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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04612413
Other study ID # ENX-CL-02-002
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date November 30, 2020
Est. completion date March 31, 2025

Study information

Verified date March 2024
Source Enlivex Therapeutics Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 160
Est. completion date March 31, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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. 11. Chronic respiratory disease. 12. Known active upper GI tract ulceration or hepatic dysfunction. 13. Known NYHA class IV heart failure or unstable angina, ventricular arrhythmias, acute coronary disease or myocardial infarction. 14. Known immunocompromised state or medications known to be immunosuppressive. 15. Organ allograft or previous history of stem cell transplantation.

Study Design


Intervention

Drug:
Allocetra-OTS
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.
Other:
Placebo
Solution containing all excipients except for the Allocetra-OTS cells

Locations

Country Name City State
Belgium Clinique Saint-Pierre Brussel
Belgium Saint-Luc Hospital University Brussel
Belgium CHU de Charleroi Charleroi
Belgium Ziekenhuis Oost-Limburg Genk
France 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 Centre Hospitalier Victor Dupouy Paris
France Reims University Hospital Robert Debre Reims
France CHU de Rennes Rennes
France Strasbourg University Hospital Strasbourg
Israel Soroka Medical Center Be'er Sheva
Israel Hillel Yaffe Medical Center Hadera
Israel Bnai Zion Medical Center Haifa
Israel Hadassah Ein Kerem Medical Center Jerusalem
Israel Beilinson Medical Center Petah tikva
Israel Poriya Medical Center Tverya
Israel Ziv Medical Center Zefat
Netherlands Canisius Wilhelmina Hospital Nijmegen
Netherlands Radboud UMC Nijmegen
Spain Clinic Barcelona University Hospital Barcelona
Spain University Hospital Sagrat Cor Barcelona
Spain Vall d'Hebron Barcelona
Spain Getafe University Hospital Getafe
Spain Dr. Josep Trueta University Hospital Girona
Spain University Hospital Arnau de Vilanova of Lleida Lleida
Spain General University Hospital Gregorio Maranon Madrid
Spain University Hospital Joan XXIII of Tarragona Tarragona

Sponsors (1)

Lead Sponsor Collaborator
Enlivex Therapeutics Ltd.

Countries where clinical trial is conducted

Belgium,  France,  Israel,  Netherlands,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Efficacy: Change from baseline in SOFA score Change from baseline in SOFA score throughout 28 days 28 days
Primary Safety: Number and severity of AEs and SAEs Number and severity of AEs and SAEs throughout 28 days follow up period 28 days
Secondary Ventilator-free days Ventilator-free days over 28 days 28 days
Secondary Vasopressor-free days Vasopressor-free days over 28 days. 28 days
Secondary Days without renal replacement therapy (dialysis). Days without renal replacement therapy (dialysis). 28 days
Secondary Time in ICU and time in hospital Time in ICU and time in hospital 28 days
Secondary Number of days with creatinine = Baseline levels +20% Number of days with creatinine = Baseline levels +20% 28 days
Secondary All-cause mortality All-cause mortality at Day 28 following first dose 28 days
Secondary Changes from baseline in CRP levels Changes from baseline in CRP levels 28 days
Secondary Number and severity of AEs and Serious Adverse Events (SAEs) Number and severity of AEs and Serious Adverse Events (SAEs) throughout 12 months follow up period 12 months
Secondary Detection of autoimmune and human leukocyte antigen (HLA) antibodies Detection of autoimmune and human leukocyte antigen (HLA) antibodies 12 months
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