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Each trial has specific eligibility criteria including age, condition, medical history, and current treatments. TrialConnect shows you trials that may match your situation, but only the trial team can confirm eligibility.

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

View on ClinicalTrials.gov ↗

At a glance

What the study gets you: Access to the study treatment being tested
Type of study: Interventional (receives a drug or procedure)
Time in hospital: In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention: Tacabrutideg (drug), Pirtobrutinib (drug)
How long the study runs: Study runs about 31 months (dates as stated)
About the drug or intervention: Tacabrutideg — drug: Tacabrutideg will be administered orally · Pirtobrutinib — drug: Pirtobrutinib will be administered orally
Patient visit burden: Not specified by the sponsor

Type of study: Testing a treatment
Ages: 18 Years and over
Who: All
Number of participants: 500
Started: 2025-09-04
Last checked: 2026-09

Plain English Summary

What is this study?

• Testing a new treatment for chronic lymphocytic leukemia
• Phase3 - 500 participants
• 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)

Who can take part?

• Ages 18 Years and over
• Diagnosed with chronic lymphocytic leukemia

Where?

• Brighton - University Hospitals Sussex Nhs Foundation Trust
• Canterbury - Kent and Canterbury Hospital
• Norwich - Norfolk and Norwich University Hospitals Nhs Foundation Trust
• Oxford - Oxford University Hospitals Nhs Foundation Trust
• +2 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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).

More detail

Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.

Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma

How this trial compares with your answers

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What we know so far

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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

Age: 18 Years and over
Who can join: All genders

What the study is looking for

✓Confirmed diagnosis of CLL or SLL, requiring treatment, based on 2018 iwCLL criteria

Who cannot take part

✗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...
✗History of ischemic stroke or intracranial hemorrhage within 6 months before first dose of the study treatment
✗Prior exposure to any Bruton tyrosine kinase (BTK) protein degraders or noncovalent Bruton tyrosine kinase inhibitor...
✗Current or history of central nervous system involvement including the brain, spinal cord, leptomeninges, and...

See the full 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.