PneumoniaPhase 2NCT07615010
A Clinical Trial to Evaluate agenT-797 Plus Standard of Care in Participants With Severe Pneumonia With Moderate to Severe Acute Hypoxemic Respiratory Failure
A Phase 2 study testing agenT-797 in people with Pneumonia, run by MiNK Therapeutics at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia
- What is being tested?
- agenT-797
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 26 May 2026to Aug 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 2 countries
United States3 sites, 3 recruiting
- Not yet recruiting
Children's Memorial Hermann Hospital
Houston, Texas, 77030
Charles Cox, MD
- Not yet recruiting
University Hospital
San Antonio, Texas, 78229
Donald Jenkins, MD
- Not yet recruiting
UCSF Medical Center at Parnassus Heights
San Francisco, California, 94143
Michael Matthay, MD
Ukraine1 site, 1 recruiting
- Recruiting
First Lviv Territorial Medical Union
Lviv, 79059
Chirstina Orlysnka, MD
About this study
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
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).
Read the 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.
- Conditions
- Pneumonia
- Being tested
- agenT-797, Placebo, Standard of Care (SOC)
- Keywords
- Acute Hypoxemic Respiratory Failure, AHRF, agenT-797
- Medical subject headings
- Pneumonia, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
agenT-797Drug
Intravenous infusion
PlaceboDrug
Intravenous infusion
Standard of Care (SOC)Drug
Antimicrobial therapy and corticosteroids per applicable guidelines.
| Study group | Role | What they receive |
|---|---|---|
| agenT-797 plus SOC | Experimental | Participants will receive agenT-797 and SOC. Receives: Drug: agenT-797; Drug: Standard of Care (SOC) |
| Placebo plus SOC | Placebo comparator | Participants will receive placebo and SOC. Receives: Drug: Placebo; Drug: Standard of Care (SOC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Deaths (All-cause Mortality)
Measured: Day 1 through Day 28
Secondary outcomes (9)
Number of Oxygenation Support-free Days
Measured: Day 1 through Day 28
Time to Resolution of Hypoxemia
Measured: Day 1 through Day 28
Number of Ventilator-free Days
Measured: Day 1 through Day 28
Number of Intensive Care Unit-free Days
Measured: Day 1 through Day 28
Number of Participants Experiencing New Secondary Bacterial, Antimicrobial-resistant, or Fungal Infections
Measured: Day 1 through Day 28
Number of Antibiotic-free Days
Measured: Day 1 through Day 28
Time to Hospital Discharge
Measured: Day 1 through Day 28
Number of Deaths (All-cause Mortality)
Measured: 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.
Measured: Baseline, Day 3, Day 7, Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start26 May 2026
- Primary completionJun 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MiNK Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07615010
- Sponsor's protocol ID
- C-1300-02
- Status last verified
- Jun 2026
- First submitted
- 22 May 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No