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A Study Testing the Safety of CD19-Targeted CAR T-Cell Therapy in Children and Young Adults with Relapsed or Refractory B-Cell Cancers

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What is this trial about?

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

This study is looking at two types of cancer that affect certain white blood cells. The first is B-cell precursor ALL, which is a cancer where the bone marrow makes too many immature white blood cells. The second is B-cell Non Hodgkin Lymphoma, which is a cancer that starts in white blood cells called lymphocytes and can affect lymph nodes and other parts of the body. Both of these cancers have either come back after previous treatment or have not responded to treatment. The study will use a treatment called MB-huCART19.1, which is a type of therapy where a patient's own immune cells are collected and modified in a laboratory to better recognize and attack cancer cells that have a specific marker called CD19 on their surface. These modified cells, known as CAR T-cells, are then given back to the patient through intravenous infusion, which means the cells are delivered directly into a vein.

The purpose of this study is to find out the safest dose of these modified cells that can be given to patients and to see how well the treatment works. The study will look at how many patients experience serious side effects within 28 days after receiving the treatment, which will help determine the best dose to use in the next part of the study. The study will also measure how well the treatment works by checking if the cancer responds to the treatment and how long patients remain free from disease.

During the study, patients will first have their own immune cells collected. These cells will then be modified in a laboratory to target the cancer cells. Before receiving the modified cells back, patients may receive chemotherapy to prepare their body for the treatment. After the modified cells are given through an infusion into a vein, patients will be monitored closely for side effects and to see how well the treatment is working. The study will follow patients for up to 12 months to track their progress and see if the cancer comes back. This study is for children and young adults between 1 and 45 years of age who have tried other treatments that did not work or who cannot receive other standard treatments.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and Initial Assessment

    Your medical condition will be confirmed as relapsed or refractory CD19-positive blood cancer, which includes either B-cell precursor acute lymphoblastic leukemia (a type of blood cancer affecting white blood cells) or B-cell Non-Hodgkin Lymphoma (a cancer of the lymphatic system).

    Your doctor will verify that you have measurable disease, meaning either at least one tumor that can be measured or at least 0.1% of cancer cells in your bone marrow.

    Your overall health and ability to perform daily activities will be assessed through a performance score.

    If you are of childbearing potential, you will need to agree to use highly effective birth control methods starting from the first treatment and continuing for 12 months after receiving the last study treatment.

    You will need to agree not to breastfeed for 12 months after receiving the last study treatment.

    You will need to agree not to donate blood or organs after receiving the treatment with huCAR19 T-cells (modified immune cells designed to target cancer cells).

  2. Step 2

    Treatment with MB-huCART19.1

    You will receive MB-huCART19.1, which is a treatment involving modified immune cells called CAR T-cells. These cells are designed to recognize and attack cancer cells that have a protein called CD19 on their surface.

    The treatment will be administered as an intravenous infusion, meaning it will be given directly into your vein.

    The dose you receive will be determined based on the phase of the study and the safety observations from previous patients. The study aims to find the recommended phase 2 dose, which is the safest and most effective amount.

  3. Step 3

    Monitoring for Side Effects (First 28 Days)

    During the first 28 days after receiving the CAR T-cell infusion, you will be closely monitored for any serious side effects called Dose Limiting Toxicity.

    Your medical team will assess your response to the treatment and check for any complications.

  4. Step 4

    Disease Response Assessment at Day 28

    At day 28 after the infusion, your response to treatment will be evaluated.

    If you have B-cell precursor acute lymphoblastic leukemia, your doctor will check for MRD-negative complete remission, which means no cancer cells can be detected even with very sensitive tests.

    Your doctor will also check for B-cell aplasia, which means a very low number of B-cells in your blood (less than 5 B-cells per microliter). This is actually a sign that the CAR T-cells are working, as they target cells with the CD19 protein, which includes both cancer cells and normal B-cells.

  5. Step 5

    Disease Response Assessment at Day 90

    If you have B-cell Non-Hodgkin Lymphoma, your response to treatment will be assessed at day 90 after the infusion.

    Your doctor will determine the overall response rate according to established criteria, which includes complete disappearance of cancer (complete response) or significant reduction in tumor size (partial response).

  6. Step 6

    Monitoring for B-Cell Recovery

    Your medical team will monitor when your normal B-cells begin to recover after treatment.

    B-cell recovery is defined as having at least 10 CD19-positive B-cells per microliter in your blood, or at least 1% CD19-positive B-cells in your bone marrow.

    This recovery will need to be confirmed with a second test performed at least 2 weeks after the first test showing recovery.

  7. Step 7

    Follow-Up at 6 Months

    At 6 months after the CAR T-cell infusion, your medical team will assess several outcomes.

    Your doctor will evaluate event-free survival, which means the time you have lived without the cancer returning or worsening.

    Your overall survival will be documented.

