A Study of AZD0120 in Autoimmune Diseases
AURORA
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
2 other identifiers
interventional
27
5 countries
18
Brief Summary
This trial is a Phase 1b, open-label, multi-center, clinical study of AZD0120, a BCMA/CD19 dual targeting CAR+ T-cell therapy, to evaluate the safety and tolerability in adult participants with systemic sclerosis (SSc), idiopathic inflammatory myopathies (IIM), or difficult-to-treat rheumatoid arthritis (D2T RA).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jan 2026
Typical duration for phase_1
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 16, 2025
CompletedFirst Posted
Study publicly available on registry
December 22, 2025
CompletedStudy Start
First participant enrolled
January 9, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 22, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 22, 2028
May 1, 2026
April 1, 2026
2.1 years
October 16, 2025
April 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of participants and severity of dose limiting toxicities (DLTs) and treatment-emergent adverse events (TEAEs)
Incidence and severity of DLTs and TEAEs to evaluate the safety of AZD0120 and to confirm the recommended Phase 2 dose (RP2D) in each indication SSc, IIM, or RA
1 year
Secondary Outcomes (12)
Cellular Kinetics - Cmax
1 year
Cellular Kinetics - Tmax
1 year
Cellular Kinetics - AUC
1 year
Cellular Kinetics - t½λz
1 year
Cellular Kinetics - Clast
1 year
- +7 more secondary outcomes
Study Arms (2)
AZD0120 Regimen 1
EXPERIMENTALParticipants will receive an infusion of AZD0120 Regimen 1.
AZD0120 Regimen 2
EXPERIMENTALParticipants will receive an infusion of AZD0120 Regimen 2.
Interventions
CD19/BCMA Autologous CAR T-cell therapy product
Eligibility Criteria
You may qualify if:
- Capable of giving signed informed consent.
- Adequate physiological function and reserve at screening.
- Able to comply with recommended medication washout period.
- Participants who are suitable for the study as determined by medical evaluation and at the discretion of the investigator.
- Willingness to remain on/start appropriate, highly effective methods of birth control or other acceptable criteria.
You may not qualify if:
- BMI at screening \< 18 or \> 35kg/m2.
- Any prior CAR T exposure.
- Unable or unwilling to remain within proximity (\~2 hours travel time) of the administering investigational site for the first 28 days post study drug administration.
- Received a bone marrow or solid organ transplant at any time or on an active transplant waiting list.
- Received any investigational drug within ≥ 5 half-lives or 4 weeks, whichever is longer, prior to screening.
- Has certain heart conditions that could make it unsafe or unsuitable to take part in the study.
- Requirement for supplemental oxygen at rest (except at night for sleep apnea) or mechanical ventilation.
- Uncontrolled hypertension (\> 160/100 mmHg) or symptomatic hypertension.
- Any central nervous system disease that may impact participants safety in the investigator's opinion.
- Other concurrent autoimmune or autoinflammatory disease. Certain autoimmune/autoinflammatory diseases may be included after discussion with the medical monitor.
- Evidence of clinically significant bleeding or active bleeding conditions within 90 days before screening
- History of malignancy or ongoing treatment for prior malignancy. Certain malignancies may be excepted.
- Known genetic inborn error of immunity and/or primary immunodeficiency.
- Active viral, bacterial, or fungal infection, or any ongoing infection that requires systemic antimicrobial therapy in the 4 weeks prior to screening.
- Seropositive for HIV.
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (18)
Research Site
Tucson, Arizona, 85719, United States
Research Site
Stanford, California, 94305-5847, United States
Research Site
Chicago, Illinois, 60637, United States
Research Site
Ann Arbor, Michigan, 48109, United States
Research Site
St Louis, Missouri, 63110, United States
Research Site
New York, New York, 10032, United States
Research Site
Chapel Hill, North Carolina, 27599, United States
Research Site
Seattle, Washington, 98104, United States
Research Site
Darlinghurst, 2010, Australia
Research Site
Waratah, 2298, Australia
Research Site
Hamburg, 20246, Germany
Research Site
Mainz, 55131, Germany
Research Site
Würzburg, 97080, Germany
Research Site
Barcelona, 8035, Spain
Research Site
Madrid, 28041, Spain
Research Site
Madrid, 28046, Spain
Research Site
Edinburgh, EH4 2XU, United Kingdom
Research Site
London, SE5 9RS, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 16, 2025
First Posted
December 22, 2025
Study Start
January 9, 2026
Primary Completion (Estimated)
February 22, 2028
Study Completion (Estimated)
February 22, 2028
Last Updated
May 1, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.