Trial | NCT04612413  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Recruiting

  • Study Participants

    160
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
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.
Study Started
Nov 30
2020
Primary Completion
Jan 31
2024
Anticipated
Study Completion
Jan 31
2025
Anticipated
Last Update
Aug 24
2023

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

Cohort 1 Placebo Comparator

Single IV dose of placebo solution

Cohort 2 Experimental

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

Cohort 3 Experimental

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

Cohort 4 Experimental

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

Criteria 

Inclusion Criteria:

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:

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

Adequate source control

Exclusion Criteria:

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.
No Results Posted