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BGB-16673 versus investigator-choice chemo plus rituximab for relapsed/refractory CLL or SLL after prior BTK inhibitor

A Phase 3, Open-Label, Randomized Study of BGB-16673 Compared to Investigator's Choice in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Covalent BTK Inhibitors

Phase 3 Interventional BeOne Medicines · NCT06970743

This trial will test whether the BTK-targeted protein degrader BGB-16673 works better than bendamustine plus rituximab or high-dose methylprednisolone plus rituximab for people with relapsed or refractory CLL or SLL who have already received a covalent BTK inhibitor.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment150 (estimated)
Ages18 Years and up
SexAll
SponsorBeOne Medicines Industry-sponsored
Drugs / interventionsrituximab, chimeric antigen receptor
Locations64 sites (Hefei, Anhui and 63 other locations)
Trial IDNCT06970743 on ClinicalTrials.gov

What this trial studies

This is a randomized, phase 3 trial comparing BGB-16673 to investigator's choice of bendamustine plus rituximab or high-dose methylprednisolone plus rituximab in participants with relapsed/refractory CLL or SLL previously exposed to covalent BTK inhibitors. Approximately 150 participants will be enrolled at centers in Mainland China and Taiwan and randomly assigned to receive one of the treatment arms. The primary outcome is the length of time participants live without their disease worsening (progression-free survival), with additional safety and tolerability monitoring. Participants must meet standard inclusion criteria such as ECOG 0-2 and adequate organ function and will be followed with imaging and clinical assessments per protocol.

Who should consider this trial

Good fit: Ideal candidates are adults with relapsed or refractory CLL or SLL who previously received a covalent BTK inhibitor, have measurable disease as required, ECOG performance status 0–2, and adequate bone marrow, liver, and kidney function.

Not a fit: Patients with known or suspected Richter's transformation, central nervous system involvement, very recent CAR-T or stem cell transplant, or severe allergy to the study drugs are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, BGB-16673 could extend the time without disease progression and provide a new treatment option for patients who progressed after covalent BTK inhibitors.

How similar studies have performed: BTK-targeted protein degraders are a relatively novel approach with encouraging early-phase signals but limited large randomized phase 3 evidence to date.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Confirmed diagnosis of CLL/SLL, requiring treatment, based on 2018 international workshop on chronic lymphocytic leukemia (iwCLL) criteria.
2. Previously received treatment for CLL/SLL with a covalent BTKi.
3. Measurable disease by computer tomography/magnetic resonance imaging for patients with SLL.
4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
5. Adequate bone marrow function
6. Adequate kidney and liver function
7. Adequate blood clotting function

Exclusion Criteria:

1. Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation
2. 2\. Prior autologous stem cell transplant (unless ≥ 3 months after transplant) or chimeric antigen receptor-T cell (unless ≥ 6 months after cell infusion)
3. History of severe allergic reactions or hypersensitivity to the active ingredient and excipients of study treatment (BGB-16673, bendamustine, or rituximab)
4. Current or history of central nervous system involvement
5. History of ischemic stroke or intracranial hemorrhage within 6 months before first dose of study drug
6. History of confirmed progressive multifocal leukoencephalopathy.
7. Active fungal, bacterial, and/or viral infection requiring parenteral systemic therapy
8. Clinically significant cardiovascular disease

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Where this trial is running

Hefei, Anhui and 63 other locations

+14 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 LymphomaCLLSLLBTK-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.