Actively Recruiting

Age: 18Years +
All Genders
NCT06350994

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

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-09-02

60

Participants Needed

1

Research Sites

120 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • CAR-T cells infusion received within 3 to 5 days before the echocardiography
  • Pre-therapeutic cardiac assessment including echocardiography and ECG before conditioning and CAR-T infusion
  • Patient agrees to participate in research
  • Patient is affiliated with a social security system or beneficiary of state medical insurance help
Not Eligible

You will not qualify if you...

  • Opposition or withdrawal of consent

AI-Screening

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Trial Site Locations

Total: 1 location

1

Critical care medicine department

Paris, France, 75012

Actively Recruiting

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Research Team

J

Jérémie JOFFRE, MD, PhD

CONTACT

H

Hafid AIT-OUFELLA, Professor

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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