Systemic SclerosisPhase 1/2AURORANCT07295847
A Study of AZD0120 in Autoimmune Diseases
A Phase 1/2 study testing AZD0120 and SOC in people with Systemic Sclerosis and Idiopathic Inflammatory Myopathies, run by AstraZeneca at 25 sites in 6 countries.
Trial summary
This trial is a Phase 1b/2, 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Systemic Sclerosis, Idiopathic Inflammatory Myopathies, Rheumatoid Arthritis
- What is being tested?
- AZD0120 and SOC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 25 sitesin 6 countries
- Study dates
- 9 Jan 2026to 22 Feb 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Particpant musy be 18-years-old to ≤ 75-years-old inclusive at the time of signing the informed consent
- Others as described in Clinical Study Protocol
Who cannot join
- Any prior CAR T exposure.
- Unable or unwilling to remain within proximity (2 hours travel time) of the administering investigational site post discharge for the first 28 days post AZD0120 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 cardiac 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.
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- 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 or HTLV.
- Active viral hepatitis are excluded.
- Active syphilis, positive for Treponema pallidum antibody.
- Vaccinated with live, attenuated vaccine within 4 weeks prior to apheresis or lymphodepletion.
- Not up-to-date on vaccinations per local/national health authority or institutional guidelines for immune-compromised individuals.
- Known life threatening allergies, hypersensitivity, or intolerance to AZD0120 or its excipients, including dimethyl sulfoxide.
- Contraindications or hypersensitivity to fludarabine and cyclophosphamide.
- - Major surgery within 8 weeks prior to apheresis or has surgery planned during the study.
- Pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 1 year after receiving study treatment (whichever is later).
- Plans to father a child while enrolled in this study or within 1 year after receiving study treatment (whichever is later).
- Any issue that would impair the ability of the participant to receive or tolerate the planned treatment at the investigational site, to provide informed consent or any condition in the opinion of the investigator, participation would not be in the best interest of the participant.
- Other protocol-defined eligibility criteria may apply.
Trial locations and contacts
25 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
25 sites in 6 countries
United States11 sites, 11 recruiting
- Recruiting
Research Site
Ann Arbor, Michigan, 48109
- Not yet recruiting
Research Site
Baltimore, Maryland, 21287
- Not yet recruiting
Research Site
Chapel Hill, North Carolina, 27599
- Not yet recruiting
Research Site
Chicago, Illinois, 60637
- Not yet recruiting
Research Site
Duarte, California, 91010
- Not yet recruiting
Research Site
New York, New York, 10016
- Recruiting
Research Site
New York, New York, 10032
- Not yet recruiting
Research Site
Seattle, Washington, 98104
- Not yet recruiting
Research Site
St Louis, Missouri, 63110
- Not yet recruiting
Research Site
Stanford, California, 94305-5847
- Not yet recruiting
Research Site
Tucson, Arizona, 85719
Germany6 sites, 6 recruiting
- Not yet recruiting
Research Site
Berlin, 13353
- Not yet recruiting
Research Site
Erlangen, 91054
- Not yet recruiting
Research Site
Hamburg, 20246
- Not yet recruiting
Research Site
Jena, 07747
- Not yet recruiting
Research Site
Mainz, 55131
- Not yet recruiting
Research Site
Würzburg, 97080
Spain3 sites, 3 recruiting
- Not yet recruiting
Research Site
Barcelona, 8035
- Not yet recruiting
Research Site
Madrid, 28041
- Not yet recruiting
Research Site
Madrid, 28046
Australia2 sites, 2 recruiting
- Recruiting
Research Site
Darlinghurst, 2010
- Not yet recruiting
Research Site
Waratah, 2298
United Kingdom2 sites, 2 recruiting
- Recruiting
Research Site
Edinburgh, EH4 2XU
- Not yet recruiting
Research Site
London, SE5 9RS
About this study
Official title: A Phase 1b/2, Open-label, Multi-cohort Study of AZD0120, an Autologous CD19/BCMA Targeting Chimeric Antigen Receptor T-cell, in Adults With Autoimmune Diseases
This trial is a Phase 1b/2, 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).
