Not recruitingRare disease

Study on the Safety and Effectiveness of MB-CART2019.1 for Patients with Relapsed or Refractory Diffuse Large B Cell Lymphoma

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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 diffuse large B cell lymphoma (DLBCL), specifically in patients whose cancer has returned or has not responded to previous treatments. The study will use a treatment called MB-CART2019.1, which involves genetically engineered cells designed to target and destroy cancer cells. These cells are modified to recognize specific proteins on the surface of cancer cells, known as CD19 and CD20, and are administered to patients through an intravenous infusion.

The purpose of the study is to evaluate the effectiveness of MB-CART2019.1 in treating DLBCL. Participants will first receive a preparatory treatment to reduce the number of existing immune cells, known as a conditioning lymphodepletion regimen, before receiving the MB-CART2019.1 infusion. The study will monitor the participants' response to the treatment over time, assessing how well the cancer responds and any changes in the participants' health. Some participants may receive a placebo as part of the study to compare the effects of the treatment.

Throughout the study, participants will undergo regular health assessments, including imaging tests like MRI to track the progress of the treatment. The study aims to determine the overall response rate, which includes both partial and complete responses to the treatment. Additionally, the study will evaluate the duration of the response, progression-free survival, and overall survival, as well as monitor any side effects or adverse events that may occur. The study is expected to continue until 2027, with recruitment starting in 2024.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Enrollment
Upon joining the study, eligibility is confirmed based on specific criteria related to the condition known as relapsed/refractory diffuse large B cell lymphoma.
A series of tests and assessments are conducted to ensure the participant meets all necessary health requirements.
Step 2
Pre-treatment assessment
Before starting the treatment, a comprehensive health evaluation is performed. This includes imaging tests and laboratory assessments to establish a baseline for monitoring progress.
Step 3
Conditioning treatment
Participants receive a conditioning treatment to prepare the body for the main therapy. This involves the administration of cyclophosphamide and fludarabine through intravenous infusion.
The conditioning phase lasts for a few days, with specific dosages determined by the medical team.
Step 4
Main treatment
The main treatment involves the infusion of genetically engineered cells known as MB-CART2019.1. These cells are designed to target and attack the lymphoma cells.
This infusion is administered once, following the completion of the conditioning treatment.
Step 5
Post-treatment monitoring
After the main treatment, participants are closely monitored for any side effects or reactions. This includes regular health check-ups and laboratory tests.
The monitoring phase is crucial to assess the treatment's effectiveness and manage any potential adverse effects.
Step 6
Follow-up assessments
Participants undergo periodic follow-up assessments to evaluate the long-term effects of the treatment. These assessments occur at specified intervals over several months.
The focus is on measuring the response to treatment and overall health status.

Who can join the trial?

17 criteria

Must have a confirmed diagnosis of a type of lymphoma called diffuse large B cell lymphoma (DLBCL) or a related subtype.
The disease must have returned or not responded after trying at least two different treatments, including specific drugs like rituximab and anthracycline.
Must be 18 years of age or older.
Must have a good general health status, as measured by a scale called the Eastern Cooperative Oncology Group (ECOG) performance status, which should be 0 or 1. A score of 2 is allowed if it's due to DLBCL.
Must have measurable disease according to specific criteria used for assessing lymphoma.
Must have a sample of the tumor available from the most recent relapse, or be willing to undergo a biopsy if needed.
No signs of lymphoma in the central nervous system, unless part of a specific group in the study.
If there is a history of a stroke, it must have occurred more than 12 months before a procedure called leukapheresis, and any neurological issues must be stable.
Must have a kidney function test result called creatinine clearance greater than 60 mL/min.
Must have a heart function test result called cardiac ejection fraction of 45% or higher.
Must have a resting oxygen level greater than 90% on room air.
Must have liver function tests within certain limits, except for a condition called Gilbert's syndrome.
Must have a certain level of white blood cells, called absolute neutrophil count, greater than 1000/µL.
Must have a certain level of another type of white blood cells, called absolute lymphocyte count, greater than 100/µL.
Must have a platelet count greater than 50,000/µL.
Must have an estimated life expectancy of more than 3 months, not counting the primary disease.
If able to have children, must agree to use birth control during the study and follow-up period.

Who cannot join the trial?

5 criteria

Patients who have not failed at least two lines of therapy for their condition.
Patients who do not have relapsed or refractory diffuse large B cell lymphoma, which means their lymphoma has not returned or is not resistant to treatment.
Patients who are not within the specified age range for the study.
Patients who are not part of the clinical trial group being studied.
Patients who are not considered part of the vulnerable population selected for the study.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

KBC Zagreb
Responsive
Zagreb, Croatia
University Of Debrecen
Verified
Debrecen, Hungary

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Investigated drugs

MB-CART2019.1 is a type of therapy that uses genetically engineered cells from the patient's own body. These cells are modified to express specific receptors that target and attack cancer cells, specifically those associated with diffuse large B cell lymphoma. This therapy is designed for patients whose cancer has not responded to at least two previous treatments. The goal is to improve the patient's response to treatment by using these specially engineered cells to fight the cancer more effectively.

What is already known about the treatment

MB-CART2019.1 – This medication is administered through an infusion of genetically engineered autologous cells, specifically designed to target cancer cells. It is currently being studied in clinical trials for its effectiveness in treating relapsed or refractory diffuse large B cell lymphoma, a type of blood cancer. The main therapeutic indication is for patients who have not responded to at least two previous treatments. The mechanism of action involves the use of chimeric antigen receptors (CARs) that are engineered to recognize and bind to specific proteins, CD20 and CD19, on the surface of cancer cells, leading to their destruction. This medication falls under the pharmacological classification of CAR T-cell therapies, which are a form of immunotherapy.

Investigated diseases

Diffuse Large B-Cell Lymphoma (DLBCL) – This is a type of non-Hodgkin lymphoma that originates in the B cells, which are a type of white blood cell. It is characterized by rapidly growing tumors in the lymph nodes, spleen, liver, or other organs. The disease can progress quickly, often requiring prompt treatment. Symptoms may include swollen lymph nodes, fever, night sweats, and weight loss. Relapsed or refractory DLBCL refers to cases where the disease returns after treatment or does not respond to standard therapies.