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

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What is this study about?

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*.

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 initial assessment

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

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 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 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 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 Study?

  • 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.

Who Cannot Join the Study?

Where you can join this trial?

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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
01.09.2024

Trial locations

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.

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 ID:
2024-515328-35-00
Protocol code:
24CH009
Trial Phase:
Therapeutic confirmatory (Phase III)

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