Examining extracellular vesicles in patients receiving CAR-T cell therapy
Official title: Study of Extracellular Vesicles (EV) in Patients Undergoing CAR-T Cell Therapy
Run by IRCCS Azienda Ospedaliero-Universitaria di Bologna · NCT06554951 · Data updated 2026-11-12
This study is trying to find out if certain tiny particles in the blood can help predict how well CAR-T cell therapy will work and if it will cause side effects in people with tough blood cancers.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 90 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Drugs / interventions | CAR-T |
| Locations | 1 site (Bologna, Bologna) |
| Status | Recruiting |
| Started | August 31, 2024 |
| Main results expected | February 28, 2026 |
| Study ends | August 31, 2026 |
| Registry record updated | December 27, 2024 |
| Trial ID | NCT06554951 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older with hematological malignancies such as r/r B cell lymphoma, B cell acute leukemia, or multiple myeloma who are eligible for CAR-T cell therapy.
✕Probably not a fit
Patients with hematological malignancies who are not candidates for CAR-T cell therapy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study focuses on patients with refractory or relapsed hematologic malignancies who are candidates for CAR-T cell therapy. It aims to identify potential biomarkers in extracellular vesicles that may predict outcomes and toxicity associated with CAR-T cell infusion. By analyzing these vesicles, researchers hope to uncover factors that influence treatment response and adverse effects, particularly neurological toxicity. The study will involve collecting data from patients undergoing CAR-T cell therapy at a leading medical center.
Why it matters
Potential benefit: If successful, this study could lead to improved patient outcomes by identifying biomarkers that predict treatment response and toxicity.
How similar studies have gone: While the approach of using extracellular vesicles as biomarkers is gaining interest, this specific study is exploring a novel application in the context of CAR-T cell therapy.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, Italy Recruiting
Study contacts
- Study coordinator: Francesca Bonifazi
- Email: francesca.bonifazi@unibo.it
- Phone: +39 0512143799
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.