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 | Recruiting Phase 2 FDA Drug

• 1 other identifier: C-1300-02
• Study Type: interventional
• Target: 90
• Locations: 2 countries
• Sites: 4

Brief 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).

Conditions

Pneumonia

Keywords

Acute Hypoxemic Respiratory Failure; AHRF; agenT-797

Outcome Measures

Primary Outcomes (1)

• Number of Deaths (All-cause Mortality)

  Day 1 through Day 28

Secondary Outcomes (9)

• 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

Study Arms (2)

agenT-797 plus SOC

EXPERIMENTAL

Participants will receive agenT-797 and SOC.

Drug: agenT-797; Drug: Standard of Care (SOC)

Placebo plus SOC

PLACEBO COMPARATOR

Participants will receive placebo and SOC.

Drug: Placebo; Drug: Standard of Care (SOC)

Interventions

agenT-797 DRUG

Intravenous infusion

agenT-797 plus SOC

Placebo DRUG

Intravenous infusion

Placebo plus SOC

Standard of Care (SOC) DRUG

Antimicrobial therapy and corticosteroids per applicable guidelines.

Placebo plus SOC; agenT-797 plus SOC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MiNK Therapeutics: lead

Study Sites (4)

UCSF Medical Center at Parnassus Heights

San Francisco, California, 94143, United States

NOT YET RECRUITING

Children's Memorial Hermann Hospital

Houston, Texas, 77030, United States

NOT YET RECRUITING

University Hospital

San Antonio, Texas, 78229, United States

NOT YET RECRUITING

First Lviv Territorial Medical Union

Lviv, 79059, Ukraine

RECRUITING

MeSH Terms

Conditions

Pneumonia; Respiratory Insufficiency

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

MiNK Therapeutics Clinical Trial Information

CONTACT

1-212-994-8250; webmaster@minktherapeutics.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The Run-in Phase is open label and non-randomized, Phase 2 is double blind and randomized.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2026
• First Posted: May 29, 2026
• Study Start: May 22, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: May 29, 2026

Record last verified: 2026-05

Locations

UA (1); US (3)