AZD0486 as Monotherapy in B-cell Acute Lymphoblastic Leukaemia

Exclusion Criteria

• - Active CNS involvement by B-ALL, defined by presence of ALL blasts in CSF (CNS2 and CNS3 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 4 neurotoxicity 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.