NCT07615010 A Clinical Trial to Evaluate agenT-797 Plus Standard of Care in Participants With Severe Pneumonia With Moderate to Severe Acute Hypoxemic Respiratory Failure
| NCT ID | NCT07615010 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | MiNK Therapeutics |
| Condition | Pneumonia |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2026-05-26 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 90 participants in total. It began in 2026-05-26 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility 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/exclusion criteria may apply.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07615010 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pneumonia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07615010 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07615010 currently recruiting?
Yes, NCT07615010 is actively recruiting participants. Contact the research team at webmaster@minktherapeutics.com for enrollment information.
Where is the NCT07615010 trial being conducted?
This trial is being conducted at San Francisco, United States, Houston, United States, San Antonio, United States, Lviv, Ukraine.
Who is sponsoring the NCT07615010 clinical trial?
NCT07615010 is sponsored by MiNK Therapeutics. The trial plans to enroll 90 participants.