Study participants
malignancy, B-cell lymphoma, infection, autoimmune disease, NHL
DISEASE, B-CELL LYMPHOMA, INFECTION, NHL, ONCOLOGY, AUTOIMMUNE DISEASE
This study included male or female patients ≥ 18 years with indolent or aggressive CD19 + NHL, who had relapsed or were refractory to standard therapy, which must have included treatment with rituximab plus chemotherapy, and were not eligible for a curative treatment option. All patients must have had measurable disease (at least one lesion ≥ 1.5 cm) documented by a computed tomography (CT) scan, an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2, and a life expectancy of ≥ 6 months.Patients were excluded if their total number of B cells (healthy and malignant combined) in peripheral blood exceeded the upper limit of normal in healthy individuals (assessed by flow cytometry) or if they had central nervous system (CNS) involvement, a history of malignancy other than B-cell lymphoma within 5 years before study entry, active autoimmune disease requiring immunosuppression or uncontrolled infection. Patients who received an autologous haematopoietic stem cell transplant or treatment with alemtuzumab within 12 weeks of the start of AFM11 treatment, chemotherapy, radiotherapy, therapy with an antibody, an investigational drug or corticosteroid treatment within 4 weeks of the start of AFM11 treatment, or who had prior treatment with a CD19-targeting T-cell engager, including CD19 CAR-T cells, were also excluded.A total of 40 patients were anticipated to be enrolled based on the number of dose cohorts; the actual number of enrolled patients was dependent upon the number of dose levels assessed and the number of DLTs observed at each dose level.