Clinical Trials

Zanubrutinib is currently evaluated across numerous clinical trials spanning Phase 1 through Phase 4, with statuses ranging from actively recruiting to completed. Research focuses on various B-cell malignancies, including mantle cell lymphoma, chronic lymphocytic leukemia, and diffuse large B-cell lymphoma, as well as non-malignant conditions such as immune thrombocytopenia. Supported by pharmaceutical sponsors like BeiGene alongside academic research centers, these studies encompass Phase 2 monotherapy investigations and late-stage comparative evaluations in relapsed or refractory hematologic populations.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05976763 RECRUITING
Mantle Cell Lymphoma
Alliance for Clinical Trials in Oncology
2023-10-20 PHASE3
NCT07474961 NOT_YET_RECRUITING
Waldenstrom Macroglobulinaemia; Multiple Myeloma
Anne Louise Tølbøll Sørensen
2027-03 PHASE4
NCT07638722 NOT_YET_RECRUITING
Recurrent Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue; Recurrent Nodal Marginal Zone Lymphoma; Recurrent Splenic Marginal Zone Lymphoma; Refractory Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue; Refractory Nodal Marginal Zone Lymphoma; Refractory Splenic Marginal Zone Lymphoma
SWOG Cancer Research Network
2026-10-03 PHASE2
NCT06544785 RECRUITING
Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma
PETHEMA Foundation
2024-09-02 PHASE2
NCT06073821 ACTIVE_NOT_RECRUITING
CLL
BeOne Medicines
2023-11-11 PHASE3
NCT06824701 ACTIVE_NOT_RECRUITING
Relapsed or Refractory B-cell Non-Hodgkin Lymphoma
University of Utah
2025-09-12 PHASE1
NCT07377578 RECRUITING
Mantle Cell Lymphoma
Guangzhou Lupeng Pharmaceutical Company LTD.
2026-02-05 PHASE3
NCT07299331 NOT_YET_RECRUITING
Marginal Zone Lymphoma(MZL)
Zhengzhou University
2026-01-01
NCT07392229 RECRUITING
Anti-MAG IgM-associated Demyelinating Polyneuropathy
Azienda Ospedaliera di Padova
2026-03-24 PHASE2
NCT07277231 RECRUITING
Chronic Lymphocytic Leukemia
BeOne Medicines
2026-01-22 PHASE3
NCT06503263 RECRUITING
Diffuse Large B-cell Lymphoma
Navy General Hospital, Beijing
2024-08-30 PHASE2
NCT06520098 RECRUITING
Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma
VA Office of Research and Development
2025-10-01 PHASE2
NCT06730542 RECRUITING
CNS Lymphoma
Juan P. Alderuccio, MD
2025-04-17 PHASE1
NCT07505849 NOT_YET_RECRUITING
Follicular Lymphomas
KeshuZhou
2026-03-23 PHASE2
NCT06367374 NOT_YET_RECRUITING
Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma
Institute of Hematology & Blood Diseases Hospital, China
2024-05-30 PHASE2
NCT07682415 NOT_YET_RECRUITING
CLL / SLL
Yi Shuhua
2026-06-08 PHASE2
NCT06890585 NOT_YET_RECRUITING
BTK Inhibitors; Histone Deacetylase Inhibitor; Double Express Diffuse Large B-cell Lymphoma
Li Zhiming
2025-06-01 PHASE2
NCT07341191 RECRUITING
Mantle Cell Lymphoma
Canadian Cancer Trials Group
2026-08-24 PHASE2
NCT06664411 RECRUITING
Diffuse Large B-cell Lymphoma
Navy General Hospital, Beijing
2024-09-24 PHASE2
NCT06697184 RECRUITING
Chronic Lymphocytic Leukemia; CLL; Mantle Cell Lymphoma; MCL
BeOne Medicines
2025-01-23 PHASE1; PHASE2
NCT06854003 RECRUITING
Mantle Cell Lymphoma; Lymphoma
Christine Ryan
2025-04-22 PHASE2
NCT06846463 RECRUITING
Diffuse Large B-cell Lymphoma; DLBCL - Diffuse Large B Cell Lymphoma
Virginia Commonwealth University
2025-05-27 PHASE2
NCT07717177 NOT_YET_RECRUITING
Large B-Cell Lymphoma (LBCL)
Ruijin Hospital
2026-06-30 PHASE2
NCT07594899 NOT_YET_RECRUITING
Large B-Cell Lymphoma (LBCL)
Ruijin Hospital
2026-05-06 PHASE2
NCT05735834 ACTIVE_NOT_RECRUITING
Splenic Marginal Zone Lymphoma
International Extranodal Lymphoma Study Group (IELSG)
2024-05-21 PHASE3
