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

August 24, 2026 updated by: BeOne Medicines

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

500

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
      • Caba, Argentina, CP1114
        • Recruiting
        • Fundaleu
      • Córdoba, Argentina, X5000BFB
        • Recruiting
        • Sanatorio Allende
      • Mendoza, Argentina, M5500
        • Recruiting
        • Centro Oncologico de Integracion Regional (Coir)
      • Rosario, Argentina, S2000
        • Recruiting
        • Hospital Privado de Rosario
  • Australia
    • New South Wales
      • Concord, New South Wales, Australia, NSW 2139
        • Recruiting
        • Concord Repatriation General Hospital
      • Kogarah, New South Wales, Australia, 2217
        • Recruiting
        • St George Private Hospital
      • Westmead, New South Wales, Australia, 2145
        • Recruiting
        • Westmead Private Hospital
    • Queensland
      • Benowa, Queensland, Australia, QLD 4217
        • Recruiting
        • Pindara Private Hospital
      • Birtinya, Queensland, Australia, QLD 4575
        • Recruiting
        • Sunshine Coast Hospital and Health Service
      • Tugun, Queensland, Australia, QLD 4224
        • Recruiting
        • John Flynn Private Hospital
    • South Australia
      • Bedford PK, South Australia, Australia, SA 5042
        • Recruiting
        • Flinders Medical Centre
    • Victoria
      • Fitzroy, Victoria, Australia, VIC 3065
        • Recruiting
        • St Vincents Hospital Melbourne
      • Frankston, Victoria, Australia, VIC 3199
        • Recruiting
        • Peninsula Private Hospital
      • Heidelberg, Victoria, Australia, VIC 3084
        • Recruiting
        • Austin Health
      • Malvern, Victoria, Australia, VIC 3144
        • Recruiting
        • Cabrini Hospital Malvern
      • Melbourne, Victoria, Australia, VIC 3004
        • Recruiting
        • The Alfred Hospital
      • Melbourne, Victoria, Australia, VIC 3000
        • Recruiting
        • Peter Maccallum Cancer Centre
    • Western Australia
      • Nedlands, Western Australia, Australia, WA 6009
        • Recruiting
        • Linear Clinical Research
  • Austria
      • Graz, Austria, 8036
        • Recruiting
        • Medical University Graz
      • Innsbruck, Austria, 6020
        • Recruiting
        • Medizinische Universitatsklinik Innsbruck
      • Linz, Austria, 4020
        • Recruiting
        • Ordensklinikum Linz Gmbh Elisabethinen
      • Salzburg, Austria, 5020
        • Recruiting
        • Universitatsklinik Fur Innere Medizin Iii Universitatsklinikum Der Pmu Landeskrankenhaus Salzburg
      • Sankt Pölten, Austria, 3100
        • Recruiting
        • Uk St Poelten
  • Belgium
      • Anderlecht, Belgium, 1070
        • Recruiting
        • Institut Jules Bordet
      • Ghent, Belgium, 9000
        • Recruiting
        • UZ Gent
      • Kortrijk, Belgium, 8500
        • Recruiting
        • Az Groeninge Campus Loofstraat
      • Liège, Belgium, 4000
        • Recruiting
        • CHU de Liège
      • Liège, Belgium, 4000
        • Recruiting
        • CHC MontLegia
      • Mechelen, Belgium, 2800
        • Recruiting
        • Az Sint Maarten
      • Yvoir, Belgium, 5530
        • Recruiting
        • CHU UCL Namur
  • Brazil
      • Araçatuba, Brazil, 16015-150
        • Recruiting
        • Centro de Pesquisa Clinica Dom Bosco Ltda
      • Curitiba, Brazil, 80510-130
        • Recruiting
        • Ictr Instituto Do Cancer E Transplante de Curitiba
      • Goiânia, Brazil, 74605-020
        • Recruiting
        • Hospital de Clinicas de Goiania Ufg
      • Rio de Janeiro, Brazil, 20231-050
        • Recruiting
        • Inca Instituto Nacional de Cancer
      • Salvador, Brazil, 41950-640
        • Recruiting
        • Ensino e Terapia de Inovacao Clinica AMO Etica
      • São Paulo, Brazil, 01409-001
        • Recruiting
        • Hospital Nove de Julho Dasa
      • São Paulo, Brazil, 05403-010
        • Recruiting
        • Hcfmusp Hospital Das Clinicas Da Faculdade de Medicina Da Universidade de Sao Paulo
