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New drug aims to stop immune system from attacking transplanted livers

NCT ID NCT06455280

Disease control Sponsor: Elizabeth C. Verna Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early study tests whether siplizumab, given at the time of liver transplant, can safely prevent the immune system from attacking the new liver. Up to 8 adults with autoimmune hepatitis or primary sclerosing cholangitis will receive two doses. The main goal is to check for serious infections in the first month, while also watching for rejection or disease return over 12 months.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 8 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2024

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

autoimmune hepatitis Cholangitis, Sclerosing chronic liver failure cirrhosis of liver End Stage Liver Disease primary sclerosing cholangitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Autoimmune hepatitis Autoimmune liver disease Cirrhosis, liver End-stage liver disease Liver transplant disorder Primary sclerosing cholangitis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Columbia University Irving Medical Center/NewYork-Presbyterian Hospital

    RECRUITING

    New York, New York, 10032, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.