Clinical Trial

NAI for Sepsis With Persistent Lymphopenia

Not Yet Recruiting Phase 2
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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.
Trial Details
NCT Number NCT07578558
Lead Sponsor ImmunityBio, Inc.
Conditions Sepsis, Septic Shock, Lymphopenia, Immunosuppression, Critical Illness
Enrollment 50 participants
Start Date 2026-07-06
Primary Completion 2027-08-03 (estimated)
Study Completion 2027-10-04 (estimated)
Updated on ClinicalTrials.gov 2026-05-11