NCT04892433 Tissue Study in Patients Undergoing CAR-T Cell Therapy (CAR_21_01)
| NCT ID | NCT04892433 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna |
| Condition | CAR-T Therapy Complications |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2021-05-14 |
| Primary Completion | 2025-04 |
Trial Parameters
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Brief 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;
Eligibility Criteria
Inclusion Criteria: Patients aged ≥ 18 years. Patients with haematological pathology admitted to be subjected to CAR-T Therapy at the Advanced Cell Therapy Program, IRCCS University Hospital of Bologna. Patients who consent to participate in this study after signing informed consent. Exclusion Criteria: \-