drugset / Trial / NCT03239470

Polyclonal Regulatory T Cells (PolyTregs) for Pemphigus

NCT03239470

Non-randomizedSequentialOpen-labelTreatment

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.

Timeline

Start
2017-10-10
Primary completion
2020-12-10
Completion
2023-01-09

Drugs

EvaluationDrugModalityDoseRoute
Subject PolyTregs Cell therapy 1e+08 cells Intravenous
Subject PolyTregs Cell therapy 2.5e+08 cells Intravenous