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 adminstered 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 Expansion."

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
R/R FL
R/R MZL
Transformed B-cell NHL
Richter's transformation to DLBCL
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
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 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.

Call +1-877-828-5568

Email Study Center

Study 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

18+

Phase

PHASE1

Participants Needed

Est. Completion Date

Oct 31, 2026

Treatment Type

INTERVENTIONAL

Sponsor

BeiGene

ClinicalTrials.gov NCT Identifier

NCT05828589

Study Number

BGB-21447-101

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