A Study of AZD0120 in Autoimmune Diseases
This research is an early-stage study (Phase 1b) for a new treatment called AZD0120. It's designed to check how safe this treatment is and if people with certain serious autoimmune conditions can tolerate it well. The conditions include systemic sclerosis (which affects skin and internal organs), idiopathic inflammatory myopathies (a group of diseases causing muscle weakness and inflammation), and rheumatoid arthritis that hasn't responded to other treatments. Doctors will be looking closely at any side effects and aiming to find the best dose for future studies. About 9 to 12 adults with each condition will take part in this study.
At a glance
What is this study about?
This study is an important step in developing a new treatment called AZD0120. It's for adults in the UK who have specific long-term health conditions that are caused by the body's immune system mistakenly attacking its own tissues. These conditions are systemic sclerosis, a disease affecting skin and internal organs; idiopathic inflammatory myopathies, which cause muscle weakness and inflammation; and rheumatoid arthritis that has been very difficult to treat with current medicines.
The main goal of this early-stage study is to understand how safe AZD0120 is for people. The doctors will be giving the treatment and watching very carefully for any side effects. They also want to see if people can tolerate the treatment well. This information will help them decide the best amount of the medicine to use in future, larger studies.
AZD0120 is a type of treatment known as a CAR T-cell therapy. This involves taking some of your own immune cells, called T-cells, and changing them in a lab so they can better recognise and fight off certain cells in your body that might be causing your autoimmune disease. Once these changed cells are grown, they are put back into your body. This is a very new and advanced way of treating certain diseases, and this study aims to see if it could be a helpful option for these autoimmune conditions.
Key takeaways
- It's an early-stage study (Phase 1b) for a new treatment called AZD0120.
- The study aims to check the safety and tolerability of AZD0120 for specific autoimmune diseases.
- Conditions included are systemic sclerosis, inflammatory muscle diseases, and certain types of rheumatoid arthritis.
- Participants must be between 18 and 75 years old.
- You'll need to be closely monitored by the clinic for about 28 days after receiving the treatment.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
To join this study, you must be between 18 and 75 years old and be able to understand and sign a consent form. You also need to be generally well enough, with healthy organ function, and be able to stop other medicines if required for a certain period before getting the study treatment. The study team will make the final decision on whether you are suitable.
There are several reasons why someone might not be able to join. For example, if you have a very low or high body weight (specifically, your BMI is outside of 18-35), or if you've ever had a CAR T-cell treatment before, you won't be able to participate. You also can't have had a bone marrow or organ transplant in the past, or be on a waiting list for one. If you've recently taken part in another drug study, you might not be eligible.
Doctors will also need to check if you have certain existing health issues, such as specific heart conditions, uncontrolled high blood pressure, or serious breathing problems needing oxygen all the time. If you have another active autoimmune disease, certain infections (like HIV or Hepatitis), or a history of cancer within a certain timeframe, you might not be able to join. You'll also need to be able to stay close to the study clinic for the first 28 days after treatment.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you between 18 and 75 years old?
- Do you have systemic sclerosis, an inflammatory muscle disease, or rheumatoid arthritis that has been hard to treat?
- Are you able to stay close to the study clinic for the first month after treatment?
- Do you have healthy organ function and a BMI between 18 and 35?
- Have you never had a CAR T-cell treatment before?
- Do you currently have any serious infections or uncontrolled heart conditions?
What does participation involve?
If you decide to take part, you'll first go through a screening process to check if the study is right for you. This will involve visits to the clinic for medical exams, blood tests, and other assessments. If you qualify, you'll receive the study treatment, AZD0120. You will need to stay relatively close to the study clinic (typically within about two hours' travel) for the first 28 days after treatment so that doctors can monitor you closely.
After this initial period, you'll have regular follow-up appointments, which will involve more medical checks, blood tests, and discussions with the study team. These visits are important for monitoring your health, checking how the treatment is affecting you, and looking for any side effects. The exact number and timing of visits will be explained by the study team, and the total length of your participation will depend on the study plan and how you respond to the treatment.
Potential risks and benefits
Locations (18)
- Research SiteVerified postcodeTucson, United States· Not yet recruiting
- Research SiteVerified postcodeStanford, United States· Not yet recruiting
- Research SiteVerified postcodeChicago, United States· Not yet recruiting
- Research SiteVerified postcodeAnn Arbor, United States· Not yet recruiting
- Research SiteVerified postcodeSt Louis, United States· Not yet recruiting
- Research SiteVerified postcodeNew York, United States· Recruiting
- Research SiteVerified postcodeChapel Hill, United States· Not yet recruiting
- Research SiteVerified postcodeSeattle, United States· Not yet recruiting
- Research SiteVerified postcodeDarlinghurst, Australia· Recruiting
- Research SiteVerified postcodeWaratah, Australia· Not yet recruiting
- Research SiteVerified postcodeHamburg, Germany· Not yet recruiting
- Research SiteVerified postcodeMainz, Germany· Not yet recruiting
Common questions
What is AZD0120?
AZD0120 is a new, experimental treatment called a CAR T-cell therapy, being tested for certain autoimmune diseases.
What does 'Phase 1b' mean?
Phase 1b means it's an early study, mainly to check if a new treatment is safe and tolerable for people, and to find the right dose.
Which conditions are being studied?
The study is for adults with systemic sclerosis, idiopathic inflammatory myopathies, or rheumatoid arthritis that has been difficult to treat.
Will I have to stay in hospital?
You will need to stay fairly close to the study clinic (within about two hours' travel) for the first 28 days after the treatment, so doctors can monitor you closely.
Can I stop participating if I want to?
Yes, you are free to withdraw from the study at any time, for any reason, without it affecting your future medical care.
How to find out more
AstraZeneca Clinical Study Information Center
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.