Stronger Together in the Battle with Lupus

Are you living with lupus and treatment has been nonresponsive? If so, consider joining the MPCT-021N study, a clinical trial for people diagnosed with Systemic Lupus Erythematosus (SLE) with or without Lupus Nephritis (LN) that is investigating IMPT-514 as a new potential medication for the treatment of lupus.

Study Overview

Stronger Together in the Battle with Lupus

Are you living with lupus and treatment has been nonresponsive? If so, consider joining the MPCT-021N study, a clinical trial for people diagnosed with Systemic Lupus Erythematosus (SLE) with or without Lupus Nephritis (LN) that is investigating IMPT-514 as a new potential medication for the treatment of lupus.

Study Overview

What is the MPCT-021N study?

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).

Who can join the MPCT-021N study?

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

What will happen during the study?

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:

Sign Informed Consent Form and Complete Screening
To join the study, you will need to read and sign the Informed Consent Form (ICF) and receive assessments to determine if you qualify. This Screening period will last up to 28 days.

Your study doctor will inform you if you need to decrease or stop your current medication during this period.
Enroll in Study and Undergo Leukapheresis
If you are eligible for the study, you will complete a procedure called leukapheresis to collect some of your white blood cells, which will be used to create IMPT-514. This procedure will take place on one day.

Your study doctor will inform you if you need to decrease or stop your current medication during this period.
Manufacture IMPT-514
The manufacturing of your patient-specific study drug will take approximately 3 weeks.
Begin lymphodepleting therapy
Before your IMPT-514 infusion, you will have 3 days of lymphodepleting therapy, followed by 2 days of rest.
Receive IMPT-514 infusion and monitoring
You will be admitted to the hospital to receive your infusion of IMPT-514 and will remain in the hospital for at least 1 week.
Attend follow-up study visits
After you are discharged, you will return to see the study doctor regularly for study follow-up visits. For the first 28 days after your infusion, you will need to stay within 1 hour of the hospital with a caregiver present.
This follow-up period will last 1 year.
Enter long-term follow-up period
The study doctors will want to see you or contact you once a year through Year 15 after your infusion to monitor your health and safety. This follow-up period will last 14 years.

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.

Interested in the MPCT-021N study?

Contact a study center near you to see if you may qualify!

Study Center Locations

About the Study Medication

What is the study medication?

IMPT-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.

Will I receive the study medication?

Yes, as a participant in the MPCT-021N study, you will receive the study treatment.

What is an “investigational medication?”

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.

About CAR T Cell Therapy

What is CAR T cell therapy?

Chimeric antigen receptor (CAR) T cell therapy is an approach that uses your body’s own immune cells to help fight specific diseases.

Is CAR T cell therapy effective?

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.

How does CAR T cell therapy work?

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.

How is CAR T cell therapy created?

1. Collect T cells (leukapheresis)

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.

2. Modify T cells

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.

3. Prepare the body (lymphodepletion)

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.

4. Receive infusion

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.

1. Collect T cells (leukapheresis)

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.

2. Modify T cells

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.

3. Prepare the body (lymphodepletion)

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.

4. Receive infusion

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.

What is Systemic Lupus Erythematosus (SLE) with or without proliferative Lupus Nephritis (LN)?

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.

Where can I learn more?

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.

Overview of Clinical Trials

Here are some common questions and answers about study participation.

Study Center Locations

Find a study center near you!

Travel support may be available, if needed. To see a full list of all participating sites in the trial please visit clinicaltrials.gov.

This website is intended for U.S. audiences only.
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References: “CAR T-cell Therapy and Its Side Effects.” American Cancer Society. Last revised March 1, 2022. Accessed February 29, 2024.