In Vitro Effect Study of Interleukin-2 Muteins on Regulatory T Cells of Patients With Different A… (NCT05544448) | Clinical Trial Compass
CompletedNot Applicable
In Vitro Effect Study of Interleukin-2 Muteins on Regulatory T Cells of Patients With Different Autoimmune, Allo-immune or Inflammatory Diseases
France67 participantsStarted 2023-10-02
Plain-language summary
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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 conse…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
the percentage of phosphorylated STAT5 in LTresg compared to LTconv after incubation with IL-2 muteins