AZD0486 as Monotherapy in B-cell Acute Lymphoblastic Leukaemia

Inclusion Criteria:

• Age: 16 years and older (Part A), 12 years and older (Parts B and C).

• Participants with B-cell Acute Lymphoblastic Leukemia with CD19 expression by locallab with:

1. Bone marrow infiltration with >/= 5% blasts

2. Either relapsed or refractory after a minimum of 2 prior therapies or after 1prior line of therapy if no SOC available option.

3. Philadelphia positive participants are allowed in Part A if intolerant orrefractory 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 andCNS3 criteria).

• 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 4neurotoxicity with CAR-T or TCE therapy.

• History of other malignancy (with certain exceptions).

• Unresolved AEs >/= Grade 2, from prior therapies

• Prior therapy with 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.