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Clinical Trials in the UK / NCT07295847
Recruiting Phase 1

A Study of AZD0120 in Autoimmune Diseases

NCT07295847 · tracked via the Priya Life Science UK tracker
Sponsor
AstraZeneca
Phase
Phase 1
Started
2026-01-09
Last updated
2026-07-28

Condition(s) studied

Systemic SclerosisIdiopathic Inflammatory MyopathiesRheumatoid Arthritis

Investigational drug(s) / intervention(s)

AZD0120

AZD0120: CD19/BCMA Autologous CAR T-cell therapy product

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (22)

FacilityCityRegionStatus
Research Site Tucson Arizona Not Yet Recruiting
Research Site Stanford California Not Yet Recruiting
Research Site Chicago Illinois Not Yet Recruiting
Research Site Ann Arbor Michigan Recruiting
Research Site St Louis Missouri Not Yet Recruiting
Research Site New York New York Recruiting
Research Site Chapel Hill North Carolina Not Yet Recruiting
Research Site Seattle Washington Not Yet Recruiting
Research Site Darlinghurst Australia Recruiting
Research Site Waratah Australia Not Yet Recruiting
Research Site Berlin Germany Not Yet Recruiting
Research Site Erlangen Germany Not Yet Recruiting
Research Site Hamburg Germany Not Yet Recruiting
Research Site Jena Germany Not Yet Recruiting
Research Site Mainz Germany Not Yet Recruiting
Research Site Würzburg Germany Not Yet Recruiting
Research Site Barcelona Spain Not Yet Recruiting
Research Site Madrid Spain Not Yet Recruiting
Research Site Madrid Spain Not Yet Recruiting
Research Site Huddinge Sweden Not Yet Recruiting
Research Site Edinburgh United Kingdom Recruiting
Research Site London United Kingdom Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07295847 on ClinicalTrials.gov ↗ ← All trials in the UK