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

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.

NCT Number	NCT04254419
Lead Sponsor	Nationwide Children's Hospital
Conditions	High Grade Glioma
Enrollment	18 participants
Start Date	2025-03-04
Primary Completion	2030-12-31 (estimated)
Study Completion	2031-10 (estimated)
Updated on ClinicalTrials.gov	2025-05-13