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

Sponsor
Assistance Publique - Hôpitaux de Paris
Study ID
NCT06350994
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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).

Key Dates

First listed
Apr 8, 2024
Start date
Nov 7, 2024
Status verified
Aug 2025
Primary completion
Dec 31, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
60 participants (estimated)

Arms

  • Arm: Cardio CAR-T
    Transthoracic bedside echocardiography

Primary Outcome Measure

Estimation of the incidence of possible early CAR-T cells infusion-induced cardiotoxicity [ Time Frame: 5 days and 3 months ]

Central Contacts

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