AZD0120 CD19/BCMA CAR T-cell therapy for systemic sclerosis, inflammatory myopathies, and difficult-to-treat rheumatoid arthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1b open-label, multi-center, multi-cohort trial testing AZD0120, a CAR T-cell product that targets both CD19 and BCMA, in adult patients with systemic sclerosis (SSc), idiopathic inflammatory myopathies (IIM), or difficult-to-treat rheumatoid arthritis (D2T RA). Approximately 9–12 participants will be enrolled per disease cohort and treated to identify a recommended Phase 2 dose for each indication. The main focus is on safety and tolerability with close early follow-up, and participants must meet organ-function and other eligibility criteria (for example, no prior CAR T therapy and BMI within specified limits). Sites include US research centers in Tucson, Stanford, and Chicago, and participants need to be able to remain near the treating center during the immediate post-infusion period.

Why it matters

Who can join: the full rules

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.
* 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

Exclusion Criteria:

* 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.
* 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.

Where it's running

• Research Site
  Ann Arbor, Michigan, United States Recruiting
• Research Site
  New York, New York, United States Recruiting
• Research Site
  Chapel Hill, North Carolina, United States Recruiting
• Research Site
  Darlinghurst, Australia Recruiting
• Research Site
  Edinburgh, United Kingdom Recruiting
• Research Site
  Tucson, Arizona, United States Not yet recruiting

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.