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Study on the Safety of CNTY-101 and Aldesleukin for Patients with Active Autoimmune Diseases: Lupus, Scleroderma, and Myositis

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What is this trial about?

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

This clinical trial is focused on studying certain autoimmune diseases, which are conditions where the body's immune system mistakenly attacks its own tissues. The diseases being studied include Idiopathic Inflammatory Myositis, Systemic Lupus Erythematosus, and Systemic Sclerosis. The trial will test a new treatment called CNTY-101, which is a type of cell therapy. This treatment involves using specially modified cells to help reduce the activity of the immune system that is causing harm. The study will also use a medication called Aldesleukin, which is given as an injection under the skin.

The purpose of the study is to assess the safety of CNTY-101 in people with active autoimmune diseases driven by B-cells, which are a type of immune cell. Participants in the study will receive the treatment through an intravenous infusion, which means it will be delivered directly into the bloodstream. The study will monitor participants over time to see how they respond to the treatment and to check for any side effects.

Throughout the study, participants will be closely observed to ensure their safety and to gather information on how the treatment affects their condition. The study aims to provide valuable insights into the potential benefits and risks of using CNTY-101 for treating these autoimmune diseases. This research could lead to new ways of managing these conditions in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be informed about the trial's purpose, procedures, and potential risks and benefits. You will be asked to provide informed consent, which means you agree to participate after understanding all the information provided.
Step 2
Initial assessment
An initial assessment will be conducted to confirm your eligibility. This may include a review of your medical history, physical examination, and specific tests to ensure you meet the study criteria.
Step 3
Treatment administration
You will receive the study medication, CNTY-101, which is administered as a suspension for intravenous infusion. This means the medication is given directly into your vein through a drip.
Additionally, you may receive aldesleukin through a subcutaneous injection, which is an injection under the skin. The dosage, frequency, and duration of these medications will be explained to you by the study team.
Step 4
Monitoring and follow-up
Throughout the study, regular monitoring will be conducted to assess your health and the effects of the treatment. This may include blood tests, imaging studies, and other assessments as required.
You will have scheduled follow-up visits with the study team to discuss your progress and any side effects you may experience.
Step 5
Completion of the study
At the end of the study, a final assessment will be conducted to evaluate your overall health and the outcomes of the treatment.
You will receive information about any further steps or treatments that may be necessary after the study concludes.

Who can join the trial?

15 criteria

Must have one of the following conditions: Idiopathic inflammatory myositis, Systemic Lupus Erythematosus (SLE), or Systemic Sclerosis (SSc).
Must meet the 2019 classification criteria for Systemic Lupus Erythematosus (SLE).
Must have active muscle inflammation (myositis) shown by muscle biopsy or imaging, or signs of lung disease related to myositis.
Must test positive for at least one specific antibody related to myositis, such as aminoacyl tRNA synthetases, Mi2, MDA5, SAE, SRP, ARS, HMGCR, MJ, or TIF1gamma. If positive for TIF1gamma, a cancer screening must be done before joining the study.
If experiencing muscle weakness due to active myositis, must have muscle weakness as defined by a specific test score (MMT<142) and meet at least two additional criteria related to muscle and overall health.
Must have tried and not responded well to or cannot take glucocorticoids (a type of steroid) and at least two other treatments such as mycophenolate mofetil, ciclosporin A, tacrolimus, methotrexate, rituximab, intravenous immunoglobulins, azathioprine, cyclophosphamide, or JAK inhibitors.
Must test positive for certain antibodies related to lupus, such as anti-dsDNA, anti-histone, anti-nucleosome, or anti-Sm antibodies.
Must have active disease at screening, defined as having severe activity in at least one organ system or moderate activity in at least two organ systems.
Must meet the 2013 classification criteria for Systemic Sclerosis (SSc).
Must have diffuse SSc with positive results for specific antibodies like Scl70, RNA polymerase, Th/To, RP11/12, or U3RNP.
Must show signs of fast disease progression, such as having the disease for less than 7.5 years, a specific skin score, high levels of certain blood markers, or increased skin involvement over 6 months.
Must have tried and not responded well to or cannot take glucocorticoids and at least two other treatments such as mycophenolate mofetil, azathioprine, nintedanib, methotrexate, rituximab, cyclophosphamide, or tocilizumab, and not be eligible for or refuse a specific type of stem cell transplant (AHCT).
Must meet the 2017 classification criteria for probable or definite Idiopathic Inflammatory Myositis (IIM).
Open to both male and female participants.
Participants must be within the age range specified by the study.

