A Study of BGB-21447, a Bcl-2 Inhibitor, in Mature B-Cell Malignancies

March 10, 2026 updated by: BeOne Medicines

A Phase 1/1b Open-Label Dose-Escalation and Dose-Optimization Study of Bcl-2 Inhibitor BGB-21447 in Patients With Mature B-Cell Malignancies

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."

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.

Study Type

Interventional

Enrollment (Estimated)

112

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Blacktown, New South Wales, Australia, NSW 2148
        • Blacktown Cancer and Haematology Centre
    • Queensland
      • Benowa, Queensland, Australia, QLD 4217
        • Pindara Private Hospital
      • South Brisbane, Queensland, Australia, QLD 4101
        • Mater Cancer Care Centre
    • Victoria
      • Clayton, Victoria, Australia, VIC 3168
        • Monash Health
    • Western Australia
      • Nedlands, Western Australia, Australia, WA 6009
        • Linear Clinical Research
  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100000
        • Peking University Third Hospital
    • Fujian
      • Fuzhou, Fujian, China, 350014
        • Fujian Cancer Hospital
    • Henan
      • Zhengzhou, Henan, China, 450000
        • Henan Cancer Hospital
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
      • Yichang, Hubei, China, 443001
        • Yichang Central Peoples Hospitaljiangnan Branch
    • Jiangsu
      • Changzhou, Jiangsu, China, 213000
        • The First Peoples Hospital of Changzhou
      • Nanjing, Jiangsu, China, 210029
        • Jiangsu Province Hospital
      • Suzhou, Jiangsu, China, 215006
        • the First Affiliated Hospital of Soochow University
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • The First Affiliated Hospital of Nanchang University Branch Donghu
      • Nanchang, Jiangxi, China, 332000
        • The First Affiliated Hospital of Nanchang University Branch Xianghu
    • Liaoning
      • Shenyang, Liaoning, China, 110004
        • Shengjing Hospital Of China Medical University
    • Shandong
      • Jinan, Shandong, China, 250021
        • Shandong Provincial Hospital
      • Linyi, Shandong, China, 276000
        • Linyi Peoples Hospital
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032
        • Affiliated Zhongshan Hospital of Fudan University
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300020
        • Institute of Hematology and Hospital of Blood Disease
  • New Zealand
      • Auckland, New Zealand, 1023
        • Auckland City Hospital
  • United States
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20016
        • Sibley Memorial Hospital Johns Hopkins Medicine
    • Iowa
      • Iowa City, Iowa, United States, 52242-1009
        • University of Iowa Hospitals and Clinics
      • Waukee, Iowa, United States, 50263
        • Mission Cancer and Blood
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Sidney Kimmel Comprehensive Cancer At Johns Hopkins
    • New York
      • Mineola, New York, United States, 11501
        • Nyu Langone Health Perlmutter Cancer Center At Nyu Langone Hospital Long Island
      • New York, New York, United States, 10016-2708
        • Laura and Isaac Perlmutter Cancer Center at NYU Langone Health
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105-2108
        • Avera Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  1. Confirmed diagnosis (per World Health Organization [WHO] guidelines, unless otherwise noted) of one of the following:

    Cohort A1 and Cohort A2:

    1. 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
    2. R/R FL (for Cohort A1 and Cohort A2.2)
    3. R/R MZL (for Cohort A1 and Cohort A2.2)
    4. Transformed B-cell NHL (for Cohort A1 only)
    5. Richter's transformation to DLBCL (for Cohort A1 only)
  2. Measurable disease by computed tomography/magnetic resonance imaging.

Exclusion Criteria:

  1. 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
  2. Known central nervous system involvement by lymphoma/leukemia
  3. 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
  4. Prior allogeneic stem cell transplant.
  5. Major surgery < 4 weeks before the first dose of study treatment

NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 1 (Cohort A1): Dose escalation in patients with B-cell non-Hodgkin lymphoma (NHL)
Participants with R/R B-cell NHL (including diffuse large B-cell lymphoma [DLBCL], follicular lymphoma [FL], marginal zone lymphoma [MZL], transformed B-cell NHL (B-NHL), and Richter's transformation to DLBCL) will receive BGB-21447 once a day.
Drug: BGB-21447
BGB-21447 will be administered orally
Experimental: Part 1 (Cohort B): Dose escalation in R/R CLL/SLL participants with low tumor burden
Participants with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) will receive BGB-21447 once a day.
Drug: BGB-21447
BGB-21447 will be administered orally
Experimental: Part 2 (Cohort A2.1): BGB-21447 Monotherapy Dose Optimization in R/R DLBCL
Participants will receive BGB-21447 with two dose levels from Cohort A1 for further evaluation of safety and efficacy.
Drug: BGB-21447
BGB-21447 will be administered orally
Experimental: Part 2 (Cohort A2.2): BGB-21447 Monotherapy Dose Optimization in R/R FL or R/R MZL
Participants will receive BGB-21447 with two dose levels from Cohort A1 for further evaluation of safety and efficacy.
Drug: BGB-21447
BGB-21447 will be administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part 1: Number of participants with dose limiting toxicities (DLTs)
Time Frame: Up to approximately 1 month
Number of participants with dose limiting toxicities, as defined in the study protocol.
Up to approximately 1 month
Number of participants with adverse events (AEs)
Time Frame: From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurs first; up to approximately 12 months
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) assessed and graded based upon the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0).
From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurs first; up to approximately 12 months
Number of participants with Tumor Lysis Syndrome (TLS)
Time Frame: From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurs first; up to approximately 12 months

