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Recruiting Phase 2

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

NCT07615010 · tracked via the Priya Life Science USA tracker
Sponsor
MiNK Therapeutics
Phase
Phase 2
Started
2026-05-26
Last updated
2026-06-26

Condition(s) studied

Pneumonia

Investigational drug(s) / intervention(s)

agenT-797PlaceboStandard of Care (SOC)

agenT-797: Intravenous infusion

Placebo: Intravenous infusion

Standard of Care (SOC): Antimicrobial therapy and corticosteroids per applicable guidelines.

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

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

Trial sites (4)

FacilityCityRegionStatus
UCSF Medical Center at Parnassus Heights San Francisco California Not Yet Recruiting
Children's Memorial Hermann Hospital Houston Texas Not Yet Recruiting
University Hospital San Antonio Texas Not Yet Recruiting
First Lviv Territorial Medical Union Lviv Ukraine Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07615010 on ClinicalTrials.gov ↗ ← All trials in the USA