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NCT03239470 · ClinicalTrials.gov registry record · Phase 1
Polyclonal Regulatory T Cells (PolyTregs) for Pemphigus
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Terminated
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
NCT03239470: Clinical Trial Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT03239470 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 5 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03239470, 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
- 5 participants
- Enrollment target
Study Summary
T cells, a type of white blood cell called a lymphocyte, play an important role in the immune system. One subtype, the regulatory T cell (Treg) helps to regulate the immune system and may provide protection against the development of autoimmune disease. The hope is that these naturally occurring Treg cells can be utilized for the treatment of autoimmune disease and potentially replace the use of chronic immunosuppressive therapies that are associated with multiple side effects. There has been a small study showing safe administration of Tregs with decreased disease activity in patients with insulin-dependent diabetes. Tregs are being studied in lupus, cancer and organ transplantation. This phase I trial will be conducted as an open-label, dose-escalation, multicenter trial in adult participants with active pemphigus.The purpose of this study is to test the safety and effect of Treg therapy in participants who have skin (cutaneous) involvement due to pemphigus.
Primary Outcome
Number of significant adverse events, defined as any related National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) version 4.03 Grade 3 or higher adverse event or any related serious adverse event (SAE). Related is defined as being possibly related or related to the ex vivo expanded autologous PolyTregs, as determined by the safety review committee. An SAE is any untoward medical occurrence that, at any dose\* results in death, is life-threatening, requires hospita
Interventions
- BIOLOGICAL Cohort 1: 1.0 x 10^8 PolyTregs
- BIOLOGICAL Cohort 2: 2.5x10^8 PolyTregs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2017-10-10 |
| Est. Completion | 2023-01-09 |
| Phase | Phase 1 |
Why NCT03239470 stopped before completion
NCT03239470 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Cohort 1: 1.0 x 10^8 PolyTregs is the first listed.
NCT03239470 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03239470 about?
NCT03239470 is a clinical study titled "Polyclonal Regulatory T Cells (PolyTregs) for Pemphigus". T cells, a type of white blood cell called a lymphocyte, play an important role in the immune system. One subtype, the regulatory T cell (Treg) helps to regulate the immune system and may provide protection against the development of autoimmune disease. The hope is that these naturally occurring Tre...
What is the current status of trial NCT03239470?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2017-10-10. Estimated completion is 2023-01-09.
What interventions are being tested in trial NCT03239470?
The interventions under investigation include: Cohort 1: 1.0 x 10^8 PolyTregs (BIOLOGICAL), Cohort 2: 2.5x10^8 PolyTregs (BIOLOGICAL).
Who is sponsoring clinical trial NCT03239470?
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 NCT03239470's enrollment target sits among peer trials
5 1989th of 2000 higher than 6 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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