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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
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
Where Is This Study? (2 UK sites)
Research Site
Edinburgh EH4 2XU, United Kingdom
Research Site
London SE5 9RS, United Kingdom
How to Get in Touch
AstraZeneca Clinical Study Information Center
Sponsor contactCONTACT
