Clinical trialNCT02428309TerminatedPhase 1Interventional

Autologous Polyclonal Tregs for Lupus

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)Enrollment1Lupus Erythematosus, CutaneousLupus Erythematosus, DiscoidLupus Erythematosus, Systemic

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Anna Haemel, MD
University of California, San Francisco
Study Chair
clinicaltrials.gov ↗
David Wofsy, MD
University of California, San Francisco
Study ChairKOL profile →
clinicaltrials.gov ↗
Jeffrey Bluestone, PhD
University of California, San Francisco
Study Chair
clinicaltrials.gov ↗
Maria Dall'Era, MD
University of California, San Francisco
Study Chair
clinicaltrials.gov ↗
Michael Rosenblum, MD, PhD
University of California, San Francisco
Study Chair
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

University of California, San Francisco
San Francisco, California, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Ex vivo Expanded Human Autologous Polyclonal Regulatory T Cells

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 27 Aug 2015
Primary completion: 2 Sept 2016
Completion: 3 Oct 2018
Last update posted: 12 Nov 2019
Registered enrollment: 1
Registry id: NCT02428309

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.