  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Recruiting
        • Fujian Medical University Union Hospital
    • Gansu
      • Lanzhou, Gansu, China, 730000
        • Recruiting
        • The First Hospital of Lanzhou University
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Sun Yat Sen University Cancer Center
      • Jiangmen, Guangdong, China, 529030
        • Recruiting
        • Jiangmen Central Hospital
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • Recruiting
        • The First Affiliated Hospital of Guangxi Medical University
    • Guizhou
      • Guiyang, Guizhou, China, 550002
        • Recruiting
        • Guizhou Provincial Peoples Hospital
    • Hebei
      • Shijiazhuang, Hebei, China, 050035
        • Recruiting
        • The Fourth Hospital of Hebei Medical University East Branch
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150007
        • Recruiting
        • The First Affiliated Hospital of Harbin Medical University
    • Henan
      • Xuchang, Henan, China, 461000
        • Recruiting
        • Xuchang Central Hospitalluminghu Branch
      • Zhengzhou, Henan, China, 450000
        • Recruiting
        • Henan Cancer Hospital
    • Hubei
      • Wuhan, Hubei, China, 430056
        • Recruiting
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technologychegu Branch
    • Jiangsu
      • Nantong, Jiangsu, China, 201203
        • Recruiting
        • Affiliated Hospital of Nantong University
      • Suzhou, Jiangsu, China, 215006
        • Recruiting
        • The First Affiliated Hospital of Soochow University
      • Wuxi, Jiangsu, China, 214023
        • Recruiting
        • Wuxi Peoples Hospital
      • Xuzhou, Jiangsu, China, 221000
        • Recruiting
        • The Affiliated Hospital of Xuzhou Medical University
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Recruiting
        • The Second Affiliated Hospital of Nanchang University
    • Qinghai
      • Xining, Qinghai, China, 810001
        • Recruiting
        • Qinghai University Affiliated Hospital
    • Shaanxi
      • Xi'an, Shaanxi, China, 710004
        • Recruiting
        • The Second Affiliated Hospital of Xian Jiaotong University
    • Shandong
      • Binzhou, Shandong, China, 256603
        • Recruiting
        • Binzhou Medical University Hospital
      • Taian, Shandong, China, 271099
        • Recruiting
        • Taian City Central Hospital
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200000
        • Recruiting
        • Renji Hospital Shanghai Jiao Tong University School of Medicine
    • Shanxi
      • Taiyuan, Shanxi, China, 030032
        • Recruiting
        • Shanxi Bethune Hospital
    • Sichuan
      • Chengdu, Sichuan, China, 610071
        • Recruiting
        • Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
      • Dazhou, Sichuan, China, 635099
        • Recruiting
        • Dazhou Central Hospital
      • Luzhou, Sichuan, China, 646099
        • Recruiting
        • The Affiliated Hospital of Southwest Medical University
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300020
        • Recruiting
        • Institute of Hematology and Hospital of Blood Disease
    • Yunnan
      • Kunming, Yunnan, China, 650032
        • Recruiting
        • First Affiliated Hospital of Kunming Medical University
    • Zhejiang
      • Ningbo, Zhejiang, China, 315010
        • Recruiting
        • The First Affiliated Hospital of Ningbo University
      • Wenzhou, Zhejiang, China, 325000
        • Recruiting
        • The First Affiliated Hospital of Wenzhou Medical University
  • France
      • Bordeaux, France, 33076
        • Recruiting
        • Centre de Lutte Contre Le Cancer Institut Bergonie
      • ClermontFerrand, France, 63100
        • Recruiting
        • Hopital Estaing
      • Nantes, France, 44000
        • Recruiting
        • Centre Hospitalier Universitaire Nantes Hotel Dieu
      • Paris, France, 75010
        • Recruiting
        • Hopital Saint Louis
      • Rouen, France, 76038
        • Recruiting
        • Centre Henri Becquerel
