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A study to evaluate the effectiveness of MC0518 (mesenchymal stromal cells) in adults with acute graft-versus-host disease that has not responded to steroids and ruxolitinib

Verified siteInvestigationalNo placebo

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What is this trial about?

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

This study focuses on individuals living with acute Graft-versus-Host Disease, a condition where immune cells from a donor attack the body's own tissues after a transplant. The investigation specifically looks at cases that have not responded to corticosteroids, which are common anti-inflammatory medicines, or to ruxolitinib, a specialized medication used to control immune responses. The purpose of this study is to evaluate the effectiveness of a cell therapy known as MC0518.

The treatment involves mesenchymal stromal cells, which are specialized cells that can help regulate the immune system, that have been grown in a laboratory setting. These cells are administered through an intravenous infusion, a method where the medicine is delivered directly into a vein. During the course of the study, participants will receive these cells to see how well they can manage the symptoms and progression of the disease when other standard treatments have failed.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Administration of cell therapy
The first step involves receiving an intravenous infusion, which means the medicine is delivered directly into a vein, of the test product known as MC0518.
The dosage for this intravenous infusion consists of 2,000,000 mesenchymal stromal cells, which are specific types of cells that have been grown in a laboratory setting.
Step 2
Monitoring and evaluation
The response to the treatment is assessed at various intervals to track how the graft-versus-host disease, a condition where immune cells attack the body, reacts to the therapy.
Assessments are conducted at day 28 to determine the initial response rate.
Further evaluations occur at day 56 and at 3 months to monitor the effectiveness of the cells.
Long-term monitoring continues through 6 months and 12 months to track survival, the presence of any chronic graft-versus-host disease, and the overall safety of the treatment.

Who can join the trial?

9 criteria

You must be 18 years of age or older.
You must have undergone an allogeneic hematopoietic stem cell transplant, which is a procedure where healthy blood-forming stem cells are given to a patient from a donor to replace damaged or diseased bone marrow, whether the original condition was cancer or another blood-related illness.
You must have been diagnosed with grade II–IV acute graft-versus-host disease (aGvHD), which is a condition where newly transplanted immune cells attack the recipient's body, categorized by a specific scale called the MAGIC criteria that measures the severity of the damage.
Your condition must have not responded to corticosteroids, which are strong medicines used to reduce inflammation and immune system activity. This means your symptoms either got worse after 3 days of high-dose treatment or did not improve after 7 days of treatment.
Your condition must also be resistant to ruxolitinib, a specific medication used to treat certain immune responses. This is defined as your symptoms worsening, not improving, or getting worse again after starting this medicine.
You or your legally authorized representative must sign a consent form, which is a document where you agree to participate in the study after being fully informed about it.
You must be willing and able to follow all the study procedures, including receiving treatments and attending all scheduled medical check-ups.
Women of childbearing potential must use highly effective contraception (methods to prevent pregnancy) during the study and for at least 90 days after the last dose of the study drug.
Men with partners who can become pregnant must agree to use effective contraception during the study and for at least 90 days after the last dose of the study drug.

Who cannot join the trial?

17 criteria

You cannot join if you have a known allergy or hypersensitivity (an extreme immune reaction) to the study drug or its excipients (inactive substances used to carry the drug, such as DMSO, which is a chemical used to preserve cells).
You cannot join if you have hyper-acute GvHD, which is a very rapid form of graft-versus-host disease (a condition where transplanted immune cells attack the recipient's body) occurring within 14 days of a transplant.
You cannot join if you have previously been treated with mesenchymal stromal cells (special types of cells used in therapy) for acute graft-versus-host disease.
Pregnant women or women who are breastfeeding cannot participate.
Women who are able to become pregnant and are not willing to use highly effective contraception (methods to prevent pregnancy) during the study and for 90 days after the last dose cannot participate.
Men with partners who are able to become pregnant and are not willing to use effective contraception during the study and for 90 days after the last dose cannot participate.
You cannot join if you have severe or uncontrolled problems with your organs, such as your heart, liver, kidneys, or lungs, that might shorten your life or make it hard to complete the study.
You cannot join if you have a life-threatening condition or are getting much sicker due to causes other than graft-versus-host disease, such as severe cardiovascular disease (heart problems), uncontrolled metabolic disorders (chemical imbalances in the body), or active malignancies (cancer) other than your blood disease.
You cannot join if you have an infection from HBV (Hepatitis B), HCV (Hepatitis C), or HIV that is not under control or lacks proper medical follow-up.
You cannot join if your ECOG performance status is 3 or higher, which is a scale used by doctors to measure how much a person's disease limits their daily physical activities.
You cannot join if your CD3+ chimerism is less than 90%, which is a measure of how many immune cells in your body come from the donor versus your own body.
You cannot join if your underlying hematologic disease (blood disorder) is getting worse.
You cannot join if you have treated your acute graft-versus-host disease with any medicines other than corticosteroids (steroids used to reduce inflammation) or ruxolitinib.
You cannot join if you had chronic obstructive pulmonary disease (a lung condition that makes breathing difficult) or severe restrictive pulmonary disease (a condition where lungs cannot expand fully) at the time of your transplant.
You cannot join if you are currently taking any other investigational agents (experimental drugs not yet approved by the EMA, which is the European Medicines Agency) or have taken them within 30 days of starting the study.
You cannot join if your transplant was for a non-hematological malignancy (a cancer that is not related to the blood or bone marrow).
You cannot join if you have overlap chronic GvHD, which is a specific way that long-term graft-versus-host disease presents when it shares features with other autoimmune conditions.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
Responsive
Palermo, Italy
Azienda Sanitaria Universitaria Friuli Centrale
Verified
Udine, Italy
Fondazione IRCCS Policlinico San Matteo
Verified
Pavia, Italy

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Investigated drugs

MC0518 is a cell therapy that involves the use of specially grown stem cells. These cells are administered through an intravenous infusion (a drip into a vein) to help treat patients with a specific type of immune system reaction called graft-versus-host disease that has not responded to other treatments.

Mesenchymal Stromal Cells, Ex Vivo Cultured

What is already known about the treatment

MC0518 - This treatment is given as a liquid mixture through an intravenous infusion directly into a person's vein. Currently being studied in clinical trials, these specially grown cells are used to help treat severe graft-versus-host disease that has not responded to standard steroids or other medicines. These cells work by interacting with the body's immune system to calm down excessive inflammation and prevent it from attacking healthy tissues. This type of therapy is classified as a cell-based medicinal product.

Investigated diseases

Acute graft-versus-host disease - This condition occurs when newly transplanted immune cells attack the recipient's healthy tissues. It typically involves organs such as the skin, liver, and gastrointestinal tract. The disease can progress through different stages based on the severity of the tissue damage. In acute forms, the reaction usually develops shortly after the transplant. It is characterized by inflammation and damage to various body systems.