NCT01884688

UARK 2013-05 A Study of Autologous Expanded Natural Killer Cell Therapy for Asymptomatic Multiple Myeloma

A Phase II Study of Autologous Expanded Natural Killer Cell Therapy for Asymptomatic Multiple Myeloma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: University of Arkansas · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safety and in vivo persistence and expansion of autologous and expansion of autologous, ex vivo expanded-natural killer(ENK) cells.

Detailed description

To determine whether significant in vivo expansion of auto-ENK cells occurs, defined as a \> 4 fold increase in absolute cluster of differentiation 3(CD3)-cluster of differentiation 56 (CD56+) NK cell count/blood 7 days after infusion over the pre-study baseline level and the safety of the ENK cell therapy in research participants with high-risk asymptomatic multiple myeloma (AMM) defined as gene expression profile (GEP) 70 gene score\>-0.26.

Conditions

• Asymptomatic Multiple Myeloma

Interventions

Type	Name	Description
DRUG	ENK Cell Infusion	Day 0(1 dose) ENK Cell Infusion Day 0 to + 12 (13 doses) Aldesleukin (IL2), 3x10 IU

Timeline

• Start date: 2013-04-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2013-06-24
• Last updated: 2017-04-17
• Results posted: 2017-04-17

Locations

1 site across 1 country: United States