WithdrawnPhase 2

Nogapendekin Alfa-Inbakicept and iNKT Cells for Critically Ill Adults With Severe Community-Acquired Pneumonia (With or Without Sepsis/ARDS)

Stopped: New protocol developed

0Started 2026-04-15

Plain-language summary

This Phase 2 study tests whether adding two immune therapies - nogapendekin alfa-inbakicept (NAI) and off-the-shelf iNKT cell infusions - to standard care can safely help critically ill adults with severe community-acquired pneumonia (CAP) (with or without sepsis/ARDS) recover. The study will give NAI by subcutaneous injection (Days 1 and 10) and one IV dose of iNKT cells (Day 3), then follow participants for 90 days.

Who can participate

Age range18 Years – 105 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Age ≥ 18 years.
✓. Critically ill adult requiring ICU admission due to severe community acquired pneumonia (CAP), defined by ≥1 major criterion or ≥3 minor criteria (IDSA/ATS):
✓. Hospital admission with diagnosis of CAP within 72 hours.
✓. Lymphopenia: absolute lymphocyte count (ALC) \< 1,500/µL (not secondary to chemotherapy).
✓. Receiving antibiotics for CAP (at least one dose since ICU admission).
✓. Informed consent obtainable from participant or legally authorized representative.

Exclusion criteria

✕. Hematologic malignancy (e.g., active leukemia or lymphoma not in remission).
✕. Post CAR T therapy or hematopoietic cell transplant for ALL, NHL, or multiple myeloma \< 3 months prior to enrollment.
✕. Current diagnosis of cytokine release syndrome.
✕. Receiving colony stimulating factors (e.g., G CSF).
✕. Clinical history or imaging suggesting aspiration of gastric contents.
✕. Advanced dementia or prolonged bedridden status.
✕. Pregnancy or breastfeeding.

What they're measuring

28-day all-cause mortality

Timeframe: Day 28 (28 days after first dose)

Treatment Emergent Adverse Events (TEAEs)

Timeframe: From first study treatment to 30 days after the participant's last study dose.

Severe Adverse Events (SAEs)

Timeframe: 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

Timeframe: From first study treatment to 30 days after the participant's last study dose.

Safety laboratory tests

Timeframe: From baseline (pre-dose) through 30 days after the participant's last study dose.

Temperature

Timeframe: 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

Timeframe: 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).

Trial details

NCT IDNCT07492888

SponsorImmunityBio, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-11-15

View on ClinicalTrials.gov More Acute Respiratory Distress Syndrome trials

Plain-language summary

Who can participate

Age range18 Years – 105 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Age ≥ 18 years.
✓. Critically ill adult requiring ICU admission due to severe community acquired pneumonia (CAP), defined by ≥1 major criterion or ≥3 minor criteria (IDSA/ATS):
✓. Hospital admission with diagnosis of CAP within 72 hours.
✓. Lymphopenia: absolute lymphocyte count (ALC) \< 1,500/µL (not secondary to chemotherapy).
✓. Receiving antibiotics for CAP (at least one dose since ICU admission).
✓. Informed consent obtainable from participant or legally authorized representative.

Exclusion criteria

✕. Hematologic malignancy (e.g., active leukemia or lymphoma not in remission).
✕. Post CAR T therapy or hematopoietic cell transplant for ALL, NHL, or multiple myeloma \< 3 months prior to enrollment.
✕. Current diagnosis of cytokine release syndrome.
✕. Receiving colony stimulating factors (e.g., G CSF).
✕. Clinical history or imaging suggesting aspiration of gastric contents.
✕. Advanced dementia or prolonged bedridden status.
✕. Pregnancy or breastfeeding.

What they're measuring

28-day all-cause mortality

Timeframe: Day 28 (28 days after first dose)

Treatment Emergent Adverse Events (TEAEs)

Timeframe: From first study treatment to 30 days after the participant's last study dose.

Severe Adverse Events (SAEs)

Timeframe: 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

Timeframe: From first study treatment to 30 days after the participant's last study dose.

Safety laboratory tests

Timeframe: From baseline (pre-dose) through 30 days after the participant's last study dose.

Temperature

Timeframe: 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

Timeframe: 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).