Recruiting
Phase 1
Phase 2

Sonrotoclax

Sponsor:

BeOne Medicines

Code:

NCT06697184

Conditions

Chronic Lymphocytic Leukemia

CLL

Mantle Cell Lymphoma

MCL

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Sonrotoclax

Zanubrutinib

Study Details

Brief summary:

The purpose of this study is to establish the safety of novel dosing and ramp-up schedules for sonrotoclax in participants with hematological malignancies.

Conditions

Chronic Lymphocytic Leukemia

CLL

Mantle Cell Lymphoma

MCL

Study ID

NCT06697184

Start date

Jan 23, 2025

Status verified date

Aug, 2026

Completion date

Nov 30, 2032

Anticipated

Primary completion date

Nov 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

258 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arms: 1A,1B and 2A: Zanubrutinib + Sonrotoclax for TN CLL

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)

experimental: Arms: 1C and 2B: Zanubrutinib + Sonrotoclax for R/R MCL

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.

Interventions

Sonrotoclax

Administered orally

Zanubrutinib

Administered orally

Primary outcome measure

  • Number of Participants who Experience Tumor Lysis Syndrome (TLS) [ Time Frame: Up to approximately 4 months ]

Central Contacts and Locations

Central contacts

Locations

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612-9496

Fort Wayne Medical Oncology and Hematology

Recruiting

Fort Wayne, Indiana, United States, 46804

The University of Kansas Cancer Center

Recruiting

Westwood, Kansas, United States, 66205-2003

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215-5418

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110-1010

Fred Hutchinson Cancer Research Center

Recruiting

Seattle, Washington, United States, 98109-4433

More Information

Sponsor

BeOne Medicines

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Keywords

  • CLL previously untreated
  • Hematological Malignancies

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by BeOne Medicines on 2026-08-10.