A Study to Investigate the Safety of Novel Dose Ramp-up Schedule(s) When Initiating Sonrotoclax in Participants Treated for Blood Cancers.
A Phase 1/2 Open-label Study to Investigate the Safety of Sonrotoclax Ramp-up Schedule(s) in Adult Patients With Hematological Malignancies.
- Chronic Lymphocytic Leukemia
- CLL
- Mantle Cell Lymphoma
- MCL
At a glance
- Phase
- Phase 1
- Study type
- Interventional
- Sponsor
- BeOne Medicines
- Enrolment target
- 258
- Started
- 23 January 2025
- Main results due
- 30 November 2029
- Study sites
- 20
- Registry updated
- 28 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
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.
What this study is about
In the sponsor’s own words, from the registry.
The purpose of this study is to establish the safety of novel dosing and ramp-up schedules for sonrotoclax in participants with hematological malignancies.
Study sites(20)
Moffitt Cancer Center
Tampa, Florida, United States
Recruiting
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, United States
Recruiting
The University of Kansas Cancer Center
Westwood, Kansas, United States
Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Recruiting
Washington University School of Medicine
St Louis, Missouri, United States
Recruiting
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Recruiting
Blacktown Cancer and Haematology Centre
Blacktown, New South Wales, Australia
Recruiting
Genesiscare St Andrews
Adelaide, South Australia, Australia
Recruiting
Cabrini Hospital Malvern
Malvern, Victoria, Australia
Recruiting
The Alfred Hospital
Melbourne, Victoria, Australia
Recruiting
Rockingham Hospital
Cooloongup, Western Australia, Australia
Recruiting
Linear Clinical Research
Nedlands, Western Australia, Australia
Recruiting
Hcfmusp Pesquisa Clinica Do Servico de Hematologia E Terapia Celular
São Paulo, Brazil
Recruiting
Hospital Santa Rita de Cassia Afecc
Vitória, Brazil
Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, China
Recruiting
Chu Dijon
Dijon, France
Recruiting
Chu Montpellier Hopital Saint Eloi
Montpellier, France
Recruiting
Iuct Oncopole
Toulouse, France
Recruiting
Queen Elizabeth Hospital
Birmingham, United Kingdom
Recruiting
St Jamess University Hospital
Leeds, United Kingdom
Recruiting
Showing 20 of 20 sites. 20 of the 20 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT06697184. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
Not the right study?
Answer three questions and see the studies recruiting near you, in plain language.
Find a study for me