NCT06812715 RECRUITING
Chronic Lymphocytic Leukemia
Peter MacCallum Cancer Centre, Australia
2025-05-05 PHASE2
NCT06167785 RECRUITING
Large B-cell Lymphoma
University Health Network, Toronto
2025-06-04 PHASE2
NCT07739459 NOT_YET_RECRUITING
Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma
The Lymphoma Academic Research Organisation
2026-12 PHASE2
NCT07548255 NOT_YET_RECRUITING
Intermediate-to-High-Risk Mantle Cell Lymphoma; the Efficacy and Safety
Ruijin Hospital
2026-04-20 PHASE1
NCT06350318 RECRUITING
Follicular Lymphoma; Marginal Zone Lymphoma; B-Cell Lymphoma
H. Lee Moffitt Cancer Center and Research Institute
2024-04-19 PHASE2
NCT06859008 RECRUITING
Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma; Recurrent Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma; Recurrent Diffuse Large B-Cell Lymphoma; Recurrent Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue; Recurrent Grade 1 Follicular Lymphoma; Recurrent Grade 2 Follicular Lymphoma; Recurrent Grade 3a Follicular Lymphoma; Recurrent Mantle Cell Lymphoma; Recurrent Nodal Marginal Zone Lymphoma; Recurrent Splenic Marginal Zone Lymphoma; Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma; Refractory Diffuse Large B-Cell Lymphoma; Refractory Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue; Refractory Grade 1 Follicular Lymphoma; Refractory Grade 2 Follicular Lymphoma; Refractory Grade 3a Follicular Lymphoma; Refractory Mantle Cell Lymphoma; Refractory Nodal Marginal Zone Lymphoma; Refractory Splenic Marginal Zone Lymphoma
City of Hope Medical Center
2025-08-25 PHASE1
NCT06665217 NOT_YET_RECRUITING
Diffuse Large B-Cell Lymphoma
Navy General Hospital, Beijing
2025-09-24 PHASE2
NCT07690761 ENROLLING_BY_INVITATION
Hairy Cell Leukemia; Hairy Cell Leukemia Variant
Bnai Zion Medical Center
2026-06-01 PHASE2
NCT07514169 RECRUITING
Large B-Cell Lymphoma (LBCL)
Ruijin Hospital
2026-03-31 PHASE2
NCT07052695 RECRUITING
Leukemia; Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma; Lymphoma
Inhye Ahn
2025-11-24 PHASE1; PHASE2
NCT07608978 RECRUITING
Diffuse Large B-Cell Lymphoma (DLBCL)
The First Affiliated Hospital with Nanjing Medical University
2026-06-01 PHASE2
NCT07165769 RECRUITING
Splenic B-cell Lymphoma/Leukaemia With Prominent Nucleoli,SBLPN
Institute of Hematology & Blood Diseases Hospital, China
2025-09-04 PHASE2
NCT06547866 NOT_YET_RECRUITING
Waldenstrom Macroglobulinemia
French Innovative Leukemia Organisation
2025-12-01 PHASE2
NCT07315373 NOT_YET_RECRUITING
Immune Thrombocytopenia
Peking University People's Hospital
2025-12-25 PHASE1
NCT06634589 RECRUITING
B-cell Malignancy; Relapsed Cancer; Refractory Cancer; B-cell Lymphoma
BeOne Medicines
2024-11-27 PHASE1; PHASE2
NCT06463691 RECRUITING
MCL
Tianjin Medical University Cancer Institute and Hospital
2024-08-01 PHASE2
NCT07169331 ACTIVE_NOT_RECRUITING
Waldenström's Macroglobulinemia
BeiGene
2025-10-17 PHASE4
NCT05635162 RECRUITING
Mantle Cell Lymphoma
University College, London
2024-05-17 PHASE2
NCT07321652 RECRUITING
Chronic Lymphocytic Leukemia; Small Lymphocytic Leukemia
Alliance for Clinical Trials in Oncology
2026-04-30 PHASE3
NCT06492837 RECRUITING
Follicular Lymphoma
Fondazione Italiana Linfomi - ETS
2024-10-23 PHASE2
NCT07799220 NOT_YET_RECRUITING
Mantle Cell Lymphoma
Memorial Sloan Kettering Cancer Center
2026-09 PHASE2
NCT06647732 RECRUITING
Mucosa-associated Lymphoid Tissue Lymphoma (MALT)
Sun Yat-sen University
2024-10-30 PHASE2
NCT06742996 RECRUITING
Mantle Cell Lymphoma; B Cell Lymphoma
BeOne Medicines
2025-03-05 PHASE3
NCT06522555 RECRUITING
Diffuse Large B-Cell Lymphoma
Ruijin Hospital
2024-07-29 PHASE3
NCT06839053 RECRUITING
