NCT05828589TerminatedPhase 1
A Study of BGB-21447, a Bcl-2 Inhibitor, in Mature B-Cell Malignancies
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
Source: ClinicalTrials.gov · Last updated 14 Jul 2026
Brief summary (registry, in English)
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."
- Status (registry)
- Terminated
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 51 (actual)
- First submitted
- 12 Apr 2023
- Start date
- 20 Jun 2023
- Primary completion date
- 8 Jun 2026
- Lead sponsor
- BeOne Medicines
- NCT number
- NCT05828589
- EU CT number
- 2025-521600-21-00
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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
Other
- Known central nervous system involvement by lymphoma/leukemia
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (28)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Pindara Private Hospital Coordinator of this site? Confirm its status | Benowa | Australia | Unknown status |
| Blacktown Cancer and Haematology Centre Coordinator of this site? Confirm its status | Blacktown | Australia | Unknown status |
| Monash Health Coordinator of this site? Confirm its status | Clayton | Australia | Unknown status |
| Linear Clinical Research Coordinator of this site? Confirm its status | Nedlands | Australia | Unknown status |
| Mater Cancer Care Centre Coordinator of this site? Confirm its status | South Brisbane | Australia | Unknown status |
| Peking University Third Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| The First Peoples Hospital of Changzhou Coordinator of this site? Confirm its status | Changzhou | China | Unknown status |
| Fujian Cancer Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| Shandong Provincial Hospital Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| Linyi Peoples Hospital Coordinator of this site? Confirm its status | Linyi | China | Unknown status |
| The First Affiliated Hospital of Nanchang University Branch Xianghu Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
| The First Affiliated Hospital of Nanchang University Branch Donghu Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
| Jiangsu Province Hospital Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| Affiliated Zhongshan Hospital of Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Shengjing Hospital Of China Medical University Coordinator of this site? Confirm its status | Shenyang | China | Unknown status |
| The First Affiliated Hospital of Soochow University Coordinator of this site? Confirm its status | Suzhou | China | Unknown status |
| Institute of Hematology and Hospital of Blood Disease Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Yichang Central Peoples Hospitaljiangnan Branch Coordinator of this site? Confirm its status | Yichang | China | Unknown status |
| Henan Cancer Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
| Auckland City Hospital Coordinator of this site? Confirm its status | Auckland | New Zealand | Unknown status |
| Sidney Kimmel Comprehensive Cancer at Johns Hopkins Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| University of Iowa Hospitals and Clinics Coordinator of this site? Confirm its status | Iowa City | United States | Unknown status |
| Nyu Langone Health Perlmutter Cancer Center At Nyu Langone Hospital Long Island Coordinator of this site? Confirm its status | Mineola | United States | Unknown status |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone Health Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Avera Cancer Institute Coordinator of this site? Confirm its status | Sioux Falls | United States | Unknown status |
| Sibley Memorial Hospital Johns Hopkins Medicine Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
| Mission Cancer and Blood Coordinator of this site? Confirm its status | Waukee | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.