NAI (Nogapendekin Alfa Inbakicept) Plus Standard of Care in Critically Ill Adults With Sepsis

Sponsor
ImmunityBio, Inc.
Study ID
NCT07783789
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Sepsis
  • Septic Shock

Eligibility Criteria

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

Interventions

  • Nogapendekin alfa inbakicept (NAI) — DRUG
    Subcutaneous administration of nogapendekin alfa inbakicept (NAI; N-803, ANKTIVA®), a recombinant human IL-15 receptor agonist complex (IL-15N72D:IL-15RαSu/IgG1 Fc), at a fixed dose of 1.2 mg (0.6 mL at 2 mg/mL) on Day 1 (within 72 hours of sepsis recognition), with additional 1.2 mg doses on Day 14 if still hospitalized and on Day 21 if still hospitalized with ALC ≤ 1,000 cells/µL, given in combination with protocolized Surviving Sepsis Campaign-based standard of care.

Study Details

This study will test whether adding an immune-stimulating drug, nogapendekin alfa inbakicept (NAI), to standard intensive care treatment is safe and potentially helpful for adults with sepsis or septic shock. All participants will receive usual sepsis care. They will also get NAI as an injection under the skin on Day 1, and again on Days 14 and 21 if still in the hospital (and with low lymphocyte counts on Day 21). The study will first focus on safety in 10 patients, then enroll more (total 49) to see how many are alive at 28 days and 90 days, how their white blood cell counts recover, how much organ support they need, and how long they stay in the ICU and hospital.

Key Dates

First listed
Aug 25, 2026
Start date
Sep 15, 2026
Status verified
Aug 2026
Primary completion
Oct 12, 2027
Completion
Dec 13, 2027

Study Design

Enrollment
49 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: NAI Plus Standard of Care
    Critically ill adults with sepsis or septic shock per Sepsis-3 criteria and persistent lymphopenia (ALC ≤ 1,000 cells/µL in two measurements ≥ 12 hours apart) will receive protocolized standard of care plus NAI 1.2 mg subcutaneously on Day 1, with optional doses on Day 14 and Day 21 if still hospitalized (and ALC ≤ 1,000 for Day 21), with monitoring for safety and clinical outcomes for 90 days.

Primary Outcome Measure

28-Day Survival Rate [ Time Frame: From Day 1 (first NAI dose) through Day 28 ]

Central Contacts

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