Study of CAR-T Cell Therapy Effects and Outcomes in Adults and Young Patients with Certain Blood Cancers

What this Trial Is About

Researchers are studying patients with Diffuse Large B Cell Lymphoma DLBCL, Primary Mediastinal Large B-cell Lymphoma PMBCL, and Acute Lymphoblastic Leukemia ALL who have undergone CAR-T cell therapy. The study aims to evaluate the expansion and persistence of CAR-T cells after infusion and to explore the treatments feasibility and effectiveness in real-life settings. It also includes biological sub-studies focused on monitoring CAR-T cells, analyzing extracellular vesicles, and assessing neurological markers related to immune cell-related neurotoxicity. The study involves detailed analyses using flow cytometry and digital PCR to track CAR-T cells over time. Blood and cerebrospinal fluid samples will be collected to quantify extracellular vesicles and examine their composition, aiming to identify markers that may predict patient responses or complications. Neurological biomarkers will be evaluated before and after CAR-T infusion to understand neurotoxicity development. These assessments are done at multiple time points up to two years after CAR-T cell infusion. Participants will be closely monitored through blood tests and clinical evaluations at scheduled intervals, including days 1, 3, 7, 10, 14, 21, 30, and several later time points up to one year and beyond. Researchers will measure CAR-T cell levels, disease burden, immune recovery, and neurological biomarkers. Safety will be assessed by tracking treatment-related side effects and neurotoxicity. The study lasts up to two years, allowing for long-term observation of outcomes and complications following CAR-T therapy.

Bio-CAR-T BS Study