Active not recruitingPHASE1INTERVENTIONAL

MB-CART19.1 r/r CD19+ B-cell Malignancies (BCM)

This study, called MB-CART19.1, is exploring a new treatment for certain blood cancers, specifically types of lymphoma and leukaemia, where previous treatments haven't worked or the cancer has returned. The main goal is to find out if the treatment is safe and what the right dose should be for different groups of patients, including adults and children. Researchers will carefully watch how patients respond to different doses of MB-CART19.1. It's an early-stage study, meaning it's one of the first times this treatment is being tested in humans. Around 48 patients in total will take part across three different groups based on their specific type of cancer.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

Miltenyi Biomedicine GmbH

Enrolment target

Start

26 Nov 2018

Estimated completion

01 Jun 2026

Acute Lymphoblastic Leukemia Recurrent B-cell Lymphoma Recurrent B-cell Lymphoma Refractory Chronic Lymphocytic Leukemia Recurrent Chronic Lymphocytic Leukemia Refractory

What is this study about?

This study is looking into a new treatment called MB-CART19.1 for a group of blood cancers, including certain types of leukaemia (Acute Lymphoblastic Leukaemia and Chronic Lymphocytic Leukaemia) and lymphoma (B-cell Lymphoma). These are cancers that have either come back after treatment or haven't responded to standard therapies. The trial is open to both adults and children.

The main purpose of this early-stage study is to see how safe the MB-CART19.1 treatment is and to work out the best dose. Because this is a very new treatment, careful steps are taken to slowly increase the dose and monitor patients closely to make sure it's as safe as possible. Patients will be divided into three groups based on their specific cancer type, and the researchers will investigate the safety and dose for each group.

Over the course of the study, about 48 patients will take part. The researchers will start with a low dose and gradually increase it in small steps if it's shown to be safe. They will be looking for any significant side effects that might occur with certain doses. This careful approach helps them find a dose that is manageable for patients while still potentially being effective.

Key takeaways

This is an early-stage study testing a new treatment, MB-CART19.1, for certain blood cancers.
The main goals are to check the treatment's safety and find the right dose for patients.
It's for adults and children with specific types of leukaemia and lymphoma that have returned or not responded to other treatments.
Patients' cancer cells must have a marker called CD19 to be eligible.
You will be closely monitored throughout the study to ensure safety.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To be considered for this study, you or your child would need to have certain types of blood cancer (like specific kinds of leukaemia or B-cell lymphoma) that have either returned or not responded to previous treatments. Importantly, your cancer cells must show a specific marker called CD19.

You would need to be at least one year old. Doctors will also check your overall health, including your blood count and other health markers, to make sure you are well enough to take part. For women who could become pregnant, a negative pregnancy test is needed. There are also specific criteria depending on your exact cancer diagnosis, such as how your leukaemia has responded to past treatments or if you've had a stem cell transplant.

There are some reasons why you might not be able to join, such as having certain infections like Hepatitis B, Hepatitis C, or HIV. Your doctor will carefully review all your medical information to see if this study is a suitable option for you.

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.

Do I have a type of leukaemia or lymphoma that has come back or not responded to other treatments?
Do my cancer cells have the CD19 marker?
Am I at least one year old?
Am I generally well enough, based on my doctor's assessment?
Do I understand and agree to the study requirements?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the main part of the treatment involves receiving the MB-CART19.1. Before this, you will have several assessments, including blood tests and scans, to check your health and the status of your cancer. The treatment involves a careful process where you will receive the MB-CART19.1, and then you will be closely monitored, especially during the first four weeks after treatment, to see how your body reacts and to check for any side effects.

Due to the nature of this early-stage study, there will be frequent hospital visits and tests. The research team will track your progress over time, and you will have follow-up appointments to monitor your health. The total duration of your participation in the study will depend on how you respond to the treatment and the study's monitoring schedule, but it involves ongoing checks after the initial treatment.

Potential risks and benefits

Participating in a study like this means you might get access to a new treatment that isn't widely available yet, which could potentially help if other treatments haven't worked for your cancer. However, as it's an early-stage study, the full benefits are not yet known. There are also potential risks involved, as with any new treatment. You might experience side effects, some of which could be serious, and the research team will explain these to you in detail. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (9)

Charité - University clinic, pediatric clinic with focus on oncology and hematology
Verified postcode
Berlin, Germany
Universitätsklinikum Erlangen
Verified postcode
Erlangen, Germany
University medicine Goettingen, Clinic of hematology and medical oncology
Verified postcode
Göttingen, Germany
Children's Hospital of Dr. von Hauner by Ludwig-Maximilian University
Verified postcode
Munich, Germany
Universitätsklinikum Münster - Klink für Kinderheilkunde und Jugendmedizin / Pädiatrische Hämatologie und Onkologie
Verified postcode
Münster, Germany
Universitätsklinikum Münster - Medizinische Klinik A / KMT Zentrum
Verified postcode
Münster, Germany
Tuebingen University clinic, medical university clinic for internal medicine
Verified postcode
Tübingen, Germany
University clinic for children and youth medicine
Verified postcode
Tübingen, Germany
University clinic, pediatric hematology and oncology
Verified postcode
Würzburg, Germany

Common questions

What is MB-CART19.1?

It's a new, investigational treatment being tested for certain blood cancers that haven't responded to previous treatments or have come back.

Why is this study being done?

The main reason is to find out if MB-CART19.1 is safe and to determine the best dose to use for different types of blood cancer in adults and children.

Who can take part in this study?

Patients with specific types of leukaemia or lymphoma that have returned or not responded to other treatments, and whose cancer cells show a marker called CD19. You must also meet other health criteria and be at least one year old.

What will happen if I join the study?

You will receive the MB-CART19.1 treatment and be carefully monitored with blood tests and other checks, especially in the weeks following the treatment, to track your progress and look for side effects.

Can I stop participating in the study at any time?

Yes, you are completely free to withdraw from the study at any point, and this will not affect your ongoing medical care.