Phase 12 Study of AZD0486 to Test Safety and Effectiveness in Teens and Adults with Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia

What this Trial Is About

Researchers are evaluating AZD0486, an investigational drug given alone, in adolescents and adults with relapsed or refractory B-cell Acute Lymphoblastic Leukemia B-ALL who have had at least two prior treatments. This Phase 12 open-label study is designed to assess the safety, tolerability, and clinical activity of AZD0486. The trial includes participants aged 12 and older and aims to find the best dose and understand how the drug behaves in the body. The study has three parts Part A involves increasing doses of AZD0486 to find safe levels Part B focuses on optimizing the dose with participants randomly assigned to one of two dose schedules Part C expands treatment to more participants using the recommended dose from Part B. All doses are given via intravenous infusion. Participants will receive AZD0486 monotherapy throughout the trial. Participants will be monitored closely for side effects and response to treatment over up to 42 months. Researchers will measure treatment safety, complete remission rates within three cycles, and drug levels in the body. Additional assessments include survival outcomes, duration of remission, and immune response to the drug. The study includes safety evaluations from consent through the study period, with follow-up for long-term effects and treatment outcomes.

AZD0486 as Monotherapy in B-cell Acute Lymphoblastic Leukaemia