      • Toulouse, France, 31100
        • Recruiting
        • Iuc Toulouse Oncopole
      • Tours, France, 37000
        • Recruiting
        • Chu Tours Hopital Bretonneau
      • VandoeuvrelesNancy, France, 54511
        • Recruiting
        • Chu Nancy Hopital Brabois
  • Germany
      • Bochum, Germany, 44791
        • Recruiting
        • St Josef Hospital Klinikum Der Ruhr Universitat Bochum
      • Bonn, Germany, 53127
        • Recruiting
        • Universitätsklinikum Bonn
      • Cologne, Germany, 50937
        • Recruiting
        • Uniklinik Koeln (Aoer)
      • Dortmund, Germany, 44309
        • Recruiting
        • Gemeinschaftspraxis Fur Hamatologie Und Onkologie Dortmund
      • Karlsruhe, Germany, 76133
        • Recruiting
        • Stadtisches Klinikum Karlsruhe
      • Lübeck, Germany, 23562
        • Recruiting
        • Mvz Fur Hamatologie Und Onkologie Lubeckgmbh
      • Stuttgart, Germany, 70376
        • Recruiting
        • Robert Bosch Krankenhaus, Abteilung Hamatologie, Onkologie Und Palliativmedizin
      • Ulm, Germany, 89081
        • Recruiting
        • Universitaetsklinikum Ulm
      • Westerstede, Germany, 26655
        • Recruiting
        • Gemeinschaftspraxis Fuer Haematologie Und Onkologie Westerstede
  • Israel
      • Haifa, Israel, 31048
        • Recruiting
        • Bnai Zion Medical Center
      • Jerusalem, Israel, 91120
        • Recruiting
        • Hadassah University Hospital Ein Kerem
      • Jerusalem, Israel, 9103102
        • Recruiting
        • Shaare Zedek Medical Center
      • KfarSava, Israel, 4428164
        • Recruiting
        • Meir Medical Center
      • Petah Tikva, Israel, 49100
        • Recruiting
        • Rabin Medical Center
      • Ramat Gan, Israel, 5262100
        • Recruiting
        • Sheba Medical Center
      • Tel Aviv, Israel, 6423906
        • Recruiting
        • Sourasky Tel Aviv Medical Center
  • Italy
      • Bologna, Italy, 40138
        • Recruiting
        • Policlinico Sorsola Malpighi, Aou Di Bologna
      • Milan, Italy, 20132
        • Recruiting
        • Ospedale San Raffaele
      • Milan, Italy, 20162
        • Recruiting
        • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
      • Padova, Italy, 35128
        • Recruiting
        • Azienda Ospedaliera di Padova
  • Japan
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 464-8681
        • Recruiting
        • Aichi Cancer Center Hospital Clinical Oncology
      • Nakamuraku, Aichi-ken, Japan, 453-8511
        • Recruiting
        • Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital
    • Ehime
      • Matsuyama, Ehime, Japan, 790 8524
        • Recruiting
        • Matsuyama Red Cross Hospital
    • Fukushima
      • Fukushima, Fukushima, Japan, 960-1295
        • Recruiting
        • Fukushima Medical University Hospital
    • Hiroshima
      • Hiroshima, Hiroshima, Japan, 730-8619
        • Recruiting
        • Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 064-0804
        • Recruiting
        • Aiiku Hospital
    • Kochi
      • Nankoku, Kochi, Japan, 783-8505
        • Recruiting
        • Kochi Medical School Hospital
    • Kumamoto
      • Kumamoto, Kumamoto, Japan, 860-8556
        • Recruiting
        • Kumamoto University Hospital
    • Kyoto
      • Kyotoshi, Kyoto, Japan, 602-8026
        • Recruiting
        • Japanese Red Cross Kyoto Daini Hospital
    • Oita Prefecture
      • Ōita, Oita Prefecture, Japan, 870-8511
        • Recruiting
        • Oita Prefectural Hospital
    • Okayama-ken
      • Okayama, Okayama-ken, Japan, 700-8558
        • Recruiting
        • Okayama University Hospital
    • Osaka
      • Osaka, Osaka, Japan, 545-8586
        • Recruiting
        • Osaka Metropolitan University Hospital
      • Sakai, Osaka, Japan, 590-0197
        • Recruiting
        • Kindai University Hospital
    • Saitama
      • Koshigaya, Saitama, Japan, 503-8502
        • Recruiting
        • Dokkyo Medical University Saitama Medical Center
    • Tokyo
      • Bunkyoku, Tokyo, Japan, 113-8677
        • Recruiting
