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New drug combo shows promise for rare blood cancer

NCT ID NCT05952037

Disease control Sponsor: BeOne Medicines Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 study tests a new drug called sonrotoclax, either alone or combined with zanubrutinib, in 114 people with Waldenström macroglobulinemia, a rare blood cancer. The goal is to see if the treatment can shrink tumors and control the disease. Participants include those whose cancer has returned or not responded to prior therapy, as well as some newly diagnosed patients.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Sonrotoclax (a BCL2 inhibitor) and zanubrutinib (a BTK inhibitor)
What this could lead to
If successful, this combination could offer a new, effective treatment option for Waldenström macroglobulinemia, helping to control the disease and improve outcomes.
What could go wrong
This is a mid-stage trial with only 114 participants, so results may not apply to everyone. The drugs may cause side effects like low blood counts or infections, and the treatment may not work for all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

114 people

The number who actually took part.

Started

Oct 2023

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Clinical and definitive histologic diagnosis of WM. * Meeting ≥ 1 criterion for treatment according to consensus panel criteria from the 2nd International Workshop on Waldenström's Macroglobulinemia (IWWM). * For Cohorts 1-3, refractory or relapsed disease at study entry unless participants had intolerance to the most recent therapy. Refractory disease is defined as not attaining at least a major response, or progressing while on or within 6 months of completing therapy. Relapsed disease is defined as attaining at least a major response to therapy and meeting the criteria for disease progression beyond 6 months after completing therapy. * For Cohort 4, patients must not have received prior therapy for WM (except for plasmapheresis). * Adequate organ function. Exclusion Criteria: * Central nervous system (CNS) involvement by WM. * Transformation to aggressive lymphoma, such as diffuse large B-cell lymphoma. * History of other malignancies ≤ 2 years before study entry. * Uncontrolled active systemic infection or recent infection requiring parenteral antimicrobial therapy that was completed ≤ 14 days before the first dose of the study drug. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

lymphoma Waldenstrom macroglobulinemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Waldenstrom macroglobulinemia Waldenstrom's macroglobulinemia recurrent Waldenstrom's macroglobulinemia refractory

Contacts and locations

Locations

  • Affiliated Zhongshan Hospital of Fudan University

    Shanghai, Shanghai Municipality, 200032, China

  • Atrium Health Levine Cancer Institute (Lci)

    Charlotte, North Carolina, 28204-2990, United States

  • Azienda Sanitaria Universitaria Friuli Centrale Presidio Ospedaliero Universitario Santa Maria Del

