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About autoimmune diseases

The role of the immune system is to protect the body. With autoimmune diseases, however, some immune cells make antibodies that attack the body’s own tissues. This can cause inflammation in many parts of the body, leading to a wide range of possible symptoms.

There are more than 100 autoimmune diseases.1 Current treatments can help manage symptoms, but people still experience flare-ups—periods when symptoms worsen dramatically or new symptoms arise.2 Treatments that work differently and prove to be effective at targeting autoimmune diseases could potentially slow or stop disease progression.

  1. https://autoimmune.org/disease-information/↵
  2. https://www.autoimmuneinstitute.org/articles/outbursts-in-autoimmunity-disease-flare-ups/↵

About the Ntrust-2 study

In this study, an investigational product called NKX019 will be tested in adults living with systemic sclerosis, inflammatory myopathy, or ANCA-associated vasculitis. An investigational product is a medical product that has been tested in research laboratories and cleared by applicable health and regulatory authorities for evaluating in people. However, the safety of the product and how effective it is have not been established. The purpose of this study is to:

  • Determine if NKX019 is safe to use and how well it is tolerated.
  • Determine if NKX019 can control systemic sclerosis, inflammatory myopathy, or ANCA-associated vasculitis.
  • See if other medications like steroids can be stopped because systemic sclerosis, inflammatory myopathy, or ANCA-associated vasculitis is controlled.
  • See how the body processes NKX019 by measuring the NKX019 levels in the blood.

Supporting study participants

Taking part in a clinical study can present challenges, such as travel and other costs. In the Ntrust-2 study, costs for travel, lodging, and meals will be covered when you and your care partner go to the study clinic for required visits. Compensation for study participation may also be available to offset other potential barriers.

What is NKX019?

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

NKX019 is made from white blood cells called natural killer (NK) cells. NK cells are a normal part of the immune system and are present in everyone. The source cells used in NKX019 are collected from healthy donors and then processed.

What tests and assessments are required?

Your Ntrust-2 study doctor and team will explain these to you and answer any questions you may have about them. You may also need to have some tests or assessments not shown here.

Physical exam/vital signs

Heart tests (electrocardiograms and echocardiograms)

Discussions with your study doctor and team‡

Pregnancy test (if applicable)

Collection of blood samples

Collection of urine samples

Assessments of your autoimmune disease

Intravenous infusions

Surveys

‡ Discussions include topics such as changes in your health, side effects, and other medications you may take.

What will be expected of me during the study?

Studies like Ntrust-2 rely on the cooperation of volunteer participants. While you are in this study, you will need to:

  • Follow instructions from your study doctor and team.
  • Come to your study visits.
  • Complete the required tests and assessments.
  • Receive study infusions as scheduled.
  • Stay after each infusion of NKX019 to be watched for side effects.
  • Stay within a 60-minute trip of the study clinic for approximately 4 weeks.
  • Complete self-monitoring activities.
  • Report any changes in your health.

You will have the full support of your study doctor and team. They will answer any questions you may have about what is expected of you. The study may also include additional requirements and restrictions as needed for your safety.

Who can participate

You may be eligible to participate in this study if you:

  • Are 18 to 65 years old.
  • Have been diagnosed with systemic sclerosis, inflammatory myopathy, or ANCA-associated vasculitis.
  • Have received prior autoimmune disease treatments that may have not worked well for you.

You will also need to meet additional requirements. The study team will review these with you during your first visit to the clinic.

Prescreener entry

Step 1 of 13

Welcome to the Ntrust-2 study prescreener. In this study, an investigational product called NKX019 will be tested in adults living with systemic sclerosis, inflammatory myopathy, or ANCA-associated vasculitis.

Based on your answers in this prescreener, you may be referred to a study site. If you answer these questions and are referred to a study site, that does not mean you have to join the study.

