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RECRUITING
NCT06554951

Study of Extracellular Vesicles (EV) in Patients Undergoing CAR-T Cell Therapies

Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

View on ClinicalTrials.gov

Summary

Patients with refractory/relapse hematologic oncology disease may benefit from innovative therapy such as Car-T cells. Factors strongly predictive of outcome and response are unknown. Extracellular vesicles are recognized as a mode of intercellular communication and are reminiscent of the cell of origin. They are currently candidates to be biomarkers for this biomarker of phenomena occurring in tissues. The working hypothesis is that they may be predictive of outcome and toxicity, as some preliminary data have suggested. Therefore, the aim of the study concerns I dentification of potential CAR-EV biomarkers associated with neurological toxicity after infusion of CAR-T cells.

Official title: Study of Extracellular Vesicles (EV) in Patients Undergoing CAR-T Cell Therapy

Key Details

Gender

All

Age Range

18 Years - 90 Years

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2024-08-31

Completion Date

2026-08-31

Last Updated

2024-12-27

Healthy Volunteers

No

Interventions

OTHER

Patients who are candidates for CAR-T cell therapy for hematologic malignancy

This study will include patients who undergo CAR-T cell infusion at participating centers during the 18-month duration of the enrollment period. A total of 100 patients are expected to be enrolled, including 80 patients for the prospective part and 20 for the retrospective part.

Locations (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, Italy