PSCRecruiting

A Study of SIPLIZUMAB in AILD and LT Patients

Phase 1 · Testing Siplizumab · 1 site · Elizabeth C. Verna

Official record & contacts on ClinicalTrials.gov ↗

In plain English

What this trial is testing

This study is testing Siplizumab (a drug) as a possible treatment. Condition(s) listed: Autoimmune Liver Disease, Liver Transplant Disorder and Autoimmune Hepatitis.

It is open-label: participants know what they are receiving.

Phase 1 studies are early tests in a small group of people, mainly checking safety and dosing.

Who can join

Ages 18 and older
Any sex

Some of the main requirements, copied from the record:

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

There are also 19 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.

What's involved

About 8 participants are expected to take part.
The study has 1 group.
Start date: 2024-09-11.
Main results expected around 2027-12-31 (estimate from the record).
1 study site listed (1 marked recruiting) in United States.

Groups in this study

Open Label (listed as: experimental group)

Main thing being measured

Serious infection in the first month post-transplant, (1 Month post-transplant)

In the researchers’ words

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…

Words you might see

MELD score: a score based on lab tests used to estimate how severe liver disease is.
Cholangiocarcinoma: cancer of the bile ducts.
Open-label: everyone, including participants, knows which treatment is being given.
Induction: the first phase of treatment, aimed at getting the disease under control.
eGFR: a blood-test estimate of how well the kidneys filter.
Biopsy / histology: a small tissue sample examined under a microscope.
Autoimmune hepatitis: a liver disease where the immune system attacks the liver.

General definitions, not specific to this trial.

This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.

Questions to ask your doctor and the trial team

Am I likely to qualify, given my health history?
What would I have to do, and how often would I need to visit?
Could I get a placebo? What happens to my current treatment?
What are the possible risks and benefits?
Are travel or other costs covered?
What happens after the trial ends?

Official details

Status	Recruiting
Phase	Phase 1
Study type	Interventional
Conditions	Autoimmune Liver Disease; Liver Transplant Disorder; Autoimmune Hepatitis; Primary Sclerosing Cholangitis; End Stage Liver DIsease; Cirrhosis, Liver
Lead sponsor	Elizabeth C. Verna
Collaborators	ITB-Med LLC
Enrollment	8 (estimated)
Start date	2024-09-11
Primary completion (est.)	2027-12-31
First posted	2024-06-12
Last updated	2025-11-24
Official title	A 12-Month, Open-Label Study Evaluating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Siplizumab as Induction Therapy in Patients With Autoimmune Liver Diseases Undergoing Liver Transplantation (SET-SAIL)
ClinicalTrials.gov ID	NCT06455280

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.

Full eligibility criteria (from the record)

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

Locations (1)

Site	City	Country	Site status
Columbia University Irving Medical Center/NewYork-Presbyterian Hospital	New York, New York	United States	Recruiting

For contacts at each site, use the official record.

Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.