Using Siplizumab to prevent immune issues in liver transplant patients with autoimmune liver disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot, open-label phase 1 study evaluates the safety of siplizumab, an anti-CD2 monoclonal antibody, as induction immunosuppression in patients with autoimmune liver disease undergoing liver transplantation. The study will involve up to eight adult participants who will receive two doses of siplizumab: one on the day of transplant and another on Day 4 post-transplant. Participants will be monitored for 12 months following the transplant to assess the safety and effectiveness of the treatment in preventing immune-mediated graft injury. This approach aims to address the unmet need for effective therapies in this patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Able to provide informed consent
2. Age ≥ 18 years old
3. Clinical diagnosis of AIH and/or PSC
4. Listed for liver transplantation
5. Epstein-Barr virus (EBV) seropositive within 12 months of screening

Exclusion Criteria:

1. 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
2. Prior transplant
3. Listed for multiorgan transplant
4. Acute liver failure
5. Known malignancy, including cholangiocarcinoma and hepatocellular carcinoma
6. Other investigational products in the last 30 days or 5 half lives
7. Pregnant/lactating or unwilling to use contraception
8. Leukopenia (WBC less than 2,000/mm3
9. Absolute lymphocyte count \< 200/mm3
10. Sero-positive for HIV-1
11. Hepatitis C Virus (HCV) antibody or RNA positive (within 6 months of screening)
12. HBsAg, hepatitis B virus (HBV) DNA or HBcAb positive (within 6 months of screening)
13. 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
14. Untreated latent TB infection as detected by QuantiFERON Gold Plus Interferon Gamma Release Assay (IGRA) (or current standard interferon gamma release assay for TB)
15. Receipt of any live-attenuated vaccine within 2 months of transplant.

ADDITIONAL exclusion criteria to be reviewed at the time of transplant

1. Renal failure with dialysis or with estimated glomerular filtration rate (eGFR) \< 30 at the time of LT
2. Model for end-stage liver disease (MELD)-Na score \>30
3. 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's running

• Columbia University Irving Medical Center/NewYork-Presbyterian Hospital
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Elizabeth Verna, MD — Columbia University Irving Medical Center/ New York Presbyterian Hospital
• Study coordinator: Theresa Lukose, PharmD
• Email: tt2103@cumc.columbia.edu
• Phone: 212-305-3839

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.