Critical care medicine department
Paris, 75012, France
Location status: Recruiting
Location contact
Hafid AIT-OUFELLA, Professor
CONTACT
Jérémie JOFFRE, MD, PhD
CONTACT
NCT Number: NCT06350994
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).
Interested in participating?
Request Info18 year and older
All sexes
Observational
Paris, 75012, France
Location status: Recruiting
Hafid AIT-OUFELLA, Professor
CONTACT
Jérémie JOFFRE, MD, PhD
CONTACT
CAR-T cells (Chimeric Antigen Receptor) represent a new form of immunotherapy, based on the genetic modification of autologous T lymphocytes collected after apheresis, allowing the recognition of a tumor antigen apart from the presentation by the major complex of histocompatibility (MHC). Treatment with CAR-T cells constitutes a major therapeutic advance in patients with refractory hematological malignancies.
Nevertheless, CAR-T cell therapy is often associated with severe complications leading them to the ICU in >25%.
Among the most frequent complications are the risk of infection cytokine release syndrome (CRS)and neurotoxicity. A recent study reported serious acute cardiac events in the days following the administration of CAR-T cells in 6.5% of patients (12/187). In this work, patients did not benefit from systematic early echocardiography, but only in the event of CRS grade ≥2 or symptoms, with a risk of underdiagnosis of asymptomatic forms. Since the vast majority of reported cases are contemporaneous with CRS or sepsis, the imputability of CAR-Ts in this heart disease is debated.
The Cardio CAR-T study aims to investigate a possible early cardiac toxicity of CAR-T cells, screened by transthoracic echocardiography at the patient's bedside, between D3 and D5 after injection of CAR-T cells (period at which the inflammatory complications of this treatment occur in the majority of cases) associated with the description of routine examinations (BNP, Troponin and ECG) and cytokine analyses.
This pilot descriptive study would answer 2 questions:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 5 days and 3 months
Transthoracic bedside echocardiographic evaluation of the LVEF.
Time frame: 5 days and 3 months
Transthoracic bedside echocardiographic evaluation of the LVEF, EKG, biologicals (troponin, BNP).
Time frame: 5 days and 3 months
Multiplex bioassays for immune-inflammatory biomarkers.
Contact information is provided by the study sponsor or research team.
Hafid AIT-OUFELLA, Professor
CONTACT
Jérémie JOFFRE, MD, PhD
CONTACT
Assistance Publique - Hôpitaux de Paris
Other
Acronym: Cardio CAR-T
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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