Nogapendekin Alfa-Inbakicept and iNKT Cells for Critically Ill Adults With Severe Community-Acqui… (NCT07492888) | Clinical Trial Compass
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 range
18 Years – 105 Years
Sex
ALL
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.
. Receiving antibiotics for CAP (at least one dose since ICU admission).
. Informed consent obtainable from participant or legally authorized representative.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
28-day all-cause mortality
Timeframe: Day 28 (28 days after first dose)
2
Treatment Emergent Adverse Events (TEAEs)
Timeframe: From first study treatment to 30 days after the participant's last study dose.
3
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).
4
Grade ≥3 TEAEs
Timeframe: From first study treatment to 30 days after the participant's last study dose.
5
Safety laboratory tests
Timeframe: From baseline (pre-dose) through 30 days after the participant's last study dose.
6
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).
. 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.
. High dose immunosuppressive therapy at baseline (e.g., \> 0.5 mg/kg prednisone or equivalent). (Low dose corticosteroids for septic shock/ARDS per SOC permitted.)
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).
8
Blood pressure
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).
9
Respiratory 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).
10
Oxygen saturation
Timeframe: Baseline through End of ICU stay; intensified monitoring for 24 hours after iNKT infusion.