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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 like cell therapy that work differently in the body in how they target autoimmune diseases could potentially slow or stop disease progression. The three autoimmune diseases being researched as part of this study are: systemic sclerosis (SSc or scleroderma), idiopathic inflammatory myopathy (IIM or myositis), and ANCA-associated vasculitis (AAV or polyangiitis).

SSc,3 also known as scleroderma, is a chronic autoimmune disease that affects the connective tissues throughout the body, leading to thickening and hardening of the skin and internal organs. Subtypes include limited cutaneous SSc and diffuse cutaneous SSc.

IIM,4 also known as idiopathic inflammatory myopathy, refers to a subgroup of myositis conditions charactered by inflamed muscle tissue due to an autoimmune response in the body caused by unknown external factors (i.e., idiopathic). The five main types of IIM are polymyositis, dermatomyositis inclusion body myositis, immune-mediated necrotizing myopathy and Antisynthetase Syndrome.

AAV,5 also known as ANCA-associated vasculitis, is a serious autoimmune disease where the body’s own immune system attacks the blood vessels, which can cause nose bleeds, bloody coughs, or damage to nerves or vital organs. There are three AAV subtypes: granulomatosis with polyangiitis, microscopic polyangiitis, and eosinophilic granulomatosis with polyangiitis.

  1. autoimmune.org/disease-information ↵
  2. autoimmuneinstitute.org/articles/outbursts-in-autoimmunity-disease-flare-ups ↵
  3. hopkinsmedicine.org/health/conditions-and-diseases/scleroderma/types-of-scleroderma ↵
  4. pubmed.ncbi.nlm.nih.gov/29079590 ↵
  5. sciencedirect.com/science/article/pii/S1470211824023157 ↵

About the Ntrust-2 study

In this study, an investigational cell therapy called NKX019 will be tested in adults living with systemic sclerosis (SSc or scleroderma), idiopathic inflammatory myopathy (IIM or myositis), or ANCA-associated vasculitis (AAV or polyangiitis). An investigational cell therapy is a therapy that has been tested in research laboratories and cleared by applicable health and regulatory authorities for evaluating in people. Researchers are still learning about the safety and effectiveness of NKX019.

Currently, steroids are commonly prescribed for these conditions to reduce symptoms that arise when the body’s immune system mistakenly attacks healthy tissue and vital organs. However, steroids do not treat the actual cause of the condition, and symptoms often return.

The goal of this study is to test the investigational cell therapy’s ability to safely target the underlying cause of these diseases, rather than only addressing the symptoms after they appear.

The purpose of this study is to:

  • Determine if NKX019 is safe to use and how well it is tolerated in the body
  • See if other medications like steroids can be stopped because SSc, IIM, or AAV is controlled
  • See how the body processes NKX019 by measuring the NKX019 levels in the blood

Do I qualify?

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 study-related travel, lodging, childcare, and meals may be covered when you and your care partner go to the study clinic for required visits.

Compensation for you and your care partner may also be available to offset other potential barriers.

Who can participate

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

  • Are 18 to 70 years old
  • Have been diagnosed with systemic sclerosis (SSc or scleroderma), idiopathic inflammatory myopathy (IIM or myositis), or ANCA-associated vasculitis (AAV or polyangiitis)
  • Have received prior autoimmune disease treatments that may have not worked well for you

There are additional requirements which the study team will review with you during your first visit to the clinic.

Prescreener entry

Step 1 of 4

Welcome to the Ntrust-2 study prescreener. In this study, an investigational cell therapy called NKX019 will be tested in adults living with systemic sclerosis (SSc or scleroderma), idiopathic inflammatory myopathy (IIM or myositis), or ANCA-associated vasculitis (AAV or polyangiitis).

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

First, we need your consent to process and share any information you provide as part of this prescreener.

The information collected in this prescreener is personal. Protecting this information is a top priority for us. This is why we have a detailed privacy policy that includes making certain you understand how we will handle the information you provide here. Your participation in this prescreener process is voluntary and you can withdraw your consent at any time as described in the privacy policy. The only consequence of withdrawing your consent will be that you will not be able to continue participating in the prescreener process. Please note that our role in the study is limited to screening potentially eligible candidates only.

Are you located in the United States?

e.g., 12345

Are you between 18 and 70 years of age?

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What is NKX019?

NKX019 is an investigational cell therapy being studied for systemic sclerosis (SSc or scleroderma), idiopathic inflammatory myopathy (IIM or myositis), and ANCA-associated vasculitis (AAV or polyangiitis). It is designed to target and remove the cells that may trigger harmful antibodies, which attack the body’s own tissues in these conditions. 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 SSc, IIM and AAV may also be eliminated. This could potentially slow or stop progression of the disease.

NKX019 is made from natural killer (NK) cells, which are white blood cells and a normal part of everyone’s immune system. For this study, NK cells are collected from healthy donors and specially processed into NKX019. NKX019 is made from white blood cells called natural killer (NK) cells. NK cells are the immune system’s first responders and possess a unique, natural ability to target and kill disease-causing cells. NK cells are a normal part of the immune system and are present in everyone. The NK cells used in NKX019 are collected from healthy donors and then processed for use in NK cell therapy.

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 for at least 24 hours to be watched for side effects
  • Stay within a 60-minute trip of the study clinic for approximately four 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.

Frequently asked questions (FAQs)

  • Clinical studies, also called clinical trials, help determine if investigational medications are safe to use and work to improve the health of people. Before any investigational cell therapy 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 therapy 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.

  • To make an educated and informed decision about whether study participation is right for you, you will be provided an informed consent form. 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. 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 obligate you to join the study.

    Do I qualify?

  • 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, as some medications may not be allowed while you are in the study. 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 study-related travel, lodging, childcare, and meals for you and your care partner may be covered when you go to the study clinic for required visits. Compensation for you and your care partner may also be available to offset other potential burdens. 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 care partners 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 care partners 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 cell therapy. The safety of this therapy, 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 (SSc or scleroderma), idiopathic inflammatory myopathy (IIM or myositis), ANCA-associated vasculitis (AAV or polyangiitis), 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 is voluntary. If you choose to participate for the full duration of the study, it will help researchers learn more about NKX019 and long-term effects that it may have on systemic sclerosis (SSc or scleroderma), idiopathic inflammatory myopathy (IIM or myositis), and ANCA-associated vasculitis (AAV or polyangiitis). However, you can stop at any time and for any reason. There will be no negative impact on the medical care you receive outside the study.

  • Nkarta, Inc., is a biotechnology company based in South San Francisco advancing the development of natural killer (NK) cell therapies for autoimmune diseases. The NK cells are collected from healthy donors and engineered to target and eliminate other cells that can lead to autoimmune disease.

Find a study site near you

Use the map below to find a nearby study site and see where the Ntrust-2 study is enrolling.