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New hope for tough lymphoma: sonrotoclax trial underway

NCT ID NCT05471843

Disease control Sponsor: BeiGene 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests a drug called sonrotoclax (BGB-11417) in 125 people with mantle cell lymphoma that has relapsed or not responded to prior treatments. The trial has two parts: first to find the safest dose, then to see how well it shrinks tumors. Participants take the drug by mouth, and researchers monitor side effects and cancer response.

What this could mean

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

Active substance
sonrotoclax (BGB-11417)
What this could lead to
If it works, this could offer a new treatment option for people with mantle cell lymphoma that has stopped responding to other therapies.
What could go wrong
This is an early-phase trial with only 125 participants, so results may not apply to everyone. Side effects like tumor lysis syndrome are possible.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

125 people

The number who actually took part.

Started

Sep 2022

Expected to finish

Jan 2027

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.

Key Inclusion Criteria: 1. Histologically confirmed diagnosis of MCL 2. Prior systemic treatments for MCL (at least one line of anti-cluster of differentiation 20 (anti-CD20) based immune or chemoimmunotherapy and at least one kind of covalent or non-covalent adequate Bruton Tyrosine Kinase (BTK) inhibitor). 3. Relapsed/refractory disease 4. Presence of measurable disease 5. Availability of archival tissue confirming diagnosis of MCL, or willing to undergo fresh tumor biopsy 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2. 7. Adequate organ function Key Exclusion Criteria: 1. Known central nervous system involvement by lymphoma 2. Prior malignancy other than MCL within the past 3 years, except for curatively treated basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score 6 prostate cancer. 3. Prior exposure to a BCL-2 inhibitor (eg, venetoclax/ABT-199). 4. Prior autologous stem cell transplant within the last 3 months; or prior autologous chimeric antigen receptor T-cell therapy within the last 3 months; or prior allogeneic stem cell transplant within the last 6 months or currently has an active graft-vs-host disease requiring the use of immunosuppressants. 5. Clinically significant cardiovascular disease. 6. Major surgery or significant injury ≤ 4 weeks prior to start of study treatment. 7. Active fungal, bacterial or viral infection requiring systemic treatment. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

lymphoma mantle cell lymphoma

As listed by the trial registrant

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

Mantle cell lymphoma Refractory mantle cell lymphoma (MCL) Relapsed mantle cell lymphoma

Contacts and locations

Locations

  • AZ DELTA

    Roeselare, 8800, Belgium

  • Accamargo Cancer Center

    São Paulo, 01508-010, Brazil

  • Affiliated Cancer Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, 830000, China

  • Affiliated Hospital of Nantong University

    Nantong, Jiangsu, 201203, China

  • Anhui Provincial Cancer Hospital Aka West Branch of Anhui Province Hospital

    Hefei, Anhui, 230088, China

  • Ankara University Medical Faculty

    Ankara, 06620, Turkey (Türkiye)

  • Aou Maggiore Della Carita

    Novara, 28100, Italy

  • Assuta Ashdod Medical Center

    Ashdod, 7747629, Israel

  • Auxilio Mutuo Cancer Center

    San Juan, 00917, Puerto Rico

  • Az Sint Jan Brugge

    Bruges, 8000, Belgium

  • Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

    Brescia, 25123, Italy

  • Bagcilar Medipol Mega Hospital

    Istanbul, 34214, Turkey (Türkiye)

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142, China

  • Beijing Friendship Hospital, Capital Medical University(Tongzhou)

    Beijing, Beijing Municipality, 101100, China

  • Cancer Hospital of Guizhou Medical University

    Guiyang, Guizhou, 550000, China

  • Centre Hospitalier Le Mans

    Le Mans, 72037, France

  • Centre Hospitalier Universitaire Nantes Hotel Dieu

    Nantes, 44093, France

  • China Japan Friendship Hospital

    Beijing, Beijing Municipality, 100029, China

  • Chu Hopital Lyon Sud

    PierreBenite, 69495, France

  • Chu Tours Hopital Bretonneau Service Pneumologie

    Tours, 37000, France

  • Churchill Hospital Oxford University Hospital Nhs Trust

    Headington, OX3 7LE, United Kingdom

  • Clatterbridge Cancer Centre

    Metropolitan Borough of Wirral, CH63 4JY, United Kingdom

  • Dartmouth Cancer Center

    Lebanon, New Hampshire, 03756, United States

  • Des Moines Oncology Research Association

    Des Moines, Iowa, 50309, United States

  • Dr Abdurrahman Yurtaslan Oncology Teaching and Research Hospital

    Ankara, 06620, Turkey (Türkiye)

  • Ege University Medical Faculty

    Izmir, 35100, Turkey (Türkiye)

  • Erciyes University School of Medicine

    Kayseri, 38039, Turkey (Türkiye)

  • Fort Wayne Medical Oncology and Hematology

    Fort Wayne, Indiana, 46804, United States

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014, China

  • Gazi University

    Ankara, 6500, Turkey (Türkiye)

