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

Last updated: March 11, 2025
Sponsor: BeiGene
Overall Status: Active - Recruiting

Phase

1

Condition

Lymphoproliferative Disorders

Lymphoma, B-cell

Follicular Lymphoma

Treatment

BGB-21447

Clinical Study ID

NCT05828589
BGB-21447-101
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 Expansion."

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

  3. R/R FL

  4. R/R MZL

  5. Transformed B-cell NHL

  6. Richter's transformation to DLBCL

  7. 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

  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: 85
Treatment Group(s): 1
Primary Treatment: BGB-21447
Phase: 1
Study Start date:
June 20, 2023
Estimated Completion Date:
October 31, 2026

Connect with a study center

  • Blacktown Cancer and Haematology Centre

    Blacktown, New South Wales 2148
    Australia

    Active - Recruiting

  • Pindara Private Hospital

    Benowa, Queensland 4217
    Australia

    Active - Recruiting

  • Monash Health

    Clayton, Victoria 3168
    Australia

    Active - Recruiting

  • Linear Clinical Research

    Nedlands, Western Australia 6009
    Australia

    Active - Recruiting

  • Peking University Third Hospital

    Beijing, Beijing 100000
    China

    Active - Recruiting

  • Fujian Cancer Hospital

    Fuzhou, Fujian 350014
    China

    Active - Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan 450000
    China

    Active - Recruiting

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

    Wuhan, Hubei 430030
    China

    Active - Recruiting

  • Jiangsu Province Hospital

    Nanjing, Jiangsu 210029
    China

    Active - Recruiting

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu 215006
    China

    Active - Recruiting

  • The First Affiliated Hospital of Nanchang University Branch Donghu

    Nanchang, Jiangxi 330006
    China

    Active - Recruiting

  • The First Affiliated Hospital of Nanchang University Branch Xianghu

    Nanchang, Jiangxi 332000
    China

    Active - Recruiting

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning 110004
    China

    Active - Recruiting

  • Shandong Provincial Hospital

    Jinan, Shandong 250021
    China

    Active - Recruiting

  • Linyi Peoples Hospital

    Linyi, Shandong 276000
    China

    Active - Recruiting

  • Affiliated Zhongshan Hospital of Fudan University

    Shanghai, Shanghai 200032
    China

    Active - Recruiting

  • Institute of Hematology and Hospital of Blood Disease

    Tianjin, Tianjin 300020
    China

    Active - Recruiting

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang 310003
    China

    Active - Recruiting

  • Auckland City Hospital

    Auckland, 1023
    New Zealand

    Active - Recruiting

  • Mission Cancer and Blood

    Des Moines, Iowa 50309
    United States

    Site Not Available

  • Sidney Kimmel Comprehensive Cancer At Johns Hopkins

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Thomas Jefferson University

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Avera Cancer Institue

    Sioux Falls, South Dakota 57105
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.