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Autologous Polyclonal Tregs for Lupus

NCT02428309 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2019-11-12

Study results available
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Summary

The primary purpose of this Phase 1 study is to evaluate the safety, tolerability, and effect of 3 different doses of Treg therapy in adults with skin (cutaneous) involvement of their lupus. Targeting cutaneous disease offers the ability to control background therapy, readily detect clinical effects, and perform research analyses not only in blood but also skin. Safety, disease activity, and mechanism of Tregs will be evaluated. The intent is to support dose selection for a future larger efficacy trial in lupus.

Conditions

  • Lupus Erythematosus, Cutaneous
  • Lupus Erythematosus, Discoid
  • Lupus Erythematosus, Systemic

Interventions

BIOLOGICAL

Ex vivo Expanded Human Autologous Polyclonal Regulatory T Cells

Sponsors & Collaborators

  • Autoimmunity Centers of Excellence

    collaborator OTHER

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Maria Dall'Era, MD · University of California, San Francisco

  • Anna Haemel, MD · University of California, San Francisco

  • Jeffrey Bluestone, PhD · University of California, San Francisco

  • Michael Rosenblum, MD, PhD · University of California, San Francisco

  • David Wofsy, MD · University of California, San Francisco

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-27
Primary Completion
2016-09-02
Completion
2018-10-03

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02428309 on ClinicalTrials.gov