    The medical team will assess whether the cancer has returned (cumulative incidence of relapse).

  8. Step 8

    Follow-Up at 12 Months

    At 12 months after the CAR T-cell infusion, your medical team will perform another comprehensive assessment.

    Your doctor will evaluate event-free survival, which means the time you have lived without the cancer returning or worsening.

    Your overall survival will be documented.

    The medical team will assess whether the cancer has returned (cumulative incidence of relapse).

    This marks the end of the primary study period, though your doctor may continue to monitor your health beyond this point.

Who can join the trial?

10 criteria

  • You must be between 1 and 45 years of age
  • For the first part of the study, the first three patients must be between 12 and 45 years old. After that, patients of any age between 1 and 45 years can join once a specific treatment response is seen in earlier patients
  • You must have a blood cancer that has either come back after treatment (relapsed) or did not respond to treatment (refractory), and your cancer cells must have a protein called CD19 on their surface
  • Your disease must be measurable, meaning doctors can see at least one area of disease or find at least 0.1% of cancer cells called blasts in your bone marrow (the soft tissue inside your bones where blood cells are made)
  • You must have already tried all standard treatments that could potentially cure your disease, or you cannot receive those treatments for medical reasons
  • You must have an adequate performance score, which means you are healthy enough to participate in the study
  • If you are able to have children, you must be willing to use very effective birth control methods from the start of chemotherapy until 12 months after receiving the last study treatment
  • If you are able to breastfeed, you must agree not to breastfeed until 12 months after receiving the last study treatment
  • You must agree not to donate blood or organs after receiving the study treatment
  • You must provide written informed consent, which means you understand the study and agree to participate by signing the required documents

Who cannot join the trial?

5 criteria

  • The source data does not provide specific exclusion criteria (reasons why a patient cannot participate) for this clinical trial
  • Without detailed exclusion criteria information, it is not possible to list the specific conditions or situations that would prevent participation in this study
  • Exclusion criteria typically include things like certain other medical conditions, previous treatments, laboratory test results, or medications that would make it unsafe or inappropriate for someone to join the trial
  • In this case, the trial involves CAR T-cell therapy, which is a treatment where a patient's own immune cells are modified in a laboratory to help fight cancer cells
  • The study focuses on patients with B-cell precursor ALL (a type of blood cancer affecting white blood cells) and B-cell Non Hodgkin Lymphoma (a type of cancer affecting the lymphatic system)
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Investigated drugs

huCAR19 is a type of treatment called CAR T-cell therapy. This is a personalized cancer treatment where a patient's own immune cells (called T-cells) are collected and modified in a laboratory to recognize and attack cancer cells. Specifically, these modified cells are designed to target a protein called CD19 that is found on the surface of certain cancer cells. Once the cells are prepared, they are given back to the patient through an infusion to help fight their cancer. This treatment is being made at the point-of-care, meaning it is prepared closer to where the patient is being treated.

What is already known about the treatment

huCAR19 – This is an experimental CAR T-cell therapy that is genetically modified to target CD19, a protein found on the surface of certain B-cells. The treatment is currently being studied in clinical trials for children and young adults with B-cell precursor acute lymphoblastic leukemia (ALL) and B-cell Non-Hodgkin Lymphoma that has returned after treatment or has not responded to previous therapies. The therapy works by collecting a patient's own immune cells, modifying them in a laboratory to recognize and attack cancer cells carrying the CD19 protein, and then infusing these modified cells back into the patient's body where they can seek out and destroy the cancerous B-cells. This medication belongs to the class of immunotherapies known as chimeric antigen receptor T-cell therapies, which use the body's own immune system to fight cancer.

Investigated diseases

  • B-cell precursor acute lymphoblastic leukemia

    This is a type of blood cancer that affects the white blood cells called B-cell lymphocytes. The disease begins in the bone marrow where blood cells are made. Abnormal immature B-cells multiply rapidly and crowd out healthy blood cells. These cancer cells cannot function properly to fight infections. The disease progresses quickly as the abnormal cells accumulate in the blood and bone marrow. Without intervention, the cancer cells can spread to other organs including the lymph nodes, liver, and spleen.

  • B-cell non-Hodgkin lymphoma

    This is a cancer that develops in the lymphatic system, specifically affecting B-cells which are a type of white blood cell. The disease occurs when B-cells grow abnormally and uncontrollably, forming tumors in the lymph nodes or other organs. These cancerous cells can accumulate in various parts of the body including the lymph nodes, spleen, bone marrow, and other organs. The disease can progress at different rates depending on the specific subtype. As the cancer advances, the abnormal cells interfere with the normal function of the immune system. The cancerous B-cells can spread through the lymphatic system to different areas of the body.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-507597-40-00Protocol codeSP_MB21PACEstimated enrolment18 patientsSponsorPrincess Maxima Center For Pediatric Oncology

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