Pneumonia
Conditions
Keywords
Acute Hypoxemic Respiratory Failure, AHRF, agenT-797
Brief summary
This clinical trial will evaluate the efficacy and safety of a single intravenous dose of agenT-797 administered in addition to standard of care (SOC), compared with placebo plus SOC, in reducing short-term mortality in adult participants with severe pneumonia and moderate to severe AHRF. All participants will receive SOC management for severe pneumonia and acute respiratory distress syndrome (ARDS).
Detailed description
This trial will be conducted in 2 parts (Run-in Phase; Phase 2). The Run-in Phase is designed to characterize the baseline population of the site, where participants will receive open-label agenT-797 plus SOC. After completion of the Run-in Phase, participants will be enrolled and randomized to receive either agenT-797 plus SOC or placebo plus SOC during the double-blinded Phase 2.
Interventions
DRUGagenT-797
Intravenous infusion
DRUGPlacebo
Intravenous infusion
DRUGStandard of Care (SOC)
Antimicrobial therapy and corticosteroids per applicable guidelines.
Sponsors
MiNK Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The Run-in Phase is open label and non-randomized, Phase 2 is double blind and randomized.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Admission to an intensive care unit (ICU) with severe pneumonia of any etiology (viral, bacterial, fungal, or mixed), with and without trauma based on clinical suspicion * Acute hypoxemic respiratory failure (AHRF) * Evidence of moderate to severe acute respiratory distress syndrome (ARDS) based on Global ARDS criteria * Onset of severe pneumonia with AHRF ≤7 days prior to informed consent Key
Exclusion criteria
* More than two vasopressors to maintain a mean arterial pressure ≥65 millimeters of mercury at the time of informed consent * Pregnancy or breastfeeding * History of cytokine release syndrome, as documented in the medical record or reported by the participant, legally authorized representative, or close relative * Current participation in another interventional clinical trial, or receipt of an investigational medicinal product within 30 days prior to screening, unless reviewed and approved in writing by the medical monitor Note: Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Deaths (All-cause Mortality) | Day 1 through Day 28 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Oxygenation Support-free Days | Day 1 through Day 28 | — |
| Time to Resolution of Hypoxemia | Day 1 through Day 28 | — |
| Number of Ventilator-free Days | Day 1 through Day 28 | — |
| Number of Intensive Care Unit-free Days | Day 1 through Day 28 | — |
| Number of Participants Experiencing New Secondary Bacterial, Antimicrobial-resistant, or Fungal Infections | Day 1 through Day 28 | — |
| Number of Antibiotic-free Days | Day 1 through Day 28 | — |
| Time to Hospital Discharge | Day 1 through Day 28 | — |
| Number of Deaths (All-cause Mortality) | Day 1 through Day 90 | — |
| Change From Baseline in Cytokine Profiles | Baseline, Day 3, Day 7, Day 14 | Cytokine profiles analyzed may include interleukin-6, tumor necrosis factor-alpha, interleukin-1-beta, interleukin-1 receptor antagonist, soluble receptor for advanced glycation end product, angiopoietin-1 and -2, and tumor necrosis factor receptor 1. |
Countries
Ukraine, United States
Contacts
CONTACTMiNK Therapeutics Clinical Trial Information
Outcome results
None listed