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

StatusNot Yet Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 7 months later Oct 12, 2027 → May 12, 2028
Primary endpoint reworded 1 of 1 changed
See other at-risk trials from ImmunityBio, Inc.

Record History

  1. Primary completion pushed from Oct 12, 2027 to May 12, 2028 Primary endpoint(s) modified · Phase changed: Phase 1/2 → Phase 2 · Start date: Sep 15, 2026 to Oct 15, 2026 · 8 more Show 11 more changesShow less
    • Primary endpoint(s) modified
    • Phase changed: Phase 1/2 → Phase 2
    • Start date: Sep 15, 2026 to Oct 15, 2026
    • Completion pushed from Dec 13, 2027 to Aug 13, 2028
    • Interventions modified
    • Trial arms changed: 1 → 2
    • Enrollment target: 49 to 50
    • Eligibility criteria shortened, about 47 words
    • Secondary endpoints: details revised at 4 of 7 entries
    • Study description shortened, about 66 words
    • Study title expanded, about 4 words
  2. Secondary endpoints: details revised at 1 of 7 entriesv2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT07783789
Lead Sponsor ImmunityBio, Inc.
Conditions Sepsis
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov