NCT06106776

CAR-T Cell Induced Cardiac Dysfunction: A Prospective Study

PROSPECTIVE OBSERVATIONAL STUDY FOR THE ASSESSMENT OF CARDIAC DYSFUNCTION INDUCED BY CHIMERIC ANTIGEN RECEPTOR T (CAR-T) CELL THERAPY

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 48 (estimated)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In this observational, prospective study, patients affected by B-cell Lymphoma and candidate to chimeric antigen receptor-T (CAR-T) cell infusion will be evaluated at three timepoints to establish the rate of cardiac dysfunction, defined according to 2022 European Society of Cardiology Cardio-Oncology guidelines. Echocardiography, physical examination and cardiac/inflammatory biomarkers will be performed prior to CAR-T cell infusion and followed at 7 days and 1 month.

Detailed description

Patients will perform clinical evaluation, transthoracic echocardiogram with speckle tracking analysis and blood samples (including cardiac biomarkers of damage and fibrosis) prior to CART infusion, after 7 days and 1 month following CART infusion. Rate of Cytokine Release Syndrome and use of interleukin-6 inhibitors will be also registered.

Conditions

• Lymphoma

Interventions

Type	Name	Description
DRUG	Chimeric Antigen Receptor	This study will evaluate the incidence of cardiac dysfunction at 7 days and 1 month after chimeric antigen receptor-T cell infusion (tisagenlecleucel, axicabtagene ciloleucel e brexucabtagene autoleucel).

Timeline

• Start date: 2023-11-02
• Primary completion: 2024-11-02
• Completion: 2026-01-31
• First posted: 2023-10-30
• Last updated: 2023-10-30