NCT04623944

NKX101, Intravenous Allogeneic CAR NK Cells, in Adults With AML or MDS

A Phase 1 Study of NKX101, an Activating Chimeric Receptor Natural Killer Cell Therapy, in Subjects With Hematological Malignancies or Dysplasias

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Nkarta, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Relapsed/Refractory AML
• AML, Adult
• MDS
• Refractory Myelodysplastic Syndromes

Interventions

Type	Name	Description
BIOLOGICAL	NKX101 - CAR NK cell therapy	NKX101 is an investigational allogeneic CAR NK product targeting NKG2D ligands on cancer cells. Part 2 will use the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of NKX101 as determined in Part 1.

Timeline

• Start date: 2020-09-21
• Primary completion: 2024-10-02
• Completion: 2039-07-01
• First posted: 2020-11-10
• Last updated: 2024-12-27

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study