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

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 unrela

Trial Details

NCT ID
NCT05887882
Phase
PHASE1
Sponsor
Sabine Mueller, MD, PhD
Status
RECRUITING
Cancer Type
Brain Cancer
Interventions
  • Universal Donor (UD) Transforming growth factor beta imprinting (TGFβi) Natural Killer (NK) Cells
  • Implantation
  • Magnetic Resonance Imaging (MRI)
  • Quality-of-Life Assessment
Locations (sample)
  • Birmingham, Alabama, United States|33.52066,-86.80249
  • Los Angeles, California, United States|34.05223,-118.24368
  • San Francisco, California, United States|37.77493,-122.41942
  • Indianapolis, Indiana, United States|39.76838,-86.15804
  • Baltimore, Maryland, United States|39.29038,-76.61219

Key Eligibility Criteria

  • Participants must have a histologically-confirmed recurrent or progressive malignant brain tumor including, but not limited to, infant-type hemisph…
  • Participants should be candidates for resection of the recurrent tumor and be deemed candidate for placement of an Ommaya reservoir placed intra-ca…
  • Given the lack of a standard of care treatment for children with recurrent or progressive malignant brain tumors, participants must have completed …
  • All participants must be ≥ 1 year of age and ≤ 39 years of age at the time of entry into the study. The first 3 participants must be ≥ 8 years of a…

For full eligibility, visit ClinicalTrials.gov.

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