Study of RLS-0071 in Hospitalized Patients with Steroid-Resistant Acute Graft-versus-Host Disease (aGvHD)

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What is this study about?

This study focuses on patients with acute graft versus host disease (aGvHD), a condition that can occur after stem cell transplantation when the donor’s immune cells attack the recipient’s tissues. The study will test a new medication called RLS-0071, which is given through intravenous infusion, in combination with standard treatments including ruxolitinib.

The main purpose of this research is to determine if RLS-0071 is safe and effective for treating steroid-resistant acute graft versus host disease. The medication will be tested at different dose levels to find the most appropriate dosing. During the study, participants will receive RLS-0071 infusions for up to 14 days while in the hospital.

Throughout the study, doctors will monitor how well the treatment works by checking the condition of affected organs, including the skin, liver, and digestive system. They will also track various health measurements and collect blood samples to understand how the medication works in the body. The total duration of monitoring after treatment will be 180 days to evaluate long-term effects of the medication.

1 Initial qualification

You must be over 12 years old and weigh between 40-140 kg to participate in the trial

You need to have acute graft versus host disease (aGvHD) and be hospitalized

Your blood neutrophil count must be above 500/mL without growth factor support

2 Treatment initiation

You will receive RLS-0071 through an infusion

The treatment will be given together with or within 48 hours of starting another medication called ruxolitinib

The initial treatment period lasts 7 days

You will need to stay in the hospital for at least one week during the treatment

3 Monitoring period

Your response to treatment will be checked at days 7, 14, 28, 56, and 180

The doctors will monitor changes in your condition, particularly involving your skin, liver, and digestive system

Blood samples will be taken to measure treatment effectiveness

Your pain levels, food tolerance, and overall well-being will be assessed

4 Follow-up evaluations

The main evaluation of your response will occur at day 28

Additional check-ups will continue until day 180

The doctors will monitor your overall health and survival throughout the study period

The study will track how well you can reduce other medications, especially steroids

Who Can Join the Study?

You must be at least 12 years old
Your blood must show recovery after stem-cell transplantation with neutrophils (a type of white blood cells) count above 500/mL for at least 3 consecutive measurements
Your neutrophil count must be above 500/mL at screening without using growth factor medications
Your weight must be between 40 kg and 140 kg
You (or your legal guardian for minors) must provide written informed consent
You must be able to communicate effectively with the study team and follow study requirements
If you can have children or your partner can become pregnant, you must agree to use effective birth control during the study
You must have steroid-resistant acute graft versus host disease (condition not improving after standard steroid treatment)
You must have Grade II-IV acute graft versus host disease affecting skin, liver, or digestive system
You must be hospitalized or being admitted to hospital
You must be able to stay in hospital for at least 1 week from treatment start
You must be starting or have recently started ruxolitinib treatment (unless your doctor determines it’s not suitable for you)
You must be able to start the study medication (RLS-0071) within 48 hours of starting ruxolitinib
You cannot plan to change other medications for graft versus host disease during the first 7 days of treatment (though you can receive other necessary medical treatments)

Who Cannot Join the Study?

Age below 12 years or above 75 years
Patients with severe organ dysfunction (significant problems with heart, liver, kidneys or lungs)
Active, uncontrolled infections
Previous participation in other clinical trials within last 30 days
Known allergic reactions to similar medications
Pregnant or breastfeeding women
Patients using medications that could interfere with the study drug
Patients with uncontrolled blood pressure or unstable vital signs
History of other cancers in the past 2 years (except for successfully treated skin cancer)
Patients unable to follow study procedures or provide informed consent
Mental conditions that could affect ability to participate in the study
Patients with active bleeding disorders

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Hospital Universitario De Salamanca	Salamanca	Spain

Other Sites

Site Name	City	Country
Virgen del Rocío University Hospital	Sevilla	Spain
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany
Hnmgivhc Utgeqypollamo Mnukqiy Dm Vprnhygwgn	Santander	Spain
Ujxfljcouz Hgohllvi Cmegrrq	Cologne	Germany
Umdafkeqcjsqenaawgrsm Mfftfvba Ajz	Munster	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not yet recruiting	31.07.2024
Spain	Not yet recruiting	31.07.2024

Trial locations

Investigated drugs:

Ile-Ala-Leu-Ile-Leu-Glu-Pro-Ile-Cys-Cys-Gln-Glu-Arg-Ala-Ala-(Discrete-Polyethylene Glycol)24

RLS-0071 is an investigational medication being studied for the treatment of acute graft versus host disease (aGvHD), a condition that can occur after bone marrow transplantation. This medication is being tested in patients who have not responded well to steroid treatment. The drug is designed to help manage the complications of aGvHD in hospitalized patients. As this is a phase 2 clinical trial, researchers are working to understand how safe and effective this medication is, how it moves through the body, and what the best dosing strategy might be.

Investigated diseases:

Acute graft versus host disease

Acute Graft versus Host Disease (aGvHD) – A condition that occurs after bone marrow or stem cell transplantation when the donated immune cells attack the recipient’s body tissues. The disease typically develops within the first 100 days after transplantation and primarily affects the skin, liver, and gastrointestinal tract. The condition begins when the transplanted immune cells recognize the recipient’s tissues as foreign and launch an immune response against them. Symptoms can include skin rashes, liver dysfunction, and digestive tract problems including diarrhea and abdominal pain. The severity can range from mild to severe, depending on how many organs are affected and to what extent.

Trial ID:

2024-510582-42-00

Protocol code:

RLS-0071-203

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of RLS-0071 in Hospitalized Patients with Steroid-Resistant Acute Graft-versus-Host Disease (aGvHD)

What is this study about?

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