NCT05807789 Molecular-genetic Characterization in Patients Undergoing CAR-T Cell Infusion
| NCT ID | NCT05807789 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna |
| Condition | Hematologic Malignancy |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2023-02-23 |
| Primary Completion | 2026-05-31 |
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 2023-02-23 with a primary completion date of 2026-05-31.
⚠ 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
In recent years, the application of increasingly advanced methods of ex-vivo cell culture and cell engineering has made it possible to develop new cellular therapeutic platforms including the "CAR (Chimeric Antigen Receptor) - T cell therapy". CAR-T cell therapy is a therapy that uses T lymphocytes engineered to express a chimeric receptor directed against a specific antigen, theoretically applicable to the treatment of all neoplasms but currently more widely used in the treatment of haematological malignancies. One of the most innovative aspects introduced with CAR-T cell therapy is that of living-drug, cells that act as a drug as well as a means to build specific immunity against the neoplasm. The advantages of this therapy are therefore represented by the possibility of refueling the patient's immunity, deficient in the control of the neoplastic disease, with lymphocytes capable of expressing an antineoplastic activity with mechanisms not subject to restriction of HLA-mediated antigen recognition. However, the use of CAR-T therapies is not free from potentially serious and sometimes lethal adverse events; in the toxicity profile the following are recognizable as peculiar: * cytokine release syndrome (CRS) * B-cell aplasia (hypogammaglobulinemia) * neurological adverse reactions * haematological toxicity * infections. Therefore, considering that on the one hand adverse events are not negligible and on the other hand that a percentage \> 50% of patients lose the response obtained, it is necessary to improve the therapeutic profile of CAR-T cell therapy by increasing its efficacy and reducing its toxicity . Both of these strategies are linked to the understanding of the resistance mechanisms of neoplastic cells, as well as to the biology of CAR-T cells and of all the cellular (microenvironment) and non-cellular systems with which they interact.
Eligibility Criteria
Inclusion Criteria: 1. Patients aged ≥ 18 years. 2. Patients with haematological pathology hospitalized for CAR-T cell infusion therapeutic program (with Marketing Authorization) at the Departmental Program of Advanced Cellular Therapies, of the IRCCS AOU of Bologna 3. Patients with express consent to participate in this study, acquired by signing the informed consent. Exclusion Criteria: \-
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05807789 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Hematologic Malignancy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05807789 currently recruiting?
Yes, NCT05807789 is actively recruiting participants. Contact the research team at francesca.bonifazi@unibo.it for enrollment information.
Where is the NCT05807789 trial being conducted?
This trial is being conducted at Bologna, Italy.
Who is sponsoring the NCT05807789 clinical trial?
NCT05807789 is sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. The trial plans to enroll 150 participants.