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

Study at a glance

From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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

ClinicalTrials.gov ID

NCT05828589

Acronym / sponsor ID

BGB-21447-101

Conditions

Relapsed Non-Hodgkin Lymphoma, Refractory Non-Hodgkin Lymphoma, Relapsed Chronic Lymphocytic Leukemia, Refractory Chronic Lymphocytic Leukemia, Relapsed Follicular Lymphoma, Relapsed Marginal Zone Lymphoma

Keywords

Relapsed Non-Hodgkin Lymphoma, refractory non-Hodgkin lymphoma, Relapsed Chronic Lymphocytic Leukemia, Follicular Lymphoma, Marginal Zone Lymphoma, NHL, FL, MZL

Phase

Phase 1

Study type

Interventional

Recruitment status

TerminatedReason stopped: This decision is due to a company business decision with strategy change on the BGB-21447 development in B-cell malignancies and is not driven by safety concerns.

Enrolment

51 participants (actual)

Lead sponsor

BeOne MedicinesIndustry (pharma, biotech, devices)

Study start

20 Jun 2023 (actual)

Primary completion

8 Jun 2026 (actual)

Study completion

8 Jun 2026 (actual)

First posted

25 Apr 2023 (actual)

Results

Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Treatment

Allocation

Randomised

Intervention model

Sequential

Masking

None (open label)

Number of arms

4

Who may qualify

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Part 1: Number of participants with dose limiting toxicities (DLTs)

   Time frame: Up to approximately 1 month

   Number of participants with dose limiting toxicities, as defined in the study protocol.

2. Number of participants with adverse events (AEs)

   Time frame: From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurs first; up to approximately 12 months

   Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) assessed and graded based upon the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0).

3. Number of participants with Tumor Lysis Syndrome (TLS)

   Time frame: From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurs first; up to approximately 12 months

   TLS will be determined via laboratory values and assessed by the investigator. In laboratory tumor lysis syndrome, 2 or more metabolic abnormalities must be present during the 24-hour period within 3 days before the start of study drug treatment or up to 7 days afterward. Clinical tumor lysis syndrome requires the presence of laboratory tumor lysis syndrome plus an increased creatinine level, seizures, cardiac dysrhythmia, or death.

Results and safety

The study was stopped early (reason given: This decision is due to a company business decision with strategy change on the BGB-21447 development in B-cell malignancies and is not driven by safety concerns.). Results are not available in the source record.

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
• Individual participant dataSharing planned: Yes. BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

28 sites in 4 countries: see every site and its status.