Who is sponsoring NCT02428309?

NCT02428309 is sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

What drugs are being tested in NCT02428309?

Interventions in NCT02428309: Ex vivo Expanded Human Autologous Polyclonal Regulatory T Cells.

What condition does NCT02428309 study?

NCT02428309 studies Lupus Erythematosus, Cutaneous, Lupus Erythematosus, Discoid, Lupus Erythematosus, Systemic.

Is NCT02428309 still recruiting?

NCT02428309 is currently terminated. Last updated 12 November 2019.

Are results published for NCT02428309?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-11-12 · How we verify

NCT02428309

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Autologous Polyclonal Tregs for Lupus

Terminated Phase 1 Results posted Last updated 12 November 2019

What this trial tests

Phase 1 trial testing Ex vivo Expanded Human Autologous Polyclonal Regulatory T Cells in Lupus Erythematosus, Cutaneous in 1 participant. Terminated before completion.

Timeline

27 August 2015

Primary endpoint
2 September 2016

3 October 2018

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	1
Start date	27 August 2015
Primary completion	2 September 2016
Estimated completion	3 October 2018
Sites	1 location across United States

Drugs / interventions tested

Ex vivo Expanded Human Autologous Polyclonal Regulatory T Cells — full drug profile →

Conditions studied

Lupus Erythematosus, Cutaneous — all drugs for Lupus Erythematosus, Cutaneous →
Lupus Erythematosus, Discoid — all drugs for Lupus Erythematosus, Discoid →
Lupus Erythematosus, Systemic — all drugs for Lupus Erythematosus, Systemic →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

Adults 18 to 60, any sex, with Lupus Erythematosus, Cutaneous or Lupus Erythematosus, Discoid. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Significant Adverse Events (AEs) Through Week 48 Primary · From time of signed informed consent to Week 48

A significant adverse event is any related National Cancer Institute's Common Terminology Criteria for Adverse Events, Version 4.0 Grade 3 or higher AE or any related serious adverse event. Related is defined as being possibly, probably, or definitely related to the ex vivo expanded autologous PolyTregs, as determined by the safety review committee.

Group	Value	95% CI
Dose 1 (1x10^8)	0

Number of Significant Adverse Events (AEs) Through Week 152 Secondary · From time of signed informed consent to Week 152

Group	Value	95% CI
Dose 1 (1x10^8)	0

Number of Grade 3 or Higher Adverse Events (AEs) Through Week 152 Secondary · From time of signed informed consent to Week 152

Adverse events (AEs) Grade 3 or higher were graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events, Version 4.0.

Group	Value	95% CI
Dose 1 (1x10^8)	1

Number of Infection-Related Adverse Events (AEs) Through Week 152 Secondary · From time of signed informed consent to Week 152

If the adverse event was believed to be caused by a viral, bacterial, or fungal organism, regardless of whether it was treated with antibiotics or not, then it was classified as infection-related.

Group	Value	95% CI
Dose 1 (1x10^8)	0

Number of Lupus Flares Through Week 152 by Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) and Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) Criteria Secondary · From time of signed informed consent to Week 152

An activity score increase of ≥4 CLASI points defines a flare. A mild/moderate flare includes at least one of the following SELENA-SLEDAI criteria: Increase in the SLEDAI Score of ≥3 points, new or worse discoid, photosensitive, profundus, cutaneous vasculitis, bullous lupus, nasopharyngeal ulcers, pleuritic, pericarditis, arthritis, fever attributable to SLE; increase in prednisone (\<0.5 mg/kg/day); added NSAID or Plaquenil; increase in PhGA (\<2.5 \[on a 3.0 indexed VAS scale\]). A severe flare includes at least one of the following SELENA-SLEDAI criteria: Increase of \>12 in the SLEDAI Sco

No.of lupus flares (CLASI)

Group	Value	95% CI
Dose 1 (1x10^8)	0

No. of lupus flares (SELENA-SLEDAI)

Group	Value	95% CI
Dose 1 (1x10^8)	1

Number Infusion-Related Adverse Events (AEs) Within 24 Hours of Infusion Secondary · From time of infusion to 24 hours post infusion

Any infusion-related adverse events Grade 1 or higher within 24 hours of polyclonal Treg infusion. This study graded the severity of adverse events according to the National Cancer Institute's Common Terminology Criteria for Adverse Events, Version 4.0.

Group	Value	95% CI
Dose 1 (1x10^8)	0

Change From Baseline: Alkaline Phosphatase (ALK), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) Secondary · Baseline (Visit 0) and Weeks 4, 12, 48, and 152

Change=Post Baseline value minus Baseline value. A positive difference reflects an increased laboratory parameter value over time; a negative difference reflects a decreased laboratory parameter value over time. Normal laboratory values are based on subject age, gender, and the specific laboratory methods that were used to determine the lab values.

