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Long-Term Safety Study of MB-CART19.1, MB-CART20.1, and Zamtocabtagene Autoleucel for Patients with Advanced Melanoma or 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 focuses on the long-term follow-up of patients who have been treated with Miltenyi cell and gene therapies. The study involves patients with certain types of cancer, including unresectable stage III or IV melanoma, and relapsed or refractory CD19 positive B cell malignancies such as adult acute lymphoblastic leukemia (ALL), adult non-Hodgkin lymphoma (NHL), and chronic lymphocytic leukemia (CLL). It also includes pediatric acute lymphoblastic leukemia and aggressive non-Hodgkin lymphoma. Additionally, the study looks at relapsed or refractory CD20 positive B-cell non-Hodgkin’s lymphoma. The treatments being studied are known as MB-CART19.1, MB-CART20.1, and MB-CART2019.1, which are types of cell therapies that use the patient's own T cells, modified to target specific cancer cells.

The purpose of this study is to evaluate the long-term safety of these therapies. Patients who have received these treatments will be monitored over time to check for any late-onset side effects or serious health events. This includes looking for any new or returning cancers, serious infections, or other significant health issues. The study will also track the presence of certain cells in the blood, such as B and T lymphocytes, and other health indicators like height and weight in children. The presence of any remaining modified cells from the therapy will also be checked.

Participants in this study will have regular follow-up visits where their health will be assessed. This includes checking for any signs of the cancer returning or progressing and monitoring overall survival rates. The study aims to ensure that the treatments are safe in the long term and to gather important information that can help improve future therapies. The study is expected to continue until the end of 2040, providing valuable insights into the long-term effects of these innovative treatments.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment

    The patient must have received Miltenyi CAR T cell therapy at least 12 months before joining the follow-up study.

    Informed consent is required before participation.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to evaluate the patient's current health status.

    This includes checking for any late-onset adverse reactions or serious events related to the previous therapy.

  3. Step 3

    Regular monitoring

    The patient will undergo regular monitoring to track any adverse reactions, serious events, or disease progression.

    Monitoring includes checking B- and T-lymphocyte counts and, for pediatric patients, assessing growth and development.

  4. Step 4

    Specific tests

    Tests will be conducted to detect any replication-competent lentivirus. If two consecutive years of tests are negative, further testing will be stopped.

    Transgene levels will also be monitored, with similar criteria for stopping further tests if results are negative for two consecutive years.

  5. Step 5

    Long-term follow-up

    The follow-up period is designed to last until December 31, 2040.

    The main objective is to evaluate the long-term safety of the therapy, including any new or secondary health issues.

Who can join the trial?

5 criteria

  • The patient must have received treatment with a Miltenyi CAR T cell therapy at least 12 months before joining the long-term follow-up. CAR T cell therapy is a type of treatment where a patient's own immune cells are changed in a lab to better fight cancer.
  • The patient must have given their agreement to participate in the study, known as informed consent. This means they understand the study and agree to be part of it.
  • Both male and female patients can participate.
  • The study includes patients from different age groups, including children and adults.
  • The study is open to patients who might be considered vulnerable, meaning they may need extra care or protection.

Who cannot join the trial?

8 criteria

  • Patients with other types of cancer that are not specified in the study.
  • Patients who have not experienced a return or worsening of their cancer after previous treatments.
  • Patients who do not have the specific markers, like CD19 or CD20, on their cancer cells.
  • Patients who are not in the age range specified for the study.
  • Patients who are not able to understand or agree to the study requirements.
  • Patients who are pregnant or breastfeeding.
  • Patients with certain medical conditions that might interfere with the study treatment.
  • Patients who are currently participating in another clinical trial.
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Investigated drugs

Miltenyi CAR T Cell Therapy is a type of treatment that uses the patient's own immune cells, which are modified in the laboratory to better recognize and attack cancer cells. This therapy involves collecting T cells from the patient, altering them to produce special structures called chimeric antigen receptors (CARs) on their surface, and then infusing them back into the patient. The goal of this therapy is to enhance the body's natural ability to fight cancer.

What is already known about the treatment

Miltenyi CAR T Cell Therapy – This therapy is administered through an intravenous infusion, where modified T cells are introduced into the patient's bloodstream. It is currently being studied in clinical trials, focusing on its long-term safety and effectiveness. The main therapeutic indications include treating unresectable stage III or IV melanoma and various relapsed or refractory CD19 and CD20 positive B cell malignancies, such as adult and pediatric acute lymphatic leukemia and non-Hodgkin's lymphoma. The mechanism of action involves genetically engineering T cells to express chimeric antigen receptors (CARs) that specifically target and destroy cancer cells. This therapy falls under the pharmacological classification of cell and gene therapies, representing a novel approach in cancer treatment.

Investigated diseases

  • Unresectable Stage III or IV Melanoma

    This is a type of skin cancer that has advanced to a stage where it cannot be surgically removed. It typically spreads to other parts of the body, including lymph nodes and distant organs. The disease progresses by growing deeper into the skin and potentially affecting other tissues. Patients may experience changes in existing moles or the appearance of new skin lesions. As the disease advances, it can lead to symptoms such as fatigue, weight loss, and pain.

  • Relapsed or Refractory CD19 Positive B Cell Malignancies (Adult Acute Lymphoblastic Leukemia, Adult Non-Hodgkin Lymphoma/Chronic Lymphatic Leukemia)

    These are blood cancers that have either returned after treatment or have not responded to initial therapies. They involve the abnormal growth of B cells, a type of white blood cell. The disease can cause symptoms like fatigue, fever, and swollen lymph nodes. As it progresses, it may lead to anemia, infections, and bleeding issues. The malignancies can affect the bone marrow, blood, and lymphatic system.

  • Relapsed or Refractory CD19 Positive B Cell Malignancies (Pediatric Acute Lymphoblastic Leukemia, Aggressive Non-Hodgkin Lymphoma)

    These are aggressive blood cancers in children that have returned or are resistant to treatment. They involve the rapid proliferation of abnormal B cells. Symptoms may include fever, bone pain, and swollen lymph nodes. The disease can progress quickly, affecting the bone marrow and other organs. It may lead to complications such as infections and bleeding.

  • Relapsed or Refractory CD20 Positive B-Cell Non-Hodgkin’s Lymphoma

    This is a type of lymphoma that has returned after treatment or is resistant to therapy. It involves the abnormal growth of B cells that express the CD20 protein. The disease can cause symptoms like swollen lymph nodes, fever, and night sweats. As it progresses, it may affect the bone marrow and other organs. Patients may experience fatigue and weight loss.

  • Relapsed or Refractory B Cell Non-Hodgkin’s Lymphoma

    This is a form of lymphoma that has either returned after treatment or has not responded to initial therapies. It involves the uncontrolled growth of B cells, a type of white blood cell. Symptoms can include swollen lymph nodes, fever, and unexplained weight loss. The disease can progress to affect the bone marrow and other parts of the body. Patients may experience fatigue and increased susceptibility to infections.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2022-501648-14-00Protocol codeM-2022-393Estimated enrolment40 patientsSponsorMiltenyi Biomedicine GmbH

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