Actively Recruiting
Study on Extracellular Vesicles as Biomarkers in Adults Receiving CAR-T Cell Therapy for Blood Cancers
Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2024-12-27
100
Participants Needed
1
Research Sites
26 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are investigating the role of extracellular vesicles EV as potential biomarkers in patients with refractory or relapsed hematologic cancers undergoing CAR-T cell therapy. The study aims to identify EV biomarkers related to neurological toxicity after CAR-T infusion and to better understand factors that predict treatment outcomes and side effects. The study includes patients who are receiving or are candidates for CAR-T cell therapy for hematologic malignancies such as refractory or relapsed B cell lymphoma, B cell acute leukemia, and multiple myeloma. A total of 100 patients will be enrolled during an 18-month period, including both prospective and retrospective participants. There is no intervention beyond observation since this is an observational study. Participants will be followed to assess their response to CAR-T cell treatment over 18 months. Researchers will collect data related to extracellular vesicles and neurological side effects after therapy. The main outcome measured is the response rate to CAR-T cell treatment. Participants will provide written consent and be observed throughout the study period, which lasts until August 2026.
CONDITIONS
Brief Title
Study of Extracellular Vesicles (EV) in Patients Undergoing CAR-T Cell Therapies
Research Team
F
Francesca Bonifazi
E
Enrica Tomassini
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