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Frequently asked questions

  • Clinical studies, also called clinical trials, help determine if investigational products are safe to use and work to improve the health of people. Before any investigational product can be approved and made available to the public, it must go through several phases of clinical research and governmental review.

  • People participate in clinical studies for a variety of reasons. Some participate because they want the chance to receive an investigational product being evaluated as a potential treatment. Others might want to learn more about their disease or health condition. They may want to play a more active role in their healthcare. The hope that they might help others living with the same disease in the future can motivate people as well. Each person can have their own reasons based on their unique health journey.

  • Studies follow specific standards and are closely regulated to help protect the participants. Studies are reviewed by independent groups called Institutional Review Boards (IRBs) or Ethics Committees (ECs) before they can begin. The role of these groups is to ensure that the rights, safety, and well-being of study participants will be protected. Each study also includes strict safety measures and follows a written plan called a protocol. The protocol is designed to make sure study activities will be completed correctly and safely.

  • You will be given an informed consent form to help you decide if this study may be right for you. This document explains the study purpose, tests and assessments, and potential benefits and risks. You will need to read the consent form carefully. Your Ntrust-2 study team will review it with you and answer any questions you may have. You can also talk with your healthcare providers about the study.

  • Each clinical study includes people who meet specific requirements. These are known as eligibility criteria. Some examples are age, diagnosis, and prior treatments. If you sign the informed consent form, your Ntrust-2 study team will review your medical history and conduct tests to learn more about your overall health and your autoimmune disease. Your study doctor will review the results to determine if you meet the eligibility criteria.

    If you are interested in joining the Ntrust-2 study, you can start by answering a few questions in the study prescreener. Answering these questions does not mean you have to join the study.

    Can I participate?

  • Your Ntrust-2 study doctor and team will provide study-related care. This will include study infusions, tests, and assessments. The study doctor and team have expertise in caring for people living with autoimmune diseases. They understand the daily challenges of these diseases. You will continue to receive healthcare not related to the study from providers of your choosing.

  • You can visit any healthcare provider to meet your needs while you are in this study. You will need to let your study team know if you will be going to another provider and if any medications are prescribed. You should also let other providers you visit know that you are in a clinical study.

  • You can ask questions at any point during the study. If you are ever unsure about what you need to do or what will happen, you can ask your study doctor and team. They will want to make sure you understand all study activities, including those you will need to complete at home. It is also important that you feel comfortable with the tests and assessments that will be done.

  • Study infusions, tests, and assessments will be provided at no cost to you. Costs for travel, lodging, and meals will be covered when you and your care partner go to the study clinic for required visits. Compensation for study participation may also be available to offset other potential barriers. You can ask your Ntrust-2 study team about all the support that may be available.

  • Before you decide if you want to join the Ntrust-2 study, you may want to talk with your family members or other caregivers about the study. Together, you can decide if participating in this study may be right for you. If you choose to join the study, family members and other caregivers can provide support in many ways. For example, they can bring you to visits, ask questions, and take notes. They can also help you keep track of your visits, prepare for visits, and complete study activities at home as needed.

  • There is no promise of direct medical benefit to you if you join this study. NKX019 is an investigational product. The safety of this product and how effective it is have not been established. The visits with your study team may give you more insight into your overall health and your autoimmune disease. Additionally, what researchers learn about systemic sclerosis, inflammatory myopathy, ANCA-associated vasculitis, and NKX019 may help people living with these diseases in the future.

  • As with any clinical study, participating in the Ntrust-2 study comes with potential risks and side effects. The informed consent form that you will be given before you decide if you want to join this study describes the known risks and side effects. The study doctor and team will review these with you and answer your questions. They will watch you closely for signs of any side effects and address them as needed. It is important to know that there may also be risks and side effects that are not yet known.

  • Participating in this study for the full time will help researchers learn more about NKX019 and long-term effects that it may have on autoimmune diseases. However, you can stop at any time, for any reason. There will be no negative impact on the medical care you receive outside the study.

Locations

Click on the map below to find a study site located near you.