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.
Single group
Glofitamab
DrugGlofitamab treatment in post CAR-T R/R MCL patients
Complete Response Rate (CRR)
Complete Response Rate (CRR) at the end of treatment (C12) (assessed by the independent review committee according to Lugano 2014 criteria) and at any time during study treatment.
Overall Response Rate (ORR)
Overall Response Rate (ORR) defined as the proportion of patients achieving either a Complete Response (CR) or Partial Response (PR) (assessed by the independent review committee according to Lugano 2014 criteria), and evaluated at C6 and C12.
Progression Free Survival (PFS)
Progression Free Survival (PFS) defined as the time from the study inclusion to disease progression or death from any cause.
Overall Survival (OS)
Overall Survival (OS) defined as the time between the study inclusion and death from any cause.
Duration of Response (DOR)
Duration of Response (DOR) defined as the time from the first documentation of tumor response (Complete or Partial Response) to disease progression or death.
MRD evaluation PCR (RQ-PCR) and NGS
MRD will be analyzed using both quantitative real-time PCR (RQ-PCR) and nextgeneration sequencing (NGS) on BM, PB and plasma samples using the most validated Euro-MRD standardized procedures
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