Dynamic Individualized Risk Profiling of Patients With Relapsed/Refractory Lymphoid Malignancies and CD19-CAR T Cell Therapy (INTeRCePT 2.0)
The INTeRCePT 2 study aims to develop a predictive assay to determine which patients with B cell lymphoma are most likely to respond to CAR T cell therapy. This assay combines five components for longitudinal profiling of each patient. The goal of the trial is that the assay can be completed (feasibility). This comprehensive assay integrates five key components including circulating tumor DNA (CAPPseq), inflammation markers from peripheral blood tests (InflaMIX), PET CT imaging parameters, immune cell profiles (flow cytometry), and performance status (ECOG). Ultimately, this tool could improve treatment selection, and guide more personalized therapy decisions for lymphoma patients receiving CAR T cells.
• Written informed consent before registration and prior to any trial specific procedures
• Participants ≥ 18 years of age
• Diagnosis of relapse/refractory B-cell lymphoma according to WHO 2022 classification
• Measurable disease per response criteria specific to the disease e.g. per Lugano 2014 criteria
• Patients planned for CD19-redirected CAR T cell therapy according to clinical standard of care
• Patients who are willing to donate peripheral blood and biopsy material at indicated clinical visits