AgenT-797 plus standard care in severe pneumonia with acute hypoxemic respiratory failure
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
Run by MiNK Therapeutics · NCT07615010 · Data updated 2026-11-12
We are testing whether a single IV dose of agenT-797 added to standard care can reduce short-term death in adults with severe pneumonia and moderate to severe AHRF.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 90 (estimated) |
| Sponsor | MiNK Therapeutics Industry-sponsored |
| Locations | 4 sites (San Francisco, California and 3 other locations) |
| Status | Recruiting |
| Started | May 26, 2026 |
| Main results expected | June 2027 |
| Study ends | August 2027 |
| Registry record updated | June 26, 2026 |
| Trial ID | NCT07615010 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with severe pneumonia and moderate to severe AHRF requiring ICU care, within 7 days of pneumonia onset.
✕Probably not a fit
Patients without the hypothesized benefit or with exclusion criteria such as high vasopressor requirements or recent interventional trial participation may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 2 trial has two parts: a Run-in phase to characterize the population and an ensuing double-blind Phase 2 where participants are randomized to receive agenT-797 plus standard care or placebo plus standard care. All participants receive standard care for severe pneumonia and ARDS. The study compares the safety and possible mortality benefit of agenT-797 versus placebo when added to SOC in ICU patients with viral, bacterial, fungal, or mixed pneumonia and AHRF. Enrollment targets adults with onset of pneumonia with AHRF within 7 days, and excludes those with high vasopressor needs, pregnancy, prior cytokine release syndrome, or recent interventional trial participation. The objective is to see if agenT-797 can improve short-term outcomes in this high-risk group.
Why it matters
Potential benefit: If successful, patients may experience lower short-term mortality and better recovery when agenT-797 is added to standard care.
How similar studies have gone: Similar biologic approaches in acute respiratory failure have shown mixed results; this trial explores a targeted agent in a defined high-risk population.
Who can join: the full rules
Show full inclusion / exclusion criteria
Key Inclusion Criteria: * Admission to an intensive care unit (ICU) with severe pneumonia of any etiology (viral, bacterial, fungal, or mixed), with and without trauma based on clinical suspicion * Acute hypoxemic respiratory failure (AHRF) * Evidence of moderate to severe acute respiratory distress syndrome (ARDS) based on Global ARDS criteria * Onset of severe pneumonia with AHRF ≤7 days prior to informed consent Key Exclusion Criteria: * 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.
Where it's running
-
First Lviv Territorial Medical Union
Lviv, Ukraine Recruiting -
UCSF Medical Center at Parnassus Heights
San Francisco, California, United States Not yet recruiting -
Children's Memorial Hermann Hospital
Houston, Texas, United States Not yet recruiting -
University Hospital
San Antonio, Texas, United States Not yet recruiting
Study contacts
- Study coordinator: MiNK Therapeutics Clinical Trial Information
- Email: webmaster@minktherapeutics.com
- Phone: 1-212-994-8250
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.