AzTrials
AzTrials

Chronic Lymphocytic LeukemiaPhase 2NCT07887061

Tacabrutideg and Sonrotoclax, With Response-Guided Obinutuzumab, for the Treatment of Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

A Phase 2 study testing Tacabrutideg, Sonrotoclax and Obinutuzumab in people with Chronic Lymphocytic Leukemia and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, run by Fred Hutchinson Cancer Center at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This phase II trial tests how well tacabrutideg and sonrotoclax, with response-guided addition of obinutuzumab, works in treating patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). Tacabrutideg is a drug that degrades a protein called Bruton's tyrosine kinase (BTK). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Tacabrutideg, Sonrotoclax and Obinutuzumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
1 Jan 2027to 1 Jul 2032
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age >= 18 at time of study enrollment who are capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
  • Confirmed diagnosis of CLL/SLL by 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria
  • Meets criteria for treatment for iwCLL criteria
  • Measurable disease, as defined by at least one of the following:
  • At least one lymph node > 1.5 cm in longest diameter, as measurable by computed tomography (CT) or magnetic resonance imaging (MRI)
  • Clonal lymphocytes >= 5 x 10^9/L present on peripheral blood cytometry
Show all 29Show fewer
  • Bone marrow involvement of at least 30% by flow cytometry with peripheral blood cytopenias
  • Has not received any other CLL-directed therapy (e.g., must be TN). Patients who have received treatment for the treatment of immune thrombocytopenia or autoimmune hemolytic anemia (e.g. with rituximab or steroids) will be eligible if last treatment was >= 6 months prior to enrollment
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Absolute neutrophil count (ANC) >= 0.75 x 10^9/L if bone marrow involvement; otherwise, >= 1.00 x 10^9/L
  • Growth factor and/or transfusion support is permissible to stabilize participant prior to study treatment if needed. Patients must be free from growth factor support as evidenced by an ANC dated >= 14 days following the most recent administration of peg-filgrastim (or other pegylated myeloid growth factors) and >= 4 days following the most recent administration of filgrastim or other myeloid growth factors
  • Hemoglobin >= 8.0 g/dL, unless secondary to bone marrow infiltration by the underlying malignancy
  • Hemoglobin >= 80 g/L (independent of growth factor support or transfusion, defined as no growth factor support for >= 7 days and/or transfusion for >= 3 days); patients may have hemoglobin < 80 g/L with or without growth factor or transfusion as above if the reduced hemoglobin is secondary to bone marrow infiltration by the underlying malignancy
  • Platelets >= 50,000/uL
  • Growth factor and/or transfusion support is permissible to stabilize participant prior to study treatment if needed
  • Creatinine =< 1.5 x upper limit of normal (ULN) OR measured or calculated creatinine clearance (glomerular filtration rate [GFR] can also be used in place of creatinine or creatinine clearance [CrCl]) >= 30 mL/min for participants with creatinine levels > 1.5 x institutional ULN
  • Creatinine clearance (CrCl) should be calculated per institutional standard
  • Women of childbearing potential (WOCBP) must be willing to use a highly effective method of birth control and refrain from egg donation for the duration of the study and following the last dose of the drug, whichever comes last. (Note: when oral hormonal contraceptives are selected, an additional barrier method is required) All WOCBP must have a negative pregnancy test =< 7 days prior to the first dose of the study drug:
  • Duration of highly effective method of birth control following last dose of drug, whichever comes last:
  • BGB-16673: >= 30 days
  • Sonrotoclax: >= 7 days
  • Obinutuzumab: 18 months
  • WOCBP defined as a participant who is assigned female sex at birth and is postmenarcheal, has not reached a postmenopausal state (>= 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus)
  • Nonsterile men must also use a highly effective method of birth control along with barrier contraception and refrain from donating sperm for the duration of the study treatment period and then for the following duration:
  • Duration of highly effective method of birth control following last dose of drug, whichever comes last:
  • BGB-16673: >= 30 days
  • Sonrotoclax: >= 7 days
  • Obinutuzumab: 6 months
  • A man is considered fertile after puberty unless permanently sterile by bilateral orchidectomy. Men with known "low sperm counts" (consistent with "subfertility") are not to be considered sterile for purposes of this study

