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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)

Trial Profile

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)

Status: Not yet recruiting
Phase of Trial: Phase I

Latest Information Update: 31 Jul 2020

At a glance

  • Drugs CK 0802 (Primary)
  • Indications Adult respiratory distress syndrome; COVID 2019 infections
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms RESOLVE
  • Sponsors Cellenkos
  • Most Recent Events

    • 10 Jul 2020 Status changed from planning to not yet recruiting.
    • 06 Jul 2020 According to a Cellenkos media release, this trial is anticipated to start in the third quarter of 2020.
    • 02 Jun 2020 According to a Cellenkos media release, Dr Siddhartha Mukherjee (MD, PhD, Columbia University, New York) is the scientific advisor and collaborator on this multi-center clinical trial.According to him planned correlative assays during the clinical trial will provide insights into the mechanism of action of CK0802 and its relation to clinical outcomes.

Trial Overview

Purpose

This Phase I, placebo-controlled study is designed to assess the safety and preliminary efficacy of cryopreserved cord blood-derived T-regulatory cells (CK0802) for treatment of COVID-19 associated acute respiratory distress syndrome (hospitalized patient population).

Primary Endpoints

Regimen related ≥ grade 3 toxicity within 48 hours of first infusion

description: Regimen related ≥ grade 3 toxicity within 48 hours of first infusion (DLT)
time_frame: 48 hours

28-day treatment success, defined as S28 [ Time Frame: 28 days]

Alive and not intubated 28 days after the date of first infusion

Other Endpoints

Time to extubation

description: Time to extubation
time_frame: 28 days

Oxygenation improvement

description: Oxygenation requirement (PaO2/FiO2) change between day 0 and day +11
time_frame: 11 days

Ventilator free days

description: Ventilator free days measured at day 28
time_frame: 28 days

Organ failure free days

description: Organ failure free days measured at day 28
time_frame: 28 days

ICU free days

description: ICU free days measured at day 28
time_frame: 28 days

All-cause mortality

description: All-cause mortality at day 28
time_frame: 28 days [1]

Diseases Treated

Indication Qualifiers Patient Segments
Adult respiratory distress syndrome treatment -
COVID 2019 infections treatment -

Subjects

  • Subject Type patients
  • Number

    Planned: 45

  • Sex male & female
  • Age Group ≥ 18 years; adult

Patient 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.

Patient 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.

Trial Details

Identifiers

Identifier Owner
NCT04468971 ClinicalTrials.gov: US National Institutes of Health
CK0802-501-1 -

Organisations

  • Sponsors Cellenkos
  • Affiliations Cellenkos

Trial Dates

  • Initiation Dates

    Planned : 30 Aug 2020

  • Primary Completion Dates

    Planned : 30 Sep 2021

  • End Dates

    Planned : 30 Sep 2021

Other Details

  • Design double-blind; multicentre; parallel; prospective; randomised
  • Phase of Trial Phase I
  • Location USA
  • Focus Adverse reactions; Therapeutic Use

Interventions

Drugs Route Formulation
CK 0802Primary Drug Intravenous Infusion

Arm 2

CK0802: 1x10^8 cells
Biological: CK0802 (Cryopreserved, off the shelf, cord blood derived T regulatory cells)

Arm 3

CK0802: 3x10^8 cells
Biological: CK0802 (Cryopreserved, off the shelf, cord blood derived T regulatory cells)

Arm 1

Excipient
Drug: Placebo (Expicient)

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Darryl Adams, MD Columbia University USA
Douglas Gladstone, MD Johns Hopkins Hospital USA
Jason Mock, MD, PhD University of North Carolina USA
Kevin Harris, MD Wake Forest University USA
Tara Sadeghi
7138064787
tara.sadeghi@cellenkosinc.com
show details
Cellenkos Inc.
-

Centres

Centre Name Location Trial Centre Country
Cellenkos Inc.
-
-
Columbia University New York, New York USA
Johns Hopkins Hospital Baltimore, Maryland USA
University of North Carolina Chapel Hill, North Carolina USA
Wake Forest University Winston-Salem, North Carolina USA

Trial History

Event Date Event Type Comment
31 Jul 2020 Other trial event Last checked against ClinicalTrials.gov: US National Institutes of Health record. Updated 31 Jul 2020
16 Jul 2020 Other trial event New source identified and integrated:(ClinicalTrials.gov: US National Institutes of Health: NCT04468971). Updated 16 Jul 2020
10 Jul 2020 Status change - not yet recruiting Status changed from planning to not yet recruiting. Updated 16 Jul 2020
06 Jul 2020 Other trial event According to a Cellenkos media release, this trial is anticipated to start in the third quarter of 2020. Updated 08 Jul 2020
02 Jun 2020 Other trial event According to a Cellenkos media release, Dr Siddhartha Mukherjee (MD, PhD, Columbia University, New York) is the scientific advisor and collaborator on this multi-center clinical trial.According to him planned correlative assays during the clinical trial will provide insights into the mechanism of action of CK0802 and its relation to clinical outcomes. Updated 08 Jun 2020
02 Jun 2020 Other trial event According to a Cellenkos media release, the US Food and Drug Administration (FDA) has cleared the way to initiate this Phase 1 clinical trial of CK0802 (Cryopreserved Cord Blood Derived T-Regulatory Cells) for treatment of COVID-19 associated acute respiratory distress syndrome (ARDS). Updated 08 Jun 2020
18 Mar 2020 New trial record New trial record Updated 18 Mar 2020
17 Mar 2020 Other trial event According to a Cellenkos media release, the company has submitted a clinical development proposal to the Biomedical Advanced Research and Development Authority (BARDA) to start this study. Updated 18 Mar 2020

References

  1. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2016;.

    Available from: URL: http://clinicaltrials.gov
  2. Cellenkos. Cellenkos Inc. Focuses on the Development of Cell-Therapy for Treatment of COVID-19 Mediated Acute Respiratory Distress Syndrome (CoV-ARDS). Media-Rel 2020;.

    Media Release
  3. Cellenkos. Cellenkos(R) Inc. Announces FDA Clearance to Initiate Phase 1 Double- Blinded, Randomized, Placebo-Controlled Trial of Cryopreserved Cord Blood-Derived T-Regulatory Cells (CK0802) for Treatment of COVID-19 Associated Acute Respiratory Distress Syndrome. Media-Rel 2020;.

    Media Release
  4. Johns Hopkins University. Johns Hopkins Reports Promising Clinical Data in COVID-19 ARDS Treated with Cellenkos' Cord Blood T-Regulatory Cells. Media-Rel 2020;.

    Media Release
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