Study on the Safety and Effectiveness of Tregs and Rituximab for Children with Early Stage Type 1 Diabetes

2 1 1

What is this study about?

This clinical trial is focused on studying Type 1 Diabetes in children who have not yet shown symptoms but are at risk of developing the disease. The study aims to evaluate the safety and effectiveness of a treatment involving a combination of Tregs (a type of cell therapy) and Rituximab (an anti-CD20 antibody). Tregs are regulatory cells that help control the immune system, and Rituximab is a medication that targets specific immune cells. The trial will compare the effects of this combination treatment against Rituximab alone, Tregs alone, and a placebo.

Participants in the study will receive their assigned treatment through an intravenous infusion, which means the medication is delivered directly into the bloodstream. The study will last for a period of four weeks, during which the participants will be closely monitored. The goal is to see how long it takes for the participants to develop symptoms of Type 1 Diabetes and to observe any side effects that may occur from the treatments. The study will also track the participants’ health over a longer period to gather more information about the treatments’ long-term effects.

This trial is important for understanding how to prevent or delay the onset of **Type 1 Diabetes** in children who are at risk. By comparing different treatment options, researchers hope to find the most effective way to manage the disease before it fully develops. The study will provide valuable insights into the potential benefits and risks of using **Tregs** and **Rituximab** in treating early-stage **Type 1 Diabetes**.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes checking age, weight, and blood glucose levels.

The presence of specific autoantibodies is verified, and informed consent is obtained from legal representatives and the participant if applicable.

2 randomization

Participants are randomly assigned to one of the study groups. These groups may receive a combination of treatments or a placebo.

3 treatment administration

The treatment involves the administration of Tregs (regulatory lymphocytes) and rituximab (an anti-CD20 antibody).

The medications are given through an intravenous infusion. The specific dosage and frequency are determined by the study protocol.

4 monitoring and follow-up

Participants are monitored for any changes in their condition, including the development of dysglycemia or progression to stage 2 diabetes.

Regular follow-up visits are scheduled to assess the safety and efficacy of the treatment. This includes checking C-peptide levels and insulin requirements.

5 end of trial assessment

At the end of the trial, a comprehensive assessment is conducted to evaluate the overall outcomes and any adverse events experienced during the study.

The trial aims to determine the number of days until the onset of dysglycemia and the percentage of participants who progress to stage 2 diabetes.

Who Can Join the Study?

The child must be between the ages of 6 and 16.
The child’s legal guardians must be able to manage diabetes, which means they can check blood sugar levels at least three times a day and give the right amount of insulin.
The child must have a way to draw blood, known as venous access.
The child’s Body Mass Index (BMI) should be between the 25th and 75th percentile, with a minimum weight of 20 kg.
The child’s blood sugar levels should be less than 100 mg/dl when fasting, and they should have a normal glucose tolerance test, which means their blood sugar is less than 140 mg/dl two hours after eating.
The child should not need insulin to manage their blood sugar, known as insulin independence.
The child’s C-peptide levels should be at least 1.0 ng/ml, and these levels should increase by at least 100% after eating or stimulation.
The child should not have been diagnosed with stage 2 or 3 type 1 diabetes, meaning they have no history of abnormal blood sugar levels or symptoms of diabetes.
The child’s HbA1c level, which is a measure of average blood sugar over the past 2-3 months, should be less than 5.7%.
The child should have positive autoantibody titres, which are specific proteins in the blood that indicate an immune response. They should have low levels of two or more antibodies, or if one antibody is high, they can be tested again to confirm.
The child’s legal guardians must be able to give informed consent for the child to participate in the trial. If the child is over 13, they must also agree to participate.

Who Cannot Join the Study?

Participants who are not in the early stage of type 1 diabetes, known as presymptomatic diabetes type 1 (stage 1), cannot join the study. This means they should not have any symptoms of diabetes yet.
Participants who are not within the specified age range for the study cannot participate. The study is looking for children, so adults cannot join.
Participants who have any other serious health conditions that might interfere with the study cannot take part. This is to ensure the safety of the participants and the accuracy of the study results.
Participants who are taking medications that might affect the study results cannot participate. This is to make sure the study results are reliable.
Participants who have had a recent infection or illness that could affect their immune system cannot join. This is important because the study involves treatments that work with the immune system.
Participants who have a history of allergic reactions to the study medications cannot take part. This is to prevent any potential allergic reactions during the study.
Participants who are unable to follow the study procedures or attend the required visits cannot participate. This is to ensure that all participants can complete the study as planned.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Uniwersytecki Szpital Dzieciecy W Lublinie	Lublin	Poland
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu	Wroclaw	Poland
Pomeranian Medical University	Szczecin	Poland

Other Sites

Site Name	City	Country
Samodzielny Publiczny Dzieciecy Szpital Kliniczny Im. Jozefa Polikarpa Brudzinskiego W Warszawie	Warsaw	Poland
Gornoslaskie Centrum Zdrowia Dziecka Im. Sw. Jana Pawla II Samodzielny Publiczny Szpital Kliniczny Nr 6 Slaskiego Uniwersytetu Medycznego W Katowicach	Katowice	Poland
Uniwersytecki Szpital Kliniczny W Opolu	Opole	Poland
Uniwersytecki Dzieciecy Szpital Kliniczny Im. L. Zamenhofa W Bialymstoku samodzielny publiczny zakład opieki zdrowotnej	Bialystok	Poland
Centrum Medyczne Medyk Sp. z o.o.	Rzeszow	Poland
Ukglbabvhlr Myauucoh W Lctib	Lodz	Poland
Uvviwdzvlvyuki Ccuzqqc Knmlzrvvt	Gdansk	Poland

Trial status

Country	Status	Recruitment Start
Poland	Recruiting	01.10.2024

Trial locations

Investigated drugs:

Rituximab is a medication used in this trial to help manage the immune system. It works by targeting specific cells in the body that are involved in the immune response. In this study, it is being tested to see if it can help delay or prevent the progression of type 1 diabetes in children who are at an early stage of the disease.

Regulatory T Cells (Tregs) are a type of cell therapy used in this trial. These cells are a special kind of immune cell that help control the immune system and prevent it from attacking the body’s own tissues. In this study, artificially expanded Tregs are being used to see if they can help protect the insulin-producing cells in the pancreas and slow down the progression of type 1 diabetes in children.

Presymptomatic Type 1 Diabetes (Stage 1) – This stage of type 1 diabetes is characterized by the presence of specific autoantibodies in the blood, indicating an autoimmune response against insulin-producing cells in the pancreas. Despite the presence of these autoantibodies, blood sugar levels remain normal, and there are no symptoms of diabetes. The disease progresses as the immune system continues to attack the insulin-producing cells, eventually leading to a decrease in insulin production. Over time, this can lead to dysglycemia, where blood sugar levels become abnormal, marking the transition to stage 2. The progression from stage 1 to stage 2 can vary in duration among individuals. Monitoring and early detection are crucial during this stage to manage and potentially slow the progression of the disease.

Trial ID:

2023-505226-33-00

Protocol code:

PTG007DM1preTREG001

NCT ID:

NCT06688331

Trial Phase:

Therapeutic exploratory (Phase II)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study on the Safety and Effectiveness of Tregs and Rituximab for Children with Early Stage Type 1 Diabetes

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?