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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

A Study of AZD0120 in Autoimmune Diseases

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

A Study of AZD0120 in Autoimmune Diseases (NCT07295847) is a Phase 1 interventional studying Systemic Sclerosis and Idiopathic Inflammatory Myopathies, sponsored by AstraZeneca. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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).

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Systemic Sclerosis, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 27 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - Capable of giving signed willing to sign a consent form. - Adequate physiological function and reserve at screening. - Able to comply with recommended medication waiting period after previous treatment. - 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. Who Should NOT Join This Trial: - 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 weakened immune system. - 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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, 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.

Treatments Being Tested

BIOLOGICAL

AZD0120

CD19/BCMA Autologous CAR T-cell therapy product

Locations (18)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Research Site
Tucson, Arizona, United States
Research Site
Stanford, California, United States
Research Site
Chicago, Illinois, United States
Research Site
Ann Arbor, Michigan, United States
Research Site
St Louis, Missouri, United States
Research Site
New York, New York, United States
Research Site
Chapel Hill, North Carolina, United States
Research Site
Seattle, Washington, United States
Research Site
Darlinghurst, Australia
Research Site
Waratah, Australia
Research Site
Hamburg, Germany
Research Site
Mainz Am Rhein, Germany
Research Site
Würzburg, Germany
Research Site
Barcelona, Spain
Research Site
Madrid, Spain
Research Site
Madrid, Spain
Research Site
Edinburgh, United Kingdom
Research Site
London, United Kingdom

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07295847), the sponsor (AstraZeneca), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07295847 clinical trial studying?

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). The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07295847?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07295847?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07295847. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07295847. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.