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Allogeneic Peripheral Blood-Derived Cd56+ Natural Killer Cells, Co-Cultured With K562-Mb15-41Bbi Cell Line

This article discusses a groundbreaking clinical trial investigating the use of allogeneic peripheral blood-derived CD56+ natural killer cells, co-cultured with K562-mb15-41BBI cell line, as a potential treatment for children, adolescents, and young adults with sarcomas. This innovative immunotherapy approach aims to evaluate the safety and efficacy of activated NK cells in combination with chemotherapy and/or radiotherapy for patients with refractory sarcomas.

Table of Contents

What is this treatment?

The treatment being studied is called “Allogeneic Peripheral Blood-Derived CD56+ Natural Killer Cells, co-cultured with K562-mb15-41BBI cell line,” also known as NKAES[1]. This is a type of cell therapy, which means it uses living cells as a treatment. In this case, the treatment uses special immune cells called Natural Killer (NK) cells that are taken from a donor’s blood and then prepared in a laboratory to make them more effective at fighting cancer[1].

How does it work?

Natural Killer cells are a part of our immune system that helps fight off infections and cancer. This treatment takes NK cells from a donor (usually a parent or sibling of the patient) and modifies them in the lab to make them more powerful at recognizing and attacking cancer cells. The treated NK cells are then given back to the patient through an intravenous infusion (a drip into a vein)[1]. The hope is that these enhanced NK cells will be better at finding and destroying cancer cells in the patient’s body.

Who is this treatment for?

This treatment is being studied for children, adolescents, and young adults (ages 0-40) who have a type of cancer called sarcoma. Sarcomas are cancers that develop in bones and soft tissues. The treatment is specifically for patients whose sarcoma hasn’t responded well to standard treatments or who still have some cancer remaining after conventional therapy[1].

Current Clinical Trial

A clinical trial is currently underway to test this treatment. It’s a Phase I/II trial, which means it’s designed to test both the safety of the treatment and how well it works. The trial is open-label, meaning both the doctors and patients know which treatment is being given[1].

Objectives of the Study

The main goals of this study are:

  1. To check if the treatment is safe to use in young patients with sarcoma[1].
  2. To see how often patients experience side effects like fever, infections, or need to stay in the hospital[1].
  3. To find out how well the treatment works at stopping the cancer from growing or coming back over a 5-year period[1].
  4. To learn more about how NK cells interact with sarcoma cells, which could help researchers develop better treatments in the future[1].

Eligibility Criteria

Not everyone can participate in this clinical trial. Some key requirements for patients include:

  • Being between 0 and 40 years old with a diagnosed sarcoma that hasn’t responded well to standard treatments[1].
  • Having a compatible donor (usually a parent or sibling) to provide the NK cells[1].
  • Being in relatively good overall health, with good heart function and only mild to moderate problems with other organs[1].
  • For adult patients, being able to understand and sign an informed consent form[1].
  • For younger patients, having a parent or guardian who can provide consent, with assent from mature minors (ages 12-17)[1].

Safety and Side Effects

A major focus of this study is to evaluate the safety of this treatment. The researchers will be closely monitoring for any side effects or complications. Some potential side effects that will be watched for include:

  • Fevers and infections[1]
  • Changes in blood cell counts[1]
  • Need for hospital stays[1]

The study will use standardized criteria from the National Cancer Institute to classify and grade any side effects that occur[1].

Future Research and Potential

This study is not just about testing a new treatment. It’s also helping researchers learn more about how NK cells interact with sarcoma cells. They will be studying samples from patients to look for specific markers on the cancer cells and in the blood. This information could help identify new ways to predict how well a patient might respond to this type of treatment in the future[1].

If this treatment proves to be safe and effective, it could potentially offer a new option for young sarcoma patients who haven’t responded well to other treatments. However, it’s important to remember that this is still an experimental therapy, and more research will be needed to fully understand its benefits and risks[1].

Aspect Details
Study Type Phase I/II Clinical Trial, multicenter, open-label
Treatment Allogeneic peripheral blood-derived CD56+ natural killer cells, co-cultured with K562-mb15-41BBI cell line
Target Population Children, adolescents, and young adults (0-40 years) with refractory sarcomas
Primary Objective Evaluate safety of NK cell immunotherapy with IL-2 after lymphoablative chemotherapy and/or low-dose radiotherapy
Secondary Objectives Analyze treatment-related complications, evaluate 5-year disease progression rate, identify prognostic biomarkers
Key Eligibility Criteria Diagnosed malignant sarcoma, detectable residual disease or stable/minimal disease, Lansky/Karnofsky index > 60%
Safety Assessment Toxicity classified according to NCI CTCAE v5.0

FAQ

  • What is the main objective of this clinical trial? The main objective is to evaluate the safety of immunotherapy using haploidentical allogeneic NK cells together with IL-2 after lymphoablative chemotherapy and/or low-dose radiotherapy in pediatric, adolescent, and young adult patients with refractory sarcoma.
  • Who is eligible to participate in this trial? Patients aged 0-40 years diagnosed with malignant sarcoma who still have detectable residual disease after conventional treatment or have stable/minimal disease with poor tolerance to chemotherapy are eligible. They must also have a Lansky/Karnofsky index > 60% and mild-moderate organ functional impairment.
  • What is the treatment being studied in this trial? The trial is studying the infusion of haploidentical allogeneic NK cells (natural killer cells) in combination with chemotherapy and/or radiotherapy. These NK cells are derived from peripheral blood and co-cultured with a specific cell line to enhance their activity.
  • What are the secondary objectives of the trial? Secondary objectives include analyzing the incidence of complications like febrile neutropenia and infections, evaluating the 5-year disease progression rate, and determining the expression of NK cell inhibitory/activator ligands in tumor samples to identify potential prognostic biomarkers.
  • How will the safety of the treatment be assessed? The safety will be assessed by classifying toxicity according to the common toxicity criteria established by the National Cancer Institute (CTC NCI, version 5.0). This will help researchers understand the potential side effects and risks associated with the treatment.

Ongoing Clinical Trials on Allogeneic Peripheral Blood-Derived Cd56+ Natural Killer Cells, Co-Cultured With K562-Mb15-41Bbi Cell Line

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

    Recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

Glossary

  • Allogeneic: Refers to cells or tissues that are taken from a different individual of the same species. In this context, it means the NK cells come from a donor, not the patient.
  • NK cells (Natural Killer cells): A type of white blood cell that plays a crucial role in the body's immune defense against cancer and virally infected cells.
  • Sarcoma: A type of cancer that develops in connective tissues such as bones, muscles, or fat.
  • Haploidentical: Refers to a donor (usually a family member) who is a partial match for stem cell or bone marrow transplant.
  • Immunotherapy: A type of cancer treatment that helps the immune system fight cancer.
  • IL-2 (Interleukin-2): A type of protein that regulates the activities of white blood cells that are responsible for immunity.
  • Lymphoablative chemotherapy: A type of chemotherapy that destroys lymphocytes, a type of white blood cell, to prepare the body for certain treatments.
  • Refractory: Refers to a disease that does not respond to treatment.
  • Lansky/Karnofsky index: A scale used to measure a patient's overall performance status and ability to perform daily activities.
  • Febrile neutropenia: A condition characterized by fever and an abnormally low number of neutrophils (a type of white blood cell).
  • Biomarker: A measurable indicator of a biological condition or state, often used to predict or monitor disease progression or treatment response.

References

  1. http://clinicaltrials.eu/trial/study-of-activated-nk-cells-for-treating-sarcomas-in-children-adolescents-and-young-adults/