Liver FailurePhase 1/2TEMPO-LTNCT07634562
TLI- and ATG-Enabled Minimization Protocol in Liver Transplantation
A Phase 1/2 study testing Anti-Thymocyte Globulin, ATG (Rabbit) and Total lymphoid irradiation in people with Liver Failure, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Liver Failure
- What is being tested?
- Anti-Thymocyte Globulin, ATG (Rabbit) and Total lymphoid irradiation
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to Aug 2031
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Undergoing liver transplantation at Stanford University
- No contraindications to Total Lymphoid Irradiation or rabbit antithymocyte globulin (rATG)
Who cannot join
- 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)
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stanford University
Stanford, California, 94305
Study Team, 650-736-5138, atahsin2@stanford.edu
About this study
Official title: A Phase 1-2 Prospective Study to Evaluate the Safety and Feasibility of Total Lymphoid Irradiation (TLI) and Anti-Thymocyte Globulin (ATG) in Liver Transplantation Recipients to Induce Immune Tolerance
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.
Read more
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.
- Conditions
- Liver Failure
- Being tested
- Anti-Thymocyte Globulin, ATG (Rabbit), Total lymphoid irradiation
- Medical subject headings
- Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-Thymocyte Globulin, ATG (Rabbit)Drug
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.
Total lymphoid irradiationDevice
Participants will get 8 doses of TLI over 2 weeks with a total radiation dose of 960 cGy.
| Study group | Role | What they receive |
|---|---|---|
| Anti-thymocyte globulin and Total Lymphoid Irradiation (synchronous tolerance) | Experimental | 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. Receives: Drug: Anti-Thymocyte Globulin, ATG (Rabbit); Device: Total lymphoid irradiation |
| Anti-thymocyte globulin and Total Lymphoid Irradiation (delayed tolerance) | Experimental | 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. Receives: Drug: Anti-Thymocyte Globulin, ATG (Rabbit); Device: Total lymphoid irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After intervention through 18 months and monitored monthly up to 36 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start1 Sep 2026
- Primary completionAug 2031 (estimated)
- Study completionAug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver FailureStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephan Busque, Stanford University
- Investigators
- Stephan Busque, MD, MSc, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07634562
- Sponsor's protocol ID
- 86730
- Acronym
- TEMPO-LT
- Status last verified
- Jun 2026
- First submitted
- 4 Jun 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1-2 Prospective Study to Evaluate the Safety and Feasibility of Total Lymphoid Irradiation (TLI) and Anti-Thymocyte Globulin (ATG) in Liver Transplantation Recipients to Induce Immune Tolerance
- ClinicalTrials.gov ID
- NCT07634562
- Acronym / sponsor ID
- TEMPO-LT / 86730
- Conditions
- Liver Failure
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- Aug 2031 (estimated)
- Study completion
- Aug 2031 (estimated)
- First posted
- 9 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anti-thymocyte globulin and Total Lymphoid Irradiation (synchronous tolerance) | Experimental | Drug: Anti-Thymocyte Globulin, ATG (Rabbit), Device: Total lymphoid irradiationParticipants 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. |
| Anti-thymocyte globulin and Total Lymphoid Irradiation (delayed tolerance) | Experimental | Drug: Anti-Thymocyte Globulin, ATG (Rabbit), Device: Total lymphoid irradiationParticipants 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Undergoing liver transplantation at Stanford University
- No contraindications to Total Lymphoid Irradiation or rabbit antithymocyte globulin (rATG)
Key exclusion criteria (19 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Anti-thymocyte globulin and Total Lymphoid Irradiation (delayed tolerance), Anti-thymocyte globulin and Total Lymphoid Irradiation (synchronous tolerance) |
| Total lymphoid irradiationParticipants will get 8 doses of TLI over 2 weeks with a total radiation dose of 960 cGy. | Device | Anti-thymocyte globulin and Total Lymphoid Irradiation (delayed tolerance), Anti-thymocyte globulin and Total Lymphoid Irradiation (synchronous tolerance) |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stephan Busque, MD, MSc principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Anti-Thymocyte Globulin, ATG (Rabbit) and Total lymphoid irradiation in people with Liver Failure, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The success rate (time frame: After intervention through 18 months and monitored monthly up to 36 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.