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A Study to Evaluate the Safety and Efficacy of Tacabrutideg (BGB-16673) Compared to Pirtobrutinib in Adults With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

StatusRecruiting
PhasePhase 3
Started2025-09-04
View on ClinicalTrials.gov ↗

Amendment history

2026-09-09
Study Status, Contacts/Locations v24
Trial sites expanded: 214 → 217 locations
Trial sites expanded: 209 → 214 locations
2026-08-24
Study Identification, Study Status, Study Description, Arms and Interventions, Contacts/Locations v23
Trial sites expanded: 204 → 209 locations
InterventionsBGB-16673 (Drug), Pirtobrutinib (Drug)→Pirtobrutinib (Drug), Tacabrutideg (Drug)
Study title+15 characters
A Study to Evaluate the Safety and Efficacy of Tacabrutideg (BGB-16673) Compared to Pirtobrutinib in Adults With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
2026-08-05
Study Status, Contacts/Locations v22
Trial sites expanded: 197 → 204 locations
2026-07-22
Study Status, Contacts/Locations v21
Trial sites expanded: 186 → 197 locations
2026-07-09
Study Status, Contacts/Locations v20
Trial sites expanded: 167 → 186 locations
2026-06-17
Study Status, Contacts/Locations v19
Trial sites expanded: 156 → 167 locations
2026-06-01
Study Status, Contacts/Locations v18
Study sites154→156
2026-05-26
Study Status, Contacts/Locations v17
Trial sites expanded: 149 → 154 locations
2026-05-08
Study Status, Contacts/Locations v16
Trial sites expanded: 145 → 149 locations
2026-04-20
Study Status, Contacts/Locations v15
Study sites143→145
2026-04-14
Study Status, Contacts/Locations v14
Trial sites expanded: 129 → 143 locations
2026-03-17
Study Status, Contacts/Locations v13
Study sites126→129
2026-03-04
Study Status, Contacts/Locations v12
Study sites112→126
2026-02-20
Study Status, Contacts/Locations v11
Study sites94→112
2026-02-17
Study Status, Contacts/Locations v10
Study sites91→94
2026-02-03
Study Status, Contacts/Locations v9
Study sites68→91
2026-01-21
Study Status, Contacts/Locations v8
Study sites56→68
2026-01-09
Study Status, Study Description, Contacts/Locations v7
Study sites39→56
Study description+209 characters
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.
2025-12-22
Study Status, Contacts/Locations v6
Study sites23→39
2025-12-15
Study Status, Contacts/Locations v5
Study sites17→23
2025-11-19
Study Status, Contacts/Locations v4
Study sites16→17
2025-11-07
Study Status, Contacts/Locations v3
Study sites13→16
2025-10-23
Study Identification, Study Status, Sponsor/Collaborators, Contacts/Locations, IPDSharing v2
Study sites1→13
Lead sponsorBeiGene→BeOne Medicines
2025-09-30
Not Yet Recruiting→Recruiting Study Identification, Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-09→confirmed 2025-09-04
Study sites0→1
2025-05-07
Original filing
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).
Trial Details
NCT Number NCT06973187
Lead Sponsor BeOne Medicines
Conditions Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Enrollment 500 participants
Start Date 2025-09-04
Primary Completion 2028-04-17 (estimated)
Study Completion 2028-04-17 (estimated)
Updated on ClinicalTrials.gov 2026-09-28