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

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

PHASE1 · AstraZeneca · NCT07295847

This trial will try a dual-targeting CD19/BCMA CAR T-cell treatment (AZD0120) in adults with systemic sclerosis, idiopathic inflammatory myopathies, or difficult-to-treat rheumatoid arthritis to see if it is safe and well tolerated.

Quick facts

PhasePHASE1
Study typeInterventional
Enrollment27 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorAstraZeneca (industry)
Drugs / interventionsCAR T, cyclophosphamide, fludarabine
Locations18 sites (Tucson, Arizona and 17 other locations)
Trial IDNCT07295847 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults with SSc, IIM, or D2T RA who have adequate organ function, meet BMI and other screening criteria, have not received prior CAR T therapy, can comply with medication washouts, and can stay near the treating site for the first month after infusion.

Not a fit: Patients with certain unstable heart conditions, prior bone marrow or solid-organ transplants, recent investigational drug exposure, prior CAR T therapy, or disease not primarily driven by B cells/plasma cells are unlikely to benefit or may be excluded.

Why it matters

Potential benefit: If safe and effective, this targeted CAR T approach could produce durable disease control or remission in patients with refractory B-cell/plasma-cell–driven autoimmune diseases.

How similar studies have performed: Early case reports and small early-phase trials of B-cell or plasma-cell–targeting CAR T therapies have shown promising durable remissions in some refractory autoimmune diseases, but dual CD19/BCMA approaches remain relatively novel and untested in larger populations.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Tucson, Arizona and 17 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Systemic Sclerosis, Idiopathic Inflammatory Myopathies, Rheumatoid Arthritis, CAR-T, BCMA, CD19

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.