A 12-Month, Open-Label Study Evaluating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Siplizumab As Induction Therapy in Patients with Autoimmune Liver Diseases Undergoing Liver Transplantation (SET-SAIL)

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
New York
Columbia University Irving Medical Center/NewYork-Presbyterian Hospital
RECRUITING
New York
Contact Information
Primary
Theresa Lukose, PharmD
tt2103@cumc.columbia.edu
212-305-3839
Backup
Amanda Alonso, MHA
aa2974@cumc.columbia.edu
212-342-0261
Time Frame
Start Date: 2024-09-11
Estimated Completion Date: 2026-03-31
Participants
Target number of participants: 8
Treatments
Experimental: Open Label
subjects will receive 0.6 mg/kg/dose intravenously on the day of transplant (Day 0) intraoperatively and on post-transplant Day 4.
Sponsors
Collaborators: ITB-Med LLC
Leads: Elizabeth C. Verna

This content was sourced from clinicaltrials.gov