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

Last updated: March 10, 2026
Sponsor: BeOne Medicines
Overall Status: Active - Not Recruiting

Phase

1

Condition

Marginal Zone Lymphoma

Chronic Lymphocytic Leukemia

Lymphoma

Treatment

BGB-21447

Clinical Study ID

NCT05828589
BGB-21447-101
2025-521600-21-00
CTR20231287
CT-2023-CTN-05421-1
  • Ages > 18
  • All Genders

Study Summary

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."

Eligibility Criteria

Inclusion

Inclusion Criteria

  1. Confirmed diagnosis (per World Health Organization [WHO] guidelines, unlessotherwise noted) of one of the following: Cohort A1 and Cohort A2:

  2. R/R DLBCL (for Cohort A1 and Cohort A2.1)

  • High-grade B-cell lymphomas with translocations of MYC and Bcl-2 and/orBcl-6 are not allowed in Cohort A1 but may be allowed in Cohort A2.1
  1. R/R FL (for Cohort A1 and Cohort A2.2)

  2. R/R MZL (for Cohort A1 and Cohort A2.2)

  3. Transformed B-cell NHL (for Cohort A1 only)

  4. Richter's transformation to DLBCL (for Cohort A1 only)

  5. Measurable disease by computed tomography/magnetic resonance imaging.

Exclusion

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 bladdercancer, carcinoma in situ of the cervix or breast, or localized Gleason score ≤ 6prostate 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 studydrug. Or prior chimeric antigen receptor T-cell (CAR-T) therapy < 3 months beforethe 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 Design

Total Participants: 112
Treatment Group(s): 1
Primary Treatment: BGB-21447
Phase: 1
Study Start date:
June 20, 2023
Estimated Completion Date:
May 31, 2026

Study 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.

