A Study to Investigate Safety and Effectiveness of BGB-16673 in Combination With Other Agents in Participants With Relapsed or Refractory B-Cell Malignancies

Last updated: March 17, 2026
Sponsor: BeOne Medicines
Overall Status: Active - Recruiting

Phase

1/2

Condition

Lymphoma, B-cell

Lymphoproliferative Disorders

Neoplasms

Treatment

Mosunetuzumab

Obinutuzumab

Sonrotoclax

Clinical Study ID

NCT06634589
BGB-16673-104
CTR20244676
2024-516234-35-00
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to measure the safety, preliminary antitumor activity, pharmacokinetics, and pharmacodynamics with BGB-16673 in combination with other agents in participants with relapsed or refractory (R/R) B-cell malignancies. This study is structured as a master protocol with separate substudies. This study currently includes four substudies, and more substudies may be added as other combination agents are identified.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Must sign the informed consent form (ICF) and be capable of giving written informedconsent, which includes compliance with the requirements and restrictions listed inthe ICF

  • Confirmed diagnosis of a R/R B-cell malignancy

  • Protocol-defined measurable disease

  • Stable Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2

  • Adequate organ function

  • Female participants of childbearing potential must be willing to use a highlyeffective method of birth control and refrain from egg donation for the duration ofthe study and for 30 days after the last dose of BGB-16673 or zanubrutinib, 60 daysafter the last dose of glofitamab, or 90 days after the last dose of sonrotoclax ormosunetuzumab. A negative urine or serum pregnancy test result must be provided 10-14 days before the first dose of study treatment

  • Nonsterile male participants must be willing to use a highly effective method ofbirth control and refrain from sperm donation for the duration of the study and for 30 days after the last dose of BGB-16673 or zanubrutinib, 60 days after the lastdose of glofitamab, or 90 days after the last dose of sonrotoclax or mosunetuzumab

  • Substudies 1, 3, and 4 Inclusion Criterion:

  • Adequate renal function as indicated by estimated glomerular filtration rate (eGFR) of ≥ 50 mL/min

  • Substudy 2 Inclusion Criteria:

  • Bruton tyrosine kinase (BTK) inhibitor-naive, or previously received treatmentwith a covalent BTK inhibitor and discontinued for reasons other than clinicalprogression

  • Adequate renal function as indicated by eGFR of ≥ 30 mL/min

Exclusion

Key Exclusion Criteria:

  • Treatment-naive B-cell malignancies

  • Unable to comply with the requirements of the protocol

  • Active leptomeningeal disease or uncontrolled, untreated brain metastasis

  • Any malignancy ≤ 2 years before first dose of study treatment except for thespecific cancer under investigation in this study or any locally recurring cancerthat has been treated curatively

  • Autologous stem cell transplant ≤ 3 months prior to screening or chimeric antigenT-cell therapy ≤ 3 months prior to screening

  • Substudies 1 and 2: Prior allogeneic stem cell transplant with activegraft-versus-host disease (GVHD), or requiring immunosuppressive drugs for treatmentof GVHD, or who have taken calcineurin inhibitors within 4 weeks prior to consent

  • Participants who have a history of severe allergic reactions or hypersensitivity tothe active ingredient and excipients of BGB-16673, sonrotoclax, zanubrutinib,mosunetuzumab, or glofitamab

  • Substudy 1 Exclusion Criterion:

  • Prior treatment with a B-cell lymphoma-2 (Bcl-2) inhibitor (with exception forparticipants who relapsed ≥ 24 months after completion of a full course of aprior Bcl-2 inhibitor containing regimen)

  • Substudy 2 Exclusion Criterion:

  • Participants who discontinued prior zanubrutinib treatment due to intolerance

  • Substudies 3 and 4 Exclusion Criteria:

  • Prior exposure to a CD20 x CD3 T-cell engager antibody treatment

  • All participants with a prior allogeneic stem cell transplant

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

Study Design

Total Participants: 80
Treatment Group(s): 7
Primary Treatment: Mosunetuzumab
Phase: 1/2
Study Start date:
November 27, 2024
Estimated Completion Date:
December 02, 2029

Study Description

This new study will check how safe and helpful a potential anticancer drug called BGB-16673 is in participants with R/R B-cell malignancies when it is given in combination with other medicines - sonrotoclax in substudy 1, zanubrutinib in substudy 2, mosunetuzumab in substudy 3, and glofitamab in substudy 4.

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.

