DURGA-5
Research type
Research Study
Full title
A Phase III, Open-Label, Randomised, Multicentre Study of Consolidation with a Single Administration of AZD0120, a Dual-Targeting Autologous Chimeric Antigen Receptor T-cell (CAR-T) Therapy Directed Against BCMA and CD19, Compared with Continuous Standard Therapy in Participants with NDMM Who Are Ineligible to Receive ASCT as Initial Therapy (DURGA-5)
IRAS ID
1013438
Contact name
Assim Khan
Contact email
Sponsor organisation
AstraZeneca AB
Research summary
This is a research study funded by AstraZeneca AB. Researchers are looking for a better way to treat participants with newly diagnosed multiple myeloma (NDMM) who cannot receive an autologous stem cell transplant (a treatment that uses their own stem cells) as the first treatment they get for their cancer. This cancer affects a type of white blood cells called plasma cells in the bone marrow.
The trial drug AZD0120 is a type of treatment called chimeric antigen receptor T-cell (CAR-T) therapy. AZD0120 is designed to work by helping the body’s immune system find and kill cancer cells. AZD0120 is made by collecting a patient’s immune cells from their blood, training them to recognize and kill cancer cells, and then putting those trained cells back into the body to work through a needle into a vein. A possible benefit of receiving AZD0120 is the improvement of a participant's cancer.
Participants may be asked to join a follow-up study to be monitored, if they have received AZD0120.
To join this trial, people must be at least 18 years old and have NDMM. People cannot join the trial if they have certain medical conditions that would make it too difficult or risky to participate. The trial will be conducted by hospitals in the UK and in other countries.
Participants will receive either AZD0120 or a standard treatment combination for NDMM.
This is a Phase 3, randomized, open-label trial. Randomized means that a computer program will randomly assign the treatment each participant receives. Open-label means the participants, researchers, trial doctors, and other trial staff will know what each participant is receiving.
For the participants assigned to receive AZD0120, doctors will collect blood cells to make AZD0120.
The standard treatment will be given as injections just under the skin, as tablets or capsules taken by mouth, or through a needle directly into a vein (IV infusion), until they no longer receive benefit.REC name
London - West London & GTAC Research Ethics Committee
REC reference
26/LO/0057
Date of REC Opinion
5 May 2026
REC opinion
Further Information Favourable Opinion