NAI for Sepsis With Persistent Lymphopenia (NCT07578558) | Clinical Trial Compass
Not Yet RecruitingPhase 2
NAI for Sepsis With Persistent Lymphopenia
50 participantsStarted 2026-07-06
Plain-language summary
This is a Phase 2, randomized, open-label study evaluating the safety and efficacy of nogapendekin alfa inbakicept (NAI, ANKTIVA®) in combination with standard of care versus standard of care alone in critically ill adults with sepsis and persistent lymphopenia. The study aims to determine whether NAI can improve 28-day mortality by addressing the immunosuppressive phase of sepsis characterized by persistent lymphopenia (absolute lymphocyte count \<1,000 cells/µL). Participants will be randomized 1:1 to receive either NAI 1.2 mg subcutaneous injection on Days 3 (or earlier if ALC \<700 cells/µL), Day 14, and potentially Day 21 if ALC remains \<1,000 cells/µL, plus standard of care, or standard of care alone. The study will enroll approximately 50 participants (25 per arm) with persistent lymphopenia.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age 18 years or older at the time of informed consent
✓. Admitted to the ICU with a diagnosis of sepsis as defined by Sepsis-3 criteria: life-threatening organ dysfunction caused by a dysregulated host response to infection, operationalized as a Sequential Organ Failure Assessment (SOFA) score increase of 2 or more points
✓. Documented persistent lymphopenia defined as ALC \<1,000 cells/µL on at least two consecutive measurements within 72 hours of sepsis diagnosis (measurements must be separated by at least 12 hours)
✓. Prior initiation of appropriate antimicrobial therapy per institutional guidelines
✓. Ability to obtain written informed consent from the participant or legally authorized representative
✓. Agreement to practice effective contraception for female participants of child-bearing potential and non-sterile males (for up to 7 months after completion of therapy)
Exclusion criteria
✕. Hematologic malignancies including leukemia, lymphoma, and myelodysplastic syndromes