RecruitingPhase 1NCT04254419

Phase 1 Study of Locoregional Injections of Ex Vivo Expanded Natural Killer Cells

Phase 1 Study of Locoregional Injections of Ex Vivo Expanded Natural Killer Cells in Children and Young Adults With Recurrent, Progressive, or Refractory Brain Tumors


Sponsor

Nationwide Children's Hospital

Enrollment

18 participants

Start Date

Mar 4, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Each patient will receive up to 12 cycles of TGFβi NK cell infusions. Each cycle will be of 4 weeks duration. During the first 3 weeks, TGFβi NK cells will be infused once weekly. The 4th week will be a rest week. TGFβi NK cell infusions should be delivered at least 3 days apart (e.g., Friday of Week 1 and Monday of Week 2). Dose will be escalated in an inter-patient stepwise fashion consisting of 3 dose levels.


Eligibility

Min Age: 12 MonthsMax Age: 39 Years

Plain Language Summary

Simplified for easier understanding

This early-phase study is testing whether natural killer (NK) cells — immune cells taken from donors, grown in large numbers in a lab, and then injected directly into or around a brain tumor — are safe and can help fight brain cancers that have come back or stopped responding to treatment. **You may be eligible if:** - You have a brain tumor (confirmed by biopsy) that has come back, progressed, or is not responding to treatment - Your cancer is not a diffuse midline glioma or DIPG type - Your surgeon believes you are a candidate for placement of a small device (Ommaya reservoir) directly in or near the tumor - You meet performance and health criteria set by the study team **You may NOT be eligible if:** - You have diffuse intrinsic pontine glioma (DIPG) or diffuse midline glioma - The resection cavity or tumor is too small for safe device placement - You have significant other health conditions preventing participation 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALNK cells

The universal donor TGFβi NK cells will be cryopreserved until they are delivered bedside for infusion. The trained staff will thaw the product by the bedside. The administration of the cells will be done via an Ommaya intra-cavitary/a programable ventriculoperitoneal (VP) shunt. Once the infusion is ready for administration patients will be admitted to the infusion unit for monitoring. NK cells will be administered through the Ommaya/VP shunt in approximately 3 milliliters over approximately 2-5 minutes; followed by 1.5-2 milliliter preservative-free normal saline flush over approximately 1 minute.


Locations(1)

Nationwide Children's Hospital

Columbus, Ohio, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04254419


Related Trials