In Vitro Effect Study of Interleukin-2 Muteins on Regulatory T Cells of Patients With Different Autoimmune, Allo-immune or Inflammatory Diseases (MuTreg)

February 9, 2026 updated by: Assistance Publique - Hôpitaux de Paris

Interleukin 2 (IL-2) is a critical cytokine for the survival and function of regulatory T cells (LTreg). This cytokine has a dual role in the immune system. IL-2 stimulates immune responses by acting on the intermediate affinity IL-2R receptor, IL-2Rβγ, expressed by conventional T cells (LTconv) during activation, but also contributes to the inhibition of immune responses via LTreg that express the high affinity receptor IL-2Rαβγ.

This difference in IL-2 receptor affinity for IL-2 has led to the development of low-dose IL-2 therapy to stimulate LTreg and improve control of excessive inflammation in autoimmune (AID), inflammatory or alloimmune diseases Low-dose IL-2 therapy is being studied in several of these diseases such as systemic lupus erythematosus, type 1 diabetes, alopecia, HCV (hepatitis C virus)-induced vasculitis, atopic dermatitis and chronic allo-transplantation-related graft-versus-host disease (GVHD).

Some of these studies have shown an increase in LTreg numbers and an improvement in certain clinical signs.

To improve LTreg targeting in autoimmune diseases, inflammatory diseases or GVHD, mutated IL-2s (muteins) have been developed with selective LTreg agonist properties.

These IL-2 muteins are linked to an Fc fragment to increase their half-life. Two IL-2 variants (IL-2Vs)-Fc preferentially stimulate STAT5 phosphorylation in LTregs compared to conventional FoxP3- (LTconv) CD4+ or CD8+ T cells

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Other: Blood sample taken at a single time point

Detailed Description

Hypothesis:

In order to confirm that this differential effect of IL-2 muteins, already established in non-diseased controls, is also observed in patients with autoimmune diseases, inflammatory diseases or GVHD, a pilot in vitro study should be conducted on a small number of patient's blood samples (5 or 10 depending on the pathology).

Objective :

Conduct a multicentre pilot study to confirm the hypothesis that IL-2 muteins preferentially activate the STAT5 pathway in LTreg compared to LTconv in patients with GVHD, acquired bone marrow aplasia, systemic lupus erythematosus, multiple sclerosis, rheumatoid arthritis, autoimmune thyroiditis, vitiligo, alopecia or atopic dermatitis

Method:

At the inclusion, patients will have a blood sample collected for in vitro research purposes. Their clinical data will also be collected.

Conclusion This trial should provide in vitro proof-of-principle of the efficacy of IL-2 muteins on LTreg and could eventually lead to a therapeutic trial

Study Type

Interventional

Enrollment (Actual)

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

France
- Île-de-France Region
  - Créteil, Île-de-France Region, France, 94000
    - Hôpital Henri Mondor, 1 rue Gustave Eiffel,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Description

Inclusion Criteria:

Inclusion criteria common to all patients in different departments:
Age18 years
Affiliated to social security or entitled to
Patient who has been informed of the study and has signed a free and informed consent

Inclusion criteria specific by department:

Inclusion criteria for Clinical Hematology Department:

Patient with GVHD following allogeneic hematopoietic stem cell transplantation (HSC)
Or with acquired bone marrow suppression
Lymphocytosis > 0.5 G/L

Inclusion criteria for Nephrology and Transplantation department:

- Patient with systemic lupus erythematosus (ACR classification criteria)

Inclusion criteria for Neurology department:

- Patient with multiple sclerosis (criteria of Mc Donald 2017)

Inclusion criteria for Rheumatology Department:

- Patient with rheumatoid arthritis (ACR classification criteria)

Inclusion criteria for Internal Medicine-Endocrinology Department:

- Patient with Basedow disease, Hashimoto's thyroiditis

Inclusion criteria for Dermatology Department:

- Patient with vitiligo or alopecia areata or atopic dermatitis

Exclusion Criteria:

Non-inclusion criteria common to all patients:

Patient under guardianship, curatorship or judicial protection
Pregnant, parturient or breastfeeding woman
Patient deprived of liberty
Patient hospitalized without consent
Patient admitted to a health or social institution for purposes other than research
Minor patient
Adult patient unable to express consent
Refusal to participate
Patient on AME

Non-inclusion criteria specific by department:

Non-inclusion criteria for Clinical Hematology Department:

Ongoing treatment with high doses (>1 mg/kg/d) of systemic corticosteroid therapy
Ongoing treatment with JAK inhibitors

Non-inclusion criteria for Nephrology and Transplantation Department:

Ongoing treatment with doses >10 mg/d Prednisone
Ongoing treatment with Cellcept, Endoxan, Imurel, Belimumab, Anti-CD20, Methotrexate
Ongoing treatment with JAK inhibitors

Non-inclusion criteria for Neurology Department:

Treatment with systemic corticosteroid therapy, Fingolimod or Teriflunomide
Ongoing treatment with JAK inhibitors
Lymphocytosis < 0.5 G/L

Non-inclusion criteria for Rheumatology Department:

Ongoing treatment with doses >15 mg/d Prednisone
Treatment with Rituximab or Tocilizumab
Ongoing treatment with JAK inhibitors
Lymphocytosis < 0.5 G/L

Non-inclusion criteria for Internal Medicine - Endocrinology Department:

Ongoing immunosuppressive therapy
Ongoing treatment with JAK inhibitors

Non-inclusion criteria for Dermatology Department:

Ongoing treatment with Methotrexate
Ongoing treatment with JAK inhibitors
Ongoing treatment with doses >10 mg/d prednisone

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Basic Science
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the percentage of phosphorylated STAT5 in LTresg compared to LTconv after incubation with IL-2 muteins Time Frame: At inclusion	The measurement method is based on the quantification of the phosphorylated STAT5 molecule in LTconv and LTreg by flow cytometry after incubating the cells with IL-2 or IL-2 muteins	At inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 2, 2023

Primary Completion (Actual)

June 6, 2024

Study Completion (Actual)

June 6, 2024

Study Registration Dates

First Submitted

September 14, 2022

First Submitted That Met QC Criteria

September 14, 2022

First Posted (Actual)

September 16, 2022

Study Record Updates

Last Update Posted (Actual)

February 11, 2026

Last Update Submitted That Met QC Criteria

February 9, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

APHP220507

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.