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

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

Summary

A phase II, multi-center (approximately 10 sites in Israel), randomized, placebo-controlled, dose- finding study comparing the efficacy, safety and tolerability of different dosing regimens of Allocetra-OTS, in up to 160 adult sepsis patients with organ sysfunction.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Enlivex Therapeutics Ltd.
• Collaborator: Cato Research

Criteria

Inclusion Criteria:

• Male or female ≥45 years and ≤85 years of age.

• Suspected, presumed or documented community-acquired pneumonia by imaging.

• Treatment with antibiotics after at least one course for the suspected infection.

• Meets Sepsis 3 criteria: the presence of organ dysfunction as identified by a total SOFA score ≥2 points above pre-admission SOFA.

• Has at least one respiratory SOFA score and at least one additional SOFA in any other organ.

• Signed written informed consent by the patient, or his/her legal guardian or delayed patient consent (based on MOH guidelines and local Ethics Committee (EC) approval).

• Child-bearing potential Females must not be lactating or pregnant at Screening, as documented by a negative Beta-Human Chorionic Gonadotropin (ß-hCG) or Human Chorionic Gonadotropin (hCG) blood test.

• Women of child-bearing potential or males whose partners are women of child-bearing potential, use an effective method of contraception throughout the trial.

Exclusion Criteria:

• Sepsis due to infection other than lung infection, or sepsis patients where site of infection is unclear or unknown

• On chronic dialysis.

• Invasive ventilated patient with PaO2/FiO2 < 100 mmHg

• Weight <50 kg or >120 kg or Body Mass Index (BMI) >40 kg/m2.

• SOFA score ≥ 10 at screening (Day -1).

• Septic shock defined by persisting hypotension requiring vasopressors to maintain MAP ≥65 mmHg and having a serum lactate level >2 mmol/L (18 mg/dL) despite adequate volume resuscitation at screening and on Day 1 prior to IP administration.

• Surgical intervention, plan for surgical intervention (not including percutaneous procedure such as chest drain), or hospitalization within 30 days prior to diagnosis of sepsis.

• A known malignancy that is progressing or has required active treatment within the past 3 months.

• Patient with end-stage disease (unrelated to sepsis) defined as patients who prior to the current hospitalization are expected to live < 6 months (as assessed by the study physician).

• Known active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or chronic viral infections, such as, Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV) or other chronic infections.

• Chronic respiratory disease requiring home oxygen therapy on a regular basis for > 6 h/day.

• Known active upper Gastrointestinal (GI) tract ulceration or hepatic dysfunction including but not limited to biopsy-proven cirrhosis; End-stage cirrhosis (Child Pugh Class C); portal hypertension; episodes of past upper GI bleeding attributed to portal hypertension; or prior episodes of hepatic failure, encephalopathy, or coma.

• Known New York Heart Association (NYHA) class IV heart failure or unstable angina, ventricular arrhythmias, active ischemic heart disease, or myocardial infarction within six months prior to diagnosis of sepsis.

• Known immunocompromised state or medications known to be immunosuppressive.

• Organ allograft or previous history of stem cell transplantation.

• Participation in an interventional investigational study within 30 days prior to diagnosis of sepsis.

• Likely to be non-compliant or uncooperative during the study (e.g. substance abuse such as drug or alcohol abuse, uncontrolled psychiatric disorder or any chronic condition that may interfere with study conduct).