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A Study of Surovatamig for B-Cell Malignancies

This study is testing a new drug called surovatamig (also known as AZD0486) for people with certain types of B-cell cancers, including Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL), Mantle-cell Lymphoma (MCL), and Large B-cell Lymphoma (LBCL). Surovatamig works by targeting specific proteins (tyrosine kinase inhibitor) in cancer cells. Researchers want to see how safe surovatamig is when given alone or with other standard cancer medicines like prednisone, rituximab, cyclophosphamide, and vincristine. They will also look at how well it works to treat these cancers. You might be able to join if you are 18 or older and meet certain health criteria, including having a good general health status (ECOG performance status of 0 to 2).

Study design
This is an open-label, multi-center study, meaning both you and your doctors will know which treatment you are receiving. It plans to enroll 408 participants and includes different groups (substudies) for specific types of B-cell cancers.
What's involved
The study involves a screening period of up to 28 days, followed by a treatment period and then a follow-up period. Specific details about visits or procedures are not provided.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for up to 6 years and 4 months after treatment to monitor for side effects.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06564038

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
AstraZeneca
~408 participants
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:SurovatamigPrednisone (or equivalent)RituximabCyclophosphamideVincristineDoxorubicin

At a glance

Recruiting sites
54 of 64 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants with Adverse Events, Serious Adverse Events and Adverse Events of Special Interest
Measured over Up to 6 years 4 months
+1 more outcome measured

Conditions

Chronic Lymphocytic Leukaemia
Small Lymphocytic Lymphoma
Mantle-cell Lymphoma
Large B-cell Lymphoma
B-cell Non-Hodgkin Lymphoma

Explore related trials

B-Cell Non-Hodgkin LymphomaChronic Lymphocytic LeukemiaLarge B-cell lymphomaMantle Cell LymphomaSmall Lymphocytic Lymphoma

Where it's being run

64 sites across 21 states
Germany6
South Korea6
Spain6
China5
France5
Denmark4
Taiwan4
United Kingdom4

Who to contact

AstraZeneca Clinical Study Information Center
[email protected]
1-877-240-9479
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
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.
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.
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:
Cohort 3B:

Exclusion

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).
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.
Mediastinal grey-zone lymphoma, Burkitt, Richter's transformation, primary effusion large B-cell lymphoma (LBCL).
Cumulative dose of anthracycline \>150 mg/m2.

What this trial measures

  • Number of Participants with Adverse Events, Serious Adverse Events and Adverse Events of Special InterestUp 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)Up to 2 months

    Safety and tolerability of surovatamig as monotherapy and in combination with other anticancer agents across mature B-cell malignancies.