Phase 1 Study of UniCAR02-T-CD123 in Patients With Selected CD123 Positive Hematologic Malignancies
This is an early-stage UK clinical trial exploring a new potential treatment called UniCAR02-T-CD123. It's for adult patients who have a type of blood cancer called Acute Myeloid Leukaemia (AML). Since this is the first time this specific treatment is being used in people, doctors want to find out if it's safe and what doses can be given. They also want to see how the body reacts to it and if it might have any positive effects on the cancer. Taking part in this kind of study helps researchers learn more about new ways to fight diseases, potentially leading to new treatments in the future. Participants need to be at least 18 years old.
At a glance
What is this study about?
When doctors are looking for new ways to treat serious illnesses like cancer, they often test new medicines or treatments in special research studies called clinical trials. This particular study is in its very first stage for humans, which means it’s the first time this new treatment, called UniCAR02-T-CD123, is being given to people. The main goal at this stage is to check how safe it is and to find the right dose. It's much like a pilot test to make sure everything is working as expected before larger studies.
The specific condition this study is looking at is Acute Myeloid Leukaemia, often shortened to AML. AML is a type of cancer that starts in the bone marrow, which is the spongy tissue inside some of your bones where new blood cells are made. In AML, the body makes lots of abnormal white blood cells, which can interfere with the production of healthy blood cells.
The new treatment, UniCAR02-T-CD123, is designed to specifically target certain markers found on the AML cancer cells. By taking part in this early study, patients are helping doctors and scientists understand if this new treatment works as they hope, and how it behaves in the human body. This kind of research is really important because it helps pave the way for potentially better treatments in the future for people living with AML.
Key takeaways
- This is an early-stage study of a new treatment for Acute Myeloid Leukaemia (AML).
- It's the first time this treatment (UniCAR02-T-CD123) is being given to people.
- The main goal is to check its safety and find the right dose.
- Open to adults aged 18 and over with AML.
- Participation involves close monitoring with regular doctor visits and tests.
- You can stop taking part at any time without affecting your normal care.
Who may be eligible?
To be considered for this study, you need to be an adult, 18 years old or older. The study is open to both men and women.
While the main eligibility is around your age and having Acute Myeloid Leukaemia (AML), there will be other specific health checks your study doctor will need to do. These checks would ensure that the treatment is as safe as possible for you and that taking part in the study is the right step for your health at this time. For instance, they would look at your overall health, other medical conditions you might have, and any other medicines you are taking.
It’s important to remember that not everyone with AML will be suitable for this specific study, as clinical trials often have very strict guidelines to ensure the safety of participants and the accuracy of the study results. Your doctor can discuss all these details with you.
- Are you 18 years old or older?
- Have you been diagnosed with Acute Myeloid Leukaemia (AML)?
- Are you able to travel to study appointments?
- Are you willing to undergo regular medical tests and monitoring?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, the first step would be a screening visit to check if you meet all the health requirements. This might include blood tests, scans, and a review of your medical history. Once confirmed, you would receive the study treatment. As this is a first-in-human study, there would be many regular follow-up visits, especially in the beginning, to closely monitor your health, how you are reacting to the treatment, and any potential side effects. These visits might involve more blood tests, physical exams, and possibly other tests depending on how you're doing.
The exact number and duration of visits would be explained in detail by the study team, but generally, early-stage trials involve frequent and thorough check-ups. The total time you would be involved in the study — from the first screening to the final follow-up after treatment — would also be clearly outlined to you before you make any decisions. You would be fully informed about what to expect every step of the way.
Potential risks and benefits
Locations (2)
- —Germany
- —Netherlands
Common questions
What is Acute Myeloid Leukaemia (AML)?
AML is a type of cancer that starts in the bone marrow, where new blood cells are made. It causes the body to produce too many faulty white blood cells.
What does 'first administration to humans' mean?
It means this is the very first time this new treatment is being given to people. Doctors are mainly checking if it's safe and finding the right dose.
Will I definitely get better if I join this study?
Because this is a very early study, we don't know yet if the treatment will improve your condition. The main aim is to learn about its safety.
Who can take part in this study?
Adults aged 18 or older with Acute Myeloid Leukaemia (AML) can potentially take part. There will be other health checks too.
Can I leave the study if I change my mind?
Yes, you can decide to stop participating at any time, for any reason. It won't affect your regular medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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