Siltuximab for antibody-mediated rejection after lung transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1, inpatient randomized interventional trial adding siltuximab or placebo to routine therapies for antibody‑mediated rejection (AMR) after lung transplantation to characterize safety and tolerability. Eligible participants are adults with a new diagnosis of AMR and donor‑specific HLA antibodies (MFI >1000) who are planned to receive treatments such as carfilzomib or anti‑thymocyte globulin. Participants receive the investigational agent or placebo alongside standard-of-care AMR treatments and are closely monitored for adverse events and immunologic markers. If safety is demonstrated, subsequent studies will be needed to measure efficacy and longer‑term graft outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• Washington University School, of Medicine, Barnes-Jewish Hospital
  St Louis, Missouri, United States Recruiting
• University of Utah
  Saint Lake City, Utah, United States Recruiting

Study contacts

• Principal investigator: Ramsey Hachem, MD — University of Utah

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.