Chronic Lymphocytic Leukemia; Mantle Cell Lymphoma; Recurrent Chronic Lymphocytic Leukemia; Recurrent Mantle Cell Lymphoma; Recurrent Small Lymphocytic Lymphoma; Refractory Chronic Lymphocytic Leukemia; Refractory Mantle Cell Lymphoma; Refractory Small Lymphocytic Lymphoma; Small Lymphocytic Lymphoma
Fred Hutchinson Cancer Center
2025-06-02 PHASE2
NCT07126678 RECRUITING
Follicular Lymphoma; Treatment Naive
The First Affiliated Hospital with Nanjing Medical University
2025-07-15
NCT05100862 ACTIVE_NOT_RECRUITING
Relapsed/Refractory Follicular Lymphoma; Marginal Zone Lymphoma
BeOne Medicines
2022-03-10 PHASE3
NCT07259122 NOT_YET_RECRUITING
Waldenström Macroglobulinemia (WM)
Institute of Hematology & Blood Diseases Hospital, China
2025-12-30 PHASE2
NCT06029309 RECRUITING
Mantle Cell Lymphoma
Alvaro Alencar, MD
2024-05-03 PHASE1; PHASE2
NCT06918015 NOT_YET_RECRUITING
BTK Inhibitors; Follicular Lymphoma; Immunochemotherapy
Zhejiang Cancer Hospital
2025-05-01 PHASE2
NCT06558604 RECRUITING
Lymphoma, Mantle-Cell
The Lymphoma Academic Research Organisation
2025-02-21 PHASE2
NCT06803693 RECRUITING
Diffuse Large B-Cell Lymphoma
Ruijin Hospital
2025-04-01 PHASE2
NCT07299149 RECRUITING
Follicular Lymphoma
Institute of Hematology & Blood Diseases Hospital, China
2025-12-25 PHASE2
NCT04840602 RECRUITING
Lymphoplasmacytic Lymphoma; Waldenstrom Macroglobulinemia
National Cancer Institute (NCI)
2022-01-05 PHASE2
NCT07550855 NOT_YET_RECRUITING
Follicular Lymphoma (FL)
Sun Yat-sen University
2026-09-01 PHASE2
NCT06849713 RECRUITING
Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma (SLL)
Massachusetts General Hospital
2025-05-16 PHASE2
NCT06563596 RECRUITING
Follicular Lymphoma; Lymphoma; Non-Hodgkin Lymphoma; Relapsed Lymphoma; Refractory Lymphoma; Marginal Zone Lymphoma
Reid Merryman, MD
2025-01-21 PHASE2
NCT07371923 RECRUITING
Diffuse Large B Cell Lymphoma (DLBCL)
Beijing Tongren Hospital
2025-11-20 PHASE2
NCT05681195 RECRUITING
Primary Central Nervous System Lymphoma; Secondary Central Nervous System Lymphoma; Relapsed Cancer; Refractory Cancer
Baptist Health South Florida
2024-04-25 PHASE2
NCT06646211 NOT_YET_RECRUITING
Primary Central Nervous System Lymphoma (PCNSL); Non Hodgkin Lymphoma (NHL)
Sun Yat-sen University
2025-01-01 PHASE2
NCT07418190 RECRUITING
Relapsed/Refractory Follicular Lymphoma
The First Affiliated Hospital with Nanjing Medical University
2026-02-01 PHASE2
NCT07671378 RECRUITING
CLL (Chronic Lymphocytic Leukemia)
The First Affiliated Hospital with Nanjing Medical University
2026-06-01 PHASE2
NCT07734038 RECRUITING
Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma
Kerry Rogers
2026-10-01 PHASE2
NCT06427213 NOT_YET_RECRUITING
Lymphoma, Mantle-Cell; Lymphoma, Non-Hodgkin
Henan Cancer Hospital
2024-05-20 PHASE2
NCT07405255 NOT_YET_RECRUITING
Central Nervous System Lymphoma
Ruijin Hospital
2026-01-30 PHASE2
NCT06735664 RECRUITING
Recurrent Transformed Chronic Lymphocytic Leukemia; Refractory Transformed Chronic Lymphocytic Leukemia; Richter Syndrome; Transformed Chronic Lymphocytic Leukemia to Diffuse Large B-Cell Lymphoma
City of Hope Medical Center
2025-08-14 PHASE1
NCT06958705 RECRUITING
Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL)
The First Affiliated Hospital with Nanjing Medical University
2025-12-01 PHASE2
NCT05389293 RECRUITING
Follicular Lymphoma; Lymphoma
Memorial Sloan Kettering Cancer Center
2022-05-27 PHASE2
NCT06474481 NOT_YET_RECRUITING
FL
Tianjin Medical University Cancer Institute and Hospital
2024-07 PHASE2
NCT06136351 RECRUITING
Lymphoma, Mantle-Cell
Ruijin Hospital
2023-11-15 PHASE2
NCT07271667 RECRUITING
Chronic Lymphocytic Leukemia; B-cell Malignancies
Curis, Inc.
