NCT06350994 Early Assessment of Cardiac Function After Treatment With CAR-T Cells
| NCT ID | NCT06350994 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Car T- Cell |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-11-07 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2024-11-07 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * CAR-T cells infusion received within 3 to 5 days before the echocardiography * Pre-therapeutic cardiac assessment (in accordance with the recommendations and standard care protocol in force in the hematology department of Saint-Antoine Hospital): Echocardiography and EKG before conditioning and infusion of CAR -T cells, * Not opposed to participating in research. * Patient affiliated to a social security system or beneficiary of the "state medical insurance help" (namely aide médicale d'état). Exclusion Criteria: * Opposition or consent withdrawal
Contact & Investigator
Jérémie JOFFRE
PRINCIPAL INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Frequently Asked Questions
Who can join the NCT06350994 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Car T- Cell. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06350994 currently recruiting?
Yes, NCT06350994 is actively recruiting participants. Contact the research team at Jeremie.joffre@aphp.fr for enrollment information.
Where is the NCT06350994 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT06350994 clinical trial?
NCT06350994 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Jérémie JOFFRE at Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 60 participants.