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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 | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

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

NCT04612413•Enlivex Therapeutics Ltd.

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 90 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or female ≥18 years and ≤90 years of age.
•2. Meets Sepsis 3 criteria with a SOFA score ≥5 above pre-admission status
•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) 3.6. Skin or soft tissue infection
•4. Adequate source control

Exclusion Criteria

•1. Sepsis due to infection other than lung infection, UTI, IAI, skin/soft tissue infection or sepsis patients where site of infection is unclear or unknown.
•2. On chronic dialysis.
•3. Patients with acute pancreatitis
•4. Moribund patients
•5. Weight \<50 kg or \>120 kg or BMI \>40 kg/m\^2.
•6. SOFA score ≥14 at screening.
•7. Patients with nosocomial infection.
•8. A known malignancy.
•9. Patients with end-stage disease (unrelated to sepsis)
•10. Known active symptomatic SARS-CoV-2 or chronic viral infections, such as HBV or HCV, HIV or other chronic infections.
+5 more criteria

Locations (31)

Clinique Saint-Pierre

Brussels, Belgium

Saint-Luc Hospital University

Brussels, Belgium

CHU de Charleroi

Charleroi, Belgium

Ziekenhuis Oost-Limburg

Genk, Belgium

CHU d'Angers

Angers, France

Vendee Departmental Hospital Center

La Roche-sur-Yon, France

University Hospital of Limoges

Limoges, France

CHU de Montpellier

Montpellier, France

CHU de Nantes

Nantes, France

Bretonneau Hospital

Paris, France

Key Dates

Start Date

November 30, 2020

Primary Completion Date

January 12, 2024

Completion Date

December 16, 2024

Last Updated

August 19, 2025

Enrollment

148

ACTUAL participants

Conditions

SepsisCommunity-acquired PneumoniaUrinary Tract InfectionsCholecystitis, AcuteCholangitis AcuteIntraabdominal Infections

Interventions

Allocetra-OTS

DRUG

Placebo

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 19, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

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