Clinical trial NCT04582201: Evaluate the Safety of agenT-797 in Participants With Moderate to Severe Difficulty Breathing Secondary to SARS-CoV-2
Official title: A Phase 1/2 Study of agenT-797 to Treat Moderate to Severe Acute Respiratory Syndrome Secondary to SARS-CoV-2 or Influenza
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Respiratory Distress Syndrome, Adult
Keywords: SARS-CoV-2
Influenza
Lead sponsor: MiNK Therapeutics
Sponsor class: INDUSTRY
First posted: 2020-10-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number Of Participants With Treatment-emergent Adverse Events
timeFrame: Baseline through Month 6
measure: Number Of Participants With Dose-limiting Toxicities
timeFrame: Baseline through Month 6
Secondary outcomes:
measure: Time To Extubation
timeFrame: Up to Day 30
measure: Mean Daily Sequential Organ Failure Assessment Score
timeFrame: Day 30
measure: Change From Baseline In C-reactive Protein
timeFrame: Baseline through Day 30 (every 12 hours, as feasible)
measure: Decay In Quantitative Viral Burden From Upper And Lower Respiratory Tract Samples
timeFrame: Day 30
measure: Time From Dosing To Viral Clearance
timeFrame: Up to Day 30
measure: Number Of Participants Experiencing Viral Reactivation And Fungal Infections
timeFrame: Day 30
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Saint John's Cancer Institute
state: California
city: Louisville
country: United States
facility: Norton Cancer Institute, St. Matthews Campus
state: Kentucky
city: New York
country: United States
facility: Weill Cornell Medicine New York Presbyterian
state: New York
Study officials:
affiliation: MiNK Therapeutics
name: Medical Director
role: STUDY_DIRECTOR
References: