A Phase 1 Clinical Trial of Siltuximab for the Treatment of Antibody-Mediated Rejection After Lun… (NCT06990711) | Clinical Trial Compass
RecruitingPhase 1
A Phase 1 Clinical Trial of Siltuximab for the Treatment of Antibody-Mediated Rejection After Lung Transplantation
United States30 participantsStarted 2025-11-06
Plain-language summary
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
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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 International Society for Heart and Lung Transplantation (ISHLT) definition with plans to be treated with Carfilzomib and/or anti-thymocyte globulin,
✓. Admitted to the hospital for treatment of AMR,
✓. Donor-specific antibodies (DSA) to human leukocyte antigens (HLA) with a Mean Fluorescence Intensity (MFI) \> 1000,
✓. Able to understand the purpose of the study and willing to participate and sign informed consent.
Exclusion criteria
✕. 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,