drugset / Trial / NCT06846671

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

NCT06846671 ↗

Phase 3 Recruiting 250 enrolled BeOne Medicines
RandomizedParallel-groupOpen-labelTreatment

Summary

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).

Timeline

Start
2025-04-10
Primary completion
2028-05-15
Completion
2030-02-14

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bendamustine Small molecule — Intravenous
Comparator Idelalisib Small molecule — Oral
Comparator Rituximab Monoclonal antibody — Intravenous
Subject Tacabrutideg Unknown — Oral
Comparator Venetoclax Small molecule — Oral