A Study of BGB-21447, a Bcl-2 Inhibitor, in Mature B-Cell Malignancies
About the study
This study is testing the safety and tolerability of BGB-21447 monotherapy in participants with relapsed or refractory (R/R) non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The study aims to determine the maximum tolerated dose (MTD), maximum administered dose (MAD), recommended Phase 2 dose (RP2D), and pharmacokinetic profile of the drug. Additionally, preliminary antitumor activity will be characterized. The study is divided into 2 main parts: Part 1 "Monotherapy Dose Finding" and Part 2 "Monotherapy Dose Optimization."
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria
1. Confirmed diagnosis (per World Health Organization [WHO] guidelines, unless otherwise noted) of one of the following:
- Cohort A1 and Cohort A2:
- R/R DLBCL (for Cohort A1 and Cohort A2.1)
- High-grade B-cell lymphomas with translocations of MYC and Bcl-2 and/or Bcl-6 are not allowed in Cohort A1 but may be allowed in Cohort A2.1
- R/R FL (for Cohort A1 and Cohort A2.2)
- R/R MZL (for Cohort A1 and Cohort A2.2)
- Transformed B-cell NHL (for Cohort A1 only)
- Richter's transformation to DLBCL (for Cohort A1 only)
- Measurable disease by computed tomography/magnetic resonance imaging.
EXCLUSION CRITERIA
Exclusion Criteria:
- Prior malignancy (other than the disease under study) within the past 2 years, except for curatively treated basal or squamous skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score ≤ 6 prostate cancer or lentigo maligna melanoma that has been curatively resected
- Known central nervous system involvement by lymphoma/leukemia
- Prior autologous stem cell transplant < 3 months before the first dose of study drug. Or prior chimeric antigen receptor T-cell (CAR-T) therapy < 3 months before the first dose of study drug
- Prior allogeneic stem cell transplant.
- Major surgery < 4 weeks before the first dose of study treatment
NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Relapsed Non-Hodgkin Lymphoma,Refractory Non-Hodgkin Lymphoma,Relapsed Chronic Lymphocytic Leukemia,Refractory Chronic Lymphocytic Leukemia,Relapsed Follicular Lymphoma,Relapsed Marginal Zone Lymphoma,Relapse Diffuse Large B Cell Lymphoma,Relapsed Small Lymphocytic Lymphoma,Refractory Follicular Lymphoma,Refractory Marginal Zone Lymphoma,Refractory Small Lymphocytic Lymphoma,Richter Transformation,Refractory Diffuse Large B-cell Lymphoma,Transformed Non-Hodgkin Lymphoma
Age (in years)
18+
Phase
PHASE1
Participants needed
112
Est. Completion Date
Apr 30, 2027
Treatment type
INTERVENTIONAL
Sponsor
BeOne Medicines
ClinicalTrials.gov identifier
NCT05828589
Study number
BGB-21447-101
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