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
Launched by BEIGENE · Dec 16, 2024
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new combination treatment for adults with a type of cancer called mantle cell lymphoma (MCL) that has come back or has not responded to previous treatments. The researchers want to find out if a drug called sonrotoclax, when paired with another drug called zanubrutinib, works better than just zanubrutinib with a placebo (a harmless substitute that doesn’t contain active medication). The focus is not only on how effective this combination is but also on how safe it is for patients.
To participate in this study, a person should be between 65 and 74 years old, have a confirmed diagnosis of mantle cell lymphoma, and must have received 1 to 5 previous treatments for their cancer. They should also still need treatment, as determined by their doctor, and have measurable disease, meaning their cancer can be tracked for changes. Participants can expect to receive regular evaluations and treatments while being monitored for any side effects. This study is currently recruiting participants and aims to offer new hope for those struggling with this difficult-to-treat form of lymphoma.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Histologically confirmed diagnosis of MCL based on the World Health Organization 2022 classification of Haematolymphoid Tumors (WHO-HAEM5), or based on International Consensus Classification (ICC)
- • Received 1 to 5 prior lines of systemic therapy including an anti-CD20 monoclonal antibody (mAb)-based immunotherapy or chemoimmunotherapy and requiring treatment in the opinion of the investigator
- • Relapsed or refractory disease after the last line of therapy
- • Measurable disease defined as ≥ 1 nodal lesion that is \> 1.5 cm in longest diameter, or ≥ 1 extranodal lesion that is \> 1 cm in longest diameter
- • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
- • Adequate organ function
- Exclusion Criteria:
- • Prior therapy with B-cell lymphoma-2 inhibitor
- • Prior therapy with covalent or non-covalent Bruton tyrosine kinase inhibitor (BTKi) unless the participant was intolerant of non-zanubrutinib covalent or non-covalent BTKi
- • Prior autologous stem cell transplantation or chimeric antigen receptor T-cell therapy within 3 months before first dose of study drug
- • Prior allogeneic stem cell transplant within 6 months of the first dose of the study drug
- • Known central nervous system involvement by lymphoma
- • Clinically significant cardiovascular disease
- • History of stroke or intracranial hemorrhage within 6 months before first dose of study drug
- • Note: Other protocol defined Inclusion/Exclusion criteria may apply.
About Beigene
BeiGene is a global biotechnology company focused on discovering, developing, and commercializing innovative medicines for the treatment of cancer. With a robust pipeline of targeted therapies and immuno-oncology agents, BeiGene is dedicated to advancing precision medicine to improve patient outcomes. The company integrates cutting-edge research, clinical development, and manufacturing capabilities to deliver transformative therapies across diverse oncology indications. Committed to addressing unmet medical needs, BeiGene collaborates with healthcare professionals and institutions worldwide to accelerate the development of its product candidates and enhance the lives of patients battling cancer.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Ann Arbor, Michigan, United States
Rochester, Minnesota, United States
Saint Louis, Missouri, United States
Westmead, New South Wales, Australia
Chicago, Illinois, United States
Concord, New South Wales, Australia
Box Hill, Victoria, Australia
Durham, North Carolina, United States
Columbus, Ohio, United States
Houston, Texas, United States
Christchurch, , New Zealand
Weston, Florida, United States
Hershey, Pennsylvania, United States
Charlottesville, Virginia, United States
Cleveland, Ohio, United States
Plymouth, , United Kingdom
Curitiba, , Brazil
Birmingham, , United Kingdom
Nashville, Tennessee, United States
Glasgow, , United Kingdom
Seoul, , Korea, Republic Of
Toyohashi, Aichi, Japan
Nanjing, Jiangsu, China
Birmingham, Alabama, United States
New Haven, Connecticut, United States
Beijing, Beijing, China
Okayama, , Japan
Saint Louis, Missouri, United States
Kobe, Hyogo, Japan
Zhengzhou, Henan, China
Columbus, Ohio, United States
Chemnitz, , Germany
Dunedin, , New Zealand
Beijing, Beijing, China
Auckland, , New Zealand
Fuzhou, Fujian, China
Ogaki, Gifu, Japan
Takapuna, , New Zealand
Richmond, Virginia, United States
Beijing, Beijing, China
Shanghai, Shanghai, China
Nedlands, Western Australia, Australia
