Active — Not RecruitingPhase 1

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

United States, Australia, China112 participantsStarted 2023-06-20

Plain-language 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."

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Confirmed diagnosis (per World Health Organization \[WHO\] guidelines, unless otherwise noted) of one of the following:
. R/R DLBCL (for Cohort A1 and 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.

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Up to approximately 1 month

Number of participants with adverse events (AEs)

Timeframe: 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 Tumor Lysis Syndrome (TLS)

Timeframe: 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

Trial details

NCT IDNCT05828589

SponsorBeOne Medicines

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-05

View on ClinicalTrials.gov More Relapsed Non-Hodgkin Lymphoma trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Confirmed diagnosis (per World Health Organization \[WHO\] guidelines, unless otherwise noted) of one of the following:
. R/R DLBCL (for Cohort A1 and 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.

Exclusion criteria

What they're measuring

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

Timeframe: Up to approximately 1 month

Number of participants with adverse events (AEs)

Timeframe: 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 Tumor Lysis Syndrome (TLS)

Timeframe: 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