Polyclonal Regulatory T Cells (PolyTregs) for Pemphigus

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.

Conditions

• Pemphigus Foliaceus
• Pemphigus Vulgaris

Interventions

BIOLOGICAL

Cohort 1: 1.0 x 10^8 PolyTregs

Each participant will receive a target cell dose of 1.0 x 10\^8 polyclonal Tregs.

BIOLOGICAL

Cohort 2: 2.5x10^8 PolyTregs

Each participant will receive a target cell dose of 2.5x10\^8 polyclonal Tregs.

Sponsors & Collaborators

• Autoimmunity Centers of Excellence

  collaborator OTHER

• Rho Federal Systems Division, Inc.

  collaborator INDUSTRY

• National Institute of Allergy and Infectious Diseases (NIAID)

  lead NIH

Principal Investigators

• Haley Naik, MD,MHSc · University of California San Francisco School of Medicine: Department of Dermatology

• Anna Haemel, MD · University of California San Francisco School of Medicine: Department of Dermatology

• Michael Rosenblum, MD, Ph.D. · University of California San Francisco School of Medicine: Department of Dermatology

• Jeffrey Bluestone, Ph.D. · UCSF School of Medicine: UCSF Diabetes Clinic

• David Wofsy, M.D. · University of California San Francisco School of Medicine: Lupus Clinic and Rheumatology Clinical Research Center

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-10-10

Primary Completion

2020-12-10

Completion

2023-01-09

FDA Drug

Yes

Countries

• United States

Study Locations