    Udine, 33100, Italy

  • Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

    Brescia, 25123, Italy

  • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

    Milan, 20162, Italy

  • Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN, United Kingdom

  • Centre Hospitalier Universitaire Damiens Hopital Sud

    Amiens, 80054, France

  • Chu Clermont Ferrand Therapie Cellulaire and Hematolo

    Clermontferrand, 63100, France

  • Chu Hopital Lyon Sud

    PierreBenite, 69495, France

  • Churchill Hospital Oxford University Hospital Nhs Trust

    Headington, OX3 7LE, United Kingdom

  • City of Hope National Medical Center

    Duarte, California, 91010-3012, United States

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218, United States

  • Concord Repatriation General Hospital

    Concord, New South Wales, NSW 2139, Australia

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2, Canada

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215-5418, United States

  • Flinders Medical Centre

    Bedford PK, South Australia, SA 5042, Australia

  • Fondazione Policlinico Universitario Agostino Gemelli

    Roma, 00168, Italy

  • General Hospital of Athens Alexandra

    Athens, 115 28, Greece

  • Genesiscare North Shore

    St Leonards, New South Wales, NSW 2065, Australia

  • Guangdong Provincial Peoples Hospital

    Guangzhou, Guangdong, 510080, China

  • Hattiesburg Hematology and Oncology Clinic

    Hattiesburg, Mississippi, 39401-7233, United States

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450000, China

  • Hopital Robert Debre

    Reims, 51100, France

  • Hopital de La Pitie Salpetriere

    Paris, 75013, France

  • Hospital Clinic de Barcelona

    Barcelona, 8036, Spain

  • Hospital Universitari Mutua Terrassa

    Terrassa, 8221, Spain

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040, Spain

  • Hospital Universitario Vall Dhebron

    Barcelona, 08035, Spain

  • Hospital Universitario Virgen Del Rocio

    Seville, 41013, Spain

  • Hospital Universitario de Salamanca

    Salamanca, 37007, Spain

  • Huntsman Cancer Institute

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

  • Institut Catala Doncologia

    Barcelona, 08908, Spain

  • Institut Paoli Calmettes

    Marseille, 13009, France

  • Institute of Hematology and Hospital of Blood Disease

    Tianjin, Tianjin Municipality, 300020, China

  • Irccs Azienda Ospedaliero Universitaria Bologna

    Bologna, 40138, Italy

  • Irccs Policlinico San Matteo, Universita Degli Studi Di Pavi

    Pavia, 27100, Italy

  • Istituto Europeo Di Oncologia

    Milan, 20141, Italy

  • Linear Clinical Research

    Nedlands, Western Australia, WA 6009, Australia

  • Lions Gate Hospital Chemotherapy Clinic

    North Vancouver, British Columbia, V7L 2L7, Canada

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905-0001, United States

  • Medstar Georgetown University Hospital

    Washington D.C., District of Columbia, 20007-2113, United States

  • Memorial Sloan Kettering Cancer Center Mskcc

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

  • Mission Cancer and Blood

    Waukee, Iowa, 50263, United States

  • Monash Health

    Clayton, Victoria, VIC 3168, Australia

  • Nhs Highland

    Inverness, IV2 3BW, United Kingdom

  • Northwestern Medicine Cancer Center

    Warrenville, Illinois, 60555-3269, United States

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210-1280, United States

  • Plymouth Hospitals Nhs Trust

    Plymouth, PL6 8DH, United Kingdom

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, QLD 4102, Australia

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9, Canada

  • Qeii Health Science Center

    Halifax, Nova Scotia, B3H 2Y9, Canada

  • Royal Marsden Nhs Foundation Royal Marsden Hospital

    Sutton, SM2 5PT, United Kingdom

  • Royal Perth Hospital

    Perth, Western Australia, WA 6000, Australia

  • Shengjing Hospital of China Medical Universityshenbei Branch

    Shenyang, Liaoning, 110134, China

  • St Jamess University Hospital

    Leeds, LS9 7TF, United Kingdom

  • St Vincents Hospital Melbourne

    Fitzroy, Victoria, VIC 3065, Australia

  • The Affiliated Hospital of Qingdao University Branch South

    Qingdao, Shandong, 266000, China

  • The Christie Nhs Foundation Trust Manchester

    Manchester, M20 4BX, United Kingdom

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000, China

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361003, China

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003, China

  • The First Hospital of Jiaxing

    Jiaxing, Zhejiang, 314001, China

  • The Third Peoples Hospital of Datong

    Datong, Shanxi, 037008, China

  • Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei, 430030, China

  • University College Hospital

    London, NW1 2PG, United Kingdom

  • University Hospitals Dorset

    Bournemouth, BH7 7DW, United Kingdom

  • University of Maryland Greenebaum Comprehensive Cancer Center

    Baltimore, Maryland, 21201-1544, United States

  • University of Miami

    Miami, Florida, 33136-2107, United States

  • University of Washington

    Seattle, Washington, 98195, United States

  • Ut Southwestern Medical Center

    Dallas, Texas, 75390-7208, United States

  • Virginia Commonwealth University Massey Cancer Center

    Richmond, Virginia, 23298, United States

  • Yancheng First Peoples Hospital

    Yancheng, Jiangsu, 224006, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.