Study of Extracellular Vesicles (EV) in Patients Undergoing CAR-T Cell Therapies
Study of Extracellular Vesicles (EV) in Patients Undergoing CAR-T Cell Therapy
IRCCS Azienda Ospedaliero-Universitaria di Bologna
100 participants
Aug 31, 2024
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- patients affeccted by any hematological malignancies (r/r B cell lymphoma, B cell acute leukemia and multiple myeloma) undergoing (or whit indication to) CAR-T cell infusion with a CAR-T cell product;
- age: 18 years or greater;
- obtained written consent to the study participation.
Exclusion Criteria1
- none
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Interventions
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)
View Full Details on ClinicalTrials.gov
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NCT06554951