Study of Extracellular Vesicles (EV) in Patients Undergoing CAR-T Cell Therapies
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
none
Trial population
This study will include all patients who will undergo to CAR-T cell infusion per any hematological malignancies with AIFA approved CAR-T cell product.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Patients who are candidates for CAR-T cell therapy for hematologic malignancy
Other interventionThis 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Response rate to treatment with CAR-T cells
For lymphoma: complete remission is defined by the absence of signs, symptoms, and PET/CT of the disease as described by Mac Manus MP et al. Cancer Imaging. 2007;7:10-8 For multiple myeloma: complete remission is defined as absence of M protein signs using standard tests, disappearance of any soft tissue plasmacytomas, and less than 5% plasma cells in bone marrow aspirates (Fernandez de Larrea C et al. Biol Blood Marrow Transplant. 2011 Jul;17:1084-7). For acute leukemia: complete remission is defined with less than 5% blasts in os-seo marrow and all other blood cell counts have returned to normal levels.Dohner H et al Blood. 2022;140:1345-1377.
Time frame
18 monthsSponsors and contacts
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Source ClinicalTrials.gov