A Phase 1/2, Open-Label, Multicenter Study of KYV-101, an Autologous Fully-Human Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects with Refractory Lupus Nephritis (KYSA-3)
This study, called KYSA-3, is looking at a new type of cell therapy named KYV-101. It's designed for adults in the UK who have lupus nephritis, a severe kidney problem caused by lupus that hasn't responded to other treatments. The therapy works by using your own immune cells, called T-cells, which are specially modified in a lab to fight the disease. This is a "Phase 1/2" study, which means it's an early step in testing a new medicine. The main goals are to find out if the treatment is safe for people to use and to see if it shows any signs of working. Researchers are also trying to understand how the treatment affects the body and if it can help improve kidney function for those with lupus nephritis.
At a glance
What is this study about?
This study is trying out a brand-new way to treat lupus nephritis, a serious condition where your body's immune system attacks your kidneys. When this happens, it can cause a lot of damage and stop your kidneys from working properly. The new treatment, called KYV-101, is a type of 'CAR T-cell therapy'. This might sound complicated, but it basically involves taking some of your own immune cells (a type of white blood cell called T-cells), modifying them in a lab to make them better at fighting the disease, and then putting them back into your body.
The idea behind this treatment is to get your own immune system to target and clear out the specific cells that are causing the problems in lupus nephritis. Researchers hope this could be a more effective way to calm down the overactive immune system and protect the kidneys. Because this is an 'open-label' study, both you and the study team will know which treatment you are receiving.
This is an early-stage study, called Phase 1/2. This means it's one of the first times this particular treatment is being given to people. The main goals at this stage are to make sure the treatment is safe and to find the right dose. Researchers will also be watching very closely to see if there are any signs that the treatment is helping people with lupus nephritis. It's a key step in understanding if this new therapy could become a helpful option in the future.
Key takeaways
- This study is testing a new cell therapy (KYV-101) for severe lupus nephritis.
- It uses your own immune cells, modified to target the disease.
- It's an early-stage study focused on safety and early signs of effectiveness.
- You must be an adult (18+) with lupus nephritis that hasn't responded to other treatments.
- Participation involves cell collection, treatment, a hospital stay, and follow-up visits.
Who may be eligible?
To join this study, you must be 18 years old or older. There is no upper age limit, so people of all adult ages can be considered. The study is open to both men and women.
The main requirement is that you have a specific kidney condition called lupus nephritis, which is caused by lupus. Importantly, your lupus nephritis must not have responded well to other standard treatments, meaning it's considered 'refractory'.
The study team will check your medical history, current health, and specific test results to make sure this study is right for you and that you meet all the necessary requirements for your safety and to ensure the study can gather useful information.
- Are you 18 years old or older?
- Have you been diagnosed with lupus nephritis?
- Has your lupus nephritis not gotten better with usual treatments?
- Are you able to commit to hospital stays and regular follow-up appointments?
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, the first step would involve a screening period where doctors will perform various tests to confirm you're suitable. If you qualify, you would then have some of your blood taken so your T-cells can be collected. These cells are then sent away to a special lab to be modified into the KYV-101 therapy.
During the time your cells are being prepared, you might receive some short-term treatment to get your body ready. Once your modified cells are ready, you'll receive the KYV-101 treatment through a drip, similar to a blood transfusion. After receiving the treatment, you will need to stay in the hospital for a period of time so the medical team can closely monitor you for any side effects.
Following your hospital stay, you'll have regular follow-up appointments at the clinic. These appointments will involve blood tests, urine tests, and other check-ups to see how you're doing, whether the treatment is working, and to monitor for any delayed side effects. The total duration of your participation in the study, including all follow-up, will be explained in detail by the study team.
Potential risks and benefits
Locations (1)
- —Germany
Common questions
What is lupus nephritis?
Lupus nephritis is a serious kidney problem caused by lupus, where your body's immune system attacks your kidneys, making it hard for them to filter waste from your blood.
What is 'CAR T-cell therapy'?
It's a special treatment where some of your own immune cells are taken from your blood, trained in a lab to fight your disease, and then put back into your body.
Is this treatment a cure for lupus nephritis?
This is an early-stage study, so it's too soon to know if it could be a cure. The main goals are to check if it's safe and if it shows signs of helping the condition.
Will I have to stay in hospital?
Yes, after you receive the KYV-101 treatment, you will need to stay in hospital for a period of time so doctors can monitor you closely.
What does 'refractory' mean in this study?
It means your lupus nephritis has not responded well to standard medicines and treatments that doctors have tried before.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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