Condition: Autoimmune Liver Disease · Liver Transplant Disorder · Autoimmune Hepatitis · Sponsor: Elizabeth C. Verna
There is a significant unmet need for safe and effective therapeutic approaches to prevent immune-mediated graft injury and its complications in liver transplant (LT) recipients with autoimmune liver disease (AILD) including autoimmune hepatitis and primary sclerosing cholangitis. Siplizumab is an anti-cluster of differentiation 2 (CD2) monoclonal antibody that has demonstrated a favorable safety profile of siplizumab in over 779 human subjects and has been shown to target memory T cells-a key driver in the immune processes surrounding rejection and autoimmunity post LT in AILD. The purpose of this pilot, open-label phase 1 study is to determine the safety of siplizumab for induction in patients with AILD undergoing LT. Up to eight (8) subjects will receive siplizumab 0.6 mg/kg/dose on the day of transplant (Day 0) and Day 4 post-transplant, for a total of two doses. All subjects will be followed in the study for 12 months post-LT.
This description comes directly from the study's public registry record.
Theresa Lukose, PharmD · 212-305-3839 · tt2103@cumc.columbia.edu
Amanda Alonso, MHA · 212-342-0261 · aa2974@cumc.columbia.edu
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| Columbia University Irving Medical Center/NewYork-Presbyterian Hospital | New York, New York, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06455280