Study of Extracellular Vesicles (EV) in Patients Undergoing CAR-T Cell Therapies (CARE_24)

December 20, 2024 updated by: Francesca Bonifazi, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Bologna, Italy, 40138
        • Recruiting
        • IRCCS Azienda Ospedaliero-Universitaria di Bologna
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study 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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response rate to treatment with CAR-T cells
Time Frame: 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.
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 31, 2024

Primary Completion (Estimated)

February 28, 2026

Study Completion (Estimated)

August 31, 2026

Study Registration Dates

First Submitted

August 9, 2024

First Submitted That Met QC Criteria

August 12, 2024

First Posted (Actual)

August 15, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 20, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CARE_24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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