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Not yet recruitingNCT07783789Updated Sep 25, 2026

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

A Phase 2 interventional study of Nogapendekin alfa inbakicept (NAI) and Placebo in Sepsis, sponsored by ImmunityBio, Inc.. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.

Sponsored by ImmunityBio, Inc. · Phase 2, Interventional, and Treatment

Updated Sep 25, 2026Start date movedPrimary completion moved+7 moreGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the detailed description

This is a randomized, double-blind, placebo-controlled, parallel-assignment Phase 2a study evaluating NAI plus standard of care compared with placebo plus standard of care in critically ill adults with sepsis and persistent lymphopenia. Approximately 50 participants will be randomized in a 1:1 ratio. The first 10 randomized participants will comprise a safety run-in, with approximately 5 participants assigned to each treatment arm. Safety data will be reviewed by the designated safety review committee or DSMB before enrollment of the remaining participants proceeds.

02

Conditions studied

  • Sepsis

Keywords

  • Sepsis
  • Critical illness
  • Intensive care unit
  • Persistent lymphopenia
  • Absolute lymphocyte count
  • Nogapendekin alfa inbakicept
  • N-803
  • ANKTIVA
  • IL-15 receptor agonist
  • Immunotherapy in sepsis
03

In context

Sepsis

2,416 studies on the registry are indexed under Sepsis; 541 are open to participants now.

This study's planned enrollment of 50 is below the median of 102 across 1,165 interventional studies indexed under Sepsis.

Browse Sepsis studies →

Lead sponsor

ImmunityBio, Inc. is the lead sponsor of 83 studies on the registry; 15 are open to participants now.

Of its 23 completed or terminated interventional studies of FDA-regulated products, 17 (74%) have results posted.

Browse ImmunityBio, Inc. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Sep 25, 2026. See what changed

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age ≥18 years at the time of .
  • 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.
  • Receiving guideline-directed standard of care according to the 2026 Surviving Sepsis Campaign Guidelines.
  • Able to receive the first dose of NAI within 72 hours of sepsis recognition, targeted within 12 hours of eligibility confirmation.
  • Ability to obtain written informed consent from the participant or legally authorized representative.
  • Agreement to practice effective , as applicable, by females of and nonsterile males.

Exclusion criteria

Exclusion Criteria

  • Severe hepatic failure, including class C, or AST ≥3 times the with total >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 treated with cytotoxic chemotherapy, radiotherapy, or checkpoint-inhibitor therapy within 30 days before sepsis onset.
  • History of solid-organ transplantation.
  • Hematopoietic stem-cell transplantation within the prior 100 days.
  • Active requiring systemic .
  • Known to NAI, IL-15, recombinant IL-15 receptor-alpha sushi domain, or human IgG1 Fc.
  • Pregnancy.
  • Breastfeeding.
  • Active treatment with another therapy.
  • Participation in another interventional clinical trial within 30 days before enrollment.
  • A clinical condition or treatment limitation that, in the Investigator's opinion, precludes meaningful participation or follow-up.
  • Expected death within 24 hours.
  • Comfort-care-only orders that preclude protocol-mandated assessments.
Terms in these criteria, in plain language(12)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Child-Pugh class

A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

GVHD (graft-versus-host disease)

After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    NAI Plus Standard of Care

    Participants receive NAI 1.2 mg subcutaneously plus protocol-defined standard of care.

    Drug: Nogapendekin alfa inbakicept (NAI)

  • Placebo comparator
    Placebo plus standard of care

    Participants receive matching placebo subcutaneously plus protocol-defined standard of care.

    Drug: Placebo

Interventions

  • DrugNogapendekin alfa inbakicept (NAI)

    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.

    Also known as: N-803, ANKTIVA

  • DrugPlacebo

    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.

06

What researchers measure

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)

  5. Time to ICU Discharge

    Number of days from ICU admission at the index sepsis episode to ICU discharge, with death before ICU discharge treated as a competing event in analysis.

    Time frame: From ICU admission to ICU discharge or death (up to 90 days)

  6. Time to Hospital Discharge

    Number of days from hospital admission at the index sepsis episode to hospital discharge, with death before discharge treated as a competing event in analysis.

    Time frame: From hospital admission to hospital discharge or death (up to 90 days)

  7. Incidence of Secondary Infections Through Day 28

    Number and proportion of participants who develop one or more new infections after enrollment that are distinct from the index infection, based on clinical diagnosis and culture or other microbiologic testing.