Who cannot join

  • Diagnosis of Richter transformation
  • Central nervous system disease at time of study enrollment
  • Active fungal, bacterial, and/or viral infection requiring parenteral systemic therapy
  • Positive serological status reflecting active hepatitis B:
  • Presence of hepatitis B virus surface antigen (HBsAg)
  • Patients with presence of hepatitis B virus core antibody (HBcAb), in the absence of HBsAg, with detectable hepatitis B virus (HBV) deoxyribonucleic acid (DNA)
Show all 37Show fewer
  • Note:
  • Patients with presence of HBcAb but undetectable HBV DNA and who are willing to undergo HBV DNA monitoring every 4 weeks for HBV reactivation are eligible
  • Participants should remain on anti-viral therapy throughout study intervention and follow local guidelines for HBV anti-viral therapy post completion of study intervention
  • Positive serological status reflecting active hepatitis C:
  • Patients with the presence of hepatitis C virus (HCV) antibody and detectable HCV ribonucleic acid (RNA)
  • Note:
  • Participants must have completed curative anti-viral therapy for HCV at least 4 weeks prior to study enrollment and are willing to undergo HCV RNA monitoring every 4 weeks for HCV reactivation are eligible
  • HIV with a detectable viral load or a CD4 count =< 350 cells/uL at time of screening
  • Participants with HIV who do not meet the above criteria are eligible if they are on a stable antiretroviral therapy (ART) regimen (ART must not be strong CYP3A4 inducers) for at least 4 weeks prior to study entry and are compliant with ART are eligible
  • Participants with an AIDS-defining opportunistic infection in the past 12 months prior to screening are not eligible
  • History of a second malignancy, except for the conditions listed below:
  • Potentially curative treatment has been completed with no evidence of disease for >= 2 years
  • The time requirement does not apply to participants who underwent successful definitive resection of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ, excluding carcinoma in situ of the bladder
  • Localized prostate cancer with Gleason score =< 6
  • Patients who are unable to comply with the requirements of the protocol
  • History of ischemic stroke or intracranial hemorrhage within 6 months before first dose of study drug
  • Patients with any major surgical procedure =< 28 days before the first dose of study drug. Patients must have recovered adequately from the procedure and/or complications from the procedure before the first dose of study drug
  • Patients with clinically significant cardiovascular disease such as the following:
  • Myocardial infarction within 3 months of the first dose of study drug
  • New York Heart Association classification III or IV congestive heart failure
  • History of clinically significant arrhythmias (e.g., sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes)
  • Fridericia's formula-corrected QT interval (QTcF) > 480 milliseconds based on Fridericia's formula. Patients with prolonged QTcF due to bundle branch block can be allowed after consultation with the cardiologists.
  • History of Mobitz II second-degree or third-degree heart block without a permanent pacemaker in place
  • Uncontrolled hypertension as indicated by a minimum of 2 consecutive blood pressure measurements showing systolic blood pressure >= 160 mmHg and diastolic blood pressure >= 100 mmHg at screening
  • Patients who have received corticosteroids given with antineoplastic intent (symptom control will not be considered as antineoplastic intent) =< 7 days before the first dose of study drug. Note: A short course (=< 7 days) of systemic steroid use is allowed if needed to control CLL/SLL-related symptoms and it is tapered off within 5 days after initiation of study drug. Ongoing systemic corticosteroid treatment (defined as >= 10 mg/day of prednisone or equivalent) is not allowed unless willing to receive anti-fungal prophylaxis during the entire treatment period
  • Requires treatment with warfarin or other vitamin K antagonists
  • History of known bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention
  • Patients who have a history of severe allergic reactions or hypersensitivity to the active ingredients of the study drug(s)
  • Female patients who are pregnant or are breastfeeding
  • Patients who are unable to swallow tablets or with disease/procedure significantly affecting gastrointestinal function such as malabsorption syndrome, resection of the stomach or small bowel, bariatric surgery procedures, symptomatic inflammatory bowel disease, partial or complete bowel obstruction, or gastrointestinal perforation or fistulae. Note: Gastroesophageal reflux disease under treatment with proton-pump inhibitors is allowed (assuming no drug interaction potential)
  • Patients with known contraindications to azole antifungal agents, including hypersensitivity reactions

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jennifer J. Huang, MD, PhD contact

206-667-1358

jhuang3@fredhutch.org

United States1 site

  • Fred Hutch/University of Washington Cancer Consortium

    Seattle, Washington, 98109

    Jennifer J. Huang, MD, PhD, 206-667-1358, jhuang3@fredhutch.org

    Jennifer J. Huang, MD, PhD

Other trials in United States

About this study

Official title: Phase 2 Study of Time-Limited BGB-16673 and Sonrotoclax With MRD-Guided Addition of Obinutuzumab for Treatment-Naïve Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

This phase II trial tests how well tacabrutideg and sonrotoclax, with response-guided addition of obinutuzumab, works in treating patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). Tacabrutideg is a drug that degrades a protein called Bruton's tyrosine kinase (BTK). By degrading BTK, tacabrutideg inhibits the activation of signaling pathways that help cancer cells survive, inhibiting the growth of cancer cells that express the BTK protein. Sonrotoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking BCL-2, a protein needed for cancer cell survival. Obinutuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Giving tacabrutideg together with sonrotoclax may kill more cancer cells than giving either drug alone, and giving obinutuzumab after initial treatment with tacabrutideg and sonrotoclax may improve disease response in patients whose CLL or SLL didn't respond completely to initial treatment.

