A phase 1/2 study looking at AZD0486 in patients with relapsed or refractory B-Cell ALL
Research type
Research Study
Full title
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
IRAS ID
1008813
Contact name
Bela Wrench
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2018-002011-10
Clinicaltrials.gov Identifier
Research summary
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 be
given to participants randomly, and researchers will analyse the results to select the best dose. In Part
C (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 first
cycle, participants will receive 3 increasing doses (step-up) and then their highest (target) dose that
will be repeated every other week since then. Participants will be monitored throughout the study for
safety and to check whether the treatment is working. This trial will have up to 146 participants from
around the world and will last up to 36 months.
Participants will help researchers to learn more about AZD0486 and B-ALL whilst potentially
benefiting from B-ALL control or improvement.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
24/NE/0040
Date of REC Opinion
4 Apr 2024
REC opinion
Further Information Favourable Opinion