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Looking for participantsPhase1/Phase2

AZD0486 as Monotherapy in B-cell Acute Lymphoblastic Leukaemia

Sponsor: AstraZeneca

NCT ID: NCT06137118

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)
How long the study runs
Study runs about 57 months (dates as stated)
About the drug or intervention
Surovatamig — drug: Investigational Product administered via intravenous infusion.
Patient visit burden
Not specified by the sponsor

In plain English

This study tests AZD0486 alone as a treatment for B-cell acute lymphoblastic leukaemia (B-ALL), a blood cancer. It is for people whose cancer has come back or has not responded to earlier treatment. The study is run by AstraZeneca.

Who can take part

  • Age 12 or older
  • B-cell acute lymphoblastic leukaemia that shows a marker called CD19, with at least 5% leukaemia cells in the bone marrow
  • The leukaemia has come back (relapsed) or not responded (refractory) after at least 2 earlier treatments, or after 1 if no standard option was available (Parts A, B, C); or after at least 1 earlier treatment (Part D)
  • People with a Philadelphia chromosome are allowed if they cannot tolerate or have not responded to TKIs (a type of targeted medicine)
  • Good enough day-to-day functioning: ECOG score of 2 or less for over-16s; Lansky score of 50% or more for 16 and under

Who may not be able to

  • Leukaemia in the brain or spinal fluid (central nervous system), or signs of it
  • Cancer that has come back only outside the bone marrow
  • Leukaemia in the testicles
  • History of serious brain or nerve conditions, such as epilepsy, stroke, severe brain injury, dementia, Parkinson's disease, or psychosis; or severe (Grade 4) nerve side effects from CAR-T or similar therapy before
  • Another cancer in the past (with some exceptions)
  • Unresolved side effects of Grade 2 or worse from earlier treatment
  • Recent certain treatments: antibody-drug medicines within 3 weeks, T-cell engagers within 4 weeks, CAR T-cell therapy or own stem cell transplant within 8 weeks, or donor stem cell transplant within 12 weeks of starting
  • Graft-versus-host disease needing immune-suppressing medicine within 3 weeks of starting

What taking part involves

  • • Not stated — ask the trial team

Time commitment: Not stated — ask the trial team

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
12 Years and over
Who
All
Number of participants
255
Started
2023-12-29
Last checked
2026-08

Plain English Summary

What is this study?

  • • Testing a new treatment for b-cell acute lymphoblastic leukemia (b-all)
  • • Phase1/Phase2 - 255 participants
  • • This is a Phase 1/2, global multicentre, open-label, single-arm, dose escalation and dose optimization study of surovatamig (AZD0486) to evaluate the safety, tolerability, and efficacy of surovatamig (AZD0486) monotherapy in participants with R/R B ALL

Who can take part?

  • • Ages 12 Years and over
  • • Diagnosed with b-cell acute lymphoblastic leukemia (b-all)

Where?

  • • London - Research Site
  • • Manchester - Research Site
  • • Surrey - Research Site

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

About This Trial

This is a Phase 1/2, global multicentre, open-label, single-arm, dose escalation and dose optimization study of surovatamig (AZD0486) to evaluate the safety, tolerability, and efficacy of surovatamig (AZD0486) monotherapy in participants with R/R B ALL. The study will consist of 4 parts. Part A: monotherapy dose escalation in 3L+ B-ALL. Part B: dose optimization in 3L+ B-ALL. Part C: Dose expansion in 3L+ B-ALL. Part D: Dose optimization and efficacy expansion in R/R B-ALL (2L+)

More detail

This dose escalation and optimization study is evaluating the safety, tolerability, PK, PD and clinical activity of surovatamig (AZD0486) monotherapy in r/r B-ALL.

B-cell Acute Lymphoblastic Leukemia (B-ALL)

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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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: 12 Years and over
  • Who can join: All genders

Biomarkers mentioned

CD19Philadelphia positive

Treatment history

Treatments you must have had:

  • ✓ of therapy if no SOC available option (Parts A

What the study is looking for

  • ✓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:
  • ✓Bone marrow infiltration with \>/= 5% blasts
  • ✓Philadelphia positive participants are allowed in all parts of the study, if intolerant or refractory to TKIs.
  • ✓For participants older than 16 years, activity scale (ECOG) Performance Status less than or...

Who cannot take part

  • ✗Active CNS involvement by B-ALL, defined by presence of ALL blasts in CSF (CNS2 and CNS3 criteria), or signs of CNS...
  • ✗Isolated extramedullary disease relapse.
  • ✗Testicular leukemia
  • ✗History of other cancer (with certain exceptions).
  • ✗Unresolved AEs \>/= Grade 2, from prior therapies
See the full criteria
Inclusion Criteria: * 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: 1. Bone marrow infiltration with \>/= 5% blasts 2. Either relapsed or refractory after a minimum of 2 prior therapies or after 1 prior line of therapy if no SOC available option (Parts A, B, C); or relapsed or refractory to ≥1 prior line of therapy (Part D). 3. Philadelphia positive participants are allowed in all parts of the study, if intolerant or refractory to TKIs. * 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%. The above is a summary, other inclusion criteria details may apply. Exclusion Criteria: * 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. The above is a summary, other exclusion criteria details may apply.

Where Is This Study? (3 UK sites)

Research Site

London EC1A 7BE, United Kingdom

SUSPENDED

Research Site

Manchester M20 4BX, United Kingdom

SUSPENDED

Research Site

Surrey SM1 2DL, United Kingdom

SUSPENDED

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: 2026-08