    Time frame: From Day 1 through Day 28

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No — Individual participant data will not be shared because there is no current sponsor policy or infrastructure in place for external IPD sharing for this study.

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Start date
Sep 15, 2026→Oct 15, 2026
Sep 25, 2026
Primary completion
Oct 12, 2027→May 12, 2028
Sep 25, 2026
Study completion
Dec 13, 2027→Aug 13, 2028
Sep 25, 2026
Enrollment
49→50
Sep 25, 2026
Eligibility
6 inclusion criteria edited; 4 exclusion criteria edited, 10 added, 3 removed
What changed in the criteria
Inclusion criteria
  • EditedAdmittedAdmission to the ICU with sepsis or, without septic shock, per Sepsis -3 criteria, operationalized as a SOFA increase of ≥at least 2 points attributable to suspected or confirmed infection; septic shock defined as persistent vasopressor requirement to maintain MAP ≥ 65 mm Hg and serum lactate > 2 mmol/L despite adequate volume resuscitation.
  • EditedALC ≤ 1,000 cells/µL in two consecutive measurements separated by ≥at least 12 hours withinduring the 72 -hour screening window.
  • EditedDocumented or strongly suspected infection (bacterial, viral, fungal, or mixed) infection with reasonable diagnostic workup initiated.
  • ChangedBefore Receiving guideline-directed standard of care per 2026 Surviving Sepsis Campaign Guidelines, including as clinically appropriate: early empiric broad-spectrum antimicrobials, ≥ 30 mL/kg balanced crystalloid within 3 hours for hypoperfusion or shock, norepinephrine as first line vasopressor (MAP ≥ 65 mm Hg), lung-protective ventilation if mechanically ventilated, glycemic target 144-180 mg/dL, and venous thromboembolism and stress ulcer prophylaxis.Now Receiving guideline-directed standard of care according to the 2026 Surviving Sepsis Campaign Guidelines.
  • EditedAbility to obtain written informed consent from the participant or a legally authorized representative.
  • EditedAgreement to practice effective contraception for, as applicable, by females of childbearing potential and nonsterile males, with details as in protocol.
Exclusion criteria
  • RemovedSevere hepatic failure defined as Child Pugh class C with active hepatic encephalopathy at screening.
  • AddedSevere 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.
  • AddedSeptic shock at screening or at the time of the first dose.
  • EditedActive malignancy receivingtreated with cytotoxic chemotherapy, radiotherapy, or checkpoint -inhibitor therapy within 30 days prior tobefore sepsis onset (maintenance hormonal therapy and stable targeted therapies permitted).
  • AddedHistory of solid-organ transplantation.
  • AddedHematopoietic stem-cell transplantation within the prior 100 days.
  • EditedHematopoietic stem cell transplant within prior 100 days or activeActive graft -versus -host disease requiring systemic immunosuppression.
  • EditedKnown hypersensitivity to NAI, IL -15, recombinant IL -15 receptor -alpha sushi domain, or human IgG1 Fc.
  • RemovedPregnancy or breastfeeding; negative serum pregnancy test required for women of childbearing potential.
  • AddedPregnancy.
  • AddedBreastfeeding.
  • AddedActive treatment with another investigational therapy.
  • EditedActive second investigational therapy or participationParticipation in another interventional clinical trial within 30 days prior tobefore enrollment.
  • RemovedIn the Investigator's opinion, a clinical condition or treatment limitation precluding meaningful participation or follow up (e.g., expected death within 24 hours, comfort-care-only orders precluding protocol-mandated assessments).
  • AddedA clinical condition or treatment limitation that, in the Investigator's opinion, precludes meaningful participation or follow-up.
  • AddedExpected death within 24 hours.
  • AddedComfort-care-only orders that preclude protocol-mandated assessments.
Sep 25, 2026
Interventions
Added Drug: Placebo. Arms added: Placebo plus standard of care
Sep 25, 2026
Primary outcomes
1 edited
What changed in the outcomes
  • Edited28-Day Survival Rateday all-cause mortality rateTime frame: From Day 1 (first NAI dose) through Day 28
Sep 25, 2026
Title
NAI (Nogapendekin Alfa Inbakicept)Plus Standard of Care Compared With Placebo Plus Standard of Care in Critically Ill Adults With Sepsis
Sep 25, 2026
Design
Removed Phase 1
Sep 25, 2026
Show all 1 update
  1. Sep 25, 2026
    Start date Sep 15, 2026→Oct 15, 2026
    Primary completion Oct 12, 2027→May 12, 2028
    Study completion Dec 13, 2027→Aug 13, 2028
    Enrollment 49→50
