Liver transplant with TLI and ATG conditioning to try stopping or reducing immunosuppression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this early-phase study, adults undergoing deceased donor liver transplantation receive a conditioning regimen of TLI and rATG in addition to standard care. The goal is to induce operational tolerance so participants can reduce or stop immunosuppressive medications within about two years after transplant. The trial will monitor safety, tolerability, and immune response, with a focus on avoiding rejection while minimizing drugs. Participants are evaluated for eligibility based on specific medical criteria and contraindications to the conditioning regimens. Results from similar approaches in other organ transplants inform the rationale, but this protocol explores its applicability to liver transplantation.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Undergoing liver transplantation at Stanford University
* No contraindications to Total Lymphoid Irradiation or rabbit antithymocyte globulin (rATG)

Exclusion Criteria:

* Contraindications to Total Lymphoid Irradiation (e.g. pregnancy, bone marrow suppression or disease, autoimmune disease, prior radiation in the field)
* Contraindications to rATG
* Patients with history of hepatocellular carcinoma (HCC) or other malignancies with exception of non melanoma skin cancer in remission
* Model of End-Stage Liver Disease (MELD) score \> 25
* Liver transplants with severe reperfusion syndrome (hemodynamic instability requiring 3 or more pressors after reperfusion)
* Liver transplant with early allograft dysfunction (Orloff criteria)
* Diagnosis of hepatitis B
* Diagnosis of hepatitis C, except for patients that have been treated and eradicated of hepatitis C
* Virtual and/or flow crossmatch positive (MFI added up to 8000 for each DSA with MFI\>1000).
* Subject has previously received or is receiving another organ for transplant other than liver
* Subject is currently on dialysis
* Recipient or donor is HIV positive
* Subject has received an ABO incompatible donor
* Subject has received a donor liver greater than 65 years of age
* Subject has an active infection at the time of transplant
* Subject will require immunosuppressive agent other than those prescribed in this study
* Subject is pregnant or lactating
* Subject is unlikely to comply with the visits scheduled in the protocol, including protocol biopsies
* Subject has any form of current substance use, psychiatric disorder or condition that may invalidate communication with the Investigators

Where it's running

• Stanford University
  Stanford, California, United States Recruiting

Study contacts

• Principal investigator: Stephan Busque, MD, MSc — Stanford University

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.