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

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.

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.