Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

New drug could help lung transplant patients fight rejection

NCT ID NCT06990711

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Aug 28, 2026 · Updated 3 times

Summary

This early-stage trial tests a drug called siltuximab in 30 lung transplant patients who are experiencing antibody-mediated rejection, a serious condition that often leads to transplant failure. The drug is added to standard rejection treatment to see if it is safe and tolerable. The goal is to find the best dose with the fewest side effects for future studies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Siltuximab (a drug that blocks interleukin-6, given by IV)
What this could lead to
If it works, this could point toward a safer way to treat rejection after lung transplant, potentially improving survival.
What could go wrong
This is a very early Phase 1 trial with only 30 people, focused on safety, not effectiveness. The drug may cause side effects or not work better than current treatments.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 30 people

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

Started

Nov 2025

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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. 18 years of age or older, 2. Single or bilateral lung transplant recipient, 3. New diagnosis of clinical definite, probable, or possible antibody-mediated rejection according to the 2016 International Society for Heart and Lung Transplantation (ISHLT) definition with plans to be treated with Carfilzomib and/or anti-thymocyte globulin, 4. Admitted to the hospital for treatment of AMR, 5. Donor-specific antibodies (DSA) to human leukocyte antigens (HLA) with a Mean Fluorescence Intensity (MFI) \> 1000, 6. Able to understand the purpose of the study and willing to participate and sign informed consent. Exclusion Criteria: 1. Pregnant or breast feeding, 2. Airway anastomotic dehiscence on bronchoscopy, 3. Thoracotomy incision dehiscence, 4. Underwent lung transplantation less than 6 months before enrollment, 5. Treated with rabbit anti-thymocyte globulin (ATG) for induction immunosuppression at the time of lung transplantation, 6. Underwent other invasive surgical procedure less than 6 weeks before enrollment, 7. History of lymphoma or hematologic malignancy, 8. Treatment with IL-6 signaling blockade with 6 months of enrollment, 9. Planned treatment with plasma exchange (PLEX) for AMR, 10. Cancer other than non-melanoma skin cancer with disease-free period \< 3 years, 11. Positive respiratory virus PCR detected within 7 days of enrollment, 12. Active cytomegalovirus infection within 7 days of enrollment, 13. Positive respiratory culture for Mycobacterium tuberculosis, Mycobacterium abscessus, Mycobacterium chelonae, or Mycobacterium avium complex within 4 weeks of enrollment, 14. Absolute neutrophil count (ANC) \< 1,000 cells/mm3 at enrollment, 15. Platelet count \< 75,000 cells/mm3 at enrollment, 16. Hemoglobin ≥ 17 g/dL at enrollment, 17. ALT or AST \> 2.5 times upper limit of normal at enrollment, 18. Total bilirubin \> 2.5 times upper limit of normal at enrollment, 19. Uric acid ≥ 7 mg/dL at enrollment. 20. History of gastrointestinal tract perforation, 21. History of diverticulitis (diverticulosis is not an exclusion), 22. Plan for surgical procedure (other than bronchoscopy) within 120 days of enrollment. 23. Inability or unwillingness to give written informed consent or comply with the study protocol, 24. Any condition that in the opinion of the site investigator introduces undue risk by participating in this study or impacts the quality or interpretation of the study results.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Antibody mediated rejection of lung transplant are added.

Vår säkerhetsrekommendation!

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.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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.

Contacts and locations

Locations

  • University of Utah

    RECRUITING

    Saint Lake City, Utah, 84112, United States

  • Washington University School, of Medicine, Barnes-Jewish Hospital

    RECRUITING

    St Louis, Missouri, 63110, United States