NCT06973187Recruiting
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
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).
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.
Contacts
The trial team's contact details are shown on request.
See the official trial record- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Countries
- Switzerland, France, Germany, Italy, Austria, United States, Argentina, Australia, Belgium, Brazil, China, Israel, Japan, Mexico, Netherlands, New Zealand, Poland, Puerto Rico, Romania, Singapore, South Korea, Spain, Sweden, United Kingdom
- Sponsor
- BeOne Medicines(Industry)
- Protocol no.
- BGB-16673-304
- Conditions
- Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
- Interventions
- Drug
Treatments studied
- Tacabrutideg
- Pirtobrutinib
Locations · 217
- Bern, SwitzerlandInselspital Bern (Inselspital, Universitatsspital Bern)Recruiting at this site
- Zurich, SwitzerlandUniversitatsspital ZurichRecruiting at this site
- Bordeaux, FranceCentre de Lutte Contre Le Cancer Institut BergonieRecruiting at this site
- ClermontFerrand, FranceHopital EstaingRecruiting at this site
- Nantes, FranceCentre Hospitalier Universitaire Nantes Hotel DieuRecruiting at this site
- Paris, FranceHopital Saint LouisRecruiting at this site
- Rouen, FranceCentre Henri BecquerelRecruiting at this site
- Toulouse, FranceIuc Toulouse OncopoleRecruiting at this site
- Tours, FranceChu Tours Hopital BretonneauRecruiting at this site
- VandoeuvrelesNancy, FranceChu Nancy Hopital BraboisRecruiting at this site
- Bochum, GermanySt Josef Hospital Klinikum Der Ruhr Universitat BochumRecruiting at this site
- Bonn, GermanyUniversitatsklinikum BonnRecruiting at this site
- Cologne, GermanyUniklinik Koeln (Aoer)Recruiting at this site
- Dortmund, GermanyGemeinschaftspraxis Fur Hamatologie Und Onkologie DortmundRecruiting at this site
- Karlsruhe, GermanyStadtisches Klinikum KarlsruheRecruiting at this site
- Lübeck, GermanyMvz Fur Hamatologie Und Onkologie LubeckgmbhRecruiting at this site
- Stuttgart, GermanyRobert Bosch Krankenhaus, Abteilung Hamatologie, Onkologie Und PalliativmedizinRecruiting at this site
- Ulm, GermanyUniversitaetsklinikum UlmRecruiting at this site
- Westerstede, GermanyGemeinschaftspraxis Fuer Haematologie Und Onkologie WesterstedeRecruiting at this site
- Bologna, ItalyPoliclinico Sorsola Malpighi, Aou Di BolognaRecruiting at this site
- Milan, ItalyOspedale San RaffaeleRecruiting at this site
- Milan, ItalyAzienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano NiguardaRecruiting at this site
- Padova, ItalyAzienda Ospedaliera Di PadovaRecruiting at this site
- Graz, AustriaMedical University GrazRecruiting at this site
- Innsbruck, AustriaMedizinische Universitatsklinik InnsbruckRecruiting at this site
- Linz, AustriaOrdensklinikum Linz Gmbh ElisabethinenRecruiting at this site
- Salzburg, AustriaUniversitatsklinik Fur Innere Medizin Iii Universitatsklinikum Der Pmu Landeskrankenhaus SalzburgRecruiting at this site
- Sankt Pölten, AustriaUk St PoeltenRecruiting at this site
- Birmingham, United StatesUniversity of Alabama At Birmingham HospitalRecruiting at this site
- Phoenix, United StatesMayo Clinic PhoenixRecruiting at this site
In total, worldwide, all 217 sites listed in the registry are recruiting.
Site status per the ClinicalTrials.gov registry (last update posted: September 28, 2026).
This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.
+ 187 more locations
Other identifiers
- 2025-522860-34-00 · CTIS number
- 2025 · NIH grant
See also
Other versions
These results are indicative and do not replace medical advice — discuss them with your doctor.