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

This article discusses clinical trials investigating the use of RLS-0071, a novel peptide drug, for treating steroid-refractory acute graft-versus-host disease (aGvHD) in patients who have undergone allogeneic hematopoietic stem cell transplantation. The trials aim to evaluate the safety, tolerability, and efficacy of RLS-0071 in combination with standard treatments for this challenging condition.

Table of Contents

What is RLS-0071?

RLS-0071 is an experimental medication being developed to treat a serious condition called steroid-refractory acute graft-versus-host disease (aGvHD). It is a peptide, which means it’s made up of amino acids, the building blocks of proteins. The full name of this drug is quite complex: ILE-ALA-LEU-ILE-LEU-GLU-PRO-ILE-CYS-CYS-GLN-GLU-ARG-ALA-ALA-(DISCRETE-POLYETHYLENE GLYCOL)24. It’s also known by several other names, including PIC1, PA-dPEG24, PIC1dPEG, and PIC1-dPEG24[1][2].

What Medical Condition Does RLS-0071 Treat?

RLS-0071 is being developed to treat steroid-refractory acute graft-versus-host disease (aGvHD). This is a serious complication that can occur after a person receives a stem cell transplant from a donor. In aGvHD, the donor’s immune cells attack the recipient’s body, causing inflammation and damage to various organs. When this condition doesn’t respond well to standard steroid treatments, it’s called “steroid-refractory”[1][2].

How Does RLS-0071 Work?

While the exact mechanism of action isn’t fully described in the provided information, RLS-0071 is designed to help manage the immune system’s overactive response in aGvHD. It’s being tested as a treatment option for patients who haven’t responded well to standard steroid therapy[1][2].

Current Clinical Trial

RLS-0071 is currently being studied in a Phase 2 clinical trial. This trial aims to:

  • Evaluate the safety and tolerability of RLS-0071 in treating aGvHD
  • Determine how well patients respond to the treatment
  • Understand how the drug behaves in the body (pharmacokinetics)
  • Find the best dose and duration of treatment
  • Assess various measures of patient improvement[1][2]

The trial will look at how patients respond to the treatment at various time points (7, 14, 28, 56, and 180 days) and will measure different levels of response, including complete response, very good partial response, and partial response[1][2].

Who is Eligible for the Trial?

The trial is open to both adults and adolescents (over 12 years old) who meet certain criteria, including:

  • Having undergone their first allogeneic stem cell transplant
  • Diagnosed with Grade II-IV acute graft-versus-host disease
  • Not responding well to standard steroid treatment
  • Meeting specific health requirements related to organ function and overall condition[1][2]

It’s important to note that there are also several conditions that would exclude a person from participating in the trial, such as having certain infections or other medical complications[1][2].

Potential Benefits of RLS-0071

While it’s too early to know for certain, researchers hope that RLS-0071 might offer several potential benefits for patients with steroid-refractory aGvHD:

  • Improved response rates compared to current treatments
  • Reduction in symptoms and organ damage caused by aGvHD
  • Potential for better quality of life, as measured by factors like abdominal pain, diarrhea, and food tolerance
  • Possible reduction in the need for long-term steroid use[1][2]

Safety Considerations

As with any experimental treatment, safety is a top priority in the RLS-0071 clinical trial. The researchers will be closely monitoring participants for any side effects or adverse reactions. Some specific safety considerations include:

  • Patients with certain pre-existing conditions, such as severe organ dysfunction or active infections, are not eligible for the trial to minimize risks
  • The trial excludes individuals with known allergies to components of the drug
  • Participants will be closely monitored throughout the study period
  • The trial is designed to evaluate different doses to find the safest and most effective treatment regimen[1][2]

It’s important to remember that RLS-0071 is still in the testing phase, and more research is needed to fully understand its effectiveness and safety profile. Patients interested in this treatment should discuss it with their healthcare providers to determine if participating in the clinical trial might be appropriate for their individual situation.

