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

NCT04612413 | Completed Phase 2 DMC

• 1 other identifier: ENX-CL-02-002
• Study Type: interventional
• Target: 148
• Locations: 5 countries
• Sites: 31

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

Conditions

Sepsis; Community-acquired Pneumonia; Urinary Tract Infections; Cholecystitis, Acute; Cholangitis Acute; Intraabdominal Infections

Outcome Measures

Primary Outcomes (2)

• Efficacy: Change from baseline in SOFA score

  Change from baseline in SOFA score throughout 28 days

  28 days

• Safety: Number and severity of AEs and SAEs

  Number and severity of AEs and SAEs throughout 28 days follow up period

  28 days

Secondary Outcomes (9)

• Ventilator-free days

  28 days

• Vasopressor-free days

  28 days

• Days without renal replacement therapy (dialysis).

  28 days

• Time in ICU and time in hospital

  28 days

• Number of days with creatinine ≤ Baseline levels +20%

  28 days

Study Arms (4)

Cohort 1

PLACEBO COMPARATOR

Single IV dose of placebo solution

Other: Placebo

Cohort 2

EXPERIMENTAL

Single IV dose of 5x10\^9 Allocetra-OTS cells in suspension

Drug: Allocetra-OTS

Cohort 3

EXPERIMENTAL

Single IV dose of 10x10\^9 Allocetra-OTS cells in suspension

Drug: Allocetra-OTS

Cohort 4

EXPERIMENTAL

Single or two doses of 10x10\^9 Allocetra-OTS cells in suspension

Drug: Allocetra-OTS

Interventions

Allocetra-OTS DRUG

Allocetra-OTS is a cell-based therapy consisting of non-HLA-matched allogeneic peripheral blood mononuclear cells, derived from a healthy human donor following a leukapheresis procedure, induced to an apoptotic stable state and suspended in a solution containing DMSO.

Cohort 2; Cohort 3; Cohort 4

Placebo OTHER

Solution containing all excipients except for the Allocetra-OTS cells

Cohort 1

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female ≥18 years and ≤90 years of age.
• Meets Sepsis 3 criteria with a SOFA score ≥5 above pre-admission status
• Sepsis due to infection in at least one of the below organs:
• 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
• Adequate source control

You may not qualify if:

• 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.
• On chronic dialysis.
• Patients with acute pancreatitis
• Moribund patients
• Weight \<50 kg or \>120 kg or BMI \>40 kg/m\^2.
• SOFA score ≥14 at screening.
• Patients with nosocomial infection.
• A known malignancy.
• Patients with end-stage disease (unrelated to sepsis)
• 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.

Sponsors & Collaborators

• Enlivex Therapeutics Ltd.: lead

Study Sites (31)

Clinique Saint-Pierre

Brussels, Belgium

Location

Saint-Luc Hospital University

Brussels, Belgium

Location

CHU de Charleroi

Charleroi, Belgium

Location

Ziekenhuis Oost-Limburg

Genk, Belgium

Location

CHU d'Angers

Angers, France

Location

Vendee Departmental Hospital Center

La Roche-sur-Yon, France

Location

University Hospital of Limoges

Limoges, France

Location

CHU de Montpellier

Montpellier, France

Location

CHU de Nantes

Nantes, France

Location

Bretonneau Hospital

Paris, France

Location

Centre Hospitalier Victor Dupouy

Paris, France

Location

Reims University Hospital Robert Debre

Reims, France

Location

CHU de Rennes

Rennes, France

Location

Strasbourg University Hospital

Strasbourg, France

Location

Soroka Medical Center

Beersheba, Israel

Location

Hillel Yaffe Medical Center

Hadera, Israel

Location

Bnai Zion Medical Center

Haifa, Israel

Location

Hadassah Ein Kerem Medical Center

Jerusalem, Israel

Location

Beilinson Medical Center

Petah Tikva, Israel

Location

Ziv Medical Center

Safed, Israel

Location

Poriya Medical Center

Tiberias, Israel

Location

Canisius Wilhelmina Hospital

Nijmegen, Netherlands

Location

Radboud UMC

Nijmegen, Netherlands

Location

Clinic Barcelona University Hospital

Barcelona, Spain

Location

University Hospital Sagrat Cor

Barcelona, Spain

Location

Vall d'Hebron

Barcelona, Spain

Location

Getafe University Hospital

Getafe, Spain

Location

Dr. Josep Trueta University Hospital

Girona, Spain

Location

University Hospital Arnau de Vilanova of Lleida

Lleida, Spain

Location

General University Hospital Gregorio Maranon

Madrid, Spain

Location

University Hospital Joan XXIII of Tarragona

Tarragona, Spain

Location

MeSH Terms

Conditions

Sepsis; Community-Acquired Pneumonia; Urinary Tract Infections; Cholecystitis, Acute; Intraabdominal Infections

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Community-Acquired Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Cholecystitis; Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases

Study Officials

• Pierre Singer, MD

  Rabin medical center, Belinson Campus, Petah Tiqwa Isarel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Up to Protocol Version 10.0, eligible patients were randomized to one of the 4 treatment groups in a 1:1:1:1 ratio between the 4 Cohorts: 1. Placebo 2. Single Intravenous (IV) dose of Allocetra-OTS, 5x10\^9 cells 3. Single IV dose of Allocetra-OTS, 10x10\^9 cells 4. Single or two IV doses of Allocetra-OTS, 10x10\^9 cells in each dose Starting from Protocol Version 10.0, patient will be randomized to either Cohort 1 (Placebo) or Cohort 4 (Single or two IV doses of Allocetra-OTS, 10x10\^9 cells in each dose).

Study Record Dates

• First Submitted: October 26, 2020
• First Posted: November 3, 2020
• Study Start: November 30, 2020
• Primary Completion: January 12, 2024
• Study Completion: December 16, 2024
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (10); NL (2); ES (8); IL (7); BE (4)