Trials / Active Not Recruiting

Active Not RecruitingNCT05828589

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

Status: Active Not Recruiting
Phase: Phase 1
Study type: Interventional
Enrollment: 112 (estimated)

Sponsor: BeOne Medicines · Industry
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

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."

Detailed 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.

Conditions

Interventions

Type	Name	Description
DRUG	BGB-21447	BGB-21447 will be administered orally

Timeline

Start date: 2023-06-20
Primary completion: 2026-05-01
Completion: 2026-05-01
First posted: 2023-04-25
Last updated: 2026-03-12

Locations

28 sites across 4 countries: United States, Australia, China, New Zealand

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT05828589. Inclusion in this directory is not an endorsement.