AURORA
Research type
Research Study
Full title
A Phase 1b, Open-label, Multi-cohort Study of AZD0120, an autologous CD19/BCMA Targeting Chimeric Antigen Receptor T-cell, in Adults with Autoimmune Diseases
IRAS ID
1013265
Contact name
Krishna Varsani
Contact email
Sponsor organisation
AstraZeneca AB
Research summary
Researchers aim to improve treatments available for certain autoimmune diseases: systemic sclerosis (SSc), idiopathic inflammatory myopathies (IIM), and rheumatoid arthritis (RA) where the immune system attacks the body’s own tissues. B-cells and plasma cells are key drivers of this process, leading to skin thickening and lung problems in SSc, muscle inflammation and weakness in IIM, and painful, swollen joints in RA.
Current treatments, including steroids and immunosuppressants, do not work well for some. Some remain symptomatic or progress despite multiple medicines.
The trial drug, AZD0120 is a type of chimeric antigen receptor (CAR) T-cell therapy. It uses a person’s own T-cells, engineered to recognise and eliminate B cells (via CD19) and plasma cells (via BCMA). By targeting both, AZD0120 aims to reduce harmful autoantibodies and “reset” the immune system.
This phase 1b, open-label study will test AZD0120 in adults aged 18–75 with moderate to severe, progressive SSc, IIM, or D2T RA who have tried available treatments. Around 27–36 people (at least 6 per disease group) will join the study. Participants will be assigned to 1of 2 groups. Both groups will receive AZD0120 (single IV infusion) and doctors will collect blood cells from the participants for making AZD0120. Group 1 will differ from Group 2 in the lymphodepletion (cyclophosphamide and fludarabine) protocol.
Participants stay at least 7 days in hospital after infusion, and are followed for 12 months with clinic visits, blood tests, scans, and questionnaires. Researchers will keep track of any medical changes after participants receive AZD0120.
If AZD0120 proves safe and shows early benefit, it could offer a new option for people with few alternatives, guide larger trials, dosing, and pre-treatment strategies. Patients and study coordinators were interviewed during protocol development to shape visit schedules, materials, consent forms to ensure the study is practical and patient centred.REC name
London - West London & GTAC Research Ethics Committee
REC reference
26/LO/0069
Date of REC Opinion
18 Feb 2026
REC opinion
Further Information Favourable Opinion