    Eligibility 6 inclusion criteria edited; 4 exclusion criteria edited, 10 added, 3 removed
    What changed in the criteria
    Inclusion criteria
    • EditedAdmittedAdmission to the ICU with sepsis or, without septic shock, per Sepsis -3 criteria, operationalized as a SOFA increase of ≥at least 2 points attributable to suspected or confirmed infection; septic shock defined as persistent vasopressor requirement to maintain MAP ≥ 65 mm Hg and serum lactate > 2 mmol/L despite adequate volume resuscitation.
    • EditedALC ≤ 1,000 cells/µL in two consecutive measurements separated by ≥at least 12 hours withinduring the 72 -hour screening window.
    • EditedDocumented or strongly suspected infection (bacterial, viral, fungal, or mixed) infection with reasonable diagnostic workup initiated.
    • ChangedBefore Receiving guideline-directed standard of care per 2026 Surviving Sepsis Campaign Guidelines, including as clinically appropriate: early empiric broad-spectrum antimicrobials, ≥ 30 mL/kg balanced crystalloid within 3 hours for hypoperfusion or shock, norepinephrine as first line vasopressor (MAP ≥ 65 mm Hg), lung-protective ventilation if mechanically ventilated, glycemic target 144-180 mg/dL, and venous thromboembolism and stress ulcer prophylaxis.Now Receiving guideline-directed standard of care according to the 2026 Surviving Sepsis Campaign Guidelines.
    • EditedAbility to obtain written informed consent from the participant or a legally authorized representative.
    • EditedAgreement to practice effective contraception for, as applicable, by females of childbearing potential and nonsterile males, with details as in protocol.
    Exclusion criteria
    • RemovedSevere hepatic failure defined as Child Pugh class C with active hepatic encephalopathy at screening.
    • AddedSevere 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.
    • AddedSeptic shock at screening or at the time of the first dose.
    • EditedActive malignancy receivingtreated with cytotoxic chemotherapy, radiotherapy, or checkpoint -inhibitor therapy within 30 days prior tobefore sepsis onset (maintenance hormonal therapy and stable targeted therapies permitted).
    • AddedHistory of solid-organ transplantation.
    • AddedHematopoietic stem-cell transplantation within the prior 100 days.
    • EditedHematopoietic stem cell transplant within prior 100 days or activeActive graft -versus -host disease requiring systemic immunosuppression.
    • EditedKnown hypersensitivity to NAI, IL -15, recombinant IL -15 receptor -alpha sushi domain, or human IgG1 Fc.
    • RemovedPregnancy or breastfeeding; negative serum pregnancy test required for women of childbearing potential.
    • AddedPregnancy.
    • AddedBreastfeeding.
    • AddedActive treatment with another investigational therapy.
    • EditedActive second investigational therapy or participationParticipation in another interventional clinical trial within 30 days prior tobefore enrollment.
    • RemovedIn the Investigator's opinion, a clinical condition or treatment limitation precluding meaningful participation or follow up (e.g., expected death within 24 hours, comfort-care-only orders precluding protocol-mandated assessments).
    • AddedA clinical condition or treatment limitation that, in the Investigator's opinion, precludes meaningful participation or follow-up.
    • AddedExpected death within 24 hours.
    • AddedComfort-care-only orders that preclude protocol-mandated assessments.
    Primary outcomes 1 edited
    What changed in the outcomes
    • Edited28-Day Survival Rateday all-cause mortality rateTime frame: From Day 1 (first NAI dose) through Day 28
    Interventions Added Drug: Placebo. Arms added: Placebo plus standard of care
    Design Removed Phase 1
    Title NAI (Nogapendekin Alfa Inbakicept)Plus Standard of Care Compared With Placebo Plus Standard of Care in Critically Ill Adults With Sepsis
    + 4 other changes: index terms, verification date, description and conditions

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07783789
Lead sponsor
ImmunityBio, Inc.
Responsible party
Sponsor
First posted
Aug 25, 2026
Start date
Oct 15, 2026 (estimated)
Primary completion
May 12, 2028 (estimated)
Completion
Aug 13, 2028 (estimated)
Last update
Sep 25, 2026

Study contacts

Joseph Ward
Contact
joseph.ward@immunitybio.com
3236933913
Jim Albert
Contact
joseph.ward@immunitybio.com
310-486-6180
Lennie Sender, MD
study chair · ImmunityBio, Inc.

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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