Secondary objectives
T-cell, peripheral B-cell
BLOOD, MINIMAL RESIDUAL DISEASE
Blood samples were taken for PK analysis, biomarker and FACS analysis at regular intervals after the start of the infusion in both weeks 1 and 2. Blood samples were analysed by flow cytometry for peripheral B-cell and T-cell depletion. Serum biomarker assessments were performed at a central laboratory. Immunogenicity was assessed by analysis of the presence of ADAs using an enzyme-linked immunosorbent assay.Efficacy was determined using bone marrow assessment performed at baseline and during evaluation visits during each cycle (days 15–18). Minimal residual disease diagnostic tests were performed at baseline and at each evaluation visit by a central laboratory.The safety population included all patients receiving at least one dose of AFM11. The DLT analysis set included all patients who received ≥ 80% of the assigned dose and completed the DLT observation period or discontinued due to a DLT during the DLT observation period. The PK population was defined as all patients who received at least one dose of AFM11 and for whom serum concentrations of AFM11 were measured.