Phase 2 study

Recruiting Phase 2

Sources: ClinicalTrials.gov Checked: 11 October 2026 Not medical advice

This trial at a glance

Status Recruiting

Phase Phase 2

Sponsor BeOne Medicines

Registry number NCT06697184

Started 23 January 2025 Today 16 October 2026 Estimated completion 30 November 2029

Where this trial is running

Trial sites and the status recorded for each
Site	City	State or country	Status at this site
Blacktown Cancer and Haematology Centre	Blacktown	NSW	Recruiting
Genesiscare St Andrews	Adelaide	SA	Recruiting
Cabrini Hospital Malvern	Malvern	VIC	Recruiting
The Alfred Hospital	Melbourne	VIC	Recruiting
Rockingham Hospital	Cooloongup	WA	Recruiting
Linear Clinical Research	Nedlands	WA	Recruiting

voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice

Who can join

Age 18 Years and over

Sex Anyone, regardless of sex

Healthy volunteers Not accepted

Enrolment target 258

The official eligibility criteria

Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.

Inclusion Criteria:

1. Stable Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.

2. Adequate organ function and no very recent transfusion or blood growth factor

3. Participants of childbearing potential must be willing to use a highly effective method of birth control 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):

4. Confirmed diagnosis of CLL, based on Hallek et al 2018, and requiring treatment due to certain features of their disease

5. At least 1 measurable lesion 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):

6. Historically confirmed diagnosis of MCL based on the World Health Organization 2022 classification of Haematolymphoid Tumors (WHO-HEAM5) or based on International Consensus Classification (ICC).

7. Relapsed or refractory to the last line of therapy and have received at least 1 prior line of systemic therapy. Note: A line of therapy is considered ≥ 2 consecutive cycles of a systemic anticancer regimen. Patients with prior BTKi therapy should not have progressed during treatment or relapsed within 12 months after BTKi discontinuation.

8. Measurable disease defined as ≥ 1 nodal lesion that is \> 1.5 cm in longest diameter, or ≥ 1 extranodal lesion that is \> 1 cm in longest diameter.

Exclusion Criteria:

1. Participants unable to comply with the requirements of the protocol

2. Serologic status reflecting active viral hepatitis B virus (HBV) or hepatitis C virus (HCV) infection

3. Positive HIV serology (HIVAb) status unless certain conditions are met.

4. Participants with any major surgical procedure ≤ 28 days before first dose of study treatment

5. Prior systemic treatment for the CLL

6. Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia requiring treatment

7. Prior exposure to a BCL-2 inhibitor

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Dates on the record

Started 23 January 2025

Estimated completion 30 November 2029

Registry last updated 28 September 2026

Checked by Voxsanity 11 October 2026

Results, publications and the official record

No results are posted on the official record yet.
No publications are listed on the official record yet.
Official record and contacts on ClinicalTrials.gov – contact details for each site are kept there, and are not copied onto this page.

Sources and dates

ClinicalTrials.gov – the record this page reformats
ClinicalTrials.gov processing date: 28 September 2026.
This page last checked by Voxsanity: 11 October 2026.

Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.

Not medical advice.

Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.

Letter for your doctor

A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.

Voxsanity

Clinical trials recruiting in Australia, from the public registries · voxsanity.com.au

Date:

To: My Doctor

Re: Clinical trial enquiry

I am writing to enquire about the following clinical trial, which may be relevant to my care:

Trial: NCT06697184

Sponsor: BeOne Medicines

Phase: Phase 2

Status: Recruiting

More information: https://clinicaltrials.gov/study/NCT06697184

Eligibility criteria, as the registry published them

Reproduced exactly, unedited. Written for researchers rather than for patients.

Inclusion Criteria:

Stable Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.
Adequate organ function and no very recent transfusion or blood growth factor
Participants of childbearing potential must be willing to use a highly effective method of birth control 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):
Confirmed diagnosis of CLL, based on Hallek et al 2018, and requiring treatment due to certain features of their disease
At least 1 measurable lesion 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):
Historically confirmed diagnosis of MCL based on the World Health Organization 2022 classification of Haematolymphoid Tumors (WHO-HEAM5) or based on International Consensus Classification (ICC).
Relapsed or refractory to the last line of therapy and have received at least 1 prior line of systemic therapy. Note: A line of therapy is considered ≥ 2 consecutive cycles of a systemic anticancer regimen. Patients with prior BTKi therapy should not have progressed during treatment or relapsed within 12 months after BTKi discontinuation.
Measurable disease defined as ≥ 1 nodal lesion that is > 1.5 cm in longest diameter, or ≥ 1 extranodal lesion that is > 1 cm in longest diameter.

Exclusion Criteria:

Participants unable to comply with the requirements of the protocol
Serologic status reflecting active viral hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
Positive HIV serology (HIVAb) status unless certain conditions are met.
Participants with any major surgical procedure ≤ 28 days before first dose of study treatment
Prior systemic treatment for the CLL
Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia requiring treatment
Prior exposure to a BCL-2 inhibitor

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a registered health practitioner to access unapproved therapeutic goods for individual patients.

Not medical advice. Voxsanity reformats information published by public registries. It does not give medical advice and is not a substitute for talking to your doctor.