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RECRUITING
NCT04254419
PHASE1

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

Sponsor: Nationwide Children's Hospital

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

12 Months - 39 Years

Study Type

INTERVENTIONAL

Enrollment

18

Start Date

2025-03-04

Completion Date

2031-10

Last Updated

2025-05-13

Healthy Volunteers

No

Interventions

BIOLOGICAL

NK 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