Columbus, Ohio, United States
London, , United Kingdom
Guangzhou, Guangdong, China
Harbin, Heilongjiang, China
Madrid, , Spain
Wuhan, Hubei, China
Verona, , Italy
Barcelona, , Spain
Halle, , Germany
Guangzhou, Guangdong, China
Wenzhou, Zhejiang, China
Nanchang, Jiangxi, China
Weston, Florida, United States
Fort Wayne, Indiana, United States
Chongqing, Chongqing, China
Tauranga, , New Zealand
Zhengzhou, , China
Clayton, Victoria, Australia
Wuhan, Hubei, China
Kocaeli, , Turkey
Chongqing, Chongqing, China
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Linyi, Shandong, China
Tours, , France
Osaka, , Japan
Wirral, , United Kingdom
Baltimore, Maryland, United States
Winston Salem, North Carolina, United States
Harbin, , China
Baltimore, Maryland, United States
Linz, , Austria
Xuzhou, Jiangsu, China
Bournemouth, , United Kingdom
Linyi, , China
West Perth, Western Australia, Australia
Shenyang, Liaoning, China
Buenos Aires, , Argentina
Guangzhou, Guangdong, China
Hattiesburg, Mississippi, United States
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
St Leonards, New South Wales, Australia
Nedlands, Western Australia, Australia
Ann Arbor, Michigan, United States
Des Moines, Iowa, United States
Krakow, , Poland
Birtinya, Queensland, Australia
Joinville, , Brazil
Verona, , Italy
Wellington, , New Zealand
Barcelona, , Spain
Caba, , Argentina
Caba, , Argentina
St Poelten, , Austria
Campinas, , Brazil
Vitoria, , Brazil
Montpellier Cedex, , France
Busan, Busan Gwang'yeogsi, Korea, Republic Of
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Madrid, , Spain
Chengdu, Sichuan, China
Meldola, , Italy
Phoenix, Arizona, United States
Salzburg, , Austria
Vienna, , Austria
Nantes Cedex, , France
Pierrebenite, , France
Munich, , Germany
Bologna, , Italy
Chibashi, Chiba, Japan
Hiroshimashi, Hiroshima, Japan
Yokohamashi, Kanagawa, Japan
Sendaishi, Miyagi, Japan
Kurashikishi, Okayama, Japan
Osakashi, Osaka, Japan
Lodz, , Poland
Edirne, , Turkey
Sapporoshi, Hokkaido, Japan
Antalya Memorial Hospital, , Turkey
Qingdao, Shandong, China
Xian, Shaanxi, China
San Juan, , Puerto Rico
Headington, , United Kingdom
Sao Paulo, , Brazil
Vancouver, Washington, United States
Seongnamsi, Gyeonggi Do, Korea, Republic Of
Charlotte, North Carolina, United States
Lublin, , Poland
Ankara, , Turkey
Nagoya, Aichi, Japan
Round Rock, Texas, United States
Porto Alegrers, , Brazil
Hamburg, , Germany
Yokohamashi, , Japan
Matsuyamashi, Ehime, Japan
Tokyo, , Japan
Barretos, , Brazil
Petropolis, , Brazil
Pembroke Pines, Florida, United States
Hangzhou, Zhejiang, China
Kagoshimashi, Kagoshima, Japan
Skorzewo, , Poland
Cooloongup, Western Australia, Australia
Nedlands, W. Australia, Australia
Chattanooga, Tennessee, United States
Boston, Massachusetts, United States
West Reading, Pennsylvania, United States
Gainesville, Virginia, United States
Cordoba, , Argentina
Belo Horizonte, , Brazil
Recife, , Brazil
Frankfurt Am Main, , Germany
Mutlangen, , Germany
Leece, , Italy
Trieste, , Italy
Koshigaya, Saitama, Japan
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Skorzewo, , Poland
Wroclaw, , Poland
Barcelona, , Spain
Paramus, New Jersey, United States
Kobeshi, Hyogo, Japan
Hattiesburg, Mississippi, United States
Vancouver, Washington, United States
Nantes, , France
Bundanggu Seongnamsi, Gyeonggi Do, Korea, Republic Of
Gangnamgu, Seoul Teugbyeolsi, Korea, Republic Of
Seochogu, Seoul Teugbyeolsi, Korea, Republic Of
Seodaemungu, Seoul Teugbyeolsi, Korea, Republic Of
Songpagu, Seoul Teugbyeolsi, Korea, Republic Of
Birmingham, Alabama, United States
Phoenix, Arizona, United States
Rochester, Minnesota, United States
Houston, Texas, United States
Vitoria, , Brazil
Montpellier, , France
Pembroke Pines, Florida, United States
Waukee, Iowa, United States
Ciudad Autonoma Buenos Aires, , Argentina
St Polten, , Austria
Majadahonda, , Spain
Charlotte, North Carolina, United States
New Haven, Connecticut, United States
Od, , Poland
Dokuma, , Turkey
Boston, Massachusetts, United States
Grand Rapids, Michigan, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
West Reading, Pennsylvania, United States
Round Rock, Texas, United States
Charlottesville, Virginia, United States
Gainesville, Virginia, United States
Richmond, Virginia, United States
Wien, , Austria
Belo Horizonte, , Brazil
Recife, , Brazil
Halle Saale, , Germany
Munchen, , Germany
Seogu, Busan Gwang'yeogsi, Korea, Republic Of
Yeongdeungpogu, Seoul Teugbyeolsi, Korea, Republic Of
Dopiewo, , Poland
Wrocaw, , Poland
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Toyohashishi, Aichi, Japan
Guangzhou, Guangdong, China
Patients applied
Trial Officials
Study Director
Study Director
BeiGene
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported