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Clinical Trials in Italy / NCT06554951
Recruiting Observational

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

NCT06554951 · tracked via the Priya Life Science Italy tracker
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Phase
Observational
Started
2024-08-31
Last updated
2024-12-27

Condition(s) studied

CAR-T Cell TherapyExtracellular Vesicles

Investigational drug(s) / intervention(s)

Patients who are candidates for CAR-T cell therapy for hematologic malignancy

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.

Study 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

Sex
ALL
Min age
18 Years
Max age
90 Years
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * none

Primary outcome measure(s)

  • Response rate to treatment with CAR-T cells — 18 months
    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.

Trial sites (1)

FacilityCityRegionStatus
IRCCS Azienda Ospedaliero-Universitaria di Bologna Bologna Bologna Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06554951 on ClinicalTrials.gov ↗ ← All trials in Italy