Autologous Polyclonal Tregs for Lupus

Stopped early · Phase 1

Conditions studied: Lupus Erythematosus, Cutaneous, Lupus Erythematosus, Discoid, Lupus Erythematosus, Systemic

In brief

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.

Key facts

Study ID: NCT02428309
Run by: National Institute of Allergy and Infectious Diseases (NIAID)
People needed: 1
Starts: 2015-08-27
Expected to finish: 2018-10-03
Last updated by the study team: 2019-11-12

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Ability to provide informed consent.
Diagnosis of SLE by American College of Rheumatology (ACR) criteria or biopsy proven primary cutaneous lupus.
Presence of ≥ 2 active cutaneous lupus lesions based on (1) visual morphology and (2) at least a grade 2 erythema on CLASI activity score. Histopathologic confirmation is required unless the active lesions are of the same morphology to previously histologically proven cutaneous lupus lesions.
The cutaneous lupus lesions must include any of the following subtypes:
Acute cutaneous lupus including maculopapular lupus rash and photosensitive lupus rash,
Subacute cutaneous lupus,
Chronic cutaneous lupus including discoid lupus and hypertrophic (verrucous) lupus,
Lupus timidus
Positive test for Epstein-Barr virus (EBV) antibody.
Adequate venous access to support draw of 400 mL whole blood and infusion of investigational therapy.

You may not qualify if…

New onset of cutaneous lupus which has not been treated with broad spectrum sunscreen (UVA and UVB) in combination with either antimalarials or another systemic medication for at least 3 months.
Prednisone dose > 15mg/day within the 30 days prior to screening.
Addition of a new medication, or change in the dose of any background medication, used to treat any aspect of SLE. Specifically:
addition or change in systemic glucocorticoids, antimalarials, methotrexate, mycophenolate mofetil, mycophenolic acid, azathioprine, cyclosporine, tacrolimus, thalidomide, lenalidomide, dapsone, acitretin, or isotretinoin within 90 days prior to screening
treatment with cyclophosphamide within 90 days prior to screening.
Doses of background medications at Screening visit:
hydroxychloroquine > 400 mg/day,
chloroquine > 250 mg/day,
quinacrine >100 mg/day,
methotrexate > 25 mg/week,
mycophenolate mofetil (MMF)> 3000 mg/day,
mycophenolic acid > 720 mg/day BID,
azathioprine > 200 mg/day,
cyclosporine > 5 mg/day divided BID,
tacrolimus > 6 mg/day
thalidomide > 300 mg/day,
lenalidomide > 10 mg/day,
dapsone > 250 mg/day,
acitretin > 50 mg/d (or > 1 mg/kg/day),
isotretinoin > 120 mg/d (or > 2 mg/kg/day).
Intravenous immunoglobulin (IVIG), plasmapheresis, or leukopheresis within the 90 days prior to screening.
Use of rituximab within the 12 months prior to screening.
Change in dosing frequency, concentration, or applied surface area of topical steroids, tacrolimus, and/or pimecrolimus within 4 weeks prior to screening.
Active severe central nervous system lupus.
SELENA-SLEDAI's seizure, psychosis, organic brain syndrome, visual disturbance,cranial nerve disorder, lupus headache, cerebrovascular accident (CVA), vasculitis,arthritis, myositis, mucosal ulcers, pleurisy, pericarditis, and fever scores > 8 total.

Where it is running

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

Full record on ClinicalTrials.gov

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