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)

NCT07508995 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2025-1943NCI-2026-02423
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Lymphocytic Leukemia (CLL)

Outcome Measures

Primary Outcomes (1)

• Safety and Adverse Events (AEs)

  Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  Through study completion; an average of 1 year

Study Arms (1)

Phase 2: Treatment with BGB-16673 + Sonrotoclax

EXPERIMENTAL

Treatment will be administered on an outpatient basis. However, hospitalization is recommended at each ramp-up dose increase until 24 hours after the dose for participants with high tumor burden at TLS Risk Reassessment.

Drug: BGB-16673; Drug: BGB-11417

Interventions

BGB-16673 DRUG

Given by mouth

Phase 2: Treatment with BGB-16673 + Sonrotoclax

BGB-11417 DRUG

Given by mouth

Phase 2: Treatment with BGB-16673 + Sonrotoclax

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• a. Platelet count ≥50 x109/L and hemoglobin ≥8 g/dL (≥80 g/L). Platelet and hemoglobin requirements are independent of transfusions within 7 days of screening assessment and first dose of study drugs. b. Absolute neutrophil count ≥0.75 x 109/L. Absolute neutrophil count is independent of growth factor support within 7 days of screening assessment and first dose of study drugs.
• Adequate coagulation function a. INR ≤1.5 x ULN and aPTT ≤1.5 x ULN
• Ability to swallow tablets and comply with outpatient treatment, laboratory monitoring, and required clinic visit for the duration of study participation
• Women of childbearing potential must have a negative serum or urine beta human chorionic gonadotropin (β-hCG) pregnancy test result within 24 hours prior to the first dose of study drugs.
• o Postmenopausal (no menses in greater than or equal to 12 consecutive months).
• o History of hysterectomy or bilateral salpingo-oophorectomy.
• Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).
• History of bilateral tubal ligation or another surgical sterilization procedure.

You may not qualify if:

• 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
• Clinically significant, uncontrolled cardiovascular disease (≥3 NYHA heart failure, uncontrolled or symptomatic arrythmias), or myocardial infarction within 6 months prior to start of study drugs
• Uncontrolled hypertension defined as 2 consecutive systolic blood pressure ≥160 mmHg and /or diastolic blood pressure ≥100 mmHg within 3 months
• History of Mobitz II second degree or third-degree heart block without a permanent pacemaker in place
• Prolongation of the QT interval corrected for heart rate (QTcF) \>480 msec. Note: Patients with QTcF \>480 msec should have EKG repeated. If QTcF again is \>480 msec, then the patient should be referred to cardiology for evaluation. Patient can be enrolled later if cleared by cardiology and repeat QTcF less than 480 msec. QTcF is calculated using Fridericia's Formula (QTcF): QTcF = QT/(RR0.33)
• Correction of suspected drug-induced QTcF prolongation can be attempted at the investigator's discretion and only if clinically safe to do so with either discontinuation of the offending drug or switch to another drug not known to be associated with QTcF prolongation.
• Correction for underlying bundle branch block (BBB) allowed. Note: Patients with pacemakers are eligible if they have no history of fainting or clinically relevant arrhythmias while using the pacemaker
• Pregnancy, lactation or plan to breastfeed during the study or within 6 months of the last dose of study treatment
• Concurrent use of warfarin or another vitamin K antagonist

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

UT MD Anderson

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Website

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nitin Jain, MBBS

  UT MD Anderson

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nitin Jain, MBBS

CONTACT

(713) 745-6080; njain@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2026
• First Posted: April 3, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): July 1, 2031
• Study Completion (Estimated): July 1, 2033
• Last Updated: August 25, 2026

Record last verified: 2026-08

Locations

US (1)