TLI- and ATG-Enabled Minimization Protocol in Liver Transplantation

Part of paid clinical trials in Stanford, California.

Sponsor
Stanford University
Study ID
NCT07634562
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Liver Failure

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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regimen post liver transplant will be safe and well tolerated and will result in recipients successfully being withdrawn from immunosuppression within 2 years after liver transplantation.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

Key Dates

Start date
Aug 31, 2026
Status verified
Jun 2026
Primary completion
Aug 31, 2031
Completion
Aug 31, 2031

Study Design

Enrollment
12 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford UniversityStanfordCalifornia94305
Study Team
[email protected]
650-736-5138

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By research site
Stanford University· Stanford, CA

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