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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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). 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regimen post liver transplant will be safe and well tolerated and will result in recipients successfully being withdrawn from immunosuppression within 2 years after liver transplantation.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.
Primary Outcome
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.
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 |
What is known before NCT07634562 opens enrollment
NCT07634562 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 2 interventions - of which Anti-Thymocyte Globulin, ATG (Rabbit) is the first listed.
NCT07634562 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07634562's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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