AZD0486 monotherapy or in combination with other anti-cancer agents for mature B-cell malignancies
Research type
Research Study
Full title
A Phase I/II Open-Label Multi-Centre Master Protocol to Evaluate the Safety and Efficacy of AZD0486 Monotherapy or in Combination with Other Anticancer Agents in Participants with Mature B-Cell Malignancies
IRAS ID
1010189
Contact name
Agathe Cabarrot
Contact email
Sponsor organisation
AstraZeneca AB
Clinicaltrials.gov Identifier
Research summary
B-cell malignancies, including lymphomas, are cancers affecting the immune system. Specifically, they affect cells called B-lymphocytes/B-cells, a type of white blood cell that helps fight against infections. There are several types of B-cell lymphomas. This study concentrates on patients with chronic lymphocytic leukaemia (CLL), small lymphocytic lymphoma (SLL), Mantle Cell Lymphoma (MCL) and Large B-Cell Lymphoma (LBCL). In these types of cancers, B-lymphocytes are abnormal (do not work as they should do) and start to grow and multiply abnormally. This makes it harder for the body to fight off infections.
Currently there are several treatment options available, however, researchers from AstraZeneca AB (the Sponsor) believe AZD0486 alone or in combination with other anticancer agents, will be a safe and effective therapy, leading to fewer side effects and better disease outcomes. AZD0486 works by making a bridge between B-cells and T-cells (another cell that fights infections). This activates the T-cell, leading to killing/eating of the B-cells, which may remove these cancer cells.
The study is open label, meaning participants and researchers will know what treatment each participant is receiving. Participants may stay in the study for up to 5 years and AZD0486 will be administered to all participants every 2 weeks up to 49 times. (Of note, the first 3 doses are given a week apart at a lower dose).
Doctors will monitor participants’ health and disease progress during the trial and participants will be asked to report their symptoms.
Participants may not directly benefit from taking part in this trial as efficacy of AZD0486 is unknown, but they may help patients in the future by improving the knowledge of and possible treatment regimens for these diseases.
The trial will include approximately 180 participants in 12 countries at 50 sites. All participants will be 18 years of age or older.REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
24/EM/0223
Date of REC Opinion
25 Nov 2024
REC opinion
Further Information Favourable Opinion