Immunomonitoring and Predictive Biomarkers After CAR-T Cell Therapy in B-Cell Lymphoma and Multiple Myeloma

CARBIOM is a single-centre, non-randomized interventional study involving additional biological sampling with minimal risks and constraints. Up to 45 adults with relapsed or refractory B-cell lymphoma or multiple myeloma who are scheduled to receive standard-of-care anti-CD19 or anti-BCMA CAR-T cells will be enrolled. The study will characterize CAR-positive and endogenous CAR-negative T-cell populations and T-cell receptor clonality at apheresis, in the CAR-T product, at Day 7 +/- 3 days and at Month 1 +/- 7 days. These findings will be related to treatment response, toxicities and relapse during 12 months of follow-up. The study hypothesis is that dynamic immunological and molecular characteristics measured along the CAR-T pathway are associated with early response, toxicity and relapse risk.