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

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

Who can join

Ages 18 and older · All sexes

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.

About the study

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).

What is being tested

• agenT-797 (drug)
• Placebo (drug)
• Standard of Care (SOC) (drug)

Sponsor: MiNK Therapeutics · Participants: 90 · Started: May 26, 2026

Contact the study team

• MiNK Therapeutics Clinical Trial Information · Phone: 1-212-994-8250

Official record on ClinicalTrials.gov — NCT07615010

Locations in the U.S.

Conditions

• Pneumonia
• Respiratory Failure

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.