New drug could help lung transplant patients fight rejection
NCT ID NCT06990711
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Aug 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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. 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.
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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
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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University of Utah
RECRUITINGSaint Lake City, Utah, 84112, United States
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Washington University School, of Medicine, Barnes-Jewish Hospital
RECRUITINGSt Louis, Missouri, 63110, United States