        • Tokyo Metropolitan Komagome Hospital
      • Kotoku, Tokyo, Japan, 135-8550
        • Recruiting
        • Cancer Institute Hospital of JFCR
      • Tachikawashi, Tokyo, Japan, 190-0014
        • Recruiting
        • National Hospital Organization (Nho) Disaster Medical Center
    • Yamagata
      • Yamagata, Yamagata, Japan, 990-9585
        • Recruiting
        • Yamagata University Hospital
  • Mexico
      • Monterrey, Mexico, 64000
        • Recruiting
        • Christus Latam Hub Center of Excellence and Innovation Sc
      • México, Mexico, 3720
        • Recruiting
        • Centro de Investigacion Clinica Gramel
      • Oaxaca City, Mexico, 68020
        • Recruiting
        • Centro de Investigacion Clinica de Oaxaca
      • Toluca, Mexico, 50120
        • Recruiting
        • Centro Hemato Oncologico Privado de Toluca
  • Netherlands
      • Dordrecht, Netherlands, 3318 AT
        • Recruiting
        • Albert Schweitzer Ziekenhuis
      • EJ Eindhoven, Netherlands, 5623
        • Recruiting
        • Catharina hospital
      • Gouda, Netherlands, 2803
        • Recruiting
        • Groene Hart Hospital
      • Groningen, Netherlands, 9713 GZ
        • Recruiting
        • University of Medical Center Groningen (Umcg)
      • Nijmegen, Netherlands, 6532 SZ
        • Recruiting
        • Canisius Wilhelmina Ziekenhuis
      • Utrecht, Netherlands, 3584 CX
        • Recruiting
        • Universitair Medisch Centrum Utrecht
  • New Zealand
      • Auckland, New Zealand, 0622
        • Recruiting
        • North Shore Hospital
      • Tauranga, New Zealand, 3112
        • Recruiting
        • Tauranga Hospital
      • Wellington, New Zealand, 6021
        • Recruiting
        • Wellington Regional Hospital (Ccdhb)
  • Poland
      • Gdansk, Poland, 80-219
        • Recruiting
        • Copernicus Podmiot Leczniczy Sp Z Oo Wojewodzkie Centrum Onkologii
      • Kielce, Poland, 25-734
        • Recruiting
        • Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej w Kielcach
      • Lodz, Poland, 93-513
        • Recruiting
        • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi
      • Lublin, Poland, 20-081
        • Recruiting
        • Uniwersytecki Szpital Kliniczny nr 1 w Lublinie
      • Olsztyn, Poland, 10-228
        • Recruiting
        • Szpital Kliniczny Mswia Z Warmisko Mazurskim Centrum Onkologii
      • Torun, Poland, 87-100
        • Recruiting
        • Wojewodzki Szpital Zespolony im L Rydygiera w Toruniu
      • Warsaw, Poland, 02-781
        • Recruiting
        • Narodowy Instytut Onkologii Im Marii Sklodowskiej Curie W Warszawie
      • Wroclaw, Poland, 50-367
        • Recruiting
        • Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
  • Puerto Rico
      • San Juan, Puerto Rico, 00917
        • Recruiting
        • Auxilio Mutuo Cancer Center
  • Romania
      • Bucharest, Romania, 30171
        • Recruiting
        • Coltea Clinical Hospital
      • ClujNapoca, Romania, 400015
        • Recruiting
        • Institutul Oncologic Prof Dr Ion Chiricuta Cluj Napoca
      • Iași, Romania, 700483
        • Recruiting
        • Institutul Regional de Oncologie Iasi
  • Singapore
      • Singapore, Singapore, 168582
        • Recruiting
        • Singapore General Hospital
      • Singapore, Singapore, 308433
        • Recruiting
        • Tan Tock Seng Hospital Haematology
  • South Korea
    • Busan Gwang'Yeogsi
      • Seogu, Busan Gwang'Yeogsi, South Korea, 49241
        • Recruiting
        • Pusan National University Hospital
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, South Korea, 13620
        • Recruiting
        • Seoul National University Bundang Hospital
    • Gyeongsangnam-do
      • Jinju, Gyeongsangnam-do, South Korea, 52727
        • Recruiting
        • Gyeongsang National University Hospital
    • Seoul Teugbyeolsi
      • SeochoGu, Seoul Teugbyeolsi, South Korea, 06591
        • Recruiting
        • The Catholic University of Korea, Seoul St Marys Hospital
      • SeodaemunGu, Seoul Teugbyeolsi, South Korea, 03722
        • Recruiting
