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NCT07634562 · ClinicalTrials.gov registry record · Phase 1
TLI- and ATG-Enabled Minimization Protocol in Liver Transplantation
A Phase 1 study, sponsored by Stanford University.
- Not yet
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT07634562: Clinical Trial Phase 1 study, sponsored by Stanford University.
NCT07634562 is a Phase 1 study that has not yet begun recruiting, run by Stanford University. The registered enrollment target is 12 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07634562, a Phase 1 study, has not yet begun recruiting, sponsored by Stanford University.
- NOT YET RECRUITING
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
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regimen post liver transplant will be safe and well tolerated and will result in recipients successfully being withdrawn from immunosuppression within 2 years after liver transplantation.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.
Interventions
- DRUG Anti-Thymocyte Globulin, ATG (Rabbit)
- DEVICE Total lymphoid irradiation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2026-08 |
| Est. Completion | 2031-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07634562
The ClinicalTrials.gov registry entry for NCT07634562 describes a study currently listed as not yet recruiting, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Stanford University, which has 1,744 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Anti-Thymocyte Globulin, ATG (Rabbit) is the first listed.
NCT07634562 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07634562 about?
NCT07634562 is a clinical study titled "TLI- and ATG-Enabled Minimization Protocol in Liver Transplantation". 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 ...
What is the current status of trial NCT07634562?
This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2026-08. Estimated completion is 2031-08.
What interventions are being tested in trial NCT07634562?
The interventions under investigation include: Anti-Thymocyte Globulin, ATG (Rabbit) (DRUG), Total lymphoid irradiation (DEVICE).
Who is sponsoring clinical trial NCT07634562?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
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