Actively Recruiting
A Phase 1 Clinical Trial of Siltuximab for the Treatment of Antibody-Mediated Rejection After Lung Transplantation
Led by Washington University School of Medicine · Updated on 2025-12-31
30
Participants Needed
2
Research Sites
138 weeks
Total Duration
On this page
Sponsors
W
Washington University School of Medicine
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Antibody-mediated rejection after lung transplantation commonly results in allograft failure and death in spite of current therapeutic regimens. We are testing the safety and tolerability of the addition of a novel immunosuppressive medication to routine treatment for antibody-mediated rejection. Future studies will be needed to assess efficacy if this study demonstrates safety
CONDITIONS
Official Title
A Phase 1 Clinical Trial of Siltuximab for the Treatment of Antibody-Mediated Rejection After Lung Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Single or bilateral lung transplant recipient
- New diagnosis of clinical definite, probable, or possible antibody-mediated rejection according to the 2016 ISHLT definition with plans to be treated with Carfilzomib and/or anti-thymocyte globulin
- Admitted to the hospital for treatment of antibody-mediated rejection
- Donor-specific antibodies to human leukocyte antigens with a Mean Fluorescence Intensity (MFI) > 1000
- Able to understand the purpose of the study and willing to participate and sign informed consent
You will not qualify if you...
- Pregnant or breast feeding
- Airway anastomotic dehiscence on bronchoscopy
- Thoracotomy incision dehiscence
- Underwent lung transplantation less than 6 months before enrollment
- Treated with rabbit anti-thymocyte globulin for induction immunosuppression at the time of lung transplantation
- Underwent other invasive surgical procedure less than 6 weeks before enrollment
- History of lymphoma or hematologic malignancy
- Treatment with IL-6 signaling blockade within 6 months of enrollment
- Planned treatment with plasma exchange for antibody-mediated rejection
- Cancer other than non-melanoma skin cancer with disease-free period less than 3 years
- Positive respiratory virus PCR detected within 7 days of enrollment
- Active cytomegalovirus infection within 7 days of enrollment
- Positive respiratory culture for certain mycobacteria within 4 weeks of enrollment
- Absolute neutrophil count less than 1,000 cells/mm3 at enrollment
- Platelet count less than 75,000 cells/mm3 at enrollment
- Hemoglobin 17 g/dL or higher at enrollment
- ALT or AST more than 2.5 times upper limit of normal at enrollment
- Total bilirubin more than 2.5 times upper limit of normal at enrollment
- Uric acid 7 mg/dL or higher at enrollment
- History of gastrointestinal tract perforation
- History of diverticulitis (diverticulosis is not an exclusion)
- Plan for surgical procedure (other than bronchoscopy) within 120 days of enrollment
- Inability or unwillingness to give written informed consent or comply with the study protocol
- Any condition that introduces undue risk or impacts study results as judged by the site investigator
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Washington University School, of Medicine, Barnes-Jewish Hospital
St Louis, Missouri, United States, 63110
Actively Recruiting
2
University of Utah
Saint Lake City, Utah, United States, 84112
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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