        • Severance Hospital Yonsei University Health System
      • Seoul, Seoul Teugbyeolsi, South Korea, 03080
        • Recruiting
        • Seoul National University Hospital
  • Spain
      • Badalona, Spain, 08916
        • Recruiting
        • ICO Badalona
      • Burgos, Spain, 09006
        • Recruiting
        • Hospital Universitario de Burgos
      • Las Palmas de Gran Canaria, Spain, 35010
        • Recruiting
        • Hospital Universitario de Gran Canaria Dr Negrin
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital Universitario Fundacion Jimenez Diaz
      • Majadahonda, Spain, 28222
        • Recruiting
        • Hospital Universitario Puerta de Hierro Majadahonda
      • Palma de Mallorca, Spain, 07120
        • Recruiting
        • Hospital Universitari Son Espases
      • Seville, Spain, 41013
        • Recruiting
        • Hospital Universitario Virgen del Rocio
  • Sweden
      • Gothenburg, Sweden, 413 46
        • Recruiting
        • Sahlgrenska Universitetssjukhuset
      • Stockholm, Sweden, 171 76
        • Recruiting
        • Karolinska Universitetssjukhuset Solna
  • Switzerland
      • Bern, Switzerland, 3010
        • Recruiting
        • Inselspital Bern (Inselspital, Universitatsspital Bern)
      • Zurich, Switzerland, 8091
        • Recruiting
        • UniversitätsSpital Zürich
  • United Kingdom
      • Brighton, United Kingdom, BN2 5BE
        • Recruiting
        • University Hospitals Sussex NHS Foundation Trust
      • Canterbury, United Kingdom, CT1 3NG
        • Recruiting
        • Kent and Canterbury Hospital
      • Norwich, United Kingdom, NR4 7UY
        • Recruiting
        • Norfolk and Norwich University Hospitals NHS Foundation Trust
      • Oxford, United Kingdom, OX42PG
        • Recruiting
        • Oxford University Hospitals NHS Foundation Trust
      • Roundhay, United Kingdom, LS8 1NT
        • Recruiting
        • Spire Leeds Healthcare Spire Leeds Hospital
      • Salisbury, United Kingdom, SP2 8BJ
        • Recruiting
        • Salisbury Foundation Trust
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294-0004
        • Recruiting
        • University of Alabama At Birmingham Hospital
    • Arizona
      • Phoenix, Arizona, United States, 85054-4502
        • Recruiting
        • Mayo Clinic Phoenix
    • California
      • Irvine, California, United States, 92618-3734
        • Recruiting
        • Kaiser Permanente Southern California
      • La Jolla, California, United States, 92093-1503
        • Recruiting
        • University of California San Diego (Ucsd) Moores Cancer Center
      • Los Alamitos, California, United States, 90720-3302
        • Recruiting
        • Cancer and Blood Specialty Clinic
      • Los Angeles, California, United States, 90095-3075
        • Recruiting
        • UCLA Department of Medicine Hematologyoncology
      • Oakland, California, United States, 94611
        • Recruiting
        • Kaiser Permanente Oakland Medical Center
      • Palo Alto, California, United States, 94304-2205
        • Recruiting
        • Stanford Cancer Institute
      • Roseville, California, United States, 95661
        • Recruiting
        • Kaiser Permanente Roseville Medical Center
      • San Francisco, California, United States, 94115
        • Recruiting
        • Kaiser Permanente San Francisco Medical Center Oncology
      • Santa Clara, California, United States, 95051
        • Recruiting
        • Kaiser Permanente Santa Clara Medical Center Oncologyhematology
      • Vallejo, California, United States, 94589-2441
        • Recruiting
        • Kaiser Permanente Northern California
      • Walnut Creek, California, United States, 94596
        • Recruiting
        • Kaiser Permanente Walnut Creek Medical Center
    • Delaware
      • Newark, Delaware, United States, 19713-2055
        • Recruiting
        • Christiana Care
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20007-2113
        • Recruiting
        • MedStar Georgetown University Hospital
    • Florida
      • Jacksonville, Florida, United States, 32256
        • Recruiting
