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Study on MB-CART19.1 for Patients with Relapsed or Refractory CD19 Positive B Cell Malignancies

Verified siteInvestigationalNo placebo
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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 certain types of blood cancers, specifically relapsed or refractory CD19 positive B cell malignancies. These include conditions like acute lymphoblastic leukemia (ALL) and non-Hodgkin lymphoma (NHL) in both children and adults, as well as chronic lymphocytic leukemia (CLL) in adults. The treatment being tested is called MB-CART19.1, which involves using a patient's own T-cells that have been modified in a laboratory to better target and fight cancer cells. These modified cells are then given back to the patient through an infusion.

The purpose of this study is to evaluate how safe and effective this new treatment is for patients whose cancer has returned or has not responded to previous treatments. The study will be conducted in two phases. In the first phase, researchers will determine the best dose of MB-CART19.1 to use. In the second phase, they will assess how well the treatment works in reducing cancer cells in the body. Throughout the study, participants will receive the treatment and be monitored for any side effects and improvements in their condition.

Participants will receive the MB-CART19.1 treatment through an intravenous infusion, which means it will be delivered directly into the bloodstream. The study aims to find out if this approach can help control or eliminate the cancer, and how long any positive effects might last. The trial will also look at the overall health and survival of participants over time. Some participants may receive a placebo as part of the study to help compare the effects of the treatment. The study is expected to continue until the end of 2025.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    The trial begins with an initial assessment to confirm eligibility. This includes verifying the presence of CD19 positive B cell malignancies and ensuring that the patient meets specific health criteria.

    A series of tests will be conducted to assess overall health, including blood tests and imaging studies.

  2. Step 2

    Leukapheresis

    Leukapheresis is a procedure to collect T-cells from the patient's blood. These cells will be used to create the MB-CART19.1 therapy.

    This process involves drawing blood from the patient, separating the T-cells, and returning the remaining blood components to the body.

  3. Step 3

    Cell modification

    The collected T-cells are modified in a laboratory to express a chimeric antigen receptor (CAR) that targets CD19 on cancer cells.

    This modification process is conducted outside the body and takes several weeks to complete.

  4. Step 4

    Pre-infusion chemotherapy

    Before receiving the modified T-cells, the patient undergoes chemotherapy to prepare the body for the infusion.

    This step helps to create a favorable environment for the modified T-cells to function effectively.

  5. Step 5

    Infusion of MB-CART19.1

    The modified T-cells, now called MB-CART19.1, are infused back into the patient's bloodstream through an intravenous infusion.

    This infusion is a one-time procedure and is closely monitored by medical staff.

  6. Step 6

    Monitoring and follow-up

    After the infusion, the patient is monitored for any immediate reactions and potential side effects.

    Regular follow-up visits are scheduled to assess the response to the treatment and to monitor for any long-term effects.

  7. Step 7

    Evaluation of response

    The effectiveness of the treatment is evaluated at specific intervals, such as day 28 and month 3, to determine the overall response rate.

    This includes assessing the reduction in cancer cells and any changes in the patient's condition.

Who can join the trial?

8 criteria

  • Patients must have a type of cancer called **relapsed or refractory CD19-expressing ALL or NHL/CLL**. This means the cancer has come back or hasn't responded to treatment.
  • For all patients, the cancer cells must show **CD19**, a specific marker, which is checked using special tests like **flow cytometry** or **immunohistochemistry**.
  • Patients must be at least **1 year old** and considered fit by their doctor.
  • Patients need to have a certain number of **CD3+ T cells** in their blood, which are important immune cells.
  • Patients older than 16 years must have an **ECOG performance score** of 0-2, which measures daily living abilities. Those 16 or younger need a **Lansky performance score** of more than 50.
  • Patients must not have active infections like **Hepatitis B, Hepatitis C, or HIV**.
  • Women who can have children must have a **negative pregnancy test** before starting the trial.
  • Patients and/or their parents must sign a **consent form** to agree to participate in the trial.

Who cannot join the trial?

9 criteria

  • Patients who have a different type of cancer that is not related to CD19 positive B cell malignancies.
  • Patients who have not experienced a return or worsening of their cancer after treatment, known as relapsed or refractory conditions.
  • Patients who are not able to safely undergo the treatment due to other health conditions.
  • Patients who are pregnant or breastfeeding.
  • Patients who are unable to follow the study procedures or attend required visits.
  • Patients who have received certain treatments recently that might interfere with the study.
  • Patients who have an active infection that could affect their participation.
  • Patients who have a history of severe allergic reactions to similar treatments.
  • Patients who have a condition that affects their immune system, making them more vulnerable to infections.
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Investigated drugs

MB-CART19.1 is a type of adoptive cell therapy used in this clinical trial. It involves modifying a patient's own immune cells, specifically T cells, to better recognize and attack cancer cells that express the CD19 protein. This therapy is being tested for its safety, effectiveness, and the best dose to use in patients with certain types of B cell cancers that have not responded to other treatments or have returned after treatment.

What is already known about the treatment

MB-CART19.1 – This medication is administered through an infusion, where the patient's own modified immune cells are reintroduced into their body. It is currently being studied in clinical trials for its safety, dosage, and effectiveness in treating relapsed or refractory CD19 positive B cell malignancies, such as pediatric and adult acute lymphatic leukemia (ALL) and non-Hodgkin lymphoma (NHL). The main therapeutic use is for patients who have not responded to other treatments. MB-CART19.1 works by modifying the patient's T-cells to better recognize and attack cancer cells expressing the CD19 protein. It falls under the pharmacological classification of adoptive cell therapy, specifically using chimeric antigen receptor (CAR) T-cell technology.

Investigated diseases

  • Pediatric Acute Lymphoblastic Leukemia (ALL)

    This is a type of cancer that affects the blood and bone marrow, characterized by the overproduction of immature white blood cells called lymphoblasts. It primarily occurs in children and progresses rapidly, leading to symptoms such as fatigue, fever, and easy bruising or bleeding. The disease can spread to other parts of the body, including the lymph nodes, liver, and spleen.

  • Aggressive Non-Hodgkin Lymphoma (NHL)

    This is a group of blood cancers that develop in the lymphatic system, characterized by the rapid growth of abnormal lymphocytes. It can occur in both children and adults and may present with symptoms like swollen lymph nodes, fever, and weight loss. The disease can spread quickly to other organs and tissues.

  • Adult Acute Lymphoblastic Leukemia (ALL)

    Similar to its pediatric counterpart, this is a fast-growing cancer of the blood and bone marrow, marked by an excess of immature lymphocytes. It primarily affects adults and can cause symptoms such as fatigue, frequent infections, and bleeding. The disease can spread to other areas of the body, including the central nervous system.

  • Chronic Lymphocytic Leukemia (CLL)

    This is a slow-growing cancer of the blood and bone marrow, characterized by the accumulation of abnormal lymphocytes. It typically affects older adults and may not cause symptoms initially, but can lead to fatigue, swollen lymph nodes, and an increased risk of infections over time. The disease can progress to involve other organs.

  • Refractory/Relapsed B-cell Non-Hodgkin Lymphoma (B-NHL)

    This refers to a type of lymphoma that does not respond to initial treatment or returns after a period of remission. It involves the uncontrolled growth of B-lymphocytes and can present with symptoms such as swollen lymph nodes, fever, and night sweats. The disease can be challenging to manage due to its resistance to standard therapies.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-513334-38-00Protocol codeM-2017-322Estimated enrolment49 patientsSponsorMiltenyi Biomedicine GmbH

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