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

Stopped early · Phase 1

Conditions studied: 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

In brief

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."

Key facts

Study ID

NCT05828589

Run by

BeOne Medicines

People needed

51

Starts

2023-06-20

Expected to finish

2026-06-08

Last updated by the study team

2026-07-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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
• 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 protocol-defined Inclusion/Exclusion criteria may apply.

Where it is running

• Sibley Memorial Hospital Johns Hopkins Medicine — Washington D.C., District of Columbia, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• Mission Cancer and Blood — Waukee, Iowa, United States
• Sidney Kimmel Comprehensive Cancer At Johns Hopkins — Baltimore, Maryland, United States
• Nyu Langone Health Perlmutter Cancer Center At Nyu Langone Hospital Long Island — Mineola, New York, United States
• Laura and Isaac Perlmutter Cancer Center At Nyu Langone Health — New York, New York, United States
• Avera Cancer Institute — Sioux Falls, South Dakota, United States
• Blacktown Cancer and Haematology Centre — Blacktown, New South Wales, Australia
• Pindara Private Hospital — Benowa, Queensland, Australia
• Mater Cancer Care Centre — South Brisbane, Queensland, Australia
• Monash Health — Clayton, Victoria, Australia
• Linear Clinical Research — Nedlands, Western Australia, Australia
• Peking University Third Hospital — Beijing, Beijing Municipality, China
• Fujian Cancer Hospital — Fuzhou, Fujian, China
• Henan Cancer Hospital — Zhengzhou, Henan, China
• Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology — Wuhan, Hubei, China
• Yichang Central Peoples Hospitaljiangnan Branch — Yichang, Hubei, China
• The First Peoples Hospital of Changzhou — Changzhou, Jiangsu, China
• Jiangsu Province Hospital — Nanjing, Jiangsu, China
• The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China
• The First Affiliated Hospital of Nanchang University Branch Donghu — Nanchang, Jiangxi, China
• The First Affiliated Hospital of Nanchang University Branch Xianghu — Nanchang, Jiangxi, China
• Shengjing Hospital of China Medical University — Shenyang, Liaoning, China
• Shandong Provincial Hospital — Jinan, Shandong, China
• Linyi Peoples Hospital — Linyi, Shandong, China

Full record on ClinicalTrials.gov

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