ImmunityBio NAI Sepsis Trial: Updated Phase 2 Plan, Estimated Start and Registry Conflicts
The NAI sepsis registry now lists a 50-participant Phase 2 study and an estimated October 15, 2026 start. Recruitment has not begun according to the record; masking details conflict.
This article records evidence available when published or updated. Registration dates are not proof of trial enrollment; check the original sources for current status.
Update, October 6, 2026 (America/Chicago): The ClinicalTrials.gov NAI sepsis record, last posted September 25, now describes a Phase 2 study with estimated enrollment of 50, an estimated October 15, 2026 start, and status Not yet recruiting. It supersedes the earlier snapshot described in our September 23 correction: a Phase 1b/2, 49-participant, open-label plan with an estimated September 15 start. We retain this URL and explicitly identify the changed fields.
What is NAI being studied for?
The record names ImmunityBio, Inc. as sponsor and nogapendekin alfa inbakicept (NAI) and placebo as interventions. It lists N-803 and ANKTIVA as other names for NAI. This record concerns sepsis research, not proof of an approved sepsis indication or demonstrated benefit.
The current brief title describes NAI plus standard care compared with placebo plus standard care in critically ill adults with sepsis. The structured design identifies a randomized, parallel Phase 2 study. Its official title calls it Phase 2a.
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Prepared research question
ImmunityBio NAI Sepsis Trial: which company evidence supports or challenges the article?
Traceable citations · Unknowns marked
Has the trial started?
The current status is Not yet recruiting, and October 15 is ESTIMATED. No actual start date is supplied. The 50-participant enrollment field is also estimated. Neither number is an observed trial outcome.
A registry may lag activity at study sites. That possibility is not evidence that enrollment has started: the actual start remains UNKNOWN unless supported by a verifiable primary update.
A masking conflict that needs clarification
The official title says double-blind. The structured masking field says single, explicitly listing the participant. Its masking description mentions additional roles “as applicable.”
These statements do not support a single unqualified characterization of blinding. We preserve the conflict and do not substitute the earlier article's open-label description. The protocol or a clarified registry update is needed to resolve it. See the trial-design checklist for why role-level masking matters.
What an investor should ask next
Which source confirms actual enrollment? What are the protocol-defined endpoints and analysis plan? Has the masking inconsistency been resolved? Are there reported results for this exact sepsis study, as distinct from another use of the same molecule?
The prepared research task carries the company only when the current trusted event agrees with that identity. It should return dated primary links and UNKNOWNs, not convert a study plan into a clinical or commercial conclusion.
Primary source: NCT07783789, retrieved October 6, 2026 (America/Chicago); last posted update September 25, 2026. Research education only, not investment or medical advice.