Actively Recruiting
A Study of SIPLIZUMAB in AILD and LT Patients
Led by Elizabeth C. Verna · Updated on 2025-11-24
8
Participants Needed
1
Research Sites
185 weeks
Total Duration
On this page
Sponsors
E
Elizabeth C. Verna
Lead Sponsor
I
ITB-Med LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of SIPLIZUMAB in AILD and LT Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide informed consent
- Age 18 years or older
- Clinical diagnosis of autoimmune hepatitis and/or primary sclerosing cholangitis
- Listed for liver transplantation
- Epstein-Barr virus seropositive within 12 months of screening
You will not qualify if you...
- Significant liver disease other than autoimmune hepatitis or primary sclerosing cholangitis, 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
- Use of other investigational products within the last 30 days or 5 half lives
- Pregnant or lactating, or unwilling to use contraception
- Leukopenia with white blood cell count less than 2,000/mm3
- Absolute lymphocyte count less than 200/mm3
- HIV-1 positive
- Hepatitis C virus antibody or RNA positive within 6 months of screening
- Hepatitis B virus positive within 6 months of screening
- Alcohol use exceeding 30g/day for men or 20g/day for women, or known phosphatidylethanol level above 80 in 3 months prior to transplant
- Untreated latent tuberculosis infection as detected by standard interferon gamma release assay
- Receipt of any live-attenuated vaccine within 2 months of transplant
- Renal failure requiring dialysis or estimated glomerular filtration rate below 30 at time of transplant
- Model for end-stage liver disease sodium score above 30
- Donor organ with certain incompatible features including cardiac death donation, viral positivity, or incompatible blood type
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Columbia University Irving Medical Center/NewYork-Presbyterian Hospital
New York, New York, United States, 10032
Actively Recruiting
Research Team
T
Theresa Lukose, PharmD
CONTACT
A
Amanda Alonso, MHA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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