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Study on MB-CART2219.1 for Adults and Children with Relapsed or Refractory B-cell Malignancies

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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 treatment for certain types of blood cancers, specifically relapsed or refractory B-cell malignancies. These are cancers that have returned or are not responding to treatment. The study involves a new treatment called MB-CART2219.1, which is a type of cell therapy. This therapy is designed to target specific proteins, CD19 and CD22, found on the surface of cancer cells. The treatment is given through an intravenous infusion, which means it is delivered directly into the bloodstream through a vein.

The purpose of the study is to evaluate the safety and feasibility of using MB-CART2219.1 in patients with these types of blood cancers. The study will include both adults and children who have these cancers and have not responded to other treatments. Participants will receive the treatment and be monitored over time to see how their cancer responds and to check for any side effects. The study aims to understand how well the treatment works and how it affects the body.

Throughout the study, researchers will collect information on how the treatment affects the cancer and the immune system. This includes looking at how the cancer cells respond to the treatment and how the immune cells in the body react. The study will also track the overall health and survival of participants over time. This research is important for developing new treatments for blood cancers that are difficult to treat with existing therapies.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying the presence of CD19 or CD22 on malignant cells through specific tests.

    A pregnancy test is required for women of childbearing potential. This test must be negative before proceeding.

  2. Step 2

    Informed consent

    The patient or legal guardian must sign an informed consent document. This confirms understanding of the study and agreement to participate.

    The patient agrees to adhere to the study schedule and follow-up requirements for up to 15 years.

  3. Step 3

    Treatment preparation

    Before receiving the study medication, the patient may undergo a preparatory phase, which could include additional tests or procedures as required by the study protocol.

  4. Step 4

    Medication administration

    The study medication, MB-CART2219.1, is administered through an intravenous infusion. This means the medication is given directly into a vein.

    The dosage and frequency of the infusion are determined by the study protocol and may vary based on individual patient needs.

  5. Step 5

    Monitoring and follow-up

    After receiving the medication, the patient is monitored for any side effects or reactions. This includes regular check-ups and tests to assess the patient's response to the treatment.

    The patient agrees to refrain from donating blood and, if applicable, sperm for a specified period after the infusion.

  6. Step 6

    Long-term follow-up

    The patient agrees to participate in long-term follow-up for up to 15 years. This involves periodic assessments to monitor health and any long-term effects of the treatment.

    Women of childbearing potential must perform monthly pregnancy tests for 12 months after receiving the medication and agree to abstain from breastfeeding during this period.

Who can join the trial?

12 criteria

  • Patients must have **relapsed** or **refractory** **Lymphoma** or **Acute Lymphoblastic Leukemia (ALL)**. Relapsed means the disease has returned after treatment, and refractory means it has not responded to treatment.
  • For **Lymphoma** patients, you must be **18 years or older**.
  • For **ALL** patients, you must be **12 years or older**.
  • You or your legal guardian must understand and sign a consent form before any study-related procedures.
  • You must be able to follow the study schedule and agree to follow-up for up to **15 years**.
  • Your cancer cells must show **CD19** or **CD22** markers, which are proteins found on the surface of the cells, confirmed by specific tests.
  • If you are a woman who can have children or a man with a female partner who can have children, you must agree to use effective birth control during the study and for **12 months** after treatment.
  • Women must have a negative pregnancy test before starting the study and agree to monthly pregnancy tests for **12 months** after treatment. You must also agree not to breastfeed during the study and for **12 months** after treatment.
  • Men must agree not to donate sperm for **12 months** after the last treatment.
  • All participants must agree not to donate blood during the study and for **1 year** after stopping the study treatment.
  • For **Lymphoma** patients, you must have specific types of lymphoma or **Chronic Lymphocytic Leukemia (CLL)** that have not responded to previous treatments, or you are not eligible for a stem cell transplant.
  • For **ALL** patients, you must have had a second or later relapse, or your disease has not responded to previous treatments, and you are not eligible for a stem cell transplant.

Who cannot join the trial?

3 criteria

  • Patients who are not at least 3 years old cannot participate.
  • Patients who do not have a type of cancer called relapsed or refractory Lymphoma or ALL cannot participate. Relapsed means the cancer has come back after treatment. Refractory means the cancer did not respond to treatment. ALL stands for Acute Lymphoblastic Leukemia, a type of blood cancer.
  • Patients whose cancer cells do not have proteins called CD19 or CD22 cannot participate. These are markers found on the surface of some cancer cells.
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Investigated drugs

MB-CART2219.1 is a type of therapy that uses specially modified cells to help fight certain types of cancer. In this trial, the therapy is designed to target specific proteins found on the surface of cancer cells, known as CD19 and CD22. These proteins are often present in certain blood cancers, like B-cell malignancies. The therapy involves taking some of the patient's own immune cells, changing them in a lab to better recognize and attack the cancer cells, and then putting them back into the patient's body. The goal is to see if this approach is safe and can help treat patients whose cancer has come back or hasn't responded to other treatments.

What is already known about the treatment

MB-CART2219.1 – This medication is administered through a process called ex vivo generation, where cells are modified outside the body and then infused back into the patient. It is currently being studied in clinical trials for its safety and feasibility in treating patients with relapsed or refractory B-cell malignancies, specifically those that are positive for CD19 and/or CD22. The main therapeutic use of MB-CART2219.1 is for patients with difficult-to-treat lymphomas or acute lymphoblastic leukemia (ALL) who are 3 years or older. At the molecular level, it works by targeting specific proteins, CD19 and CD22, on the surface of cancer cells, helping the immune system to recognize and destroy these cells. This medication falls under the pharmacological classification of CAR-T cell therapies, which are a type of immunotherapy designed to enhance the body's natural defenses against cancer.

Investigated diseases

  • Lymphoma

    Lymphoma is a type of cancer that begins in the lymphatic system, which is part of the body's immune system. It involves the abnormal growth of lymphocytes, a type of white blood cell. As the disease progresses, these abnormal cells can spread to other parts of the body, including the bone marrow, spleen, and other organs. Lymphoma can cause swelling of the lymph nodes, fatigue, fever, and weight loss. There are two main types: Hodgkin lymphoma and non-Hodgkin lymphoma, each with different characteristics and progression patterns. The disease can vary greatly in how quickly it progresses, depending on the specific type and individual factors.

  • Acute Lymphoblastic Leukemia (ALL)

    Acute Lymphoblastic Leukemia is a cancer of the blood and bone marrow that affects white blood cells. It progresses rapidly and creates immature blood cells rather than mature ones. These immature cells, called lymphoblasts, multiply quickly and crowd out normal cells, leading to symptoms like fatigue, frequent infections, and easy bruising or bleeding. As the disease advances, it can spread to other parts of the body, including the lymph nodes, liver, spleen, and central nervous system. ALL is most common in children but can also occur in adults. The progression of the disease can vary, with some cases advancing more quickly than others.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-516838-35-00Protocol codeMBCART2219.1Estimated enrolment36 patientsSponsorUniversitaetsklinikum Tuebingen AöR

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This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).