Can a new drug help sepsis patients with weak immune systems?
NCT ID NCT07578558
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This Phase 2 trial tests whether adding the drug nogapendekin alfa inbakicept (NAI) to standard sepsis care can improve survival in critically ill adults with sepsis and persistently low lymphocyte counts (a sign of immune suppression). About 50 participants will be randomly assigned to receive either NAI injections plus standard care or standard care alone. The main goal is to see if NAI reduces deaths within 28 days.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- nogapendekin alfa inbakicept (NAI, also known as N-803 or ANKTIVA)
- What this could lead to
- If successful, this could point toward a new treatment to boost the immune system in sepsis patients, potentially reducing deaths and complications.
- What could go wrong
- This is a small, early Phase 2 trial with only 50 participants, so results may not apply to all sepsis patients. The drug may not improve survival or could cause side effects.
Why investors are watching
ImmunityBio is running a Phase 2 trial of its drug nogapendekin alfa inbakicept (NAI) in critically ill sepsis patients with persistent low lymphocyte counts. The trial compares NAI plus standard care against standard care alone in 50 patients, measuring 28-day mortality. For a small company, this readout matters because a positive result would expand NAI's potential use beyond cancer into a common, life-threatening condition.
If it works: A positive result could show NAI improves survival in sepsis, opening a new market for the drug. That would give ImmunityBio a second major use case and strengthen its commercial story.
If it fails: The trial is small and sepsis is hard to treat, so failure is a real risk. A negative or unclear result could set back the drug's expansion plans and hurt the company's credibility with investors.
AI-written from the trial record. Speculative, and not investment advice.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Jul 2026
An estimate. Start dates often move.
- Expected to finish
-
Oct 2027
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age 18 years or older at the time of informed consent 2. Admitted to the ICU with a diagnosis of sepsis as defined by Sepsis-3 criteria: life-threatening organ dysfunction caused by a dysregulated host response to infection, operationalized as a Sequential Organ Failure Assessment (SOFA) score increase of 2 or more points 3. Documented persistent lymphopenia defined as ALC \<1,000 cells/µL on at least two consecutive measurements within 72 hours of sepsis diagnosis (measurements must be separated by at least 12 hours) 4. Prior initiation of appropriate antimicrobial therapy per institutional guidelines 5. Ability to obtain written informed consent from the participant or legally authorized representative 6. Agreement to practice effective contraception for female participants of child-bearing potential and non-sterile males (for up to 7 months after completion of therapy) Exclusion Criteria: 1. Hematologic malignancies including leukemia, lymphoma, and myelodysplastic syndromes 2. Prior CAR-T cell therapy or hematopoietic stem cell transplant (HSCT) within 3 months of screening 3. Active cytokine release syndrome (CRS) at screening 4. Current or recent (within 7 days) use of colony stimulating factors (G-CSF, GM-CSF) 5. Lymphopenia attributable to chemotherapy, radiation therapy, or immunosuppressive medications administered within 30 days prior to screening 6. High-dose immunosuppressive therapy (\>0.5 mg/kg prednisone equivalent daily), excluding physiologic replacement and stress-dose hydrocortisone for septic shock 7. Life expectancy less than 24 hours as assessed by the treating physician 8. Active uncontrolled bleeding requiring \>2 units of packed red blood cells in the preceding 24 hours 9. Known HIV infection with CD4 count \<350 cells/µL and detectable viral load 10. Known active viral hepatitis (hepatitis B or C with detectable viral load) 11. Advanced dementia or other conditions precluding meaningful participation 12. Known hypersensitivity to any component of the investigational products 13. Participation in another interventional trial with an investigational immunomodulatory agent within 30 days prior to screening 14. Pregnant or breastfeeding
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Critical illness are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can warming the body help sepsis patients who cannot make a fever?
- Four-Part check may reveal hidden malnutrition in sickest kids
- Can a Dentist's toothbrush keep ICU patients healthier?
- Can a simple ultrasound measurement reveal heart strain in sepsis?
- Chilling fever: can cooling septic shock patients save lives?
- Can a simple bedside panel make intensive care feel more human?