A Study of SIPLIZUMAB in AILD and LT Patients
Recruiting now · Phase 1
Conditions studied: Autoimmune Liver Disease, Liver Transplant Disorder, Autoimmune Hepatitis, Primary Sclerosing Cholangitis, End Stage Liver DIsease, Cirrhosis, Liver
In brief
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.
Key facts
- Study ID
- NCT06455280
- Run by
- Elizabeth C. Verna
- People needed
- 8
- Starts
- 2024-09-11
- Expected to finish
- 2028-03-31
- Last updated by the study team
- 2025-11-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
- Pregnant/lactating or unwilling to use contraception
- Leukopenia (WBC less than 2,000/mm3
- Absolute lymphocyte count < 200/mm3
- Sero-positive for HIV-1
- Hepatitis C Virus (HCV) antibody or RNA positive (within 6 months of screening)
- HBsAg, hepatitis B virus (HBV) DNA or HBcAb positive (within 6 months of screening)
- Alcohol use exceeding 30g/day for men or 20g/day for women, and/or known phosphatidylethanol (PETH) level >80 in the 3 months prior to LT
- Untreated latent TB infection as detected by QuantiFERON Gold Plus Interferon Gamma Release Assay (IGRA) (or current standard interferon gamma release assay for TB)
- Receipt of any live-attenuated vaccine within 2 months of transplant.
- ADDITIONAL exclusion criteria to be reviewed at the time of transplant
- Renal failure with dialysis or with estimated glomerular filtration rate (eGFR) < 30 at the time of LT
- Model for end-stage liver disease (MELD)-Na score >30
- Donor features of Donation after Cardiac Death (DCD), HCV Ab or nucleic acid testing (NAT+), HBcAb or HBsAg+, or blood types A, B, and O incompatible organ
Where it is running
- Columbia University Irving Medical Center/NewYork-Presbyterian Hospital — New York, New York, United States (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.