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia, 750004, China

  • Guangdong Provincial Peoples Hospital Huifu Branch

    Guangzhou, Guangdong, 510120, China

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601, United States

  • Hadassah En Karem Medical Center

    Jerusalem, 9112001, Israel

  • Hainan General Hospital

    Haikou, Hainan, 570206, China

  • Hcfmusp Servico de Hematologia, Hemoterapia E Terapia Celular

    São Paulo, 05402-000, Brazil

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450000, China

  • Hopital Pitie Salpetriere Service Hematologie

    Paris, 75013, France

  • Hospital Aleman

    Buenos Aires, C1118, Argentina

  • Hospital Beneficencia Portuguesa de Sao Paulo

    São Paulo, 01323-001, Brazil

  • Hospital Das Clinicas Da Faculdade de Medicina de Ribeirao Preto Usp

    Ribeirão Preto, 14051-140, Brazil

  • Hospital Erasto Gaertner

    Curitiba, 81520-060, Brazil

  • Hospital Mae de Deus

    Porto Alegre, 90110-270, Brazil

  • Hospital Sao Rafael (Rede Dor)

    Salvador, 41253-190, Brazil

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040, Spain

  • Hospital Universitario Vall Dhebron

    Barcelona, 08035, Spain

  • Hospital Universitario Virgen Del Rocio

    Seville, 41013, Spain

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013, China

  • Institute of Hematology and Hospital of Blood Disease

    Tianjin, Tianjin Municipality, 300020, China

  • Instituto Americas Ensino, Pesquisa E Inovacao

    Rio de Janeiro, 22775-001, Brazil

  • Instituto Dor de Pesquisa E Ensino Sao Paulo

    São Paulo, 01401-002, Brazil

  • Irccs Istituto Tumori Giovanni Paolo Ii

    Bari, 70124, Italy

  • Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Irst

    Meldola, 47014, Italy

  • Jiangmen Central Hospital

    Jiangmen, Guangdong, 529030, China

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029, China

  • Jiangxi Province Cancer Hospital

    Nanchang, Jiangxi, 330029, China

  • Kocaeli Universitesi Tip Fakultesi

    Kocaeli, 41380, Turkey (Türkiye)

  • Liaoning Cancer Hospital and Institute

    Shenyang, Liaoning, 110042, China

  • Luminis Health Anne Arundel Medical Center

    Annapolis, Maryland, 21401, United States

  • Maryland Oncology Hematology, Pa

    Columbia, Maryland, 21044, United States

  • Medstar Georgetown University Hospital

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

  • Narodowy Instytut Onkologii Im Marii Skodowskiej Curie Pastwowy Instytut Badawczy

    Warsaw, 02-034, Poland

  • Nebraska Cancer Specialists

    Grand Island, Nebraska, 68803, United States

  • Necker University Hospital

    Paris, 75015, France

  • Novant Health Hematology Charlotte

    Charlotte, North Carolina, 28204, United States

  • Oncoclinicas Rio de Janeiro Sa

    Rio de Janeiro, 22250-905, Brazil

  • Ondokuz Mayis University Medicine Faculty Hospital

    Atakum Samsun, 55200, Turkey (Türkiye)

  • Policlinico Sorsola Malpighi, Aou Di Bologna

    Bologna, 40138, Italy

  • Pratia McM Krakow

    Krakow, 30-727, Poland

  • Qeii Health Science Center

    Halifax, Nova Scotia, B3H 2Y9, Canada

  • Rabin Medical Center

    Petah Tikva, 49100, Israel

  • Shaare Zedek Medical Center

    Jerusalem, 9103102, Israel

  • Shandong Cancer Hospital

    Jinan, Shandong, 250117, China

  • Shanxi Provincial Cancer Hospital

    Taiyuan, Shanxi, 030013, China

  • Sheba Medical Center

    Tel Aviv, 5262100, Israel

  • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

    São Paulo, 05653-120, Brazil

  • Sourasky Tel Aviv Medical Center

    Tel Aviv, 64239, Israel

  • Sun Yat Sen University Cancer Center

    Guangzhou, Guangdong, 510060, China

  • The Affiliated Hospital of Qingdao University Branch West Coast

    Qingdao, Shandong, 266555, China

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu, 221000, China

  • The Christie Hospital

    Greater Manchester, M20 4BX, United Kingdom

  • The First Affiliated Hospital of Nanchang University Branch Donghu

    Nanchang, Jiangxi, 330006, China

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052, China

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003, China

  • The First Peoples Hospital of Kashgar

    Kashgar, Xinjiang, 844099, China

  • The Tumor Hospital Affiliated to Guangxi Medical University

    Nanning, Guangxi, 530021, China

  • The University of Texas Md Anderson Cancer Center

    Houston, Texas, 77030-4009, United States

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300060, China

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

    Wuhan, Hubei, 430030, China

  • Tulane Cancer Center

    New Orleans, Louisiana, 70112, United States

  • Universitair Ziekenhuis Gent

    Ghent, 9000, Belgium

  • Universitatsklinikum Dusseldorf

    Düsseldorf, 40225, Germany

  • Universitatsklinikum Essen (Aor)

    Essen, D-45147, Germany

  • Universitatsklinikum Koln, Innere Medizin I

    Cologne, 50937, Germany

  • Universitatsklinikum Schleswig Holstein, Campus Kiel

    Kiel, 24105, Germany

  • University College Hospital

    London, NW1 2PG, United Kingdom

  • University Hospitals Leuven

    Leuven, 3000, Belgium

  • University of Alabama At Birmingham Hospital

    Birmingham, Alabama, 35294, United States

  • University of Missouri Hospital, Ellis Fischel Cancer Center

    Columbia, Missouri, 65212, United States

  • Uniwersytecki Szpital Kliniczny Nr W Lublinie

    Lublin, 20-090, Poland

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-952, Poland

  • Vkv American Hospital

    Istanbul, 34365, Turkey (Türkiye)

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041, China

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022, China

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