Connect with a study center

  • St George Hospital

    Kogarah, New South Wales NSW 2217
    Australia

    Active - Recruiting

  • St George Hospital

    Kogarah 2161185, New South Wales 2155400 NSW 2217
    Australia

    Site Not Available

  • Mater Cancer Care Centre

    South Brisbane, Queensland QLD 4101
    Australia

    Active - Recruiting

  • Mater Cancer Care Centre

    South Brisbane 2207259, Queensland 2152274 QLD 4101
    Australia

    Site Not Available

  • Monash Health

    Clayton, Victoria VIC 3168
    Australia

    Active - Recruiting

  • Peter Maccallum Cancer Centre

    Melbourne, Victoria VIC 3000
    Australia

    Active - Recruiting

  • The Alfred Hospital

    Melbourne, Victoria VIC 3004
    Australia

    Active - Recruiting

  • Monash Health

    Clayton 2171400, Victoria 2145234 VIC 3168
    Australia

    Site Not Available

  • Peter Maccallum Cancer Centre

    Melbourne 2158177, Victoria 2145234 VIC 3000
    Australia

    Active - Recruiting

  • The Alfred Hospital

    Melbourne 2158177, Victoria 2145234 VIC 3004
    Australia

    Site Not Available

  • Linear Clinical Research

    Nedlands, Western Australia WA 6009
    Australia

    Active - Recruiting

  • Linear Clinical Research

    Nedlands 2064874, Western Australia 2058645 WA 6009
    Australia

    Site Not Available

  • Hospital Sirio Libanes Brasilia

    Brasilia, 70200-730
    Brazil

    Site Not Available

  • Hospital Sirio Libanes Brasilia

    Brasília, 70200-730
    Brazil

    Active - Recruiting

  • Hospital Sirio Libanes Brasilia

    Brasília 3469058, 70200-730
    Brazil

    Site Not Available

  • Ensino E Terapia de Inovacao Clinica Amo Etica

    Salvador, 41950-640
    Brazil

    Active - Recruiting

  • Ensino E Terapia de Inovacao Clinica Amo Etica

    Salvador 3450554, 41950-640
    Brazil

    Site Not Available

  • Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto

    Sao Jose Do Rio Preto, 15090-000
    Brazil

    Site Not Available

  • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

    Sao Paulo, 05653-120
    Brazil

    Site Not Available

  • Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto

    São José do Rio Preto, 15090-000
    Brazil

    Active - Recruiting

  • Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto

    São José do Rio Preto 3448639, 15090-000
    Brazil

    Site Not Available

  • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

    São Paulo, 05652-900
    Brazil

    Active - Recruiting

  • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

    São Paulo 3448439, 05652-900
    Brazil

    Site Not Available

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian 350001
    China

    Active - Recruiting

  • Fujian Medical University Union Hospital

    Fuzhou 1810821, Fujian 1811017 350001
    China

    Site Not Available

  • Sun Yat Sen University Cancer Center

    Guangzhou, Guangdong 510060
    China

    Active - Recruiting

  • Sun Yat Sen University Cancer Center

    Guangzhou 1809858, Guangdong 1809935 510060
    China

    Site Not Available

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu 215006
    China

    Active - Recruiting

  • The First Affiliated Hospital of Soochow University

    Suzhou 1886760, Jiangsu 1806260 215006
    China

    Site Not Available

  • The First Affiliated Hospital, Zhejiang University School of Medicinechengzhan

    Hangzhou, Zhejiang 310002
    China

    Active - Recruiting

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang 325000
    China

    Active - Recruiting

  • The First Affiliated Hospital, Zhejiang University School of Medicinechengzhan

    Hangzhou 1808926, Zhejiang 1784764 310002
    China

    Site Not Available

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou 1791388, Zhejiang 1784764 325000
    China

