AuthorisedTherapeutic exploratory (Phase II)Interventional

Efficacy of cell therapy with allo-MSCs in patients with gvhd resistant to ruxolitinib second line therapy: a Phase IIB Clinical Trial - MSC-GRR2 Study

This research study, called MSC-GRR2, is looking into a new treatment for Graft-versus-Host Disease (GVHD), a serious condition that can affect people after a stem cell transplant. This particular study focuses on patients whose GVHD has not improved with standard treatments like ruxolitinib and steroids. The new treatment, called MC0518, uses special cells to try and reduce the effects of GVHD. The main goal is to see how many patients show an improvement in their GVHD within 28 days of starting the treatment. Researchers will also be checking how long any improvements last, how the treatment affects their quality of life, and if there are any side effects.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

Enrolment target

Start

28 Apr 2026

Gvhd Resistant to ruxolitinib and steroids

What is this study about?

This study, called MSC-GRR2, is exploring a new way to treat Graft-versus-Host Disease (GVHD). GVHD is a serious complication that can happen to people after they've had a stem cell transplant. In this condition, the new donor cells see the patient's body as 'foreign' and start to attack it, causing a range of problems in different organs.

For many patients, current treatments like steroids and ruxolitinib can help manage GVHD. However, for some, these treatments don't work well enough, and their GVHD continues to be a problem. This study is specifically for these patients, offering a new treatment called MC0518. This treatment uses special types of cells to try and calm down the immune system and reduce the harmful effects of GVHD.

The main aim of this study is to see how many patients experience an improvement in their GVHD within the first 28 days of receiving MC0518. Researchers will carefully track improvements and side effects to understand if this new cell therapy could be a good option for people whose GVHD hasn't responded to other treatments.

Key takeaways

This study is testing a new cell therapy (MC0518) for GVHD.
It's for people whose GVHD hasn't improved with standard treatments like ruxolitinib and steroids.
The main goal is to see if the treatment improves GVHD symptoms within 28 days.
Researchers will also check long-term effects, quality of life, and safety.
Participation involves receiving the treatment and regular health check-ups for up to 12 months.

Who may be eligible?

To be considered for this study, you must be 18 years old or over, and there is no upper age limit. Both men and women can take part.

The key requirement is that you have Graft-versus-Host Disease (GVHD) that has not improved with standard treatments, specifically ruxolitinib and steroids. This means your doctors will have already tried these other medications, and your GVHD is still active and causing problems.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have Graft-versus-Host Disease (GVHD)?
Has your GVHD not improved with ruxolitinib treatment?
Has your GVHD not improved with steroid treatment?
Are you able to attend regular appointments for up to 12 months?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the new treatment, MC0518. Researchers would then closely monitor your health and the progress of your GVHD. This would involve regular check-ups, likely including blood tests and assessments of your symptoms. These visits would be scheduled frequently at the beginning, especially within the first 28-56 days, to see how your body responds to the treatment. You would be followed for at least 3 months, and some follow-up would continue up to 12 months to understand the longer-term effects of the treatment, including your overall health and quality of life. The total duration of your participation, including treatment and follow-up, would be up to 12 months.

Potential risks and benefits

Taking part in this study could potentially offer a new treatment option for your GVHD, especially if other treatments haven't worked for you. It might help improve your condition and quality of life. However, as with any new treatment, there could be risks or side effects, some of which might be serious, as your body reacts to the new cells. These will be carefully explained to you by the study team. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Italy

Common questions

What is GVHD?

GVHD (Graft-versus-Host Disease) is a condition where new cells given during a stem cell transplant attack your body, as they see it as foreign. It can cause problems in various organs.

What is MC0518?

MC0518 is a new type of cell therapy being tested in this study. It uses special cells to try and help your immune system and reduce the effects of GVHD.

How long will the study last for me?

If you take part, you'll be involved in the study for up to 12 months, which includes receiving the treatment and follow-up check-ups.

What does 'Overall response rate' mean?

This is how doctors measure if the treatment is working. It means seeing a significant improvement in your GVHD symptoms, either completely or partly, within a set timeframe.

Will this treatment cure my GVHD?

This is a research study to see if MC0518 can help improve GVHD that hasn't responded to other treatments. We don't know yet if it will cure GVHD, but we hope it will offer a new way to manage it.