        • Cancer Specialists of North Florida
      • Jacksonville, Florida, United States, 32224-1865
        • Recruiting
        • Mayo Clinic Jacksonville
      • Miami, Florida, United States, 33140
        • Recruiting
        • Mount Sinai Medical Center Braman Comprehensive Cancer Center
    • Illinois
      • Chicago, Illinois, United States, 60637-1443
        • Recruiting
        • University of Chicago Medical Center
    • Iowa
      • Waukee, Iowa, United States, 50263
        • Recruiting
        • Mission Cancer and Blood
    • Kansas
      • Westwood, Kansas, United States, 66205-2003
        • Recruiting
        • The University of Kansas Cancer Center
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809-3738
        • Recruiting
        • Mary Bird Perkins Cancer Center
      • Baton Rouge, Louisiana, United States, 70808-4365
        • Recruiting
        • Our Lady of the Lake Hospital
      • New Orleans, Louisiana, United States, 70121-2429
        • Recruiting
        • Ochsner Clinic Foundation
    • Massachusetts
      • Boston, Massachusetts, United States, 02215-5418
        • Recruiting
        • Dana Farber Cancer Institute
    • Michigan
      • Detroit, Michigan, United States, 48201-2013
        • Recruiting
        • Karmanos Cancer Institute
    • Minnesota
      • Rochester, Minnesota, United States, 55905-0001
        • Recruiting
        • Mayo Clinic Rochester
    • Missouri
      • St Louis, Missouri, United States, 63110-1010
        • Recruiting
        • Washington University School of Medicine
    • New Jersey
      • East Brunswick, New Jersey, United States, 08816-4096
        • Recruiting
        • Titan Health Partners Llc Dba Astera Cancer Care
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • John Theurer Cancer Center Hackensack University Medical Center
    • New York
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Medical Center
      • New York, New York, United States, 10065-6800
        • Recruiting
        • Memorial Sloan Kettering Cancer Center Mskcc
      • Rochester, New York, United States, 14642-0001
        • Recruiting
        • University of Rochester
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514-4220
        • Recruiting
        • University of North Carolina at Chapel Hill
      • Charlotte, North Carolina, United States, 28204-2990
        • Recruiting
        • Atrium Health Levine Cancer Institute (Lci)
      • Durham, North Carolina, United States, 27705-3976
        • Recruiting
        • Duke University Medical Center
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Atrium Health Wake Forest Baptist
    • Ohio
      • Dayton, Ohio, United States, 45415
        • Recruiting
        • Dayton Physician Network
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111-2434
        • Recruiting
        • Fox Chase Cancer Center
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Tennessee Oncology, Pllc Nashville
    • Texas
      • Houston, Texas, United States, 77030-3907
        • Recruiting
        • MD Anderson Cancer Center
    • Virginia
      • Roanake, Virginia, United States, 24014
        • Recruiting
        • Blue Ridge Cancer Care (Oncology and Hematology Associates of Southwest Virginia)
    • Washington
      • Seattle, Washington, United States, 98109-4433
        • Recruiting
        • Fred Hutchinson Cancer Research Center
      • Spokane, Washington, United States, 99208-1129
        • Recruiting
        • Summit Cancer Centers
      • Tacoma, Washington, United States, 98405
        • Recruiting
        • Northwest Medical Specialties
    • Wisconsin
      • La Crosse, Wisconsin, United States, 54601-5467
        • Recruiting
        • Gunderson Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm B: Pirtobrutinib
Participants will receive pirtobrutinib orally.
Drug: Pirtobrutinib
Pirtobrutinib will be administered orally
Other Names:
  • Jaypirca
Experimental: Arm A: Tacabrutideg
Participants will receive tacabrutideg orally.
Drug: Tacabrutideg
Tacabrutideg will be administered orally
Other Names:
  • BGB-16673

