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.
Plain-language title generated from the registry record
Registry title: AZD0486 as Monotherapy in B-cell Acute Lymphoblastic Leukaemia
Key facts
- Where
- Bergamo, Bologna, Meldola, Monza, Naples, and Rome, ItalySee the 6 sites
- Phase
- Phase 1/2
Where in Italy
- Azienda Socio Sanitaria Territoriale Papa Giovanni XXIIIBergamo, ItalyTaking people
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere ScientificoBologna, ItalyTaking people
- Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.lMeldola, ItalyTaking people
- Fondazione IRCCS San Gerardo dei TintoriMonza, ItalyTaking people
- Azienda Ospedaliera Santobono PausiliponNaples, ItalyTaking people
- Ospedale Pediatrico Bambino GesùRome, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- AstraZeneca
- Trial code
- NCT06137118EU 2023-505840-20-00
- Record updated
- 13 October 2026
- Original description
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+)Read full original descriptionShow less
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
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+)
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:; 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.
Exclusion: 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.