RECRUITING

A Study of GEn-1124 in Subjects with Acute Respiratory Distress Syndrome (ARDS)

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Conditions

Respiratory Distress Syndrome, Acute

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

GEn1E-1124-002 is a two-part Phase 2 study to evaluate the safety and tolerability of GEn-1124 in subjects with ARDS. Treatment with IV infusion dosing as early as possible after ARDS diagnosis. Subjects will be given a second dose approximately 8 hours after the first dose and will continue with twice daily dosing (BID regimen) for 5 days.

Official Title

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

Quick Facts

Study Start:2023-04-04
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05795465

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Male or female subject between the ages of 18 and 80 years old, inclusive.
  2. 2. Written informed consent .
  3. 3. Dosing as early as possible after first meeting ARDS 2023 Global definition.
  4. 4. Acceptable method of birth control.
  1. 1. Subject, surrogate, or physician not committed, or eligible, to receive full supportive care measures.
  2. 2. Pregnant or breastfeeding
  3. 3. Currently incarcerated in a correctional institution or involuntarily committed to an inpatient mental health facility.
  4. 4. Active malignancy (other than non-melanoma skin cancer) requiring treatment within the last 3 months or within the last 6 months if an anti-B cell antibody was received.
  5. 5. Any other irreversible disease or condition for which 6-month mortality is estimated to be \>50%.
  6. 6. Moderate to severe liver failure.
  7. 7. Estimated glomerular filtration rate (eGFR) \<10 mL/min/1.73 m2 or requiring dialysis at screening.
  8. 8. Acute Left ventricular failure or congestive heart failure, defined as New York Heart Association Class IV.
  9. 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. 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. 11. History of any type of solid organ or cellular transplant.
  12. 12. Receiving immunosuppressive therapy for solid organ or hematopoietic cancer, transplant anti-rejection medication, and/or other chronic conditions.
  13. 13. Moribund subject not expected to survive 24 hours.
  14. 14. Do not resuscitate (DNR) status.
  15. 15. World Health Organization (WHO) functional class III or IV pulmonary hypertension.
  16. 16. Burn victims currently undergoing treatment for \>20% total body surface area (TBSA) involvement or for known airway inhalation injury.
  17. 17. Neuromuscular disease that could impact ability to wean from mechanical ventilation.
  18. 18. 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).
  19. 19. Active Hepatitis B, positive Hepatitis C (and has not completed antiviral treatment), or positive human immunodeficiency (HIV) screen.
  20. 20. Use of any investigational drug or device within last 30 days of dosing or 5 half-lives, whichever is longer.
  21. 21. 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.

Contacts and Locations

Study Contact

Ritu Lal, PhD, MS
CONTACT
(650) 248-2429
clinical@gen1elifesci.com

Principal Investigator

Ritu Lal, PhD, MS
STUDY_DIRECTOR
GEn1E Lifesciences

Study Locations (Sites)

Medstar Washington Hospital Center
Washington, D.C., District of Columbia, 20010
United States
University of Kansas Medical Center
Kansas City, Kansas, 66160
United States
Ocean Springs Hospital
Ocean Springs, Mississippi, 39564
United States
Washington University School of Medicine
Saint Louis, Missouri, 63110
United States
The Mount Sinai Hospital
New York, New York, 10029
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
Houston Methodist Hospital
Houston, Texas, 77030
United States
Intermountain Medical Center
Murray, Utah, 84107
United States

Collaborators and Investigators

Sponsor: GEn1E Lifesciences

  • Ritu Lal, PhD, MS, STUDY_DIRECTOR, GEn1E Lifesciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-04
Study Completion Date2025-12

Study Record Updates

Study Start Date2023-04-04
Study Completion Date2025-12

Terms related to this study

Additional Relevant MeSH Terms

  • Respiratory Distress Syndrome, Acute