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Study on Extracellular Vesicles in Hematology Patients Treated with Brexucabtagene Autoleucel and Drug Combination

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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 certain blood-related diseases and the effects of a treatment known as *CAR-T cell therapy*. This therapy involves using specially modified cells to target and fight cancer cells. The study will use several medications, including *Tecartus*, *Abecma*, *Kymriah*, *Breyanzi*, and *Yescarta*. These medications are all forms of *CAR-T cell therapy*, which is a type of treatment that uses the patient's own immune cells, modified in a lab, to attack cancer cells. Another medication, *Gadovist*, will be used as a contrast agent during imaging tests to help visualize the body's internal structures.

The purpose of the study is to understand how tiny particles called *extracellular vesicles* change over time when patients receive *CAR-T cell therapy*. These vesicles are small structures released by cells that can carry signals and materials between cells. The study will also look at a condition called *Immune effector Cell-Associated Neurotoxicity Syndrome (ICANS)*, which can occur during this type of treatment. ICANS is a temporary condition that affects the nervous system and can cause symptoms like confusion or difficulty speaking.

Participants in the study will receive *CAR-T cell therapy* and will be monitored over time to see how their *extracellular vesicles* change before and after treatment. The study will also examine how these changes relate to the presence of *ICANS* and other factors like cytokine levels, which are proteins that help control the immune system. Additionally, the study will explore the relationship between these vesicles and any neurological symptoms or sleep apnea that may occur. Imaging tests, such as *MRI*, will be used to observe any changes in the brain before and after treatment. The study aims to provide a better understanding of how *CAR-T cell therapy* affects the body and to improve the management of side effects like *ICANS*.

The research process

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

  1. Step 1

    Joining the study

    Eligibility is confirmed based on criteria such as age over 18, indication for CAR-T treatment, and social security affiliation.

    Informed consent is obtained, and a consent form is co-signed with the investigator.

  2. Step 2

    Initial assessment

    Initial assessments are conducted to establish baseline health status and to prepare for treatment.

  3. Step 3

    CAR-T cell therapy

    CAR-T cell therapy involves the administration of specific medications through IV infusion.

    Medications include brexucabtagene autoleucel, idecabtagene vicleucel, tisagenlecleucel, lisocabtagene maraleucel, and axicabtagene ciloleucel.

    Each medication is provided as a dispersion for infusion, with specific cell concentrations.

  4. Step 4

    Monitoring and evaluation

    Regular monitoring is conducted to evaluate the characteristics of endothelial extracellular vesicles (EVs) and their changes over time.

    The presence and severity of immune effector cell-associated neurotoxicity syndrome (ICANS) are assessed.

  5. Step 5

    Follow-up assessments

    Further assessments include the quantification and characterization of various EV subtypes before and after CAR-T cell treatment.

    Additional evaluations may involve cognitive assessments and MRI scans, particularly in relation to ICANS.

  6. Step 6

    Completion of study participation

    Participation in the study continues until the estimated end date of November 1, 2027, unless otherwise specified by the study protocol.

Who can join the trial?

4 criteria

  • Patient over 18 years old
  • Patients for whom CAR-T treatment of their disease is indicated. CAR-T treatment is a type of therapy that uses the patient's own immune cells to fight cancer.
  • Patient affiliated to or entitled under a social security scheme. This means the patient should have access to a government or employer-provided health insurance program.
  • Patient has received informed consent to participate in the study and has co-signed a consent form with the investigator. This means the patient understands the study and agrees to take part in it by signing a document with the researcher.
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Investigated drugs

CAR-T Cells are a type of cellular therapy used in this clinical trial. They are specially modified T cells, which are a part of the immune system, designed to better recognize and attack cancer cells. In this study, the focus is on understanding how these cells interact with the body, particularly looking at their effects on the brain and nervous system, which can sometimes lead to a condition known as Immune effector Cell-Associated Neurotoxicity Syndrome (ICANS). The trial aims to observe changes in the body before and after the administration of CAR-T cells to better understand and manage potential side effects.

What is already known about the treatment

CAR-T Cells – CAR-T cells are administered through an intravenous infusion, allowing them to circulate in the bloodstream and target specific cancer cells. Currently, CAR-T cell therapy is a well-established treatment in medical literature, particularly for certain types of blood cancers. The main therapeutic indication for CAR-T cells is in hematology, specifically for treating conditions like leukemia and lymphoma. At the molecular level, CAR-T cells work by genetically modifying a patient's T-cells to express a chimeric antigen receptor (CAR) that can recognize and bind to specific proteins on cancer cells, leading to their destruction. This therapy falls under the pharmacological classification of immunotherapy, as it harnesses the body's immune system to fight cancer.

Investigated diseases

Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) – This condition is a neurological complication that can occur after certain cancer treatments, particularly those involving CAR-T cell therapy. It is characterized by a range of symptoms, including confusion, difficulty speaking, and seizures. The severity of ICANS can vary, with symptoms appearing within days to weeks after treatment. The condition progresses as the immune system's response to the therapy affects the brain, leading to inflammation and other neurological changes. Monitoring and understanding the progression of ICANS is crucial for managing its impact on patients undergoing CAR-T cell therapy.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515328-35-00Protocol code24CH009Estimated enrolment60 patientsSponsorCentre Hospitalier Universitaire De Saint Etienne

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