A Phase 1/2 interventional study of AZD0120 and SOC in Systemic Sclerosis, Idiopathic Inflammatory Myopathies and Rheumatoid Arthritis, sponsored by AstraZeneca. Recruiting at 27 sites in 6 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by AstraZeneca · Phase 1/2, Interventional, and Treatment
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).
610 studies on the registry are indexed under Scleroderma, Systemic; 218 are open to participants now.
This study's planned enrollment of 27 is below the median of 37 across 446 interventional studies indexed under Scleroderma, Systemic.
Browse Scleroderma, Systemic studies →AstraZeneca is the lead sponsor of 3,499 studies on the registry; 270 are open to participants now.
Of its 368 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Nov 2, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive an infusion of AZD0120 Regimen.
Biological: AZD0120
Participants will receive SOC Regimen 1 in RA cohort
Drug: SOC
Participants will receive SOC regimen 2 in RA cohort
Drug: SOC
CD19/BCMA Autologous CAR T-cell therapy product
Also known as: GC012F
SOC
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
Time frame: 1 year
Proportion of Participants Achieving a Revised-CRISS Response
Revised-CRISS responder status in participants with systemic sclerosis (SSc).
Time frame: Baseline, Week 52
Proportion of participants achieving TIS response and low corticosteroid dose
Disease activity measures in IIM participants.
Time frame: 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.
Time frame: Baseline, Week 12
Cellular Kinetics - Cmax
The maximum concentration of CAR T cells achieved in the body.
Time frame: 1 year
Cellular Kinetics - Tmax
The time point at which the Cmax is reached
Time frame: 1 year
Cellular Kinetics - AUC
The area under the concentration-time curve, which represents the total drug exposure over a specific period.
Time frame: 1 year
Cellular Kinetics - t½λz
The terminal elimination half-life.
Time frame: 1 year
Cellular Kinetics - Clast
The last observed quantifiable concentration of CAR T-cells.
Time frame: 1 year
Cellular Kinetics - Tlast
The time to last quantifiable concentration.
Time frame: 1 year
Cellular Kinetics - AUClast
The area under the concentration-time curve to the last measurable concentration.
Time frame: 1 year
Anti-drug antibodies (ADA) developed against AZD0120 from baseline
Humoral immunogenicity assessment of AZD0120 in participants with SSc, IIM, or RA.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, week 52
Change From Baseline in Clinical Measures of Disease Activity
Change from baseline in clinical measures of joint and overall disease activity.
Time frame: 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).
Time frame: 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.
Time frame: 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 '
Time frame: 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.
Time frame: Baseline, Week 12
Proportion of Participants Achieving Disease Remission
Disease remission by composite disease activity index.
Time frame: Baseline, Week 12
Proportion of Participants Achieving American College of Rheumatology Response
Proportion of participants achieving ACR20, ACR50, or ACR70 response criteria.
Time frame: 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.
Time frame: Baseline, Week 52
Plan to share: 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.
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.
Data sharing details ↗ · vivli.org
No publications or documents are linked to this record.
Started Jan 2026 (actual). Primary completion is estimated for Feb 2028, 25 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drug tested here: Autologous Bispecific BCMA/CD19-targeted CAR-T Cells GC012F