Who cannot join the trial?

10 criteria

Patients with any other **autoimmune disease** not specified in the study.
Patients who have had a **serious infection** in the past month.
Patients who are currently receiving treatment with **immunosuppressive drugs** (medications that lower the body's ability to fight infections).
Patients with a history of **cancer** in the past five years, except for certain types of skin cancer.
Patients who have received a **live vaccine** within the last four weeks. A live vaccine contains a version of the living virus that has been weakened so it does not cause serious disease in people with healthy immune systems.
Patients with **uncontrolled high blood pressure** or other significant heart problems.
Patients who are pregnant or breastfeeding.
Patients with a history of **substance abuse** or alcohol dependency in the past year.
Patients who have participated in another clinical trial within the last 30 days.
Patients with known **allergies** to any component of the study medication.

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Verified sites

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Universitaetsklinikum Erlangen AöR
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Erlangen, Germany

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Investigated drugs

CNTY-101 is a type of therapy that uses special cells called NK cells, which are derived from stem cells. These NK cells are designed to target and destroy certain cells in the body that are causing problems. In this trial, the NK cells are being used to help treat autoimmune diseases by targeting and reducing the number of B cells, which are a type of immune cell that can sometimes attack the body's own tissues. This therapy aims to help manage diseases like lupus, scleroderma, and inflammatory muscle diseases by reducing the harmful activity of these B cells.

Aldesleukin

What is already known about the treatment

CNTY-101 – CNTY-101 is administered as an infusion, meaning it is delivered directly into the bloodstream through a vein. This medication is currently being studied in clinical trials and is not yet widely available in medical practice. It is being investigated for its potential to treat autoimmune diseases such as idiopathic inflammatory myositis, systemic lupus erythematosus, and systemic sclerosis. CNTY-101 works by targeting and depleting B cells, which are a type of immune cell that can contribute to these diseases. It belongs to a class of treatments known as cell therapies, specifically using engineered immune cells to fight disease.

Investigated diseases

Idiopathic Inflammatory Myositis
Idiopathic inflammatory myositis is a group of conditions characterized by inflammation of the muscles, leading to muscle weakness. The disease often begins with muscle pain and tenderness, primarily affecting the shoulders, hips, and thighs. Over time, individuals may experience difficulty with activities such as climbing stairs, lifting objects, or even standing up from a seated position. The progression can vary, with some experiencing a gradual worsening of symptoms, while others may have periods of improvement and relapse. In some cases, the skin may also be affected, leading to rashes. The exact cause of the inflammation is unknown, but it is believed to involve an abnormal immune response.
Systemic Lupus Erythematosus
Systemic lupus erythematosus is an autoimmune disease where the immune system mistakenly attacks healthy tissues throughout the body. It can affect various organs, including the skin, joints, kidneys, brain, and other organs. Symptoms often include fatigue, joint pain, skin rashes, and fever, which can fluctuate in severity. The disease can progress with periods of flares, where symptoms worsen, followed by periods of remission. Over time, it may lead to complications in the affected organs, depending on the severity and areas involved. The exact cause is unknown, but genetic and environmental factors are believed to play a role.
Systemic Sclerosis
Systemic sclerosis, also known as scleroderma, is a chronic connective tissue disease characterized by changes in the skin, blood vessels, muscles, and internal organs. The disease often begins with skin thickening and hardening, particularly on the hands and face. As it progresses, it can lead to restricted movement and joint pain due to skin and tissue tightening. Internal organs such as the lungs, heart, and digestive system may also be affected, leading to various complications. The progression and severity can vary widely among individuals. The cause of systemic sclerosis is not fully understood, but it involves an overproduction of collagen and an abnormal immune response.