RecruitingNCT06350994

Early Assessment of Cardiac Function After Treatment With CAR-T Cells


Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

60 participants

Start Date

Nov 7, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

CAR-T cells (Chimeric Antigen Receptor) are a new immunotherapy, based on the genetic modification of autologous T lymphocytes. CAR-T cell therapy is not devoid of complications. Among the most frequent complications are the risk of infection, cytokine release syndrome (CRS) and neurotoxicity. Nevertheless, some authors have reported serious acute cardiac events in a limited number of patients, often contemporaneous with CRS or sepsis, questioning the imputability of CAR-T cells in this heart disease. This study aims to estimate the incidence of a possible early cardiotoxicity associated with CAR-T cells. The main endpoint will be the change in cardiac function (LVEF: left ventricular ejection fraction) assessed by ultrasound between the pre CAR-T assessment and the early post CAR-T ultrasound (D3-D5).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study uses heart ultrasounds (echocardiograms) to monitor cardiac function early after patients receive CAR-T cell therapy — a form of immunotherapy — to detect potential heart side effects quickly. **You may be eligible if...** - You received CAR-T cell infusion within the past 3 to 5 days - You had a baseline heart assessment (echocardiogram and EKG) before receiving CAR-T - You are affiliated with a social security system in France or covered by state medical insurance - You have not objected to participating in research **You may NOT be eligible if...** - You declined to participate or withdrew consent - You did not have a pre-treatment heart assessment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.


Locations(1)

Critical care medicine department

Paris, France

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06350994


Related Trials