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Cls12311

The RED4MS clinical trial is investigating a novel treatment approach for relapsing-remitting multiple sclerosis (RRMS) using a drug called CLS12311. This innovative therapy involves autologous red blood cells chemically coupled with antigenic peptides, aiming to induce antigen-specific immune tolerance in patients with RRMS. The study is designed to assess the safety, tolerability, and efficacy of CLS12311 through a combined Phase Ib/IIa trial structure.

Table of Contents

What is CLS12311?

CLS12311 is an innovative medical treatment being developed for patients with relapsing-remitting multiple sclerosis (RRMS)[1]. RRMS is a form of multiple sclerosis characterized by periods of symptom flare-ups followed by periods of recovery. CLS12311 consists of the patient’s own red blood cells (RBCs) that have been chemically modified to carry specific protein fragments (peptides) on their surface[1].

How Does CLS12311 Work?

The goal of CLS12311 is to treat RRMS by inducing what’s called “antigen-specific immune tolerance”[1]. In simpler terms, this means teaching the immune system to stop attacking the body’s own tissues, specifically those in the nervous system. By presenting specific peptides on the surface of red blood cells, CLS12311 aims to “retrain” the immune system to recognize these peptides as harmless, potentially reducing the inflammatory attacks that cause damage in multiple sclerosis[1].

Clinical Trial Design: The RED4MS Study

The RED4MS trial is a clinical study designed to assess the safety, tolerability, and effectiveness of CLS12311 in patients with RRMS. This trial is divided into two parts[1]:

  • Part A (Phase Ib): This is an open-label, dose-escalation study. It will enroll 9 RRMS patients in three groups, each receiving a different dose of CLS12311 (low, medium, and high). The first patient in each group will receive one treatment cycle, while the others will receive two cycles[1].
  • Part B (Phase IIa): This part will involve 45 patients with active disease as shown on magnetic resonance imaging (MRI). Patients will be randomly assigned to one of three dosing groups in equal numbers. Each patient will receive two cycles of therapy[1].

Safety and Efficacy Measures

The RED4MS trial will assess several important aspects of CLS12311’s performance[1]:

  • Safety: Researchers will monitor the number and severity of side effects, including any worsening of MS symptoms. This will be done using standardized measures like the CTCAE v4.0 (a system for grading side effects) and by tracking MS relapses and changes in brain MRI scans[1].
  • Efficacy: The main measure of how well CLS12311 works will be the reduction in the number of new brain lesions (areas of damage seen on MRI) after treatment compared to before treatment[1].
  • Functional Assessments: The study will also look at changes in various tests that measure MS progression, including:
    • EDSS (Expanded Disability Status Scale): A method of measuring disability in MS[1].
    • T25-FW (Timed 25-Foot Walk): A test of walking speed[1].
    • 9-HPT (9-Hole Peg Test): A test of hand function[1].
    • SDMT (Symbol Digit Modalities Test): A test of cognitive processing speed[1].

Potential Benefits of CLS12311

If successful, CLS12311 could offer several potential benefits for RRMS patients[1]:

  • Personalized Treatment: CLS12311 uses the patient’s own red blood cells, potentially reducing the risk of rejection or other complications[1].
  • Targeted Approach: By focusing on specific peptides involved in MS, CLS12311 aims to address the root cause of the disease rather than just managing symptoms[1].
  • Reduced Disease Activity: The primary goal is to reduce the formation of new brain lesions, which could potentially slow or halt the progression of MS[1].
  • Improved Quality of Life: If CLS12311 can effectively reduce MS activity, it may help maintain or improve patients’ physical and cognitive functions, as measured by the various tests in the study[1].

It’s important to note that CLS12311 is still in the experimental stages, and more research is needed to fully understand its effectiveness and safety profile. The RED4MS trial is an important step in this process, and its results will help guide future development of this promising treatment approach[1].

Aspect Details
Study Name RED4MS Trial
Drug CLS12311 (Peptide-coupled Red Blood Cells)
Condition Relapsing-remitting Multiple Sclerosis (RRMS)
Study Design Phase Ib/IIa, open-label dose-escalation (Part A) and randomized, dose-blinded (Part B)
Participants 54 total (9 in Part A, 45 in Part B)
Treatment Duration Two cycles of therapy
Primary Outcomes Safety (adverse events) and Efficacy (reduction in new brain lesions)
Secondary Outcomes Safety and efficacy measures in each dose group, changes in EDSS, T25-FW, 9-HPT, SDMT
Follow-up Duration On average 48 weeks

FAQ

  • What is CLS12311 and how does it work? CLS12311 is a treatment made from a patient's own red blood cells that are chemically coupled with specific peptides. It aims to treat relapsing-remitting multiple sclerosis by helping the immune system become more tolerant to certain substances that may be causing the disease.
  • How is the RED4MS trial structured? The RED4MS trial has two parts: Part A is an open-label, dose-escalation study with 9 patients, and Part B is a randomized, dose-blinded study with 45 patients. Both parts aim to test different doses of CLS12311 for safety and effectiveness.
  • What are the main goals of the RED4MS trial? The main goals are to assess the safety and tolerability of CLS12311, as well as its effectiveness in reducing new brain lesions in patients with relapsing-remitting multiple sclerosis.
  • How long does the trial last for each patient? On average, patients participate in the trial for about 48 weeks, with the treatment phase lasting approximately 24 weeks.
  • What kind of measurements are used to evaluate the treatment's effectiveness? The trial uses various measurements, including brain MRI scans to count new lesions, clinical assessments like the Expanded Disability Status Scale (EDSS), and tests such as the Timed 25-Foot Walk, 9-Hole Peg Test, and Symbol Digit Modalities Test.

Ongoing Clinical Trials on Cls12311

  • Study on the Safety and Efficacy of CLS12311 and Autologous Red Blood Cells for Patients with Relapsing Remitting Multiple Sclerosis

    Not recruiting

    1
    Investigated diseases:
    Investigated drugs:
    Czechia Germany Italy

Glossary

  • Relapsing-remitting Multiple Sclerosis (RRMS): A form of multiple sclerosis characterized by clearly defined attacks of new or increasing neurologic symptoms, followed by periods of partial or complete recovery (remissions).
  • Autologous: Referring to cells or tissues obtained from the same individual. In this trial, it means using the patient's own red blood cells for treatment.
  • Peptide-coupled Red Blood Cells: Red blood cells that have been chemically attached to specific protein fragments (peptides) to create a therapeutic treatment.
  • Antigen-specific immune tolerance: A state where the immune system does not react against specific substances (antigens) that it would normally attack, potentially reducing harmful inflammation in diseases like multiple sclerosis.
  • MRI (Magnetic Resonance Imaging): A medical imaging technique that uses magnetic fields and radio waves to create detailed images of organs and tissues in the body, commonly used to detect and monitor MS lesions in the brain.
  • EDSS (Expanded Disability Status Scale): A method of measuring disability in multiple sclerosis and monitoring changes in the level of disability over time.
  • T25-FW (Timed 25-Foot Walk): A test that measures how long it takes a person to walk 25 feet, used to assess walking ability and leg function in MS patients.
  • 9-HPT (9-Hole Peg Test): A test that measures finger dexterity and upper limb function, often used in MS assessments.
  • SDMT (Symbol Digit Modalities Test): A cognitive test that assesses processing speed and working memory, commonly used in MS to evaluate cognitive function.
  • CTCAE (Common Terminology Criteria for Adverse Events): A set of criteria for the standardized classification of adverse effects of drugs used in cancer therapy and other diseases, including their severity.

References