A Study to Evaluate the Safety and Efficacy of Tacabrutideg (BGB-16673) Compared to Pirtobrutinib in Adults With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
A Phase 3, Open-Label, Randomized Study to Evaluate the Safety and Efficacy of BGB-16673 Compared to Pirtobrutinib in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
- Chronic Lymphocytic Leukemia
- Small Lymphocytic Lymphoma
At a glance
- Phase
- Phase 3
- Study type
- Interventional
- Sponsor
- BeOne Medicines
- Enrolment target
- 500
- Started
- 4 September 2025
- Main results due
- 17 April 2028
- Study sites
- 217
- Registry updated
- 28 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
Inclusion Criteria: * Confirmed diagnosis of CLL or SLL, requiring treatment, based on 2018 iwCLL criteria * Previously received treatment for CLL/SLL with a covalent Bruton tyrosine kinase inhibitor (cBTKi). Patients should have disease relapsed after or refractory to at least 1 line of therapy including a cBTKi. * Participants with SLL must have measurable disease by computed tomography/magnetic resonance imaging, defined as ≥ 1 lymph node \> 1.5 cm in longest diameter and measurable in 2 perpendicular diameters. Exclusion Criteria: * Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation. * History of known bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention * History of ischemic stroke or intracranial hemorrhage within 6 months before first dose of study drug * Prior exposure to any Bruton tyrosine kinase (BTK) protein degraders or noncovalent Bruton tyrosine kinase inhibitor (ncBTKi). * Current or history of central nervous system involvement including the brain, spinal cord, leptomeninges, and cerebrospinal fluid (as documented by imaging, cytology, or biopsy) by CLL/SLL NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
What this study is about
In the sponsor’s own words, from the registry.
The purpose of this study is to evaluate the efficacy and safety of tacabrutideg alone compared with pirtobrutinib in patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who had been previously treated with a covalent Bruton tyrosine kinase inhibitor (cBTKi).
Study sites(217)
University of Alabama At Birmingham Hospital
Birmingham, Alabama, United States
Recruiting
Mayo Clinic Phoenix
Phoenix, Arizona, United States
Recruiting
Kaiser Permanente Southern California
Irvine, California, United States
Recruiting
University of California San Diego (Ucsd) Moores Cancer Center
La Jolla, California, United States
Recruiting
Cancer and Blood Specialty Clinic
Los Alamitos, California, United States
Recruiting
UCLA Department of Medicine Hematologyoncology
Los Angeles, California, United States
Recruiting
Kaiser Permanente Oakland Medical Center
Oakland, California, United States
Recruiting
Stanford Cancer Institute
Palo Alto, California, United States
Recruiting
Kaiser Permanente Roseville Medical Center
Roseville, California, United States
Recruiting
Kaiser Permanente San Francisco Medical Center Oncology
San Francisco, California, United States
Recruiting
Kaiser Permanente Santa Clara Medical Center Oncologyhematology
Santa Clara, California, United States
Recruiting
Kaiser Permanente Northern California
Vallejo, California, United States
Recruiting
Kaiser Permanente Walnut Creek Medical Center
Walnut Creek, California, United States
Recruiting
Christiana Care
Newark, Delaware, United States
Recruiting
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, United States
Recruiting
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
Recruiting
Cancer Specialists of North Florida
Jacksonville, Florida, United States
Recruiting
Mount Sinai Medical Center Braman Comprehensive Cancer Center
Miami, Florida, United States
Recruiting
University of Chicago Medical Center
Chicago, Illinois, United States
Recruiting
Mission Cancer and Blood
Waukee, Iowa, United States
Recruiting
The University of Kansas Cancer Center
Westwood, Kansas, United States
Recruiting
Our Lady of the Lake Hospital
Baton Rouge, Louisiana, United States
Recruiting
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States
Recruiting
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Recruiting
Karmanos Cancer Institute
Detroit, Michigan, United States
Recruiting
Mayo Clinic Rochester
Rochester, Minnesota, United States
Recruiting
Washington University School of Medicine
St Louis, Missouri, United States
Recruiting
Titan Health Partners Llc Dba Astera Cancer Care
East Brunswick, New Jersey, United States
Recruiting
John Theurer Cancer Center Hackensack University Medical Center
Hackensack, New Jersey, United States
Recruiting
Columbia University Medical Center
New York, New York, United States
Recruiting
Weill Cornell Medical College Newyork Presbyterian Hospital
New York, New York, United States
Recruiting
Memorial Sloan Kettering Cancer Center Mskcc
New York, New York, United States
Recruiting
University of Rochester
Rochester, New York, United States
Recruiting
University of North Carolina At Chapel Hill
Chapel Hill, North Carolina, United States
Recruiting
Atrium Health Levine Cancer Institute (Lci)
Charlotte, North Carolina, United States
Recruiting
Duke University Medical Center
Durham, North Carolina, United States
Recruiting
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, United States
Recruiting
Dayton Physician Network
Dayton, Ohio, United States
Recruiting
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Recruiting
Medical University of South Carolina
Charleston, South Carolina, United States
Recruiting
Tennessee Oncology, Pllc Nashville
Nashville, Tennessee, United States
Recruiting
Md Anderson Cancer Center
Houston, Texas, United States
Recruiting
Texas Oncology Palestine Cancer Center
Palestine, Texas, United States
Recruiting
Blue Ridge Cancer Care (Oncology and Hematology Associates of Southwest Virginia)
Roanake, Virginia, United States
Recruiting
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Recruiting
Summit Cancer Centers
Spokane, Washington, United States
Recruiting
Northwest Medical Specialties
Tacoma, Washington, United States
Recruiting
Gunderson Health System
La Crosse, Wisconsin, United States
Recruiting
FUNDALEU
Caba, Argentina
Recruiting
Sanatorio Allende
Córdoba, Argentina
Recruiting
Centro Oncologico de Integracion Regional (Coir)
Mendoza, Argentina
Recruiting
Hospital Privado de Rosario
Rosario, Argentina
Recruiting
Concord Repatriation General Hospital
Concord, New South Wales, Australia
Recruiting
St George Private Hospital
Kogarah, New South Wales, Australia
Recruiting
Westmead Private Hospital
Westmead, New South Wales, Australia
Recruiting
Pindara Private Hospital
Benowa, Queensland, Australia
Recruiting
Sunshine Coast Hospital and Health Service
Birtinya, Queensland, Australia
Recruiting
John Flynn Private Hospital
Tugun, Queensland, Australia
Recruiting
Flinders Medical Centre
Bedford PK, South Australia, Australia
Recruiting
Showing 60 of 217 sites — filter to narrow it down. 217 of the 217 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT06973187. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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