A Study of SIPLIZUMAB in AILD and LT Patients (NCT06455280) | Clinical Trial Compass
RecruitingPhase 1
A Study of SIPLIZUMAB in AILD and LT Patients
United States8 participantsStarted 2024-09-11
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Able to provide informed consent
✓. Age ≥ 18 years old
✓. Clinical diagnosis of AIH and/or PSC
✓. Listed for liver transplantation
✓. Epstein-Barr virus (EBV) seropositive within 12 months of screening
Exclusion criteria
✕. Presence or history of significant liver disease other than AIH or PSC, including viral hepatitis, alcohol-related liver disease and biopsy-proven non-alcoholic steatohepatitis
✕. Prior transplant
✕. Listed for multiorgan transplant
✕. Acute liver failure
✕. Known malignancy, including cholangiocarcinoma and hepatocellular carcinoma
✕. Other investigational products in the last 30 days or 5 half lives
What they're measuring
1
Serious infection in the first month post-transplant,