A Study of AZD0120 in Autoimmune Diseases

NCT ID
NCT07295847
Registry status
Recruiting
Study type
Interventional
Phase
Phase 1
Sponsor
AstraZeneca
Conditions
Idiopathic Inflammatory Myopathies, Rheumatoid Arthritis, Systemic Sclerosis

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: 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

Enrollment: 27 participants (Estimated).

What is being studied

  • Biological: AZD0120

Who may be eligible

Ages
18 Years to 75 Years
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility criteria.

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.

Study locations

21 study locations are listed.

Recruiting site status is explicitly provided for 21 locations; 4 are listed as Recruiting.

Countries: Australia, Germany, Spain, Sweden, United Kingdom, United States

  • Arizona, United States: 1
  • California, United States: 1
  • Illinois, United States: 1
  • Michigan, United States: 1
  • Missouri, United States: 1
  • New York, United States: 1
  • North Carolina, United States: 1
  • Washington, United States: 1

Sample of listed locations

  • Research Site — Darlinghurst, 2010, Australia — Recruiting
  • Research Site — Edinburgh, EH4 2XU, United Kingdom — Recruiting
  • Research Site — Ann Arbor, Michigan, 48109, United States — Recruiting
  • Research Site — New York, New York, 10032, United States — Recruiting
  • Research Site — Waratah, 2298, Australia — Not yet recruiting
  • Research Site — Berlin, 13353, Germany — Not yet recruiting
  • Research Site — Erlangen, 91054, Germany — Not yet recruiting
  • Research Site — Hamburg, 20246, Germany — Not yet recruiting
  • Research Site — Jena, 07747, Germany — Not yet recruiting
  • Research Site — Mainz, 55131, Germany — Not yet recruiting
  • Research Site — Würzburg, 97080, Germany — Not yet recruiting
  • Research Site — Barcelona, 8035, Spain — Not yet recruiting
  • Research Site — Madrid, 28041, Spain — Not yet recruiting
  • Research Site — Huddinge, 141 57, Sweden — Not yet recruiting
  • Research Site — London, SE5 9RS, United Kingdom — Not yet recruiting
  • Research Site — Tucson, Arizona, 85719, United States — Not yet recruiting
  • Research Site — Stanford, California, 94305-5847, United States — Not yet recruiting
  • Research Site — Chicago, Illinois, 60637, United States — Not yet recruiting
  • Research Site — St Louis, Missouri, 63110, United States — Not yet recruiting
  • Research Site — Chapel Hill, North Carolina, 27599, United States — Not yet recruiting
  • Research Site — Seattle, Washington, 98104, United States — Not yet recruiting

Study details

Start date
January 9, 2026
Primary completion date
February 22, 2028
Completion date
February 22, 2028
First posted
December 22, 2025

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07295847
Registry last updated
July 28, 2026
QualifiedStudies registry data refreshed
October 2, 2026
QualifiedStudies record fetched
October 2, 2026

View NCT07295847 on ClinicalTrials.gov

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