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Comparing a BTK-targeted protein degrader (BGB-16673) with pirtobrutinib for adults with relapsed or refractory CLL or SLL

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

Phase 3 Interventional BeOne Medicines · NCT06973187

This trial tests whether BGB-16673 works better and is as safe as pirtobrutinib for adults whose CLL or SLL has come back or not responded after prior covalent BTK inhibitor treatment.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment500 (estimated)
Ages18 Years and up
SexAll
SponsorBeOne Medicines Industry-sponsored
Drugs / interventionspirtobrutinib
Locations149 sites (Phoenix, Arizona and 148 other locations)
Trial IDNCT06973187 on ClinicalTrials.gov

What this trial studies

This Phase 3 randomized trial compares BGB-16673, a Bruton tyrosine kinase (BTK)–targeted protein degrader, with pirtobrutinib, a noncovalent BTK inhibitor, in adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after prior covalent BTK inhibitor therapy. Eligible participants are assigned to receive one of the two oral agents and are followed for response rates, safety, and duration of benefit. Key inclusion criteria require prior cBTKi exposure and, for SLL, measurable lymph nodes; key exclusions include Richter's transformation, certain bleeding disorders, recent stroke or intracranial hemorrhage, and prior exposure to BTK protein degraders. Primary and secondary endpoints focus on efficacy outcomes and safety measures typical of late-phase CLL trials.

Who should consider this trial

Good fit: Adults with relapsed or refractory CLL or SLL who require treatment and previously received at least one covalent BTK inhibitor (and for SLL have measurable lymph nodes) are the intended candidates.

Not a fit: Patients with known Richter's transformation, certain bleeding disorders, recent ischemic stroke or intracranial hemorrhage, or prior exposure to BTK protein degraders may be excluded or unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, this could provide a new treatment option that achieves better or more durable responses for patients whose CLL or SLL returned or did not respond after covalent BTK inhibitor therapy.

How similar studies have performed: Pirtobrutinib has shown clinical activity in similar previously treated CLL/SLL populations, while BTK-targeted protein degraders like BGB-16673 are a newer approach with encouraging early-phase data but not yet proven in late-stage trials.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Phoenix, Arizona and 148 other locations

+99 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Chronic Lymphocytic LeukemiaSmall Lymphocytic LymphomaNoncovalent Bruton tyrosine kinase inhibitorBruton tyrosine kinase-targeted protein degrader
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.