A Phase 3 interventional study of Tacabrutideg and Pirtobrutinib in Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, sponsored by BeOne Medicines. Recruiting at 217 sites in 24 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by BeOne Medicines · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate the efficacy and safety of tacabrutideg alone compared with pirtobrutinib in patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who had been previously treated with a covalent Bruton tyrosine kinase inhibitor (cBTKi).
Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.
Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Participants will receive tacabrutideg orally.
Drug: Tacabrutideg
Participants will receive pirtobrutinib orally.
Drug: Pirtobrutinib
Tacabrutideg will be administered orally
Also known as: BGB-16673
Pirtobrutinib will be administered orally
Also known as: Jaypirca
Progression-Free Survival (PFS) per Independent Review Committee (IRC)
PFS is defined as time from the date of randomization to the date of first disease progression or death, whichever occurs first, as determined by IRC using modified 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria for participants with chronic lymphocytic leukemia (CLL) and Lugano classification for participants with small lymphocytic lymphoma (SLL).
Time frame: Up to approximately 3 years
Overall Survival (OS)
OS is defined as the time from the date of randomization to the date of death due to any cause.
Time frame: Up to approximately 3 years
PFS per Investigator (INV)
PFS per INV is defined as time from the date of randomization to the date of first disease progression or death, whichever occurs first, as determined by investigator using modified 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria for participants with CLL and Lugano classification for participants with SLL.
Time frame: Up to approximately 3 years
Overall Response Rate (ORR) per IRC and INV
ORR is defined as the percentage of participants with a best overall response of complete response, complete response with incomplete bone marrow recovery, nodular partial remission, or partial response, as assessed by the investigator and IRC using modified 2018 iwCLL criteria for patients with CLL and Lugano classification for patients with SLL.
Time frame: Up to approximately 3 years
Rate of Partial Response with Lymphocytosis (PR-L) or Higher per IRC and INV
The rate of PR-L or higher is defined as the percentage of participants with a best overall response of complete response, complete response with incomplete bone marrow recovery, nodular partial remission, partial response, or PR-L.
Time frame: Up to approximately 3 years
Duration of Response (DOR) per IRC and INV
DOR is defined as the time from initial response to disease progression or death, whichever occurs first.
Time frame: Up to approximately 3 years
Time to Next Anti-CLL/SLL Treatment (TTNT)
TTNT is defined as the time from the date of randomization to the date of next anti-CLL/SLL treatment.
Time frame: Up to approximately 3 years
Number of Participants with Adverse Events (AEs)
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including laboratory abnormalities.
Time frame: Up to approximately 3 years
Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire EORTC IL409
EORTC IL409 consists of a set of 19 questions derived from the EORTC quality of life questionnaire core 30 (QLQ-C30) and its CLL module CLL17. The EORTC IL409 includes questions on global health status (GHS)/quality of life, physical functioning, role functioning, physical condition/fatigue, and symptom burden.Higher scores in GHS and functional scales and lower scores in symptom scales indicate better health-related quality of life.
Time frame: Baseline and up to approximately 3 years
Showing the first 100 of 217 sites across 24 countries.
Plan to share: Yes — BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.
Supporting information: Study protocol, Sap, Csr
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Leukemia, Lymphocytic, Chronic, B-Cell→
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