SepsisPhase 2NCT07578558
NAI for Sepsis With Persistent Lymphopenia
A Phase 2 study testing Nogapendekin alfa inbakicept (NAI) in people with Sepsis and Septic Shock, run by ImmunityBio, Inc..
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Septic Shock, Lymphopenia
- What is being tested?
- Nogapendekin alfa inbakicept (NAI)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 6 Jul 2026to 4 Oct 2027
- 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 or older at the time of informed consent
- Admitted to the ICU with a diagnosis of sepsis as defined by Sepsis-3 criteria: life-threatening organ dysfunction caused by a dysregulated host response to infection, operationalized as a Sequential Organ Failure Assessment (SOFA) score increase of 2 or more points
- Documented persistent lymphopenia defined as ALC <1,000 cells/µL on at least two consecutive measurements within 72 hours of sepsis diagnosis (measurements must be separated by at least 12 hours)
- Prior initiation of appropriate antimicrobial therapy per institutional guidelines
- Ability to obtain written informed consent from the participant or legally authorized representative
- Agreement to practice effective contraception for female participants of child-bearing potential and non-sterile males (for up to 7 months after completion of therapy)
Who cannot join
- Hematologic malignancies including leukemia, lymphoma, and myelodysplastic syndromes
- Prior CAR-T cell therapy or hematopoietic stem cell transplant (HSCT) within 3 months of screening
- Active cytokine release syndrome (CRS) at screening
- Current or recent (within 7 days) use of colony stimulating factors (G-CSF, GM-CSF)
- Lymphopenia attributable to chemotherapy, radiation therapy, or immunosuppressive medications administered within 30 days prior to screening
- High-dose immunosuppressive therapy (>0.5 mg/kg prednisone equivalent daily), excluding physiologic replacement and stress-dose hydrocortisone for septic shock
Show all 14Show fewer
- Life expectancy less than 24 hours as assessed by the treating physician
- Active uncontrolled bleeding requiring >2 units of packed red blood cells in the preceding 24 hours
- Known HIV infection with CD4 count <350 cells/µL and detectable viral load
- Known active viral hepatitis (hepatitis B or C with detectable viral load)
- Advanced dementia or other conditions precluding meaningful participation
- Known hypersensitivity to any component of the investigational products
- Participation in another interventional trial with an investigational immunomodulatory agent within 30 days prior to screening
- Pregnant or breastfeeding
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Tamra Madenwald contact
About this study
Official title: Phase 2, Randomized, Open-Label Clinical Trial Evaluating Nogapendekin Alfa Inbakicept in Combination With Standard of Care Versus Standard of Care Alone in Critically Ill Adults With Sepsis and Persistent Lymphopenia
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.
Read the detailed description
Sepsis is characterized by a biphasic immune response: an initial hyperinflammatory phase followed by a prolonged immunosuppressive phase with persistent lymphopenia. The majority of sepsis deaths (>70%) occur during the immunosuppressive phase rather than the initial hyperinflammatory phase. This acquired immunosuppression correlates with markedly increased 28-day mortality rates exceeding 40% and significantly elevated risk of secondary infections.
This study evaluates NAI, an IL-15 receptor agonist that promotes proliferation and activation of NK cells and CD8+ T cells, as a potential therapy to restore immune function in critically ill adults with sepsis and persistent lymphopenia (ALC <1,000 cells/µL on two consecutive measurements within 72 hours of sepsis diagnosis).
Study Arms:
- Experimental Arm: NAI 1.2 mg subcutaneous injection administered on Days 3 (or earlier than Day 3 if ALC is <700 cells/µL), Day 14, and Day 21 if needed for ALC <1,000 cells/µL, plus institutional standard of care for sepsis
- Control Arm: Institutional standard of care for sepsis alone Standard of care may include antimicrobial therapy, fluid resuscitation, vasopressor support, organ support, and mechanical ventilation as clinically indicated. Treatment will be discontinued if a participant has unacceptable toxicity, withdraws consent, or if the Investigator feels it is no longer in the participant's best interest to continue.
