This study is being done to determine the highest tolerated dose of an investigational cell therapy called DVX201 in patients hospitalized with COVID-19. DVX201 is an allogeneic NK (natural killer) cell therapy. NK cells are a normal part of your immune system that have the ability to identify and kill cells in the body that are infected by viruses such as COVID-19. There is evidence that both NK cell exhaustion and low numbers of NK cell in the blood occur in COVID-19 patients, and this may contribute to worsening of the infection. Therefore, infusion of healthy functional NK cells (like DVX201) may help overcome COVID-19 infection and prevent progression of the disease. This study is being done to look at the safety and tolerability of DVX201 in patients with COVID-19 and to gather information on how COVID-19 responds to treatment with DVX201.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Single infusion of DVX201, an allogeneic NK cell therapy derived from CD34+ hematopoietic stem cells
Fred Hutch/University of Washington Medical Center
Seattle, Washington, United States
Incidence of dose limiting toxicities (DLT)
DLTs defined as grade 3 or greater infusion related reactions within 24 hours and any treatment emergent toxicity grade 3 or greater within 7 days apart from known complications of COVID-19
Time frame: 7 days
reduction/clearance of viral load/viral shedding
time in days to clearance of virus
Time frame: through study completion, an average of 28 days post cell infusion
Oxygen requirements
Time in days on supplemental oxygen and time in days to resolution of hypoxia
Time frame: through study completion, an average of 28 days post cell infusion
Disease progression
Incidence of disease progression to ICU admission and/or ventilatory support
Time frame: through study completion, an average of 28 days post cell infusion
CRS
Incidence of cytokine release syndrome requiring clinical intervention
Time frame: through study completion, an average of 28 days post cell infusion
hospital discharge
Time in days post infusion of DVX201 to hospital discharge
Time frame: through study completion, an average of 28 days post cell infusion
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