Study on BGB-11417 for Treating Relapsed or Hard-to-Treat Mantle Cell Lymphoma

Sponsor: BeiGene

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05471843

Provider View

This clinical trial is testing a new drug, BGB-11417, to see if it is safe and effective for patients with mantle cell lymphoma that has returned or not responded to previous treatments.

Patient Parameters

Program Overview

The study is divided into two parts. The first part focuses on finding out how safe BGB-11417 (also known as sonrotoclax) is for patients and determining the best dose to use. The second part tests how well this dose works in treating mantle cell lymphoma that has come back or is difficult to treat.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of mantle cell lymphoma (MCL).
  • Have received at least one previous treatment for MCL, including a type of immune or chemoimmunotherapy and a Bruton Tyrosine Kinase (BTK) inhibitor.
  • The disease must have returned or not responded to previous treatments.
  • Have measurable cancer that can be tracked.
  • Be able to provide a previous tissue sample confirming MCL diagnosis or agree to a new biopsy.
  • Be in relatively good health with an ECOG performance status of 0, 1, or 2.
  • Have adequate organ function.

Exclusion Criteria

  • Have lymphoma that has spread to the brain or spinal cord.
  • Have had another type of cancer within the past 3 years, except for certain skin cancers, superficial bladder cancer, or localized prostate cancer.
  • Have previously taken a BCL-2 inhibitor like venetoclax.
  • Have had a stem cell transplant or CAR-T cell therapy recently, or have active graft-vs-host disease.
  • Have significant heart disease.
  • Have had major surgery or a serious injury within the last 4 weeks.
  • Have an active infection that requires treatment with medication.

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