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Compound · clinical trials

Zanubrutinib

Also listed in trial records as Brukinsa, BGB-3111
Source: ClinicalTrials.gov, U.S. National Library of Medicine — the 37 trials in our China, USA, UK and Ireland registers that name Zanubrutinib as an intervention. Synced 24 Sep 2026
37Trials tracked
18Recruiting now
15Lead sponsors
4Country registers
Maintained by Sreepriya Prasannan
MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany HSE Spark Ignite 2026 — Top 14 finalist
Compiled from ClinicalTrials.gov registry records · Last verified · Editorial standards

Zanubrutinib is named as a drug or biological intervention in 37 clinical trials in our China, USA, UK and Ireland trial registers, 18 of which are recruiting. Lead sponsors include BeOne Medicines (12), Ruijin Hospital (7) and BeiGene (3). Registered phases: Phase 2, Phase 3, Phase 1/2, Phase 1, Observational, Phase 4 and Phase 2/3. Conditions studied include Chronic Lymphocytic Leukemia; Mantle Cell Lymphoma; Marginal Zone Lymphoma.

Zanubrutinib also has an approved-drug profile on this site (FDA label data): Brukinsa (Zanubrutinib) →
01

Clinical trials of Zanubrutinib

37 trials
NCT IDStudyPhaseStatusLead sponsorRegister
NCT07270835 Zanubrutinib Combined With Rituximab in the Treatment of Secondary HLH in B-cell Lymphoma (ClinicalTrials.gov ↗)
Hemophagocytic Lymphohistiocytosis, B Cell Lymphoma
 Phase 4 Recruiting The First Affiliated Hospital of Soochow University China
NCT06742996 A Study to Investigate the Efficacy and Safety of Sonrotoclax Plus Zanubrutinib Compared With Placebo Plus Zanubrutinib in Adults With Relapsed/Refractory Mantle Cell Lymphoma (CELESTIAL-RRMCL) (ClinicalTrials.gov ↗)
Mantle Cell Lymphoma, B Cell Lymphoma
 Phase 3 Recruiting BeOne Medicines UK, USA, China
NCT07277231 A Study to Investigate Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Acalabrutinib in Adults With Previously Untreated Chronic Lymphocytic Leukemia
Chronic Lymphocytic Leukemia
 Phase 3 Recruiting BeOne Medicines UK, USA, China
NCT05199909 Safety and Efficacy of Zanubrutinib in the Treatment of Antiphospholipid Syndrome With Secondary Thrombocytopenia (ClinicalTrials.gov ↗)
Antiphospholipid Syndrome, Thrombocytopenia, Treatment
 Phase 2 Recruiting Institute of Hematology & Blood Diseases Hospital, China China
NCT05348213 Novel Targeted Drugs Combined With R-ICE Regimen in Relapsed and Refractory Diffuse Large B-cell Lymphoma (ClinicalTrials.gov ↗)
Diffuse Large B Cell Lymphoma
 Phase 2 Recruiting Ruijin Hospital China
NCT06005870 Zanubrutinib Combined With R-CHOP in the Treatment of Newly Diagnosed DLBCL With p53 Protein Expression (ClinicalTrials.gov ↗)
Diffuse Large B Cell Lymphoma
 Phase 2 Recruiting Huazhong University of Science and Technology China
NCT06136351 A Study of the Zanubrutinib Given in Combination With Bendamustine and Rituximab in (Elderly or TP53 Alterations or Chemotherapy Intolerance) Patients With Newly Diagnosed Mantle Cell Lymphoma (ClinicalTrials.gov ↗)
Lymphoma, Mantle-Cell
 Phase 2 Recruiting Ruijin Hospital China
NCT06553352 Zanubrutinib in Combination With Obinutuzumab (ZO) for Newly Diagnosed Follicular Lymphoma (ClinicalTrials.gov ↗)
Follicular Lymphoma, Newly Diagnosed
 Phase 2 Recruiting The First Affiliated Hospital of Xiamen University China
NCT06803693 Efficacy and Safety of Pola-RCHP-X vs Pola-RCHP in Untreated DLBCL (ClinicalTrials.gov ↗)
Diffuse Large B-Cell Lymphoma
 Phase 2 Recruiting Ruijin Hospital China
