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A Study of SIPLIZUMAB in AILD and LT Patients

NCT06455280 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2025-11-24

No results posted yet for this study

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
  • Cirrhosis, Liver

Interventions

DRUG

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.

Sponsors & Collaborators

  • ITB-Med LLC

    collaborator INDUSTRY

  • Elizabeth C. Verna

    lead OTHER

Principal Investigators

  • Elizabeth Verna, MD · Columbia University Irving Medical Center/ New York Presbyterian Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-11
Primary Completion
2027-12-31
Completion
2028-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06455280 on ClinicalTrials.gov