RecruitingPhase 1NCT05887882

Intra-Tumoral Injections of Natural Killer Cells for Recurrent Malignant Pediatric Brain Tumors

A Phase I Study of Intra-Tumoral Injections of Ex Vivo Expanded Natural Killer Cells in Children and Young Adults With Recurrent or Progressive Malignant Brain Tumors


Sponsor

Sabine Mueller, MD, PhD

Enrollment

24 participants

Start Date

May 31, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This phase I trial tests the safety, side effects, and best dose of ex vivo expanded natural killer cells in treating patients with cancerous (malignant) tumors affecting the upper part of the brain (supratentorial) that have come back (recurrent) or that are growing, spreading, or getting worse (progressive). Natural killer (NK) cells are immune cells that recognize and get rid of abnormal cells in the body, including tumor cells and cells infected by viruses. NK cells have been shown to kill different types of cancer, including brain tumors in laboratory settings. Giving NK cells from unrelated donors who are screened for optimal cell qualities and determined to be safe and healthy may be effective in treating supratentorial malignant brain tumors in children and young adults.


Eligibility

Min Age: 1 YearMax Age: 38 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether injecting natural killer (NK) cells — a type of immune cell — directly into a brain tumor cavity can fight recurrent or progressive malignant brain tumors in children after initial treatment has failed. **You may be eligible if...** - Your child has a recurrent or progressive malignant brain tumor confirmed by biopsy (such as high-grade glioma, gliosarcoma, ependymoma, or intracranial sarcoma) - Your child has already completed first-line treatment - Your child is a candidate for surgical removal of the recurrent tumor, which would leave a cavity large enough to hold the device used for NK cell delivery - Your child is in adequate health to undergo surgery **You may NOT be eligible if...** - The tumor cannot be surgically accessed - The post-surgical cavity is too small for the treatment device - Your child has uncontrolled infections or serious organ problems - Your child cannot safely undergo anesthesia Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALUniversal Donor (UD) Transforming growth factor beta imprinting (TGFβi) Natural Killer (NK) Cells

The TGFβi NK cell product will be manufactured in the Cell Therapy Laboratory at Nationwide Children's Hospital and given via infusion.

PROCEDUREImplantation

Undergo placement of Ommaya reservoir

PROCEDUREMagnetic Resonance Imaging (MRI)

Imaging procedure

OTHERQuality-of-Life Assessment

Ancillary studies


Locations(10)

University of Alabama Birmingham

Birmingham, Alabama, United States

Children's Hospital Los Angeles

Los Angeles, California, United States

University of California, San Francisco

San Francisco, California, United States

Indiana University

Indianapolis, Indiana, United States

Johns Hopkins

Baltimore, Maryland, United States

Washington University in Saint Louis

St Louis, Missouri, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

Nationwide Children's Hospital

Columbus, Ohio, United States

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Seattle Children's

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT05887882


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