Phase
Condition
Lymphoma, B-cell
Lymphoproliferative Disorders
Hematologic Cancer
Treatment
BGB-16673
sonrotoclax
Mosunetuzumab
Clinical Study ID
Ages > 18 All Genders
Study Summary
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
Study Description
Connect with a study center
St George Hospital
Kogarah, New South Wales 2217
AustraliaActive - Recruiting
Mater Cancer Care Centre
South Brisbane, Queensland 4101
AustraliaActive - Recruiting
Monash Health
Clayton, Victoria 3168
AustraliaSite Not Available
Peter Maccallum Cancer Centre
Melbourne, Victoria 3000
AustraliaActive - Recruiting
The Alfred Hospital
Melbourne, Victoria 3004
AustraliaSite Not Available
Linear Clinical Research
Nedlands, Western Australia 6009
AustraliaActive - Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian 350001
ChinaSite Not Available
Sun Yat Sen University Cancer Center
Guangzhou, Guangdong 510060
ChinaSite Not Available
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu 215006
ChinaSite Not Available
The First Affiliated Hospital, Zhejiang University School of Medicinechengzhan
Hangzhou, Zhejiang 310002
ChinaActive - Recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang 325000
ChinaSite Not Available
Universitatsklinikum Carl Gustav Carus An Der Technischen Universitat Dresden
Dresden, 01307
GermanySite Not Available
Universitatsklinikum Jena Klinik Fur Innere Medizin Ii
Jena, 07747
GermanySite Not Available
Universitatsklinikum Schleswig Holstein, Campus Kiel
Kiel, 24105
GermanySite Not Available
Medizinische Universitaetsklinik
Tuebingen, 72076
GermanySite Not Available
Universitaetsklinikum Ulm, Innere Medizin Iii
Ulm, 89081
GermanySite Not Available
Azienda Ospedaliera Universitaria Policlinico Santorsola Malpighi
Bologna, 40138
ItalySite Not Available
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milano, 20162
ItalySite Not Available
Istituto Nazionale Tumori Fondazione G Pascale
Napoli, 80131
ItalySite Not Available
Istituto Clinico Humanitas
Rozzano, 20089
ItalySite Not Available
Centro Ricerche Cliniche Di Verona
Verona, 37134
ItalySite Not Available
Auckland City Hospital
Auckland, 1023
New ZealandActive - Recruiting
North Shore Hospital
Takapuna, 0622
New ZealandSite Not Available
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-952
PolandSite Not Available
Samodzielny Publiczny Szpital Kliniczny Nr W Lublinie
Lublin, 20-081
PolandSite Not Available
Szpital Kliniczny Mswia Z Warminsko Mazurskim Centrum Onkologii
Olsztyn, 10-228
PolandSite Not Available
Szpital Kliniczny Mswia Z Warmisko Mazurskim Centrum Onkologii
Olsztyn, 10-228
PolandSite Not Available
Szpital Wojewodzki W Opolu Sp Z Oo Oddzia Hematologii I Onkologii Hematologicznej
Opole, 45-061
PolandSite Not Available
Narodowy Instytut Onkologii Im Marii Skodowskiej Curie Hematology Unit
Warsaw, 02-781
PolandSite Not Available
Mayo Clinic Phoenix
Phoenix, Arizona 85254
United StatesSite Not Available
University of Southern Californianorris Comprehensive
Los Angeles, California 90033
United StatesSite Not Available
Mayo Clinic Jacksonville
Jacksonville, Florida 32224
United StatesSite Not Available
Moffitt Cancer Center
Tampa, Florida 33612-9497
United StatesActive - Recruiting
The University of Kansas Cancer Center
Westwood, Kansas 66205
United StatesSite Not Available
University of Michigan Health System
Ann Arbor, Michigan 48109
United StatesSite Not Available
Mayo Clinic Rochester
Rochester, Minnesota 55905
United StatesSite Not Available
Washington University School of Medicine
Saint Louis, Missouri 63110
United StatesActive - Recruiting
Summit Medical Group
Florham Park, New Jersey 07932
United StatesActive - Recruiting
Icahn School of Medicine At Mount Sinai
New York, New York 10029
United StatesSite Not Available
Memorial Sloan Kettering Cancer Center Mskcc
New York, New York 10065
United StatesSite Not Available
Weill Cornell Medical College Newyork Presbyterian Hospital
New York, New York 10021
United StatesSite Not Available
University of Rochester
Rochester, New York 14642
United StatesSite Not Available
Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111
United StatesActive - Recruiting
The University of Texas Md Anderson Cancer Center
Houston, Texas 77030-4009
United StatesSite Not Available
Huntsman Cancer Institute
Salt Lake City, Utah 84112
United StatesSite Not Available
University of Wisconsin
Madison, Wisconsin 53792
United StatesSite Not Available
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United StatesSite Not Available
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