drugset / Trial / NCT02781467

A Safety Study of Human Cord Blood Derived, Culture Expanded Natural Killer Cell (PNK-007) Infusion With Subcutaneous Recombinant Human IL-2 (rhIL-2) in Adults With Relapsed and/or Refractory Acute Myeloid Leukemia (AML)

NCT02781467

Phase 1 Terminated 10 enrolled Celularity Incorporated
NaSingle-groupOpen-labelTreatment

Summary

This study will find the highest acceptable treatment dose of cord blood, culture expanded natural killer (NK) cells, a kind of immune cell, in patients with relapsed and/or refractory acute myeloid leukemia. The NK cells will be given with chemotherapy and Recombinant human interleukin 2 (rhIL-2) to help the NK cells expand in the body. The safety of this treatment will be studied and researchers want to learn if NK cells will help in treating the AML.

Timeline

Start
2016-07-11
Primary completion
2017-12-07
Completion
2017-12-07

Drugs

EvaluationDrugModalityDoseRoute
Subject flt3 ligand Protein / enzyme biologic Intravenous
Background Cyclophosphamide Other / unclassified
Background Fludarabine Small molecule
Background Human recombinant Interleukin-2 Protein / enzyme biologic Subcutaneous