NCT06564038 · AstraZeneca
A Study of AZD0486 Monotherapy or in Combination With Other Anti-Cancer Agents for Mature B-Cell Malignancies
(Soundtrack-E)
What this study is about
The purpose of this study is to assess the safety and effectiveness of AZD0486 administered as treatment given alone or in combination with other anticancer agents in participants with hematological malignancies.
View original scientific description
The purpose of this study is to assess the safety and efficacy of AZD0486 administered as monotherapy or in combination with other anticancer agents in participants with hematological malignancies.
Interventions
DRUG
Surovatamig
Surovatamig will be administered as either SC injection or IV infusion.
DRUG
Prednisone (or equivalent)
Prednisone (or equivalent) will be administered either oral or IV infusion as per standard of care.
DRUG
Rituximab
Rituximab will be administered as IV infusion as per standard of care.
DRUG
Cyclophosphamide
Cyclophosphamide will be administered as IV infusion as per standard of care.
DRUG
Vincristine
Vincristine will be administered as IV infusion as per standard of care.
DRUG
Doxorubicin
Doxorubicin will be administered as IV infusion as per standard of care.
DRUG
Acalabrutinib
Acalabrutinib will be administered orally
Primary outcome measures
Number of Participants with Adverse Events, Serious Adverse Events and Adverse Events of Special Interest
Time frame: Up to 6 years 4 months
Safety and tolerability of surovatamig as monotherapy and in combination with other anticancer agents across mature B-cell malignancies.
Number of Participants with Dose Limiting Toxicity (DLTs)
Time frame: Up to 2 months
Safety and tolerability of surovatamig as monotherapy and in combination with other anticancer agents across mature B-cell malignancies.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
- 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.
- Histologically confirmed diagnosis of previously untreated large B-cell Lymphoma (LBCL) per WHO 2022.
- 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
- Boston, Massachusetts
- Hackensack, New Jersey
- New Brunswick, New Jersey
- New York, New York
- Charlotte, North Carolina
- Columbus, Ohio
- Portland, Oregon
- Philadelphia, Pennsylvania
- Pittsburgh, Pennsylvania
- Providence, Rhode Island
- Houston, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 8, 2026 · Source of record for eligibility and locations