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Looking for participantsPhase1/Phase2

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

Sponsor: AstraZeneca

NCT ID: NCT06564038

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Surovatamig (drug), Prednisone (or equivalent) (drug), Rituximab (drug), Cyclophosphamide (drug)
How long the study runs
Study runs about 53 months (dates as stated)
About the drug or intervention
Surovatamig — drug: Surovatamig will be administered as either SC injection or IV infusion. · Prednisone (or equivalent) — drug: Prednisone (or equivalent) will be administered either oral or IV infusion as per standard of care. · Rituximab — drug: Rituximab will be administered as IV infusion as per standard of care. · Cyclophosphamide — drug: Cyclophosphamide will be administered as IV infusion as per standard of care. · Vincristine — drug: Vincristine will be administered as IV infusion as per standard of care. · Doxorubicin — drug: Doxorubicin will be administered as IV infusion as per standard of care. · Acalabrutinib — drug: Acalabrutinib will be administered orally
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
408
Started
2025-01-30
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for chronic lymphocytic leukaemia
  • • Phase1/Phase2 - 408 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with chronic lymphocytic leukaemia

Where?

  • • Derriford - Research Site
  • • London - Research Site
  • • Oxford - Research Site
  • • Southampton - Research Site

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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

More detail

This is open-label, multi-center study to evaluate the safety and preliminary efficacy of surovatamig administered as monotherapy and in combination with other anticancer agents in participants with mature B-cell hematologic malignancies. This master study currently includes 3 substudies and each substudy focusing on a defined population: Substudy 1: Relapsed/refractory (R/R) Chronic lymphocytic leukaemia (CLL)/ Small lymphocytic lymphoma (SLL) Substudy 2: R/R Mantle-cell lymphoma (MCL) Substudy 3: Large B-cell lymphoma (LBCL) or R/R B-cell non-Hodgkin lymphoma (B-NHL) (not applicable to US) The study will have the following sequential periods: 1. Screening period of 28 days 2. Treatment period 3. Follow-up period

Chronic Lymphocytic LeukaemiaSmall Lymphocytic LymphomaMantle-cell LymphomaLarge B-cell LymphomaB-cell Non-Hodgkin Lymphoma

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

CD19

Treatment history

Treatments you must have had:

  • ✓ treatment according to the international workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria
  • ✓ of therapy

What the study is looking for

  • ✓Master Inclusion Criteria applicable to all substudies:
  • ✓activity scale (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:

Who cannot take part

  • ✗Master Exclusion Criteria applicable to all substudies:
  • ✗Central nervous system (CNS) lymphoma.
  • ✗Surgery within 14 days of the study treatment.
  • ✗Clinically significant cardiovascular (CV) disease.
  • ✗Unresolved Grade \>2 AEs from prior anticancer therapy (except alopecia or fatigue).
See the full criteria
Inclusion Criteria: 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: 1. Histologically confirmed diagnosis of previously untreated large B-cell Lymphoma (LBCL) per WHO 2022. 2. R/R B-NHL after at least 1 prior lines of systemic therapy. 3. International Prognostic Index (IPI) 2-5. * Cohort 3B: 1. Histologically confirmed diagnosis of previously untreated large B-cell Lymphoma (LBCL) per WHO 2022. 2. IPI score of 2 to 5. Exclusion Criteria: 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 Is This Study? (4 UK sites)

Research Site

Derriford PL6 5FP, United Kingdom

Recruiting

Research Site

London SE5 9RS, United Kingdom

Recruiting

Research Site

Oxford 0X3 7LJ, United Kingdom

Recruiting

Research Site

Southampton SO16 6YD, United Kingdom

Recruiting

How to Get in Touch

AstraZeneca Clinical Study Information Center

Sponsor contact

CONTACT

1-877-240-9479 information.center@astrazeneca.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09