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A Study of Obecabtagene Autoleucel for Patients with Severe Lupus and Active Kidney Inflammation Not Responding to Standard 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 people with Systemic Lupus Erythematosus with active lupus nephritis. Systemic Lupus Erythematosus is a long-term condition where the body's defense system mistakenly attacks its own tissues and organs, causing inflammation and damage in various parts of the body. Lupus nephritis is a serious complication where this attack affects the kidneys, causing inflammation and potentially reducing their ability to filter waste from the blood. The treatment being tested is called obecabtagene autoleucel, also known by its code name AUTO1. This is a specialized treatment made from the patient's own immune cells called T cells, which are collected and modified in a laboratory to target specific proteins found on certain immune cells. Before receiving this treatment, participants will be given two medications to prepare their body: cyclophosphamide and fludarabine phosphate. These medications help reduce the number of existing immune cells to make room for the modified cells.

The purpose of this study is to evaluate how well obecabtagene autoleucel works and how safe it is for people with severe lupus that has not responded well to other treatments and who have active kidney involvement. The study will measure whether the treatment can help improve kidney function by looking at protein levels in urine and the rate at which the kidneys filter blood, and whether these improvements can be achieved without needing additional rescue treatments.

During the study, participants will first undergo a screening process to determine if they are suitable. If eligible, they will have their T cells collected through a process where blood is drawn from the body, the needed cells are separated, and the remaining blood is returned. These cells are then sent to a facility where they are modified and grown. Before receiving the modified cells back through an infusion into a vein, participants will receive the two preparatory medications over several days. After the infusion of the modified cells, participants will be monitored closely for side effects and will have regular follow-up visits for up to two years. Throughout this time, various tests will be performed to check kidney function, measure disease activity, assess quality of life, monitor for side effects, and track how long the modified cells remain in the body and how they affect the immune system.

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
Lymphodepletion chemotherapy preparation
Before receiving the main treatment, your body will be prepared through a process called lymphodepletion. This means that certain cells in your immune system will be reduced to make room for the new treatment.
You will receive two chemotherapy medications: Cyclophosphamide and Fludarabine Phosphate.
Both medications will be given through a vein, which is called intravenous infusion.
This preparation phase occurs on Day -6, which is six days before the main treatment infusion.
Step 2
Main treatment infusion
You will receive the main treatment called obecabtagene autoleucel, also referred to as obe-cel or AUTO1.
This treatment consists of your own immune cells that have been modified in a laboratory to target specific proteins on certain cells in your body.
The treatment will be given through a vein as an intravenous infusion.
This infusion takes place on Day 0, which marks the start of your treatment timeline.
Step 3
Early monitoring period
After receiving the treatment, you will be monitored closely during the first month.
Blood samples will be collected at 9 different time points between Day 1 and Day 28 to check for the presence of the modified cells in your blood.
Additional blood tests will be performed on Day 1 and Day 28 to measure certain immune cells called B cells.
On Day 28, blood samples will also be taken to measure antibodies and proteins related to your condition, including tests for inflammation markers.
Step 4
Month 2 to Month 3 follow-up
At Month 2 and Month 3, you will have follow-up visits.
Blood samples will be collected to continue monitoring the modified cells in your bloodstream.
At Month 3, additional blood tests will measure your antibody levels and inflammation markers.
These visits help assess how your body is responding to the treatment.
Step 5
Month 6 primary assessment
At Month 6, an important assessment will be conducted to evaluate how well the treatment is working.
Your kidney function will be measured through urine and blood tests, including a urine protein creatinine ratio and an estimated glomerular filtration rate, which shows how well your kidneys are filtering waste.
Your overall disease activity will be assessed using standardized scoring systems.
Blood tests will continue to monitor antibodies and inflammation markers.
Step 6
Month 6 to Month 12 regular monitoring
From Month 6 through Month 12, you will have follow-up visits every three months.
At each visit, blood samples will be collected to monitor the modified cells and measure antibody levels and inflammation markers.
Your disease activity, kidney function, and overall health will be assessed at each visit.
Questionnaires about your fatigue levels, daily activities, and quality of life will be completed.
Step 7
Month 12 to Month 24 extended follow-up
From Month 12 through Month 24, follow-up visits will occur every six months.
Blood samples will continue to be collected to monitor the modified cells and measure B cells in your blood.
Tests for antibodies and inflammation markers will also be performed at these visits.
Your kidney function, disease activity, and quality of life will continue to be assessed.
The study period ends at Month 24, which is two years after receiving the treatment infusion.

Who can join the trial?

7 criteria

You must have a diagnosis of Systemic Lupus Erythematosus, which is a condition where the body's defense system attacks its own tissues, confirmed by meeting the 2019 classification criteria set by international medical organizations
You must test positive for at least one of the following autoantibodies, which are proteins made by your immune system that attack your own body: antinuclear antibodies at a level of 1:80 or higher, or anti-dsDNA antibodies, or anti-Smith antibodies
You must have severe, active Systemic Lupus Erythematosus, meaning your condition is currently causing significant symptoms and problems in your body
You must have severe active lupus nephritis, which means your lupus is causing serious inflammation and damage to your kidneys
You must have refractory Systemic Lupus Erythematosus, which means your condition has not improved with previous standard treatments
You must be an adult, aged 18 years or older
Both male and female participants can take part in this study

Who cannot join the trial?

3 criteria

The source data does not provide specific exclusion criteria for this clinical trial
Exclusion criteria are reasons why a person cannot take part in a research study, but this information is not available in the provided documents
To learn what conditions or situations would prevent participation in this study, you would need to review the complete study protocol or contact information that is not included here

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Investigated drugs

Obecabtagene autoleucel (also called obe-cel) is a personalized cell therapy made from a patient's own immune cells. Doctors collect certain white blood cells from the patient's body and modify them in a laboratory to help them recognize and attack specific disease-causing cells. Once prepared, these modified cells are given back to the patient through an infusion into a vein. This treatment is being tested to see if it can help people with severe lupus, particularly when the disease affects the kidneys and has not responded well to other treatments.

What is already known about the treatment

Obecabtagene Autoleucel – This is an experimental cell therapy currently being studied in clinical trials for the treatment of severe, treatment-resistant systemic lupus erythematosus that affects the kidneys. The medication is given as a one-time infusion into the bloodstream after being specially prepared from the patient's own immune cells. It works by using genetically modified cells called CAR-T cells that are designed to target and eliminate specific B cells (a type of white blood cell) that contribute to the autoimmune attack in lupus, potentially resetting the immune system and reducing kidney inflammation.

Investigated diseases

Systemic Lupus Erythematosus with Active Lupus Nephritis – Systemic Lupus Erythematosus is a chronic autoimmune disease where the body's immune system mistakenly attacks its own tissues and organs. When this condition affects the kidneys, it is called lupus nephritis, which represents one of the most serious complications of the disease. Active lupus nephritis means that the kidney inflammation is currently causing damage and symptoms. The condition leads to problems with the kidneys' ability to filter waste from the blood properly. Protein leaks into the urine, and kidney function may decline over time. The disease can cause swelling in the legs and ankles, high blood pressure, and changes in urination patterns.