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Clinical Trials in the UK / NCT06564038
Recruiting Phase 1/2

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

NCT06564038 · tracked via the Priya Life Science UK tracker
Sponsor
AstraZeneca
Phase
Phase 1/2
Started
2025-01-30
Last updated
2026-09-08

Condition(s) studied

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

Investigational drug(s) / intervention(s)

SurovatamigPrednisone (or equivalent)RituximabCyclophosphamideVincristineDoxorubicinAcalabrutinib

Surovatamig: Surovatamig will be administered as either SC injection or IV infusion.

Prednisone (or equivalent): Prednisone (or equivalent) will be administered either oral or IV infusion as per standard of care.

Rituximab: Rituximab will be administered as IV infusion as per standard of care.

Cyclophosphamide: Cyclophosphamide will be administered as IV infusion as per standard of care.

Vincristine: Vincristine will be administered as IV infusion as per standard of care.

Doxorubicin: Doxorubicin will be administered as IV infusion as per standard of care.

Acalabrutinib: Acalabrutinib will be administered orally

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (65)

FacilityCityRegionStatus
Research Site Boston Massachusetts Recruiting
Research Site Hackensack New Jersey Recruiting
Research Site New Brunswick New Jersey Recruiting
Research Site New York New York Recruiting
Research Site New York New York Withdrawn
Research Site Charlotte North Carolina Recruiting
Research Site Charlotte North Carolina Not Yet Recruiting
Research Site Columbus Ohio Recruiting
Research Site Portland Oregon Recruiting
Research Site Philadelphia Pennsylvania Recruiting
Research Site Pittsburgh Pennsylvania Recruiting
Research Site Providence Rhode Island Recruiting
Research Site Houston Texas Not Yet Recruiting
Research Site Heidelberg Australia Recruiting
Research Site Melbourne Australia Recruiting
Research Site Nedlands Australia Recruiting
Research Site Beijing China Recruiting
Research Site Guangzhou China Recruiting
Research Site Jinan China Withdrawn
Research Site Tianjin China Recruiting
Research Site Zhengzhou China Recruiting
Research Site Ostrava - Poruba Czechia Recruiting
Research Site Prague Czechia Recruiting
Research Site Praha 2 - Nové Město Czechia Recruiting
Research Site Aalborg Denmark Recruiting
Research Site Aarhus N Denmark Recruiting
Research Site Copenhagen Denmark Recruiting
Research Site Odense C Denmark Recruiting
Research Site Clermont-Ferrand France Not Yet Recruiting
Research Site Montpellier France Recruiting
Research Site Paris France Recruiting
Research Site Saint-Cloud France Recruiting
Research Site Villejuif France Recruiting
Research Site Cologne Germany Not Yet Recruiting
Research Site Homburg Germany Not Yet Recruiting
Research Site Kiel Germany Recruiting
Research Site Mainz Germany Not Yet Recruiting
Research Site München Germany Recruiting
Research Site Würzburg Germany Recruiting
Research Site Bologna Italy Not Yet Recruiting

+ 25 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06564038 on ClinicalTrials.gov ↗ ← All trials in the UK