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Poltreg-T1D

A groundbreaking clinical trial is underway to evaluate the safety and effectiveness of Poltreg-T1D, a cell therapy using artificially expanded regulatory T cells (Tregs), in combination with an anti-CD20 antibody for children with presymptomatic type 1 diabetes. This phase II study aims to explore new treatment options for managing the early stages of this autoimmune condition and potentially slow or prevent its progression.

Table of Contents

What is POLTREG-T1D?

POLTREG-T1D is an innovative medical treatment being studied for children with early-stage type 1 diabetes. It is classified as a cell therapy, which means it uses living cells as a treatment[1]. Specifically, POLTREG-T1D is made up of a type of white blood cell called regulatory T cells (also known as Tregs). These cells are important for controlling the immune system and preventing it from attacking the body’s own tissues.

How Does POLTREG-T1D Work?

In type 1 diabetes, the immune system mistakenly attacks and destroys the insulin-producing cells in the pancreas. POLTREG-T1D aims to stop this process by using specially prepared regulatory T cells. These cells are taken from the patient’s own blood, increased in number in a laboratory, and then given back to the patient through an intravenous infusion (a drip into a vein)[1]. The hope is that these cells will help to control the immune system and prevent further damage to the insulin-producing cells.

Clinical Trial Details

POLTREG-T1D is currently being tested in a phase II clinical trial. This means that while it has shown promise in earlier studies, researchers are now looking at how well it works and how safe it is in a larger group of patients[1]. The trial is specifically for children with presymptomatic type 1 diabetes (stage 1), which means they have signs that diabetes is developing but haven’t yet developed symptoms.

The main goal of the trial is to see if POLTREG-T1D, either alone or combined with another drug called rituximab, can safely delay or prevent the progression of diabetes[1]. The researchers will be looking at how long it takes for participants to develop signs of more advanced diabetes, as well as monitoring for any side effects.

Who Can Participate in the Trial?

The trial is open to children aged 6 to 16 who are in the very early stages of type 1 diabetes development. Some key criteria for participation include:

  • Normal blood sugar levels
  • Presence of certain diabetes-related antibodies in the blood
  • No need for insulin or other diabetes medications
  • Good overall health

There are also several factors that would prevent a child from participating, such as certain infections, other autoimmune diseases, or a history of cancer[1].

Potential Benefits of POLTREG-T1D

If successful, POLTREG-T1D could have several important benefits for children with early-stage type 1 diabetes:

  1. Delay or prevent the onset of symptomatic diabetes
  2. Preserve the body’s ability to produce insulin
  3. Reduce or eliminate the need for insulin injections
  4. Improve long-term health outcomes by preventing complications of diabetes

The researchers will be measuring these outcomes by looking at things like blood sugar control, insulin production, and quality of life[1].

Safety Considerations

As with any new treatment, safety is a top priority in the POLTREG-T1D trial. The researchers will be carefully monitoring for any side effects or adverse events. Some potential risks could include:

  • Reactions to the infusion
  • Increased risk of infections due to changes in the immune system
  • Unexpected effects on other parts of the body

It’s important to note that these are potential risks, and the purpose of the trial is to better understand both the benefits and risks of this treatment[1].

Aspect Details
Study Type Phase II, multicenter, randomized, blinded, placebo-controlled
Target Population Children aged 6-16 with presymptomatic type 1 diabetes (stage 1)
Treatment Poltreg-T1D (Tregs) and anti-CD20 antibody (rituximab)
Primary Objectives Assess safety and efficacy of treatment combinations
Secondary Objectives Evaluate clinical parameters, disease progression, and quality of life
Key Inclusion Criteria Normal blood glucose, positive autoantibodies, no prior anti-diabetic medication use
Key Exclusion Criteria Active infections, autoimmune diseases other than type 1 diabetes, history of cancer
Primary Endpoints Time to dysglycemia onset, number of adverse events
Secondary Endpoints Disease progression rates, C-peptide levels, insulin dosage, remission rates

FAQ

  • What is Poltreg-T1D? Poltreg-T1D is a cell therapy product made from artificially expanded CD4+CD25+CD127- regulatory T cells (Tregs). It is being studied as a potential treatment for early-stage type 1 diabetes in children.
  • Who is eligible for this clinical trial? The trial is open to children aged 6-16 with presymptomatic type 1 diabetes (stage 1), normal blood glucose levels, positive autoantibody titers, and no history of using anti-diabetic medications. Participants must meet specific health criteria and have the ability to manage diabetes-related tasks.
  • What does the treatment involve? The treatment involves a combination of Poltreg-T1D (Tregs) and an anti-CD20 antibody (rituximab). Some participants may receive only one of these treatments or a placebo, depending on their assigned group in the study.
  • What are the main goals of this clinical trial? The primary goals are to assess the safety of the treatment and determine how long it takes for participants to progress to stage 2 diabetes. The study will also evaluate various clinical parameters related to diabetes development, including blood sugar control, C-peptide levels, and quality of life measures.
  • How long will the trial last? The exact duration of the trial is not specified in the provided information. However, the study will monitor participants for at least two years after the first dose of Tregs, with annual follow-ups continuing until the end of the trial.

Ongoing Clinical Trials on Poltreg-T1D

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

    Recruiting

    1 1
    Investigated drugs:
    Poland

Glossary

  • Presymptomatic diabetes type 1 (stage 1): An early stage of type 1 diabetes where individuals have normal blood sugar levels but test positive for diabetes-related autoantibodies, indicating an increased risk of developing the full-blown disease.
  • Regulatory T cells (Tregs): A type of white blood cell that helps regulate or suppress other cells in the immune system. In this trial, artificially expanded CD4+CD25+CD127- Tregs are being studied as a potential treatment for type 1 diabetes.
  • Anti-CD20 antibody (rituximab): A medication that targets and reduces B cells, which are involved in the immune response. It is being studied in combination with Tregs as a potential treatment for early-stage type 1 diabetes.
  • HbA1c: Glycated hemoglobin, a blood test that measures average blood sugar levels over the past 2-3 months. It is used to diagnose and monitor diabetes.
  • C-peptide: A substance produced along with insulin by the pancreas. Measuring C-peptide levels helps assess how much insulin the body is producing.
  • Autoantibodies: Antibodies produced by the immune system that mistakenly target the body's own tissues. In type 1 diabetes, these antibodies attack insulin-producing cells in the pancreas.
  • Dysglycemia: Abnormal blood sugar levels, either too high (hyperglycemia) or too low (hypoglycemia).

References

  1. http://clinicaltrials.eu/trial/study-on-the-safety-and-effectiveness-of-tregs-and-rituximab-for-children-with-early-stage-type-1-diabetes/