Molecular-Genetic Study of Blood Cancers in Patients Receiving CAR-T Cell Therapy

What this Trial Is About

Researchers are investigating CAR-T cell therapy, a treatment using specially engineered T lymphocytes to target cancer cells. This therapy is mainly used for blood cancers and works by boosting the patient's immune system with cells that can fight the disease without being limited by usual antigen recognition methods. While CAR-T therapy shows promise, it can cause serious side effects like cytokine release syndrome, B-cell aplasia, neurological issues, blood toxicity, and infections. Improving its effectiveness and reducing these risks requires understanding how cancer cells resist treatment and how CAR-T cells interact with other cells and the body environment. The study focuses on patients receiving approved CAR-T cell treatments after lymphodepleting chemotherapy. The therapy process includes collecting lymphocytes through apheresis, engineering and expanding these cells, and then infusing them back into the patient. The research will analyze blood samples collected at multiple times before and after infusion to study genetic and cellular changes. This includes examining CAR-positive and CAR-negative lymphoid cells and myeloid cells using advanced single-cell RNA sequencing methods to understand how these relate to treatment response and side effects. Participants will provide peripheral blood samples at specified times from collection through one year post-infusion, following routine clinical care schedules. Researchers will study genetic markers and cell populations to link these with clinical outcomes such as treatment response and adverse events like cytokine release syndrome and neurological symptoms. The study aims to include about 150 adult patients treated at the specialized center in Bologna, with ongoing monitoring to improve understanding of CAR-T therapy's benefits and risks.

Molecular-genetic Characterization in Patients Undergoing CAR-T Cell Infusion