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

NCT07783789 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: ResQ2205-Sepsis
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

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

Outcome Measures

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.

  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 (2)

NAI Plus Standard of Care

EXPERIMENTAL

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

Drug: Nogapendekin alfa inbakicept (NAI)

Placebo plus standard of care

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Placebo DRUG

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.

Placebo plus standard of care

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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• ImmunityBio, Inc.: lead

MeSH Terms

Conditions

Sepsis; Critical Illness

Interventions

ALT-803

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; 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 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participant, Care Provider, Investigator, Outcomes Assessor, as applicable
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2026
• First Posted: August 25, 2026
• Study Start: October 15, 2026
• Primary Completion (Estimated): May 12, 2028
• Study Completion (Estimated): August 13, 2028
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share