Can a drug rev up the immune system to fight sepsis?

NCT ID NCT07783789

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 25, 2026 · Last updated Aug 27, 2026 · Updated 2 times

Summary

This trial is testing whether adding an immune-stimulating drug called nogapendekin alfa inbakicept (NAI) to standard intensive care can help adults with sepsis or septic shock. Participants receive NAI as an injection under the skin on the first day, with possible additional doses if they remain hospitalized. The study will look at safety, survival rates at 28 and 90 days, immune cell recovery, and how much organ support and hospital care patients need.

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), an immune-stimulating drug given as an injection under the skin
What this could lead to
If it works, this could point toward a new way to boost the immune system in sepsis patients, potentially improving survival and recovery.
What could go wrong
This is an early-stage trial with a small number of participants, so results may not apply broadly. The drug could also cause side effects or fail to improve outcomes.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 49 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 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 at the time of informed consent. 2. Admitted to the ICU with sepsis or septic shock per Sepsis 3 criteria, operationalized as a SOFA increase of ≥ 2 points attributable to suspected or confirmed infection; septic shock defined as persistent vasopressor requirement to maintain MAP ≥ 65 mm Hg and serum lactate \> 2 mmol/L despite adequate volume resuscitation. 3. ALC ≤ 1,000 cells/µL in two consecutive measurements separated by ≥ 12 hours within the 72 hour screening window. 4. Documented or strongly suspected infection (bacterial, viral, fungal, or mixed) with reasonable diagnostic workup initiated. 5. Receiving guideline-directed standard of care per 2026 Surviving Sepsis Campaign Guidelines, including as clinically appropriate: early empiric broad-spectrum antimicrobials, ≥ 30 mL/kg balanced crystalloid within 3 hours for hypoperfusion or shock, norepinephrine as first line vasopressor (MAP ≥ 65 mm Hg), lung-protective ventilation if mechanically ventilated, glycemic target 144-180 mg/dL, and venous thromboembolism and stress ulcer prophylaxis. 6. Able to receive the first dose of NAI within 72 hours of sepsis recognition, targeted within 12 hours of eligibility confirmation. 7. Ability to obtain written informed consent from the participant or a legally authorized representative. 8. Agreement to practice effective contraception for females of childbearing potential and nonsterile males, with details as in protocol. Exclusion Criteria: 1. Severe hepatic failure defined as Child Pugh class C with active hepatic encephalopathy at screening. 2. Active malignancy receiving cytotoxic chemotherapy, radiotherapy, or checkpoint inhibitor therapy within 30 days prior to sepsis onset (maintenance hormonal therapy and stable targeted therapies permitted). 3. Hematopoietic stem cell transplant within prior 100 days or active graft versus host disease requiring systemic immunosuppression. 4. Known hypersensitivity to NAI, IL 15, recombinant IL 15 receptor alpha sushi domain, or human IgG1 Fc. 5. Pregnancy or breastfeeding; negative serum pregnancy test required for women of childbearing potential. 6. Active second investigational therapy or participation in another interventional trial within 30 days prior to enrollment. 7. In the Investigator's opinion, a clinical condition or treatment limitation precluding meaningful participation or follow up (e.g., expected death within 24 hours, comfort-care-only orders precluding protocol-mandated assessments).

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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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