2026-04-23 PHASE2
NCT06973811 RECRUITING
Primary Intraocular Lymphoma
Peking Union Medical College Hospital
2024-10-10 PHASE2
NCT05707377 ACTIVE_NOT_RECRUITING
Primary Membranous Nephropathy
BeOne Medicines
2023-04-17 PHASE2; PHASE3
NCT04271956 RECRUITING
Richter Transformation
German CLL Study Group
2020-02-19 PHASE2
NCT07261163 RECRUITING
Mantle Cell Lymphoma
Institute of Hematology & Blood Diseases Hospital, China
2025-12-20 PHASE2
NCT06959732 RECRUITING
Follicular Lymphoma ( FL)
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
2025-01-01 PHASE2
NCT07003464 NOT_YET_RECRUITING
Chronic Lymphocytic Leukemia
The First Hospital of Jilin University
2025-06-15 PHASE2
NCT06646666 NOT_YET_RECRUITING
B-cell Non Hodgkin Lymphoma
Ruijin Hospital
2024-12-01 PHASE2
NCT04277637 ACTIVE_NOT_RECRUITING
Mature B-Cell Malignancies
BeOne Medicines
2020-03-24 PHASE1
NCT04458610 ACTIVE_NOT_RECRUITING
Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
M.D. Anderson Cancer Center
2020-05-26 PHASE2
NCT07674810 NOT_YET_RECRUITING
Chronic Lymphocytic Leukemia
M.D. Anderson Cancer Center
2026-12-31 PHASE2
NCT06942507 NOT_YET_RECRUITING
Waldenström's Macroglobulinemia (WM)
Peking Union Medical College Hospital
2025-05-01
NCT07270835 RECRUITING
Hemophagocytic Lymphohistiocytosis; B Cell Lymphoma
The First Affiliated Hospital of Soochow University
2025-11-01 PHASE4
NCT05650723 ACTIVE_NOT_RECRUITING
Leukemia, Lymphocytic, Chronic, B-Cell
Weill Medical College of Cornell University
2023-05-08 PHASE2
NCT04002297 ACTIVE_NOT_RECRUITING
Mantle Cell Lymphoma; Non-Hodgkin Lymphoma
BeOne Medicines
2019-08-20 PHASE3
NCT03824483 ACTIVE_NOT_RECRUITING
Chronic Lymphocytic Leukemia (CLL); Small Lymphocytic Leukemia (SLL)
Memorial Sloan Kettering Cancer Center
2019-02-22 PHASE2
NCT04515238 ACTIVE_NOT_RECRUITING
Chronic Lymphoid Leukemia
German CLL Study Group
2020-10-01 PHASE2
NCT04662255 ACTIVE_NOT_RECRUITING
Lymphoma, Mantle-Cell
Loxo Oncology, Inc.
2021-04-08 PHASE3
NCT06764017 RECRUITING
Diffuse Large B-Cell Lymphoma
First Affiliated Hospital of Ningbo University
2025-02-01 PHASE2
NCT05890352 RECRUITING
Grade 3b Follicular Lymphoma; High Grade B-Cell Lymphoma; High Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6 Rearrangements; Recurrent Diffuse Large B-Cell Lymphoma; Refractory Diffuse Large B-Cell Lymphoma; Transformed Non-Hodgkin Lymphoma
SWOG Cancer Research Network
2023-09-26 PHASE2
NCT06375733 RECRUITING
Large B-cell Lymphoma
Genfleet Therapeutics (Shanghai) Inc.
