This is a Phase 2, multicentre, single arm study that evaluates the efficacy and safety of glofitamab in MCL patients with inadequate response or relapse following CAR T-cell therapy.
Able to provide written informed consent forms approved by the National Ethics Committee (NEC) prior to the initiation of any screening or study-specific procedures and able to understand and to comply with the requirements of the study and the schedule of assessments.
Histologically confirmed MCL after CAR T-cells failure (CD20+ by flow cytometry or immunohistochemistry). Note: Availability of archival material is mandatory for the study to perform central pathology review. Central pathology confirmation is not required to start treatment.
Age ≥ 18.
Stable disease (SD) or progressive disease (PD) up to D+90; after CAR T-cells infusion (from D+30 to D+90);
Prior exposure to an anti-CD20xCD3 bispecific antibody (bsAbs).
Participants not able to give consent.
Grade ≥ 3 adverse events except for Grade 3 endocrinopathy managed with replacement therapy;
Grade 1-2 adverse events that did not resolve to baseline after treatment discontinuation.