- Being tested
- AZD0120, SOC
- Keywords
- Systemic Sclerosis, Idiopathic Inflammatory Myopathies, Rheumatoid Arthritis, CAR-T, BCMA, CD19
- Medical subject headings
- Scleroderma, Systemic, Myositis, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD0120Biological
Also called GC012F
CD19/BCMA Autologous CAR T-cell therapy product
SOCDrug
SOC
| Study group | Role | What they receive |
|---|---|---|
| AZD0120 Regimen 1 | Experimental | Participants will receive an infusion of AZD0120 Regimen. Receives: Biological: AZD0120 |
| SOC Regimen 1 | Active comparator | Participants will receive SOC Regimen 1 in RA cohort Receives: Drug: SOC |
| SOC Regimen 2 | Active comparator | Participants will receive SOC regimen 2 in RA cohort Receives: Drug: SOC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Proportion of Participants Achieving a Revised-CRISS Response
Revised-CRISS responder status in participants with systemic sclerosis (SSc).
Measured: Baseline, Week 52
Proportion of participants achieving TIS response and low corticosteroid dose
Disease activity measures in IIM participants.
Measured: Baseline, Week 52
Proportion of participants achieving Disease Activity Score 28 C reactive protein (DAS28-CRP) < 2.6
Disease activity measures in D2T RA participants.
Measured: Baseline, Week 12
Secondary outcomes (19)
Cellular Kinetics - Cmax
The maximum concentration of CAR T cells achieved in the body.
Measured: 1 year
Cellular Kinetics - Tmax
The time point at which the Cmax is reached
Measured: 1 year
Cellular Kinetics - AUC
The area under the concentration-time curve, which represents the total drug exposure over a specific period.
Measured: 1 year
Cellular Kinetics - t½λz
The terminal elimination half-life.
Measured: 1 year
Cellular Kinetics - Clast
The last observed quantifiable concentration of CAR T-cells.
Measured: 1 year
Cellular Kinetics - Tlast
The time to last quantifiable concentration.
Measured: 1 year
Cellular Kinetics - AUClast
The area under the concentration-time curve to the last measurable concentration.
Measured: 1 year
Anti-drug antibodies (ADA) developed against AZD0120 from baseline
Humoral immunogenicity assessment of AZD0120 in participants with SSc, IIM, or RA.
Measured: 1 year
Proportion of participants with detectable replication competent lentivirus (RCL) at pre-specified post infusion timepoints.
Incidence of vector-derived RCL in participant receiving AZD0120.
Measured: 1 year
Change from baseline in the Disease Activity Score (DAS) 28-C-reactive protein (CRP).
Disease activity measures in RA participants. The DAS28-CRP is a measure from 0-10 with higher scores indicating greater disease activity.
Measured: 1 year
Change from baseline in modified Rodnan Skin Score (mRSS).
Disease activity measures in SSc participants. Change from baseline in modified Rodnan skin score (mRSS) over time.The mRSS is a measure of skin thickness with a range of 0-51 with higher scores indicating more severe disease.
Measured: Baseline, week 52
Change From Baseline in Clinical Measures of Disease Activity
Change from baseline in clinical measures of joint and overall disease activity.
Measured: Baseline, Week 12
Change From Baseline in Pulmonary Function Parameters
Change from baseline in percent predicted forced vital capacity (ppFVC), forced vital capacity (FVC), and diffusing capacity of the lungs for carbon monoxide (DLCO) parameters in participants with SSc-associated or IIM-associated interstitial lung disease (ILD).
Measured: Baseline, Week 52
Proportion of Participants Achieving Prespecified Total Improvement Score Thresholds
Proportion of participants with idiopathic inflammatory myopathy (IIM) achieving prespecified Total Improvement Score (TIS) thresholds.
Measured: Baseline, Week 12
Change From Baseline in Cutaneous Disease Activity
Change from baseline in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) and Cutaneous Dermatomyositis Investigator Global Assessment (CDA-IGA) scores '
Measured: Baseline, Week 52
Proportion of Participants Achieving Prespecified Corticosteroid Use Outcomes
Proportion of participants achieving prespecified corticosteroid use outcomes and assessment of cumulative corticosteroid exposure.
Measured: Baseline, Week 12
Proportion of Participants Achieving Disease Remission
Disease remission by composite disease activity index.
Measured: Baseline, Week 12
Proportion of Participants Achieving American College of Rheumatology Response
Proportion of participants achieving ACR20, ACR50, or ACR70 response criteria.
Measured: Baseline, week 12
Change From Baseline in Patient-Reported Outcome Measures
Change from baseline in prespecified disease-specific and general health patient-reported outcome measures.
