NKX101, Intravenous Allogeneic CAR NK Cells, in Adults With AML or MDS
brief summary
This is a single-arm, open-label, multi-center, Phase 1 study to determine safety and tolerability of an experimental therapy called NKX101 (allogeneic CAR NK cells targeting NKG2D ligands) in patients with relapsed/refractory AML or intermediate, high and very high risk relapsed/refractory MDS.
detailed description
This is a dose-finding study of NKX101 and will be conducted in 2 parts:
Part 1: dose finding with two dosing regimens, utilizing modified "3+3" enrollment schema.
Part 2: dose expansion to further evaluate safety and tolerability, cellular kinetics, pharmacodynamics and anti-tumor response in expansion cohorts of patients with either AML or MDS.
official title
A Phase 1 Study of NKX101, an Activating Chimeric Receptor Natural Killer Cell Therapy, in Subjects With Hematological Malignancies or Dysplasias