2024-03-20 PHASE1; PHASE2
NCT05939037 ACTIVE_NOT_RECRUITING
Monoclonal Gammopathy of Uncertain Significance
UMC Utrecht
2024-03-01 PHASE2
NCT04170283 ACTIVE_NOT_RECRUITING
B-cell Malignancies
BeOne Medicines
2020-01-16 PHASE3
NCT06563505 RECRUITING
Lymphoma
M.D. Anderson Cancer Center
2024-12-11 PHASE2
NCT06504199 ACTIVE_NOT_RECRUITING
Mantle Cell Lymphoma
Institute of Hematology & Blood Diseases Hospital, China
2024-07-18 PHASE2
NCT05873712 RECRUITING
Recurrent Transformed Chronic Lymphocytic Leukemia; Refractory Transformed Chronic Lymphocytic Leukemia; Transformed Chronic Lymphocytic Leukemia to Diffuse Large B-Cell Lymphoma; Recurrent Transformed B-Cell Non-Hodgkin Lymphoma; Recurrent Transformed Non-Hodgkin Lymphoma; Refractory Transformed Non-Hodgkin Lymphoma; Refractory Transformed B-cell Non-Hodgkin Lymphoma; Refractory Transformed
Aseel Alsouqi
2023-07-28 PHASE2
NCT06471738 RECRUITING
Ann Arbor Stage II Follicular Lymphoma; Grade 1 Follicular Lymphoma; Ann Arbor Stage III Follicular Lymphoma; Ann Arbor Stage IV Follicular Lymphoma; Grade 2 Follicular Lymphoma; Grade 3a Follicular Lymphoma
Chinese PLA General Hospital
2024-07-10 PHASE2
NCT06561347 RECRUITING
Waldenstrom Macroglobulinemia
Massachusetts General Hospital
2024-12-20 PHASE2
NCT06549335 NOT_YET_RECRUITING
Follicular Lymphoma
Ruijin Hospital
2024-12-01 PHASE2
NCT06594432 NOT_YET_RECRUITING
Diffuse Large B Cell Lymphoma (DLBCL)
The First Affiliated Hospital with Nanjing Medical University
2024-10 PHASE2
NCT06695013 RECRUITING
B-NHL; CART Therapy
Ruijin Hospital
2024-11-20 PHASE2
NCT06652165 NOT_YET_RECRUITING
DLBCL
Ruijin Hospital
2024-11-01 PHASE2
NCT06669143 NOT_YET_RECRUITING
Diffuse Large B Cell Lymphoma
Ruijin Hospital
2024-11 PHASE2
NCT06637501 ACTIVE_NOT_RECRUITING
Chronic Lymphocytic Leukemia
BeOne Medicines
2024-11-14 PHASE2
NCT05168930 RECRUITING
Chronic Lymphocytic Leukemia (CLL); Small Lymphocytic Lymphoma (SLL)
Dana-Farber Cancer Institute
2022-02-18 PHASE2
NCT05202782 ACTIVE_NOT_RECRUITING
Diffuse Large B-Cell Lymphoma Associated With Chronic Inflammation; EBV-Positive Diffuse Large B-Cell Lymphoma, Not Otherwise Specified; High Grade B-Cell Lymphoma, Not Otherwise Specified; Large B-Cell Lymphoma With IRF4 Rearrangement; Primary Cutaneous Diffuse Large B-Cell Lymphoma, Leg Type; Recurrent Aggressive B-Cell Non-Hodgkin Lymphoma; Recurrent Diffuse Large B-Cell Lymphoma, Not Otherwise Specified; Recurrent High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements; Recurrent Intravascular Large B-Cell Lymphoma; Recurrent Primary Mediastinal (Thymic) Large B-Cell Lymphoma; Recurrent T-Cell/Histiocyte-Rich Large B-Cell Lymphoma; Recurrent Transformed B-Cell Non-Hodgkin Lymphoma; Refractory Aggressive B-Cell Non-Hodgkin Lymphoma; Refractory Diffuse Large B-Cell Lymphoma, Not Otherwise Specified; Refractory High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements; Refractory Intravascular Large B-Cell Lymphoma; Refractory Primary Mediastinal (Thymic) Large B-Cell Lymphoma; Refractory T-Cell/Histiocyte-Rich Large B-Cell Lymphoma; Refractory Transformed B-Cell Non-Hodgkin Lymphoma
Northwestern University
2022-03-21 PHASE2
NCT05952037 ACTIVE_NOT_RECRUITING
Waldenstrom Macroglobulinemia; Waldenstrom's Macroglobulinemia Recurrent; Waldenstrom's Macroglobulinemia Refractory
BeOne Medicines
2023-10-23 PHASE2
NCT05718869 ACTIVE_NOT_RECRUITING
Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma
City of Hope Medical Center
2023-05-18 PHASE2
NCT06554600 RECRUITING
Refractory or Relapsed Diffuse Large B Cell Lymphoma
Second Affiliated Hospital, Zhejiang University, School of Medicine
2024-08-31 PHASE2
NCT07012980 NOT_YET_RECRUITING
Diffuse Large B-Cell Lymphoma
Shanghai Zhongshan Hospital
2025-06-01 PHASE2
NCT06005870 RECRUITING
Diffuse Large B Cell Lymphoma
Huazhong University of Science and Technology
