A Study of SIPLIZUMAB in AILD and LT Patients

Part of paid clinical trials in New York, New York.

Sponsor
Elizabeth C. Verna
Study ID
NCT06455280
Phase
PHASE1
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Siplizumab — DRUG
    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.

Study Details

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 Dates

Start date
Sep 11, 2024
Status verified
Nov 2025
Primary completion
Dec 31, 2027
Completion
Mar 31, 2028

Study Design

Enrollment
8 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Columbia University Irving Medical Center/NewYork-Presbyterian HospitalNew YorkNew York10032
Theresa Lukose, PharmD
[email protected]
212-305-3839
Elizabeth Verna, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in New York, NY

By research site
Columbia University Irving Medical Center/NewYork-Presbyterian Hospital· New York, NY

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