Early heart function check after CAR-T treatment
Early Assessment of Cardiac Function After Treatment With CAR-T Cells
Assistance Publique - Hôpitaux de Paris · NCT06350994
We will test whether people treated with CAR‑T cells for blood cancers have early changes in heart function by doing an ultrasound and blood tests 3–5 days after infusion.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris (other) |
| Drugs / interventions | CAR-T, Chimeric Antigen Receptor, immunotherapy |
| Locations | 1 site (Paris) |
| Trial ID | NCT06350994 on ClinicalTrials.gov |
What this trial studies
This observational study screens patients who receive CAR‑T cell therapy for early cardiac dysfunction using bedside transthoracic echocardiography between days 3 and 5 after infusion. The primary outcome is the change in left ventricular ejection fraction (LVEF) from the pre‑CAR‑T baseline to the early post‑infusion echocardiogram, and routine biomarkers (BNP, troponin) and ECGs are also recorded. Eligible participants are those with a pre‑therapeutic cardiac assessment who receive CAR‑T treatment at the participating center. The aim is to estimate the incidence of early cardiotoxicity and to detect asymptomatic heart dysfunction that may be missed without systematic early screening.
Who should consider this trial
Good fit: Ideal candidates are patients with hematologic malignancies who receive CAR‑T infusion, have a pre‑treatment echocardiogram and ECG, and can undergo bedside echocardiography 3–5 days after infusion.
Not a fit: Patients who lack a pre‑CAR‑T cardiac assessment, cannot attend the in‑hospital 3–5 day window, decline participation, or are too unstable for bedside imaging are unlikely to benefit from this screening protocol.
Why it matters
Potential benefit: If successful, this approach could help clinicians detect and treat early CAR‑T–related heart problems sooner, potentially reducing related complications and ICU stays.
How similar studies have performed: Previous reports have documented acute cardiac events after CAR‑T therapy, but systematic early bedside echocardiographic screening is relatively novel and not yet proven to change outcomes.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Paris
- Critical care medicine department — Paris, France (RECRUITING)
Study contacts
- Principal investigator: Jérémie JOFFRE — Assistance Publique - Hôpitaux de Paris
- Study coordinator: Jérémie JOFFRE, MD, PhD
- Email: Jeremie.joffre@aphp.fr
- Phone: +33 1 49 28 21 45
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Car T- Cell, Hematologic Malignancy, Acute Lymphoblastic Leukemia, Lymphoma, B-Cell, Multiple Myeloma, CAR-T cells, Hematological malignancies, Cardiomyopathy