Not currently recruiting at University of California Health

A Clinical Trial to Evaluate agenT-797 Plus Standard of Care in Participants With Severe Pneumonia With Moderate to Severe Acute Hypoxemic Respiratory Failure

a study on Pneumonia

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
study ends around
Principal Investigator
by Michael Matthay, MD (ucsf)
Headshot of Michael Matthay
Michael Matthay

Description

Summary

This clinical trial will evaluate the efficacy and safety of a single intravenous dose of agenT-797 administered in addition to standard of care (SOC), compared with placebo plus SOC, in reducing short-term mortality in adult participants with severe pneumonia and moderate to severe AHRF. All participants will receive SOC management for severe pneumonia and acute respiratory distress syndrome (ARDS).

Official Title

Phase 2 Adaptive Randomized, Placebo -Controlled Trial of agenT-797 + Standard of Care Vs. Placebo + Standard of Care in Severe Pneumonia With Moderate to Severe Acute Hypoxemic Respiratory Failure (AHRF) By Global ARDS Criteria

Details

This trial will be conducted in 2 parts (Run-in Phase; Phase 2). The Run-in Phase is designed to characterize the baseline population of the site, where participants will receive open-label agenT-797 plus SOC. After completion of the Run-in Phase, participants will be enrolled and randomized to receive either agenT-797 plus SOC or placebo plus SOC during the double-blinded Phase 2.

Keywords

Pneumonia, Acute Hypoxemic Respiratory Failure, AHRF, agenT-797, Respiratory Insufficiency, Standard of Care

Eligibility

You can join if…

Open to people ages 18 years and up

You CAN'T join if...

  • More than two vasopressors to maintain a mean arterial pressure ≥65 millimeters of mercury at the time of informed consent
  • Pregnancy or breastfeeding
  • History of cytokine release syndrome, as documented in the medical record or reported by the participant, legally authorized representative, or close relative
  • Current participation in another interventional clinical trial, or receipt of an investigational medicinal product within 30 days prior to screening, unless reviewed and approved in writing by the medical monitor

Note: Other protocol-defined inclusion/exclusion criteria may apply.

Locations

  • UCSF Medical Center at Parnassus Heights not yet accepting patients
    San Francisco California 94143 United States
  • University Hospital not yet accepting patients
    San Antonio Texas 78229 United States
  • Children's Memorial Hermann Hospital not yet accepting patients
    Houston Texas 77030 United States
  • First Lviv Territorial Medical Union accepting new patients
    Lviv 79059 Ukraine

Lead Scientist at University of California Health

  • Michael Matthay, MD (ucsf)
    Dr. Matthay's overall focus is on improving clinical care of patients with acute respiratory failure from the acute respiratory distress syndrome and from sepsis. His research and clinical trials groups are very well funded by grants from the National Institute of Health. He also spends considerable time mentoring physicians and young faculty in career development and academic medicine.

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
MiNK Therapeutics
ID
NCT07615010
Phase
Phase 2 Pneumonia Research Study
Study Type
Interventional
Participants
Expecting 90 study participants
Last Updated