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

Primary Purpose

COVID-19 Pneumonia

Status

Unknown status

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

DVX201

About this trial

This is an interventional treatment trial for COVID-19 Pneumonia focused on measuring NK cells, Cell therapy, Allogeneic

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Be capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent
Be between 18 and 80 years of age and weigh at least 40 kg, inclusive, at time of informed consent
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
Symptomatic onset within 7 days of signing consent
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
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:

Weight less than 40 kg
Be ventilator dependent or be diagnosed with ARDS or multi-system organ failure
Have elevated oxygen requirement exceeding 4L oxygen by nasal cannula
Expected intubation within 24 hours per investigators assessment
Expected discharge from hospital within 72 hours of planned DVX201 date of infusion
Have a known hypersensitivity to constituents of DVX201, such as DMSO or atinhistamine medications
Have a history of symptomatic pulmonary or chronic pulmonary disease or severe asthma on chronic therapy for treatment
Have a history of baseline requirement of supplemental oxygen prior to COVID-19 diagnosis
Active autoimmune disorder or other medical condition requiring systemic immunosuppressive therapy (including steroids at > 5 mg prednisone or equivalent daily)
Be pregnant or breast-feeding
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

Sites / Locations

Fred Hutch/University of Washington Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DVX201 infusion

Arm Description

Subjects will enroll and the MTD and/or the recommended phase 2 dose of DVX201 will be determined utilizing a modified "3+3" enrollment schema. This study will enroll a minimum 3 subjects who each receive a single dose of DVX201 and who are evaluable for toxicities at each dose level. Depending on the occurrence of DLTs and the number of dose levels evaluated, additional subjects may be enrolled (approximately 3-15 additional subjects). All subjects will be followed for 28 days post infusion of DVX201.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

reduction/clearance of viral load/viral shedding

time in days to clearance of virus

Oxygen requirements

Time in days on supplemental oxygen and time in days to resolution of hypoxia

Disease progression

Incidence of disease progression to ICU admission and/or ventilatory support

CRS

Incidence of cytokine release syndrome requiring clinical intervention

hospital discharge

Time in days post infusion of DVX201 to hospital discharge

Full Information

NCT ID

NCT04900454

First Posted

May 20, 2021

Last Updated

February 11, 2022

Sponsor

Deverra Therapeutics, Inc.

Collaborators

Fred Hutchinson Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT04900454

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Unknown status

Study Start Date

August 2, 2021 (Actual)

Primary Completion Date

October 31, 2022 (Anticipated)

Study Completion Date

December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Deverra Therapeutics, Inc.

Collaborators

Fred Hutchinson Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19 Pneumonia

Keywords

NK cells, Cell therapy, Allogeneic

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Model Description

This is an, open-label, non-randomized Phase 1 dose-finding study of DVX201 in patients hospitalized with COVID-19. Subjects will enroll and the MTD and/or the RP2D of DVX201 will be determined utilizing a modified "3+3" enrollment schema.

Masking

None (Open Label)

Allocation

N/A

Enrollment

18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

DVX201 infusion

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

DVX201

Intervention Description

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

Primary Outcome Measure Information:

Title

Incidence of dose limiting toxicities (DLT)

Description

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

Secondary Outcome Measure Information:

Title

reduction/clearance of viral load/viral shedding

Description

time in days to clearance of virus

Time Frame