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A Study of BGB-21447, a Bcl-2 Inhibitor, in Mature B-Cell Malignancies
Sponsor: BeOne Medicines
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."
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
112
Start Date
2023-06-20
Completion Date
2026-05
Last Updated
2026-03-12
Healthy Volunteers
No
Conditions
Interventions
BGB-21447
BGB-21447 will be administered orally
Locations (28)
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
Affiliated Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Institute of Hematology and Hospital of Blood Disease
Tianjin, Tianjin Municipality, China
Auckland City Hospital
Auckland, New Zealand