Skip to main content
UK clinical trials - updated daily from ClinicalTrials.gov
TrialConnect
← Back to Search
Looking for participantsPhase1

A Study of AZD0120 in Autoimmune Diseases

Sponsor: AstraZeneca

NCT ID: NCT07295847

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
AZD0120 (biological)
How long the study runs
Study runs about 25 months (dates as stated)
About the drug or intervention
AZD0120 — biological: CD19/BCMA Autologous CAR T-cell therapy product
Patient visit burden
Not specified by the sponsor

In plain English

This study, run by AstraZeneca, is testing a new medicine called AZD0120 in people with autoimmune conditions. These are conditions where the immune system attacks the body by mistake. The conditions being studied are systemic sclerosis, idiopathic inflammatory myopathies, and rheumatoid arthritis.

Who can take part

  • You are able to give signed informed consent (agree to take part after being told about the study).
  • Your body is working well enough to take part, based on checks done at the start of the study.
  • You can stop taking certain medicines for a set time before the study starts, if needed.
  • The study doctor thinks you are suitable and healthy enough to take part.
  • You are willing to use highly effective birth control, or meet other accepted criteria, to avoid pregnancy during the study.

Who may not be able to

  • Your body mass index (BMI) is below 18 or above 35 at screening.
  • You have had CAR T-cell therapy before (a type of immune cell treatment).
  • You cannot stay within about 2 hours' travel of the study centre for the first 28 days after receiving the study medicine.
  • You have had a bone marrow or solid organ transplant, or you are on an active transplant waiting list.
  • You have taken another experimental drug within the last 4 weeks or longer (depending on how long it stays in the body).
  • You have certain heart conditions that could make taking part unsafe.
  • You need extra oxygen while resting during the day (night-time oxygen for sleep apnoea is allowed) or a ventilator.
  • You have uncontrolled or symptomatic high blood pressure (above 160/100 mmHg).
  • You have a disease of the brain or nervous system that could affect your safety, in the doctor's opinion.
  • You have another autoimmune or auto-inflammatory disease at the same time, unless the study doctors agree it can be allowed.
  • You have had serious or active bleeding within 90 days before screening.
  • You have had cancer or are still having treatment for cancer, with some exceptions.
  • You have a known genetic problem with your immune system that you were born with.
  • You have an active infection (viral, bacterial, or fungal) or needed infection treatment in the 4 weeks before screening.
  • You are HIV positive.
  • You have active viral hepatitis.
  • You have active syphilis or a positive test for the syphilis bacterium (Treponema pallidum).
  • You had a live weakened (live, attenuated) vaccine within 4 weeks before apheresis or lymphodepletion (steps in preparing you for the treatment).
  • Your vaccinations are not up to date as advised for people with weakened immune systems.
  • You have life-threatening allergies or bad reactions to AZD0120 or its ingredients, including dimethyl sulfoxide.
  • You cannot take or are allergic to fludarabine and cyclophosphamide (medicines used in the study).
  • You have had or are planning major surgery during the study.
  • You are pregnant, breastfeeding, or planning to become pregnant during the study or within 1 year after treatment (whichever is later).
  • You are planning to father a child during the study or within 1 year after treatment (whichever is later).
  • There is any other reason, in the doctor's opinion, why taking part would not be in your best interests.

What taking part involves

  • • You would receive AZD0120, an experimental (investigational) medicine.
  • • Before the study medicine, the process includes steps called apheresis and lymphodepletion, and medicines called fludarabine and cyclophosphamide are used — Not stated — ask the trial team for full details of what these involve.
  • • Other aspects of the treatment are not stated — ask the trial team.

Time commitment: You would need to stay within about 2 hours' travel of the study centre for the first 28 days after receiving the study medicine; total study length and number of visits are not stated — ask the trial team.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years to 75 Years
Who
All
Number of participants
27
Started
2026-01-09
Last checked
2026-07

Plain English Summary

What is this study?

  • • Testing a new treatment for systemic sclerosis
  • • Phase1 - 27 participants
  • • 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)

Who can take part?

  • • Ages 18 Years to 75 Years
  • • Diagnosed with systemic sclerosis

Where?

  • • Edinburgh - Research Site
  • • London - Research Site

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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).

More detail

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.

Systemic SclerosisIdiopathic Inflammatory MyopathiesRheumatoid Arthritis

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 75 Years
  • Who can join: All genders

What the study is looking for

  • ✓Capable of giving signed agreement to take part.
  • ✓healthy physiological 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...
  • ✓Willingness to remain on/start appropriate, highly effective methods of birth control or other acceptable criteria.

Who cannot take part

  • ✗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...
  • ✗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.
See the full 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 Is This Study? (2 UK sites)

Research Site

Edinburgh EH4 2XU, United Kingdom

Recruiting

Research Site

London SE5 9RS, United Kingdom

NOT_YET_RECRUITING

How to Get in Touch

AstraZeneca Clinical Study Information Center

Sponsor contact

CONTACT

1-877-240-9479 information.center@astrazeneca.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-07