Evaluating GEn-1124 for Acute Respiratory Distress Syndrome

A Phase 2, Two-Part Study to Evaluate the Safety and Tolerability of GEn-1124 in Subjects With Acute Respiratory Distress Syndrome (ARDS)

This study is testing a new treatment called GEn-1124 to see if it is safe and helps people with Acute Respiratory Distress Syndrome feel better.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: GEn1E Lifesciences (Industry-sponsored)
• Locations: 11 sites (Washington D.C., District of Columbia and 10 other locations)
• Trial ID: NCT05795465 on ClinicalTrials.gov

What this trial studies

This Phase 2 study assesses the safety and tolerability of GEn-1124 in patients diagnosed with Acute Respiratory Distress Syndrome (ARDS). Participants will receive an intravenous infusion of GEn-1124 or a placebo as soon as possible after diagnosis, followed by a second dose approximately 8 hours later and continued dosing for 5 days. The study is randomized, double-blind, and placebo-controlled, focusing on pharmacokinetics, pharmacodynamics, and overall safety. An independent Safety Review Committee will monitor the study's progress.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 who have recently been diagnosed with ARDS.

Not a fit: Patients with severe comorbid conditions or those not eligible for full supportive care may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve outcomes for patients suffering from ARDS.

How similar studies have performed: While there have been studies on ARDS treatments, the specific approach with GEn-1124 is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. Male or female subject between the ages of 18 and 85 years old, inclusive.
2. Written informed consent .
3. Dosing as early as possible after first meeting ARDS 2023 Global definition.
4. Acceptable method of birth control.

Exclusion Criteria:

1. Subject, surrogate, or physician not committed, or eligible, to receive full supportive care measures.
2. Pregnant or breastfeeding
3. Currently incarcerated in a correctional institution or involuntarily committed to an inpatient mental health facility.
4. Active malignancy (other than non-melanoma skin cancer) requiring treatment with immunosuppressant drugs within the last 3 months or within the last 6 months if an anti-B cell antibody was received.
5. Any other irreversible disease or condition for which 6-month mortality is estimated to be \>50%.
6. Moderate to severe liver failure.
7. Estimated glomerular filtration rate (eGFR) \<10 mL/min/1.73 m2 or requiring dialysis at screening.
8. Subjects with known:

   1. New York Heart Association Class IV heart disease; or
   2. Acute Coronary Syndrome within the past 30 days (e.g., myocardial infarction, unstable angina) or dosing; or
   3. Cardiac arrest within 30 days of dosing with sequelae likely to increase mortality.
9. Severe chronic respiratory disease with continuous home oxygen \>2 liters per minute (LPM) or \>28% (adjusted for altitude); and/or home noninvasive ventilation (except for the treatment of obstructive sleep apnea).
10. Poly-traumatic injury resulting in significant blood loss and/or likely to require major surgery within the study period, or subject condition that would interfere with study procedures.
11. History of any type of solid organ or cellular transplant.
12. Receiving immunosuppressive therapy for solid organ or hematopoietic cancer, transplant anti-rejection medication, and/or other chronic conditions.
13. Moribund subject not expected to survive 24 hours.
14. Do not resuscitate (DNR) status.
15. World Health Organization (WHO) functional class III or IV pulmonary hypertension.
16. Subject has been on mechanical ventilation for more than 7 days at time of dosing.
17. Burn victims currently undergoing treatment for \>40% total body surface area (TBSA) involvement or for known airway inhalation injury.
18. Neuromuscular disease that could impact ability to wean from mechanical ventilation.
19. History of tuberculosis (TB); undergoing treatment for latent TB infection (LTBI); untreated LTBI (as determined by documented results within 3 months of Screening of a positive TB test).
20. Active Hepatitis B, positive Hepatitis C (and has not completed antiviral treatment), or positive human immunodeficiency (HIV) screen.
21. Use of any investigational drug or device within last 30 days of dosing or 5 half-lives, whichever is longer.
22. Any other medical, psychiatric, or social condition that, in the opinion of the investigator, is likely to unfavorably alter the risk-benefit of subject participation, to interfere with protocol compliance, or to confound safety.

Where this trial is running

Washington D.C., District of Columbia and 10 other locations

• Medstar Washington Hospital Center — Washington D.C., District of Columbia, United States (Withdrawn)
• University of Kansas Medical Center — Kansas City, Kansas, United States (Recruiting)
• University of Maryland Medical Center — Baltimore, Maryland, United States (Recruiting)
• University of Maryland - Baltimore Washington Medical Center — Glen Burnie, Maryland, United States (Recruiting)
• Ocean Springs Hospital — Ocean Springs, Mississippi, United States (Completed)
• Washington University School of Medicine — St Louis, Missouri, United States (Recruiting)
• Cooper University Hospital — Camden, New Jersey, United States (Recruiting)
• The Mount Sinai Hospital — New York, New York, United States (Recruiting)
• Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
• Houston Methodist Hospital — Houston, Texas, United States (Withdrawn)
• Intermountain Medical Center — Murray, Utah, United States (Recruiting)

Study contacts

• Study coordinator: Ritu Lal, PhD, MS

Conditions Respiratory Distress Syndrome, Acute