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NCT06697184From ClinicalTrials.govRecruiting

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.

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A Study to Investigate the Safety of Novel Dose Ramp-up Schedule(s) When Initiating Sonrotoclax in Participant | Trialion