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 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2021-05-14 with a primary completion date of 2025-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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: \-
Contact & Investigator
Francesca Bonifazi, MD
PRINCIPAL INVESTIGATOR
Advanced Cell Therapy Program, IRCCS University Hospital of Bologna
Frequently Asked Questions
Who can join the NCT04892433 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying CAR-T Therapy Complications. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04892433 currently recruiting?
Yes, NCT04892433 is actively recruiting participants. Contact the research team at francesca.bonifazi@unibo.it for enrollment information.
Where is the NCT04892433 trial being conducted?
This trial is being conducted at Bologna, Italy.
Who is sponsoring the NCT04892433 clinical trial?
NCT04892433 is sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. The principal investigator is Francesca Bonifazi, MD at Advanced Cell Therapy Program, IRCCS University Hospital of Bologna. The trial plans to enroll 150 participants.