Allogeneic Natural Killer (NK) Cell Therapy in Subjects Hospitalized for COVID-19

COVID-19 Pneumonia Clinical Trial

Official title:

A Phase 1 Study of DVX201, an Allogeneic Natural Killer (NK) Cell Therapy in Subjects Hospitalized for COVID-19

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04900454
• Other study ID #: DVX201-COV-01
• Secondary ID: RG1121470
• Status: Completed
• Phase: Phase 1
• Start date: August 1, 2021
• Est. completion date: July 1, 2022

Study information

• Verified date: March 2024
• Source: Coeptis Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 1, 2022
• Est. primary completion date: June 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Be capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent

2. Be between 18 and 80 years of age and weigh at least 40 kg, inclusive, at time of informed consent

3. Be confirmed positive for COVID-19 (SARS-CoV-2) infection as determined by validated clinical PCR assay or by a hospital validated serological test within 7 days of consent

4. Symptomatic onset within 7 days of signing consent

5. Require hospitalization and meet the following:

1. Radiographic infiltrates by imaging (chest x-ray, CT scans)

2. Able to maintain a SpO2 = 93% at rest. Supplemental oxygen to a maximum 4L by low flow O2-delivery is allowed, but not required

3. Meet 2 out of the 3 following criteria:

i. IL-6 < 150 pg/mL ii. CRP < 100 mg/L (10 mg/dL) iii. Ferritin < 1000 ng/mL

6. Women/men of reproductive potential must have agreed to use an effective contraceptive method during the study and for a minimum of 90 days after study treatment

Exclusion Criteria:

1. Weight less than 40 kg

2. Be ventilator dependent or be diagnosed with ARDS or multi-system organ failure

3. Have elevated oxygen requirement exceeding 4L oxygen by nasal cannula

4. Expected intubation within 24 hours per investigators assessment

5. Expected discharge from hospital within 72 hours of planned DVX201 date of infusion

6. Have a known hypersensitivity to constituents of DVX201, such as DMSO or atinhistamine medications

7. Have a history of symptomatic pulmonary or chronic pulmonary disease or severe asthma on chronic therapy for treatment

8. Have a history of baseline requirement of supplemental oxygen prior to COVID-19 diagnosis

9. Active autoimmune disorder or other medical condition requiring systemic immunosuppressive therapy (including steroids at > 5 mg prednisone or equivalent daily)

10. Be pregnant or breast-feeding

11. Have inadequate organ function as defined by:

1. Acute or chronic kidney injury requiring intermittent or continuous venovenous hemodialysis or estimated GFR of < 60 mL/min/1.73 m2

2. Abnormal liver function defined by AST (aspartate aminotransferase), ALT (alanine aminotransferase) or alkaline phosphatase = 5 times the upper limit of normal

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Pneumonia

Intervention

Biological:
• DVX201
Single infusion of DVX201, an allogeneic NK cell therapy derived from CD34+ hematopoietic stem cells

Locations

Country	Name	City	State
United States	Fred Hutch/University of Washington Medical Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Coeptis Therapeutics	Fred Hutchinson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Length of time that DVX201 (NK cells) remain in the blood	Evaluation of persistence of DVX201 in the peripheral blood	through 28 days post infusion
Primary	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	7 days
Secondary	reduction/clearance of viral load/viral shedding	time in days to clearance of virus	through study completion, an average of 28 days post cell infusion
Secondary	Oxygen requirements	Time in days on supplemental oxygen and time in days to resolution of hypoxia	through study completion, an average of 28 days post cell infusion
Secondary	Disease progression	Incidence of disease progression to ICU admission and/or ventilatory support	through study completion, an average of 28 days post cell infusion
Secondary	CRS	Incidence of cytokine release syndrome requiring clinical intervention	through study completion, an average of 28 days post cell infusion
Secondary	hospital discharge	Time in days post infusion of DVX201 to hospital discharge	through study completion, an average of 28 days post cell infusion