SepsisPhase 2NCT07783789
NAI Plus Standard of Care Compared With Placebo Plus Standard of Care in Critically Ill Adults With Sepsis
A Phase 2 study testing Nogapendekin alfa inbakicept (NAI) in people with Sepsis, run by ImmunityBio, Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- Nogapendekin alfa inbakicept (NAI)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2026to 13 Aug 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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 contraception, as applicable, by females of childbearing potential and nonsterile males.
Who cannot join
- 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.
- Hematopoietic stem-cell transplantation within the prior 100 days.
- Active graft-versus-host disease requiring systemic immunosuppression.
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- Known hypersensitivity to NAI, IL-15, recombinant IL-15 receptor-alpha sushi domain, or human IgG1 Fc.
- Pregnancy.
- Breastfeeding.
- Active treatment with another investigational 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Phase 2a, Randomized, Double-Blind, Placebo-Controlled Clinical Trial Evaluating the Safety and Efficacy of Nogapendekin Alfa Inbakicept (NAI) Plus Standard of Care (SOC) Compared to SOC Alone in Critically Ill Adults With Sepsis
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.
- Conditions
- Sepsis
- Being tested
- Nogapendekin alfa inbakicept (NAI), Placebo
- 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
- Medical subject headings
- Sepsis, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nogapendekin alfa inbakicept (NAI)Drug
Also called N-803, ANKTIVA
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| NAI Plus Standard of Care | Experimental | Participants receive NAI 1.2 mg subcutaneously plus protocol-defined standard of care. Receives: Drug: Nogapendekin alfa inbakicept (NAI) |
| Placebo plus standard of care | Placebo comparator | Participants receive matching placebo subcutaneously plus protocol-defined standard of care. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day all-cause mortality rate
Proportion of participants who die from any cause by Day 28 after the first dose of study treatment.
Measured: From Day 1 (first NAI dose) through Day 28
Secondary outcomes (7)
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.
Measured: Baseline (Day 1 pre-dose) through end of hospital stay (up to 90 days)
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.
Measured: From Day 1 (first NAI dose) through Day 90
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.
Measured: Day 28 after Day 1 (first NAI dose)
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.
Measured: Baseline (Day 1) through end of ICU stay (up to 90 days)
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.
Measured: From ICU admission to ICU discharge or death (up to 90 days)
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.
Measured: From hospital admission to hospital discharge or death (up to 90 days)
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.
Measured: From Day 1 through Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start15 Oct 2026 (estimated)
- Primary completion12 May 2028 (estimated)
- Study completion13 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by ImmunityBio, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ImmunityBio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lennie Sender, MD, Study chair, ImmunityBio, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07783789
- Sponsor's protocol ID
- ResQ2205-Sepsis
- Status last verified
- Sep 2026
- First submitted
- 21 Aug 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2a, Randomized, Double-Blind, Placebo-Controlled Clinical Trial Evaluating the Safety and Efficacy of Nogapendekin Alfa Inbakicept (NAI) Plus Standard of Care (SOC) Compared to SOC Alone in Critically Ill Adults With Sepsis
- ClinicalTrials.gov ID
- NCT07783789
- Acronym / sponsor ID
- ResQ2205-Sepsis
- Conditions
- Sepsis
- Keywords
- Sepsis, Critical illness, Intensive care unit, Persistent lymphopenia, Absolute lymphocyte count, Nogapendekin alfa inbakicept, N-803, ANKTIVA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- ImmunityBio, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 12 May 2028 (estimated)
- Study completion
- 13 Aug 2028 (estimated)
- First posted
- 25 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NAI Plus Standard of Care | Experimental | Drug: Nogapendekin alfa inbakicept (NAI)Participants receive NAI 1.2 mg subcutaneously plus protocol-defined standard of care. |
| Placebo plus standard of care | Placebo comparator | Drug: PlaceboParticipants receive matching placebo subcutaneously plus protocol-defined standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
- Receiving guideline-directed standard of care according to the 2026 Surviving Sepsis Campaign Guidelines.
Key exclusion criteria (14 listed)
- 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.
- Hematopoietic stem-cell transplantation within the prior 100 days.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nogapendekin alfa inbakicept (NAI)Also: N-803, ANKTIVASubcutaneous 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. | Drug | NAI Plus Standard of Care |
| PlaceboMatching 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. | Drug | Placebo plus standard of care |
Primary outcome
28-day all-cause mortality rate
Time frame: From Day 1 (first NAI dose) through Day 28
Proportion of participants who die from any cause by Day 28 after the first dose of study treatment.
7 secondary outcomes
Change in Absolute Lymphocyte Count (ALC) From Baseline
Time frame: Baseline (Day 1 pre-dose) through end of hospital stay (up to 90 days)
90-Day Survival Rate
Time frame: From Day 1 (first NAI dose) through Day 90
Proportion of Participants Alive and Free of Organ Support at Day 28
Time frame: Day 28 after Day 1 (first NAI dose)
Change From Baseline in SOFA Score
Time frame: Baseline (Day 1) through end of ICU stay (up to 90 days)
Time to ICU Discharge
Time frame: From ICU admission to ICU discharge or death (up to 90 days)
Time to Hospital Discharge
Time frame: From hospital admission to hospital discharge or death (up to 90 days)
Incidence of Secondary Infections Through Day 28
Time frame: From Day 1 through Day 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: 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.
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Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lennie Sender, MD study chair
ImmunityBio, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nogapendekin alfa inbakicept (NAI) in people with Sepsis, run by ImmunityBio, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joseph Ward (3236933913, joseph.ward@immunitybio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day all-cause mortality rate (time frame: From Day 1 (first NAI dose) through Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.