All participants will be followed for 90 days post the first dose of study treatment to capture late adverse events, rehospitalization, or mortality.
- Conditions
- Sepsis, Septic Shock, Lymphopenia, Immunosuppression, Critical Illness
- Being tested
- Nogapendekin alfa inbakicept (NAI), Standard of Care (SOC)
- Keywords
- Sepsis, Septic shock, Persistent lymphopenia, Immunosuppression, IL-15 receptor agonist, Nogapendekin alfa inbakicept, N-803, ANKTIVA, Immune reconstitution, Critical care, ICU
- Medical subject headings
- Sepsis, Shock, Septic, Lymphopenia, 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, Nogapendekin alfa-inbakicept
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 group | Role | What they receive |
|---|---|---|
| NAI + Standard of Care | Experimental | 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 Receives: Drug: Nogapendekin alfa inbakicept (NAI); Other: Standard of Care (SOC) |
| Standard of Care Alone | Active comparator | Institutional standard of care for sepsis including antimicrobial therapy, fluid resuscitation, vasopressor support, and mechanical ventilation as clinically indicated Receives: Other: Standard of Care (SOC) |
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 within 28 days of randomization
Measured: 28 days
Secondary outcomes (5)
Change in absolute lymphocyte count (ALC)
Change in ALC from baseline (Day 1 pre-dose) through Day 28
Measured: Baseline through Day 28
ICU re-admission rate
Proportion of participants re-admitted to ICU after discharge by Day 90
Measured: Up to Day 90
Secondary infections
Proportion of participants with secondary infections after discharge by Day 90
Measured: Up to Day 90
90-day all-cause mortality rate
Proportion of participants who die from any cause within 90 days of randomization
Measured: 90 days
Safety and tolerability
Incidence and severity of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and Grade ≥3 TEAEs graded per NCI CTCAE v6.0
Measured: Through Day 30 after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2026
- Study start6 Jul 2026 (estimated)
- Primary completion3 Aug 2027 (estimated)
- Study completion4 Oct 2027 (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.
- 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
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ImmunityBio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07578558
- Sponsor's protocol ID
- ResQ2204-SEPSIS
- Status last verified
- May 2026
- First submitted
- 5 May 2026
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2, Randomized, Open-Label Clinical Trial Evaluating Nogapendekin Alfa Inbakicept in Combination With Standard of Care Versus Standard of Care Alone in Critically Ill Adults With Sepsis and Persistent Lymphopenia
- ClinicalTrials.gov ID
- NCT07578558
- Acronym / sponsor ID
- ResQ2204-SEPSIS
- Conditions
- Sepsis, Septic Shock, Lymphopenia, Immunosuppression, Critical Illness
- Keywords
- Sepsis, Septic shock, Persistent lymphopenia, Immunosuppression, IL-15 receptor agonist, 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
- 6 Jul 2026 (estimated)
- Primary completion
- 3 Aug 2027 (estimated)
- Study completion
- 4 Oct 2027 (estimated)
- First posted
- 11 May 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 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.
Detailed description
Sepsis is characterized by a biphasic immune response: an initial hyperinflammatory phase followed by a prolonged immunosuppressive phase with persistent lymphopenia. The majority of sepsis deaths (>70%) occur during the immunosuppressive phase rather than the initial hyperinflammatory phase. This acquired immunosuppression correlates with markedly increased 28-day mortality rates exceeding 40% and significantly elevated risk of secondary infections.
This study evaluates NAI, an IL-15 receptor agonist that promotes proliferation and activation of NK cells and CD8+ T cells, as a potential therapy to restore immune function in critically ill adults with sepsis and persistent lymphopenia (ALC <1,000 cells/µL on two consecutive measurements within 72 hours of sepsis diagnosis).
Study Arms:
- Experimental Arm: NAI 1.2 mg subcutaneous injection administered on Days 3 (or earlier than Day 3 if ALC is <700 cells/µL), Day 14, and Day 21 if needed for ALC <1,000 cells/µL, plus institutional standard of care for sepsis
- Control Arm: Institutional standard of care for sepsis alone Standard of care may include antimicrobial therapy, fluid resuscitation, vasopressor support, organ support, and mechanical ventilation as clinically indicated. Treatment will be discontinued if a participant has unacceptable toxicity, withdraws consent, or if the Investigator feels it is no longer in the participant's best interest to continue.
