Recruiting
Phase 1
Phase 2

ATG & TLI

Sponsor:

Stanford University

Code:

NCT07634562

Conditions

Liver Failure

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

Anti-Thymocyte Globulin, ATG (Rabbit)

Total lymphoid irradiation

Study Details

Brief 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regimen post liver transplant will be safe and well tolerated and will result in recipients successfully being withdrawn from immunosuppression within 2 years after liver transplantation.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.

Conditions

Liver Failure

Study ID

NCT07634562

Start date

Sep 1, 2026

Status verified date

Jun, 2026

Completion date

Aug, 2031

Anticipated

Primary completion date

Aug, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

12 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

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.

Interventions

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.

Total lymphoid irradiation

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

Primary outcome measure

  • The success rate [ Time Frame: After intervention through 18 months and monitored monthly up to 36 months. ]

Central Contacts and Locations

Locations

Stanford University

Recruiting

Stanford, California, United States, 94305

Contacts

Study Team

650-736-5138atahsin2@stanford.edu

More Information

Sponsor

Stanford University

Last update posted

Oct 7, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-08. This information was provided to ClinicalTrials.gov by Stanford University on 2026-10-07. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.