NCT06554951

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• CAR-T Cell Therapy
• Extracellular Vesicles

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-08-31
• Primary completion: 2026-02-28
• Completion: 2026-08-31
• First posted: 2024-08-15
• Last updated: 2024-12-27

Locations

1 site across 1 country: Italy