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 study is for patients with B-cell Acute Lymphoblastic Leukemia (B-ALL) that is refractory or had relapsed after ? 2 treatments. B-ALL is a type of blood cancer that affects the bone marrow (the site where the blood cells are produced). B-ALL causes an uncontrolled production of a white blood cell called B-lymphocytes (B-cells), affecting the normal production and function of all blood cells. AZD0486 work by helping the immune system cells called T-cells to find and kill cancerous B-cells.Researchers think that AZD0486 can help decrease the cancer cells, and want to learn if AZD0486 works safely for people with B-ALL.This study is open-label and all participants will receive AZD0486 and doctors and trial staff will know. The study comprises three parts. Part A (dose escalation), involving 3 to 5 participant groups receiving increasing dose levels. Safety results are reviewed after each group before deciding to open a new dose level. In Part B (dose optimization), two doses with clinical benefit from Part A, will begiven to participants randomly, and researchers will analyse the results to select the best dose. In PartC (dose expansion) the dose from part B will be tested in a larger group of participants.AZD0486 will be given through a needle into the vein (IV infusion) in cycles of 28 days. On firstcycle, participants will receive 3 increasing doses (step-up) and then their highest (target) dose thatwill be repeated every other week since then. Participants will be monitored throughout the study forsafety and to check whether the treatment is working. This trial will have up to 146 participants fromaround the world and will last up to 36 months.Participants will help researchers to learn more about AZD0486 and B-ALL whilst potentiallybenefiting from B-ALL control or improvement.