A Study of Tacabrutideg (BGB-16673) Compared to Investigator's Choice in Participants With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Both Bruton Tyrosine Kinase (BTK) and B-cell Leukemia/Lymphoma 2 Protein (BCL2) Inhibitors

NCT06846671 · tracked via the Priya Life Science USA tracker

Sponsor

BeOne Medicines

Phase

Phase 3

Started

2025-04-10

Last updated

2026-09-14

Condition(s) studied

CLLChronic Lymphocytic Leukemia

Investigational drug(s) / intervention(s)

TacabrutidegBendamustineIdelalisibRituximabVenetoclax

Tacabrutideg: Administered orally

Bendamustine: Administered intravenously

Idelalisib: Administered orally

Rituximab: Administered intravenously

Venetoclax: Administered orally

Study summary

The purpose of this study is to investigate the efficacy and safety of tacabrutideg compared with investigator's choice (idelalisib plus rituximab \[for CLL only\] or bendamustine plus rituximab or venetoclax plus rituximab retreatment) in participants with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) previously exposed to both BTK inhibitors (BTKi) and BCL2 inhibitors (BCL2i).

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: 1. Confirmed diagnosis of CLL or SLL, requiring treatment, based on 2018 international workshop on chronic lymphocytic leukemia (iwCLL) criteria. 2. Previously received treatment for CLL/SLL with both a BTKi and a BCL2i. 3. Participants with SLL must have measurable disease by computer tomography (CT)/magnetic resonance imaging (MRI) 4. Eastern Cooperative Oncology Group (ECOG) score 0, 1, or 2 5. Adequate liver function 6. Adequate blood clotting function Exclusion Criteria: 1. Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation 2. Prior autologous stem cell transplant or chimeric antigen receptor-T cell therapy in the last 3 months 3. Known central nervous system involvement 4. Prior exposure to any BTK protein degraders 5. Active fungal, bacterial and/or viral infection requiring parenteral systemic therapy 6. Clinically significant cardiovascular disease NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcome measure(s)

Progression-Free Survival (PFS) by Independent Review Committee (IRC) — Approximately 36 Months
PFS is defined as time from the date of randomization to the date of first disease progression or death, whichever occurs first, as determined by IRC using modified 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria for participants with chronic lymphocytic leukemia (CLL) and Lugano classification for participants with small lymphocytic lymphoma (SLL).

Trial sites (130)

Facility	City	Region	Status
St Bernards Medical Center	Jonesboro	Arkansas	Recruiting
UCLA Department of Medicine Hematologyoncology	Los Angeles	California	Recruiting
Scripps Prebys Cancer Center	San Diego	California	Recruiting
Pih Health Whittier Hospital	Whittier	California	Recruiting
Rocky Mountain Cancer Centers (Williams) Usor	Aurora	Colorado	Recruiting
Florida Oncology and Hematology	Fort Myers	Florida	Recruiting
Baptist Md Anderson Cancer Center	Jacksonville	Florida	Recruiting
Cleveland Clinic Florida	Weston	Florida	Recruiting
Emory University Winship Cancer Institute	Atlanta	Georgia	Recruiting
Northside Cancer Center	Atlanta	Georgia	Recruiting
Our Lady of the Lake Hospital	Baton Rouge	Louisiana	Recruiting
American Oncology Partners of Maryland Pa	Bethesda	Maryland	Recruiting
Corewell Health the Michigan Cancer Consortium	Grand Rapids	Michigan	Recruiting
St Lukes Center For Cancer Care	Chesterfield	Missouri	Recruiting
Oncology Hematology Associates	Springfield	Missouri	Recruiting
St Vincent Frontier Cancer Center	Billings	Montana	Recruiting
Oncology Hematology West, Pc Dba Nebraska Cancer Specialists	Omaha	Nebraska	Recruiting
Memorial Sloan Kettering Cancer Center Mskcc	New York	New York	Recruiting
New York Cancer and Blood Specialists	Shirley	New York	Recruiting
Optum Medical Care, Pc	Westbury	New York	Recruiting
University Hospitals	Cleveland	Ohio	Recruiting
Dayton Physician Network	Dayton	Ohio	Recruiting
Oncology Associates of Oregon Willamette Valley Cancer Center	Eugene	Oregon	Recruiting
West Penn Hospital	Pittsburgh	Pennsylvania	Recruiting
Cancer Care Associates of York	York	Pennsylvania	Recruiting
Baylor Scott and White Health	Temple	Texas	Recruiting
Texas Oncology Tyler	Tyler	Texas	Recruiting
Hospital Aleman	Caba	Argentina	Recruiting
CEMIC	Caba	Argentina	Recruiting
FUNDALEU	Caba	Argentina	Recruiting
Hospital Italiano de Buenos Aires	Ciudad Autonoma Buenos Aires	Argentina	Recruiting
Instituto Alexander Fleming (Iaf)	Ciudad Autonoma Buenos Aires	Argentina	Recruiting
Cice 9 de Julio Sanatorio 9 de Julio	San Miguel de Tucumán	Argentina	Recruiting
Concord Repatriation General Hospital	Concord	New South Wales	Recruiting
Gosford Hospital	Gosford	New South Wales	Recruiting
Port Macquarie Base Hospital	Port Macquarie	New South Wales	Recruiting
Prince of Wales Hospital	Randwick	New South Wales	Recruiting
Toowoomba Hospital	Toowoomba	Queensland	Recruiting
Flinders Medical Centre	Bedford PK	South Australia	Recruiting
The Alfred Hospital	Melbourne	Victoria	Recruiting

+ 90 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06846671 on ClinicalTrials.gov ↗ ← All trials in the USA