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New treatment option for Antibody Mediated Rejection of Lung Transplant
Official title A Phase 1 Clinical Trial of Siltuximab for the Treatment of Antibody-Mediated Rejection After Lung Transplantation
ClinicalTrials.gov ID: NCT06990711
What this study is testing
What is Siltuximab?
Siltuximab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for antibody mediated rejection of lung transplant.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Admitted to the hospital for treatment of AMR,
- Donor-specific antibodies (DSA) to human leukocyte antigens (HLA) with a Mean Fluorescence Intensity (MFI) \> 1000,
You likely can't join if
- 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,
See the full eligibility 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- St Louis, Missouri, United States
- Saint Lake City, Utah, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include St Louis, Missouri, United States; Saint Lake City, Utah, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.