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AZD0486 for B-cell Acute Lymphoblastic Leukemia

This study is testing a new drug called AZD0486 for people aged 12 and older with B-cell Acute Lymphoblastic Leukemia (B-ALL). B-ALL is a type of cancer that affects white blood cells. You might be able to join if your B-ALL has come back or hasn't responded to at least two previous treatments, or one treatment if no standard options are available. The study aims to find out if AZD0486 is safe, how well people tolerate it, and how effective it is. Researchers will look at how often serious side effects occur and how many participants achieve a complete remission (when signs of cancer disappear) within three treatment cycles. The study is currently recruiting participants.

Study design
This is a global, multi-center study that will enroll up to 236 participants. It is a single-arm study, meaning all participants will receive AZD0486, and it is open-label, so both you and your doctors will know what treatment you are receiving.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored from the time you sign the consent form through data cutoff, which could be up to 42 months.

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

NCT06137118

AZD0486 as Monotherapy in B-cell Acute Lymphoblastic Leukaemia

Recruiting
PHASE1Ages 12+InterventionalTreatment
AstraZeneca
~255 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:Surovatamig

At a glance

Recruiting sites
35 of 82 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part A: Frequency of DLTs
Measured over Up to 28 days
+3 more outcomes measured

Conditions

B-cell Acute Lymphoblastic Leukemia (B-ALL)

Explore related trials

B Acute Lymphoblastic LeukemiaCD19 Gene

Where it's being run

82 sites across 23 states
Germany12
Japan11
China10
France6
Spain6
Italy5
South Korea5
Taiwan5

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

Age: 12 years and above (Parts A, B, C and D).
Participants with B-cell Acute Lymphoblastic Leukemia with CD19 expression by local lab with:
For participants older than 16 years, Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to 2. For Participants 16 years or younger, Lansky score more or equal to 50%.

Exclusion

Active CNS involvement by B-ALL, defined by presence of ALL blasts in CSF (CNS2 and CNS3 criteria), or signs of CNS involvement.
Isolated extramedullary disease relapse.
Testicular leukemia
History or presence of clinically relevant CNS pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis; or prior Grade 4 neurotoxicity with CAR-T or TCE therapy.
History of other malignancy (with certain exceptions).
Unresolved AEs \>/= Grade 2, from prior therapies
Prior therapy with ADCs within 3 weeks, TCEs within 4 weeks, CAR T-cell therapy or autologous HSCT within 8 weeks or prior alloSCT within 12 weeks of start of therapy.
GVHD requiring immunosuppressive therapy within 3 weeks prior to AZD0486 treatment.

What this trial measures

  • Part A: Frequency of DLTsUp to 28 days

    DLTs are dose-limiting toxicities as defined in the study protocol

  • Parts A & B: Safety Evaluation of AZD0486From signing of informed consent through data cutoff, up to 57 months

    Frequency, severity, and relationship to study drug of AEs and SAEs; dose modifications; changes in laboratory evaluations; QTc, and vital signs changes.

  • Parts B & C: Rate of CR within 3 cyclesUp to three cycles of 28 days each

    To evaluate the efficacy of surovatamig based on NCCN response criteria (in Part B and C).

  • Part D: CR/CRh within 3 cyclesUp to three cycles of 28 days each

    To evaluate the efficacy of surovatamig in Part D based on NCCN response criteria. CR/CRh is defined as a best response of CR/CRh within 3 cycles.