Read the detailed description

OUTLINE:

Patients receive tacabrutideg orally (PO) once daily (QD) on days 1-28 of cycles 1-14 and sonrotoclax PO QD on days 1-28 of cycles 3-14. Cycles repeat every 28 days for up to 14 cycles in the absence of disease progression or unacceptable toxicity. Patients who are minimal residual disease (MRD) positive after cycle 14 continue receiving tacabrutideg PO QD and sonrotoclax PO QD on days 1-28 of cycles 15-20 and also receive obinutuzumab intravenously (IV) on days 8, 9, 15 and 22 of cycle 15 and day 8 of cycles 16-20. Cycles repeat every 28 days for up to 6 additional cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo transthoracic echocardiography (TTE) or multigated acquisition scan (MUGA) at screening and undergo computed tomography (CT) and collection of blood samples throughout the trial.

After completion of study treatment, patients are followed up at 30 days and then every 12 months thereafter.

Being tested
Tacabrutideg, Sonrotoclax, Obinutuzumab, Transthoracic Echocardiography Test, Biospecimen Collection
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TacabrutidegDrug

    Also called BGB 16673, BGB-16673, BGB16673, BTK Degrader BGB-16673

    Given PO

  • SonrotoclaxDrug

    Also called B-cell Lymphoma-2 Inhibitor BGB-11417, Bcl-2 Inhibitor BGB-11417, Beqalzi, BGB 11417

    Given PO

  • ObinutuzumabBiological

    Also called Anti-CD20 Monoclonal Antibody R7159, GA 101, GA-101, GA101

    Given IV

  • Transthoracic Echocardiography TestProcedure or surgery

    Also called TRANSTHORACIC ECHOCARDIOGRAPHY, TTE

    Undergo TTE

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Sample Collection

    Undergo collection of blood samples

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT

  • Multigated Acquisition ScanProcedure or surgery

    Also called MUGA, MUGA Scan, Multi-Gated Acquisition Scan, Blood Pool Scan

    Undergo MUGA

Study groups in NCT07887061
Study groupRoleWhat they receive
Treatment (tacabrutideg, sonrotoclax, obinutuzumab)ExperimentalPatients receive tacabrutideg PO QD on days 1-28 of cycles 1-14 and sonrotoclax PO QD on days 1-28 of cycles 3-14. Cycles repeat every 28 days for up to 14 cycles in the absence of disease progression or unacceptable toxicity. Patients who are MRD positive after cycle 14 continue receiving tacabrutideg PO QD and sonrotoclax PO QD on days 1-28 of cycles 15-20 and also receive obinutuzumab IV on days 8, 9, 15 and 22 of cycle 15 and day 8 of cycles 16-20. Cycles repeat every 28 days for up to 6 additional cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo TTE or MUGA at screening and undergo CT and collection of blood samples throughout the trial.
Receives: Drug: Tacabrutideg; Drug: Sonrotoclax; Biological: Obinutuzumab; Procedure: Transthoracic Echocardiography Test; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Multigated Acquisition Scan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of participants who have undetectable measurable residual disease at a sensitivity of 10^-4 (uMRD4)

    Measured: After completion of cycle 14 (cycle length = 28 days)

Secondary outcomes (4)

  1. Incidence of treatment-emergent adverse events

    Will assess the incidence, type, and severity of treatment-related treatment-emergent adverse events.

    Measured: Up to 30 days after last treatment

  2. Incidence of discontinuation due to adverse events

    Measured: Up to completion of 14-20 cycles (cycle length = 28 days)

  3. Proportion of participants who achieve both a complete response (or complete clinical response) and uMRD4

    Measured: Up to completion of 14-20 cycles (cycle length = 28 days)

  4. Proportion of patients with uMRD4 after addition of obinutuzumab, if needed

    Measured: After completion of cycles 15-20 (cycle length = 28 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2026
  2. Study start1 Jan 2027 (estimated)
  3. Primary completion1 Jul 2031 (estimated)
  4. Study completion1 Jul 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07887061
Sponsor's protocol ID
RG1126572
Other IDs
NCI-2026-07174
Status last verified
Oct 2026
First submitted
15 Oct 2026
Last updated
21 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tacabrutideg, Sonrotoclax and Obinutuzumab in people with Chronic Lymphocytic Leukemia and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, run by Fred Hutchinson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 29 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jennifer J. Huang, MD, PhD (206-667-1358, jhuang3@fredhutch.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of participants who have undetectable measurable residual disease at a sensitivity of 10^-4 (uMRD4) (time frame: After completion of cycle 14 (cycle length = 28 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07887061.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in