Experimental immune therapy aims to reduce deaths in severe pneumonia
NCT ID NCT07615010
First seen Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 2 times
Summary
This study tests whether a single dose of an experimental immune cell therapy called agenT-797, given alongside standard care, can lower the risk of death in adults with severe pneumonia and breathing failure. About 90 people in intensive care will receive either agenT-797 or a placebo, plus usual treatments like antibiotics and steroids. The main goal is to see if more people survive with the added therapy.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- agenT-797 (an experimental immune cell therapy given as a single intravenous infusion)
- What this could lead to
- If it works, this could point toward a new treatment to reduce deaths from severe pneumonia with respiratory failure.
- What could go wrong
- This is a small, early Phase 2 trial with only 90 participants, so results may not apply broadly. The treatment is experimental and may not improve survival or could cause side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 90 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Children's Memorial Hermann Hospital
NOT_YET_RECRUITINGHouston, Texas, 77030, United States
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First Lviv Territorial Medical Union
RECRUITINGLviv, 79059, Ukraine
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UCSF Medical Center at Parnassus Heights
NOT_YET_RECRUITINGSan Francisco, California, 94143, United States
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University Hospital
NOT_YET_RECRUITINGSan Antonio, Texas, 78229, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can donated immune cells calm the cytokine storm?
- Steroid dose showdown: can more dexamethasone save lives in respiratory failure?
- Breathing machine settings put to the test in severe lung injury
- Can a digital assistant and quick tests stop unnecessary antibiotics for kids?
- The hidden breath: how a mismatch between patient and machine may shape ARDS recovery
- Scientists hunt for hidden subgroups in sudden respiratory failure