Connect with a study center

  • Blacktown Cancer and Haematology Centre

    Blacktown, New South Wales NSW 2148
    Australia

    Site Not Available

  • Blacktown Cancer and Haematology Centre

    Blacktown 2175411, New South Wales 2155400 NSW 2148
    Australia

    Site Not Available

  • Pindara Private Hospital

    Benowa, Queensland QLD 4217
    Australia

    Site Not Available

  • Mater Cancer Care Centre

    South Brisbane, Queensland QLD 4101
    Australia

    Site Not Available

  • Pindara Private Hospital

    Benowa 2176127, Queensland 2152274 QLD 4217
    Australia

    Site Not Available

  • Mater Cancer Care Centre

    South Brisbane 2207259, Queensland 2152274 QLD 4101
    Australia

    Site Not Available

  • Monash Health

    Clayton, Victoria VIC 3168
    Australia

    Site Not Available

  • Monash Health

    Clayton 2171400, Victoria 2145234 VIC 3168
    Australia

    Site Not Available

  • Linear Clinical Research

    Nedlands, Western Australia WA 6009
    Australia

    Site Not Available

  • Linear Clinical Research

    Nedlands 2064874, Western Australia 2058645 WA 6009
    Australia

    Site Not Available

  • Peking University Third Hospital

    Beijing, Beijing Municipality 100000
    China

    Site Not Available

  • Peking University Third Hospital

    Beijing 1816670, Beijing Municipality 2038349 100000
    China

    Site Not Available

  • Fujian Cancer Hospital

    Fuzhou, Fujian 350014
    China

    Site Not Available

  • Fujian Cancer Hospital

    Fuzhou 1810821, Fujian 1811017 350014
    China

    Site Not Available

  • Henan Cancer Hospital

    Zhengzhou, Henan 450000
    China

    Site Not Available

  • Henan Cancer Hospital

    Zhengzhou 1784658, Henan 1808520 450000
    China

    Site Not Available

  • Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei 430030
    China

    Site Not Available

  • Yichang Central Peoples Hospitaljiangnan Branch

    Yichang, Hubei 443001
    China

    Site Not Available

  • Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology

    Wuhan 1791247, Hubei 1806949 430030
    China

    Site Not Available

  • Yichang Central Peoples Hospitaljiangnan Branch

    Yichang 1786764, Hubei 1806949 443001
    China

    Site Not Available

  • The First Peoples Hospital of Changzhou

    Changzhou, Jiangsu 213000
    China

    Site Not Available

  • Jiangsu Province Hospital

    Nanjing, Jiangsu 210029
    China

    Site Not Available

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu 215006
    China

    Site Not Available

  • The First Peoples Hospital of Changzhou

    Changzhou 1815456, Jiangsu 1806260 213000
    China

    Site Not Available

  • Jiangsu Province Hospital

    Nanjing 1799962, Jiangsu 1806260 210029
    China

    Site Not Available

  • The First Affiliated Hospital of Soochow University

    Suzhou 1886760, Jiangsu 1806260 215006
    China

    Site Not Available

  • The First Affiliated Hospital of Nanchang University Branch Donghu

    Nanchang, Jiangxi 330006
    China

    Site Not Available

  • The First Affiliated Hospital of Nanchang University Branch Xianghu

    Nanchang, Jiangxi 332000
    China

    Site Not Available

  • The First Affiliated Hospital of Nanchang University Branch Donghu

    Nanchang 1800163, Jiangxi 1806222 330006
    China

    Site Not Available

  • The First Affiliated Hospital of Nanchang University Branch Xianghu

    Nanchang 1800163, Jiangxi 1806222 332000
    China

    Site Not Available

  • The First Hospital of Jilin University

    Changchun, Jilin 130021
    China

    Site Not Available

  • The First Hospital of Jilin University

    Changchun 2038180, Jilin 2036500 130021
    China

    Site Not Available

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning 110004
    China

    Site Not Available

  • Shengjing Hospital of China Medical University

    Shenyang 2034937, Liaoning 2036115 110004
    China

    Site Not Available

  • Shandong Provincial Hospital

    Jinan, Shandong 250021
    China

    Site Not Available

  • Linyi Peoples Hospital

    Linyi, Shandong 276000
    China

    Site Not Available

  • Shandong Provincial Hospital

    Jinan 1805753, Shandong 1796328 250021
    China

    Site Not Available

  • Linyi Peoples Hospital

    Linyi 1803318, Shandong 1796328 276000
    China

    Site Not Available

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai 200000
    China

    Site Not Available

  • Affiliated Zhongshan Hospital of Fudan University

    Shanghai, Shanghai Municipality 200032
    China

    Site Not Available

  • Affiliated Zhongshan Hospital of Fudan University

    Shanghai 1796236, Shanghai Municipality 1796231 200032
    China

    Site Not Available

  • Fudan University Shanghai Cancer Center

    Shanghai 1796236, Shanghai Municipality 1796231 200000
    China

    Site Not Available

  • West China Hospital, Sichuan University

    Chengdu, Sichuan 610041
    China

    Site Not Available

  • West China Hospital, Sichuan University

    Chengdu 1815286, Sichuan 1794299 610041
    China

    Site Not Available

  • Institute of Hematology and Hospital of Blood Disease

    Tianjin, Tianjin Municipality 300020
    China

    Site Not Available

  • Institute of Hematology and Hospital of Blood Disease

    Tianjin 1792947, Tianjin Municipality 1792943 300020
    China

    Site Not Available

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang 310003
    China

    Site Not Available

  • Chu Dijon

    Dijon, 21000
    France

    Site Not Available

  • Chu Dijon

    Dijon 3021372, 21000
    France

    Site Not Available

  • Chu Montpellier Hopital Saint Eloi

    Montpellier, 34090
    France

    Site Not Available

  • Chu Montpellier Hopital Saint Eloi

    Montpellier 2992166, 34090
    France

    Site Not Available

  • Hopital Saint Louis

    Paris, 75010
    France

    Site Not Available

  • Hopital Saint Louis

    Paris 2988507, 75010
    France

    Site Not Available

  • Iuc Toulouse Oncopole

    Toulouse, 31100
    France

    Site Not Available

  • Iuc Toulouse Oncopole

    Toulouse 2972315, 31100
    France

    Site Not Available

  • Azienda Ospedaliera Universitaria Policlinico Santorsola Malpighi

    Bologna, 40138
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Policlinico Santorsola Malpighi

    Bologna 3181928, 40138
    Italy

    Site Not Available

  • Istituto Nazionale Tumori Fondazione G Pascale

    Napoli, 80131
    Italy

    Site Not Available

  • Istituto Nazionale Tumori Fondazione G Pascale

    Napoli 9031661, 80131
    Italy

    Site Not Available

  • Istituto Clinico Humanitas

    Rozzano, 20089
    Italy

    Site Not Available

  • Istituto Clinico Humanitas

    Rozzano 3168837, 20089
    Italy

    Site Not Available

  • Centroricerche Cliniche Di Verona Srl

    Verona, 37134
    Italy

    Site Not Available

  • Centroricerche Cliniche Di Verona Srl

    Verona 3164527, 37134
    Italy

    Site Not Available

  • Auckland City Hospital

    Auckland, 1023
    New Zealand

    Site Not Available

  • Auckland City Hospital

    Auckland 2193733, 1023
    New Zealand

    Site Not Available

  • Sibley Memorial Hospital Johns Hopkins Medicine

    Washington D.C., District of Columbia 20016
    United States

    Site Not Available

  • Sibley Memorial Hospital Johns Hopkins Medicine

    Washington D.C. 4140963, District of Columbia 4138106 20016
    United States

    Site Not Available

  • Mission Cancer and Blood

    Des Moines, Iowa 50309
    United States

    Site Not Available

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa 52242-1009
    United States

    Site Not Available

  • Mission Cancer and Blood

    Waukee, Iowa 50263
    United States

    Site Not Available

  • University of Iowa Hospitals and Clinics

    Iowa City 4862034, Iowa 4862182 52242-1009
    United States

    Site Not Available

  • Mission Cancer and Blood

    Waukee 4880981, Iowa 4862182 50263
    United States

    Site Not Available

  • Sidney Kimmel Comprehensive Cancer At Johns Hopkins

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Sidney Kimmel Comprehensive Cancer At Johns Hopkins

    Baltimore 4347778, Maryland 4361885 21287
    United States

    Site Not Available

  • Nyu Langone Health Perlmutter Cancer Center At Nyu Langone Hospital Long Island

    Mineola, New York 11501
    United States

    Site Not Available

  • Laura and Isaac Perlmutter Cancer Center At Nyu Langone Health

    New York, New York 10016-2708
    United States

    Site Not Available

  • Nyu Langone Health Perlmutter Cancer Center At Nyu Langone Hospital Long Island

    Mineola 5127134, New York 5128638 11501
    United States

    Site Not Available

  • Laura and Isaac Perlmutter Cancer Center At Nyu Langone Health

    New York 5128581, New York 5128638 10016-2708
    United States

    Site Not Available

  • Thomas Jefferson University

    Philadelphia, Pennsylvania 19107-4216
    United States

    Site Not Available

  • Thomas Jefferson University

    Philadelphia 4560349, Pennsylvania 6254927 19107-4216
    United States

    Site Not Available

  • Avera Cancer Institue

    Sioux Falls, South Dakota 57105-2108
    United States

    Site Not Available

  • Avera Cancer Institute

    Sioux Falls, South Dakota 57105-2108
    United States

    Site Not Available

  • Avera Cancer Institute

    Sioux Falls 5231851, South Dakota 5769223 57105-2108
    United States

    Site Not Available

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