A Phase 2 Trial Of The Bruton Tyrosine Kinase Degrader BGB-16673 In Combination With BCL-2 Inhibi… (NCT07508995) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Phase 2 Trial Of The Bruton Tyrosine Kinase Degrader BGB-16673 In Combination With BCL-2 Inhibitor Sonrotoclax For Patients With Treatment-Naive Chronic Lymphocytic Leukemia (CLL)
United States40 participantsStarted 2026-09-01
Plain-language summary
This is an open-label, single-arm, phase II study which will assess the safety and efficacy of BGB16673 in combination with sonrotoclax as a time-limited approach for participants with treatment-naive CLL/SLL.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Patients with a diagnosis of previously untreated CLL/SLL meeting iwCLL 2018 indication for treatment (Note: patients who receive steroids and/or CD20 monoclonal antibody for cytoreduction in those patients presenting with significantly elevated WBC count or significant adenopathy/organomegaly and those who previously received steroids/CD20 monoclonal antibody for immune cytopenias are eligible to enroll; Washout of 4 weeks applies for CD20 monoclonal antibody and dose of prednisone (or equivalent) should be less than 20mg/day by day 1 of study initiation)
✓. Age ≥ 18 years
✓. Eastern Cooperative Oncology Group (ECOG) Performance status of 0-2
✓. Adequate hepatic function a. Total bilirubin ≤1.5 x upper limit of normal (ULN) or ≤3 x ULN for patients with Gilbert's disease or documented disease involvement of liver (In pts with elevated total bilirubin due to increased indirect bilirubin, pts with direct bilirubin ≤1.5 x ULN are eligible) b. ALT and AST ≤3.0 x ULN, or ≤5.0 x ULN if documented disease involvement of liver
✓. Adequate renal function
✓. Adequate renal function defined by a value ≥50 mL/min determined via estimated GFR calculated according to the CKD-EPI equation
✓. Adequate hematologic function
✓. Adequate coagulation function a. INR ≤1.5 x ULN and aPTT ≤1.5 x ULN
Exclusion criteria
✕1. Ability to understand and the willingness to sign a written informed consent document.
✕
What they're measuring
1
Safety and Adverse Events (AEs)
Timeframe: Through study completion; an average of 1 year
. Major surgery within 4 weeks prior to the first dose of study drugs
✕. Uncontrolled active systemic infection
✕. Known positive serology for human immunodeficiency virus (HIV)
✕. Active hepatitis B infection (defined as the presence of detectable HBV DNA, HBe antigen or HBs antigen). Patients with serologic evidence of prior vaccination (HBsAg negative, anti-HBs antibody positive, anti-HBc antibody negative) are eligible. Patients who are HBsAg negative/HBsAb positive but HBcAb positive are eligible, provided HBV DNA is negative and they are willing to take appropriate anti-viral prophylaxis
✕. Active hepatitis C infection (defined as detectable hepatitis C RNA in plasma by PCR)
✕. Known active cytomegalovirus (CMV) infection. Unknown or negative status are eligible
✕. Active, uncontrolled autoimmune phenomenon (autoimmune hemolytic anemia or immune thrombocytopenia) requiring steroid therapy with \>20 mg daily of prednisone or equivalent