What this study is
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's being tested
- agenT-797
Intervention · DRUG
- Placebo
Intervention · DRUG
- Standard of Care (SOC)
Intervention · DRUG
Antimicrobial therapy and corticosteroids per applicable guidelines.
Both agenT-797 and Placebo
Intravenous infusion
Study details
- Official title
- 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
- Sponsor
- MiNK Therapeutics
- Conditions
- Pneumonia
- Enrolling
- 90 people
- Starts
- 2026-05-26
- Est. completion
- 2027-08
- Design
- Quadruple-blind, randomized, sequential groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou 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 can't join 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (4)
4 openUCSF Medical Center at Parnassus Heights
San Francisco, California, United States
- Michael Matthay, MD · Principal investigator
Not yet recruitingChildren's Memorial Hermann Hospital
Houston, Texas, United States
- Charles Cox, MD · Principal investigator
Not yet recruitingUniversity Hospital
San Antonio, Texas, United States
- Donald Jenkins, MD · Principal investigator
Not yet recruiting
1 site outside the US
First Lviv Territorial Medical Union
Lviv, Ukraine
- Chirstina Orlysnka, MD · Principal investigator
Recruiting
Study team
Sponsor
MiNK Therapeutics
Study ID C-1300-02
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.