All participants will be followed for 90 days post the first dose of study treatment to capture late adverse events, rehospitalization, or mortality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NAI + Standard of Care | Experimental | Drug: Nogapendekin alfa inbakicept (NAI), Other: Standard of Care (SOC)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 |
| Standard of Care Alone | Active comparator | Other: Standard of Care (SOC)Institutional standard of care for sepsis including antimicrobial therapy, fluid resuscitation, vasopressor support, and mechanical ventilation as clinically indicated |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 years or older at the time of informed consent
- Admitted to the ICU with a diagnosis of sepsis as defined by Sepsis-3 criteria: life-threatening organ dysfunction caused by a dysregulated host response to infection, operationalized as a Sequential Organ Failure Assessment (SOFA) score increase of 2 or more points
- Documented persistent lymphopenia defined as ALC <1,000 cells/µL on at least two consecutive measurements within 72 hours of sepsis diagnosis (measurements must be separated by at least 12 hours)
- Prior initiation of appropriate antimicrobial therapy per institutional guidelines
- Ability to obtain written informed consent from the participant or legally authorized representative
Key exclusion criteria (14 listed)
- Hematologic malignancies including leukemia, lymphoma, and myelodysplastic syndromes
- Prior CAR-T cell therapy or hematopoietic stem cell transplant (HSCT) within 3 months of screening
- Active cytokine release syndrome (CRS) at screening
- Current or recent (within 7 days) use of colony stimulating factors (G-CSF, GM-CSF)
- Lymphopenia attributable to chemotherapy, radiation therapy, or immunosuppressive medications administered within 30 days prior to screening
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, ANKTIVA, Nogapendekin alfa-inbakiceptIL-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 | Drug | NAI + Standard of Care |
| Standard of Care (SOC)Institutional standard of care for sepsis including antimicrobial therapy, fluid resuscitation, vasopressor support, organ support, and mechanical ventilation as clinically indicated | Other | NAI + Standard of Care, Standard of Care Alone |
Primary outcome
28-day all-cause mortality rate
Time frame: 28 days
Proportion of participants who die from any cause within 28 days of randomization
5 secondary outcomes
Change in absolute lymphocyte count (ALC)
Time frame: Baseline through Day 28
ICU re-admission rate
Time frame: Up to Day 90
Secondary infections
Time frame: Up to Day 90
90-day all-cause mortality rate
Time frame: 90 days
Safety and tolerability
Time frame: Through Day 30 after last dose
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 11 May 2026.
- Individual participant dataSharing planned: No
Related trials for Sepsis
RecruitingPhase 1
NADPH Oxidase Correction in mRNA-transfected Granulocyte-enriched Cells in Chronic Granulomatous Disease (CGD)
Chronic Granulomatous Disease, Infection
Not yet recruitingObservational study
Comparative Study of the Genomic Characteristics of Uropathogenic Escherichia Coli According to the Severity of Community-Acquired Urinary Tract Infections in Guadeloupe (COLIGENURI)
Urinary Tract Infections
RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Peer Bullying Intervention, Vodcast
Recruiting
Veno-arterial Carbon Dioxide Partial Pressure Difference (CO2gap) for Early Resuscitation of Septic Shock
Sepsis - to Reduce Mortality in the Intensive Care Unit, Septic Shock
Active, not recruitingPhase 1/2
A Study to Evaluate AZD7760 Safety and Pharmacokinetics in Healthy Adults (Phase I) and Adults With End-stage Kidney Disease on Hemodialysis With a Central Venous Catheter (Phase IIa)
Staphylococcus Aureus
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.
Tamra Madenwald contact
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nogapendekin alfa inbakicept (NAI) in people with Sepsis and Septic Shock, 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 6 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 11 May 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. 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 Alex Golway (516-225-0068, Alex.Golway@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: 28 days). 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 11 May 2026.