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

Enlivex Therapeutics

Status and phase: Active, not recruiting; Phase 2

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

Treatments: Other: Placebo; Drug: Allocetra-OTS

Study type: Interventional

Funder types: Industry

Identifiers

NCT04612413

ENX-CL-02-002

Details and patient eligibility

About

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

Full 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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No 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.
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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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160 participants in 4 patient groups, including a placebo group

Cohort 1

Placebo Comparator group

Description:

Single IV dose of placebo solution

Treatment:

Other: Placebo

Cohort 2

Experimental group

Description:

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

Treatment:

Drug: Allocetra-OTS

Cohort 3

Experimental group

Description:

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

Treatment:

Drug: Allocetra-OTS

Cohort 4

Experimental group

Description:

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

Treatment:

Drug: Allocetra-OTS