Examining extracellular vesicles in patients receiving CAR-T cell therapy
Study of Extracellular Vesicles (EV) in Patients Undergoing CAR-T Cell Therapy
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 |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Drugs / interventions | CAR-T |
| Locations | 1 site (Bologna, Bologna) |
| Trial ID | NCT06554951 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with hematological malignancies who are not candidates for CAR-T cell therapy may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Bologna, Bologna
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna, Bologna, Italy (Recruiting)
Study contacts
- Study coordinator: Francesca Bonifazi
- Email: francesca.bonifazi@unibo.it
- Phone: +39 0512143799
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.