The MPCT-021N clinical research study is for people who have Systemic Lupus Erythematosus (SLE) with or without Lupus Nephritis (LN). The study will test a new investigational treatment, a CAR T cell therapy (IMPT-514), to learn if it can be used for people with active Systemic Lupus Erythematosus (SLE) with or without Lupus Nephritis (LN).
People may be able to join the study if they meet the following requirements:
18 years or older
Able to undergo the required study procedures
A diagnosis of Systemic Lupus Erythematosus (SLE) with or without Lupus Nephritis (LN)
Other study requirements will apply
Participation in the MPCT-021N study includes a main treatment and follow up period that lasts about 1 year, as well as a long-term safety follow up period that extends to 15 years. The FDA requires that participants receiving cell therapy products such as IMPT-514 are followed for up to 15 years for long term safety monitoring. Study participants can expect the following:
Participation in a clinical study is voluntary. You can ask any questions you have and may leave the study at any time, for any reason.
Contact a study center near you to see if you may qualify!
Study Center LocationsIMPT-514 is a type of CAR T-cell therapy. To create IMPT-514, some of your own white blood cells will be collected and modified so that they can identify the B cells that are causing inflammation. Then, the white blood cells will be given back to you by intravenous infusion to potentially kill the B cells that are causing the inflammation.
IMPT-514 is investigational, which means it can only be used in research studies. It has not been approved by the United States Food and Drug Administration (FDA) as a therapy for lupus.
Yes, as a participant in the MPCT-021N study, you will receive the study treatment.
Investigational medication means the study treatment that is being given to you on this study is not approved by regulatory authorities like the US Food and Drug Administration (FDA), and it can only be used in clinical research studies like MPCT-021N.
Chimeric antigen receptor (CAR) T cell therapy is an approach that uses your body’s own immune cells to help fight specific diseases.
Several CAR T cell therapies are approved to treat certain types of cancer, including cancers that have not responded to other treatments.
New investigational CAR T cell therapies are still being studied for other diseases.
Early research suggests that CAR T cell therapy may be highly effective in treating immune system diseases such as lupus, but more studies are needed to confirm its safety and effectiveness.
T cells are a type of immune cell that helps protect your body by recognizing and eliminating disease-causing cells. Normally, T cells can only recognize specific targets. If the disease-causing cells do not have a recognizable target, they may not be detected and the T cells will not eliminate them.
CAR stands for chimeric antigen receptor. This is a specially designed receptor added to T cells, allowing them to recognize and attack cells that were previously undetected.
In CAR T cell therapy, your own T cells are collected and modified in a lab to recognize new targets on disease-causing cells. These modified T cells are then put back into your body to find and eliminate the disease-causing cells.
During a procedure called leukapheresis, blood is drawn from your vein and passed through a machine that separates out the T cells. The rest of the blood is returned to your body. This process usually takes about 4 to 6 hours.
The collected T cells are sent to a manufacturing facility, where they are changed in a lab to recognize disease-causing cells. This process may take approximately 3 weeks and results in your new CAR T cells.
These cells are carefully tested to ensure they meet high-quality standards before being sent back to your study team.
Before you receive your new CAR T cells, you undergo a process called lymphodepletion. This involves receiving medications by IV (into a vein) to decrease the amount of other immune cells in your body.
Lymphodepletion can cause low blood counts for 1 to 3 weeks.
You are admitted to the cell therapy unit (or cell therapy infusion bed) to receive your new CAR T cells through an IV. You will stay in the hospital for at least 1 week for safety observation to monitor for any side effects.
During a procedure called leukapheresis, blood is drawn from your vein and passed through a machine that separates out the T cells. The rest of the blood is returned to your body. This process usually takes about 4 to 6 hours.
The collected T cells are sent to a manufacturing facility, where they are changed in a lab to recognize disease-causing cells. This process may take approximately 3 weeks and results in your new CAR T cells.
These cells are carefully tested to ensure they meet high-quality standards before being sent back to your study team.
Before you receive your new CAR T cells, you undergo a process called lymphodepletion. This involves receiving medications by IV (into a vein) to decrease the amount of other immune cells in your body.
Lymphodepletion can cause low blood counts for 1 to 3 weeks.
You are admitted to the cell therapy unit (or cell therapy infusion bed) to receive your new CAR T cells through an IV. You will stay in the hospital for at least 1 week for safety observation to monitor for any side effects.
Systemic Lupus Erythematosus (SLE) with or without Lupus Nephritis (LN) is a chronic autoimmune disease characterized by widespread inflammation that may involve multiple organ systems (most commonly the skin and joints) and significantly impact patient quality of life. Lupus Nephritis is type of SLE with significant inflammation in the kidneys. Over time, such kidney inflammation can lead to kidney failure.
If you have additional questions about participating in this clinical research study, contact a study center near you. Travel support may be available, if needed. To see a full list of all participating sites in this trial please click here to visit the MPCT-021N study page on www.clinicaltrials.gov.
Here are some common questions and answers about study participation.
Clinical research studies, or trials, help scientists and doctors explore whether a medical strategy, device, or medication is safe and effective for people. Before any medication can be approved and made available to the public, it must go through several phases of clinical research.
Before enrolling in a clinical trial, you must sign an Informed Consent Form (ICF). The ICF contains information about the study, including study goals, how long the study will last, benefits and risks, and the tests and procedures you will receive.
Study participation usually involves visiting a center regularly, taking or receiving an investigational medicine, and having assessments to monitor your health. You can still see your regular doctor, but you should let them know that you are participating in a study.
Participation in clinical research studies is your choice, and you may stop at any time.
Travel support may be available, if needed. To see a full list of all participating sites in the trial please visit clinicaltrials.gov.