Recruiting

Phase 3

BGB-16673 vs. Idelalisib & Rituximab, Bendamustine & Rituximab, Venetoclax & RituximabA 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

Sponsor:

BeOne Medicines

Code:

NCT06846671

Conditions

CLL

Chronic Lymphocytic Leukemia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tacabrutideg

Bendamustine

Idelalisib

Rituximab

Venetoclax

Study Details

Brief 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).

Conditions

CLL

Chronic Lymphocytic Leukemia

Study ID

NCT06846671

Start date

Apr 10, 2025

Status verified date

Aug, 2026

Completion date

Feb 14, 2030

Anticipated

Primary completion date

May 15, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A: Tacabrutideg monotherapy

Participants will receive tacabrutideg once daily until any of the treatment discontinuation criteria are met

active comparator: Arm B: Investigator's Choice

Participants will receive investigator's choice of idelalisib plus rituximab for CLL only or bendamustine plus rituximab, or venetoclax plus rituximab retreatment.

Interventions

Tacabrutideg

Administered orally

Bendamustine

Administered intravenously

Idelalisib

Administered orally

Rituximab

Administered intravenously

Venetoclax

Administered orally

Primary outcome measure

Progression-Free Survival (PFS) by Independent Review Committee (IRC) [ Time Frame: Approximately 36 Months ]

Central Contacts and Locations

Central contacts

Study Director

1.877.828.5568 clinicaltrials@beonemed.com

Locations

St Bernards Medical Center

Recruiting

Jonesboro, Arkansas, United States, 72401

UCLA Department of Medicine Hematologyoncology

Recruiting

Los Angeles, California, United States, 90095-3075

Pih Health Whittier Hospital

Recruiting

Whittier, California, United States, 90602

Rocky Mountain Cancer Centers (Williams) Usor

Recruiting

Aurora, Colorado, United States, 80012-5405

Florida Oncology and Hematology

Recruiting

Fort Myers, Florida, United States, 33912

Baptist Md Anderson Cancer Center

Recruiting

Jacksonville, Florida, United States, 32207-8432

Cleveland Clinic Florida

Recruiting

Weston, Florida, United States, 33331-3609

Emory University Winship Cancer Institute

Recruiting

Atlanta, Georgia, United States, 30322-1013

Northside Cancer Center

Recruiting

Atlanta, Georgia, United States, 30342

Our Lady of the Lake Hospital

Recruiting

Baton Rouge, Louisiana, United States, 70808-4365

American Oncology Partners of Maryland Pa

Recruiting

Bethesda, Maryland, United States, 20817-7847

Corewell Health the Michigan Cancer Consortium

Recruiting

Grand Rapids, Michigan, United States, 49503-2560

St Lukes Center For Cancer Care

Recruiting

Chesterfield, Missouri, United States, 63017

Oncology Hematology Associates

Recruiting

Springfield, Missouri, United States, 65807-5288

St Vincent Frontier Cancer Center

Recruiting

Billings, Montana, United States, 59102-6746

Oncology Hematology West, Pc Dba Nebraska Cancer Specialists

Recruiting

Omaha, Nebraska, United States, 68130-2042

Memorial Sloan Kettering Cancer Center Mskcc

Recruiting

New York, New York, United States, 10065-6800

New York Cancer and Blood Specialists

Recruiting

Shirley, New York, United States, 11967

Optum Medical Care, Pc

Recruiting

Westbury, New York, United States, 11590-5119

University Hospitals

Recruiting

Cleveland, Ohio, United States, 44106-1716

Dayton Physician Network

Recruiting

Dayton, Ohio, United States, 45415

Oncology Associates of Oregon Willamette Valley Cancer Center

Recruiting

Eugene, Oregon, United States, 97401

West Penn Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Cancer Care Associates of York

Recruiting

York, Pennsylvania, United States, 17403-5049

Baylor Scott and White Health

Recruiting

Temple, Texas, United States, 76508-0001

Texas Oncology Tyler

Recruiting

Tyler, Texas, United States, 75702-7522

Juravinski Cancer Centre

Recruiting

Hamilton, Ontario, Canada, L8V 5C2

London Health Sciences Centre

Recruiting

London, Ontario, Canada, N6A 5W9

The Ottawa Hospital Cancer Centre

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Centre Integre de Sante Et de Services Sociaux de La Monteregie Centre

Recruiting

Greenfield Park, Quebec, Canada, J4V 2H1

Jewish General Hospital

Recruiting

Montreal, Quebec, Canada, QC H3t 1E2

Unite de Recherche Clinique Du Cisss Des Laurentides

Recruiting

SaintJerome, Quebec, Canada, J7Z 5T3

More Information

Sponsor

BeOne Medicines

Last update posted

Aug 24, 2026

Last verified

Aug, 2026

Keywords

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by BeOne Medicines on 2026-08-24.