    Site Not Available

  • Universitatsklinikum Carl Gustav Carus An Der Technischen Universitat Dresden

    Dresden, 01307
    Germany

    Active - Recruiting

  • Universitatsklinikum Carl Gustav Carus An Der Technischen Universitat Dresden

    Dresden 2935022, 01307
    Germany

    Site Not Available

  • Universitatsklinikum Jena Klinik Fur Innere Medizin Ii

    Jena, 07747
    Germany

    Active - Recruiting

  • Universitatsklinikum Jena Klinik Fur Innere Medizin Ii

    Jena 2895044, 07747
    Germany

    Site Not Available

  • Universitatsklinikum Schleswig Holstein, Campus Kiel

    Kiel, 24105
    Germany

    Active - Recruiting

  • Universitatsklinikum Schleswig Holstein, Campus Kiel

    Kiel 2891122, 24105
    Germany

    Site Not Available

  • Medizinische Universitaetsklinik

    Tubingen, 72076
    Germany

    Site Not Available

  • Medizinische Universitaetsklinik

    Tuebingen, 72076
    Germany

    Site Not Available

  • Medizinische Universitaetsklinik

    Tübingen 2820860, 72076
    Germany

    Site Not Available

  • Universitaetsklinikum Ulm

    Ulm, 89081
    Germany

    Active - Recruiting

  • Universitaetsklinikum Ulm, Innere Medizin Iii

    Ulm, 89081
    Germany

    Site Not Available

  • Universitaetsklinikum Ulm

    Ulm 2820256, 89081
    Germany

    Site Not Available

  • Azienda Ospedaliera Universitaria Policlinico Santorsola Malpighi

    Bologna, 40138
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Universitaria Policlinico Santorsola Malpighi

    Bologna 3181928, 40138
    Italy

    Site Not Available

  • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

    Milan, 20162
    Italy

    Active - Recruiting

  • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

    Milan 6951411, 20162
    Italy

    Site Not Available

  • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

    Milano, 20162
    Italy

    Site Not Available

  • Istituto Nazionale Tumori Fondazione G Pascale

    Napoli, 80131
    Italy

    Active - Recruiting

  • Istituto Nazionale Tumori Fondazione G Pascale

    Napoli 9031661, 80131
    Italy

    Site Not Available

  • Istituto Clinico Humanitas

    Rozzano, 20089
    Italy

    Active - Recruiting

  • Istituto Clinico Humanitas

    Rozzano 3168837, 20089
    Italy

    Site Not Available

  • Centro Ricerche Cliniche Di Verona

    Verona, 37126
    Italy

    Site Not Available

  • Centroricerche Cliniche Di Verona Srl

    Verona, 37134
    Italy

    Active - Recruiting

  • Centroricerche Cliniche Di Verona Srl

    Verona 3164527, 37134
    Italy

    Site Not Available

  • Auckland City Hospital

    Auckland, 1023
    New Zealand

    Active - Recruiting

  • North Shore Hospital

    Auckland, 0622
    New Zealand

    Active - Recruiting

  • Auckland City Hospital

    Auckland 2193733, 1023
    New Zealand

    Site Not Available

  • North Shore Hospital

    Auckland 2193733, 0622
    New Zealand

    Active - Recruiting

  • North Shore Hospital

    Takapuna, 0622
    New Zealand

    Site Not Available

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-214
    Poland

    Active - Recruiting

  • Uniwersyteckie Centrum Kliniczne

    Gdansk 3099434, 80-214
    Poland

    Site Not Available

  • Uniwersyteckie Centrum Kliniczne

    Gdask, 80-214
    Poland

    Site Not Available

  • Samodzielny Publiczny Szpital Kliniczny Nr W Lublinie

    Lublin, 20-081
    Poland

    Site Not Available

  • Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie

    Lublin, 20-081
    Poland

    Active - Recruiting

  • Uniwersytecki Szpital Kliniczny Nr W Lublinie

    Lublin, 20-081
    Poland

    Active - Recruiting

  • Samodzielny Publiczny Szpital Kliniczny Nr W Lublinie

    Lublin 765876, 20-081
    Poland

    Site Not Available

  • Uniwersytecki Szpital Kliniczny Nr W Lublinie

    Lublin 765876, 20-081
    Poland

    Site Not Available

  • Szpital Kliniczny Mswia Z Warminsko Mazurskim Centrum Onkologii

    Olsztyn, 10-228
    Poland

    Site Not Available

  • Szpital Kliniczny Mswia Z Warmisko Mazurskim Centrum Onkologii

    Olsztyn, 10-228
    Poland

    Active - Recruiting

  • Szpital Kliniczny Mswia Z Warmisko Mazurskim Centrum Onkologii

    Olsztyn 763166, 10-228
    Poland

    Site Not Available

  • Szpital Wojewodzki W Opolu Sp Z Oo Oddzia Hematologii I Onkologii Hematologicznej

    Opole, 45-061
    Poland

    Active - Recruiting

  • Szpital Wojewodzki W Opolu Sp Z Oo Oddzia Hematologii I Onkologii Hematologicznej

