NAI for Sepsis With Persistent Lymphopenia
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorImmunityBio, Inc.
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Hematologic malignancies including leukemia, lymphoma, and myelodysplastic syndromes
Prior CAR-T cell therapy or hematopoietic stem cell transplant (HSCT) within 3 months of screening
Active cytokine release syndrome (CRS) at screening
Current or recent (within 7 days) use of colony stimulating factors (G-CSF, GM-CSF)
Trial design
Treatments tested in this trial
- Nogapendekin alfa inbakicept (NAI)
- Standard of Care (SOC)
Treatment groups
50 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov