Clinical Trial Details

Primary Objective:
1.1 Primary Objectives
1.1.1
To determine the proportion of relapsed/refractory (R/R) mantle cell lymphoma (MCL) patients with an objective response (OR) to glofitamab after prior treatment with chimeric antigen receptor (CAR)-T.

Secondary Objectives:
1.2 Secondary Objectives
1.2.1
To describe the proportion of patients with a complete response (CR).
1.2.2
To describe the progression-free survival (PFS) and overall survival (OS) at 24 months.
1.2.3
To describe the incidence of grade 3-4 cytokine release syndrome (CRS).
1.2.4
To describe the incidence of grade 3-4 neurologic toxicity.
1.2.5
To describe the relationship between glofitamab clearance at baseline, changes in clearance over time, treatment response, and duration of response.

Exploratory Objectives:
1.3 Exploratory Objectives
1.3.1
To evaluate the relationship between circulating tumor DNA (ctDNA) detection in plasma, treatment response, and duration of response.
1.3.2
To evaluate the relationship between CAR T-cell levels in plasma, immunophenotype, treatment response, and duration of response.
1.3.3
To evaluate the relationship between fluorodeoxyglucose positron emission tomography/ computed tomography (FDG PET/CT) interlesional treatment response heterogeneity and survival outcomes.
1.3.4
To evaluate the relationship between organ-specific changes in standardized uptake value (SUV) metrics and immune-related adverse events (AEs).