Study on the Safety and Effectiveness of MB-CART2019.1, Fludarabine, and Cyclophosphamide in Children with Relapsed or Refractory B Cell Neoplasms

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What is this study about?

This clinical trial is focused on studying a treatment for children and adolescents with a type of cancer called mature B-cell neoplasms. These are cancers that affect certain white blood cells and can be difficult to treat, especially if they come back after initial treatment or do not respond to the first treatment. The study is testing a new treatment called MB-CART2019.1, which is a type of cell therapy. This therapy involves using a special technique to modify the patient’s own immune cells to help them fight the cancer more effectively.

The purpose of the study is to determine how safe MB-CART2019.1 is and how well it works in treating these cancers. The study will also use other medications, including fludarabine, cyclophosphamide, and tocilizumab, which are given to help prepare the body for the cell therapy or to manage side effects. Participants will receive these treatments through an intravenous infusion, which means the medicine is given directly into a vein.

During the study, participants will receive the treatment and be monitored closely to see how their cancer responds and to check for any side effects. The study will take place over several months, with regular check-ups to assess the effectiveness of the treatment and the health of the participants. The goal is to find out if this new approach can provide a better outcome for children and adolescents with these challenging types of cancer.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and performing necessary tests to ensure adequate organ function and overall health status.

2 pre-treatment preparation

Before starting the main treatment, a preparation phase involves the administration of two medications: fludarabine and cyclophosphamide. These are given through an intravenous administration to prepare the body for the main treatment. The exact dosage and frequency are determined by the medical team based on individual needs.

3 main treatment

The main treatment involves the infusion of MB-CART2019.1, a specialized therapy designed to target B-cell neoplasms. This is administered intravenously. The goal is to assess the safety and effectiveness of this treatment in managing the condition.

4 monitoring and follow-up

After the main treatment, regular monitoring is conducted to observe the body’s response. This includes checking for any side effects and assessing the effectiveness of the treatment. Follow-up visits are scheduled at specific intervals, such as Day 28, Week 8, Week 12, Week 24, Week 52, and Week 78, to evaluate progress and make any necessary adjustments.

5 supportive care

Throughout the trial, supportive care may be provided as needed. This can include the use of tocilizumab to manage certain side effects, as well as other medications or therapies to support overall health and well-being.

6 long-term follow-up

The study includes a long-term follow-up period to monitor the lasting effects of the treatment. This involves periodic assessments and may continue for several years to ensure the safety and effectiveness of the therapy over time.

Who Can Join the Study?

The patient must be able to give consent or have a guardian who can provide consent before any study procedures begin.
The patient must have a confirmed diagnosis of a specific type of B-cell cancer, such as Burkitt lymphoma or diffuse large B-cell lymphoma.
The patient must have B-cell cancer that has returned after one or more treatments or did not respond to the first treatment. They must have received standard chemotherapy that includes certain drugs.
The patient must be a child or teenager between 6 months and less than 18 years old.
The patient must weigh at least 6 kilograms (about 13 pounds).
The patient must have a measurable disease, meaning the cancer can be seen and measured using specific criteria.
Tissue samples from the patient must be available for review to confirm the diagnosis.
The patient must have a performance status score of 60 or higher, which measures their ability to perform daily activities.
The patient must have adequate bone marrow function, which includes having enough white blood cells, platelets, and hemoglobin.
The patient must have adequate organ function, including kidney, liver, and lung function.
Female patients who can have children must agree to take pregnancy tests before receiving the study treatment.
If the patient is sexually active, they must agree to use effective birth control methods during the study and for 12 months after receiving the study treatment.

Who Cannot Join the Study?

Patients who have not experienced a return of their disease after previous treatments cannot participate.
Patients who have not tried at least one other treatment before cannot participate.
Patients with a type of disease that does not respond to initial treatment cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are not part of the specified gender groups for the study cannot participate.
Patients who are not considered part of a vulnerable population cannot participate.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Institut Gustave Roussy	Villejuif	France

Other Sites

Site Name	City	Country
Fondazione IRCCS San Gerardo Dei Tintori	Monza	Italy
Prinses Maxima Centrum voor Kinderoncologie B.V.	Utrecht	The Netherlands
Hopital Beaujon	Clichy	France
Ospedale Pediatrico Bambino Gesu’	Rome	Italy
Ugdajivuxavzpqeuclrcj Mhwqkdug Apw	Munster	Germany

Trial status

Country	Status	Recruitment Start
France	Recruiting	02.06.2025
Germany	Not yet recruiting	02.06.2025
Italy	Recruiting	02.06.2025
The Netherlands	Not yet recruiting	02.06.2025

Trial locations

Investigated drugs:

MB-CART2019.1 is a type of therapy used in this clinical trial. It is designed for children with certain types of B-cell cancers that have returned or did not respond to previous treatments. This therapy involves modifying the patient’s own immune cells to better recognize and attack cancer cells. The main goal of using MB-CART2019.1 is to evaluate its safety and effectiveness in treating these difficult cases of cancer.

Investigated diseases:

Mature B Cell Neoplasms – These are a group of cancers that originate from B cells, which are a type of white blood cell responsible for producing antibodies. In relapsed or refractory cases, the disease returns or does not respond to initial treatment. The progression involves the uncontrolled growth of abnormal B cells, which can accumulate in lymph nodes, bone marrow, or other organs. This can lead to symptoms such as swollen lymph nodes, fatigue, fever, and weight loss. The disease can vary in its rate of progression, with some forms being more aggressive than others.

Trial ID:

2023-506348-17-00

Protocol code:

M-2021-389

NCT ID:

NCT06508951

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Safety and Effectiveness of MB-CART2019.1, Fludarabine, and Cyclophosphamide in Children with Relapsed or Refractory B Cell Neoplasms

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?