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A Study of Tacabrutideg (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

Study acronym: CaDAnCe-302
StatusRecruiting
PhasePhase 3
Started2025-04-10
View on ClinicalTrials.gov ↗

Amendment history

2026-09-10
Study Status, Contacts/Locations v35
Study sites130 entries, revised
HospitalScripps SantaPrebys Joana Recife Saarland University MedicalCancer Center Universitatsklinikum Des Saarlandes
2026-08-21
Study Identification, Study Status, Study Description, Arms and Interventions, Contacts/Locations v34
Trial sites expanded: 127 → 130 locations
InterventionsBGB-16673 (Drug), Bendamustine (Drug), Idelalisib (Drug), Rituximab (Drug), Venetoclax (Drug)→Bendamustine (Drug), Idelalisib (Drug), Rituximab (Drug), Tacabrutideg (Drug), Venetoclax (Drug)
Study description+9 characters
[...] were previously exposed to a BTKi and a BCL2i will receive BGB-16673tacabrutideg or the investigator's choice of idelalisib plus rituximab ( [...] CLL or SLL worsening between those participants who receive BGB-16673tacabrutideg versus the investigator's choice of treatment (idelalisib p [...] . Participants will be randomly allocated to receive either BGB-16673tacabrutideg or the investigator's choice of treatment. "Our company, pr [...]
Study title+15 characters
A Study of Tacabrutideg (BGB-16673) Compared to Investigator's Choice in Participants With Chro [...]
2026-08-06
Study Status, Contacts/Locations v33
Trial sites expanded: 124 → 127 locations
2026-07-21
Study Status, Contacts/Locations v32
Study sites123→124
2026-07-08
Study Status, Contacts/Locations v31
Trial sites expanded: 120 → 123 locations
2026-06-18
Study Status, Contacts/Locations v30
Trial sites expanded: 117 → 120 locations
2026-05-28
Study Status, Contacts/Locations v29
Study sites116→117
2026-05-08
Study Status, Contacts/Locations v28
Study sites115→116
2026-04-21
Study Status, Contacts/Locations v27
Study sites114→115
2026-04-15
Study Status, Contacts/Locations v26
Study sites112→114
2026-03-18
Study Status, Contacts/Locations v25
Study sites104→112
2026-03-03
Study Status, Contacts/Locations v24
Study sites98→104
2026-02-19
Study Status, Contacts/Locations v23
Study sites94→98
2026-02-09
Study Status, Contacts/Locations v22
Study sites86→94
2026-01-21
Study Status, Contacts/Locations v21
Study sites78→86
2026-01-15
Study Status, Study Description, Contacts/Locations v20
Study sites74→78
Study description+212 characters
[...] either BGB-16673 or the investigator's choice of treatment. "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."
2026-01-05
Study Status, Contacts/Locations v19
Study sites72→74
2025-12-15
Study Status, Contacts/Locations v18
Study sites66→72
2025-11-20
Study Status, Contacts/Locations v17
Study sites64→66
2025-11-11
Study Status, Sponsor/Collaborators, Contacts/Locations, IPDSharing v16
Study sites51→64
Lead sponsorBeiGene→BeOne Medicines
2025-10-23
Study Identification, Study Status, Contacts/Locations v15
Study sites125→51
2025-09-23
Study Status, Contacts/Locations v14
Study sites123→125
2025-09-12
Study Status, Contacts/Locations v13
Study sites122→123
2025-09-01
Study Status, Contacts/Locations v12
Study sitesdetails revised at 1 of 122 sites
2025-08-19
Study Status, Contacts/Locations v11
Study sites114→122
2025-08-05
Study Status, Contacts/Locations v10
Study sites105→114
2025-07-24
Study Status, Contacts/Locations v9
Study sites102→105
2025-07-11
Study Status, Contacts/Locations v8
Study sites101→102
2025-06-20
Study Status, Contacts/Locations v7
Study sites101 entries, revised
CampbelltownMemorial Hospital LiverpoolSloan Hospital CentroKettering de Investigacion Clinica Gramel Christus Latam HubCancer Center Mskcc Oncology Associates of ExcellenceOregon andWillamette InnovationValley ScCancer Center CentroFondazione deIrccs InvestigacionCa ClinicaGranda deOspedale OaxacaMaggiore Policlinico Azienda Ospedaliera Universitaria Federico Ii Irccs Policlinico San Matteo, Universita Degli Studi Di Pavi
2025-06-05
Study Status, Contacts/Locations v6
Study sites99→101
2025-05-27
Study Identification, Study Status v5
Re-verified, no change to tracked fields
2025-05-13
Study Identification, Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v4
Study sites95→99
Eligibility criteria+61 characters
Inclusion Criteria: Confirmed diagnosis of CLL or SLL, requiring treatment, based on 2018 international workshop [...] emia (iwCLL) criteria. Previously received treatment for CLL/SLL with both a BTKi and a BCL2i. MeasurableParticipants with SLL must have measurable disease by computer tomography (CT)/magnetic resonance imaging (MRI) Eastern Cooperative Oncology Group (ECOG) score 0, 1, or 2 [...]
Secondary endpoints10 entries, revised
Progression-Free Survival (PFS) in Participants Withwith Prior Exposure to Noncovalent Bruton Tyrosine Kinase Inhibitor(s) (ncBTKi) by IRC PFS as Assessed by the Investigator Assessment Rate of PRPartial Response with Lymphocytosis (PR-L) or Higher Determined by IRC and by investigatorInvestigator assessmentAssessment Time to Next Anti-CLL/SLL Treatment (TTNT) Number of Participants withWith Treatment-emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) Change from baselineBaseline in European Organization for Research and Treatment of Canc [...]
Study description+23 characters
[...] disease-related symptoms. In this study, participants with relapserelapsed/refractory (R/R) CLL who were previously exposed to a BTKi [...] 3 or the investigator's choice of idelalisib plus rituximab (for CLL only) or bendamustine plus rituximab or venetoclax plus rituximab [...] the length of time that participants live without their CLL or SLL worsening between those participants who receive BGB-16673 [...]
Study title+30 characters
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
2025-04-30
Study Status, Contacts/Locations v3
Study sites93→95
2025-04-11
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-04-11→confirmed 2025-04-10
Study sites89→93
2025-03-13
Study Status v1
Start date2025-03-11→2025-04-11
2025-02-21
Original filing
The purpose of this study is to investigate the efficacy and safety of tacabrutideg compared with investigator's choice (idelalisib plus rituximab \[for CLL only\] or bendamustine plus rituximab or venetoclax plus rituximab retreatment) in participants with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) previously exposed to both BTK inhibitors (BTKi) and BCL2 inhibitors (BCL2i).
Trial Details
NCT Number NCT06846671
Lead Sponsor BeOne Medicines
Conditions CLL, Chronic Lymphocytic Leukemia
Enrollment 250 participants
Start Date 2025-04-10
Primary Completion 2028-05-15 (estimated)
Study Completion 2030-02-14 (estimated)
Updated on ClinicalTrials.gov 2026-09-28