NCT07261163 Obinutuzumab, Zanubrutinib, and Lenalidomide in First-line Treatment of Mantle Cell Lymphoma (ClinicalTrials.gov ↗)
Mantle Cell Lymphoma
 Phase 2 Recruiting Institute of Hematology & Blood Diseases Hospital, China China
NCT07271667 A Study of Emavusertib + An Approved Bruton Tyrosine Kinase Inhibitor (BTKi) in Participants With Chronic Lymphocytic Leukemia (CLL) and Other B-cell Malignancies (ClinicalTrials.gov ↗)
Chronic Lymphocytic Leukemia, B-cell Malignancies
 Phase 2 Recruiting Curis, Inc. USA
NCT07371923 Application of Zanubrutinib-based Combination Regimens in the Treatment of Newly-diagnosed Diffuse Large B-cell Lymphoma (ClinicalTrials.gov ↗)
Diffuse Large B Cell Lymphoma (DLBCL)
 Phase 2 Recruiting Beijing Tongren Hospital China
NCT07608978 Efficacy and Safety of Polatuzumab Vedotin in Combination With Zanubrutinib, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone in Patients With Previously Untreated Diffuse Large B-Cell Lymphoma of the MCD/BN2/N1 Subtypes (ClinicalTrials.gov ↗)
Diffuse Large B-Cell Lymphoma (DLBCL)
 Phase 2 Recruiting The First Affiliated Hospital with Nanjing Medical University China
NCT06375733 A Study of GFH009 in Combination With Zanubrutinib in Subjects With Relapsed or Refractory DLBCL (ClinicalTrials.gov ↗)
Large B-cell Lymphoma
 Phase 1/2 Recruiting Genfleet Therapeutics (Shanghai) Inc. China
NCT06634589 A Study to Investigate Safety and Effectiveness of Tacabrutideg (BGB-16673) in Combination With Other Agents in Participants With Relapsed or Refractory B-Cell Malignancies (ClinicalTrials.gov ↗)
B-cell Malignancy, Relapsed Cancer, Refractory Cancer
 Phase 1/2 Recruiting BeOne Medicines USA, China
NCT06697184 A Study to Investigate the Safety of Novel Dose Ramp-up Schedule(s) When Initiating Sonrotoclax in Participants Treated for Blood Cancers. (ClinicalTrials.gov ↗)
Chronic Lymphocytic Leukemia, CLL, Mantle Cell Lymphoma
 Phase 1/2 Recruiting BeOne Medicines UK, USA
NCT05640102 Observational Study Evaluating the Efficacy and Safety of Zanubrutinib in Participants With Waldenström Macroglobulinemia
Waldenstrom Macroglobulinemia
 Observational Recruiting BeiGene USA
NCT07233720 Zanubrutinib Combined With Rituximab in the Treatment for Patients With Marginal Zone Lymphoma (ClinicalTrials.gov ↗)
Marginal Zone Lymphoma
 Observational Recruiting Henan Cancer Hospital China
NCT06646666 ARTA-based Chemo-free Bridging/Maintenance Therapy in CAR-T Treatment for High-Risk R/R B-NHL Ineligible for HDCT and ASCT (ClinicalTrials.gov ↗)
B-cell Non Hodgkin Lymphoma
 Phase 2 Not yet open Ruijin Hospital China
NCT07003464 Phase II Trial of Zanubrutinib, Obinutuzumab, Bendamustine (ZGB) as First-Line Therapy for Chronic Lymphocytic Leukemia: A Single-Center Study (ClinicalTrials.gov ↗)
Chronic Lymphocytic Leukemia
 Phase 2 Not yet open The First Hospital of Jilin University China
NCT07405255 Zillion: Zanubrutinib Combined With Chemotherapy for Newly Diagnosed CNS Lymphoma (ClinicalTrials.gov ↗)
Central Nervous System Lymphoma
 Phase 2 Not yet open Ruijin Hospital China
NCT07594899 AI-Driven Treatment Strategy vs Pola-R-CHP in Untreated LBCL (ClinicalTrials.gov ↗)
Large B-Cell Lymphoma (LBCL)
 Phase 2 Not yet open Ruijin Hospital China
NCT07717177 AI-Driven Treatment Strategy vs ZR2 in Older Treatment-naive Patients With LBCL (ClinicalTrials.gov ↗)
Large B-Cell Lymphoma (LBCL)
 Phase 2 Not yet open Ruijin Hospital China
NCT06468943 Polatuzumab Vedotin and Zanubrutinib Plus R-CHP for Patients With Newly Diagnosed Untreated Non-GCB DLBCL (ClinicalTrials.gov ↗)
