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

NCT06350994 | Recruiting

• 2 other identifiers: APHP230625IDRCB 2023-A01957-38
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Car T- Cell; Hematologic Malignancy; Acute Lymphoblastic Leukemia; Lymphoma, B-Cell; Multiple Myeloma

Keywords

CAR-T cells; Hematological malignancies; Cardiomyopathy; Cardiotoxicity; Pharmacovigilance

Outcome Measures

Primary Outcomes (1)

• Estimation of the incidence of possible early CAR-T cells infusion-induced cardiotoxicity

  Transthoracic bedside echocardiographic evaluation of the LVEF.

  5 days and 3 months

Secondary Outcomes (2)

• Characterization of the putative CAR-T cells infusion-induced cardiotoxicity: incidence, phenotype, clinical, rhythmic and biological manifestations

  5 days and 3 months

• Determination of its possible association with a cytokine release syndrome and the levels of inflammatory biomarkers from the analysis of the serum library of these patients

  5 days and 3 months

Study Arms (1)

Cardio CAR-T

Transthoracic bedside echocardiography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients (\>18 years old) receiving CAR-T cell therapy for hematological malignancies (acute lymphoblastic -B cell leukemia, lymphoma and multiple myeloma) hospitalized in hematology department or in intensive care unit.

You may qualify if:

• 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).

You may not qualify if:

• Opposition or consent withdrawal

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Critical care medicine department

Paris, 75012, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

MeSH Terms

Conditions

Hematologic Neoplasms; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Lymphoma, B-Cell; Multiple Myeloma; Cardiomyopathies; Cardiotoxicity

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Study Officials

• Jérémie JOFFRE

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jérémie JOFFRE, MD, PhD

CONTACT

+33 1 49 28 21 45; Jeremie.joffre@aphp.fr

Hafid AIT-OUFELLA, Professor

CONTACT

+33 1 49 28 21 45; hafid.ait-oufella@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: April 8, 2024
• Study Start: November 7, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: September 2, 2025

Record last verified: 2025-08

Locations

FR (1)