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Study on the Safety and Effects of EryDex with Dexamethasone Sodium Phosphate for Patients with Ataxia Telangiectasia

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a rare genetic disorder called Ataxia Telangiectasia (A-T). A-T affects the nervous system and other parts of the body, leading to problems with movement and coordination. The study will use a treatment called EryDex, which involves the use of a medication named Dexamethasone sodium phosphate. This medication is encapsulated into the patient's own red blood cells and then infused back into the body. The purpose of the study is to evaluate the safety and tolerability of EryDex in patients with A-T and to explore its effects on neurological symptoms.

Participants in this study will have previously completed another study related to A-T. During the course of the study, participants will receive the EryDex treatment and be monitored for any side effects or changes in their health. The study will assess any treatment-emergent adverse events, which are any new or worsening medical issues that occur during the study. This includes serious adverse events, changes in vital signs, and findings from physical and neurological examinations.

The study aims to provide valuable information on how EryDex affects patients with A-T, particularly in terms of safety and its potential impact on neurological symptoms. The study will continue until 2026, allowing researchers to gather comprehensive data on the treatment's effects over time.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit

    Upon joining the study, the first step involves an initial visit. During this visit, a healthcare professional will review your medical history and confirm that you have completed the previous study, IEDAT-04-2022, including the final assessments.

    Your body weight will be measured to ensure it is at least 15 kg, as this is a requirement for participation.

  2. Step 2

    Treatment administration

    The treatment involves the administration of dexamethasone sodium phosphate, which is a solution given through an intravenous infusion. This means the medication is delivered directly into your bloodstream through a vein.

    The medication is encapsulated into your own red blood cells, a process known as autoerythrocyte encapsulation, to help manage symptoms of Ataxia Telangiectasia (A-T).

  3. Step 3

    Regular monitoring

    Throughout the study, regular monitoring will be conducted to evaluate the safety and tolerability of the treatment. This includes checking for any side effects or adverse events that may occur.

    Your vital signs, such as blood pressure and heart rate, will be regularly assessed. Laboratory tests will be performed to monitor your health, and physical and neurological examinations will be conducted.

  4. Step 4

    Safety assessments

    Safety assessments will include the use of the Columbia Suicide Severity Rating Scale (C-SSRS) to ensure your mental well-being is monitored throughout the trial.

    Any changes in your health or any adverse events will be documented and evaluated to ensure the treatment remains safe for you.

  5. Step 5

    Completion of study

    The study is expected to continue until October 31, 2026. Upon completion, a final assessment will be conducted to evaluate the overall effects of the treatment on your neurological symptoms and general health.

    The results of these assessments will help determine the long-term safety and effectiveness of the treatment for Ataxia Telangiectasia.

Who can join the trial?

4 criteria

  • The participant must have completed the previous study called IEDAT-04-2022, including the final assessments, and must not have any safety issues that would prevent continuing treatment, as determined by the study doctor.
  • The participant's body weight must be at least 15 kg (about 33 pounds).
  • The study is open to both male and female participants.
  • The study includes participants from vulnerable populations, which means it considers people who might need special protection or care.

Who cannot join the trial?

8 criteria

  • Patients who are not diagnosed with Ataxia Telangiectasia (A-T) cannot participate. Ataxia Telangiectasia is a rare genetic disorder that affects movement and coordination.
  • Patients who are not within the specified age range cannot participate. The study is open to certain age groups only.
  • Patients who are not able to follow the study procedures or attend the required visits cannot participate.
  • Patients who have other medical conditions that might interfere with the study cannot participate.
  • Patients who are taking medications that might interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have participated in another clinical trial recently cannot participate.
  • Patients who have a history of allergic reactions to the study medication cannot participate.
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Investigated drugs

EryDex is a treatment being studied for its safety and effects on neurological symptoms in patients with a condition called Ataxia Telangiectasia (A-T). This therapy involves using a patient's own red blood cells to deliver a steroid called dexamethasone slowly over time. The goal is to see if this method can help manage symptoms of A-T, which is a rare genetic disorder that affects movement and coordination. The study is looking at how well patients tolerate this treatment and whether it can improve their neurological symptoms.

What is already known about the treatment

EryDex – EryDex is administered as an infusion, where the medication is delivered directly into the bloodstream. It is currently being studied in clinical trials for its safety and effectiveness in treating Ataxia Telangiectasia (A-T), a rare genetic disorder. The main purpose of EryDex is to help manage neurological symptoms associated with A-T. At the molecular level, EryDex works by delivering a steroid called dexamethasone encapsulated in red blood cells, which helps reduce inflammation and improve neurological function. It is classified as a corticosteroid therapy.

Investigated diseases

Ataxia Telangiectasia – Ataxia Telangiectasia is a rare genetic disorder that affects various systems in the body, primarily the nervous and immune systems. It is characterized by progressive difficulty with coordination and balance, known as ataxia, which typically begins in early childhood. As the disease progresses, individuals may experience involuntary movements, muscle twitches, and difficulty with speech. Telangiectasia, or small dilated blood vessels, often appear on the skin and eyes. The condition can also lead to a weakened immune system, making individuals more susceptible to infections. Over time, neurological symptoms may worsen, impacting daily activities and mobility.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513618-37-00Protocol codeIEDAT-05-2024Estimated enrolment106 patientsSponsorQuince Therapeutics S.p.A.

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