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Tissue Study in Patients Undergoing CAR-T Cell Therapy (CAR_21_01)

NCT04892433 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2024-12-27

No results posted yet for this study

Summary

The "CAR-T" immunotherapy ("Chimeric Antigen Receptor T cell therapies") is a therapy based on T cells expressing a chemical receptor for a specific antigen indicated for patients with some types of oncohematological pathologies that have not responded to other forms treatment, such as: relapsed or refractory non-Hodgkin's lymphomas, including diffuse large B-cell lymphoma, primary B-cell mediastinal lymphoma, transformed follicular lymphoma, mantle cell lymphoma, acute lymphoblastic leukemia, in children and young adults (\<26 years) and multiple myeloma. This therapy is an absolutely innovative approach which consists of a personalized live cell immunotherapy that modifies the immune system of the recipient patient to make it able to recognize and eradicate the neoplastic cells expressing the antigen towards which the cells have been engineered.

This approach has several biological advantages:

1. to supply the patient with "reprogrammed T cells" with a new and specific activation mechanism;
2. overcoming immune tolerance towards cancer cells;
3. bypassing HLA-mediated antigen recognition restriction mechanisms;

Conditions

  • CAR-T Therapy Complications

Sponsors & Collaborators

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    lead OTHER

Principal Investigators

  • Francesca Bonifazi, MD · Advanced Cell Therapy Program, IRCCS University Hospital of Bologna

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-14
Primary Completion
2025-04-30
Completion
2026-04-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04892433 on ClinicalTrials.gov