Could a radiation and antibody combo free liver transplant patients from daily pills?
NCT ID NCT07634562
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial tests whether a combination of total lymphoid irradiation (a type of radiation) and anti-thymocyte globulin (an antibody drug) can help liver transplant recipients safely stop taking immunosuppressive drugs. The study will enroll 12 adults receiving a liver transplant at Stanford University. The goal is to see if this approach can induce 'operational tolerance,' meaning the body accepts the new liver without needing long-term medication.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Anti-Thymocyte Globulin (ATG) and Total Lymphoid Irradiation (TLI)
- What this could lead to
- If successful, this could allow liver transplant recipients to stop taking lifelong immunosuppressive drugs, reducing side effects and improving quality of life.
- What could go wrong
- This is a very early, small trial with only 12 participants, so results may not apply widely. The conditioning regimen carries risks like infection, bone marrow suppression, and graft rejection.
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
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 12 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2031
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 55 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Stanford University
Stanford, California, 94305, United States
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