Study Design and Patients
toxicity, B-cell lymphoma, CRS
DISEASE PROGRESSION, B-CELL LYMPHOMA, CYTOKINE RELEASE SYNDROME, ONCOLOGY, -11
This was a phase I/II, single-arm, multicenter, open-label, dose-escalation/dose-expansion study in patients with relapsed, progressive, and/or refractory mature B-cell lymphoma (EPCORE NHL-1; GCT3013-01; ClinicalTrials.gov identifier: Eligible patients were at least age 18 years with an Eastern Cooperative Oncology Group performance status of 0 to 2 and documented CD20Patients received subcutaneous epcoritamab with cycle 1 step-up dosing consisting of a 0.16-mg priming dose once on day 1, followed by a 0.8-mg intermediate dose once on day 8, and subsequent full 48-mg doses once on day 15 and beyond until disease progression or unacceptable toxicity. Epcoritamab was administered as a 1-mL injection once weekly in cycles 1-3, once every 2 weeks during cycles 4-9 (days 1 and 15), and once every 4 weeks from cycle 10. No initial B-cell–depleting treatment was administered. During cycle 1, prophylaxis for cytokine release syndrome (CRS) included prednisolone 100 mg orally (or intravenous equivalent) administered 30-120 minutes before each epcoritamab dose (once daily on days 1-4 for the priming dose, once daily on days 8-11 for the intermediate dose, once daily on days 15-18 for the first full dose, and once daily on days 22-25 for the second full dose). In addition, diphenhydramine 50 mg orally or intravenously (or equivalent) and acetaminophen 650-1,000 mg orally were administered once daily on days 1, 8, 15, and 22 of cycle 1. If grade 2 or higher CRS occurred after the fourth epcoritamab administration during cycle 1, corticosteroids were given with epcoritamab for 4 days or until resolution of CRS occurred.To ensure patient safety and to better characterize CRS, 24-hour inpatient monitoring was required for the first full epcoritamab dose.The Protocol (online only) was approved by site-specific institutional review boards and/or institutional or central ethics committees before study initiation. The study was conducted in accordance with the International Council for Harmonisation E6 (R2) guidelines on good clinical practice and the principles of the Declaration of Helsinki. All patients reviewed and signed informed consent forms before enrollment.