drugset / Trial / NCT04254419

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

NCT04254419

Phase 1 Recruiting 18 enrolled Nationwide Children's Hospital
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2025-03-04
Primary completion
2030-12-31
Completion
2031-10

Drugs

EvaluationDrugModalityDoseRoute
Subject TROCULEUCEL Cell therapy 3 ml Other

Indications