A Phase 1/2 interventional study of Sonrotoclax and Zanubrutinib in Chronic Lymphocytic Leukemia, CLL and Mantle Cell Lymphoma, sponsored by BeOne Medicines. Recruiting at 22 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by BeOne Medicines · Phase 1/2, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 11 studies testing sonrotoclax in Leukemia, Lymphocytic, Chronic, B-Cell — 8 open to participants now, 11 under way, 4 of them phase 3. sonrotoclax · Leukemia, Lymphocytic, Chronic, B-Cell.
Among the 11 studies testing sonrotoclax in Leukemia, Lymphocytic, Chronic, B-Cell, this one is the 5th largest by planned enrollment, is one of 3 that started in 2025, is the only one in phase 1/2, reaches primary completion later than 7 of the 10 other live ones, and was the 5th registered.
2,036 studies on the registry are indexed under Leukemia, Lymphocytic, Chronic, B-Cell; 237 are open to participants now.
Browse Leukemia, Lymphocytic, Chronic, B-Cell studies →8 of the 11 studies testing sonrotoclax in Leukemia, Lymphocytic, Chronic, B-Cell are open now, in 12 countries. Recruiting first, the newest first:
Alliance for Clinical Trials in Oncology · Sites in United States
Ages 65+
BeOne Medicines · Sites in United States, Australia, Brazil and 14 more countries
Ages 18+
City of Hope Medical Center · Sites in United States
Ages 18+
BeOne Medicines · Sites in United States, Argentina, Australia and 18 more countries
Ages 18+
City of Hope Medical Center · Sites in United States
Ages 18+
By country, each count listing its studies:
sonrotoclax: first FDA approval 2026 (BEQALZI). What it is approved for, and how studies give it, is on its page →
Of the 188 Leukemia, Lymphocytic, Chronic, B-Cell studies recruiting now, 150 (80%) set no upper age limit and 15 (8%) stop at 75 or younger; 17 take children under 18; 13 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
11 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 6 · Phase 3 4
First in 2022; this study’s year is marked. 3 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 258 is above the median of 39 across 1,603 interventional studies indexed under Leukemia, Lymphocytic, Chronic, B-Cell.
Median enrollment 100 across the 11 interventional studies. None of them has completed or been terminated yet.
This tab as a report to print or save as PDF → With an account.
6 of 11 have an industry lead sponsor. The 6 most frequent:
BeOne Medicines is the lead sponsor of 69 studies on the registry; 49 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
18 studies in Leukemia, Lymphocytic, Chronic, B-Cell by BeOne Medicines: 7 open now, 12 under way, 7 of them phase 3. Of 6 finished, 3 (50%) have results posted.
Among the 18 studies in Leukemia, Lymphocytic, Chronic, B-Cell by BeOne Medicines, this one is the 8th largest by planned enrollment, is one of 5 that started in 2025, is one of 5 in phase 1/2, reaches primary completion later than 8 of the 11 other live ones, and was the 13th registered.
BeOne Medicines’s Leukemia, Lymphocytic, Chronic, B-Cell studies by the year they started, since 2017.
2 of the studies testing sonrotoclax in Leukemia, Lymphocytic, Chronic, B-Cell that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06637501BeOne MedicinesA Study to Investigate Sonrotoclax Combined With Zanubrutinib Versus Zanubrutinib Alone in Participants With Previously Untreated Chronic Lymphocytic Leukemia | 2026-11 |
| NCT07674810M.D. Anderson Cancer CenterA Phase 2 Trial Of The Combination Of Zanubrutinib, Sonrotoclax, And Obinutuzumab For Patients With Treatment-Naïve Chronic Lymphocytic Leukemia | 2027-04-30 |
Add all 2 to your calendar (.ics) → With an account.
Among the 11 studies testing sonrotoclax in Leukemia, Lymphocytic, Chronic, B-Cell, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among BeOne Medicines’s 18 in Leukemia, Lymphocytic, Chronic, B-Cell:
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to establish the safety of novel dosing and ramp-up schedules for sonrotoclax in participants with hematological malignancies.
