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Study of Blinatumomab Treatment in Patients with Systemic Lupus Erythematosus, Systemic Sclerosis, or Granulomatosis with Polyangiitis: Safety and Effectiveness Evaluation

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What is this trial about?

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

This clinical study focuses on evaluating a medication called Blinatumomab in treating three different autoimmune conditions: Systemic Lupus Erythematosus (a disease that can affect multiple organs and tissues), Systemic Sclerosis (a condition causing hardening of the skin and internal organs), and Granulomatosis with Polyangiitis (an inflammation of blood vessels that affects various body organs). These conditions are all driven by abnormal activity of B-cells, which are part of the immune system.

The purpose of this research is to determine if Blinatumomab is safe and well-tolerated by patients with these conditions. The medication is given through an intravenous infusion, which means it is delivered directly into a vein. The treatment involves receiving the medicine over a period of 10 days, with a specific daily amount that has been carefully determined for safety.

During the study, patients will be monitored for 52 weeks (one year) to check how their body responds to the treatment. The research team will track any side effects that may occur and measure how well the treatment works by checking blood tests for specific antibodies and evaluating disease symptoms. This is an open-label study, which means all participants will receive the active medication.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment period
You will receive blinatumomab (BLINCYTO) through an intravenous infusion (delivered directly into your vein)
The medication will be given as a solution containing 38.5 micrograms of the active substance
This first phase of treatment will last for 12 weeks
Step 2
Monitoring phase
Your health status will be closely monitored for any side effects that may occur during the first 12 weeks of treatment
Medical staff will track changes in your condition using specific assessment tools depending on your diagnosis:
- For lupus (SLE): Using the Selena SLEDAI measurement
- For systemic sclerosis (SSc): Using the ACR-CRISS score
- For granulomatosis with polyangiitis (GPA): Using the BVAS score
Step 3
Extended observation period
After the initial 12 weeks, monitoring will continue until week 52
During this time, your blood will be tested to measure levels of specific antibodies related to your condition
The medical team will continue to track any changes in your health status
Step 4
Final evaluation
At the end of the 52-week period, your overall response to the treatment will be assessed
The medical team will evaluate the changes in your condition compared to the start of the treatment
This will include reviewing any side effects experienced during the entire study period

Who can join the trial?

12 criteria

Must be at least 18 years old
For patients with Systemic Lupus Erythematosus (SLE):
- Must have been diagnosed with SLE for more than 6 months
- Must have positive blood tests showing:
  - Positive ANA test (level 1:160)
  - Positive anti-dsDNA antibodies above normal range
  - Low levels of complement proteins (C3 or C4)
  - Must have tried and failed treatment with at least two different immunosuppressive medications
  - Must have active disease with a SLEDAI2k score above 6 and specific disease activity measures
  - For patients with Systemic Sclerosis (SSc):
    
    Must have diffuse cutaneous SSc diagnosed using specific medical criteria
    First symptoms (not including Raynaud's) must have started within the last 6 years
    For patients with Granulomatosis with Polyangiitis (GPA):
    
    Must have active or resistant disease
    Must meet Chapel Hill Consensus Conference definition for diagnosis
    Must have positive Pr3-ANCA blood test either currently or in past medical records

Who cannot join the trial?

15 criteria

Age below 18 years or above 65 years
Currently pregnant or breastfeeding women
Active or chronic infections, including hepatitis B, hepatitis C, or HIV
History of severe allergic reactions to biological treatments
Active cancer or history of cancer within the past 5 years
Severe heart conditions or uncontrolled high blood pressure
Severe kidney or liver problems
Recent live vaccinations (within 4 weeks before starting treatment)
Current participation in other clinical trials
History of neurological disorders or seizures
Severe mental health conditions that could affect participation
Substance abuse or alcohol dependency within the past year
Unable to provide informed consent
Major surgery within 8 weeks before starting the study
Any condition that, in the opinion of the study doctor, would make participation unsafe

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Verified sites

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Universitaet Leipzig
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Leipzig, Germany

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Investigated drugs

Blinatumomab is a medication that targets and removes specific B-cells (a type of white blood cell) from the immune system. It's designed to help patients with autoimmune conditions where B-cells are causing inflammation and damage to the body's tissues. This medication works by connecting toxic T-cells to harmful B-cells, leading to the destruction of these problematic B-cells. It's given through an infusion into the bloodstream and is being studied as a potential treatment for several autoimmune diseases, including systemic lupus erythematosus (SLE), systemic sclerosis (SSc), and granulomatous polyangiitis (GPA).

Blinatumomab

What is already known about the treatment

Blinatumomab - A specialized biologic medication administered through intravenous infusion that belongs to the class of bispecific T-cell engager (BiTE) antibodies. This innovative therapeutic agent works by simultaneously binding to CD19 on B cells and CD3 on T cells, creating a bridge that allows T cells to recognize and eliminate abnormal B cells involved in autoimmune diseases like Systemic Lupus Erythematosus, Systemic Sclerosis, and Granulomatous Polyangiitis. Initially approved for certain types of leukemia, it is now being investigated in clinical trials for autoimmune conditions where B cells play a significant pathogenic role, with the goal of modulating the immune response and reducing disease activity.

Investigated diseases

Systemic Lupus Erythematosus
A chronic autoimmune disease where the body's immune system mistakenly attacks healthy tissues and organs. It can affect multiple parts of the body, including joints, skin, kidneys, blood cells, brain, heart, and lungs. The condition typically develops gradually, with periods of increased symptoms (flares) alternating with periods of mild or no symptoms (remission). Most people with lupus experience joint pain, skin rashes particularly on the face, and fatigue.
Systemic Sclerosis
A chronic autoimmune disease characterized by hardening and tightening of the skin and connective tissues. The condition causes an overproduction of collagen, which builds up in the skin and internal organs. It typically begins with Raynaud's phenomenon, where fingers and toes change color in response to cold or stress. The skin gradually becomes thick and tight, particularly on the hands and face.
Granulomatosis with Polyangiitis
A rare autoimmune condition that causes inflammation of blood vessels in various parts of the body. The disease mainly affects the blood vessels in the nose, sinuses, throat, lungs, and kidneys. It develops when the immune system attacks healthy blood vessels, leading to the formation of inflammatory tissue masses called granulomas. Common early signs include persistent runny nose, nasal crusting, and sinus problems.