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Study of Activated NK Cells for Treating Sarcomas in Children, Adolescents, and Young Adults

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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 the treatment of sarcomas, which are a type of cancer that can occur in various tissues of the body, such as bones or muscles. The treatment being tested involves the use of a special type of immune cells known as natural killer (NK) cells. These NK cells are derived from blood and are specially prepared in a laboratory to enhance their ability to fight cancer. In this study, the NK cells are combined with a substance called IL-2, which helps boost the immune system. The treatment is given through an intravenous infusion, which means it is delivered directly into the bloodstream.

The purpose of this study is to evaluate the safety of this new treatment approach in children, adolescents, and young adults who have sarcomas that have not responded well to standard treatments. Participants will receive the NK cell treatment after undergoing a process called lymphoablative chemotherapy and/or low-dose radiotherapy. Lymphoablative chemotherapy is a type of treatment that reduces the number of certain immune cells to make room for the new NK cells to work more effectively. The study will monitor participants for any side effects and assess how well the treatment works over time.

Throughout the study, researchers will also look at various factors, such as the occurrence of infections, the recovery of blood cells, and the overall progression of the disease over a five-year period. They will use imaging techniques to track changes in the tumors and analyze samples to understand how the NK cells interact with the cancer. This research aims to provide new insights into the potential benefits of using NK cells in treating sarcomas, especially for those who have limited options with existing therapies.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying the diagnosis of sarcoma and ensuring that the patient meets specific health criteria, such as organ function and heart health.

    A pregnancy test is required for women of childbearing age, and consent forms must be signed by adult participants or legal guardians for minors.

  2. Step 2

    Pre-treatment preparation

    Before receiving the main treatment, patients undergo lymphoablative chemotherapy and/or low-dose radiotherapy. This step is designed to prepare the body for the infusion of activated NK cells.

  3. Step 3

    Infusion of activated nk cells

    The main treatment involves the infusion of allogeneic peripheral blood-derived CD56+ natural killer cells, which are co-cultured with a specific cell line. This is administered through an intravenous infusion.

    The goal of this step is to evaluate the safety of this immunotherapy approach in treating sarcomas.

  4. Step 4

    Administration of il-2

    Following the NK cell infusion, patients receive IL-2, a substance that helps boost the immune system. This is part of the treatment protocol to enhance the effectiveness of the NK cells.

  5. Step 5

    Monitoring and follow-up

    Patients are closely monitored for any side effects or complications. This includes checking for toxicity levels, infections, and other health indicators.

    Regular imaging tests are conducted to assess the progression of the disease and the response to treatment.

  6. Step 6

    Long-term evaluation

    The study includes a long-term follow-up to evaluate the five-year disease progression rate after treatment. This involves periodic assessments using imaging techniques.

    Additional tests may be conducted to analyze the expression levels of certain markers in tumor samples and blood.

Who can join the trial?

8 criteria

  • Patients must be between 0 and 40 years old and have been diagnosed with a type of cancer called **sarcoma**. They should still have signs of the disease after regular treatment or have not benefited from chemotherapy.
  • Patients need to have a **Lansky/Karnofsky index** greater than 60%. This is a score that measures how well a person can perform everyday activities.
  • Patients can have mild to moderate problems with their organs, like the liver, kidneys, or lungs, but not severe issues. This is based on guidelines from the National Cancer Institute.
  • The heart's ability to pump blood, known as the **left ventricular ejection fraction**, should be more than 39%.
  • Adults must sign a form agreeing to participate in the study before any procedures begin.
  • For children, a parent or legal guardian must sign the consent form. If the child is between 12 and 17 years old, they also need to agree to participate.
  • Women who can have children must have a negative pregnancy test before joining the study and agree to use effective birth control methods during the study and for 30 days after their last visit.
  • There must be a suitable **haploidentical donor**, which means a parent or sibling who can donate certain cells for the treatment.

Who cannot join the trial?

15 criteria

  • Patients who have a different type of cancer than sarcomas cannot participate. Sarcomas are a type of cancer that starts in certain tissues like bone or muscle.
  • Patients who are not in the age range of children, adolescents, or young adults are excluded.
  • Patients who are not willing or able to follow the study procedures cannot join.
  • Patients who have other serious health conditions that might interfere with the study are not allowed to participate.
  • Patients who are pregnant or breastfeeding cannot take part in the study.
  • Patients who have received certain treatments recently that might affect the study results are excluded.
  • Patients who have allergies to any of the study medications or treatments cannot participate.
  • Patients who have an active infection that requires treatment are not allowed to join the study.
  • Patients who have a history of certain heart problems are excluded.
  • Patients who have a history of certain lung problems cannot participate.
  • Patients who have a history of certain liver problems are not allowed to join.
  • Patients who have a history of certain kidney problems cannot take part in the study.
  • Patients who have a history of certain blood disorders are excluded.
  • Patients who have a history of certain immune system disorders cannot participate.
  • Patients who have participated in another clinical trial recently are not allowed to join this study.
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Investigated drugs

  • Activated NK Cells

    are a type of immune cell used in this trial. They are natural killer cells that have been activated to help the body fight cancer cells more effectively. These cells are infused into the patient to target and destroy sarcoma cells.

  • IL-2

    is a protein that helps boost the immune system. In this trial, it is used alongside activated NK cells to enhance their ability to fight cancer. IL-2 supports the growth and activity of the NK cells, making them more effective in attacking the cancer cells.

  • Lymphoablative Chemotherapy

    is a treatment that involves using strong drugs to reduce the number of immune cells in the body. This process helps create space for the infused NK cells to work more effectively. It is used before the infusion of NK cells to prepare the patient's body for the treatment.

  • Low-Dose Radiotherapy

    is a treatment that uses small amounts of radiation to help weaken the cancer cells. In this trial, it is used to make the cancer cells more vulnerable to the NK cells, improving the chances of the immune cells successfully attacking the cancer.

What is already known about the treatment

Activated NK Cells – This treatment involves the infusion of natural killer (NK) cells, which are a type of immune cell, into the patient. It is currently being studied in clinical trials, specifically for its safety and effectiveness in treating sarcomas in children, adolescents, and young adults. The main therapeutic indication is for refractory sarcomas, which are tumors that do not respond to standard treatments. The mechanism of action involves NK cells targeting and destroying cancer cells, aided by interleukin-2 (IL-2) to enhance their activity. This approach falls under the pharmacological classification of immunotherapy, as it utilizes the body's immune system to fight cancer.

Investigated diseases

Sarcomas – Sarcomas are a group of cancers that begin in the bones and soft tissues, such as fat, muscles, nerves, fibrous tissues, blood vessels, or deep skin tissues. They can occur in any part of the body but are most commonly found in the arms, legs, and trunk. Sarcomas often start as a painless lump, which may grow over time. As they progress, they can invade nearby tissues and spread to other parts of the body. The growth rate and behavior of sarcomas can vary significantly depending on the specific type and location. They are generally classified into two main types: bone sarcomas and soft tissue sarcomas.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2024-513431-25-00Estimated enrolment10 patientsSponsorHospital Universitario La Paz

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