ClinicalTrials.gg
RecruitingNCT07634562TEMPO-LTUpdated Oct 7, 2026

TLI- and ATG-Enabled Minimization Protocol in Liver Transplantation

A Phase 1/2 interventional study of Anti-Thymocyte Globulin, ATG (Rabbit) and Total lymphoid irradiation in Liver Failure, sponsored by Stanford University. Recruiting at 1 site in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-10-07.

Sponsored by Stanford University · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2026; still recruiting 2 months later.
Updated Oct 7, 2026Now RecruitingSite recruiting status changed+1 moreGo to Updates ↓
Phase
Phase 1/2
Study type
Interventional
Enrollment
12
Allocation
Non-randomized
Ages
18 Years to 55 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 49 studies in Liver Failure with a site in United States — 6 open to participants now, 8 under way, none of them phase 3. Liver Failure · United States.

Planned enrollment
31st of 38
12 · median 31
Started
2026
with 1 other
Phase 1/2
2 of 49
1 open now
Registered
49th of 49
by date
Lead sponsor
2 of 49
Stanford University

Among the 49 studies in Liver Failure with a site in United States, this one is the 31st largest by planned enrollment of the 38 interventional ones that give a count, is one of 2 that started in 2026, is one of 2 in phase 1/2, and was the 49th registered.

Liver Failure

190 studies on the registry are indexed under Liver Failure; 33 are open to participants now.

Browse Liver Failure studies →

Open to participants now

6 of the 49 studies in Liver Failure with a site in United States are open now. Recruiting first, the newest first:

All 6 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 22 Liver Failure studies recruiting now, 11 (50%) set no upper age limit and 8 (36%) stop at 75 or younger; 4 take children under 18; 1 take healthy volunteers.

This study: 18 Years to 55 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 49 studies in Liver Failure with a site in United States, or all of them as a file.
02

Study summary

The unmet medical need in solid organ transplantation is to eliminate the lifelong requirement of powerful immune suppression drug combinations with their attendant side effects, and to prevent immune mediated rejection of the organ transplant. The proposed trial is designed to study if following a 'standard of care' deceased donor liver transplant host conditioning using Total Lymphoid Irradiation (TLI) and Anti-Tthymocyte Globulin (ATG) will result in operational tolerance and ultimately allow for immunosuppression drug minimization or cessation.

It has been hypothesized that the ATG and TLI conditioning regimen post liver transplant will be safe and well tolerated and will result in recipients successfully being withdrawn from immunosuppression within 2 years after liver transplantation. We will test the hypothesis that by using a conditioning regimen of ATG and TLI to induce this operational tolerance will allow immunosuppressive drug minimization and cessation while maintaining normal graft function and without the risk of graft rejection.

Importance of this knowledge:

Operational tolerance occurs spontaneously in a minority of liver transplant recipients; however, predictable and reproducible induction of tolerance remains an unmet need. Building on extensive experience with TLI-based tolerance induction in kidney transplantation at Stanford, this study aims to evaluate whether a non-myeloablative conditioning regimen using TLI and ATG can safely facilitate immunosuppression minimization and withdrawal in liver transplant recipients without the use of donor hematopoietic cell infusion.

03

Conditions studied

  • Liver Failure

Browse trials for

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • to Total Lymphoid Irradiation (e.g. pregnancy, bone marrow suppression or disease, disease, prior radiation in the field)
  • Contraindications to rATG
  • Patients with history of hepatocellular carcinoma (HCC) or other 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
  • Diagnosis of , 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 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 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
  • Subject has any form of current substance use, psychiatric disorder or condition that may invalidate communication with the Investigators
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
12 participants (estimated)

Study arms

  • Experimental
    Anti-thymocyte globulin and Total Lymphoid Irradiation (synchronous tolerance)

    Participants undergo a conditioning regimen with Anti-thymocyte globulin of 1.5 mg/kg ATG intravenously over 3 - 4 days immediately after liver transplant surgery and Total Lymphoid Irradiation post liver transplant surgery to induce immune tolerance, which thereby, improves graft engraftment.

    Drug: Anti-Thymocyte Globulin, ATG (Rabbit) · Device: Total lymphoid irradiation

  • Experimental
    Anti-thymocyte globulin and Total Lymphoid Irradiation (delayed tolerance)

    Participants undergo a conditioning regimen with Anti-thymocyte globulin of 1.5 mg/kg ATG intravenously over 3 - 4 days after a while after liver transplant surgery and Total Lymphoid Irradiation post liver transplant surgery to induce immune tolerance, which thereby, improves graft engraftment.

    Drug: Anti-Thymocyte Globulin, ATG (Rabbit) · Device: Total lymphoid irradiation

Interventions

  • 1.5 mg/kg ATG will be administered intravenously over 3-4 days. The ATG doses will be completed within 5 days of the liver transplant.

  • DeviceTotal lymphoid irradiation

    Participants will get 8 doses of TLI over 2 weeks with a total radiation dose of 960 cGy.

06

What researchers measure

Primary outcomes

  1. The success rate

    The success rate is defined as the percentage of participants free from all immunosuppressive drugs by 18 months after the start of the conditioning regimen). This will be estimated with standard errors by the Kaplan-Meier procedure and the Greenwood formula.

    Time frame: After intervention through 18 months and monitored monthly up to 36 months.

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Started Sep 2026 (actual). Primary completion is estimated for Aug 2031, 59 months after the start.

Start moved once since we started tracking on Sep 25, 2026: Aug 2026 → Sep 2026, on Oct 7, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Jun 4, 2026
First posted
Jun 9, 2026
StartActual
Sep 1, 2026was Aug 2026
Primary completionEst.
Aug 2031
CompletionEst.
Aug 2031
Last update
Oct 7, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting
changed Oct 7, 2026
Sites
Stanford University is now Recruiting
Oct 7, 2026
Start date
Aug 2026→Sep 1, 2026 (actual)
Oct 7, 2026
Show all 1 update
  1. Oct 7, 2026
    Not yet recruiting→Recruiting
    Stanford University is now Recruiting
    Start date Aug 2026→Sep 1, 2026 (now actual)
    + 1 other change: criteria formatting

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07634562
Responsible party
Stephan Busque (Professor, Department of Surgery, Division of Abdominal Transplant Surgery, Stanford School of Medicine, Stanford University) — Principal investigator
First posted
Jun 9, 2026
Start date
Sep 1, 2026
Primary completion
Aug 2031 (estimated)
Completion
Aug 2031 (estimated)
Last update
Oct 7, 2026

Study contacts

Stephan Busque, MD, MSc
principal investigator · Stanford University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Rabbit meat

Start the discussion