A Clinical Trial to Evaluate the Safety of agenT-797 in COVID-19 Participants With ARDS

December 22, 2025 updated by: MiNK Therapeutics

A Phase 1 Study of agenT-797 to Treat Moderate to Severe Acute Respiratory Syndrome in COVID-19 Patients

A Phase 1 study of agenT-797 to treat moderate to severe acute respiratory syndrome in Coronavirus disease 2019 (COVID-19) participants.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a Phase 1 study to evaluate the safety and efficacy of agenT-797, an unmodified, allogeneic invariant natural killer T cells (iNKT) therapy, in participants with COVID-19, requiring mechanical ventilation, and with moderate to severe acute respiratory distress syndrome (ARDS) as determined by the Berlin definition.

The study will be conducted in 2 parts. Part 1 will employ a standard 3+3 dose escalation design of agenT-797. All participants will receive a single infusion of agenT-797. Participants will also receive other treatments and supportive care per discretion of the principal investigator. Once the maximum tolerated dose of agenT-797 has been cleared in Part 1, Part 2 of the study will be opened and enroll eligible participants in the Expansion Cohort.

A safety monitoring committee will be established to assess safety and decide on escalation to next cohort and expansion dose, as well as any protocol modification to include less severe cases.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Santa Monica, California, United States, 90404
        • Saint John's Cancer Institute
    • Kentucky
      • Louisville, Kentucky, United States, 40207
        • Norton Cancer Institute, St. Matthews Campus
    • New York
      • New York, New York, United States, 10022
        • Weill Cornell Medicine New York Presbyterian

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Dosage and Cohorts

Cohort 1: 100 × 10^6 iNKT cells; Cohort 2: 300 × 10^6 iNKT cells; Cohort 3: 1000 × 10^6 iNKT cells

Dosage Frequency and Mode of Administration: agenT-797 will be administered to hospitalized participants as a single intravenous infusion.
Drug: agenT-797
agenT-797 is an off-the-shelf cell therapy consisting of ≥ 95% allogeneic human unmodified iNKT cells isolated from 1 healthy donor mononuclear cell apheresis unit and expanded ex vivo.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of Participants with Treatment-emergent Adverse Events
Time Frame: Baseline through Month 6
Baseline through Month 6
Number of Participants with Dose-limiting Toxicities
Time Frame: Baseline through Month 6
Baseline through Month 6

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to Extubation
Time Frame: Up to Day 30
Up to Day 30
Change from Baseline in C-reactive Protein (CRP)
Time Frame: Baseline through Day 30 (every 12 hours, as feasible)
CRP levels will be used to assess cytokine release syndrome.
Baseline through Day 30 (every 12 hours, as feasible)
All-cause Mortality
Time Frame: Day 30 and Month 6
Day 30 and Month 6
Decay in Quantitative Viral Burden from Upper and Lower Respiratory Tract Samples
Time Frame: Day 30
Day 30
Change from Baseline at Day 30 in Number of Allogeneic iNKT Cells
Time Frame: Baseline, Day 30
Baseline, Day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
MiNK Therapeutics

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Medical Director, MiNK Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 21, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 23, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 23, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 6, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 8, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 9, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 30, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • C-1300-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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