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NCT Number: NCT06554951

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

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.

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Key information

Conditions

CAR-T Cell Therapy Extracellular Vesicles

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

Location status: Recruiting

Location contact

Francesca Bonifazi

CONTACT

[email protected]

0390512143799

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

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.

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Enrica Tomassini

CONTACT

[email protected]

Francesca Bonifazi

CONTACT

[email protected]

+39 0512143799

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 15, 2024
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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