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Monoclonal Antibodies

Siplizumab for Autoimmune Liver Disease (SET-SAIL Trial)

Phase 1
Recruiting
Led By Elizabeth Verna, MD
Research Sponsored by Elizabeth C. Verna
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Clinical diagnosis of AIH and/or PSC
Listed for liver transplantation
Must not have
Listed for multiorgan transplant
Acute liver failure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 month post treatment
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to test the safety of a drug called siplizumab in patients with autoimmune liver disease who are undergoing liver transplant. The drug targets memory T cells, which are involved in rejection

Who is the study for?
This trial is for liver transplant recipients with autoimmune liver diseases like autoimmune hepatitis and primary sclerosing cholangitis. Participants should not have other conditions that could interfere with the study or pose a risk.
What is being tested?
The trial tests Siplizumab, an anti-CD2 monoclonal antibody, to see if it's safe and can prevent immune-mediated graft injury post-transplant in patients with AILD. It involves two doses of the drug given around the time of transplant.
What are the potential side effects?
While specific side effects are not listed here, monoclonal antibodies like Siplizumab may cause reactions at the infusion site, infections due to immune suppression, allergic reactions, and potential impact on organ function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with autoimmune hepatitis or primary sclerosing cholangitis.
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I am on the waiting list for a liver transplant.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am on the waiting list for a multiorgan transplant.
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I am experiencing sudden liver failure.
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I have been diagnosed with a type of cancer, such as bile duct or liver cancer.
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I have an untreated latent TB infection confirmed by a TB blood test.
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I have had an organ or tissue transplant.
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I have not received a live vaccine within 2 months before my transplant.
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I have or had liver disease not related to AIH or PSC.
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My organ donor had a non-heart-beating donation or tested positive for hepatitis or had a different blood type.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 month post treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 month post treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Serious infection in the first month post-transplant
Secondary study objectives
Incidence of BPAR
Incidence of development of donor specific antibodies (DSA)
Incidence of graft loss or death
+4 more
Other study objectives
CD2 receptor occupancy by dose level and subject
Change in Concentration T-Cells
Change in Concentration of B- cells
+6 more

Side effects data

From 2020 Phase 1 trial • 15 Patients • NCT01445535
100%
Albumin, serum-low (hypoalbuminemia)
100%
Febrile neutropenia
100%
Hemoglobin
100%
Lymphopenia
100%
Neuropathy: sensory
100%
Neutrophils/granulocytes (ANC/AGC)
100%
Leukocytes (total WBC)
100%
Platelets
67%
Mucositis/stomatitis (clinical exam)::Oral cavity
67%
Phosphate, serum-low (hypophosphatemia)
67%
Rash/desquamation
67%
CD4 count
67%
Hypotension
67%
Hypoxia
67%
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
67%
Diarrhea
67%
Nausea
33%
Hair loss/alopecia (scalp or body)
33%
Fatigue (asthenia, lethargy, malaise)
33%
Heartburn/dyspepsia
33%
ALT, SGPT (serum glutamic pyruvic transaminase)
33%
Insomnia
33%
Infection with normal ANC or Grade 1 or 2 neutrophils::Abdomen NOS
33%
Pain::Lymph node
33%
Constipation
33%
Dizziness
33%
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
33%
Mucositis/stomatitis (functional/symptomatic)::Oral cavity
33%
Pain::Back
33%
Vomiting
33%
Cardiac troponin I (cTnI)
33%
Infection with normal ANC or Grade 1 or 2 neutrophils::Middle ear (otitis media)
33%
Palpitations
33%
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils
33%
Cough
33%
AST, SGOT(serum glutamic oxaloacetic transaminase)
33%
Hemorrhage, pulmonary/upper respiratory::Nose
33%
Infection (documented clinically or microbiologically)
33%
Pain::Middle ear
33%
Pain::Oral cavity
33%
Calcium, serum-low (hypocalcemia)
33%
Potassium, serum-low (hypokalemia)
33%
Sodium, serum-low (hyponatremia)
33%
Pain::Pain NOS
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 3 - 8.5 mg/kg
Cohort 4 - 15 mg/kg
Cohort 1 - 3.4 mg/kg
Cohort 2 - 4.8 mg/kg

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Open LabelExperimental Treatment1 Intervention
subjects will receive 0.6 mg/kg/dose intravenously on the day of transplant (Day 0) intraoperatively and on post-transplant Day 4.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Siplizumab
2009
Completed Phase 1
~20

Find a Location

Who is running the clinical trial?

Elizabeth C. VernaLead Sponsor
ITB-Med LLCIndustry Sponsor
11 Previous Clinical Trials
385 Total Patients Enrolled
Elizabeth Verna, MDPrincipal InvestigatorColumbia University Irving Medical Center/ New York Presbyterian Hospital
1 Previous Clinical Trials
59 Total Patients Enrolled
~5 spots leftby Dec 2025
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