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Study on the Safety of MB-CART19.1 for Patients with Active Systemic Lupus Erythematosus, Systemic Sclerosis, or Dermatomyositis/Polymyositis

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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 the effects of a new treatment for certain autoimmune diseases. The diseases being studied are Systemic Lupus Erythematosus, Systemic Sclerosis, and Dermatomyositis/Polymyositis. These are conditions where the body's immune system mistakenly attacks its own tissues. The treatment being tested is called MB-CART19.1, which involves using a patient's own T-cells that have been modified to better target and fight the disease. These T-cells are changed using a special process involving a lentiviral vector to express a chimeric antigen receptor directed against a protein called CD19.

The purpose of the study is to assess the safety of this new treatment in patients with active forms of these autoimmune diseases. Participants in the study will receive the treatment through an infusion, which means it will be administered directly into the bloodstream. The study will monitor participants for any side effects or reactions to the treatment, particularly focusing on any signs of Cytokine Release Syndrome and CAR T cell Associated Neurotoxicity Syndrome within the first few weeks after receiving the treatment.

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 of this innovative therapy for managing these challenging autoimmune diseases. The trial is expected to continue until 2026, allowing researchers to collect comprehensive data on the treatment's safety and effects over time.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and current health status.
Eligibility criteria include being 18 years or older, having a diagnosis of systemic sclerosis, dermatomyositis, polymyositis, or systemic lupus erythematosus, and meeting specific health and treatment history requirements.
Step 2
Preparation for treatment
Before receiving the treatment, a series of tests and evaluations are performed to ensure safety and readiness. This may include blood tests, imaging studies, and other assessments as needed.
Step 3
Treatment administration
The treatment involves the infusion of MB-CART19.1, which consists of modified T-cells designed to target specific cells in the body. This is administered intravenously.
The infusion process is monitored closely to manage any immediate reactions or side effects.
Step 4
Post-treatment monitoring
Following the infusion, monitoring is conducted to observe any side effects or reactions. This includes checking for symptoms of cytokine release syndrome and neurotoxicity, which are potential side effects of the treatment.
Monitoring is particularly intensive during the first four weeks after treatment.
Step 5
Follow-up assessments
Regular follow-up visits are scheduled to assess the ongoing effects of the treatment and to ensure the patient's health and safety.
These assessments may include physical examinations, laboratory tests, and questionnaires about symptoms and quality of life.
Step 6
Long-term follow-up
Long-term follow-up is conducted to evaluate the lasting effects of the treatment and to gather data on its safety and effectiveness over time.
This phase continues until the estimated end date of the trial in May 2026.

Who can join the trial?

18 criteria

Must be an adult aged 18 years or older at the time of giving consent.
For those with **Systemic Sclerosis (SSc)**: Must meet the 2013 classification criteria for SSc.
For SSc: Must test positive for at least one specific SSc marker, such as certain antibodies, either during screening or from past medical records.
For SSc: Must show signs of fast disease progression, like having the disease for 7 years or less, a specific skin score between 10-35, or increased inflammation markers in the blood.
For SSc: Must have not responded well or cannot tolerate at least two specific treatments like mycophenolate mofetil or methotrexate.
For those with **Dermatomyositis/Polymyositis (DM/PM)**: Must meet the 2017 classification criteria for probable or definite DM or PM.
For DM/PM: Must have active muscle inflammation shown by a muscle biopsy or MRI, or signs of lung disease related to DM/PM.
For DM/PM: Must test positive for at least one specific myositis antibody during screening or from past medical records.
For DM/PM: Must have muscle weakness and meet at least two other specific criteria, like a certain level of muscle enzyme or activity level.
For DM/PM: Must have not responded well or cannot tolerate glucocorticoids and at least two other treatments like azathioprine or methotrexate.
Must understand and voluntarily sign an informed consent form, including consent for data protection.
Must have adequate kidney, liver, heart, and lung function.
Male participants, unless surgically sterile, must agree to use two methods of contraception during the trial and for 12 months after treatment.
Females who can have children must have a negative pregnancy test at screening and agree to use a highly effective contraceptive method during the trial and for 12 months after treatment.
For those with **Systemic Lupus Erythematosus (SLE)**: Must meet the 2019 classification criteria for SLE.
For SLE: Must test positive for specific antibodies like anti-dsDNA during screening or from past medical records.
For SLE: Must have active disease at screening, defined by a specific score indicating severe or moderate disease activity.
For SLE: Must have not responded well or cannot tolerate glucocorticoids and at least two other treatments like azathioprine or rituximab.

