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

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What is this study about?

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.

Who Can Join the Study?

  • 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 Study?

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

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name City Country Status
Charite Universitaetsmedizin Berlin KöR Berlin Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Recruiting
26.02.2026

Trial locations

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.

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.

Trial ID:
2024-511198-31-00
Protocol code:
KYV101-004
Trial Phase:
Therapeutic use (Phase IV)

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