NCT04582201

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: MiNK Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Respiratory Distress Syndrome, Adult

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-09-21
• Primary completion: 2023-04-23
• Completion: 2023-04-23
• First posted: 2020-10-09
• Last updated: 2025-12-30

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study