Actively Recruiting
Study of Extracellular Vesicles in Patients Undergoing 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
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are exploring how extracellular vesicles (EVs), which are tiny particles released by cells, might predict outcomes and side effects in patients receiving CAR-T cell therapy for blood cancers. This study focuses on patients with refractory or relapsed hematologic malignancies such as B cell lymphoma, B cell acute leukemia, and multiple myeloma. The goal is to identify EV biomarkers that could be linked to neurological toxicity after CAR-T cell infusion. The study will include about 100 patients who are candidates for CAR-T cell therapy at participating centers. This includes 80 patients in a prospective part and 20 in a retrospective part over an 18-month enrollment period. Patients will receive CAR-T cell infusions as part of their treatment for their hematologic cancer. Participants will be monitored during and after treatment to assess their response to CAR-T cell therapy over 18 months. Researchers will study the presence and characteristics of extracellular vesicles in relation to treatment response and neurological side effects. The main outcome measured is the response rate to CAR-T cell treatment at 18 months.
CONDITIONS
Official Title
Study of Extracellular Vesicles (EV) in Patients Undergoing CAR-T Cell Therapies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with any hematological malignancies (refractory/relapsed B cell lymphoma, B cell acute leukemia, or multiple myeloma) undergoing or planned for CAR-T cell infusion with a CAR-T cell product
- Age 18 years or older
- Provided written consent to participate in the study
You will not qualify if you...
- None
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Trial Site Locations
Total: 1 location
1
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, Italy, 40138
Actively Recruiting
Research Team
F
Francesca Bonifazi
E
Enrica Tomassini
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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