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

NCT04623944 Phase 1 ACTIVE_NOT_RECRUITING

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.

Details

Lead sponsor	Nkarta, Inc.
Phase	Phase 1
Status	ACTIVE_NOT_RECRUITING
Enrolment	61
Start date	2020-09-21
Completion	2039-07

Conditions

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

Interventions

• NKX101 - CAR NK cell therapy

Primary outcomes

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] — 30 days after last dose of NKX101
  Incidence, nature, and severity of treatment related adverse events will be evaluated. An adverse event is any unfavorable and unintended sign including clinically significant abnormal laboratory findings, symptom or disease.
• Response rate to NKX101 (for Part 2) — 28 days from first dose of NKX101
  Responses will be assessed per modified ELN criteria and will include complete and partial remission with and without varying degrees of hematologic recovery

Countries

United States