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

NCT05887882 · Status: SUSPENDED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-04-24

No results posted yet for this study

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.

Conditions

  • Pediatric Brain Tumor
  • Recurrent Pediatric Brain Tumor
  • Pediatric Neoplasm

Interventions

BIOLOGICAL

Universal 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.

PROCEDURE

Implantation

Undergo placement of Ommaya reservoir

PROCEDURE

Magnetic Resonance Imaging (MRI)

Imaging procedure

OTHER

Quality-of-Life Assessment

Ancillary studies

Sponsors & Collaborators

  • Rally Foundation

    collaborator UNKNOWN

  • Washington University School of Medicine

    collaborator OTHER

  • Nationwide Children's Hospital

    collaborator OTHER

  • CureSearch

    collaborator UNKNOWN

  • Tommy Strong Foundation

    collaborator UNKNOWN

  • Sabine Mueller, MD, PhD

    lead OTHER

Principal Investigators

  • Sabine Mueller, MD, PhD · University of California, San Francisco

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
1 Year
Max Age
38 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-31
Primary Completion
2027-12-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05887882 on ClinicalTrials.gov