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.

Inclusion Criteria: * Age 18 years or older. * Relapsed or refractory B-cell lymphoma or multiple myeloma. * Indication for anti-CD19 or anti-BCMA CAR-T cell treatment. * Signed informed consent. * Affiliation to or beneficiary status under a health insurance scheme. Exclusion Criteria: * Previous exposure to anti-BCMA bispecific antibodies or need for anti-BCMA bispecific antibodies as bridging therapy before anti-BCMA CAR-T cell administration. * Pregnant or breastfeeding. * Absence of informed consent. * Primary central nervous system lymphoma or primary vitreoretinal lymphoma. * Body weight below 30 kg. * Protected adult or person deprived of liberty under guardianship or curatorship. * Inability to understand the study or comply with study constraints for language, psychological, geographical or other reasons.