The CALiPSO-1 Study: A Study of CNTY-101, a CD19-targeted CAR iNK Cell Product, in Participants with Refractory B cell-mediated Autoimmune Diseases
The CALiPSO-1 study is testing a new and experimental treatment called CNTY-101 for certain severe autoimmune diseases. These conditions include systemic lupus erythematosus, which can affect many parts of the body including the kidneys (lupus nephritis), a group of conditions causing muscle inflammation (idiopathic inflammatory myopathy), and a specific type of skin hardening (diffuse cutaneous systemic sclerosis). This is an early stage, 'Phase 1' study, which means researchers are primarily focused on checking the safety of CNTY-101 and understanding how it behaves in the human body. They want to see if it could be a safe and effective way to help people whose conditions haven't responded well to other treatments.
At a glance
What is this study about?
The CALiPSO-1 study is exploring a new type of treatment for conditions where your body's immune system mistakenly attacks healthy cells. These are called autoimmune diseases. The conditions being studied here are systemic lupus erythematosus (often called lupus, which can also affect the kidneys and is then called lupus nephritis), a group of conditions that cause muscle inflammation (idiopathic inflammatory myopathy), and a specific form of a condition that causes skin hardening (diffuse cutaneous systemic sclerosis).
The new treatment is called CNTY-101. It's a special type of cell therapy that targets specific immune cells called B cells, which are thought to play a key role in these autoimmune conditions. By targeting these cells, the hope is to calm down the overactive immune system and reduce the symptoms of these challenging diseases.
This is a 'Phase 1' study, which is the very first stage of testing a new treatment in people. The main goal at this stage isn't to cure the disease, but to carefully check if the treatment is safe and to understand what dose works best and how it moves through the body. Researchers will be looking closely for any side effects and seeing if the treatment has any early signs of helping patients whose conditions haven't improved with other medicines.
Key takeaways
- New study for severe autoimmune conditions like lupus, muscle inflammation, and skin hardening.
- Testing an experimental cell therapy called CNTY-101.
- This is an early-stage study focusing on safety and how the treatment works.
- For adults aged 18 and over, whose conditions haven't improved with other treatments.
- Participation involves receiving the treatment and regular follow-up visits.
Who may be eligible?
To be considered for this study, you must be an adult, 18 years old or older. The study is open to both men and women.
You would be considered if you have one of the following specific autoimmune conditions: systemic lupus erythematosus (including if it affects your kidneys, known as lupus nephritis), idiopathic inflammatory myopathy (a type of muscle inflammation), or diffuse cutaneous systemic sclerosis (a specific kind of skin hardening).
Importantly, the study is for people whose diseases haven't responded well to standard treatments. More detailed criteria will be discussed by the study team, as not everyone with these conditions will be suitable.
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?
- Have you been diagnosed with systemic lupus erythematosus (lupus), lupus nephritis, idiopathic inflammatory myopathy, or diffuse cutaneous systemic sclerosis?
- Has your condition not responded well to other treatments you've tried?
- Are you able to attend regular hospital visits and follow study procedures?
What does participation involve?
Taking part in this study would involve a number of hospital visits and assessments. You would receive the study treatment, CNTY-101, which is a one-time treatment. Before and after receiving the treatment, you would have medical check-ups, blood tests, and possibly other scans or procedures to monitor your health and how the treatment is working. The exact length of follow-up will be detailed by the study team, but typically, early-stage studies involve careful monitoring over an extended period. This can include regular visits and check-ins for several months or even longer to track your progress and any long-term effects.
Potential risks and benefits
Locations (3)
- —UnverifiedItaly
- —UnverifiedGermany
- —UnverifiedFrance
Common questions
What is an autoimmune disease?
It's a condition where your body's immune system mistakenly attacks healthy tissues, causing inflammation and damage.
What does 'Phase 1' mean for a clinical trial?
It's the first step where a new treatment is tested in people. The main goals are to check its safety and how it works in the body.
What is CNTY-101?
CNTY-101 is a new, experimental cell therapy that aims to target specific immune cells involved in autoimmune diseases.
What medical conditions are being studied?
The study is looking at severe forms of lupus (including lupus affecting the kidneys), muscle inflammation, and a type of skin hardening.
Will I get better if I join this study?
There's no guarantee the treatment will make you better. The aim is to study its safety and if it has potential to help.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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