Actively Recruiting

Age: 18Years - 90Years
All Genders
ID06554951

Study of Extracellular Vesicles in Patients Undergoing CAR-T Cell Therapy for Blood Cancers

Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2024-12-27

100

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are exploring how extracellular vesicles (EVs), which are tiny particles released by cells, might predict outcomes and side effects in patients receiving CAR-T cell therapy for blood cancers. This study focuses on patients with refractory or relapsed hematologic malignancies such as B cell lymphoma, B cell acute leukemia, and multiple myeloma. The goal is to identify EV biomarkers that could be linked to neurological toxicity after CAR-T cell infusion. The study will include about 100 patients who are candidates for CAR-T cell therapy at participating centers. This includes 80 patients in a prospective part and 20 in a retrospective part over an 18-month enrollment period. Patients will receive CAR-T cell infusions as part of their treatment for their hematologic cancer. Participants will be monitored during and after treatment to assess their response to CAR-T cell therapy over 18 months. Researchers will study the presence and characteristics of extracellular vesicles in relation to treatment response and neurological side effects. The main outcome measured is the response rate to CAR-T cell treatment at 18 months.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with any hematological malignancies (refractory/relapsed B cell lymphoma, B cell acute leukemia, or multiple myeloma) undergoing or planned for CAR-T cell infusion with a CAR-T cell product
  • Age 18 years or older
  • Provided written consent to participate in the study
Not Eligible

You will not qualify if you...

  • None

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, Italy, 40138

Actively Recruiting

Loading map...

Research Team

F

Francesca Bonifazi

E

Enrica Tomassini

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

Similar Trials

A Study of A-CAR028 Treatment for Relapsed or Refractory Acu...

Acute Myeloid Leukemia (AML)

Actively Recruiting

1 location

Characterization of Extracellular Vesicles From Cord Blood i...

Intraventricular Hemorrhage

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here