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NCT03654040 · ClinicalTrials.gov registry record · Phase 1
Liver Transplantation With Tregs at UCSF
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Terminated
- Registry status
- Phase 1
- Development phase
- 42
- Enrollment target
NCT03654040: Clinical Trial Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT03654040 is a Phase 1 study that was terminated before completion, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 42 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03654040, a Phase 1 study, was terminated before completion, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 42 participants
- Enrollment target
Study Summary
This is a single-center, prospective, open-label, non-randomized clinical trial exploring cellular therapy to facilitate immunosuppression withdrawal in liver transplant recipients.
Primary Outcome
* AEs will be attributed to alloantigen-reactive Tregs (arTreg) when the AE is reported with possible or related attribution to arTreg. * Grading: According to the NCI Common Terminology Criteria for Adverse Events Manual \[NCI-CTCAE version 5.0, published November 27, 2017\].
Interventions
- DRUG cyclophosphamide
- DRUG everolimus
- PROCEDURE leukapheresis
- DRUG mesna
- BIOLOGICAL arTreg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2021-04-22 |
| Est. Completion | 2023-03-06 |
| Phase | Phase 1 |
Why NCT03654040 stopped before completion
NCT03654040 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% lower).
The record links to 0 conditions, and to 5 interventions - of which cyclophosphamide is the first listed.
NCT03654040 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03654040 about?
NCT03654040 is a clinical study titled "Liver Transplantation With Tregs at UCSF". This is a single-center, prospective, open-label, non-randomized clinical trial exploring cellular therapy to facilitate immunosuppression withdrawal in liver transplant recipients.
What is the current status of trial NCT03654040?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2021-04-22. Estimated completion is 2023-03-06.
What interventions are being tested in trial NCT03654040?
The interventions under investigation include: cyclophosphamide (DRUG), everolimus (DRUG), leukapheresis (PROCEDURE), mesna (DRUG), arTreg (BIOLOGICAL).
Who is sponsoring clinical trial NCT03654040?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03654040's enrollment target sits among peer trials
42 1105th of 2000 higher than 876 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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