Study Evaluating Safety and Tolerability of Allocetra-OTS in Patients With COVID-19

NCT04659304 | Unknown Phase 1 DMC

• 1 other identifier: ENX-CL-03-001
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief Summary

Phase 1b, multi-center, open label, sequential dose escalation trial assessing 3 dose cohorts using a 3+3 design to evaluate safety and tolerability of Allocetra-OTS in adult patients with moderate COVID-19. The sample size for this trial is anticipated to range from 9 to 18 patients.

Conditions

Covid19

Keywords

Cell therapy; Allocetra-OTS

Outcome Measures

Primary Outcomes (2)

• Safety - Adverse Events

  Number and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs).

  28 days

• Maximum Tolerated Dose (MTD)

  The highest dose of Allocetra-OTS that did not cause a Dose-Limiting Toxicity (DLT) in 2/6 cohort patientsor maximally administered dose if no DLT is seen.

  28 days

Secondary Outcomes (4)

• Efficacy - PaO2 or SO2/FiO2 Ratio

  28 days

• Efficacy - mortality

  28 days

• Efficacy - organ function / support measurements

  28 days

• Efficacy - NEWS2 Score

  28 days

Study Arms (3)

Cohort 1

ACTIVE COMPARATOR

Single Intravenous (IV) dose of Allocetra-OTS with 5x10\^9 cells

Drug: Allocetra-OTS

Cohort 2

ACTIVE COMPARATOR

Single Intravenous (IV) dose of Allocetra-OTS with 10x10\^9 cells

Drug: Allocetra-OTS

Cohort 3

ACTIVE COMPARATOR

Two IV doses of Allocetra-OTS with 10x10\^9 cells in each dose

Drug: Allocetra-OTS

Interventions

Allocetra-OTS DRUG

Cell-based therapy comprised of allogeneic non-HLA matched peripheral blood mononuclear cells induced to an early apoptotic state.

Cohort 1; Cohort 2; Cohort 3

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female \> 18 and \< 80 years of age.
• Laboratory confirmation of SARS-CoV-2 infection by RT-PCR from any diagnostic sampling source.
• Patient hospitalized due to COVID-19 in the last 24 hours.
• Hospitalized patients meeting the criteria for moderate COVID-19, as set forth by the May 2020 FDA Guidance for Industry: COVID-19: Developing Drugs and Biological Products for Treatment or Prevention, Patients with symptoms of moderate illness with COVID-19, which could include any symptom of mild illness (such as fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, without shortness of breath or dyspnea) or shortness of breath with exertion with at least one of the following clinical signs:
• Respiratory rate: ≥ 20 breaths/minute;
• SpO2: \> 93% on room air at sea level;
• Heart rate: ≥ 90 beats/minute;
• Signed written informed consent by the patient.
• Women and men who are of childbearing potential, willing to use acceptable contraceptive measures during 4 weeks from enrolment .

You may not qualify if:

• Any signs indicative of Severe or Critical Illness Severity requiring hospitalization as defined below:
• Severe COVID-19: Shortness of breath in rest, or respiratory distress, or respiratory rate (RR≥30 per minute , or heart rate (HR) ≥125 bpm, or SpO2≤93% on room air at sea level or PaO2/FiO2\<300
• Critical COVID-19- at least one of the following:
• Respiratory failure required at least one of the following: mechanical ventilation, oxygen delivered by high-flow nasal cannula, noninvasive positive pressure ventilation, ECMO.
• Shock
• Multi-organ dysfunction/failure.
• Women who are pregnant or breast feeding.
• Weight \<50 kg or \>110 kg.
• Stage 4 and 5 severe chronic kidney disease or requiring dialysis with eGFR \< 30 ml/min.
• Patients with active malignant tumor.
• Patients who are participating in other concurrent investigational clinical trials or have been treated with any experimental agents within 30 days prior to enrollment.
• Known active chronic viral infections including, but not limited to, active HBV, HCV, or HIV/AIDS or other chronic infections.
• Based on medical history and concomitant therapies that would suggest infection, have suspected clinical diagnosis of current active TB or, if known, latent TB treated for less than 4 weeks with appropriate anti-TB therapy per institutional guidelines; Based on medical history and concomitant therapies that would suggest infection, suspected serious, active bacterial, fungal, viral (including, but not limited to, active HBV, HCV, or HIV/AIDS).
• Known immunocompromised state or immunosuppressing medications taken for indications other than SARS-CoV-2 (i.e., agents including chronic corticosteroids \> 10 mg/day, azathioprine, cyclosporine, cyclophosphamide).
• Known New York Heart Association (NYHA) class III and IV heart failure or unstable angina, ventricular arrhythmias, active ischemic heart disease , or myocardial infarction within six months prior to diagnosis of COVID-19.

Sponsors & Collaborators

• Enlivex Therapeutics Ltd.: lead

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Oren Hershkovitz, PhD

  Enlivex Therapeutics R&D

  STUDY DIRECTOR

Central Study Contacts

Odelia Ben Shitrit, MBA

CONTACT

972-548887609; odelia@enlivexpharm.com

Lior Binder

CONTACT

972-548054899; lior@enlivexpharm.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: sequential dose escalation using a 3+3 design

Study Record Dates

• First Submitted: December 7, 2020
• First Posted: December 9, 2020
• Study Start: December 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: December 1, 2022
• Last Updated: August 18, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share