Study of Sonrotoclax (BGB-11417) Monotherapy in Participants With Relapsed or Refractory Mantle Cell Lymphoma

Prior treatment

• Prior exposure to a BCL-2 inhibitor (eg, venetoclax/ABT-199).
• Prior autologous stem cell transplant within the last 3 months; or prior autologous chimeric antigen receptor T-cell therapy within the last 3 months; or prior allogeneic stem cell transplant within the last 6 months or currently has an active graft-vs-host disease requiring the use of immunosuppressants.
• Major surgery or significant injury ≤ 4 weeks prior to start of study treatment.

Other illness

• Prior malignancy other than MCL within the past 3 years, except for curatively treated basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score 6 prostate cancer.
• Clinically significant cardiovascular disease.
• Active fungal, bacterial or viral infection requiring systemic treatment.
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Other

• Known central nervous system involvement by lymphoma

• Histologically confirmed diagnosis of MCL
• Prior systemic treatments for MCL (at least one line of anti-cluster of differentiation 20 (anti-CD20) based immune or chemoimmunotherapy and at least one kind of covalent or non-covalent adequate Bruton Tyrosine Kinase (BTK) inhibitor).
• Relapsed/refractory disease
• Presence of measurable disease
• Availability of archival tissue confirming diagnosis of MCL, or willing to undergo fresh tumor biopsy
• Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2.
• Adequate organ function