AuthorisedTherapeutic exploratory (Phase II)Interventional

A multi-center single arm Phase II study to evaluate the safety and efficacy of genetically engineered autologous cells expressing anti-CD20 and anti-CD19 specific chimeric antigen receptor in subjects with relapsed and/or refractory diffuse large B cell lymphoma

This research trial is testing a new treatment called MB-CART2019.1 for adults with a type of blood cancer called diffuse large B-cell lymphoma. This is for patients whose cancer has either returned after initial treatment or hasn't responded to previous therapies. The study is in Phase II, meaning it's focusing on understanding how safe the treatment is and how well it works. The treatment uses the patient's own specially modified immune cells to fight the cancer. Researchers will be looking at how many patients respond to the treatment and for how long, as well as checking for any side effects.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Miltenyi Biomedicine GmbH

Enrolment target

Start

21 Jun 2024

Relapsed/refractory diffuse large B cell lymphoma (R-R DLBCL)

What is this study about?

This study is designed to explore a new way to treat a type of blood cancer called diffuse large B-cell lymphoma. This particular study is for people whose cancer has either come back after treatment or hasn't improved with other treatments. It's called MB-CART2019.1 and it's a type of 'cell therapy'. This means doctors will take some of your own immune cells, called T-cells, and send them to a lab. There, they'll be specially modified to better recognise and fight the cancer cells.

Once these cells are ready, they're given back to you through a drip. They are designed to target specific markers, called CD19 and CD20, on the cancer cells to help your body fight the disease. The main goal of this study is to see how many people respond to this new treatment and how long that response lasts. Researchers also want to find out about any side effects and how they can be managed.

This is a 'Phase II' study, which means it builds on earlier research that showed some promise. The focus now is on getting more information about how well the treatment works and its safety in a larger group of people. This information is crucial for deciding if this new treatment could be a good option for future patients.

Key takeaways

This study evaluates a new cell therapy (MB-CART2019.1) for specific lymphoma patients.
It's for people whose diffuse large B-cell lymphoma has returned or hasn't responded to other treatments.
The therapy uses your own modified immune cells to fight the cancer.
Researchers will check how well the treatment works and any potential side effects.
This is a Phase II study, focusing on safety and effectiveness.
Your participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, participants must be adults, aged 18 years or older. Both men and women can take part.

Beyond age and sex, there will be specific medical requirements that your doctor will check. These might include details about your specific type of lymphoma and how well your other body systems (like your heart, kidneys, and liver) are working. You will also need to meet certain criteria related to your previous treatments and your general health condition.

It's important to remember that these are just general guidelines. A medical team will carefully review your health records and conduct tests to decide if this study is the right fit for you. They will ensure it's safe for you to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have diffuse large B-cell lymphoma that has come back or not responded to past treatments?
Are you able to attend regular hospital visits and follow-up appointments?
Are you willing to undergo blood tests and other medical procedures as part of the study?
Are you generally well enough to participate in a clinical trial?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve several steps over a period. Initially, you would undergo a series of tests to confirm your eligibility. If you qualify, doctors would collect some of your blood to create the special MB-CART2019.1 cells. This process can take several weeks.

Before you receive the MB-CART2019.1 cells, you might be given other medications like chemotherapy (such as cyclophosphamide and fludarabine) to prepare your body. You would then receive the MB-CART2019.1 treatment through an intravenous drip, similar to a blood transfusion. Following the treatment, you would be closely monitored in the hospital for some time to check for any immediate side effects.

After leaving the hospital, you would have regular follow-up appointments, blood tests, and scans over many months, and possibly years. These appointments help the research team understand how well the treatment is working and to monitor your health. You might also receive other supportive medications like paracetamol or levetiracetam as part of your care within the trial. The total duration of your participation would involve the treatment period and a long-term follow-up to track your health and the treatment's effects.

Potential risks and benefits

Like all treatments, particularly new ones, there are potential benefits and risks to consider. The potential benefit is that this new cell therapy could be an effective treatment for your lymphoma, especially if other treatments haven't worked or have stopped working. However, potential risks include side effects from the treatment, which can range from mild to serious, such as fever, headaches, or more significant immune reactions. The study team will carefully monitor you for these. It's very important to remember that participating in any clinical trial is always voluntary, and you are free to withdraw from the study at any time without affecting your standard medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Hungary
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Unverified
Croatia

Common questions

What is diffuse large B-cell lymphoma?

It's a fast-growing type of cancer that affects a specific kind of white blood cell, which are part of your immune system.

What does 'relapsed and/or refractory' mean?

Relapsed means the cancer has come back after treatment. Refractory means the cancer hasn't responded to previous treatments.

What is MB-CART2019.1?

It's a new type of therapy where your own immune cells are specially modified in a lab to find and fight your cancer.

What will doctors be looking for in this study?

They want to see how many people respond to the treatment, how long the response lasts, and what kind of side effects might occur.

Is this a new type of treatment?

Yes, it's an investigational treatment being tested in a clinical trial to learn more about its safety and effectiveness.