Recruiting

Phase 3

BGB-16673 vs. PirtobrutinibA 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

Sponsor:

BeOne Medicines

Code:

NCT06973187

Conditions

Chronic Lymphocytic Leukemia

Small Lymphocytic Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tacabrutideg

Pirtobrutinib

Study Details

Brief summary:

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).

Conditions

Chronic Lymphocytic Leukemia

Small Lymphocytic Lymphoma

Study ID

NCT06973187

Start date

Sep 4, 2025

Status verified date

Aug, 2026

Completion date

Apr 17, 2028

Anticipated

Primary completion date

Apr 17, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A: Tacabrutideg

Participants will receive tacabrutideg orally.

active comparator: Arm B: Pirtobrutinib

Participants will receive pirtobrutinib orally.

Interventions

Tacabrutideg

Tacabrutideg will be administered orally

Pirtobrutinib

Pirtobrutinib will be administered orally

Primary outcome measure

Progression-Free Survival (PFS) per Independent Review Committee (IRC) [ Time Frame: Up to approximately 3 years ]

Central Contacts and Locations

Central contacts

Study Director

1-877-828-5568 clinicaltrials@beonemed.com

Locations

University of Alabama At Birmingham Hospital

Recruiting

Birmingham, Alabama, United States, 35294-0004

Mayo Clinic Phoenix

Recruiting

Phoenix, Arizona, United States, 85054-4502

Kaiser Permanente Southern California

Recruiting

Irvine, California, United States, 92618-3734

University of California San Diego (Ucsd) Moores Cancer Center

Recruiting

La Jolla, California, United States, 92093-1503

Cancer and Blood Specialty Clinic

Recruiting

Los Alamitos, California, United States, 90720-3302

UCLA Department of Medicine Hematologyoncology

Recruiting

Los Angeles, California, United States, 90095-3075

Kaiser Permanente Oakland Medical Center

Recruiting

Oakland, California, United States, 94611

Stanford Cancer Institute

Recruiting

Palo Alto, California, United States, 94304-2205

Kaiser Permanente Roseville Medical Center

Recruiting

Roseville, California, United States, 95661

Kaiser Permanente San Francisco Medical Center Oncology

Recruiting

San Francisco, California, United States, 94115

Kaiser Permanente Santa Clara Medical Center Oncologyhematology

Recruiting

Santa Clara, California, United States, 95051

Kaiser Permanente Northern California

Recruiting

Vallejo, California, United States, 94589-2441

Kaiser Permanente Walnut Creek Medical Center

Recruiting

Walnut Creek, California, United States, 94596

Christiana Care

Recruiting

Newark, Delaware, United States, 19713-2055

Medstar Georgetown University Hospital

Recruiting

Washington D.C., District of Columbia, United States, 20007-2113

Mayo Clinic Jacksonville

Recruiting

Jacksonville, Florida, United States, 32224-1865

Cancer Specialists of North Florida

Recruiting

Jacksonville, Florida, United States, 32256

Mount Sinai Medical Center Braman Comprehensive Cancer Center

Recruiting

Miami, Florida, United States, 33140

University of Chicago Medical Center

Recruiting

Chicago, Illinois, United States, 60637-1443

Mission Cancer and Blood

Recruiting

Waukee, Iowa, United States, 50263

The University of Kansas Cancer Center

Recruiting

Westwood, Kansas, United States, 66205-2003

Our Lady of the Lake Hospital

Recruiting

Baton Rouge, Louisiana, United States, 70808-4365

Mary Bird Perkins Cancer Center

Recruiting

Baton Rouge, Louisiana, United States, 70809-3738

Ochsner Clinic Foundation

Recruiting

New Orleans, Louisiana, United States, 70121-2429

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215-5418

Karmanos Cancer Institute

Recruiting

Detroit, Michigan, United States, 48201-2013

Mayo Clinic Rochester

Recruiting

Rochester, Minnesota, United States, 55905-0001

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110-1010

Titan Health Partners Llc Dba Astera Cancer Care

Recruiting

East Brunswick, New Jersey, United States, 08816-4096

John Theurer Cancer Center Hackensack University Medical Center

Recruiting

Hackensack, New Jersey, United States, 07601

Columbia University Medical Center

Recruiting

New York, New York, United States, 10032

Memorial Sloan Kettering Cancer Center Mskcc

Recruiting

New York, New York, United States, 10065-6800

University of Rochester

Recruiting

Rochester, New York, United States, 14642-0001

University of North Carolina At Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27514-4220

Atrium Health Levine Cancer Institute (Lci)

Recruiting

Charlotte, North Carolina, United States, 28204-2990

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27705-3976

Atrium Health Wake Forest Baptist

Recruiting

Winston-Salem, North Carolina, United States, 27157

Dayton Physician Network

Recruiting

Dayton, Ohio, United States, 45415

Fox Chase Cancer Center

Recruiting

Philadelphia, Pennsylvania, United States, 19111-2434

Tennessee Oncology, Pllc Nashville

Recruiting

Nashville, Tennessee, United States, 37203

Md Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030-3907

Blue Ridge Cancer Care (Oncology and Hematology Associates of Southwest Virginia)

Recruiting

Roanake, Virginia, United States, 24014

Fred Hutchinson Cancer Research Center

Recruiting

Seattle, Washington, United States, 98109-4433

Summit Cancer Centers

Recruiting

Spokane, Washington, United States, 99208-1129

Northwest Medical Specialties

Recruiting

Tacoma, Washington, United States, 98405

Gunderson Health System

Recruiting

La Crosse, Wisconsin, United States, 54601-5467

More Information

Sponsor

BeOne Medicines

Last update posted

Aug 26, 2026

Last verified

Aug, 2026

Keywords

Noncovalent Bruton tyrosine kinase inhibitor
Bruton tyrosine kinase-targeted protein degrader

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by BeOne Medicines on 2026-08-26.