Experimental cell therapy takes on COVID-19 lung crisis

NCT ID NCT04582201

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

Sep 2020

Finished

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

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

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

  • Norton Cancer Institute, St. Matthews Campus

    Louisville, Kentucky, 40207, United States

  • Saint John's Cancer Institute

    Santa Monica, California, 90404, United States

  • Weill Cornell Medicine New York Presbyterian

    New York, New York, 10022, United States

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