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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03239470
The ClinicalTrials.gov registry entry for NCT03239470 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
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 reports 0 study locations.
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.
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