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A Study of Idecabtagene Vicleucel CAR-T Cell Therapy for Patients with Autoimmune Diseases That Did Not Respond to B Cell Removal Treatment

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What is this trial about?

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

This study involves patients with severe autoimmune diseases that have not responded well to previous treatments that target B cells. The specific conditions being studied are systemic lupus erythematosus, idiopathic inflammatory myopathy, systemic sclerosis, and primary Sjögren's syndrome. Autoimmune diseases occur when the body's immune system mistakenly attacks its own tissues, causing inflammation and damage to various organs. The treatment being tested is idecabtagene vicleucel, also known as Abecma, which is a type of cell therapy where special immune cells called T cells are modified to target a protein called BCMA. This treatment is given as a single intravenous infusion, which means it is delivered directly into a vein.

The purpose of this study is to evaluate the safety of this cell therapy in patients whose autoimmune disease has continued to progress despite receiving treatments that remove B cells from the body. B cells are a type of immune cell that produces antibodies, and in autoimmune diseases, these cells can contribute to the harmful immune response. The study will specifically look at serious side effects including problems with the immune system's response to the treatment, such as cytokine release syndrome and nervous system complications, as well as damage to organs that does not improve quickly.

During the study, patients will receive the modified T cell treatment and will be closely monitored for any side effects and how their body responds to the therapy. The study will track whether patients experience any severe reactions and how long it takes for these reactions to resolve with appropriate medical care. Patients participating in this study will have already tried multiple standard treatments for their autoimmune disease without success, including at least one treatment specifically designed to eliminate B cells from the body.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial enrollment and preparation
After signing the informed consent form and data protection documents, your participation in the trial will begin.
Your medical history will be reviewed to confirm the presence of specific antibodies related to your autoimmune condition.
Various tests will be performed to assess your organ function, including kidney function (measured as GFR, which indicates how well your kidneys filter waste), liver function (measured through blood tests called AST and ALT), heart function (including ejection fraction, which measures how well your heart pumps blood), and lung function (measured through breathing tests called FV and DLCO).
Step 2
Disease activity assessment
Your disease activity will be evaluated using specific scoring systems appropriate for your autoimmune condition.
This assessment will confirm that your disease remains active despite previous treatments with medications that target B cells (a type of immune cell).
Your treatment history will be reviewed to verify that you have tried at least two standard treatments without sufficient improvement or have experienced disease recurrence.
Additional tests such as blood work, imaging studies, or biopsies may be performed depending on your specific autoimmune condition.
Step 3
Cell collection procedure
Your own immune cells will be collected through a process that separates specific cells from your blood.
These collected cells will be sent to a specialized facility where they will be modified in a laboratory to create the treatment product called idecabtagene vicleucel.
The manufacturing process will take several weeks while your cells are transformed into CAR T-cells, which are specially engineered cells designed to target specific proteins involved in your autoimmune disease.
Step 4
Preparation treatment phase
Before receiving the modified cells, you may receive preparatory medications to help your body accept the treatment.
This preparation phase is designed to create an optimal environment in your body for the CAR T-cells to work effectively.
Step 5
CAR T-cell infusion
You will receive the treatment called Abecma (idecabtagene vicleucel) as a single infusion into your vein.
The dose will contain between 260 to 500 million cells, administered as a liquid preparation given through intravenous infusion.
The infusion will be performed in a medical facility equipped to monitor and manage any potential reactions.
Step 6
Immediate monitoring period
Following the infusion, you will be closely monitored for potential side effects.
Medical staff will watch for signs of cytokine release syndrome (CRS), a condition where your immune system becomes very active and may cause fever, low blood pressure, and difficulty breathing.
You will also be monitored for immune effector cell-associated neurotoxicity syndrome (ICANS), which can affect your nervous system and cause confusion, difficulty speaking, or changes in consciousness.
Any side effects that occur will be treated promptly according to established medical protocols.
Monitoring will continue until any significant side effects resolve to mild levels or disappear completely.
Step 7
Follow-up assessment period
Regular follow-up visits will be scheduled to assess your response to the treatment and monitor for any delayed side effects.
Blood tests and other evaluations will be performed to measure changes in your disease activity.
Your organ function will be checked periodically to ensure your kidneys, liver, heart, and lungs continue to work properly.
The effectiveness of the treatment will be evaluated based on improvements in your specific autoimmune condition symptoms and laboratory findings.
Long-term monitoring will continue as specified in the trial protocol to track your progress and safety.

Who can join the trial?

12 criteria

You must understand and voluntarily sign a consent form, including written permission for your data to be protected and used
You must be 18 years of age or older at the time you agree to join the study
Your kidneys must work well enough, with a GFR (a measure of how well your kidneys filter waste) greater than 30
Your liver must work properly, with certain enzyme levels not too high, unless the high levels are caused by muscle inflammation or lupus-related liver problems. You cannot have severe liver disease called Child Pugh C
Your heart must work well enough, with no severe heart failure and your heart must pump blood effectively with an ejection fraction (a measure of how much blood your heart pumps with each beat) of at least 45 percent
Your lungs must work well enough, with lung function tests showing at least 35 percent of normal capacity
You must have one of the following autoimmune diseases: SLE (systemic lupus erythematosus, also called lupus), IIM (inflammatory muscle disease), SSc (systemic sclerosis, also called scleroderma), or PSS (primary Sjögren's syndrome)
If you have SLE, you must meet official classification criteria and have certain antibodies in your blood. You must have active disease affecting at least one major organ severely or two organs moderately. Your disease must not have responded well to, or came back after, at least two previous treatments
If you have IIM, you must meet official classification criteria and have specific muscle disease antibodies in your blood. You must have had adequate cancer screening. You must have signs of active muscle inflammation seen on biopsy or imaging, or lung disease related to your condition, along with muscle weakness and other symptoms. Your disease must not have responded well to, or came back after, at least two previous treatments
If you have SSc, you must meet official classification criteria with widespread skin involvement and have certain antibodies or a tissue sample confirming the disease. Your disease must be progressing quickly within 5 years of first symptoms, with a skin thickness score of at least 15 and worsening within 6 months. You must have high inflammation markers in your blood. Your disease must not have responded well to, or came back after, at least two previous treatments, and you must not be eligible for or must refuse stem cell transplant
If you have PSS, you must meet official classification criteria and have specific antibodies in your blood or a tissue sample confirming the disease. You must have active disease with a disease activity score greater than 6 and have low complement levels or high inflammation markers in your blood. Your disease must not have responded well to, or came back after, at least two previous treatments
Your disease must not have responded well to, or came back after, at least one treatment that targets and removes B cells (a type of immune cell), such as rituximab or similar medications

