KYSA-6: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell Therapy, in Patients With Generalized Myasthenia Gravis
This research is looking into a new treatment called KYV-101 for adults living with generalized myasthenia gravis, a condition that causes muscle weakness. Myasthenia gravis is an autoimmune disease, meaning the body's immune system mistakenly attacks healthy tissues, in this case, parts of the muscles. The new treatment, KYV-101, is a type of cell therapy that works by targeting and removing specific immune cells called B cells, which are thought to play a role in causing myasthenia gravis. The study aims to find out if KYV-101 is safe and effective in reducing the symptoms of muscle weakness and improving the overall quality of life for those with the condition. It’s a significant step towards finding new ways to manage this challenging disease.
At a glance
What is this study about?
Myasthenia gravis is a long-term condition where your muscles become weak and tired easily because your immune system mistakenly attacks the connections between your nerves and muscles. This can make everyday tasks like walking, talking, or even smiling difficult. While there are treatments available, they don't work for everyone, and some people still experience significant challenges.
This study is exploring a new type of treatment called KYV-101, which is a cell therapy. Think of it as retraining your body's own defense system. The treatment specifically targets and removes certain immune cells, called B cells, which are believed to be heavily involved in causing myasthenia gravis. By getting rid of these problematic B cells, the hope is to reduce the immune system's attack on your muscles and lessen your symptoms.
The researchers want to see if KYV-101 can safely and effectively improve muscle strength and overall well-being for people living with generalized myasthenia gravis. This research is important because it could offer a new option for patients who haven't found enough relief from current treatments. It’s about finding better ways to help people regain more control over their daily lives.
Key takeaways
- This study is testing a new cell therapy (KYV-101) for generalized myasthenia gravis.
- The therapy aims to reduce muscle weakness by targeting specific immune cells.
- It's for adults aged 18-75 who haven't fully responded to other treatments.
- Participation involves ongoing monitoring and clinic visits.
- The study could provide a new treatment option for myasthenia gravis.
- You can withdraw from the study at any time.
Who may be eligible?
This study is looking for adults aged 18 to 75 who have been diagnosed with generalized myasthenia gravis. To be considered, you would need to have specific antibodies in your blood related to myasthenia gravis, and your muscle weakness should be at a certain level according to standard medical tests.
You would also need to have tried and not fully responded to at least two other common treatments for myasthenia gravis, or one treatment if you regularly need procedures like plasma exchange or IVIG to manage your symptoms. Your current medications for myasthenia gravis should also be at a stable dose for a certain period before joining.
There are also some reasons why you might not be able to join. For example, if you have other serious neurological conditions, an uncontrolled mental health illness, or certain other medical problems that the doctors think would make participating unsafe or complicate the study's results, you might not be eligible.
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?
- Have you been diagnosed with generalized myasthenia gravis?
- Have you tried at least two other common myasthenia gravis treatments that weren't fully effective?
- Are you able to attend regular clinic visits?
- Do you have the specific antibodies related to myasthenia gravis in your blood?
What does participation involve?
If you decide to take part, you would have several visits to the study clinic for check-ups and assessments. The main treatment involves a special process where some of your immune cells (T-cells) are collected, sent away to be modified to become KYV-101, and then given back to you as an infusion. Before this, you might receive some short-term treatment to prepare your body.
Throughout the study, you'd have regular blood tests, physical examinations, and assessments of your muscle strength and daily activities to see how the treatment is affecting you. The total duration of your participation would involve the treatment period and then regular follow-up visits to monitor your health and the treatment’s effects. You’ll be told the exact schedule of visits and procedures if you are interested in joining.
Potential risks and benefits
Locations (22)
- Ronald Reagan UCLA Medical CenterVerified postcodeLos Angeles, United States· Not yet recruiting
- University of California, IrvineVerified postcodeOrange, United States· Recruiting
- Stanford University Medical CenterVerified postcodePalo Alto, United States· Recruiting
- University of MiamiVerified postcodeMiami, United States· Recruiting
- Indiana University HealthVerified postcodeIndianapolis, United States· Recruiting
- University of MissouriVerified postcodeColumbia, United States· Recruiting
- Oregon Health & Science UniversityVerified postcodePortland, United States· Not yet recruiting
- Thomas Jefferson University HospitalVerified postcodePhiladelphia, United States· Recruiting
- Houston Methodist HospitalVerified postcodeHouston, United States· Recruiting
- Intermountain Medical CenterVerified postcodeMurray, United States· Recruiting
- Westmead Institute for Medical ResearchVerified postcodeWestmead, Australia· Recruiting
- Hospital Israelita Albert EinsteinVerified postcodeSão Paulo, Brazil· Recruiting
Common questions
What is generalized myasthenia gravis?
It's a long-term condition that causes muscle weakness and tiredness due to your immune system attacking the connections between nerves and muscles.
What is KYV-101?
It's a new type of cell therapy that works by targeting and removing specific immune cells called B cells, which are involved in myasthenia gravis.
How is KYV-101 given?
Your own immune cells are collected, modified, and then given back to you as an infusion (like a drip).
Will I still take my regular myasthenia gravis medication?
You'll need to be on stable doses of your current medications for a period before the study, and your doctors will advise on any changes during the trial.
What are the phases of this study?
This study is in Phase 2 and Phase 3, meaning it's still testing the safety and effectiveness of the new treatment in larger groups of people.
How to find out more
Kyverna Therapeutics, Inc.
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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