NAI (Nogapendekin Alfa Inbakicept) Plus Standard of Care in Critically Ill Adults With Sepsis

NCT07783789 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: ResQ2205-Sepsis
• Study Type: interventional
• Target: 49
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will test whether adding an immune-stimulating drug, nogapendekin alfa inbakicept (NAI), to standard intensive care treatment is safe and potentially helpful for adults with sepsis or septic shock. All participants will receive usual sepsis care. They will also get NAI as an injection under the skin on Day 1, and again on Days 14 and 21 if still in the hospital (and with low lymphocyte counts on Day 21). The study will first focus on safety in 10 patients, then enroll more (total 49) to see how many are alive at 28 days and 90 days, how their white blood cell counts recover, how much organ support they need, and how long they stay in the ICU and hospital.

Conditions

Sepsis; Septic Shock

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 28-Day Survival Rate

  Proportion of participants who are alive 28 days after the first dose of nogapendekin alfa inbakicept (NAI). Survival status will be determined by review of hospital records and/or direct contact (in person or by phone) on Day 28 after Day 1 dosing.

  From Day 1 (first NAI dose) through Day 28

Secondary Outcomes (7)

• Change in Absolute Lymphocyte Count (ALC) From Baseline

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

• 90-Day Survival Rate

  From Day 1 (first NAI dose) through Day 90

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

  Day 28 after Day 1 (first NAI dose)

• Change From Baseline in SOFA Score

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

• Time to ICU Discharge

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

Study Arms (1)

NAI Plus Standard of Care

EXPERIMENTAL

Critically ill adults with sepsis or septic shock per Sepsis-3 criteria and persistent lymphopenia (ALC ≤ 1,000 cells/µL in two measurements ≥ 12 hours apart) will receive protocolized standard of care plus NAI 1.2 mg subcutaneously on Day 1, with optional doses on Day 14 and Day 21 if still hospitalized (and ALC ≤ 1,000 for Day 21), with monitoring for safety and clinical outcomes for 90 days.

Drug: Nogapendekin alfa inbakicept (NAI)

Interventions

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.

Also known as: N-803, ANKTIVA

NAI Plus Standard of Care

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 at the time of informed consent.
• Admitted to the ICU with sepsis or septic shock per Sepsis 3 criteria, operationalized as a SOFA increase of ≥ 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.
• ALC ≤ 1,000 cells/µL in two consecutive measurements separated by ≥ 12 hours within the 72 hour screening window.
• Documented or strongly suspected infection (bacterial, viral, fungal, or mixed) with reasonable diagnostic workup initiated.
• 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.
• 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 a legally authorized representative.
• Agreement to practice effective contraception for females of childbearing potential and nonsterile males, with details as in protocol.

You may not qualify if:

• Severe hepatic failure defined as Child Pugh class C with active hepatic encephalopathy at screening.
• Active malignancy receiving cytotoxic chemotherapy, radiotherapy, or checkpoint inhibitor therapy within 30 days prior to sepsis onset (maintenance hormonal therapy and stable targeted therapies permitted).
• Hematopoietic stem cell transplant within prior 100 days or active graft versus host disease requiring systemic immunosuppression.
• Known hypersensitivity to NAI, IL 15, recombinant IL 15 receptor alpha sushi domain, or human IgG1 Fc.
• Pregnancy or breastfeeding; negative serum pregnancy test required for women of childbearing potential.
• Active second investigational therapy or participation in another interventional trial within 30 days prior to enrollment.
• In 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).

Sponsors & Collaborators

• ImmunityBio, Inc.: lead

MeSH Terms

Conditions

Sepsis; Shock, Septic; Critical Illness

Interventions

ALT-803

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Disease Attributes

Study Officials

• Lennie Sender, MD

  ImmunityBio, Inc.

  STUDY CHAIR

Central Study Contacts

Joseph Ward

CONTACT

3236933913; joseph.ward@immunitybio.com

Jim Albert

CONTACT

310-486-6180; joseph.ward@immunitybio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single-arm trial of NAI plus standard of care in critically ill adults with sepsis or septic shock.

Study Record Dates

• First Submitted: August 21, 2026
• First Posted: August 25, 2026
• Study Start (Estimated): September 15, 2026
• Primary Completion (Estimated): October 12, 2027
• Study Completion (Estimated): December 13, 2027
• Last Updated: August 26, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share