Alkaline Phosphatase (ALK) at Week 4

Group	Value	95% CI
Dose 1 (1x10^8)	-9	± NA

Alkaline Phosphatase (ALK) at Week 12

Group	Value	95% CI
Dose 1 (1x10^8)	4	± NA

Alkaline Phosphatase (ALK) at Week 48

Group	Value	95% CI
Dose 1 (1x10^8)	4	± NA

Alkaline Phosphatase (ALK) at Week 152

Group	Value	95% CI
Dose 1 (1x10^8)	-2	± NA

Alanine Aminotransferase (ALT) at Week 4

Group	Value	95% CI
Dose 1 (1x10^8)	-1	± NA

Alanine Aminotransferase (ALT) at Week 12

Group	Value	95% CI
Dose 1 (1x10^8)	-3	± NA

Alanine Aminotransferase (ALT) at Week 48

Group	Value	95% CI
Dose 1 (1x10^8)	-1	± NA

Alanine Aminotransferase (ALT) at Week 152

Group	Value	95% CI
Dose 1 (1x10^8)	-1	± NA

Change From Baseline in g/dL: Albumin, Hemoglobin Secondary · Baseline (Visit 0) and Weeks 4, 12, 48, and 152

Change=Post Baseline value minus Baseline value. A positive difference reflects an increased laboratory parameter value over time; a negative difference reflects a decreased laboratory parameter value over time. Normal laboratory values depend on a subject age, gender, and the specific laboratory methods that were used to determine the lab values.

Albumin at Week 4

Group	Value	95% CI
Dose 1 (1x10^8)	NA	± NA

Albumin at Week 12

Group	Value	95% CI
Dose 1 (1x10^8)	0.4	± NA

Albumin at Week 48

Group	Value	95% CI
Dose 1 (1x10^8)	0.2	± NA

Albumin at Week 152

Group	Value	95% CI
Dose 1 (1x10^8)	0.2	± NA

Hemoglobin at Week 4

Group	Value	95% CI
Dose 1 (1x10^8)	1.6	± NA

Hemoglobin at Week 12

Group	Value	95% CI
Dose 1 (1x10^8)	1.5	± NA

Hemoglobin at Week 48

Group	Value	95% CI
Dose 1 (1x10^8)	1.3	± NA

Hemoglobin at Week 152

Group	Value	95% CI
Dose 1 (1x10^8)	1.0	± NA

Change From Baseline in mg/dL: Total Bilirubin, Creatinine Secondary · Baseline (Visit 0) and Weeks 4, 12, 48, and 152

Change=Post Baseline value minus Baseline value. A positive difference reflects an increased laboratory parameter value over time; a negative difference reflects a decreased laboratory parameter value over time. Normal laboratory values depend on a subject age, gender, and the specific laboratory methods that were used to determine the lab values.

Total Bilirubin at Week 4

Group	Value	95% CI
Dose 1 (1x10^8)	0.1	± NA

Total Bilirubin at Week 12

Group	Value	95% CI
Dose 1 (1x10^8)	-0.2	± NA

Total Bilirubin at Week 48

Group	Value	95% CI
Dose 1 (1x10^8)	0.0	± NA

Total Bilirubin at Week 152

Group	Value	95% CI
Dose 1 (1x10^8)	-0.2	± NA

Creatinine at Week 4

Group	Value	95% CI
Dose 1 (1x10^8)	0.1	± NA

Creatinine at Week 12

Group	Value	95% CI
Dose 1 (1x10^8)	0.0	± NA

Creatinine at Week 48

Group	Value	95% CI
Dose 1 (1x10^8)	0.1	± NA

Creatinine at Week 152

Group	Value	95% CI
Dose 1 (1x10^8)	0.1	± NA

Change From Baseline in mmol/L: Potassium, Sodium, Chloride Secondary · Baseline (Visit 0) and Weeks 4, 12, 48, and 152

Change=Post Baseline value minus Baseline value. A positive difference reflects an increased laboratory parameter value over time; a negative difference reflects a decreased laboratory parameter value over time. Normal laboratory values depend on a subject age, gender, and the specific laboratory methods that were used to determine the lab values.

Total Potassium at Week 4

Group	Value	95% CI
Dose 1 (1x10^8)	-0.2	± NA

Total Potassium at Week 12

Group	Value	95% CI
Dose 1 (1x10^8)	-0.4	± NA

Total Potassium at Week 48

Group	Value	95% CI
Dose 1 (1x10^8)	-0.3	± NA

Total Potassium at Week 152

Group	Value	95% CI
Dose 1 (1x10^8)	-0.7	± NA

Sodium at Week 4

Group	Value	95% CI
Dose 1 (1x10^8)	4	± NA

Sodium at Week 12

Group	Value	95% CI
Dose 1 (1x10^8)	2	± NA

Sodium at Week 48

Group	Value	95% CI
Dose 1 (1x10^8)	3	± NA

Sodium at Week 152

Group	Value	95% CI
Dose 1 (1x10^8)	5	± NA

Change From Baseline in Cell Counts: White Blood Cells (WBC), Total Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Platelets Secondary · Baseline (Visit 0) and Weeks 4, 12, 48, and 152

Change=Post Baseline value minus Baseline value. A positive difference reflects an increased laboratory parameter value over time; a negative difference reflects a decreased laboratory parameter value over time. Normal laboratory values depend on a subject age, gender, and the specific laboratory methods that were used to determine the lab values.

White Blood Cells (WBC) at Week 4

Group	Value	95% CI
Dose 1 (1x10^8)	0.8	± NA

White Blood Cells (WBC) at Week 12

Group	Value	95% CI
Dose 1 (1x10^8)	1.3	± NA

White Blood Cells (WBC) at Week 48

Group	Value	95% CI
Dose 1 (1x10^8)	1.2	± NA

White Blood Cells (WBC) at Week 152

Group	Value	95% CI
Dose 1 (1x10^8)	1.1	± NA

Total Neutrophils at Week 4

Group	Value	95% CI
Dose 1 (1x10^8)	0.6	± NA

Total Neutrophils at Week 12

Group	Value	95% CI
Dose 1 (1x10^8)	0.9	± NA

Total Neutrophils at Week 48

Group	Value	95% CI
Dose 1 (1x10^8)	0.9	± NA

Total Neutrophils at Week 152

Group	Value	95% CI
Dose 1 (1x10^8)	0.8	± NA

Change From Baseline Red Blood Cell Count Secondary · Baseline (Visit 0) and Weeks 4, 12, 48, and 152

Change=Post Baseline value minus Baseline value. A positive difference reflects an increased laboratory parameter value over time; a negative difference reflects a decreased laboratory parameter value over time. Normal laboratory values depend on a subject age, gender, and the specific laboratory methods that were used to determine the lab values.

Red Blood Cell Count at Week 4

Group	Value	95% CI
Dose 1 (1x10^8)	0.6	± NA

Red Blood Cell Count at Week 12

Group	Value	95% CI
Dose 1 (1x10^8)	0.7	± NA

Red Blood Cell Count at Week 48

Group	Value	95% CI
Dose 1 (1x10^8)	0.6	± NA

Red Blood Cell Count at Week 152

Group	Value	95% CI
Dose 1 (1x10^8)	0.9	± NA

Adverse events — posted to ClinicalTrials.gov

Time frame: From time of signed informed consent to Week 48.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Dose 1 (1x10^8)

Serious: 1/1 (100%)

Deaths: 0/1

Serious adverse events (1 terms)

Reaction	System	Dose 1 (1x10^8)
Neuropathy peripheral	Nervous system disorders	—

Other adverse events (4 terms — click to expand)

Reaction	System	Dose 1 (1x10^8)
Pericarditis	Cardiac disorders	—
Oedema peripheral	General disorders	—
Hypokalaemia	Metabolism and nutrition disorders	—
Cutaneous lupus erythematosus	Skin and subcutaneous tissue disorders	—

Most-reported serious reactions: Neuropathy peripheral.

Data from ClinicalTrials.gov NCT02428309 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Next-generation regulatory T cell therapy.
Ferreira LMR, Muller YD, Bluestone JA, Tang Q. · · 2019 · cited 385× · PMID 31541224 · DOI 10.1038/s41573-019-0041-4
Past, Present, and Future of Regulatory T Cell Therapy in Transplantation and Autoimmunity.
Romano M, Fanelli G, Albany CJ, Giganti G, et al · · 2019 · cited 375× · PMID 30804926 · DOI 10.3389/fimmu.2019.00043
Treg Enhancing Therapies to Treat Autoimmune Diseases.
Eggenhuizen PJ, Ng BH, Ooi JD. · · 2020 · cited 167× · PMID 32977677 · DOI 10.3390/ijms21197015
Regulatory T cells (Tregs) and their therapeutic potential against autoimmune disorders - Advances and challenges.
Goswami TK, Singh M, Dhawan M, Mitra S, et al · · 2022 · cited 153× · PMID 35240914 · DOI 10.1080/21645515.2022.2035117
Adoptive Treg Cell Therapy in a Patient With Systemic Lupus Erythematosus.
Dall'Era M, Pauli ML, Remedios K, Taravati K, et al · · 2019 · cited 123× · PMID 30277008 · DOI 10.1002/art.40737
Therapeutic induction of antigen-specific immune tolerance.
Kenison JE, Stevens NA, Quintana FJ. · · 2024 · cited 94× · PMID 38086932 · DOI 10.1038/s41577-023-00970-x
Opportunities for Treg cell therapy for the treatment of human disease.
Bluestone JA, McKenzie BS, Beilke J, Ramsdell F. · · 2023 · cited 90× · PMID 37153574 · DOI 10.3389/fimmu.2023.1166135
IL233, A Novel IL-2 and IL-33 Hybrid Cytokine, Ameliorates Renal Injury.
Stremska ME, Jose S, Sabapathy V, Huang L, et al · · 2017 · cited 82× · PMID 28539382 · DOI 10.1681/asn.2016121272

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02428309 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Institute of Allergy and Infectious Diseases (NIAID)
Last refreshed: 12 November 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02428309.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT02428309

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (1 terms)

Sponsor's own description

Publications & conference data

Related trials

Other National Institute of Allergy and Infectious Diseases (NIAID) trials

Verify against primary sources