Brief Title
A Phase 2 Study Evaluating Efficacy, Safety and Tolerability of Different Doses and Regimens of Allocetra-OTS for the Treatment of Organ Failure in Adult Sepsis Patients
Official Title
A Phase 2, Multi-Center, Randomized, Placebo-Controlled, Dose-Finding Study Evaluating Efficacy, Safety and Tolerability of Different Doses and Regimens of Allocetra-OTS for the Treatment of Organ Failure in Adult Sepsis Patients
Brief Summary
A Phase 2, Multi-Center, Randomized, Placebo-Controlled, Dose-Finding Study Evaluating
Efficacy, Safety and Tolerability of Different Doses and Regimens of Allocetra-OTS for the
Treatment of Organ Failure in Adult Sepsis Patients
Detailed Description
Allocetra-OTS is an immunomodulatory cell-based therapy consisting of allogeneic peripheral
blood mononuclear cells that have been modified to be engulfed by macrophages and reprogram
them into their homeostatic state.
This is a multi-center, randomized, placebo-controlled, dose-finding study comparing the
efficacy, safety and tolerability of different dosing regimens of Allocetra-OTS, in patients
with sepsis. The study aims to compare the safety and efficacy of different doses and
regimens of Allocetra-OTS, as well as the clinical manifestations following Allocetra-OTS
treatment, to that of Placebo in the treatment of organ failure in adult sepsis patients.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Efficacy: Change from baseline in SOFA score
Secondary Outcome
Ventilator-free days
Condition
Sepsis
Intervention
Allocetra-OTS
Study Arms / Comparison Groups
Cohort 1
Description: Single IV dose of placebo solution
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
160
Start Date
November 30, 2020
Completion Date
September 1, 2024
Primary Completion Date
July 1, 2023
Eligibility Criteria
Inclusion Criteria:
1. Male or female ≥18 years and ≤90 years of age.
2. Meets Sepsis 3 criteria
3. Sepsis due to infection in at least one of the below organs:
3.1. Community-Acquired Pneumonia (CAP). 3.2. Urinary tract infection 3.3. Acute
cholecystitis diagnosed by Tokyo criteria 3.4. Acute cholangitis diagnosed by Tokyo
criteria 3.5. Other intra-abdominal infections (IAI)
4. Adequate source control
Exclusion Criteria:
1. On chronic dialysis.
2. Patients with acute pancreatitis
3. Invasive ventilated patient and PaO2/FiO2 < 100 mmHg
4. SOFA score ≥ 10 at screening.
5. Patients with nosocomial infection.
6. A known malignancy.
7. Known active symptomatic SARS-CoV-2 or chronic viral infections, such as HBV or HCV,
HIV or other chronic infections.
8. Chronic respiratory disease.
9. Known active upper GI tract ulceration or hepatic dysfunction.
10. Known NYHA class IV heart failure or unstable angina, ventricular arrhythmias, acute
coronary disease or myocardial infarction.
11. Known immunocompromised state or medications known to be immunosuppressive.
12. Organ allograft or previous history of stem cell transplantation.
Gender
All
Ages
18 Years - 90 Years
Accepts Healthy Volunteers
No
Contacts
Pierre Singer, MD, 972-54-232-1982, [email protected]
Location Countries
Greece
Location Countries
Greece
Administrative Informations
NCT ID
NCT04612413
Organization ID
ENX-CL-02-002
Responsible Party
Sponsor
Study Sponsor
Enlivex Therapeutics Ltd.
Collaborators
Cato Research
Study Sponsor
Pierre Singer, MD, Principal Investigator, Rabin medical center, Belinson Campus, Petah Tiqwa Isarel
Verification Date
August 2022