A Study of AZD0486 Monotherapy or in Combination With Other Anti-Cancer Agents for Mature B-Cell Malignancies

Recruiting now · Phase 1/Phase 2

Conditions studied: Chronic Lymphocytic Leukaemia, Small Lymphocytic Lymphoma, Mantle-cell Lymphoma, Large B-cell Lymphoma, B-cell Non-Hodgkin Lymphoma

In brief

The purpose of this study is to assess the safety and efficacy of surovatamig (formerly AZD0486) administered as monotherapy or in combination with other anticancer agents in participants with hematological malignancies

Key facts

Study ID

NCT06564038

Run by

AstraZeneca

People needed

408

Starts

2025-01-30

Expected to finish

2029-06-11

Last updated by the study team

2026-07-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Master Inclusion Criteria applicable to all substudies:
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
• Contraception use during treatment and at least 90 days after final dose.
• Confirmed CD19 expression if prior anti-CD19 therapy.
• Substudy 1 Specific Inclusion Criteria:
• Participants with CLL must require treatment according to the international workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria.
• SLL: at least 1 measurable site per Lugano.
• Absolute lymphocyte count (ALC) <25000 cells/mcL.
• Cohort 1A and 1C: at least 2 prior lines of systemic therapy for CLL/SLL.
• Cohort 1B: at least 1 prior line of therapy and is bruton tyrosine kinase inhibitor (BTKi)-sensitive.
• Substudy 2 Specific Inclusion Criteria:
• MCL diagnosis per WHO.
• Clinical Stage II, III, or IV by Ann Arbor Classification.
• At least 1 measurable site per Lugano.
• ALC < 25000 cells/mcL.
• Cohort 2A and 2C: Relapse or progressed after 2 or more lines of therapy including BTKi.
• Substudy 3 Specific Inclusion Criteria:
• At least 1 measurable site as per Lugano.
• Left ventricular ejection fraction (LVEF) ≥50%.
• Participant must be no older than 79 years of age at the time of signing ICF.
• Contraception at least 90 days after last dose of surovatamig or 4 months after last dose of vincristine, and 6 months after the last dose of cyclophosphamide, or doxorubicin.
• Cohort 3A:
• Histologically confirmed diagnosis of previously untreated large B-cell Lymphoma (LBCL) per WHO 2022.
• R/R B-NHL after at least 1 prior lines of systemic therapy.
• International Prognostic Index (IPI) 2-5.

You may not qualify if…

• Master Exclusion Criteria applicable to all substudies:
• Central nervous system (CNS) lymphoma.
• Surgery within 14 days of study drug.
• Clinically significant cardiovascular (CV) disease.
• Unresolved Grade >2 AEs from prior anticancer therapy (except alopecia or fatigue).
• Any systemic therapy within 5 half-lives or 21 days (whichever is shorter) prior to treatment.
• Radiation therapy within 28 days.
• Prior CAR T-cell therapy or autologous-haematopoietic stem cell transplant (HSCT) within 12 weeks or prior T-cell engager (TCE) within 8 weeks.
• Prior Grade > 3 cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) event.
• Prior allogeneic HSCT or solid organ transplantation within 24 weeks of starting Cycle 1 Day 1.
• Active, significant, uncontrolled infection or autoimmune disease requiring systemic therapy including participants with known history of haemophagocytic lymphohistiocytosis (HLH).
• Substudy 1 Specific Exclusion Criteria:
• CLL/SLL transformation to more aggressive form of lymphoma.
• Cohort 1B: bleeding diathesis, CYP3A inhibitor or inducer, history of ICH or stroke within 24 weeks, GI malabsorption, receiving vitamin K antagonist.
• Substudy 3 Specific Exclusion Criteria:
• Mediastinal grey-zone lymphoma, Burkitt, Richter's transformation, primary effusion large B-cell lymphoma (LBCL).
• Cumulative dose of anthracycline >150 mg/m2.

Where it is running

• Research Site — Aarhus N, Denmark (enrolling)
• Research Site — Odense C, Denmark (enrolling)
• Research Site — Boston, Massachusetts, United States (enrolling)
• Research Site — Hackensack, New Jersey, United States (enrolling)
• Research Site — Copenhagen, Denmark (enrolling)
• Research Site — New Brunswick, New Jersey, United States (enrolling)
• Research Site — Columbus, Ohio, United States (enrolling)
• Research Site — New York, New York, United States (enrolling)
• Research Site — Philadelphia, Pennsylvania, United States (enrolling)
• Research Site — Pittsburgh, Pennsylvania, United States (enrolling)
• Research Site — Providence, Rhode Island, United States (enrolling)
• Research Site — Charlotte, North Carolina, United States (enrolling)
• Research Site — Heidelberg, Australia (enrolling)
• Research Site — Melbourne, Australia (enrolling)
• Research Site — Nedlands, Australia (enrolling)
• Research Site — Beijing, China (enrolling)
• Research Site — Guangzhou, China (enrolling)
• Research Site — Portland, Oregon, United States (enrolling)
• Research Site — Tianjin, China (enrolling)
• Research Site — Zhengzhou, China (enrolling)
• Research Site — Ostrava - Poruba, Czechia (enrolling)
• Research Site — Prague, Czechia (enrolling)
• Research Site — Praha 2 - Nové Město, Czechia (enrolling)
• Research Site — Aalborg, Denmark (enrolling)
• Research Site — Montpellier, France (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.