Nogapendekin Alfa-Inbakicept and iNKT Cells for Critically Ill Adults With Severe Community-Acquired Pneumonia (With or Without Sepsis/ARDS)
← catalyst calendarNCT07492888 · readout in 87 d
Sponsored by ImmunityBio, Inc. (industry) · IBRX — their whole pipeline →.
Phase
Phase 2
Status
Withdrawn
Study type
Interventional
Design
Na · None · Treatment
Enrollment
0actual
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Why the sponsor stopped it
New protocol developed
As filed on the registry record, in the sponsor's own words.
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2026-04-15 | estimated | When the study began enrolling |
| Primary completion | 2026-11-15 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-01-15 | estimated | The whole study's end, after follow-up |
| First posted | 2026-03-25 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-05-08 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Acute Respiratory Distress Syndrome
- Severe Community-Acquired Pneum
- Sepsis
- Lymphopenia / Immunoparalysis in Critically Ill Adults
Interventions
- Drug: Nogapendekin Alfa-Inbakicept (NAI) — also filed as Anktiva, N-803, ALT-803
- Drug: Allogeneic invariant Natural Killer T (iNKT) Cells (AgenT-797)
Primary outcomes
what the primary-completion date above is the date OF28-day all-cause mortality
measured Day 28 (28 days after first dose)
Treatment Emergent Adverse Events (TEAEs)
measured From first study treatment to 30 days after the participant's last study dose.
Severe Adverse Events (SAEs)
measured From first study treatment to 30 days after the participant's last study dose (SAEs related to study product reported regardless of last dose date).
Grade ≥3 TEAEs
measured From first study treatment to 30 days after the participant's last study dose.
Safety laboratory tests
measured From baseline (pre-dose) through 30 days after the participant's last study dose.
Temperature
measured Baseline (pre-dose) through End of ICU stay; intensified monitoring for 24 hours after iNKT infusion (vitals every ≥4 hours; continuous telemetry as indicated).
Heart rate
measured Baseline (pre-dose); maximum post-dose within 24 hours after iNKT infusion (intensified monitoring during this 24-hour window); overall reporting through End of ICU stay (up to 28 days).
Blood pressure
measured Baseline (pre-dose); maximum post-dose within 24 hours after iNKT infusion (intensified monitoring during this 24-hour window); overall reporting through End of ICU stay (up to 28 days).
Respiratory rate
measured Baseline (pre-dose); maximum post-dose within 24 hours after iNKT infusion (intensified monitoring during this 24-hour window); overall reporting through End of ICU stay (up to 28 days).
Oxygen saturation
measured Baseline through End of ICU stay; intensified monitoring for 24 hours after iNKT infusion.
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