A Phase 1 Clinical Trial of Siltuximab for the Treatment of Antibody-Mediated Rejection After Lung Transplantation

Exclusion Criteria24

• 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 (ATG) 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 with 6 months of enrollment,
• Planned treatment with plasma exchange (PLEX) for AMR,
• Cancer other than non-melanoma skin cancer with disease-free period < 3 years,
• Positive respiratory virus PCR detected within 7 days of enrollment,
• Active cytomegalovirus infection within 7 days of enrollment,
• Positive respiratory culture for Mycobacterium tuberculosis, Mycobacterium abscessus, Mycobacterium chelonae, or Mycobacterium avium complex within 4 weeks of enrollment,
• Absolute neutrophil count (ANC) < 1,000 cells/mm3 at enrollment,
• Platelet count < 75,000 cells/mm3 at enrollment,
• Hemoglobin ≥ 17 g/dL at enrollment,
• ALT or AST > 2.5 times upper limit of normal at enrollment,
• Total bilirubin > 2.5 times upper limit of normal at enrollment,
• Uric acid ≥ 7 mg/dL 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 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.