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

  • STATUS
    Recruiting
  • End date
    Sep 1, 2024
  • participants needed
    160
  • sponsor
    Enlivex Therapeutics Ltd.
Updated on 17 September 2022
sepsis
pneumonia
antibiotics
fever
flank pain
tenderness
inflammatory response
organ failure
shock
nitrite
chills
hematuria
septic shock
urinary urgency
leukocyte esterase

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

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.

Details
Condition Sepsis, Community-acquired Pneumonia, Urinary Tract Infections, Cholecystitis, Acute, Cholangitis Acute, Intraabdominal Infections
Treatment Placebo, Allocetra-OTS
Clinical Study IdentifierNCT04612413
SponsorEnlivex Therapeutics Ltd.
Last Modified on17 September 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female ≥18 years and ≤90 years of age
Meets Sepsis 3 criteria
Sepsis due to infection in at least one of the below organs
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)
Adequate source control

Exclusion Criteria

Patients with acute pancreatitis
On chronic dialysis
SOFA score ≥ 10 at screening
Patients with nosocomial infection
A known malignancy
Known active symptomatic SARS-CoV-2 or chronic viral infections, such as HBV or HCV, HIV or other chronic infections
Chronic respiratory disease
Known active upper GI tract ulceration or hepatic dysfunction
Known NYHA class IV heart failure or unstable angina, ventricular arrhythmias, acute coronary disease or myocardial infarction
Known immunocompromised state or medications known to be immunosuppressive
Organ allograft or previous history of stem cell transplantation
Invasive ventilated patient and PaO2/FiO2 < 100 mmHg
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