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Study on MB-CART2019.1 for Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma Not Eligible for High-Dose Chemotherapy and Stem Cell Transplantation

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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 type of cancer called relapsed/refractory diffuse large B-cell lymphoma (R-R DLBCL). This is a condition where the cancer has returned or has not responded to initial treatment. The trial is comparing a new treatment called MB-CART2019.1 with a standard treatment known as R-GemOx, which includes the medications rituximab, gemcitabine, and oxaliplatin. The purpose of the study is to see if the new treatment can help patients live longer without the disease getting worse.

Participants in the study will receive either the new treatment or the standard treatment. The new treatment, MB-CART2019.1, is given as an infusion, which means it is administered directly into the bloodstream through a vein. The standard treatment, R-GemOx, also involves infusions of the three medications. The study will monitor participants over a period to see how well the treatments work and to check for any side effects.

The study aims to find out if MB-CART2019.1 is more effective than the standard treatment in helping patients with R-R DLBCL who are not eligible for high-dose chemotherapy and stem cell transplantation. Participants will be closely monitored by healthcare professionals throughout the study to ensure their safety and to gather information on the effectiveness of the 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

    Joining the study

    Upon joining the study, participation is confirmed for individuals with relapsed or refractory diffuse large B-cell lymphoma (R-R DLBCL).

    Eligibility is based on specific criteria, including previous treatment history and measurable disease.

  2. Step 2

    Randomization

    Participants are randomly assigned to one of two treatment groups: the MB-CART2019.1 group or the standard of care (SoC) therapy group.

    The SoC therapy includes a combination of rituximab, gemcitabine, and oxaliplatin.

  3. Step 3

    Treatment administration

    For those in the MB-CART2019.1 group, the treatment involves an intravenous infusion of the study drug.

    Participants in the SoC group receive rituximab, gemcitabine, and oxaliplatin through intravenous infusion as per the standard regimen.

  4. Step 4

    Monitoring and evaluation

    Regular monitoring is conducted to assess the response to treatment and any side effects.

    Evaluations include imaging studies and laboratory tests to track disease progression or response.

  5. Step 5

    Follow-up

    Participants are followed up to evaluate long-term outcomes such as event-free survival, progression-free survival, and overall survival.

    The follow-up period extends until the estimated end date of the trial in March 2030.

Who can join the trial?

12 criteria

  • The patient must have a confirmed diagnosis of **diffuse large B cell lymphoma (DLBCL)** or related types, based on the World Health Organization's classification from 2016.
  • The patient must be at least 18 years old.
  • The patient must have **relapsed** (the disease has returned) or **refractory** (the disease did not respond to treatment) disease after the first round of treatment that included a combination of drugs called **chemoimmunotherapy**.
  • The patient must have received a first-line treatment that included an **anthracycline-based regimen** (a type of chemotherapy) and **rituximab** (a medication that targets specific cells).
  • The patient must have a **measurable disease** according to specific criteria, meaning the affected areas must be of a certain size and show up on a special scan called a **positron emission tomography (PET) scan**.
  • The patient must have a life expectancy of more than 3 months for reasons other than the primary disease.
  • The patient must be considered unable to receive **high-dose chemotherapy (HDC)** followed by **autologous stem cell transplantation (ASCT)**, based on the doctor's assessment.
  • The patient must provide a sample of tumor tissue that was collected within the last 2 years (preferably within the last 2 months) for a central review to confirm the DLBCL diagnosis.
  • Men with partners who can become pregnant must agree to use highly effective birth control methods.
  • Women who can become pregnant must agree to use highly effective birth control methods.
  • The patient must have the mental ability and legal capacity to agree to participate in the study.
  • The patient must be able to follow all study-related procedures, take medications as instructed, and attend evaluations, according to the study doctor's opinion.

Who cannot join the trial?

5 criteria

  • Patients who are eligible for high-dose chemotherapy and **autologous stem cell transplantation (ASCT)** cannot participate. **Autologous stem cell transplantation** is a procedure where a patient's own stem cells are used to replace damaged or destroyed bone marrow.
  • Patients who do not have **relapsed/refractory diffuse large B cell lymphoma (R-R DLBCL)** are excluded. **Relapsed/refractory** means the disease has returned or is not responding to treatment.
  • Patients who are not in the age range specified for the study cannot participate.
  • Patients who are not part of the clinical trial groups specified for the study are excluded.
  • Patients who are not considered part of the vulnerable population selected for the study cannot participate.
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Investigated drugs

  • MB-CART2019.1

    is a type of advanced therapy that uses modified immune cells to target and destroy cancer cells. In this trial, it is being tested for its effectiveness and safety in treating patients with a specific type of lymphoma, known as relapsed or refractory diffuse large B-cell lymphoma (R-R DLBCL). This therapy is being compared to standard treatments to see if it can improve patient outcomes.

  • Rituximab

    is a medication that targets specific proteins on the surface of cancer cells, helping the immune system to destroy them. It is commonly used in combination with other drugs to treat certain types of lymphoma, including R-R DLBCL.

  • Gemcitabine

    is a chemotherapy drug that works by interfering with the DNA of cancer cells, preventing them from growing and dividing. It is often used in combination with other medications to treat various types of cancer, including lymphoma.

  • Oxaliplatin

    is another chemotherapy drug that damages the DNA of cancer cells, leading to their death. It is used in combination with other drugs to enhance the treatment of certain cancers, including lymphoma.

What is already known about the treatment

MB-CART2019.1 – This medication is administered through an intravenous infusion and is currently being studied in clinical trials for its effectiveness in treating relapsed or refractory diffuse large B-cell lymphoma (R-R DLBCL). It is not yet widely available in medical practice, as it is still under investigation. The main therapeutic indication for MB-CART2019.1 is for patients with R-R DLBCL who are not eligible for high-dose chemotherapy and autologous stem cell transplantation. The medication works by modifying the patient's own immune cells to better recognize and attack cancer cells. It is classified as a type of CAR T-cell therapy, which is a form of immunotherapy.

Investigated diseases

Relapsed/Refractory Diffuse Large B Cell Lymphoma (R-R DLBCL) – This is a type of non-Hodgkin lymphoma that affects B cells, which are a type of white blood cell. It is characterized by the return or persistence of the disease after initial treatment. The disease typically presents with rapidly growing lymph nodes, often in the neck, armpit, or groin. As it progresses, it can spread to other parts of the body, including the bone marrow, spleen, and liver. Symptoms may include fever, night sweats, and unexplained weight loss. The condition is considered rare and can be challenging to manage due to its aggressive nature.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-506270-13-00Protocol codeM-2020-371Estimated enrolment232 patientsSponsorMiltenyi Biomedicine GmbH

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