Descartes-08 CAR-T Cells in Generalized Myasthenia Gravis (MG)
This study is for people who have Generalized Myasthenia Gravis (MG), a condition that causes muscle weakness. Researchers are testing a new treatment called Descartes-08 CAR T-cells. This is a Phase IIb study, which means it's an early stage to see if the treatment is safe for people and if it starts to show benefits. The study will look at how well people with MG respond to this new treatment and if there are any side effects. Both people who test positive or negative for certain antibodies related to MG can take part. The main goal is to find out if Descartes-08 could be a helpful new option for managing generalized MG.
At a glance
What is this study about?
This study is exploring a new type of treatment called Descartes-08 CAR T-cells for people who have a condition called Generalized Myasthenia Gravis (MG). MG is a long-term condition that causes muscle weakness and tiredness. This happens because the body's own immune system accidentally attacks the connections between nerves and muscles.
Descartes-08 is a special kind of treatment that uses your own immune cells, called T-cells, which are then modified in a lab to specifically target and clear out certain cells thought to be involved in MG. The aim is to calm down the immune system's attack on the muscles. This particular study is in an early stage, known as Phase IIb, which means it's being tested to see how safe it is for people with MG and if it starts to show signs of being effective in improving their condition.
The researchers are keen to see if this new approach can help reduce the symptoms of MG and improve the quality of life for those living with it. While it's an investigational treatment, the hope is that it could offer a new way to manage generalized MG for some people in the future.
Key takeaways
- This study is testing a new treatment called Descartes-08 for Generalized Myasthenia Gravis.
- It's an early-stage study (Phase IIb) to check for safety and if it helps symptoms.
- Adults aged 18 and over with Generalized MG can be considered.
- Both 'seropositive' and 'seronegative' MG patients are included.
- You cannot participate if pregnant, breastfeeding, or have other serious uncontrolled illnesses.
Who may be eligible?
To be considered for this study, you need to be at least 18 years old and have been diagnosed with Generalized Myasthenia Gravis. Your doctor must also believe that you need ongoing medication to control your condition. Interestingly, this study includes people with MG whether they test positive or negative for certain common blood markers sometimes used to diagnose MG.
However, some people won't be able to join. For example, if you have another serious long-term illness that isn't under control, and the study doctor thinks it might make taking part risky for you. Also, if you are pregnant or breastfeeding, unfortunately, you wouldn't be able to participate in this study.
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 18 years old or older?
- Do you have a diagnosis of Generalized Myasthenia Gravis?
- Does your doctor think you need medication for your MG?
- Are you NOT currently pregnant or breastfeeding?
- Do you NOT have any other major uncontrolled chronic illnesses?
What does participation involve?
While the detailed plan for participation isn't fully described, usually taking part in a clinical trial involves a number of steps. You would first have screening appointments to check if you meet all the study's requirements. If you qualify, you would receive the Descartes-08 treatment. This type of treatment often involves collecting your specific immune cells, sending them away to be specially prepared, and then giving them back to you.
After treatment, you would likely have regular follow-up visits to check on your health, how you're responding to the treatment, and to look for any side effects. These visits might include blood tests, physical examinations, and questionnaires about your symptoms and how you are generally feeling. The exact number and frequency of visits, as well as the total length of your involvement in the study, would be fully explained to you by the study team.
Potential risks and benefits
Locations (15)
- Profound ResearchVerified postcodeCarlsbad, United States
- University of California IrvineVerified postcodeIrvine, United States
- University of Colorado Anschutz Medical CampusVerified postcodeAurora, United States
- SFM Clinical Research, LLCVerified postcodeBoca Raton, United States
- Neurology Associates, P.A.Verified postcodeOrlando, United States
- University of South FloridaVerified postcodeTampa, United States
- University of AugustaVerified postcodeAugusta, United States
- University of Kansas Medical Center Research InstituteVerified postcodeKansas City, United States
- Dent Neurologic InstituteVerified postcodeAmherst, United States
- University of North CarolinaVerified postcodeChapel Hill, United States
- Oregon Health & Science UniversityVerified postcodePortland, United States
- University of PennsylvaniaVerified postcodePhiladelphia, United States
Common questions
What is Generalized Myasthenia Gravis?
It's a long-term condition that causes weakness in muscles throughout your body, as your immune system mistakenly attacks nerve-muscle connections.
What are 'CAR T-cells'?
CAR T-cells are a special type of treatment where your own immune cells are modified to find and fight certain other cells in your body.
What does Phase IIb mean for a study?
It means the study is an early stage to check if the new treatment is safe for people and if it starts to show benefits for the condition.
Will I get 'Descartes-08' if I join?
If you meet all the study's requirements and are accepted, you will receive the Descartes-08 treatment as part of the study.
Can I join if I'm already on other MG medicines?
Yes, if your doctor thinks you need ongoing immunosuppressive medications for your MG, you can still be considered for the study.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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