RecruitingRare disease

A long-term safety study of KYV-101 in patients previously treated for lupus nephritis, systemic sclerosis, myasthenia gravis, rheumatoid arthritis, or stiff person syndrome

Fast replyInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on individuals who have previously received treatment with KYV-101, a medication administered through an infusion, which is a method of delivering fluids or medicine directly into a vein. The research involves people living with several different conditions, including Lupus Nephritis, which is kidney inflammation caused by an immune system problem, Systemic Sclerosis, a disease that affects connective tissues, Myasthenia Gravis, a condition that causes muscle weakness, Rheumatoid Arthritis, which affects the joints, and Stiff Person Syndrome, a rare disorder causing muscle stiffness. Autoimmune disorders are conditions where the body's immune system mistakenly attacks its own healthy cells.

The purpose of the study is to evaluate the long-term safety of KYV-101. Participants will be monitored over an extended period to observe how the body reacts to the medication over time. This involves checking for the development of new health issues, such as malignancy, which refers to cancerous growths, or any changes in existing neurologic conditions, which are related to the brain and nervous system. The study also tracks changes in rheumatologic issues, which involve the joints and connective tissues, or hematologic disorders, which are conditions affecting the blood.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
<b>long-term follow-up</b>
The long-term follow-up period begins for individuals who have previously received treatment with kyv-101.
The primary goal of this stage is to monitor safety over an extended period of time.
Step 2
<b>safety monitoring</b>
During this period, safety is assessed by monitoring for any new malignancies, which are uncontrolled growths of cells in the body.
Changes in existing neurologic disorders (conditions affecting the brain or nerves), rheumatologic disorders (conditions affecting joints or connective tissues), or autoimmune disorders (conditions where the immune system attacks the body) are tracked.
Any new hematologic disorders, which are conditions affecting the blood, are monitored.
Any new injections or potential reactions related to the product are recorded.
The presence of kyv-101 in the body is measured using a specialized test called ddpcr.
The presence of rcl is monitored using a laboratory test called qpcr.

Who can join the trial?

4 criteria

The patient must have been diagnosed with one of the following conditions: Lupus Nephritis (a condition where the body's immune system attacks the kidneys), Systemic Sclerosis (a disease that causes hardening and thickening of the skin and connective tissues), Myasthenia Gravis (a disease that causes weakness in the muscles used for breathing, swallowing, and eye movement), Rheumatoid Arthritis (a disease that causes swelling and pain in the joints), or Stiff Person Syndrome (a rare disorder that causes progressive muscle stiffness and spasms).
The patient must have already received at least one infusion (a method of delivering medicine directly into a vein through a needle or tube) of the study drug called KYV-101 during a previous treatment program.
The study is open to both males and females.
The patient must fall within the specific age range defined for this study (ages 2 to 5 years old).

Who cannot join the trial?

1 criterion

There are no specific medical conditions or rules listed that would prevent you from joining this study.

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Verified sites

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Charite Universitaetsmedizin Berlin KöR
Verified
Berlin, Germany
Katholisches Klinikum Bochum gGmbH
Responsive
Bochum, Germany
Medizinische Hochschule Hannover
Verified
Hanover, Germany

Trial locations

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Investigated drugs

KYV-101 is an experimental therapy being studied to see how it affects patients over a long period of time after they have received it.

Kyv-101

What is already known about the treatment

KYV-101 - This experimental medicine is given as a liquid suspension through an intravenous infusion directly into the bloodstream. It is currently an investigational substance undergoing clinical study and is not yet widely available in general medical practice. The medication is being studied to treat various immune system and muscle disorders, such as lupus nephritis, rheumatoid arthritis, and myasthenia gravis. It works by targeting specific molecules in the body to help regulate and calm an overactive immune response.

Investigated diseases

Lupus Nephritis
This condition occurs when the immune system attacks the kidneys due to systemic lupus erythematosus. It causes inflammation within the kidney's filtering units. As the disease progresses, the inflammation can lead to damage in the kidney tissues. This process can result in the leakage of proteins and blood into the urine. Over time, the damage may affect how well the kidneys filter waste from the blood.
Systemic Sclerosis
This is an autoimmune disorder characterized by the hardening and tightening of the skin and connective tissues. It is caused by the body's immune system attacking healthy tissues, leading to excessive amounts of collagen production. The disease often begins with skin thickening and can spread to internal organs like the lungs, heart, or digestive tract. As it advances, the affected tissues become increasingly stiff.
Myasthenia Gravis
This is a chronic autoimmune neuromuscular disorder. It occurs when the immune system mistakenly attacks the communication points between nerves and muscles. This interruption prevents muscles from receiving signals correctly. The condition typically manifests as muscle weakness that worsens with activity and improves with rest. Over time, the weakness can affect various muscle groups throughout the body.
Rheumatoid Arthritis
This is an autoimmune and inflammatory disease that primarily affects the joints. The immune system attacks the synovium, which is the lining of the membranes that surround the joints. This causes the lining to thicken, leading to swelling and discomfort. As the disease progresses, the inflammation can cause bone erosion and joint deformity. It often affects multiple joints symmetrically on both sides of the body.
Stiff Person Syndrome
This is a rare neurological disorder characterized by progressive muscle stiffness and aching. It is caused by an immune system malfunction that affects the nerve cells controlling muscle movement. The stiffness typically begins in the abdomen and trunk before spreading to the limbs. This can lead to involuntary muscle spasms triggered by unexpected stimuli. The condition results in increased difficulty with movement and posture.