Who cannot join the trial?

3 criteria

Patients with **Dermatomyositis/Polymyositis** cannot participate. These are conditions that cause muscle weakness and skin rashes.
Patients with **Systemic Sclerosis** cannot participate. This is a condition that causes hardening and tightening of the skin and connective tissues.
Patients with **Systemic Lupus Erythematosus** cannot participate. This is a condition where the immune system attacks its own tissues, causing inflammation.

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Universitaetsklinikum Erlangen AöR
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Erlangen, Germany

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Investigated drugs

Anti-CD19 CAR T Cell Therapy is a treatment that uses specially modified cells from the patient's own immune system. These cells are changed in the lab to better recognize and attack certain cells in the body that are causing the autoimmune disease. This therapy is being tested to see if it is safe for people with autoimmune diseases like systemic lupus erythematosus (SLE), systemic sclerosis (SSc), and dermatomyositis/polymyositis (DM/PM).

Autologous T-Cells Transduced With Lentiviral Vector Expressing A Chimeric Antigen Receptor Directed Against Cd19

What is already known about the treatment

Anti-CD19 CAR T Cell Therapy – This medication is administered through an intravenous infusion, where specially modified T cells are introduced into the patient's bloodstream. It is currently being studied in clinical trials for its potential to treat autoimmune diseases such as Systemic Lupus Erythematosus, Systemic Sclerosis, and Dermatomyositis/Polymyositis. The therapy works by targeting and eliminating B cells that contribute to these autoimmune conditions. It is classified as a form of immunotherapy, specifically a type of chimeric antigen receptor (CAR) T cell therapy, which is a cutting-edge approach in treating diseases driven by B cells.

Investigated diseases

Dermatomyositis
This is an inflammatory disease characterized by muscle weakness and a distinctive skin rash. It primarily affects the muscles and skin, leading to muscle inflammation and damage. The skin rash often appears as a reddish or purplish discoloration, typically on the face, knuckles, and other areas. Muscle weakness can progress over weeks or months, affecting the ability to perform daily activities. The exact cause is unknown, but it is believed to involve an autoimmune response.
Polymyositis
This is a chronic inflammatory disease that causes muscle weakness, primarily affecting the muscles closest to the trunk of the body. It involves inflammation of the muscle fibers, leading to muscle damage and weakness. The condition progresses gradually, often affecting both sides of the body. Individuals may experience difficulty climbing stairs, lifting objects, or rising from a seated position. The cause is not fully understood, but it is thought to be related to an abnormal immune response.
Systemic Sclerosis
Also known as scleroderma, this is a connective tissue disease characterized by changes in the skin, blood vessels, muscles, and internal organs. It involves the overproduction and accumulation of collagen, leading to skin thickening and hardening. The disease can progress to affect internal organs, such as the lungs, heart, and kidneys. Symptoms vary widely and can include skin tightness, joint pain, and digestive issues. The exact cause is unknown, but it is believed to involve an autoimmune component.
Systemic Lupus Erythematosus
This is a chronic autoimmune disease that can affect various parts of the body, including the skin, joints, kidneys, and brain. It is characterized by periods of illness, called flares, and periods of remission. Symptoms can vary widely and may include fatigue, joint pain, skin rashes, and fever. The disease progresses unpredictably, with symptoms ranging from mild to severe. The cause is not fully understood, but it involves an abnormal immune response attacking healthy tissues.