2022-11-26 PHASE2
NCT04850495 ACTIVE_NOT_RECRUITING
Diffuse Large B-Cell Lymphoma; Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma; Transformed Marginal Zone Lymphoma to Diffuse Large B-Cell Lymphoma
Yazeed Sawalha
2021-11-16 PHASE1
NCT06468943 ENROLLING_BY_INVITATION
Effects of Chemotherapy; Safety Issues
The First Affiliated Hospital of Soochow University
2023-07-01 PHASE2
NCT05478512 ACTIVE_NOT_RECRUITING
High Risk CLL; Chronic Lymphocytic Leukemia
Gruppo Italiano Malattie EMatologiche dell'Adulto
2023-07-21 PHASE2
NCT06553352 RECRUITING
Follicular Lymphoma; Newly Diagnosed
The First Affiliated Hospital of Xiamen University
2024-03-31 PHASE2
NCT06445257 UNKNOWN
Primary Central Nervous System Lymphoma
Huai'an First People's Hospital
2023-09-15
NCT06341556 RECRUITING
Mantle Cell Lymphoma; Maintenance Therapy
Fudan University
2024-05-24 PHASE2
NCT07141511 COMPLETED
Healthy Volunteers
BeOne Medicines
2025-09-24 PHASE1
NCT06067048 ACTIVE_NOT_RECRUITING
Lymphoma
Stichting Hemato-Oncologie voor Volwassenen Nederland
2024-07-26 PHASE2
NCT04116437 COMPLETED
Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma; Mantle Cell Lymphoma; Marginal Zone Lymphoma; Waldenstrom Macroglobulinemia
BeiGene
2019-10-15 PHASE2
NCT06255704 NOT_YET_RECRUITING
Mantle Cell Lymphoma
Shanxi Province Cancer Hospital
2024-03-15 PHASE2
NCT05896007 UNKNOWN
PCNSL
Ruijin Hospital
2023-07-13 PHASE2
NCT05214391 RECRUITING
Immune Thrombocytopenia; Treatment
Institute of Hematology & Blood Diseases Hospital, China
2022-02-15 PHASE2
NCT05369364 UNKNOWN
Immune Thrombocytopenia
Peking University People's Hospital
2022-06-01 PHASE2
NCT05179733 UNKNOWN
Diffuse Large B-Cell Lymphoma
Ruijin Hospital
2022-03-02 PHASE3
NCT06547944 ACTIVE_NOT_RECRUITING
Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma; Newly Diagnosed
Institute of Hematology & Blood Diseases Hospital, China
2024-01-01 PHASE1
NCT04835870 UNKNOWN
Non-GCB/ABC Diffuse Large B-Cell Lymphoma
The First Affiliated Hospital of Soochow University
2021-04-01 PHASE2
NCT06021977 UNKNOWN
Refractory/Relapsed Autoimmune Hemolytic Anemia
Institute of Hematology & Blood Diseases Hospital, China
2023-09-01 PHASE2
NCT05940064 UNKNOWN
Diffuse Large B Cell Lymphoma
Peng Liu
2023-07-20 PHASE2
NCT05940051 UNKNOWN
Diffuse Large B Cell Lymphoma
Peng Liu
2023-07-20 PHASE2
NCT06033820 UNKNOWN
Diffuse Large B-cell Lymphoma Recurrent; Diffuse Large B Cell Lymphoma Refractory
RenJi Hospital
2023-10-12 PHASE2
NCT05665530 COMPLETED
Aggressive B-Cell Non-Hodgkin's Lymphoma (NHL); Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL); Mantle Cell Lymphoma (MCL); Richter's Syndrome; T-cell Lymphoma; Diffuse Large B-cell Lymphoma (DLBCL); Marginal Zone Lymphoma; Myeloid Malignancies; Acute Myeloid Leukemia (AML); Chronic Myelomonocytic Leukemia (CMML); Myelodysplastic Syndrome (MDS); MDS/Myeloproliferative Neoplasm (MPN) Overlap Syndrome
Prelude Therapeutics
2023-09-12 PHASE1
NCT05348213 RECRUITING
Diffuse Large B Cell Lymphoma
Ruijin Hospital
2022-05-16 PHASE2
NCT05369377 UNKNOWN
Immune Thrombocytopenia
Peking University People's Hospital
2022-06-01 PHASE2
NCT05428670 UNKNOWN
Diffuse Large B Cell Lymphoma
First Affiliated Hospital of Wenzhou Medical University
2022-06-15 PHASE2
NCT05979948 UNKNOWN
Waldenström's Macroglobulinemia
Shanghai Changzheng Hospital
2023-08-01 PHASE2
NCT05068440 COMPLETED
Relapsed Diffuse Large B-cell Lymphoma; Refractory Diffuse Large B-cell Lymphoma
BeiGene
2021-08-11 PHASE2
NCT05914662 UNKNOWN
Waldenstrom Macroglobulinemia
Institute of Hematology & Blood Diseases Hospital, China
2023-02-15 PHASE2
NCT04602598 COMPLETED
IgG4 Related Disease
Matthew C. Baker
2022-08-01 PHASE2
NCT04743687 UNKNOWN
Idiopathic Multicentric Castleman's Disease
Peking Union Medical College Hospital
2021-01-01 PHASE2
NCT05189197 UNKNOWN
Diffuse Large B-cell Lymphoma(DLBCL)
