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NCT06137118RecruitingPhase 1/2

A trial to understand if surovatamig (AZD0486) is safe and helps in people with Relapsed or Refractory B-cell acute lymphoblastic leukemia (B-ALL)

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

Source: EU CTIS (euclinicaltrials.eu) · Last updated 23 Oct 2026

Brief summary (registry, in English)

Part A: To assess the safety and tolerability of AZD0486 in participants with Ph(+) or Ph(-) R/R B-ALL, aged 12 years and above Part B, C & D: To evaluate the efficacy of AZD0486 in participants with Ph(+) or Ph(-) R/R B-ALL, aged 12 years and above

Status (registry)
Recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
73 (estimated)
First submitted
21 Dec 2023
Start date
21 Sept 2026
Lead sponsor
Astrazeneca AB
NCT number
NCT06137118
EU CT number
2023-505840-20-00

What you commit to

  • Study type: Interventional · Phase 1/2
  • Planned participants: 73
  • 31 sites in 4 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • Isolated extramedullary disease relapse.
  • History of other malignancy (with certain exceptions).

Other

  • Active CNS involvement by B-ALL, defined by presence of ALL blasts in CSF (CNS2 and CNS3 criteria).
  • Testicular leukemia
  • The above is a summary, other exclusion criteria details may apply.

Who the study is looking for

  • Age: 12 years and above
  • Participants with CD19+ B-cell Acute Lymphoblastic Leukemia by local lab with Bone marrow infiltration with >/= 5% blasts
  • Participants with CD19+ B-cell Acute Lymphoblastic Leukemia by local lab with 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-C) or after 1 prior line of therapy (Part D).
  • Participants with CD19+ B-cell Acute Lymphoblastic Leukemia by local lab with Philadelphia positive participants are allowed in All Parts if intolerant or refractory to TKIs.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to 2 OR Lansky score more or equal to 50%.
  • The above is a summary, other inclusion criteria details may apply

Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (31)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Charite Universitaetsmedizin Berlin KöR
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BerlinGermanyRecruiting
University Hospital Cologne AöR
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CologneGermanyRecruiting
Universitaetsklinikum Duesseldorf AöR
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DuesseldorfGermanyRecruiting
Universitaetsklinikum Essen (AoR)
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EssenGermanyRecruiting
Goethe University Frankfurt
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Frankfurt Am MainGermanyRecruiting
Medical Center- University of Freiburg
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Freiburg im BreisgauGermanyRecruiting
Martin-Luther-Universitaet Halle-Wittenberg
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Halle (Saale)GermanyRecruiting
University Medical Center Hamburg-Eppendorf
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HamburgGermanyRecruiting
Universitaetsklinikum Schleswig-Holstein AöR
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KielGermanyRecruiting
Universitaet Muenster
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MuensterGermanyRecruiting
Klinikum der Universitaet Muenchen AöR
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MunichGermanyRecruiting
Universitaetsklinikum Wuerzburg AöR
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WuerzburgGermanyRecruiting
Hospital Clinic de Barcelona
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BarcelonaSpainRecruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainRecruiting
MD Anderson Cancer Center
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MadridSpainRecruiting
Hospital Universitario La Paz
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MadridSpainRecruiting
Hospital Universitario De Salamanca
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SalamancaSpainRecruiting
University Hospital Virgen Del Rocio S.L.
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SevillaSpainRecruiting
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainRecruiting
Centre Hospitalier Universitaire de Caen Normandie
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CaenFranceRecruiting
Institut Paoli-Calmettes
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MarseilleFranceRecruiting
Centre Hospitalier Universitaire de Nantes
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NantesFranceRecruiting
Robert Debre University Hospital
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ParisFranceRecruiting
Hospices Civils de Lyon
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Pierre-BéniteFranceRecruiting
Centre Hospitalier Universitaire De Toulouse
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Toulouse Cedex 9FranceRecruiting
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
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BergamoItalyRecruiting
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
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BolognaItalyRecruiting
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l
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MeldolaItalyRecruiting
Fondazione IRCCS San Gerardo dei Tintori
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MonzaItalyRecruiting
Azienda Ospedaliera Santobono Pausilipon
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NaplesItalyRecruiting
Ospedale Pediatrico Bambino Gesù
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RomeItalyRecruiting

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This page is information, not medical advice. Discuss any trial with your doctor.