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NAI Plus Standard of Care Compared With Placebo Plus Standard of Care in Critically Ill Adults With Sepsis

ConditionSepsis
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorImmunityBio, Inc.

About this trial

This Phase 2a study will evaluate the safety and efficacy of nogapendekin alfa inbakicept (NAI) plus standard of care compared with placebo plus standard of care in critically ill adults with sepsis and persistent lymphopenia. Participants will be randomized approximately 1:1 and treated under double-blind conditions. The study includes a safety run-in for the first 10 randomized participants, followed by enrollment of the remaining participants after safety review. Outcomes include safety, 28-day survival, absolute lymphocyte count recovery, organ-support-free status, organ dysfunction, and ICU and hospital outcomes

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years at the time of informed consent.

Admission to the ICU with sepsis, without septic shock, per Sepsis-3 criteria, operationalized as a SOFA increase of at least 2 points attributable to suspected or confirmed infection.

ALC ≤1,000 cells/µL in two consecutive measurements separated by at least 12 hours during the 72-hour screening window.

Documented or strongly suspected bacterial, viral, fungal, or mixed infection with reasonable diagnostic workup initiated.

Disqualifiers

Severe hepatic failure, including Child-Pugh class C, ALT or AST ≥3 times the ULN with total bilirubin >2 times the ULN, or ALT or AST ≥5 times the ULN.

Septic shock at screening or at the time of the first dose.

Active malignancy treated with cytotoxic chemotherapy, radiotherapy, or checkpoint-inhibitor therapy within 30 days before sepsis onset.

History of solid-organ transplantation.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Placebo

    Drug

    Matching placebo administered subcutaneously according to the same dosing schedule and under the same conditions as nogapendekin alfa inbakicept (NAI), in combination with standard of care. The placebo is designed to maintain blinding and contains no active NAI.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: NAI Plus Standard of CareExperimental treatment 1 intervention
Group B: Placebo plus standard of carePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

28-day all-cause mortality rate

Proportion of participants who die from any cause by Day 28 after the first dose of study treatment.

Time frame
From Day 1 (first NAI dose) through Day 28

Secondary outcomes

1

Change in Absolute Lymphocyte Count (ALC) From Baseline

Change in absolute lymphocyte count (cells/µL) from baseline (Day 1 pre-dose) at each assessment through the end of hospital stay, using local complete blood counts with differential collected at least every 3 days.

Time frame
Baseline (Day 1 pre-dose) through end of hospital stay (up to 90 days)
2

90-Day Survival Rate

Proportion of participants who are alive 90 days after the first dose of nogapendekin alfa inbakicept (NAI). Survival status will be determined by review of records and/or direct contact (in person or by phone) on Day 90 after Day 1 dosing.

Time frame
From Day 1 (first NAI dose) through Day 90
3

Proportion of Participants Alive and Free of Organ Support at Day 28

Proportion of participants who are alive and not requiring mechanical ventilation, vasopressors, or renal replacement therapy on Day 28 after the first NAI dose. Organ support status will be determined from ICU/hospital records.

Time frame
Day 28 after Day 1 (first NAI dose)
4

Change From Baseline in SOFA Score

Change from baseline in Sequential Organ Failure Assessment (SOFA) score at each daily intensive care unit (ICU) assessment. The SOFA score evaluates dysfunction across six organ systems: respiratory, coagulation, hepatic, cardiovascular, central nervous system, and renal. Each organ system is scored from 0 to 4, resulting in a total score ranging from 0 to 24. Higher scores indicate greater organ dysfunction and a worse clinical outcome. Change from baseline is calculated as the score at each daily ICU assessment minus the baseline score; a positive change indicates worsening organ dysfunction, while a negative change indicates improvement.

Time frame
Baseline (Day 1) through end of ICU stay (up to 90 days)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ImmunityBio, Inc.

Lead sponsor

Source ClinicalTrials.gov

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