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

NCT04582201 | Completed Phase 1 FDA Drug

• 1 other identifier: C-1300-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Respiratory Distress Syndrome, Adult

Keywords

SARS-CoV-2

Outcome Measures

Primary Outcomes (2)

• Number of Participants with Treatment-emergent Adverse Events

  Baseline through Month 6

• Number of Participants with Dose-limiting Toxicities

  Baseline through Month 6

Secondary Outcomes (5)

• Time to Extubation

  Up to Day 30

• Change from Baseline in C-reactive Protein (CRP)

  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

Study Arms (1)

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.

Drug: agenT-797

Interventions

agenT-797 DRUG

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.

Dosage and Cohorts

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MiNK Therapeutics: lead

Study Sites (3)

Saint John's Cancer Institute

Santa Monica, California, 90404, United States

Location

Norton Cancer Institute, St. Matthews Campus

Louisville, Kentucky, 40207, United States

Location

Weill Cornell Medicine New York Presbyterian

New York, New York, 10022, United States

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Medical Director

  MiNK Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2020
• First Posted: October 9, 2020
• Study Start: September 21, 2020
• Primary Completion: April 23, 2023
• Study Completion: April 23, 2023
• Last Updated: December 30, 2025

Record last verified: 2025-12

Locations

US (3)