand how the treatment affects their condition and to ensure their safety throughout the process. The trial aims to provide insights into the potential benefits of combining RNK001 and aldesleukin for patients with AML and related conditions.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, participants will be informed about the trial's purpose, procedures, and potential risks and benefits. Written informed consent is required to proceed.

  2. Step 2

    Pre-treatment phase

    Participants may receive Hydrea to control blast count until three days before the start of chemotherapy. Hypomethylating agents such as decitabine or azacitidine are allowed until seven days before the start of chemotherapy.

  3. Step 3

    Conditioning regimen

    A non-myeloablative immunosuppressive conditioning regimen will be administered to prepare the body for the infusion of RNK001 NK cells.

  4. Step 4

    Infusion of NK cells

    Participants will receive an infusion of ex vivo-generated allogeneic natural killer cells (RNK001 NK cells). This is done to evaluate the safety and effect of the treatment.

  5. Step 5

    Administration of IL-2

    Following the NK cell infusion, subcutaneous IL-2 will be administered. This involves injecting IL-2 under the skin to support the activity of the NK cells.

  6. Step 6

    Monitoring and evaluation

    Participants will be closely monitored for any side effects or toxicities using established criteria. The main focus is on safety during the initial phase and clinical response in the later phase.

  7. Step 7

    Follow-up assessments

    Regular follow-up assessments will be conducted to evaluate the response to the treatment. The primary endpoint is assessed by day 28 after the NK cell administration.

Who can join the trial?

10 criteria

  • Must have a medical condition called MDS with excess blasts, MDS/AML, or AML. These are types of blood disorders.
  • The disease should be stable or not getting worse quickly, with or without medication to control it.
  • Can be in one of the following situations:
    • Have the disease come back or not respond to treatment after receiving strong chemotherapy, specific drugs, or a stem cell transplant at least 6 months ago.
    • Newly diagnosed and not yet treated, but not eligible for a stem cell transplant.
    • Must be 18 years old or older.
    • Must have a WHO performance status of 0-2, which means being able to carry out daily activities with little or no help.
    • Must have a life expectancy of more than 4 months.
    • Must provide written informed consent, which means agreeing to participate after understanding the study details.
    • Can use a medication called Hydrea to control blast count until 3 days before starting the study treatment.
    • Can use hypomethylating agents like decitabine or azacitidine until 7 days before starting the study treatment, as long as the last dose was more than 28 days before starting chemotherapy.

Who cannot join the trial?

4 criteria

  • Patients who do not have MDS with excess blasts, MDS/AML, or AML cannot participate. These are specific types of blood disorders.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Patients who are part of a vulnerable population, such as those unable to give consent, are not eligible.
  • Patients who do not meet the safety requirements for the study cannot participate. This includes any health conditions that might make the study unsafe for them.
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Investigated drugs

  • RNK001 NK cells

    are a type of immune cell that is grown outside the body and then given to patients. These cells are called natural killer cells, and they are part of the body's natural defense system. In this trial, they are used to help fight against acute myeloid leukemia (AML) by targeting and destroying cancer cells. The goal is to see if these cells can be safely given to patients and if they can help reduce the cancer.

  • IL-2

    is a protein that helps boost the immune system. It is given as an injection under the skin. In this trial, IL-2 is used to support the activity of the natural killer cells. By enhancing the immune response, IL-2 may help the natural killer cells work better in attacking the cancer cells in patients with acute myeloid leukemia.

What is already known about the treatment

RNK001 NK cells – This medication involves the infusion of specially prepared natural killer (NK) cells, which are a type of immune cell, directly into the bloodstream. It is currently being studied in clinical trials for its potential use in treating certain blood cancers, specifically myelodysplastic syndromes (MDS) with excess blasts, MDS/acute myeloid leukemia (AML), or AML. The main goal is to see if these NK cells can help fight cancer by boosting the body's immune response. The NK cells work by recognizing and destroying cancer cells, and they are given alongside a small injection of a substance called IL-2 under the skin to help them work better. This treatment is still in the research phase, and scientists are studying its safety and effectiveness.

Investigated diseases

  • Myelodysplastic Syndromes with Excess Blasts

    Myelodysplastic Syndromes (MDS) with excess blasts is a group of disorders caused by poorly formed or dysfunctional blood cells. In this condition, the bone marrow produces immature cells, known as blasts, which do not develop into healthy blood cells. Over time, these blasts accumulate, leading to a shortage of healthy blood cells. This can result in symptoms such as fatigue, infections, and easy bruising or bleeding. The disease can progress slowly or rapidly, and in some cases, it may transform into acute myeloid leukemia (AML).

  • Acute Myeloid Leukemia

    Acute Myeloid Leukemia (AML) is a type of cancer that starts in the blood-forming cells of the bone marrow and quickly progresses to affect the blood. It is characterized by the rapid growth of abnormal white blood cells that accumulate in the bone marrow and interfere with the production of normal blood cells. This leads to symptoms such as fatigue, fever, frequent infections, and easy bruising or bleeding. AML can progress rapidly, requiring prompt medical attention. The disease is more common in older adults but can occur at any age.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-515357-16-00Protocol codeHEMAML42-NK4AMLEstimated enrolment16 patientsSponsorStichting Radboud universitair medisch centrum

sourced from the EU Clinical Trials Register and site verification

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