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

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: Completed
• Conditions: Respiratory Distress Syndrome, Adult
• Intervention / Treatment: Drug: agenT-797

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: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Time Frame
Number of Participants with Treatment-emergent Adverse Events	Baseline through Month 6
Number of Participants with Dose-limiting Toxicities	Baseline through Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Extubation		Up to Day 30
Change from Baseline in C-reactive Protein (CRP)	CRP levels will be used to assess cytokine release syndrome.	Baseline through Day 30 (every 12 hours, as feasible)
All-cause Mortality		Day 30 and Month 6
Decay in Quantitative Viral Burden from Upper and Lower Respiratory Tract Samples		Day 30
Change from Baseline at Day 30 in Number of Allogeneic iNKT Cells		Baseline, Day 30

Collaborators and Investigators

• Sponsor: MiNK Therapeutics
• Investigators: Study Director: Medical Director, MiNK Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2020
• Primary Completion (Actual): April 23, 2023
• Study Completion (Actual): April 23, 2023

Study Registration Dates

• First Submitted: October 6, 2020
• First Submitted That Met QC Criteria: October 8, 2020
• First Posted (Actual): October 9, 2020

Study Record Updates

• Last Update Posted (Actual): December 30, 2025
• Last Update Submitted That Met QC Criteria: December 22, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: SARS-CoV-2
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Respiratory Distress Syndrome
• Other Study ID 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