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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
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
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
Where Is This Study? (3 UK sites)
Research Site
London EC1A 7BE, United Kingdom
Research Site
Manchester M20 4BX, United Kingdom
Research Site
Surrey SM1 2DL, United Kingdom
How to Get in Touch
AstraZeneca Clinical Study Information Center
Sponsor contactCONTACT
