A Phase I, First In Human, open-label study of escalating doses of INA03 administered intravenously as single agent in adult patients with relapse/refractory Acute Leukemia
This study is testing a new drug, INA03, for adults who have acute leukaemia that has either returned after treatment (relapsed) or hasn't improved with other treatments (refractory). This is a very early-stage study, known as a Phase I trial, meaning it's the first time this medication is being given to people. Researchers will slowly increase the dose of INA03 to find out if it's safe, how the body handles it, and what are the right dosage levels. The main goal is to understand its safety and side effects, rather than its effectiveness at this stage. It’s an ‘open-label’ study, meaning both you and the study team will know you are receiving INA03.
At a glance
What is this study about?
This study is being carried out for people who have a type of blood cancer called acute leukaemia. Sometimes, even after treatment, leukaemia can come back (this is called 'relapsed leukaemia') or it might not get better with the usual treatments (this is called 'refractory leukaemia'). When this happens, doctors look for new ways to help.
This study is testing a new medicine called INA03. It's really important to understand that this is the very first time this particular medicine is being given to people. This type of research is called a Phase I study. The main aim at this early stage is not to cure the cancer, but to carefully check if the medicine is safe and to find the right amount (dose) to give to people. Researchers will start with very small amounts of INA03 and slowly increase the dose for different groups of patients, watching very closely for any side effects.
By taking part, you would be helping doctors learn more about this new medicine. This information is a vital step in developing new treatments that could help people with leukaemia in the future. The study team will be looking at how your body reacts to INA03, how it uses the medicine, and how it gets rid of it.
Key takeaways
- This is an early-stage study (Phase I) for a new medicine called INA03.
- It's for adults with leukaemia that has relapsed or not responded to previous treatments.
- The main aim is to check the safety of INA03 and find the right dose.
- Participants will receive INA03 through a drip.
- You will have very close medical monitoring throughout the study.
- You can stop participating at any time.
Who may be eligible?
This study is looking for adult patients who have acute leukaemia that has either come back after treatment or hasn't responded to previous treatments. You must be at least 18 years old to be considered for this study.
The research team will have a full list of specific health requirements and conditions that could mean you can or cannot take part. For example, they will need to check your general health, how well your organs are working, and what other medical conditions you might have.
If you are interested, the study team will go through all the details with you, asking about your medical history and doing some tests to make sure the study is a safe and suitable option for you.
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.
- Am I 18 years old or older?
- Do I have acute leukaemia that has come back or not responded to treatment?
- Am I willing to have the study medicine given through a drip?
- Am I able to attend regular hospital appointments for monitoring?
What does participation involve?
If you decide to take part, you would receive the new medicine, INA03, directly into your bloodstream through a drip (intravenously). This is an 'open-label' study, which means both you and the study doctors will know you are receiving INA03.
The study will involve regular visits to the hospital. These visits will be important for the doctors to give you your medication and to monitor your health very closely. They will do this by taking blood samples, checking your vital signs (like your heart rate and blood pressure), and asking you about how you are feeling and any side effects you might be experiencing. The total length of your participation, including follow-up appointments after you stop taking the medicine, will be explained in detail by the study team.
Potential risks and benefits
Locations (1)
- —UnverifiedFrance
Common questions
What does 'relapsed/refractory' mean for my leukaemia?
It means your leukaemia has either come back after treatment, or it hasn't improved with the standard treatments you've received so far.
What is a Phase I study?
A Phase I study is the first time a new medicine is given to people. The main goal is to check how safe it is and find the right dose, rather than to see how well it treats the disease.
What is INA03?
INA03 is the name of the new experimental medicine being tested in this study.
Will I know if I'm getting the new medicine?
Yes, in this study (which is 'open-label'), both you and the doctors will know you are receiving INA03.
How will the medicine be given to me?
The medicine will be given directly into your bloodstream through a drip, which is called 'intravenous administration'.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.