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Mb-Cart20.1

This article discusses a clinical trial investigating the long-term safety and effectiveness of MB-CART20.1, a promising CAR T-cell therapy for patients with advanced B-cell malignancies. The study aims to evaluate potential late-onset side effects, monitor patient outcomes, and assess the persistence of the treatment in patients who have received this innovative therapy.

Table of Contents

What is MB-CART20.1?

MB-CART20.1 is an innovative medical treatment classified as a cell and gene therapy. It is specifically designed to treat certain types of blood cancers, particularly B-cell non-Hodgkin’s lymphoma (NHL) that have not responded well to other treatments or have come back after previous treatments.[1]

This therapy is also known by other names, including:

  • CD20 CAR transduced T cells: This name describes how the treatment works, which we’ll explain in more detail below.
  • Miltenyi CAR T cell therapy: This refers to the company developing the treatment, Miltenyi Biomedicine GmbH.

How Does MB-CART20.1 Work?

MB-CART20.1 is a type of treatment called CAR T-cell therapy. Here’s a simplified explanation of how it works:[1]

  1. Cell collection: First, some of your own T-cells (a type of immune cell) are collected through a process called leukapheresis.
  2. Genetic modification: These T-cells are then genetically modified in a laboratory to produce special receptors on their surface called Chimeric Antigen Receptors (CARs).
  3. Cell multiplication: The modified cells are grown in large numbers in the lab.
  4. Infusion: The CAR T-cells are then given back to you through an intravenous infusion (a drip into your vein).
  5. Targeting cancer cells: Once in your body, these modified T-cells can recognize and attack cancer cells that have a specific protein (CD20) on their surface.

The “20” in MB-CART20.1 refers to CD20, which is the specific protein on B-cell lymphoma cells that this therapy targets.

Medical Conditions Treated

MB-CART20.1 is being studied for the treatment of:[1]

  • Relapsed or refractory CD20 positive B-cell non-Hodgkin’s lymphoma (NHL): This means NHL that has either come back after treatment (relapsed) or didn’t respond well to previous treatments (refractory).

It’s important to note that this therapy is specifically for lymphomas that are “CD20 positive,” meaning the cancer cells have the CD20 protein on their surface.

Clinical Trial Overview

MB-CART20.1 is currently being studied in a clinical trial. This trial is a long-term follow-up study designed to gather more information about the safety and effectiveness of this treatment over time.[1]

The main goals of this study are:

  • To evaluate the long-term safety of MB-CART20.1
  • To assess how well the treatment continues to work over time
  • To monitor for any late-onset side effects
  • To check if the modified T-cells persist in the body

Eligibility Criteria

To participate in this long-term follow-up study, patients must meet the following criteria:[1]

  • Have received treatment with MB-CART20.1 at least 12 months before enrolling in the long-term follow-up
  • Provide informed consent to participate in the study

There are no specific exclusion criteria for this long-term follow-up trial.

Safety and Efficacy Monitoring

During the long-term follow-up, researchers will be closely monitoring several aspects of patients’ health and the treatment’s effectiveness:[1]

  • Safety monitoring: This includes tracking any late-onset side effects, serious adverse events, life-threatening infections, and the development of new or secondary cancers.
  • Blood cell counts: Regular checks of B-cell and T-cell counts will be performed.
  • Treatment effectiveness: Researchers will monitor how many patients experience a relapse or progression of their disease, and track survival rates over time.
  • Persistence of modified cells: Tests will be done to check if the CAR T-cells are still present and active in the body.
  • Virus checks: Patients will be monitored for the presence of replication-competent lentivirus, which is related to the method used to modify the T-cells.

For pediatric patients, additional monitoring will include tracking height, weight, and developmental milestones.

This long-term follow-up study is crucial for understanding the full potential and any long-term effects of MB-CART20.1, helping to ensure its safe and effective use in treating B-cell non-Hodgkin’s lymphoma.

Aspect Details
Study Drug MB-CART20.1 (CD20 CAR transduced T cells)
Target Conditions Relapsed or refractory CD20 positive B-cell non-Hodgkin’s lymphoma (NHL), B-cell malignancies
Main Objective Evaluate long-term safety after treatment with Miltenyi CAR T cell therapy
Key Inclusion Criteria Treatment with Miltenyi CAR T cell therapy at least 12 months prior to enrollment
Primary Endpoint Percentage of patients with late-onset adverse reactions, serious adverse events, and events of special interest
Secondary Endpoints B- and T-lymphocyte count, growth monitoring in pediatric patients, detection of replication-competent lentivirus, relapse/progression rates, transgene persistence

FAQ

  • What is MB-CART20.1? MB-CART20.1 is a type of CAR T-cell therapy that uses a patient's own modified T-cells to target CD20-positive B-cell non-Hodgkin's lymphoma. It consists of autologous CD20 Chimeric Antigen Receptor (CAR) transduced CD4/CD8 enriched T cells, derived from a leukapheresis procedure.
  • What types of conditions does this clinical trial focus on? The trial focuses on patients with relapsed or refractory CD20-positive B-cell non-Hodgkin's lymphoma (NHL) and other B-cell malignancies, including adult and pediatric acute lymphoblastic leukemia (ALL), and chronic lymphocytic leukemia (CLL).
  • What is the main objective of this clinical trial? The main objective of this trial is to evaluate the long-term safety of patients treated with MB-CART20.1 therapy, particularly focusing on late-onset adverse reactions, serious adverse events, and adverse events of special interest.
  • How long will patients be followed in this study? Patients will be enrolled in the long-term follow-up study at least 12 months after their initial treatment with MB-CART20.1. The exact duration of follow-up is not specified in the provided information.
  • What are some of the secondary objectives of the trial? Secondary objectives include assessing blood counts, monitoring growth and development in pediatric patients, evaluating the presence of replication-competent lentivirus, measuring long-term treatment efficacy, and determining the persistence of the transgene in patients.

Ongoing Clinical Trials on Mb-Cart20.1

  • Long-Term Safety Study of MB-CART19.1, MB-CART20.1, and Zamtocabtagene Autoleucel for Patients with Advanced Melanoma or B-Cell Malignancies

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

Glossary

  • CAR T-cell therapy: A type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood, then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor (CAR).
  • Leukapheresis: A laboratory procedure in which white blood cells are separated from a sample of blood. It's often used to collect cells for CAR T-cell therapy.
  • B-cell non-Hodgkin's lymphoma (NHL): A type of cancer that starts in white blood cells called lymphocytes, specifically in B cells. It's a common type of blood cancer.
  • Acute lymphoblastic leukemia (ALL): A type of cancer of the blood and bone marrow that affects white blood cells. It progresses rapidly and creates immature blood cells rather than mature ones.
  • Chronic lymphocytic leukemia (CLL): A type of cancer that starts from white blood cells (called lymphocytes) in the bone marrow. It mainly affects older adults and often progresses slowly.
  • Refractory: In medicine, this term describes a disease or condition that does not respond to treatment.
  • Relapsed: The return of a disease or the signs and symptoms of a disease after a period of improvement.
  • Adverse event: Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure.
  • Transgene: A gene or genetic material that has been transferred from one organism to another.
  • Replication-competent lentivirus: A virus capable of infecting cells and reproducing itself. In gene therapy, it's important to ensure that the viral vectors used cannot replicate to avoid potential safety issues.

References

  1. http://clinicaltrials.eu/trial/long-term-safety-study-of-mb-cart19-1-mb-cart20-1-and-zamtocabtagene-autoleucel-for-patients-with-advanced-melanoma-or-b-cell-malignancies/