Respiratory Distress Syndrome, AdultPhase 1NCT04582201
A Clinical Trial to Evaluate the Safety of agenT-797 in COVID-19 Participants With ARDS
A Phase 1 study testing agenT-797 in people with Respiratory Distress Syndrome, Adult, run by MiNK Therapeutics at 3 sites in United States.
Trial summary
A Phase 1 study of agenT-797 to treat moderate to severe acute respiratory syndrome in Coronavirus disease 2019 (COVID-19) participants. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Distress Syndrome, Adult
- What is being tested?
- agenT-797
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesUnited States
- Study dates
- 21 Sep 2020to 23 Apr 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- Active systemic bacterial or fungal infection or viral co-infection.
- Legally incapacitated or has limited legal capacity.
- Pregnant or lactating women.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Norton Cancer Institute, St. Matthews Campus
Louisville, Kentucky, 40207
Weill Cornell Medicine New York Presbyterian
New York, New York, 10022
Saint John's Cancer Institute
Santa Monica, California, 90404
About this study
Official title: 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.
Read the 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.
- Conditions
- Respiratory Distress Syndrome, Adult
- Being tested
- agenT-797
- Keywords
- SARS-CoV-2
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
agenT-797Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Dosage and Cohorts | Experimental | 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. Receives: Drug: agenT-797 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Treatment-emergent Adverse Events
Measured: Baseline through Month 6
Number of Participants with Dose-limiting Toxicities
Measured: Baseline through Month 6
Secondary outcomes (5)
Time to Extubation
Measured: Up to Day 30
Change from Baseline in C-reactive Protein (CRP)
CRP levels will be used to assess cytokine release syndrome.
Measured: Baseline through Day 30 (every 12 hours, as feasible)
All-cause Mortality
Measured: Day 30 and Month 6
Decay in Quantitative Viral Burden from Upper and Lower Respiratory Tract Samples
Measured: Day 30
Change from Baseline at Day 30 in Number of Allogeneic iNKT Cells
Measured: Baseline, Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2020
- Study start21 Sep 2020
- Primary completion23 Apr 2023
- Study completion23 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory Distress Syndrome, AdultStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- MiNK Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, MiNK Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04582201
- Sponsor's protocol ID
- C-1300-01
- Status last verified
- Dec 2025
- First submitted
- 6 Oct 2020
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Hammond TC, Purbhoo MA, Kadel S, Ritz J, Nikiforow S, Daley H, Shaw K, van Besien K, Gomez-Arteaga A, Stevens D, Ortuzar W, Michelet X, Smith R, Moskowitz D, Masakayan R, Yigit B, Boi S, Soh KT, Chamberland J, Song X, Qin Y, Mishchenko I, Kirby M, Nasonenko V, Buffa A, Buell JS, Chand D, van Dijk M, Stebbing J, Exley MA. A phase 1/2 clinical trial of invariant natural killer T cell therapy in moderate-severe acute respiratory distress syndrome. Nat Commun. 2024 Feb 6;15(1):974. doi: 10.1038/s41467-024-44905-z.
PubMed 38321023
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of agenT-797 to Treat Moderate to Severe Acute Respiratory Syndrome in COVID-19 Patients
- ClinicalTrials.gov ID
- NCT04582201
- Acronym / sponsor ID
- C-1300-01
- Conditions
- Respiratory Distress Syndrome, Adult
- Keywords
- SARS-CoV-2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- MiNK TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 21 Sep 2020 (actual)
- Primary completion
- 23 Apr 2023 (actual)
- Study completion
- 23 Apr 2023 (actual)
- First posted
- 9 Oct 2020 (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.
A Phase 1 study of agenT-797 to treat moderate to severe acute respiratory syndrome in Coronavirus disease 2019 (COVID-19) participants.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dosage and Cohorts | Experimental | Drug: agenT-797Cohort 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
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-797agenT-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. | Drug | Dosage and Cohorts |
Primary outcome
Number of Participants with Treatment-emergent Adverse Events
Time frame: Baseline through Month 6
Number of Participants with Dose-limiting Toxicities
Time frame: Baseline through Month 6
5 secondary outcomes
Time to Extubation
Time frame: Up to Day 30
Change from Baseline in C-reactive Protein (CRP)
Time frame: Baseline through Day 30 (every 12 hours, as feasible)
All-cause Mortality
Time frame: Day 30 and Month 6
Decay in Quantitative Viral Burden from Upper and Lower Respiratory Tract Samples
Time frame: Day 30
Change from Baseline at Day 30 in Number of Allogeneic iNKT Cells
Time frame: Baseline, Day 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
- Derived from this study: PubMed 38321023Hammond TC, Purbhoo MA, Kadel S, Ritz J, Nikiforow S, Daley H, Shaw K, van Besien K, Gomez-Arteaga A, Stevens D, Ortuzar W, Michelet X, Smith R, Moskowitz D, Masakayan R, Yigit B, Boi S, Soh KT, Chamberland J, Song X, Qin Y, Mishchenko I, Kirby M, Nasonenko V, Buffa A, Buell JS, Chand D, van Dijk M, Stebbing J, Exley MA. A phase 1/2 clinical trial of invariant natural killer T cell therapy in moderate-severe acute respiratory distress syndrome. Nat Commun. 2024 Feb 6;15(1):974. doi: 10.1038/s41467-024-44905-z.
Related trials for Respiratory Distress Syndrome, Adult
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
Not yet recruitingObservational study
Development and Multicenter Validation of an Explainable System for Neonatal ARDS-Compatible Phenotyping
Acute Respiratory Distress Syndrome
RecruitingObservational study
Assessment of Blood Viscosity in ARDS (Acute Respiratory Distress Syndrome)
ARDS
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
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. This study is not recruiting at the moment.
Medical Director study director
MiNK Therapeutics
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing agenT-797 in people with Respiratory Distress Syndrome, Adult, run by MiNK Therapeutics at 3 sites in United States.
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 5 inclusion and 9 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: finished, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Treatment-emergent Adverse Events (time frame: Baseline through Month 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04582201, which also lists 1 linked publication.
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 30 Dec 2025.