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Taking people in FrancePhase 1/2

Tests surovatamig alone in teens and adults with relapsed or refractory B-cell leukemia

Tests surovatamig alone in people whose B-cell leukemia returned or did not respond.

Key facts

Who runs it
AstraZeneca
Where
Caen, Marseille, Nantes, Paris, Pierre-Bénite, and Toulouse Cedex 9, FranceSee the 6 sitesAlso in 12 other countries, 70 sites
Registry title
AZD0486 as Monotherapy in B-cell Acute Lymphoblastic Leukaemia
Status
Recruiting
Phase
Phase 1/2
People taking part
255 people, planned
Started
29 Dec 2023
Expected to end
10 Aug 2028
Type of study
Interventional, 4 groups
Treatments tested
  • Surovatamig
Record updated
13 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people aged 12 and older with B-cell acute lymphoblastic leukaemia (B-ALL) that has come back or did not respond to earlier treatment. The leukaemia cells must show CD19.

Age
12 years and above
Sex
All sexes can join.
Disease stage
B-ALL with CD19 on the leukaemia cells and 5% or more blasts in the bone marrow. It must have relapsed or not responded to treatment. Parts A, B and C: after at least 2 earlier therapies, or after 1 if no standard option is available. Part D: after at least 1 earlier therapy.
Earlier treatment
Must have had earlier treatment as described above. Philadelphia positive people can join if they cannot tolerate TKIs or the leukaemia did not respond to them. Cannot join: antibody-drug conjugates within 3 weeks, T-cell engagers within 4 weeks, CAR T-cell therapy or autologous stem cell transplant within 8 weeks, or donor stem cell transplant within 12 weeks.
Biomarker or test result
CD19 on the leukaemia cells, tested by the local lab.

Main reasons for not taking part

  • Leukaemia in the brain or spinal fluid, or signs of it
  • Leukaemia only outside the bone marrow, or leukaemia in the testicles
  • Serious brain or nerve disease, or severe nerve damage from earlier CAR-T or T-cell engager therapy
  • History of another cancer (with certain exceptions)
  • Graft-versus-host disease needing immune-suppressing drugs within 3 weeks before treatment

The registry criteria, word for word

Show all 11 criteriaShow less

Who can take part

  • 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; 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); 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

Who cannot take part

  • 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
  • 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
  • Isolated extramedullary disease relapse
  • History of other malignancy (with certain exceptions)
  • Active CNS involvement by B-ALL, defined by presence of ALL blasts in CSF (CNS2 and CNS3 criteria), or signs of CNS involvement
  • Testicular leukemia

Where in France

Also in 12 other countries, 70 sites

  • Centre Hospitalier Universitaire de Caen NormandieCaen, FranceTaking people
  • Institut Paoli-CalmettesMarseille, FranceTaking people
  • Centre Hospitalier Universitaire de NantesNantes, FranceTaking people
  • Robert Debre University HospitalParis, FranceTaking people
  • Hospices Civils de LyonPierre-Bénite, FranceTaking people
  • Centre Hospitalier Universitaire De ToulouseToulouse Cedex 9, FranceTaking people

About the trial

What the trial wants to find out

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+)

The 4 groups in the trial

  • Part A: AZD0486 Dose EscalationTreatment being tested

    Ascending dose level cohorts of surovatamig (AZD0486) in B-ALL participants aged 12 years and above.

    Treatment: Surovatamig

  • Part B: Dose OptimizationTreatment being tested

    Up to 2 cohorts will be evaluated prior declared safe-doses and schedules in order to determine the recommended phase 2 dose (RP2D). Participants, aged 12 years and above, will receive surovatamig (AZD0486) IV infusions and will be randomized in a 1:1 ratio.

    Treatment: Surovatamig

  • Part C: Dose ExpansionTreatment being tested

    Part C will consist of 1 cohort of participants aged 12 years and above, treated with the optimal dose selected in Part B and receive IV surovatamig (AZD0486) monotherapy.

    Treatment: Surovatamig

  • Part D: Dose Optimization and Efficacy Expansion in 2L+Treatment being tested

    Part D will enroll participants aged 12 years and above with Ph(+) and Ph(-) B-ALL relapsed/refractory to ≥1 prior line of therapy. Participants will be randomized 1:1 to 2 dose levels of surovatamig IV.

    Treatment: Surovatamig

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Phase 1/2 Study to Evaluate the Safety and Efficacy of AZD0486 in Adolescent and Adult Participants With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukaemia
Plain-language title
Tests surovatamig alone in teens and adults with relapsed or refractory B-cell leukemiaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Publications
Record updated
13 October 2026