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

NCT05828589 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2026-03-12

No results posted yet for this 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 Optimization."

Conditions

  • 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

Interventions

DRUG

BGB-21447

BGB-21447 will be administered orally

Sponsors & Collaborators

  • BeOne Medicines

    lead INDUSTRY

Principal Investigators

  • Study Director · BeOne Medicines

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-20
Primary Completion
2026-05-31
Completion
2026-05-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • China
  • New Zealand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05828589 on ClinicalTrials.gov