REgulatory T Cell infuSion fOr Lung Injury Due to COVID-19 PnEumonia (RESOLVE)

• ClinicalTrials.gov Identifier: NCT04468971
• Recruitment Status: Active, not recruiting
• First Posted: July 13, 2020
• Last Update Posted: June 22, 2021
• Sponsor: Cellenkos, Inc.
• Information provided by (Responsible Party): Cellenkos, Inc.

Study Description

Brief Summary:

To assess the safety and efficacy of CK0802 in treatment of patients with COVID-19 induced moderate-to-severe PNA-ARDS.

Condition or disease	Intervention/treatment	Phase
COVID19; ARDS	Biological: CK0802; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 45 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Multi-center, prospective, double-blinded, placebo controlled Phase 1 randomized clinical trial.
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Phase 1 Double-Blinded, Randomized, Placebo Controlled Safety and Early Efficacy Trial of Cryopreserved Cord Blood Derived T-Regulatory Cell Infusions (CK0802) In The Treatment Of COVID-19 Induced Acute Respiratory Distress Syndrome (ARDS)
• Actual Study Start Date: September 29, 2020
• Estimated Primary Completion Date: September 30, 2021
• Estimated Study Completion Date: September 30, 2021

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Arm 1; Excipient	Drug: Placebo; Expicient
Experimental: Arm 2; CK0802: 1x10^8 cells	Biological: CK0802; Cryopreserved, off the shelf, cord blood derived T regulatory cells
Experimental: Arm 3; CK0802: 3x10^8 cells	Biological: CK0802; Cryopreserved, off the shelf, cord blood derived T regulatory cells

Outcome Measures

Primary Outcome Measures :

1. Regimen related ≥ grade 3 toxicity within 48 hours of first infusion [ Time Frame: 48 hours ]
   Regimen related ≥ grade 3 toxicity within 48 hours of first infusion (DLT)
2. 28-day treatment success, defined as S28 [ Time Frame: 28 days ]
   Alive and not intubated 28 days after the date of first infusion

Secondary Outcome Measures :

1. Time to extubation [ Time Frame: 28 days ]
   Time to extubation
2. Oxygenation improvement [ Time Frame: 11 days ]
   Oxygenation requirement (PaO2/FiO2) change between day 0 and day +11
3. Ventilator free days [ Time Frame: 28 days ]
   Ventilator free days measured at day 28
4. Organ failure free days [ Time Frame: 28 days ]
   Organ failure free days measured at day 28
5. ICU free days [ Time Frame: 28 days ]
   ICU free days measured at day 28
6. All-cause mortality [ Time Frame: 28 days ]
   All-cause mortality at day 28

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Documented to have an RT-PCR-based diagnosis of SARS-CoV-2 infection by RT-PCR
• Moderate-to-severe ARDS as defined by the Berlin Criteria: ratio of partial pressure of arterial oxygen (PaO2) to the fraction of inspired oxygen (FiO2) of 200 mm Hg or less assessed with a positive end-expiratory pressure (PEEP) of >5 cm H2O.
• Intubated for less than 120 hours
• Age ≥18 years
• Ability to provide informed consent or duly appointment health care proxy with the authority to provide informed consent.

Exclusion Criteria:

1. In the opinion of the investigator, unlikely to survive for >48 hours from screening.
2. Any physical examination findings and/or history of any illness that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the patient by their participation in the study.
3. Currently receiving extracorporeal membrane oxygenation (ECMO) or high frequency oscillatory ventilation (HFOV).
4. Females who are pregnant.
5. Patients with active bacteremia at start of therapy enrollment or concurrently active moderate to severe other infectious which in the opinion of the investigator may possibly affect the safety of CK0802 treatment.
6. Patients who have been intubated for more than 120 hours.
7. Known hypersensitivity to DMSO or to porcine or bovine protein.
8. Any end-stage organ disease which in the opinion of the investigator may possibly affect the safety of CK0802 treatment.
9. High dose steroids.
10. Receiving an investigational cellular therapy agent.

Contacts and Locations

Locations

United States, Maryland

Johns Hopkins Hospital

Baltimore, Maryland, United States, 21287

United States, New York

Columbia University

New York, New York, United States, 10027

United States, North Carolina

University of North Carolina

Chapel Hill, North Carolina, United States, 27514

Wake Forest University

Winston-Salem, North Carolina, United States, 27157

United States, Texas

Baylor College of Medicine, St Luke's Hospital

Houston, Texas, United States, 77005

Sponsors and Collaborators

Cellenkos, Inc.

More Information

• Responsible Party: Cellenkos, Inc.
• ClinicalTrials.gov Identifier: NCT04468971
• Other Study ID Numbers: CK0802.501.1
• First Posted: July 13, 2020
• Last Update Posted: June 22, 2021
• Last Verified: September 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Cellenkos, Inc.:

COVID19; ARDS; CK0802; T regulatory cells; cord blood