Fudan University
2022-01-18 PHASE2
NCT04624958 ACTIVE_NOT_RECRUITING
Mantle Cell Lymphoma; Newly-diagnosed Mantle Cell Lymphoma
Sun Yat-sen University
2020-12-01 PHASE2
NCT05922839 UNKNOWN
Warm Autoimmune Hemolytic Anemia
Chen Miao
2023-11-11 PHASE2
NCT04668365 SUSPENDED
Diffuse Large B Cell Lymphoma; CD79A Gene Mutation; CD79B Gene Mutation
Henan Cancer Hospital
2020-12-25 PHASE2
NCT05596097 UNKNOWN
Diffuse Large B-cell Lymphoma (DLBCL)
LanZhou University
2022-10-30 PHASE2
NCT05527912 UNKNOWN
Double Express Diffuse Large B-cell Lymphoma
Sun Yat-sen University
2023-02-24 PHASE2
NCT04282018 COMPLETED
Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma; Follicular Lymphoma; Marginal Zone Lymphoma; Mantle Cell Lymphoma; Diffuse Large B Cell Lymphoma; Advanced Solid Tumor
BeiGene
2020-04-29 PHASE1; PHASE2
NCT05887726 UNKNOWN
Diffuse Large B Cell Lymphoma
Liaoning Cancer Hospital & Institute
2023-08-01 PHASE2
NCT05797948 UNKNOWN
Relapsed or Refractory B-cell Non-Hodgkin Lymphoma
The First Affiliated Hospital of Soochow University
2022-07-01
NCT05287984 UNKNOWN
Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma; Newly Diagnosed
Institute of Hematology & Blood Diseases Hospital, China
2022-03-22 PHASE2
NCT05290090 UNKNOWN
Diffuse Large B Cell Lymphoma
Zhejiang Cancer Hospital
2021-10-01 PHASE2
NCT05392257 UNKNOWN
Overall Survival
Qingdao Central Hospital
2022-05-01 PHASE2
NCT06029309 Not yet recruiting
Mantle Cell Lymphoma
Alvaro Alencar MD|BeiGene|Incyte Corporation|MorphoSys AG|University of Miami
2024-05-01 Phase 1|Phase 2
NCT04436107 COMPLETED
Relapsed/Refractory Diffuse Large B-Cell Lymphoma
BeiGene
2020-09-11 PHASE1
NCT06350318 Recruiting
Follicular Lymphoma|Marginal Zone Lymphoma|B-Cell Lymphoma
H. Lee Moffitt Cancer Center and Research Institute|BeiGene Ltd.
2024-03-13 Phase 2
NCT05398224 UNKNOWN
Secondary Central Nervous System Lymphoma
Peking University
2021-02-26 PHASE2
NCT04643470 COMPLETED
Lupus Nephritis
BeiGene
2020-12-22 PHASE2
NCT05356858 TERMINATED
Neuromyelitis Optica
Xuanwu Hospital, Beijing
2022-05-07 PHASE2
NCT05200312 UNKNOWN
Non Hodgkin Lymphoma; Diffuse Large B Cell Lymphoma
The First Affiliated Hospital with Nanjing Medical University
2022-02-01 PHASE2
NCT06067048 Not yet recruiting
Lymphoma
Stichting Hemato-Oncologie voor Volwassenen Nederland
2024-02-01 Phase 2
NCT05290337 UNKNOWN
Diffuse Large B Cell Lymphoma
Fudan University
2022-01-04 PHASE2
NCT05199909 RECRUITING
Antiphospholipid Syndrome; Thrombocytopenia; Treatment
Institute of Hematology & Blood Diseases Hospital, China
2022-01-25 PHASE2
NCT05164770 UNKNOWN
High Grade B-Cell Lymphoma, Not Otherwise Specified; High Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6 Rearrangements; Diffuse Large B Cell Lymphoma; B-cell Non Hodgkin Lymphoma; Mantle Cell Lymphoma
Shandong Provincial Hospital
2021-03-01 PHASE3
NCT05665530 Recruiting
Aggressive B-Cell Non-Hodgkin''s Lymphoma|Aggressive B-Cell NHL|Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma|Mantle Cell Lymphoma (MCL)|Richter''s Syndrome|T-cell Lymphoma
Prelude Therapeutics|BeiGene
2023-09-12 Phase 1
NCT05320575 COMPLETED
HLH
Beijing Friendship Hospital
2022-02-01 PHASE3
NCT05504603 UNKNOWN
Untreated Mantle Cell Lymphoma
The First Affiliated Hospital of Soochow University
2020-07-27 PHASE2
NCT04172246 COMPLETED
Mature B-cell Malignancies
BeiGene
2020-01-29 PHASE1; PHASE2
NCT05767398 COMPLETED
Healthy Volunteers
BeiGene
2023-03-07 PHASE1
NCT04899570 UNKNOWN
Intravascular Large B-Cell Lymphoma
Peking Union Medical College Hospital
2021-04-01 PHASE2
NCT02914938 TERMINATED
Chronic Lymphocytic Leukemia (CLL); Small Lymphocytic Lymphoma (SLL); Follicular Lymphoma (FL); Marginal Zone B Cell Lymphoma; Diffuse Large B-cell Lymphoma (DLBCL); High Grade Non-Hodgkin's Lymphoma; Mantle Cell Lymphoma (MCL)
MEI Pharma, Inc.
