NCT04797975

Off-the-shelf NK Cells (KDS-1000) as Immunotherapy for COVID-19

A Phase 1/2a Multicenter Randomized Double-blind Placebo-controlled Trial of Off-the-shelf Natural Killer Cells (KDS-1000) as Immunotherapy for Adult Patients With Mild to Moderate COVID-19 Symptoms at Risk for Complications

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Kiadis Pharma · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

It is hypothesized that immunotherapy with off-the-shelf NK cells (KDS-1000) early in the course of COVID-19 disease is safe and may augment innate immunity, thereby limiting disease progression and improving survival.

Detailed description

Several publications have suggested a potential role of NK cells, an essential part of the early innate response system, in the management of viral infections like COVID-19. Clinical data has shown that COVID-19 disease severity is correlated with a reduction in the number of NK cells, exhaustion of NK cells and the lack of certain mature, potent NK cell phenotypes. The power of NK cells to fight various other viral infections, such as caused by CMV, HBV and hepatitis C virus (HCV), influenza virus and human immunodeficiency virus (HIV) have been well described, with a durable change in the NK cell profile towards those more mature and potent phenotypes in recovered patients. In view of the lack of (functional) NK cells in patients with COVID-19, adoptive NK cell therapy with KDS-1000 cells may improve survival and reduce rates of disease progression from SARS-CoV-2 infection. Adoptive transfer of expanded NK cells (KDS-1000) early in the course of disease may augment innate immunity, thereby limiting disease progression and could confer a survival benefit to patients infected with SARS-CoV-2.

Conditions

• Covid19

Interventions

Type	Name	Description
BIOLOGICAL	KDS-1000	Non-randomized part of study: * At the beginning of each dose level (Cohort), 3 patients will receive KDS-1000. These initial patients will be enrolled in a staggered manner to ensure detection of any early safety signals. Randomized part of the study (Can start when there are no safety concerns in the non-randomized cohorts): * Cohort 1: Low Dose, 2x10E8 cells/dose * Cohort 2: High Dose, 1x10E9 cells/dose
OTHER	Placebo	0.9% Normal Saline

Timeline

• Start date: 2020-12-01
• Primary completion: 2021-04-01
• Completion: 2021-04-01
• First posted: 2021-03-15
• Last updated: 2021-08-30

Regulatory

• FDA-regulated drug study