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


The study consists of two parts. Part 1 determines the safety and tolerability of BGB-11417 (sonrotoclax) monotherapy, the maximum tolerated dose, and the recommended Phase 2 dose of BGB-11417 monotherapy for relapsed or refractory mantle cell lymphoma. Part 2 evaluates efficacy of BGB-11417 monotherapy at the recommended Phase 2 dose with recommended ramp-up schedule from Part 1.


  • Mantle Cell Lymphoma
  • Refractory Mantle Cell Lymphoma (MCL)
  • Relapsed Mantle Cell Lymphoma


Eligible Ages
Over 18 Years
Eligible Genders
Accepts Healthy Volunteers

Inclusion Criteria

  1. Histologically confirmed diagnosis of MCL 2. 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). 3. Relapsed/refractory disease 4. Presence of measurable disease 5. Availability of archival tissue confirming diagnosis of MCL, or willing to undergo fresh tumor biopsy 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2. 7. Adequate organ function

Exclusion Criteria

  1. Known central nervous system involvement by lymphoma 2. 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. 3. Prior exposure to a BCL-2 inhibitor (eg, venetoclax/ABT-199). 4. 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. 5. Clinically significant cardiovascular disease. 6. Major surgery or significant injury ≤ 4 weeks prior to start of study treatment. 7. Active fungal, bacterial or viral infection requiring systemic treatment. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Phase 1/Phase 2
Study Type
Intervention Model
Single Group Assignment
Primary Purpose
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Single Arm
Participants will receive sonrotoclax
  • Drug: BGB-11417
    Administered orally
    Other names:
    • sonrotoclax

Recruiting Locations

University of Alabama At Birmingham Hospital
Birmingham, Alabama 35294

More Details


Study Contact