TLS will be determined via laboratory values and assessed by the investigator.

In laboratory tumor lysis syndrome, 2 or more metabolic abnormalities must be present during the 24-hour period within 3 days before the start of study drug treatment or up to 7 days afterward. Clinical tumor lysis syndrome requires the presence of laboratory tumor lysis syndrome plus an increased creatinine level, seizures, cardiac dysrhythmia, or death.
From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurs first; up to approximately 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum observed plasma concentration (Cmax) After a Single Dose of BGB-21447
Time Frame: Up to approximately 8 weeks
Up to approximately 8 weeks
Area under the curve from time 0 to the last sampling time point within the dose interval (AUC0-t) After a Single Dose of BGB-21447
Time Frame: Up to approximately 8 weeks
Up to approximately 8 weeks
Area under the curve from time 0 extrapolated to infinity time (AUCinf) After a Single Dose of BGB-21447
Time Frame: Up to approximately 8 weeks
Up to approximately 8 weeks
Time to reach maximum observed plasma concentration (Tmax) After a Single Dose of BGB-21447
Time Frame: Up to approximately 8 weeks
Up to approximately 8 weeks
Apparent terminal elimination half-life (t1/2) After a Single Dose of BGB-21447
Time Frame: Up to approximately 8 weeks
Up to approximately 8 weeks
Apparent oral clearance (CL/F) After a Single Dose of BGB-21447
Time Frame: Up to approximately 8 weeks
Up to approximately 8 weeks
Apparent volume of distribution (Vz/F) After a Single Dose of BGB-21447
Time Frame: Up to approximately 8 weeks
Up to approximately 8 weeks
Steady state maximum observed plasma concentration (Cmax,ss) of BGB-21447
Time Frame: Up to approximately 8 weeks
Up to approximately 8 weeks
Steady state pre-dose trough concentration (Ctrough,ss) of BGB-21447
Time Frame: Up to approximately 8 weeks
Up to approximately 8 weeks
Steady state area under the curve from time 0 to the quantifiable concentration (AUClast,ss) of BGB-21447
Time Frame: Up to approximately 8 weeks
Up to approximately 8 weeks
Steady state time to reach maximum observed plasma concentration (Tmax,ss) of BGB-21447
Time Frame: Up to approximately 8 weeks
Up to approximately 8 weeks
Overall response rate (ORR)
Time Frame: Up to approximately 24 months
Defined as the percentage of patients who achieve partial response or better for diffuse large B-cell lymphoma, marginal zone lymphoma, follicular lymphoma, transformed B-NHL, and Richter's transformation to DLBCL as per the Lugano Classification for non-Hodgkin lymphoma.
Up to approximately 24 months
Duration of Response (DOR)
Time Frame: Up to approximately 24 months
Defined as the time from the first response documentation to the date that progression is documented after treatment initiation or death due to any cause, whichever occurs first.
Up to approximately 24 months
Time to response (TTR)
Time Frame: Up to approximately 24 months
Defined as the time from treatment initiation to the first documentation of response.
Up to approximately 24 months
Part 2: Progression-free survival (PFS)
Time Frame: Up to approximately 24 months
Defined as the time from treatment initiation to the first documented disease progression or death due to any cause, whichever occurs first.
Up to approximately 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BeOne Medicines

Investigators

  • Study Director: Study Director, BeOne Medicines

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 20, 2023

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

April 12, 2023

First Submitted That Met QC Criteria

April 12, 2023

First Posted (Actual)

April 25, 2023

Study Record Updates

Last Update Posted (Actual)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 10, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BGB-21447-101
  • CTR20231287 (Other Identifier: ChinaDrugTrials)
  • CT-2023-CTN-05421-1 (Other Identifier: Australia Clinical Trial Number)
  • 2025-521600-21-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved.

BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations.

Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.

IPD Sharing Time Frame

See plan description

IPD Sharing Access Criteria

See plan description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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