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A Study of Tacabrutideg (BGB-16673) Compared to Investigator's Choice in Participants With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Both Bruton Tyrosine Kinase (BTK) and B-cell Leukemia/Lymphoma 2 Protein (BCL2) Inhibitors

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), Bendamustine (drug), Idelalisib (drug), Rituximab (drug)
How long the study runs: Study runs about 58 months (dates as stated)
About the drug or intervention: Tacabrutideg — drug: Administered orally · Bendamustine — drug: Administered intravenously · Idelalisib — drug: Administered orally · Rituximab — drug: Administered intravenously · Venetoclax — drug: 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: 250
Started: 2025-04-10
Last checked: 2026-09

Plain English Summary

What is this study?

• Testing a new treatment for cll
• Phase3 - 250 participants
• The purpose of this study is to investigate the efficacy and safety of tacabrutideg compared with investigator's choice (idelalisib plus rituximab \[for CLL only\] or bendamustine plus rituximab or venetoclax plus rituximab retreatment) in participants with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) previously exposed to both BTK inhibitors (BTKi) and BCL2 inhibitors (BCL2i)

Who can take part?

• Ages 18 Years and over
• Diagnosed with cll

Where?

• Aberdeen - Aberdeen Royal Infirmary
• Birmingham - Birmingham Heartlands Hospital
• Bournemouth - The Royal Bournemouth and Christchurch Hospitals Nhs Foundation
• London - University College Hospital
• +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 investigate the efficacy and safety of tacabrutideg compared with investigator's choice (idelalisib plus rituximab \[for CLL only\] or bendamustine plus rituximab or venetoclax plus rituximab retreatment) in participants with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) previously exposed to both BTK inhibitors (BTKi) and BCL2 inhibitors (BCL2i).

More detail

Chronic lymphocytic leukemia is a type of blood cancer that affects people around the world. People with CLL suffer from enlarged lymph nodes, spleen, or liver, or have symptoms like night sweats, weight loss and fever. They have shorter life expectancy compared to healthy people. There is an urgent need for new treatment to prolong life and control disease-related symptoms. In this study, participants with relapsed/refractory (R/R) CLL who were previously exposed to a BTKi and a BCL2i will receive tacabrutideg or the investigator's choice of idelalisib plus rituximab (for CLL only) or bendamustine plus rituximab or venetoclax plus rituximab retreatment. The main purpose of this study is to compare the length of time that participants live without their CLL or SLL worsening between those participants who receive tacabrutideg versus the investigator's choice of treatment (idelalisib plus rituximab or bendamustine plus rituximab, or venetoclax plus rituximab). Approximately 250 participants will be included in this study around the world. Participants will be randomly allocated to receive either tacabrutideg or the investigator's choice of treatment. "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."

CLLChronic Lymphocytic Leukemia

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What we know so far

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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

Treatment history

Treatments you must have had:

✓ measurable disease by computer tomography (CT)/magnetic resonance imaging (MRI)

What the study is looking for

✓Confirmed diagnosis of CLL or SLL, requiring treatment, based on 2018 international workshop on chronic lymphocytic...
✓Previously received treatment for CLL/SLL with both a BTKi and a BCL2i.
✓Participants with SLL must have cancer that can be measured on scans by computer tomography (CT)/magnetic resonance imaging (MRI)
✓activity scale (ECOG) score 0, 1, or 2
✓healthy liver

Who cannot take part

✗Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation
✗Prior autologous stem cell transplant or chimeric antigen receptor-T cell therapy in the last 3 months
✗Known central nervous system involvement
✗Prior exposure to any BTK protein degraders
✗Active fungal, bacterial and/or viral infection requiring parenteral treatment that goes through your whole body

See the full criteria

Inclusion Criteria: 1. Confirmed diagnosis of CLL or SLL, requiring treatment, based on 2018 international workshop on chronic lymphocytic leukemia (iwCLL) criteria. 2. Previously received treatment for CLL/SLL with both a BTKi and a BCL2i. 3. Participants with SLL must have measurable disease by computer tomography (CT)/magnetic resonance imaging (MRI) 4. Eastern Cooperative Oncology Group (ECOG) score 0, 1, or 2 5. Adequate liver function 6. Adequate blood clotting function Exclusion Criteria: 1. Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation 2. Prior autologous stem cell transplant or chimeric antigen receptor-T cell therapy in the last 3 months 3. Known central nervous system involvement 4. Prior exposure to any BTK protein degraders 5. Active fungal, bacterial and/or viral infection requiring parenteral systemic therapy 6. Clinically significant cardiovascular disease NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.