Safety of TEG001 in patients with r/r AML/high-risk MDS or r/r MM
This study is an early-stage clinical trial, which means it's one of the first times this new medicine, called TEG001, is being given to people. It's for adult patients who have acute myeloid leukaemia (AML), myelodysplastic syndrome (MDS), or multiple myeloma (MM). These are types of blood and bone marrow cancers. The study is specifically for people whose cancer has either come back after treatment (relapsed) or hasn't responded to treatment (refractory), or if they have high-risk MDS. The main aim is to find out if TEG001 is safe and well-tolerated when given to humans. Researchers will also be looking to see what dose of TEG001 is best and if it has any effects on the cancers.
At a glance
What is this study about?
This study is looking at a new treatment called TEG001. It's designed for adults who have specific types of blood cancer: acute myeloid leukaemia (AML), myelodysplastic syndrome (MDS), or multiple myeloma (MM). These conditions affect your blood cells and bone marrow. We understand that hearing your cancer has come back or isn't responding to treatment can be very worrying. This study is an opportunity to explore a potential new option.
This is a 'Phase 1' study, which is the very first step in testing a new medicine in people. This means we don't know much yet about how TEG001 works in the human body. The most important thing we want to find out is whether TEG001 is safe for patients and what the right amount (dose) to give is. Researchers will be carefully checking for any side effects and how your body reacts to the treatment.
By taking part, you would be helping doctors learn more about TEG001. Even though it's an early study, the information gathered from people like you is crucial for developing new and better treatments for these challenging cancers in the future. Your contribution could make a real difference to others living with these conditions.
Key takeaways
- This is an early-stage study looking at a new treatment called TEG001.
- It's for adults with specific types of blood cancer (AML, MDS, MM) that are difficult to treat.
- The main goal is to find out if TEG001 is safe for people to use.
- Participants will receive the new treatment and have their health closely monitored.
- Your involvement could help doctors develop new therapies for these conditions.
Who may be eligible?
This study is for adults aged 18 and over. It's open to both men and women. To be considered for this study, you must have been diagnosed with one of the following blood cancers:
* **Acute Myeloid Leukaemia (AML):** Specifically, if your AML has come back after treatment (relapsed) or hasn't responded to treatment (refractory). * **Myelodysplastic Syndrome (MDS):** If you have a high-risk type of MDS. * **Multiple Myeloma (MM):** If your multiple myeloma has come back after treatment (relapsed) or hasn't responded to treatment (refractory).
There will be other, more detailed requirements that the study doctors will discuss with you. These usually involve checking your general health, organ function, and any other medical conditions you might have, to make sure it's safe for you to take part. It's important to understand that not everyone with these conditions will be able to join, depending on these additional criteria.
- Are you 18 years old or older?
- Do you have acute myeloid leukaemia (AML) that has come back or isn't responding to treatment?
- Do you have high-risk myelodysplastic syndrome (MDS)?
- Do you have multiple myeloma (MM) that has come back or isn't responding to treatment?
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, you will first go through a screening process. This involves several tests and checks to make sure the study is right for you and you meet all the requirements. If you are eligible, you will then start the treatment with TEG001.
The study involves regular visits to the hospital or clinic. During these visits, you will have blood tests, physical exams, and other checks to monitor your health and see how you are responding to the treatment. The doctors will also be looking very closely for any side effects. You will receive the study medication (TEG001) as directed by the study team.
The duration of your participation in the study will depend on how you respond to the treatment and the decisions made by your study doctor. After the treatment phase, there will likely be a period of follow-up visits to continue monitoring your health and any long-term effects of TEG001.
Potential risks and benefits
Locations (1)
- —Netherlands
Common questions
What does 'relapsed' or 'refractory' mean?
It means your cancer has either come back after treatment, or it hasn't responded to the standard treatments.
What is a 'Phase 1' study?
It's the very first time a new medicine is given to people. The main purpose is to see if it's safe and to find the right dose.
Will I get better if I join this study?
We don't know yet. While there's a chance the treatment could help, the main goal of this early study is to find out if it's safe.
How long would I be in the study?
The exact length would depend on your individual response and how the study progresses. The doctors will give you more details.
Can I stop being in the study if I change my mind?
Yes, absolutely. You can withdraw from the study at any time, for any reason. Your decision will not affect your future medical care.
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.