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A Single-Arm, Open-Label, Multicenter Phase 1/2 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of BCL2 Inhibitor BGB-11417 in Patients With Relapsed or Refractory Mantle Cell Lymphoma

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Trial Profile

A Single-Arm, Open-Label, Multicenter Phase 1/2 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of BCL2 Inhibitor BGB-11417 in Patients With Relapsed or Refractory Mantle Cell Lymphoma

Status: Active, no longer recruiting
Phase of Trial: Phase I/II

Latest Information Update: 17 Mar 2026

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At a glance

  • Drugs Sonrotoclax (Primary)
  • Indications Mantle-cell lymphoma
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors BeOne Medicines

Most Recent Events

  • 26 Feb 2026 According to BeOne Medicines media release, the USFDA regulatory action on NDA for Sonrotoclax as monotherapy treatment of adult patients with R/R MCL is expected in 1H 2026.
  • 26 Feb 2026 According to BeOne Medicines media release, the company has submitted the MAA in the European Union for the treatment of adult patients with R/R MCL.
  • 06 Jan 2026 According to BeOne Medicines media release, company announced the first-in-world approval of sonrotoclax, for adult patients with relapsed/refractory (R/R) mantle cell lymphoma (MCL) and R/R chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) globally. The approval, granted in China, is supported by data demonstrating deep and durable responses and manageable tolerability, underscoring sonrotoclaxs emerging role as a foundational medicine across B-cell malignancies.

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