This study will test the safety of novel sonrotoclax dosing with gradual increases of sonrotoclax dose over specified periods until the intended target daily dose is reached. The focus will be on tumor lysis syndrome (TLS) and related toxicity signals.
Sonrotoclax is a drug that works by blocking a protein called B-cell lymphoma-2 (BCL-2). When sonrotoclax blocks BCL-2 it slows down or stops the growth of tumor cells and helps them die. This can lead to improvements in patients with certain malignant diseases including chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL). The start of treatment with BCL-2 inhibitor requires a gradual ramp-up over the first weeks to avoid potential consequences of initial tumor cell breakage and the release of cell content in the bloodstream. Several ramp-up schedules have already been explored, and this study aims to optimize the dosing ramp-up schedule that may be beneficial to patients and caregivers. Zanubrutinib is a commercialized product that works by blocking a protein called Bruton's tyrosine kinase (BTK) and controlling the activity and survival of malignant B cells. Zanubrutinib has received approval in over 65 countries/regions worldwide for the treatment of adult participants with B-cell malignancies, including CLL and MCL.
This study will take place at multiple centers worldwide. The overall time to participate in this study is approximately 17 months for treatment-naïve (TN) CLL participants or approximately 32 months for relapsed/refractory (R/R) MCL participants.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants of must be willing to use a highly effective method of and refrain from egg donation for the duration of the study and for ≥ 7 days after the last dose of sonrotoclax or 1 month after the last dose of zanubrutinib, whichever is later.
Only for participants with Chronic Lymphocytic Leukemia (CLL):
At least 1 based on computed tomography (CT)/magnetic resonance imaging (MRI) and no history of prolymphocytic leukemia or Richter's transformation.
Only for participants with Mantle cell lymphoma (MCL):
Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive zanubrutinib alone, followed by a combination with sonrotoclax initiated with a ramp-up according to each schedule defined in the protocol. The total treatment duration is of 15 cycles of 28 days (including the phase of sonrotoclax dose ramp-up)
Drug: Sonrotoclax · Drug: Zanubrutinib
Participants will receive zanubrutinib alone, followed by a combination with sonrotoclax initiated with a ramp-up according to each schedule defined in the protocol, for a total of 27 cycles of 28 days (including the phase of sonrotoclax ramp-up), then will continue on zanubrutinib alone until progression of their disease or other treatment discontinuation criteria.
Drug: Sonrotoclax · Drug: Zanubrutinib
Administered orally
Also known as: BGB-11417
Administered orally
Also known as: BGB-3111
Number of Participants who Experience Tumor Lysis Syndrome (TLS)
TLS will be defined by Howard criteria during the schedule-limiting toxicity (SLT) evaluation window
Time frame: Up to approximately 4 months
Number of Participants with Adverse Events (AEs)
Safety will be assessed by monitoring and recording of all treatment emergent adverse events (AEs) graded by National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 and tolerability as determined by protocol-defined Cs during the SLT evaluation window
Time frame: Up to approximately 4 months
Number of Participants with Dose Modifications During the SLT Evaluation Window
Time frame: Up to approximately 4 months
Plan to share: Yes — BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: See plan description
Access criteria: See plan description
Data sharing details ↗ · beonemedicines.com
No publications or documents are linked to this record.
Started Jan 2025 (actual). Primary completion is estimated for Nov 2029, 58 months after the start.
Of 50 industry-sponsored phase 1/2 interventional studies under Leukemia, Lymphocytic, Chronic, B-Cell, half reached primary completion within 80 months of starting (the median), counting those still running; a quarter within 51 and three quarters within 104. This study's planned 58 months is below that.
Counting every sponsor, half of 90 studies reached it within 78 months; a quarter within 51 and three quarters within 103.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Sonrotoclax
Leukemia, Lymphocytic, Chronic, B-Cell →