    Opole 3090048, 45-061
    Poland

    Site Not Available

  • Narodowy Instytut Onkologii Im Marii Sklodowskiej Curie Hematology Unit

    Warsaw, 02-781
    Poland

    Active - Recruiting

  • Narodowy Instytut Onkologii Im Marii Skodowskiej Curie Hematology Unit

    Warsaw, 02-781
    Poland

    Site Not Available

  • Narodowy Instytut Onkologii Im Marii Sklodowskiej Curie Hematology Unit

    Warsaw 756135, 02-781
    Poland

    Site Not Available

  • Narodowy Instytut Onkologii Im Marii Skodowskiej Curie Hematology Unit

    Warszawa, 02-781
    Poland

    Site Not Available

  • Mayo Clinic Phoenix

    Phoenix, Arizona 85054-4502
    United States

    Active - Recruiting

  • Mayo Clinic Phoenix

    Phoenix 5308655, Arizona 5551752 85054-4502
    United States

    Site Not Available

  • University of Southern Californianorris Comprehensive

    Los Angeles, California 90033
    United States

    Active - Recruiting

  • University of Southern Californianorris Comprehensive

    Los Angeles 5368361, California 5332921 90033
    United States

    Site Not Available

  • Mayo Clinic Jacksonville

    Jacksonville, Florida 32224-1865
    United States

    Active - Recruiting

  • Moffitt Cancer Center

    Tampa, Florida 33612-9496
    United States

    Active - Recruiting

  • Mayo Clinic Jacksonville

    Jacksonville 4160021, Florida 4155751 32224-1865
    United States

    Site Not Available

  • Moffitt Cancer Center

    Tampa 4174757, Florida 4155751 33612-9496
    United States

    Site Not Available

  • The University of Kansas Cancer Center

    Westwood, Kansas 66205-2003
    United States

    Active - Recruiting

  • The University of Kansas Cancer Center

    Westwood 4281639, Kansas 4273857 66205-2003
    United States

    Site Not Available

  • University of Michigan Health System

    Ann Arbor, Michigan 48109-5316
    United States

    Site Not Available

  • Mayo Clinic Rochester

    Rochester, Minnesota 55905-0001
    United States

    Active - Recruiting

  • Mayo Clinic Rochester

    Rochester 5043473, Minnesota 5037779 55905-0001
    United States

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri 63110-1010
    United States

    Site Not Available

  • Washington University School of Medicine

    St Louis, Missouri 63110-1010
    United States

    Active - Recruiting

  • Washington University School of Medicine

    St Louis 4407066, Missouri 4398678 63110-1010
    United States

    Site Not Available

  • Summit Medical Group

    Florham Park, New Jersey 07932-1049
    United States

    Active - Recruiting

  • Summit Medical Group

    Florham Park 5098095, New Jersey 5101760 07932-1049
    United States

    Site Not Available

  • Columbia University Medical Center

    New York, New York 10032
    United States

    Active - Recruiting

  • Icahn School of Medicine At Mount Sinai

    New York, New York 10029-6504
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center Mskcc

    New York, New York 10065-6800
    United States

    Active - Recruiting

  • Weill Cornell Medical College Newyork Presbyterian Hospital

    New York, New York 10065-4870
    United States

    Active - Recruiting

  • University of Rochester

    Rochester, New York 14642-0001
    United States

    Active - Recruiting

  • Columbia University Medical Center

    New York 5128581, New York 5128638 10032
    United States

    Site Not Available

  • Icahn School of Medicine At Mount Sinai

    New York 5128581, New York 5128638 10029-6504
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center Mskcc

    New York 5128581, New York 5128638 10065-6800
    United States

    Active - Recruiting

  • Weill Cornell Medical College Newyork Presbyterian Hospital

    New York 5128581, New York 5128638 10065-4870
    United States

    Active - Recruiting

  • University of Rochester

    Rochester 5134086, New York 5128638 14642-0001
    United States

    Site Not Available

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania 19111-2434
    United States

    Active - Recruiting

  • Fox Chase Cancer Center

    Philadelphia 4560349, Pennsylvania 6254927 19111-2434
    United States

    Site Not Available

  • The University of Texas Md Anderson Cancer Center

    Houston, Texas 77030-4009
    United States

    Active - Recruiting

  • The University of Texas Md Anderson Cancer Center

    Houston 4699066, Texas 4736286 77030-4009
    United States

    Site Not Available

  • Huntsman Cancer Institute

    Salt Lake City, Utah 84112-5550
    United States

    Active - Recruiting

  • Huntsman Cancer Institute

    Salt Lake City 5780993, Utah 5549030 84112-5550
    United States

    Site Not Available

  • University of Wisconsin

    Madison, Wisconsin 53792-0001
    United States

    Active - Recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226-1222
    United States

    Active - Recruiting

  • University of Wisconsin

    Madison 5261457, Wisconsin 5279468 53792-0001
    United States

    Site Not Available

  • Medical College of Wisconsin

    Milwaukee 5263045, Wisconsin 5279468 53226-1222
    United States

    Site Not Available

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