2016-10 PHASE1
NCT04736914 UNKNOWN
Mantle Cell Lymphoma
Sun Yat-sen University
2021-01-31 PHASE2
NCT04705129 UNKNOWN
Primary Mediastinal Large B Cell Lymphoma; EBV-Positive DLBCL, Nos
Ruijin Hospital
2021-01-01 PHASE2
NCT05117814 UNKNOWN
CNS Lymphoma
Peking University People's Hospital
2021-09
NCT05547399 COMPLETED
Healthy Volunteers
BeiGene
2022-06-07 PHASE1
NCT04463953 COMPLETED
Waldenström Macroglobulinemia
Institute of Hematology & Blood Diseases Hospital, China
2020-06-01 PHASE2
NCT04938297 UNKNOWN
Central Nervous System Lymphoma
Henan Cancer Hospital
2021-05-26 PHASE2
NCT05279872 COMPLETED
Immune Thrombocytopenia; Bruton Tyrosine Kinase
Peking University People's Hospital
2022-01-01 PHASE2
NCT03734016 COMPLETED
Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma
BeiGene
2018-11-01 PHASE3
NCT04899453 UNKNOWN
Primary Vitreoretinal Lymphoma
Peking Union Medical College Hospital
2020-08-01 PHASE2
NCT03846427 COMPLETED
Marginal Zone Lymphoma; MZL
BeiGene
2019-02-19 PHASE2
NCT04551963 COMPLETED
B-cell Malignancies
BeiGene
2020-11-15 PHASE1
NCT04460248 ACTIVE_NOT_RECRUITING
Diffuse Large B Cell Lymphoma
Ruijin Hospital
2020-08-26 PHASE2
NCT03332017 COMPLETED
Relapsed/Refractory Follicular Non-Hodgkin Lymphoma
BeiGene
2017-11-14 PHASE2
NCT03336333 ACTIVE_NOT_RECRUITING
Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma
BeiGene
2017-10-31 PHASE3
NCT02343120 COMPLETED
B-cell Malignancies
BeiGene
2014-09-04 PHASE1; PHASE2
NCT04382586 COMPLETED
COVID-19 Pulmonary Complications; COVID-19
BeiGene
2020-07-06 PHASE2
NCT02795182 COMPLETED
Lymphoma; Leukemia
BeiGene
2016-06-29 PHASE1
NCT04470908 COMPLETED
Healthy; Male
BeiGene
2020-07-29 PHASE1
NCT02569476 COMPLETED
B-cell Lymphoid Malignancies
BeiGene
2016-01-13 PHASE1
NCT03520920 COMPLETED
Marginal Zone Lymphoma; Follicular Lymphoma; Diffuse Large B-Cell Lymphoma
BeiGene
2018-01-04 PHASE2
NCT03189524 COMPLETED
B-cell Lymphoma
BeiGene
2016-07-05 PHASE1
NCT03145064 COMPLETED
Diffuse Large B-cell Lymphoma
BeiGene
2017-06-30 PHASE2
NCT03332173 COMPLETED
Waldenström's Macroglobulinemia (WM)
BeiGene
2017-08-31 PHASE2
NCT03206970 COMPLETED
Refractory Mantle Cell Lymphoma; Relapsed Mantle Cell Lymphoma
BeiGene
2017-03-02 PHASE2
NCT03465059 COMPLETED
Hepatic Insufficiency & Healthy Subjects
BeiGene
2018-05-30 PHASE1
NCT03206918 COMPLETED
Relapsed or Refractory Chronic Lymphocytic Leukemia; Relapsed or Refractory Small Lymphocytic Lymphoma
BeiGene
2017-03-09 PHASE2
NCT03561298 COMPLETED
Healthy Subjects
BeiGene
2018-06-07 PHASE1
NCT03432884 COMPLETED
Healthy Volunteers
BeiGene
2018-01-25 PHASE1
NCT04163523 COMPLETED
Healthy Volunteers
BeiGene
2016-05-25 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-09-02)

Check the Zanubrutinib (BGB-3111) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Zanubrutinib functions as a potent and selective irreversible Bruton's tyrosine kinase inhibitor that covalently binds to the cysteine 481 residue in the active site, thereby blocking autophosphorylation and downstream B-cell receptor signal transduction pathways. This enzymatic blockade inhibits cellular proliferation and promotes apoptosis in malignant B lymphocytes, directly underpinning its therapeutic efficacy in clinical trials evaluating mantle cell lymphoma, chronic lymphocytic leukemia, and other B-cell malignancies.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

Note: Technical data last updated: Sep 1, 2026.