Measured: Baseline, Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start9 Jan 2026
- Primary completion22 Feb 2028 (estimated)
- Study completion22 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic SclerosisStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Model description
- Multi-indication cohort
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07295847
- Sponsor's protocol ID
- D8318C00001
- Other IDs
- 29707
- Acronym
- AURORA
- Status last verified
- Oct 2026
- First submitted
- 16 Oct 2025
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b/2, Open-label, Multi-cohort Study of AZD0120, an Autologous CD19/BCMA Targeting Chimeric Antigen Receptor T-cell, in Adults With Autoimmune Diseases
- ClinicalTrials.gov ID
- NCT07295847
- Acronym / sponsor ID
- AURORA / D8318C00001
- Keywords
- Systemic Sclerosis, Idiopathic Inflammatory Myopathies, Rheumatoid Arthritis, CAR-T, BCMA, CD19
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 9 Jan 2026 (actual)
- Primary completion
- 22 Feb 2028 (estimated)
- Study completion
- 22 Feb 2028 (estimated)
- First posted
- 22 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is a Phase 1b/2, 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Multi-indication cohort
| Arm | Type | Receives |
|---|---|---|
| AZD0120 Regimen 1 | Experimental | Biological: AZD0120Participants will receive an infusion of AZD0120 Regimen. |
| SOC Regimen 1 | Active comparator | Drug: SOCParticipants will receive SOC Regimen 1 in RA cohort |
| SOC Regimen 2 | Active comparator | Drug: SOCParticipants will receive SOC regimen 2 in RA cohort |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (25 listed)
- Any prior CAR T exposure.
- Unable or unwilling to remain within proximity (2 hours travel time) of the administering investigational site post discharge for the first 28 days post AZD0120 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 cardiac conditions that could make it unsafe or unsuitable to take part in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD0120Also: GC012FCD19/BCMA Autologous CAR T-cell therapy product | Biological | AZD0120 Regimen 1 |
| SOCSOC | Drug | SOC Regimen 1, SOC Regimen 2 |
Primary outcome
Number of participants and severity of dose limiting toxicities (DLTs) and treatment-emergent adverse events (TEAEs)
Time frame: 1 year
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
Proportion of Participants Achieving a Revised-CRISS Response
Time frame: Baseline, Week 52
Revised-CRISS responder status in participants with systemic sclerosis (SSc).
Proportion of participants achieving TIS response and low corticosteroid dose
Time frame: Baseline, Week 52
Disease activity measures in IIM participants.
Proportion of participants achieving Disease Activity Score 28 C reactive protein (DAS28-CRP) < 2.6
Time frame: Baseline, Week 12
Disease activity measures in D2T RA participants.
19 secondary outcomes
Cellular Kinetics - Cmax
Time frame: 1 year
Cellular Kinetics - Tmax
Time frame: 1 year
Cellular Kinetics - AUC
Time frame: 1 year
Cellular Kinetics - t½λz
Time frame: 1 year
Cellular Kinetics - Clast
Time frame: 1 year
Cellular Kinetics - Tlast
Time frame: 1 year
Cellular Kinetics - AUClast
Time frame: 1 year
Anti-drug antibodies (ADA) developed against AZD0120 from baseline
Time frame: 1 year
Proportion of participants with detectable replication competent lentivirus (RCL) at pre-specified post infusion timepoints.
Time frame: 1 year
Change from baseline in the Disease Activity Score (DAS) 28-C-reactive protein (CRP).
Time frame: 1 year
Change from baseline in modified Rodnan Skin Score (mRSS).
Time frame: Baseline, week 52
Change From Baseline in Clinical Measures of Disease Activity
Time frame: Baseline, Week 12
Change From Baseline in Pulmonary Function Parameters
Time frame: Baseline, Week 52
Proportion of Participants Achieving Prespecified Total Improvement Score Thresholds
Time frame: Baseline, Week 12
Change From Baseline in Cutaneous Disease Activity
Time frame: Baseline, Week 52
Proportion of Participants Achieving Prespecified Corticosteroid Use Outcomes
Time frame: Baseline, Week 12
Proportion of Participants Achieving Disease Remission
Time frame: Baseline, Week 12
Proportion of Participants Achieving American College of Rheumatology Response
Time frame: Baseline, week 12
Change From Baseline in Patient-Reported Outcome Measures
Time frame: Baseline, Week 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
AstraZeneca Clinical Study Information Center contact
25 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AZD0120 and SOC in people with Systemic Sclerosis and Idiopathic Inflammatory Myopathies, run by AstraZeneca at 25 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States, Germany, Spain, Australia, United Kingdom and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants and severity of dose limiting toxicities (DLTs) and treatment-emergent adverse events (TEAEs) (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.