NAI for Sepsis With Persistent Lymphopenia

Sponsor
ImmunityBio, Inc.
Study ID
NCT07578558
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Critical Illness
  • Immunosuppression
  • Lymphopenia
  • Sepsis
  • Septic Shock

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nogapendekin alfa inbakicept (NAI) — DRUG
    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
  • Standard of Care (SOC) — OTHER
    Institutional standard of care for sepsis including antimicrobial therapy, fluid resuscitation, vasopressor support, organ support, and mechanical ventilation as clinically indicated

Study Details

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.

Key Dates

First listed
May 11, 2026
Start date
Jul 6, 2026
Status verified
May 2026
Primary completion
Aug 3, 2027
Completion
Oct 4, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: NAI + Standard of Care
    NAI 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, plus institutional standard of care for sepsis
  • Active Comparator: Standard of Care Alone
    Institutional standard of care for sepsis including antimicrobial therapy, fluid resuscitation, vasopressor support, and mechanical ventilation as clinically indicated

Primary Outcome Measure

28-day all-cause mortality rate [ Time Frame: 28 days ]

Central Contacts

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