A Study of BGB-16673 Compared to Investigator's Choice in Participants With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Both Bruton Tyrosine Kinase (BTK) and B-cell Leukemia/Lymphoma 2 Protein (BCL2) Inhibitors
Launched by BEIGENE · Feb 21, 2025
Trial Information
Current as of July 23, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment called BGB-16673 for patients with chronic lymphocytic leukemia (CLL) who have already received certain other treatments. The goal is to see how effective and safe BGB-16673 is compared to other existing treatment options that doctors might choose for these patients, such as combinations of idelalisib with rituximab, bendamustine with rituximab, or venetoclax with rituximab. The study is currently recruiting participants who are between 65 and 74 years old and meet specific health criteria.
To be eligible for this trial, participants must have a confirmed diagnosis of CLL that needs treatment and must have previously been treated with both a BTK inhibitor (a type of drug that blocks signals that help cancer cells grow) and a BCL2 inhibitor (which helps to make cancer cells die). Participants should also have measurable disease and good overall health as assessed by a specific scoring system. Those interested can expect to receive either the new treatment or the doctor’s choice of existing treatments and will be closely monitored for any effects. It's important to note that there are certain health conditions that would exclude someone from participating, so discussing eligibility with a healthcare provider is crucial.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Confirmed diagnosis of CLL or SLL, requiring treatment, based on 2018 international workshop on chronic lymphocytic leukemia (iwCLL) criteria.
- • 2. Previously received treatment for CLL/SLL with both a BTKi and a BCL2i.
- • 3. Participants with SLL must have measurable disease by computer tomography (CT)/magnetic resonance imaging (MRI)
- • 4. Eastern Cooperative Oncology Group (ECOG) score 0, 1, or 2
- • 5. Adequate liver function
- • 6. Adequate blood clotting function
- Exclusion Criteria:
- • 1. Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation
- • 2. Prior autologous stem cell transplant or chimeric antigen receptor-T cell therapy in the last 3 months
- • 3. Known central nervous system involvement
- • 4. Prior exposure to any BTK protein degraders
- • 5. Active fungal, bacterial and/or viral infection requiring parenteral systemic therapy
- • 6. Clinically significant cardiovascular disease
- • 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
Liverpool, New South Wales, Australia
Concord, New South Wales, Australia
Toowoomba, Queensland, Australia
Melbourne, Victoria, Australia
Aberdeen, , United Kingdom
Nottingham, , United Kingdom
Curitiba, , Brazil
Southampton, , United Kingdom
Birmingham, , United Kingdom
Kashiwa, Chiba, Japan
London, , United Kingdom
Milano, , Italy
Campbelltown, New South Wales, Australia
Ottawa, Ontario, Canada
London, Ontario, Canada
Kumamoto, , Japan
Seoul, , Korea, Republic Of
Hradec Kralove, , Czechia
Napoli, , Italy
Osakasayama, Osaka, Japan
Okayama, , Japan
Brno, , Czechia
Brno, , Czechia
Chemnitz, , Germany
Auckland, , New Zealand
Takapuna, , New Zealand
London, , United Kingdom
Bari, , Italy
Milano, , Italy
Weston, Florida, United States
Homburg, , Germany
Hirakata, Osaka, Japan
Roma, , Italy
Katowice, , Poland
Osaka, , Japan
Dortmund, , Germany
Bournemouth, , United Kingdom
Nottingham, , United Kingdom
Novara, , Italy
Daegu, Daegu Gwang'yeogsi, Korea, Republic Of
West Perth, Western Australia, Australia
Sapporo, Hokkaido, Japan
Jonesboro, Arkansas, United States
Izmir, , Turkey
Firenze, , Italy
Oaxaca, , Mexico
Niteroi, , Brazil
Toowoomba, Queensland, Australia
Rio De Janeiro, , Brazil
Goteborg, , Sweden
Greenfield Park, Quebec, Canada
Krakow, , Poland
York, Pennsylvania, United States
Joinville, , Brazil
Perugia, , Italy
Caba, , Argentina
Caba, , Argentina
Florianopolis, , Brazil
Porto Alegre, , Brazil
Rio De Janeiro, , Brazil
Sao Paulo, , Brazil
Vitoria, , Brazil
Pavia, , Italy
Busan, Busan Gwang'yeogsi, Korea, Republic Of
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Katowice, , Poland
Leipzig, , Germany
Brasilia, , Brazil
Praha, , Czechia
Wroclaw, , Poland
Eugene, Oregon, United States
Chibashi, Chiba, Japan
Hiroshimashi, Hiroshima, Japan
Sendaishi, Miyagi, Japan
Kurashikishi, Okayama, Japan
Chuoku, Tokyo, Japan
Kyoto, , Japan
Lodz, , Poland
Ankara, , Turkey
Matsuyamashi, Ehime, Japan
Amagasakicity, Hyogo, Japan
Antalya Memorial Hospital, , Turkey
Berlin, , Germany
Brzozow, , Poland
Sao Paulo, , Brazil
Monterrey, , Mexico
Montreal, Quebec, Canada
Sao Paulo, , Brazil
Hwasungun, Jeollanam Do, Korea, Republic Of
Wroclaw, , Poland
Ankara, , Turkey
Frankfurt, , Germany
Lublin, , Poland
Nagoya, Aichi, Japan
Augsburg, , Germany
Hamburg, , Germany
Niigatashi, Niigata, Japan
Atlanta, Georgia, United States
Kagoshimashi, Kagoshima, Japan
Seoul, 서울 Seoul, Korea, Republic Of
Caba, , Argentina
Belo Horizonte, , Brazil
Rio De Janeiro, , Brazil
Sao Paulo, , Brazil
Koblenz, , Germany
Munster, , Germany
Kawagoeshi, Saitama, Japan
Shinagawaku, Tokyo, Japan
Goyang Si, Gyeonggi Do, Korea, Republic Of
Mexico, , Mexico
Sapporoshi, Hokkaido, Japan
Westbury, New York, United States
Tyler, Texas, United States
Aurora, Colorado, United States
New York, New York, United States
Ilsandonggu Goyangsi, Gyeonggi Do, Korea, Republic Of
Gangnamgu, Seoul Teugbyeolsi, Korea, Republic Of
Seochogu, Seoul Teugbyeolsi, Korea, Republic Of
Bethesda, Maryland, United States
Vitoria, , Brazil
Balcova, , Turkey
Grand Rapids, Michigan, United States
Ciudad Autonoma Buenos Aires, , Argentina
Rio De Janeiro, , Brazil
Saintjerome, Quebec, Canada
Hradec Kralove, , Czechia
Kyotoshi, Kyoto, Japan
Seogu, Busan Gwang'yeogsi, Korea, Republic Of
Ciudad Autonoma Buenos Aires, , Argentina
Belo Horizonte, , Brazil
Frankfurt Am Main, , Germany
Shinagawaku, Tokyo, Japan
Junggu, Daegu Gwang'yeogsi, Korea, Republic Of
Oaxaca De Juarez, , Mexico
Od, , Poland
Wrocaw, , Poland
Dokuma, , Turkey
Cleveland, Ohio, United States
Baton Rouge, Louisiana, United States
Belo Horizonte, , Brazil
Omaha, Nebraska, United States
Patients applied
Trial Officials
Study Director
Study Director
BeiGene
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported