NCT03081780

Open Label NK Cell Infusion (FATE-NK100) With Subq IL-2 in Adults With AML

Open Label Dose Escalation Trial of an Adaptive Natural Killer (NK) Cell Infusion (FATE-NK100) With Subcutaneous IL-2 in Adults With Refractory or Relapsed Acute Myelogenous Leukemia (AML)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase I open-label dose escalation study of a single infusion of FATE-NK100 and a short course of subcutaneous interleukin-2 (IL-2) administered after lymphodepleting chemotherapy (CY/FLU) in subjects with refractory or relapsed acute myelogenous leukemia (AML). FATE-NK100 is a natural killer (NK) cell product that is enriched for NK cells with an "adaptive", or human cytomegalovirus (CMV)-induced, phenotype. The NK cell product is comprised of peripheral blood (PB) leukocytes sourced from a related donor (HLA-haploidentical or better but not fully HLA-matched) that is seropositive for cytomegalovirus (CMV+), and enriched for adaptive NK cells by depletion of CD3+ (T-lymphocytes) and CD19+ (B-lymphocytes) cells followed by ex-vivo culture expansion.

Conditions

• Refractory Acute Myelogenous Leukemia
• Relapsed Acute Myelogenous Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	FATE-NK100	Preparative regimen: * Fludarabine 25 mg/m2 x 5 days start Day -6 * Cyclophosphamide 60 mg/kg x 2 days on Day -5 and -4 Apheresis cell collection (collected from the Donor Day - 8) will be enriched for FATE-NK100 per CMC. IL-2 at 6 million IU subcutaneously (SC) every other day (EOD) for 6 doses with Dose 1 on Day 0 (no sooner than 4 hours post NK cells) and last dose no later than Day +12.

Timeline

• Start date: 2017-04-27
• Primary completion: 2020-08-01
• Completion: 2020-12-01
• First posted: 2017-03-16
• Last updated: 2021-03-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study