Molecular-genetic analysis in patients receiving CAR-T cell therapy
Molecular-genetic Characterization in Patients Undergoing CAR-T Cell Infusion
This study is testing how well a new type of cancer treatment using specially modified immune cells can help patients with blood cancers.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Drugs / interventions | CAR-T, Chimeric Antigen Receptor, chemotherapy |
| Locations | 1 site (Bologna, Italy) |
| Trial ID | NCT05807789 on ClinicalTrials.gov |
What this trial studies
This study focuses on the molecular-genetic characterization of patients undergoing CAR-T cell infusion for hematologic malignancies. It involves collecting lymphocytes from patients, engineering them to express chimeric receptors, and infusing them back after lymphodepleting chemotherapy. The aim is to enhance the patient's immune response against cancer by utilizing these engineered T cells as a living drug. The study will analyze the effectiveness and mechanisms of this innovative therapy in treating hematologic cancers.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with hematologic malignancies who are hospitalized for CAR-T cell infusion.
Not a fit: Patients with non-hematologic malignancies or those not eligible for CAR-T cell therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the effectiveness of CAR-T cell therapy in treating hematologic malignancies.
How similar studies have performed: Other studies have shown promising results with CAR-T cell therapy, indicating that this approach is both innovative and supported by prior successes.
Eligibility criteria
Show full inclusion / exclusion 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: \-
Where this trial is running
Bologna, Italy
- Programma Dipartimentale Terapie Cellulari Avanzate — Bologna, Italy, Italy (Recruiting)
Study contacts
- Study coordinator: Francesca Bonifazi, MD
- Email: francesca.bonifazi@unibo.it
- Phone: +39 0512143799
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.