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NCT07578558

PHASE2

NAI for Sepsis With Persistent Lymphopenia

Sponsor: ImmunityBio, Inc.

View on ClinicalTrials.gov

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.

Official title: Phase 2, Randomized, Open-Label Clinical Trial Evaluating Nogapendekin Alfa Inbakicept in Combination With Standard of Care Versus Standard of Care Alone in Critically Ill Adults With Sepsis and Persistent Lymphopenia

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-07-06

Completion Date

2027-10-04

Last Updated

2026-05-11

Healthy Volunteers

Conditions

Sepsis Septic Shock Lymphopenia Immunosuppression Critical Illness

Interventions

DRUG

Nogapendekin alfa inbakicept (NAI)

IL-15 receptor agonist complex; 1.2 mg subcutaneous injection administered on Days 3 (or earlier if ALC \<700 cells/µL), Day 14, and Day 21 if needed for ALC \<1,000 cells/µL

OTHER

Standard of Care (SOC)

Institutional standard of care for sepsis including antimicrobial therapy, fluid resuscitation, vasopressor support, organ support, and mechanical ventilation as clinically indicated

Inclusion Criteria: 1. Age 18 years or older at the time of informed consent 2. 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 3. 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) 4. Prior initiation of appropriate antimicrobial therapy per institutional guidelines 5. Ability to obtain written informed consent from the participant or legally authorized representative 6. 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: 1. Hematologic malignancies including leukemia, lymphoma, and myelodysplastic syndromes 2. Prior CAR-T cell therapy or hematopoietic stem cell transplant (HSCT) within 3 months of screening 3. Active cytokine release syndrome (CRS) at screening 4. Current or recent (within 7 days) use of colony stimulating factors (G-CSF, GM-CSF) 5. Lymphopenia attributable to chemotherapy, radiation therapy, or immunosuppressive medications administered within 30 days prior to screening 6. High-dose immunosuppressive therapy (\>0.5 mg/kg prednisone equivalent daily), excluding physiologic replacement and stress-dose hydrocortisone for septic shock 7. Life expectancy less than 24 hours as assessed by the treating physician 8. Active uncontrolled bleeding requiring \>2 units of packed red blood cells in the preceding 24 hours 9. Known HIV infection with CD4 count \<350 cells/µL and detectable viral load 10. Known active viral hepatitis (hepatitis B or C with detectable viral load) 11. Advanced dementia or other conditions precluding meaningful participation 12. Known hypersensitivity to any component of the investigational products 13. Participation in another interventional trial with an investigational immunomodulatory agent within 30 days prior to screening 14. Pregnant or breastfeeding