Recruiting
Phase 1

SIPLIZUMAB

Sponsor:

Elizabeth C. Verna

Code:

NCT06455280

Conditions

Autoimmune Liver Disease

Liver Transplant Disorder

Autoimmune Hepatitis

Primary Sclerosing Cholangitis

End Stage Liver DIsease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Siplizumab

Study Details

Brief 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.

Conditions

Autoimmune Liver Disease

Liver Transplant Disorder

Autoimmune Hepatitis

Primary Sclerosing Cholangitis

End Stage Liver DIsease

Study ID

NCT06455280

Start date

Sep 11, 2024

Status verified date

Nov, 2025

Completion date

Mar 31, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

8 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Siplizumab

Siplizumab is an anti-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.

Primary outcome measure

  • Serious infection in the first month post-transplant, [ Time Frame: 1 Month post-transplant ]

Central Contacts and Locations

Central contacts

Theresa Lukose, PharmD

212-305-3839tt2103@cumc.columbia.edu

Amanda Alonso, MHA

212-342-0261aa2974@cumc.columbia.edu

Locations

Columbia University Irving Medical Center/NewYork-Presbyterian Hospital

Recruiting

New York, New York, United States, 10032

Contacts

Theresa Lukose, PharmD

212-305-3839tt2103@cumc.columbia.edu

Principal Investigator:

Elizabeth Verna, MD

More Information

Sponsor

Elizabeth C. Verna

Last update posted

Nov 24, 2025

Last verified

Nov, 2025

Keywords

  • Autoimmune Liver Disease
  • Liver Transplant Disorder
  • Autoimmune Hepatitis
  • Primary Sclerosing Cholangitis
  • End Stage Liver DIsease
  • Cirrhosis, Liver

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Elizabeth C. Verna on 2025-11-24.