Experimental cell therapy takes on COVID-19 lung crisis
NCT ID NCT04582201
First seen Jun 27, 2026 ยท Last updated Jun 27, 2026
Summary
This early-stage trial tested a new cell therapy called agenT-797 in 20 hospitalized COVID-19 patients with moderate to severe breathing distress. The therapy uses immune cells from a healthy donor to calm inflammation and fight the virus. The main goals were to check safety and side effects, with additional measures like time on a ventilator and survival rates.
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 (a type of immune cell therapy made from donor cells)
- What this could lead to
- If successful, this could point toward a new treatment option for severe respiratory distress caused by COVID-19.
- What could go wrong
- This is a very early Phase 1 trial with only 20 participants, so results may not apply broadly. The therapy involves donor cells, which could cause immune reactions or other 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 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
20 people
The number who actually took part.
- Started
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Sep 2020
- Finished
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Apr 2023
- Lead sponsor
-
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
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
-
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.
Inclusion Criteria: * Voluntarily agree to participate and ability to provide informed consent or have duly appointed health care proxy with the authority to consent. * Confirmed diagnosis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection by polymerase chain reaction test or equivalent approved test. * Inpatient hospitalization. * Evidence of SARS-CoV-2 infection with the diagnosis of moderate to severe ARDS per Berlin definition, no more than 2 weeks prior to study enrollment. * Participants, or duly appointed health care proxy with the authority to consent, must consent to placement of a central venous access line for the administration of agenT-797. Exclusion Criteria: * Currently participating and receiving study therapy of an investigational agent that is not registered for any other indication. Note: Participants may receive the standard of care for SARS-CoV-2 infection as per institutional practices. * Presence of comorbidities limiting expected survival of \<1 month. * Any comorbidity which in the opinion of the investigator may preclude/confound study required safety and efficacy assessments. * Clinically significant cardiomyopathy. * Receipt of non-oncology vaccines containing live virus for prevention of infectious diseases within 4 weeks prior to first dose of study treatment. * Known hypersensitivity to natural killer cells or their preservation solution. * Active systemic bacterial or fungal infection or viral co-infection. * Legally incapacitated or has limited legal capacity. * Pregnant or lactating women.
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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.
Contacts and locations
Locations
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Norton Cancer Institute, St. Matthews Campus
Louisville, Kentucky, 40207, United States
-
Saint John's Cancer Institute
Santa Monica, California, 90404, United States
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Weill Cornell Medicine New York Presbyterian
New York, New York, 10022, United States
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