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agenT-797 for Severe Pneumonia with Acute Hypoxemic Respiratory Failure

This study is testing a drug called agenT-797, given through an IV, along with standard medical care, for adults with severe pneumonia and moderate to severe acute hypoxemic respiratory failure (AHRF), which means your body isn't getting enough oxygen. Some participants will receive agenT-797, while others will receive a placebo (an inactive substance) plus standard care. The main goal is to see if agenT-797 can reduce the number of deaths within 28 days. You could be eligible if you are in the intensive care unit (ICU) with severe pneumonia and have moderate to severe acute respiratory distress syndrome (ARDS). The study is currently unclear on its recruitment status and plans to enroll 90 participants.

Study design
This study is interventional and will involve 90 participants. It has two parts: an initial 'Run-in Phase' where participants receive agenT-797 openly, followed by a 'Phase 2' where participants are randomly assigned to receive either agenT-797 or placebo, both in addition to standard care, without knowing which they are getting (double-blinded).
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, number of deaths, will be measured from Day 1 through Day 28.

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NCT07615010

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
MiNK Therapeutics
~90 participants
Updated 2026-06-26 on ClinicalTrials.gov
What's tested:agenT-797PlaceboStandard of Care (SOC)

At a glance

Recruiting sites
1 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Deaths (All-cause Mortality)
Measured over Day 1 through Day 28

Conditions

Pneumonia

Explore related trials

Acute hypoxemic respiratory failureAcute Respiratory Distress SyndromePneumonia

Where it's being run

4 sites across 3 states
Texas2
California1
Ukraine1

Who to contact

MiNK Therapeutics Clinical Trial Information
[email protected]
1-212-994-8250
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Number of Deaths (All-cause Mortality)Day 1 through Day 28