RecruitingPhase 2NCT06688331

Treatment of Presymptomatic (Stage 1) Type 1 Diabetes Pediatric Patients With Treg Cell Preparations and Anti-CD20 Antibody

A Multicenter, Randomized, Blinded, Placebo Controlled, Phase II Study to Evaluate the Safety and Efficacy of Cell Therapy Based With Artificially Expanded CD4+CD25+CD127- Regulatory Lymphocytes and Anti-CD20 Antibody in Pediatric Patients With Presymptomatic Diabetes Type 1 (Stage 1)


Sponsor

PolTREG S.A.

Enrollment

150 participants

Start Date

Mar 12, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The main purpose of the study is to check: * Can therapy with a preparation of regulatory cells (Tregs lymphocytes) and/or an anti-CD20 antibody preparation (rituximab) be successfully used in children with pre-diabetes to treat or delay type 1 diabetes? * Is therapy with a preparation of regulatory cells (Tregs lymphocytes) and/or a preparation of antiCD20 antibodies (rituximab) safe for children with pre-diabetes, and what side effects may be associated with it? The study will include patients at high risk for type 1 diabetes whose laboratory tests have confirmed preserved normal/high insulin production. First (part 1 of the study), tests will be performed to determine the risk of the disease (determination of autoantibodies that characterize the autoimmune background). In order to confirm the effectiveness of the therapy, not all patients will receive the study treatment. The study will be a so-called blinded randomized trial. This means that in this trial, all participants will undergo the same study procedures, but the participant will be randomly assigned to one of four (4) groups that will receive different treatment regimens before entering the study. The participant will be randomly assigned to one of four groups: * Group I will receive a preparation of regulatory cells (Tregs lymphocytes) along with a preparation of antiCD20 antibodies, * Group II will receive a preparation of regulatory cells (Tregs lymphocytes) together with an inert substance (placebo) * Group III will receive a preparation of antiCD20 antibodies along with a sham treatment (inert substance) * Group IV will receive an agent containing an inert substance and sham treatment. Approximately 150 patients aged 6-16 who are at risk of developing type 1 diabetes will be enrolled in the study, which will last up to 96 months. Each enrolled participant will remain in the study for up to five years.


Eligibility

Min Age: 6 YearsMax Age: 16 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new approach to prevent type 1 diabetes in children who show early warning signs — specifically, kids who have diabetes-related antibodies in their blood but haven't developed the disease yet. Researchers are using a combination of immune-regulating cells (called Treg cells) and an antibody drug (anti-CD20) to try to stop diabetes from progressing. **You may be eligible if...** - You are a child aged 6–16 - You have two or more diabetes-related antibodies in your blood (like GAD, IAA, IA-2, or ZnT8) but no diabetes symptoms yet - Your blood sugar levels and HbA1c are in the normal range - Your BMI is in the healthy range for your age and you weigh at least 20 kg - You have not yet been diagnosed with stage 2 or 3 type 1 diabetes **You may NOT be eligible if...** - You already have type 1 diabetes or abnormal blood sugar - You have a history of cancer, active infection, or immune system problems - You are pregnant, breastfeeding, or not willing to use contraception - You have another autoimmune disease (such as Hashimoto's thyroiditis or celiac disease) - You are currently taking any anti-diabetic medications including insulin Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALex vivo expanded CD4+CD25+CD127- regulatory T cells (Tregs)

regulatory T cells with the phenotype CD3(+)CD4(+)CD25(high)CD127(-)doublet(-)lin(-)

BIOLOGICALAnti-CD20 (rituximab)

rituximab

OTHERPlacebo

intrevenous 0,9% NaCl

OTHERTreg sham

intrevenous 0,9% NaCl


Locations(8)

Uniwersytecki Dzieciecy Szpital Kliniczny Im. L. Zamenhofa W Bialymstoku

Bialystok, Poland

Uniwersyteckie Centrum Kliniczne

Gdansk, Poland

Gornoslaskie Centrum Zdrowia Dziecka Im. Sw. Jana Pawla II Samodzielny Publiczny Szpital Kliniczny Nr 6 Slaskiego Uniwersytetu Medycznego W Katowicach

Katowice, Poland

Uniwersytet Medyczny W Lodzi

Lodz, Poland

Uniwersytecki Szpital Dzieciecy w Lublinie

Lublin, Poland

Uniwersytecki Szpital Kliniczny w Opolu

Opole, Poland

Centrum Medyczne Medyk Sp. z o.o. S.K.

Rzeszów, Poland

Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu

Wroclaw, Poland

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NCT06688331


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