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Can a new drug help sepsis patients with weak immune systems?

NCT ID NCT07578558

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

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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

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  1. The official record

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