Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Phase 2 Open Label Prospective Dose-Ranging Clinical Trial with Escalation and Expansion Cohorts to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Dosing, and Efficacy of RLS-0071 for the Treatment of Hospitalized Patients with Steroid -Refractory Acute Graft-versus-Host Disease

This research is looking into a new treatment called RLS-0071 for patients in hospital who have acute graft-versus-host disease (aGvHD). This is a serious condition that can happen after a stem cell transplant, where the new immune cells attack the patient's body. The study focuses on patients whose aGvHD hasn't improved with standard steroid medications. Our main goals are to check if RLS-0071 is safe, how well patients tolerate it, and whether it helps improve their condition. We also want to find the most effective dose. We'll be closely monitoring how patients respond to the treatment over several months to understand its full effects.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Realta Life Sciences Inc.

Enrolment target

Start

11 Nov 2024

Acute graft versus host disease (aGvHD)

What is this study about?

This study is about a condition called acute graft-versus-host disease (aGvHD). This can happen after someone has a stem cell transplant, often for blood cancer. In aGvHD, the new immune cells from the donor (the 'graft') see the patient's body (the 'host') as foreign and start to attack it. This can cause symptoms like skin rashes, sickness, and problems with the gut or liver. It's a serious complication, and while steroids are often the first treatment, they don't work for everyone.

That's why doctors are looking for new treatments. This study is testing a new medicine called RLS-0071. It's a 'Phase 2' study, which means it has already been tested in a small number of people and is now being given to a slightly larger group to gain more information. We want to understand several things: Is RLS-0071 safe and does it cause side effects? How does the body handle the drug? How much of the drug is needed for the best effect? And most importantly, does it help to improve aGvHD symptoms?

The patients in this study are those who are in hospital with aGvHD that hasn't gotten better with steroid treatment. We'll be carefully watching how their symptoms change and whether the drug helps them improve or get better. By doing this, we hope to learn if RLS-0071 could be a helpful new option for people struggling with this challenging condition.

Key takeaways

This study is for hospital patients with aGvHD that isn't responding to steroids.
It's testing a new drug called RLS-0071 to see if it's safe and effective.
The study aims to find the best dose of RLS-0071.
Your aGvHD symptoms and overall health will be closely monitored.
Participation involves regular check-ups and follow-up for up to 6 months.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old. The study is open to both men and women.

Importantly, this study is specifically for hospitalised patients who have acute graft-versus-host disease (aGvHD) that has not responded to treatment with steroids. This means your doctors have tried standard steroid medications for your aGvHD, but your condition hasn't improved as much as hoped or has gotten worse.

There might be other health conditions or medications that would mean you couldn't take part, to ensure the study is as safe as possible for everyone involved. Your medical team will carefully review all your information to see if this study is right for you.

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?
Are you currently in hospital?
Do you have acute graft-versus-host disease (aGvHD)?
Has your aGvHD not improved with standard steroid treatment?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive the new study drug, RLS-0071. The study team will decide the dose you get. You will have regular check-ups while you are in hospital, which will involve doctors examining you and asking about your symptoms. They will also take blood samples and possibly other tests to see how the medicine is affecting your body and your aGvHD. The main period of the study where you receive the drug and are closely monitored will be for the first 28 days, but doctors will continue to check on your condition for up to 180 days (about 6 months) to see how you are doing over a longer time.

Potential risks and benefits

Taking part in a study like this might offer a potential benefit if the new drug, RLS-0071, helps improve your aGvHD when other treatments haven't worked. However, there's always a risk that the drug might not work for you, or you could experience side effects. These risks will be explained to you in detail by the study team. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (2)

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

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Unverified
Germany
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Unverified
Spain

Common questions

What is aGvHD?

Acute graft-versus-host disease (aGvHD) is a complication that can happen after a stem cell transplant where the donor's immune cells attack the patient's body.

What does 'steroid-refractory' mean?

It means the aGvHD hasn't responded well or has gotten worse despite being treated with steroid medications.

What is RLS-0071?

RLS-0071 is the new study drug being tested to see if it can help treat aGvHD.

How long will the study last for me?

You will be closely monitored for 28 days for the main treatment response, with follow-ups for up to 180 days (about 6 months).

Can I stop being part of the study?

Yes, you can choose to leave the study at any time without it affecting your future medical care.