NAI for Sepsis With Persistent Lymphopenia

NCT07578558 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: ResQ2204-SEPSIS
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

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; Immune reconstitution; Critical care; ICU

Outcome Measures

Primary Outcomes (1)

• 28-day all-cause mortality rate

  Proportion of participants who die from any cause within 28 days of randomization

  28 days

Secondary Outcomes (5)

• Change in absolute lymphocyte count (ALC)

  Baseline through Day 28

• ICU re-admission rate

  Up to Day 90

• Secondary infections

  Up to Day 90

• 90-day all-cause mortality rate

  90 days

• Safety and tolerability

  Through Day 30 after last dose

Study Arms (2)

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

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

Other: Standard of Care (SOC)

Interventions

Nogapendekin alfa inbakicept (NAI) DRUG

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

Also known as: N-803, ANKTIVA, Nogapendekin alfa-inbakicept

NAI + Standard of Care

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

NAI + Standard of Care; Standard of Care Alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• ImmunityBio, Inc.: lead

MeSH Terms

Conditions

Sepsis; Shock, Septic; Lymphopenia; Critical Illness

Interventions

ALT-803; Standard of Care

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Alex Golway

CONTACT

516-225-0068; Alex.Golway@ImmunityBio.com

Tamra Madenwald

CONTACT

Tamra.Madenwald@ImmunityBio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 11, 2026
• Study Start (Estimated): July 6, 2026
• Primary Completion (Estimated): August 3, 2027
• Study Completion (Estimated): October 4, 2027
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share