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A Multicenter, Open-Label, Phase I Study to Evaluate the Safety, Efficacy, Tolerability and Pharmacokinetics of Escalating Doses of Glofitamab (RO7082859) as a Single Agent and in Combination With Obinutuzumab Administered After a Fixed, Single Dose Pre-Treatment of Obinutuzumab (GazyvaÂ/Gazyvaroâ) in Patients With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma
This trial has three parts, to which eligible patients will be assigned: dose escalation (Parts 1 and 2) and dose expansion (Part 3). In Part 1, single participant cohorts will receive pre-treatment obinutuzumab, followed by a starting dose (Cycle 1) and then an ascending dose (from Cycle 2 onwards) of glofitamab for 12 Cycles or until the participant experiences unacceptable toxicity or disease progression. Part 2 will include multiple participant dose-escalation cohorts, in which patients will receive glofitamab as a single-agent, in combination with a fixed dose of obinutuzumab or as an initial low dose, followed by a higher dose on Cycle 1 Day 8 (step-up dosing). Part 3 (dose expansion) will commence once a maximum tolerated dose has been identified. In this part, patients will receive pre-treatment with obinituzumab, followed by glofitamab at a fixed dose regimen or step-up dose regimen as determined by Part 2 of the study and administered over 12 cycles.