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

NCT ID: NCT06554951

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-31

Study Completion Date

2026-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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CAR-T Cell Therapy Extracellular Vesicles

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role lead

Responsible Party

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Francesca Bonifazi, MD

Head of Program of Advanced Cellular Therapies

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Francesca Bonifazi

Role: CONTACT

Phone: +39 0512143799

Email: [email protected]

Enrica Tomassini

Role: CONTACT

Email: [email protected]

Facility Contacts

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Francesca Bonifazi

Role: primary

Other Identifiers

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CARE_24

Identifier Type: -

Identifier Source: org_study_id