Who cannot join the trial?

6 criteria

The study has not provided specific exclusion criteria in the available information. This means the detailed list of reasons why patients cannot participate has not been included in the trial data.
Generally, clinical trials may exclude patients based on factors such as other serious medical conditions, certain medications, pregnancy, or laboratory test results that fall outside acceptable ranges.
If you have a progressive systemic autoimmune disease (a long-term condition where the immune system attacks the body's own tissues and gets worse over time) that has not responded to B cell depletion (a treatment that removes certain immune cells called B cells), you may be eligible for this study, but specific exclusion details are not available.
The study is designed for adults and elderly patients with conditions like SLE (systemic lupus erythematosus, an autoimmune disease affecting multiple organs), IIM (idiopathic inflammatory myopathies, diseases causing muscle inflammation), SSc (systemic sclerosis, a disease causing hardening of skin and organs), and PSS (progressive systemic sclerosis, another term for systemic sclerosis).
Both male and female patients may be considered for participation.
The trial involves a vulnerable population, meaning it includes people who may need special protection during research.

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Universitaetsklinikum Erlangen AöR
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Erlangen, Germany

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Investigated drugs

Ide-cel is a type of CAR-T cell therapy, which is a treatment that uses your own immune cells that have been modified in a laboratory. These modified cells are designed to target and destroy specific cells in your body that are contributing to autoimmune disease. In this trial, ide-cel targets a protein called BCMA, which is found on certain immune cells. The treatment is being tested for people with autoimmune diseases that have not responded to other treatments that reduce B cells in the body.

Idecabtagene Vicleucel

What is already known about the treatment

Idecabtagene vicleucel – Idecabtagene vicleucel is a type of CAR-T cell therapy given as a one-time infusion into a vein, where a patient's own immune cells are collected, modified in a laboratory to target specific disease-causing cells, and then returned to the patient's body. This treatment is currently being studied in clinical trials for severe autoimmune diseases that have not responded to standard treatments that eliminate B cells, including systemic lupus erythematosus, inflammatory muscle diseases, systemic sclerosis, and primary Sjögren's syndrome. The medication works by engineering the patient's T cells to recognize and destroy cells that produce a protein called BCMA, which is found on certain immune cells involved in autoimmune responses. It belongs to a class of medications called chimeric antigen receptor T-cell therapies, which represent an advanced form of personalized immunotherapy.

Investigated diseases

Systemic Lupus Erythematosus
Systemic lupus erythematosus is a long-term autoimmune disease where the immune system mistakenly attacks healthy tissues throughout the body. It can affect multiple organs including the skin, joints, kidneys, heart, and lungs. The disease typically progresses in cycles with periods of illness called flares and periods of remission when symptoms improve or disappear. Common symptoms include extreme fatigue, joint pain and swelling, skin rashes especially on the face, and fever. The severity and pattern of symptoms vary greatly from person to person. In some cases, the disease may become resistant to standard treatments that target B cells, a type of immune cell.
Idiopathic Inflammatory Myopathy
Idiopathic inflammatory myopathy is a group of rare autoimmune diseases that cause chronic muscle inflammation and weakness. The immune system attacks the muscle fibers, leading to progressive muscle damage over time. The main symptom is muscle weakness that typically affects the muscles closest to the trunk of the body, such as those in the hips, thighs, shoulders, and neck. Patients may experience difficulty climbing stairs, lifting objects, or rising from a seated position. Some forms also affect the skin, lungs, and other organs. The disease progresses gradually, and muscle strength continues to decline without appropriate management.
Systemic Sclerosis
Systemic sclerosis is a chronic autoimmune disease characterized by hardening and tightening of the skin and connective tissues. The disease occurs when the body produces too much collagen, causing tissue to become thick and fibrous. It can affect only the skin or spread to internal organs such as the lungs, heart, kidneys, and digestive system. Early symptoms often include fingers and toes that turn white or blue in response to cold or stress, followed by skin thickening. The disease progresses slowly over months or years, with the extent and speed varying among individuals. Internal organ involvement can develop as the disease advances.
Primary Sjögren Syndrome
Primary Sjögren syndrome is a chronic autoimmune disease that primarily affects the glands that produce moisture in the body. The immune system attacks the tear and saliva glands, leading to decreased production of tears and saliva. The main symptoms are dry eyes and dry mouth, which can cause difficulty swallowing, speaking, and increased dental cavities. The disease can also affect other parts of the body including joints, skin, lungs, kidneys, and blood vessels. Symptoms typically develop gradually and worsen over time. Some patients may experience periods where symptoms are more severe followed by periods of improvement.