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A Multicenter, Open-Label, Phase I/II 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 (Gazyva/Gazyvaro) in Patients With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma

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Trial Profile

A Multicenter, Open-Label, Phase I/II 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 (Gazyva/Gazyvaro) in Patients With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 02 Feb 2024

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At a glance

  • Drugs Glofitamab (Primary) ; Obinutuzumab (Primary) ; Tocilizumab
  • Indications B-cell lymphoma; Diffuse large B cell lymphoma; Follicular lymphoma; Mantle-cell lymphoma; Non-Hodgkin's lymphoma; Richter's syndrome
  • Focus Adverse reactions; First in man; Pharmacokinetics; Registrational; Therapeutic Use
  • Sponsors Roche

    • Most Recent Events

    • 12 Dec 2023 Results assessing mechanisms underlying response and resistance to glofitamab, presented at the 65th American Society of Hematology Annual Meeting and Exposition
    • 12 Dec 2023 Result(As of May 1, 2023, n=145) assessing dose-escalation and expansion cohorts ,presented at the 65th American Society of Hematology Annual Meeting and Exposition
    • 12 Dec 2023 Results ( As of May 1, 2023, n=154) assessing extended follow up, as well as subgroup analyses in patients with prior chimeric antigen receptor (CAR) T-cell therapy and by baseline total metabolic tumor volume presented at the 65th American Society of Hematology Annual Meeting and Exposition
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