Toxicity
neutropenia, febrile neutropenia, necrotic tumor, toxicity, infection
NEUTROPENIA, FEBRILE NEUTROPENIA, NECROTIC TUMOR, ADVERSE EVENTS, INFECTION
Among the 17 patients enrolled, 4 patients received NEO-201 at DL 1 (1 mg/kg), 7 patients received NEO-201 at DL 2 (2 mg/kg) and 6 patients received NEO-201 at DL 1.5 (1.5 mg/kg) (Table Most common grade 3 (Gr3) and grade 4 (Gr4) adverse events (AEs) in all patientsSee Supplementary Table Due to the ability of NEO-201 to kill neutrophils expressing core 1 O-glycans through ADCC [Three patients received NEO-201 at DL 1 for two doses without experiencing a DLT. After completion of 2 doses in three patients at DL 2, one patient experienced a DLT of prolonged neutropenia. DL 2 was subsequently expanded to 6 patients (1 patient withdrew consent after the first dose and was therefore not evaluable for DLT and was replaced in the enrollment). A second patient at DL 2 developed grade 4 febrile neutropenia (DLT). On further review of baseline imaging, this patient was noted to have necrotic tumor in close proximity to bowel, that was considered high risk for infection.After completion of the first 3 patients in DL 2, the protocol was amended to recognize severe neutropenia as an expected toxicity and to allow for administration of filgrastim to shorten the duration of the neutropenia and to reduce the risk of infection. Patients who developed neutrophil decrease after NEO-201 infusion were treated with filgrastim until the absolute neutrophil count (ANC) exceeded 1000/mm