Status:
RECRUITING
A Phase 1 Clinical Trial of Siltuximab for the Treatment of Antibody-Mediated Rejection After Lung Transplantation
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
University of Utah
Conditions:
Antibody Mediated Rejection of Lung Transplant
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 addit...
Detailed Description
Long-term outcomes after lung transplantation remain disappointing, and the median survival is 6.7 years. Chronic lung allograft dysfunction (CLAD) is the leading cause of death beyond the first year ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 6 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2028
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06990711
Start Date
November 6 2025
End Date
June 30 2028
Last Update
December 31 2025
Active Locations (2)
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1
Washington University School, of Medicine, Barnes-Jewish Hospital
St Louis, Missouri, United States, 63110
2
University of Utah
Saint Lake City, Utah, United States, 84112