Effects of Chemotherapy, Safety Issues
 Phase 2 By invitation The First Affiliated Hospital of Soochow University China
NCT07169331 A Study to Evaluate the Efficacy and Safety of Zanubrutinib in Chinese Adults With Treatment-Naive Waldenström Macroglobulinemia (ClinicalTrials.gov ↗)
Waldenström's Macroglobulinemia
 Phase 4 Active, closed BeiGene China
NCT03336333 A Study Comparing Zanubrutinib With Bendamustine Plus Rituximab in Participants With Previously Untreated CLL or SLL
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
 Phase 3 Active, closed BeiGene UK, USA, China
NCT04002297 A Study to Investigate the Efficacy of Zanubrutinib Plus Rituximab Compared With Bendamustine Plus Rituximab in Adults With Previously Untreated Mantle Cell Lymphoma Who Are Ineligible for Stem Cell Transplantation (ClinicalTrials.gov ↗)
Mantle Cell Lymphoma; Non-Hodgkin Lymphoma
 Phase 3 Active, closed BeOne Medicines Ireland, UK, USA, China
NCT04170283 A Study to Evaluate Long-term Safety of Zanubrutinib Regimens in Participants With B-Cell Malignancies Who Participated in BeiGene Parent Studies of Zanubrutinib (ClinicalTrials.gov ↗)
B-cell Malignancies
 Phase 3 Active, closed BeOne Medicines UK, USA, China
NCT04662255 Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL) (ClinicalTrials.gov ↗)
Lymphoma, Mantle-Cell
 Phase 3 Active, closed Loxo Oncology, Inc. UK, USA, China
NCT05100862 A Study of Zanubrutinib Plus Anti-CD20 Versus Lenalidomide Plus Rituximab in Participants With Relapsed/Refractory Follicular or Marginal Zone Lymphoma (ClinicalTrials.gov ↗)
Relapsed/Refractory Follicular Lymphoma, Marginal Zone Lymphoma
 Phase 3 Active, closed BeOne Medicines Ireland, UK, USA, China
NCT06073821 Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Obinutuzumab in Participants With Chronic Lymphocytic Leukemia (CLL) (ClinicalTrials.gov ↗)
CLL
 Phase 3 Active, closed BeOne Medicines UK, USA, China
NCT05707377 A Study to Examine the Efficacy and Safety of Zanubrutinib Given to Adults With Primary Membranous Nephropathy (ClinicalTrials.gov ↗)
Primary Membranous Nephropathy
 Phase 2/3 Active, closed BeOne Medicines UK, USA, China
NCT05952037 A Study to Investigate Efficacy and Safety of BCL2 Inhibitor Sonrotoclax as Monotherapy and in Combination With Zanubrutinib in Adults With Waldenström Macroglobulinemia (ClinicalTrials.gov ↗)
Waldenstrom Macroglobulinemia, Waldenstrom's Macroglobulinemia Recurrent, Waldenstrom's Macroglobulinemia Refractory
 Phase 2 Active, closed BeOne Medicines UK, USA, China
NCT06637501 A Study to Investigate Sonrotoclax Combined With Zanubrutinib Versus Zanubrutinib Alone in Participants With Previously Untreated Chronic Lymphocytic Leukemia
Chronic Lymphocytic Leukemia
 Phase 2 Active, closed BeOne Medicines USA, China
NCT06647732 Zanubrutinib Plus Rituximab as Front-line Treatment for Mucosa-associated Lymphoid Tissue Lymphoma (MALT) (ClinicalTrials.gov ↗)
Mucosa-associated Lymphoid Tissue Lymphoma (MALT)
 Phase 2 Active, closed Sun Yat-sen University China
NCT04277637 Study of Bcl-2 Inhibitor Sonrotoclax (BGB-11417) in Participants With Mature B-Cell Malignancies (ClinicalTrials.gov ↗)
Mature B-Cell Malignancies
 Phase 1 Active, closed BeOne Medicines UK, USA
NCT06547944 Zanubrutinib, Obinutuzumab and Lenalidomide in Newly Diagnosed Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) (ClinicalTrials.gov ↗)
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Newly Diagnosed
 Phase 1 Active, closed Institute of Hematology & Blood Diseases Hospital, China China

Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.

02

Conditions studied

38 conditions
Condition (as registered)Trials
Chronic Lymphocytic Leukemia7
Mantle Cell Lymphoma3
Marginal Zone Lymphoma2
Small Lymphocytic Lymphoma2
Lymphoma, Mantle-Cell2
B Cell Lymphoma2
CLL2
B-cell Malignancies2
Waldenstrom Macroglobulinemia2
Newly Diagnosed2
Large B-Cell Lymphoma (LBCL)2
Diffuse Large B Cell Lymphoma2
Relapsed/Refractory Follicular Lymphoma1
Mantle Cell Lymphoma; Non-Hodgkin Lymphoma1
MCL1
Mature B-Cell Malignancies1
Primary Membranous Nephropathy1
Waldenstrom's Macroglobulinemia Recurrent1
Waldenstrom's Macroglobulinemia Refractory1
B-cell Malignancy1
Relapsed Cancer1
Refractory Cancer1
B-cell Lymphoma1
Diffuse Large B Cell Lymphoma (DLBCL)1
Large B-cell Lymphoma1
Antiphospholipid Syndrome1
Thrombocytopenia1
Treatment1
Follicular Lymphoma1
Mucosa-associated Lymphoid Tissue Lymphoma (MALT)1
Diffuse Large B-Cell Lymphoma (DLBCL)1
B-cell Non Hodgkin Lymphoma1
Diffuse Large B-Cell Lymphoma1
Effects of Chemotherapy1
Safety Issues1
Waldenström's Macroglobulinemia1
Hemophagocytic Lymphohistiocytosis1
Central Nervous System Lymphoma1
03

Sponsors

lead sponsor per trial
Lead sponsorTrials
BeOne Medicines12
Ruijin Hospital7
BeiGene3
Institute of Hematology & Blood Diseases Hospital, China3
The First Affiliated Hospital of Soochow University2
Loxo Oncology, Inc.1
Curis, Inc.1
Beijing Tongren Hospital1
Genfleet Therapeutics (Shanghai) Inc.1
The First Affiliated Hospital of Xiamen University1
Sun Yat-sen University1
The First Affiliated Hospital with Nanjing Medical University1
Henan Cancer Hospital1
Huazhong University of Science and Technology1
The First Hospital of Jilin University1
04

Trials by country register

RegisterZanubrutinib trials
Clinical trials in China33
Clinical trials in USA16
Clinical trials in UK12
Clinical trials in Ireland2

A trial with sites in more than one country appears in each of those registers.

How this page is built

Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Zanubrutinib works or whether it is effective. Each trial links to its own record so you can check it yourself.

This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Zanubrutinib (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 24 Sep 2026.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician — our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us — we correct promptly and log it.