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A Study of AZD0120 in Autoimmune Diseases | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

NCT07295847•AstraZeneca

View on ClinicalTrials.gov

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).

Detailed Description

This is a Phase 1b, open-label, multi-center, multi-cohort clinical study of AZD0120, a CD19/BCMA dual CAR T-cell therapy, to evaluate the safety in adult participants with systemic sclerosis (SSc), idiopathic inflammatory myopathies (IIM), or difficult-to-treat rheumatoid arthritis (D2T RA) for determination of the recommended phase 2 dose for each disease cohort. Approximately 9-12 participants will be evaluated per disease cohort.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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.
+16 more criteria

Locations (18)

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

Key Dates

Start Date

January 9, 2026

Primary Completion Date

February 22, 2028

Completion Date

February 22, 2028

Last Updated

February 11, 2026

Enrollment

ESTIMATED participants

Conditions

Systemic SclerosisIdiopathic Inflammatory MyopathiesRheumatoid Arthritis

Interventions

AZD0120

BIOLOGICAL

Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479 information.center@astrazeneca.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 11, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of AZD0120 in Autoimmune Diseases

Inclusion Criteria

Exclusion Criteria

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