A Phase 1/2 study of agenT-797 to treat moderate to severe acute respiratory distress syndrome (ARDS) secondary to acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or influenza.
This is a Phase 1/2 study to evaluate the safety and potential efficacy of agenT-797, an
unmodified, allogeneic invariant natural killer T (iNKT) cell therapy, in participants with
moderate to severe ARDS secondary to SARS-CoV-2 or influenza, either with intubation or at
high risk to be intubated, as determined using Berlin definition(s).
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 investigator. Once the maximum tolerated dose of
agenT-797 has been cleared in Part 1, an Expansion Cohort will be opened.
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.
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.
Inclusion Criteria:
1. Voluntarily agree to participate and can provide informed consent or have a duly
appointed health care proxy establish which/who has the authority to consent on behalf
of the participant
2. Inpatient hospitalization
3. Evidence of SARS-CoV-2 infection with the diagnosis of moderate to severe ARDS
secondary to SARS-CoV-2 or influenza per Berlin definition (ARDS 2012)
4. Participants, or study participant's duly appointed health care proxy with the
authority to consent on behalf of the participant, must consent to placement of a
central venous access line for the administration of agenT-797
Exclusion Criteria:
1. Currently participating and receiving study therapy of an investigational agent that
is not registered for any other indication
2. Clinically significant cardiomyopathy
3. Pre-existing respiratory disease, such as significant chronic obstructive pulmonary
disease requiring home oxygen, hospitalization, or systemic steroid use during the
past year
4. "Significant" pulmonary hypertension, defined as mean pulmonary artery pressure ≥ 20
millimeters of mercury and evidence of right ventricular dysfunction or enlargement
5. Receipt of vaccines containing live virus within 4 weeks prior to first dose of study
treatment
6. Known hypersensitivity to donor-derived cell therapy or their preservation solution
7. Active systemic bacterial or fungal infection or viral co-infection
8. Pregnant or lactating women
9. Presence of multiorgan dysfunction syndrome; no organ failure should be seen other
than the organ of interest, which is the lung
Saint John's Cancer Institute
Santa Monica, California, United States
Norton Cancer Institute, St. Matthews Campus
Louisville, Kentucky, United States
Weill Cornell Medicine New York Presbyterian
New York, New York, United States
Medical Director, Study Director
Agenus Inc.