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

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).

Study Overview

• Status: Recruiting
• Conditions: Pneumonia
• Intervention / Treatment: Drug: Placebo; Drug: agenT-797; Drug: Standard of Care (SOC)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: MiNK Therapeutics Clinical Trial Information; Phone Number: 1-212-994-8250; Email: webmaster@minktherapeutics.com

Study Locations

• Ukraine
  • Lviv, Ukraine, 79059
    • Recruiting
    • First Lviv Territorial Medical Union
    • Principal Investigator: Chirstina Orlysnka, MD
• United States
  • California
    • San Francisco, California, United States, 94143
      • Not yet recruiting
      • UCSF Medical Center at Parnassus Heights
      • Principal Investigator: Michael Matthay, MD
  • Texas
    • Houston, Texas, United States, 77030
      • Not yet recruiting
      • Children's Memorial Hermann Hospital
      • Principal Investigator: Charles Cox, MD
    • San Antonio, Texas, United States, 78229
      • Not yet recruiting
      • University Hospital
      • Principal Investigator: Donald Jenkins, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: agenT-797 plus SOC; Participants will receive agenT-797 and SOC.	Drug: agenT-797; Intravenous infusion; Drug: Standard of Care (SOC); Antimicrobial therapy and corticosteroids per applicable guidelines.
Placebo Comparator: Placebo plus SOC; Participants will receive placebo and SOC.	Drug: Placebo; Intravenous infusion; Drug: Standard of Care (SOC); Antimicrobial therapy and corticosteroids per applicable guidelines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Deaths (All-cause Mortality)	Day 1 through Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Oxygenation Support-free Days		Day 1 through Day 28
Time to Resolution of Hypoxemia		Day 1 through Day 28
Number of Ventilator-free Days		Day 1 through Day 28
Number of Intensive Care Unit-free Days		Day 1 through Day 28
Number of Participants Experiencing New Secondary Bacterial, Antimicrobial-resistant, or Fungal Infections		Day 1 through Day 28
Number of Antibiotic-free Days		Day 1 through Day 28
Time to Hospital Discharge		Day 1 through Day 28
Number of Deaths (All-cause Mortality)		Day 1 through Day 90
Change From Baseline in Cytokine Profiles	Cytokine profiles analyzed may include interleukin-6, tumor necrosis factor-alpha, interleukin-1-beta, interleukin-1 receptor antagonist, soluble receptor for advanced glycation end product, angiopoietin-1 and -2, and tumor necrosis factor receptor 1.	Baseline, Day 3, Day 7, Day 14

Collaborators and Investigators

• Sponsor: MiNK Therapeutics

Study record dates

Study Major Dates

• Study Start (Estimated): May 22, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: May 22, 2026
• First Submitted That Met QC Criteria: May 22, 2026
• First Posted (Actual): May 29, 2026

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Acute Hypoxemic Respiratory Failure; AHRF; agenT-797
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Respiratory Insufficiency; Pneumonia; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: C-1300-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No