Trial intelligence / Profile preview

Anktiva in Critically Ill Adults With Sepsis

NCT07783789Phase 2

Key facts

Status: Not yet recruiting
Start: Oct 2026
Primary completion: May 2028
Sponsor: ImmunityBio, Inc.

Drugs: nogapendekin alfa inbakicept
Conditions: sepsis

Overview

Phase 2, randomised, double-blind trial in sepsis comparing NAI Plus Standard of Care with Placebo plus standard of care (2 arms). Primary endpoint: 28-day all-cause mortality rate. Planned start Oct 2026; status: not yet recruiting.

Design

2 arms

Study design: RandomizedDouble-blind

NAI Plus Standard of Care
Participants receive Anktiva 1.2 mg subcutaneously plus protocol-defined standard of care.
Placebo plus standard of care
Participants receive matching placebo subcutaneously plus protocol-defined standard of care.

Who it enrols

Critically ill adults admitted to the ICU with sepsis (without septic shock) and persistent lymphopenia (ALC <= 1,000 cells/µL), receiving standard of care. Excludes patients with severe hepatic failure, septic shock, recent active malignancy treatment, or recent transplantation.

Endpoints

Primary

28-day all-cause mortality rate28 days

Secondary

Change in Absolute Lymphocyte Count (ALC) From Baselineup to 90 days
90-Day Survival Rate90 days
Proportion of Participants Alive and Free of Organ Support at Day 2828 days
Change From Baseline in SOFA Scoreup to 90 days
Time to ICU Dischargeup to 90 days
Time to Hospital Dischargeup to 90 days
Incidence of Secondary Infections Through Day 2828 days

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