NCT07634562 · Stanford University
TLI- and ATG-Enabled Minimization Protocol in Liver Transplantation
(TEMPO-LT)
What this study is about
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.
View original scientific description
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regimen post liver transplant will be safe and well tolerated and will result in recipients successfully being withdrawn from immunosuppression within 2 years after liver transplantation.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.
Interventions
DRUG
Anti-Thymocyte Globulin, ATG (Rabbit)
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.
DEVICE
Total lymphoid irradiation
Participants will get 8 doses of TLI over 2 weeks with a total radiation dose of 960 cGy.
Primary outcome measures
The success rate
Time frame: After intervention through 18 months and monitored monthly up to 36 months.
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Stanford, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 7, 2026 · Source of record for eligibility and locations