Aspect Details
Drug Name RLS-0071 (Ile-Ala-Leu-Ile-Leu-Glu-Pro-Ile-Cys-Cys-Gln-Glu-Arg-Ala-Ala-(Discrete-Polyethylene Glycol)24)
Trial Phase Phase 2
Condition Steroid-refractory acute graft-versus-host disease (aGvHD)
Study Design Open-label, prospective, dose-ranging with escalation and expansion cohorts
Primary Objectives Safety, tolerability, and overall response rate at 28 days
Key Secondary Objectives Complete response, very good partial response, partial response rates, pharmacokinetics, patient outcomes
Eligibility Adults and adolescents >12 years, post-allogeneic HSCT, with steroid-refractory aGvHD
Treatment Duration Up to 14 days
Follow-up Period Up to 180 days

FAQ

  • What is RLS-0071? RLS-0071 is an investigational drug consisting of a peptide sequence (Ile-Ala-Leu-Ile-Leu-Glu-Pro-Ile-Cys-Cys-Gln-Glu-Arg-Ala-Ala) attached to a polyethylene glycol tail. It is being studied for the treatment of steroid-refractory acute graft-versus-host disease.
  • What is the main goal of these clinical trials? The main goals are to demonstrate the safety and tolerability of RLS-0071 in treating acute graft-versus-host disease and to determine its overall response rate at 28 days.
  • Who can participate in these trials? Participants must be adults or adolescents over 12 years old who have undergone allogeneic stem cell transplantation and developed steroid-refractory acute graft-versus-host disease. They must meet specific criteria regarding neutrophil recovery, weight, and disease severity.
  • How is RLS-0071 administered in the trials? RLS-0071 is administered as an infusion. The trials are evaluating different doses and durations of treatment to determine the most effective regimen.
  • What are some of the key outcomes being measured? The trials are measuring various outcomes, including overall response rate, complete response rate, very good partial response rate, partial response rate, changes in disease staging, corticosteroid use, and patient-reported outcomes such as quality of life and symptom improvement.

Ongoing Clinical Trials on Ile-Ala-Leu-Ile-Leu-Glu-Pro-Ile-Cys-Cys-Gln-Glu-Arg-Ala-Ala-(Discrete-Polyethylene Glycol)24

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

    Not yet recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Germany Spain

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

    Not recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Germany Spain

Glossary

  • Acute graft-versus-host disease (aGvHD): A complication that can occur after allogeneic stem cell transplantation, where the donor's immune cells attack the recipient's tissues, causing inflammation and damage to organs such as the skin, liver, and gastrointestinal tract.
  • Allogeneic hematopoietic stem cell transplantation (allo-HSCT): A procedure where stem cells from a donor are transplanted into a recipient to treat various blood disorders and cancers.
  • Steroid-refractory: A condition that does not respond adequately to treatment with corticosteroids, which are typically the first-line therapy for acute graft-versus-host disease.
  • Overall Response Rate (ORR): The proportion of patients who have a partial or complete response to treatment.
  • Complete Response (CR): The disappearance of all signs of a disease in response to treatment.
  • Very Good Partial Response (VGPR): A significant improvement in disease symptoms and markers, but not a complete resolution.
  • Partial Response (PR): A decrease in disease severity or extent in response to treatment, but not a complete resolution.
  • Pharmacokinetics (PK): The study of how a drug moves through the body, including its absorption, distribution, metabolism, and excretion.
  • Pharmacodynamics: The study of the biochemical and physiological effects of drugs on the body, including their mechanisms of action and relationship between drug concentration and effect.
  • FACT-BMT: Functional Assessment of Cancer Therapy – Bone Marrow Transplant, a quality of life assessment tool specific to bone marrow transplant patients.
  • MAGIC biomarkers: Mount Sinai Acute GVHD International Consortium biomarkers, specifically ST2 and REG3a, which are used to assess and predict outcomes in acute graft-versus-host disease.
  • Ruxolitinib: A medication used to treat certain blood disorders and steroid-refractory acute graft-versus-host disease.
  • Total parenteral nutrition (TPN): A method of feeding that bypasses the gastrointestinal tract and provides nutrients directly into the bloodstream.
  • Neutrophil recovery: The return of neutrophils (a type of white blood cell) to normal levels after stem cell transplantation, indicating successful engraftment.

References

  1. http://clinicaltrials.eu/trial/study-on-rls-0071-for-treating-hospitalized-patients-with-steroid-refractory-acute-graft-versus-host-disease-2/
  2. http://clinicaltrials.eu/trial/study-on-rls-0071-for-treating-hospitalized-patients-with-steroid-refractory-acute-graft-versus-host-disease/