Sonrotoclax + Zanubrutinib for Chronic Lymphocytic Leukemia

Recruiting at 23 trial locations

Overseen By Study Director

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: BeOne Medicines

Disqualifiers: Previous CLL treatment, Prolymphocytic leukemia, CNS involvement, PML, Cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: 16 months

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of two treatment combinations for individuals with chronic lymphocytic leukemia (CLL) who have not previously received treatment. One group receives a combination of sonrotoclax (a new potential drug) and zanubrutinib, while another group receives venetoclax and acalabrutinib. Researchers aim to determine which combination is more effective and safe. Individuals diagnosed with CLL who require treatment and have not undergone any prior CLL treatments may be suitable candidates for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to potentially groundbreaking treatment advancements.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the combination of sonrotoclax and zanubrutinib is generally safe. In previous studies, patients with chronic lymphocytic leukemia (CLL) tolerated this combination well. Few patients discontinued treatment due to side effects, and there were no reports of tumor lysis syndrome, a serious condition where cancer cells break down too quickly.

The FDA has already approved venetoclax and acalabrutinib for other uses, so their side effects are well-known, providing extra safety assurance.

Overall, research indicates that both treatment combinations in this study are generally safe and well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of Sonrotoclax and Zanubrutinib for treating Chronic Lymphocytic Leukemia (CLL) because these drugs work in a unique way. Unlike standard treatments that often focus on inhibiting a single pathway, Sonrotoclax targets proteins that help cancer cells survive, while Zanubrutinib is a more selective Bruton’s tyrosine kinase (BTK) inhibitor that blocks signals needed for cancer cell growth. This dual approach might offer a more effective and targeted attack on leukemia cells, potentially leading to better outcomes for patients. The combination aims to improve treatment response by tackling the disease from multiple angles, which is why researchers are optimistic about its potential.

What evidence suggests that this trial's treatments could be effective for chronic lymphocytic leukemia?

This trial will compare two treatment combinations for chronic lymphocytic leukemia (CLL). Participants in one arm will receive sonrotoclax and zanubrutinib. Studies have shown that this combination looks very promising for treating CLL, with the cancer being undetectable in 92% of cases after 48 weeks. This indicates that the cancer could not be found at a certain level, which is a strong sign of effectiveness. The treatment was also well-tolerated, with few participants stopping due to side effects. Overall, early research suggests this combination could be a strong option for managing CLL. ^{1 3 6 7 8}

Who Is on the Research Team?

Study Director

Principal Investigator

BeOne Medicines

Are You a Good Fit for This Trial?

Inclusion Criteria

I can take care of myself and am up and about more than half of my waking hours.

I have chronic lymphocytic leukemia needing treatment and haven't received any.

My organs and bone marrow are functioning well.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either sonrotoclax plus zanubrutinib or venetoclax plus acalabrutinib for a fixed duration

16 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to approximately 70 months

What Are the Treatments Tested in This Trial?

Interventions

• Acalabrutinib
• Sonrotoclax
• Venetoclax
• Zanubrutinib

How Is the Trial Designed?

Group I: Arm A: Sonrotoclax plus Zanubrutinib Experimental Treatment 2 Interventions

Participants will receive sonrotoclax and zanubrutinib for a fixed duration followed by observation.

Group II: Arm B: Venetoclax plus Acalabrutinib Active Control 2 Interventions

Participants will receive venetoclax and acalabrutinib for a fixed duration followed by observation.

Who Is Running the Clinical Trial?

BeOne Medicines

Lead Sponsor

Citations

1.

ashpublications.org

ashpublications.org/blood/article/146/Supplement%201/3891/550914/Frontline-treatment-of-sonrotoclax-BGB-11417-and

Frontline treatment of sonrotoclax (BGB-11417) and ...

Sonrotoclax (160 and 320 mg) + zanubrutinib was well tolerated in patients with TN CLL/SLL, with low rates of treatment discontinuation due to TEAE and no TLS.

2.

cllsociety.org

cllsociety.org/2026/05/sonrotoclax-and-zanubrutinib-are-a-strong-combination-in-cll/

Sonrotoclax and Zanubrutinib Are a Strong Combination in ...

In frontline CLL patients, taking sonrotoclax 320 mg plus zanubrutinib led to undetectable measurable disease (uMRD) in 92% at 48 weeks and ...

3.

beonemedinfo.com

beonemedinfo.com/CongressDocuments/Cheah_BGB-11417-101_SZ_RR_CLL_EHA_Presentation_2025.pdf

Updated Results From the Phase 1 Study of Sonrotoclax

cAll MRD-evaluable set includes patients with ≥1 post-baseline MRD sample or disease progression or death prior to MRD assessment, excluding ...

4.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0006497125066376

Zanubrutinib + obinutuzumab + sonrotoclax in patients with ...

Presented here are initial safety and efficacy data for zanubrutinib + obinutuzumab + sonrotoclax combination therapy in patients with treatment-naive (TN) CLL/ ...

5.

conference-correspondent.com

conference-correspondent.com/highlights/ash/ash-2023-cll/phase-1-2-study-data-of-combination-sonrotoclax-bgb-11417-plus-zanubrutinib-in-treatment-naive-cll-sll

Phase 1/2 Study Data of Combination Sonrotoclax (BGB- ...

Data from an ongoing, first-in-human phase 1/2 study suggests that combination sonrotoclax (160 mg and 320 mg) plus zanubrutinib therapy was well tolerated ...

6.

iwcll.org

iwcll.org/work/biennial-meetings/iwcll-xxi-biennial-meeting-2025/2025-poster-gallery/updated-results-from-the-phase-1-study-of-sonrotoclax-bgb-11417-a-novel-b-cell-lymphoma-2-inhibitor-in-combination-with-zanubrutinib-for-relapsed-refractory-chronic-lymphocytic-leukemia-small-lymp/

Updated Results From the Phase 1 Study of Sonrotoclax ...

Sonrotoclax + zanubrutinib combination treatment demonstrated a tolerable safety profile across all dose levels tested. Antitumor activity of this combination ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06859008

Study Details | NCT06859008 | Zanubrutinib in ...

Zanubrutinib and sonrotoclax have been shown to be an effective treatment for B-cell cancers. Giving zanubrutinib in combination with sonrotoclax may be ...

8.

beonemedinfo.com

beonemedinfo.com/CongressDocuments/OpatBGB-11417-101iwCLLPoster2025.pdf

OpatBGB-11417-101iwCLLPoster2025.pdf

• Sonrotoclax + zanubrutinib combination treatment had a tolerable safety profile in patients ... Abbreviations: CLL/SLL, chronic lymphocytic leukemia/small ...