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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07615010
- Acronym / sponsor ID
- C-1300-02
- Conditions
- Pneumonia
- Keywords
- Acute Hypoxemic Respiratory Failure, AHRF, agenT-797
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- MiNK TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 26 May 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 29 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| agenT-797 plus SOC | Experimental | Drug: agenT-797, Drug: Standard of Care (SOC)Participants will receive agenT-797 and SOC. |
| Placebo plus SOC | Placebo comparator | Drug: Placebo, Drug: Standard of Care (SOC)Participants will receive placebo and SOC. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| agenT-797Intravenous infusion | Drug | agenT-797 plus SOC |
| PlaceboIntravenous infusion | Drug | Placebo plus SOC |
| Standard of Care (SOC)Antimicrobial therapy and corticosteroids per applicable guidelines. | Drug | Placebo plus SOC, agenT-797 plus SOC |
Primary outcome
Number of Deaths (All-cause Mortality)
Time frame: Day 1 through Day 28
9 secondary outcomes
Number of Oxygenation Support-free Days
Time frame: Day 1 through Day 28
Time to Resolution of Hypoxemia
Time frame: Day 1 through Day 28
Number of Ventilator-free Days
Time frame: Day 1 through Day 28
Number of Intensive Care Unit-free Days
Time frame: Day 1 through Day 28
Number of Participants Experiencing New Secondary Bacterial, Antimicrobial-resistant, or Fungal Infections
Time frame: Day 1 through Day 28
Number of Antibiotic-free Days
Time frame: Day 1 through Day 28
Time to Hospital Discharge
Time frame: Day 1 through Day 28
Number of Deaths (All-cause Mortality)
Time frame: Day 1 through Day 90
Change From Baseline in Cytokine Profiles
Time frame: Baseline, Day 3, Day 7, Day 14
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing agenT-797 in people with Pneumonia, run by MiNK Therapeutics at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact MiNK Therapeutics Clinical Trial Information (1-212-994-8250, webmaster@minktherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Deaths (All-cause Mortality) (time frame: Day 1 through Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.