Clinical Trial 63490

Houston, TX 77090


Summary:

The Ntrust-1 study: The Ntrust-1 study is part of a broad effort of the global research community to develop more treatment options for people living with lupus nephritis (LN).

Lupus is an autoimmune disease, in which some immune cells make antibodies that attack the body’s own tissues, instead of working to protect the body. This can cause inflammation in many parts of the body. Each person living with lupus can experience a unique set of symptoms with unpredictable flare-ups. Pain, swelling, and fatigue are among the most common.

Although current treatments can help manage symptoms, lupus can cause damage to vital organs, including the kidney. More clinical studies are needed to find treatments that target the root of lupus, which could potentially slow or stop its damaging effects. Do you want to help advance lupus medical research? Consider enrolling in the Ntrust-1 study.

What is Ntrust-1 study?
The Ntrust-1 study is a clinical study evaluating an investigational cell therapy, called NKX019, in adults living with lupus nephritis (LN).

What is NKX019?
NKX019 is an investigational cell therapy. It is designed to target and eliminate the cells that can lead to lupus. Academic studies of a small number of autoimmune patients treated with other cell therapy products have indicated that if these cells can be removed, the harmful antibodies that attack the body’s own tissues in lupus may also be eliminated. This could potentially slow or stop progression of lupus.

What is the purpose of this study?
As many as half of all adults living with lupus have kidney disease related to their lupus.1 This condition, called lupus nephritis, can worsen over time and may lead to kidney failure.2 Studies like this are designed to assess the safety and activity of a new investigational therapy.

The purpose of the Ntrust-1 study is to:

  • Determine if NKX019 is safe to use and how well it is tolerated.
  • Determine if NKX019 can improve kidney function.
  • See if other medications like steroids can be stopped because lupus is controlled.
  • See how the body processes NKX019 by measuring the NKX019 levels in the blood.

Who can join this study?
You may be eligible to participate in this study if you:

  • Are 18 to 65 years old.
  • Have been diagnosed with lupus nephritis.
  • Have received at least two prior therapies for lupus nephritis.

You will also need to meet additional requirements. The study team will review these with you.

Compensation: . If you are eligible and choose to participate, you will receive NKX019 and health assessments from a team with expertise in caring for people living with lupus. Costs for travel, lodging, and meals will be covered when you go to the study clinic. Compensation for study participation may also be available.

Sources:

  1. https://www.niddk.nih.gov/health-information/kidney-disease/lupus-nephritis
  2. https://www.kidney.org/kidney-topics/lupus-nephritis


Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.