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS) per Independent Review Committee (IRC)
Time Frame: Up to approximately 3 years
PFS is defined as time from the date of randomization to the date of first disease progression or death, whichever occurs first, as determined by IRC using modified 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria for participants with chronic lymphocytic leukemia (CLL) and Lugano classification for participants with small lymphocytic lymphoma (SLL).
Up to approximately 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Up to approximately 3 years
OS is defined as the time from the date of randomization to the date of death due to any cause.
Up to approximately 3 years
PFS per Investigator (INV)
Time Frame: Up to approximately 3 years
PFS per INV is defined as time from the date of randomization to the date of first disease progression or death, whichever occurs first, as determined by investigator using modified 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria for participants with CLL and Lugano classification for participants with SLL.
Up to approximately 3 years
Overall Response Rate (ORR) per IRC and INV
Time Frame: Up to approximately 3 years
ORR is defined as the percentage of participants with a best overall response of complete response, complete response with incomplete bone marrow recovery, nodular partial remission, or partial response, as assessed by the investigator and IRC using modified 2018 iwCLL criteria for patients with CLL and Lugano classification for patients with SLL.
Up to approximately 3 years
Rate of Partial Response with Lymphocytosis (PR-L) or Higher per IRC and INV
Time Frame: Up to approximately 3 years
The rate of PR-L or higher is defined as the percentage of participants with a best overall response of complete response, complete response with incomplete bone marrow recovery, nodular partial remission, partial response, or PR-L.
Up to approximately 3 years
Duration of Response (DOR) per IRC and INV
Time Frame: Up to approximately 3 years
DOR is defined as the time from initial response to disease progression or death, whichever occurs first.
Up to approximately 3 years
Time to Next Anti-CLL/SLL Treatment (TTNT)
Time Frame: Up to approximately 3 years
TTNT is defined as the time from the date of randomization to the date of next anti-CLL/SLL treatment.
Up to approximately 3 years
Number of Participants with Adverse Events (AEs)
Time Frame: Up to approximately 3 years
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including laboratory abnormalities.
Up to approximately 3 years
Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire EORTC IL409
Time Frame: Baseline and up to approximately 3 years
EORTC IL409 consists of a set of 19 questions derived from the EORTC quality of life questionnaire core 30 (QLQ-C30) and its CLL module CLL17. The EORTC IL409 includes questions on global health status (GHS)/quality of life, physical functioning, role functioning, physical condition/fatigue, and symptom burden.Higher scores in GHS and functional scales and lower scores in symptom scales indicate better health-related quality of life.
Baseline and up to approximately 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BeOne Medicines

Investigators

  • Study Director: Study Director, BeOne Medicines

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 4, 2025

Primary Completion (Estimated)

April 17, 2028

Study Completion (Estimated)

April 17, 2028

Study Registration Dates

First Submitted

May 7, 2025

First Submitted That Met QC Criteria

May 7, 2025

First Posted (Actual)

May 15, 2025

Study Record Updates

Last Update Posted (Actual)

August 26, 2026

Last Update Submitted That Met QC Criteria

August 24, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BGB-16673-304
  • 2025 (U.S. NIH Grant/Contract: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • 2025-522860-34-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved.

BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations.

Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.

IPD Sharing Time Frame

See plan description

IPD Sharing Access Criteria

See plan description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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