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11902A

A new clinical trial is exploring an innovative approach to treating metastatic fusion-driven sarcomas in children and young adults. This phase I/II trial focuses on using a personalized peptide vaccine called IPX vaccine, which contains PERVI-FUS, PERVI-NEO, and 11902A. The study aims to assess the vaccine’s ability to induce T-cell responses in patients with Ewing sarcoma, alveolar rhabdomyosarcoma, or synovial sarcoma who have achieved complete remission or partial response after standard treatment.

Table of Contents

What is the IPX Vaccine?

The IPX vaccine is an innovative, personalized peptide vaccine being studied for the treatment of certain types of metastatic sarcomas in children and young adults[1]. This vaccine is unique because it is tailored to each individual patient, using specific proteins (peptides) that are designed to target their particular cancer[1].

The IPX vaccine contains three main components[1]:

  • PERVI-FUS: A peptide targeting fusion proteins in the cancer cells
  • PERVI-NEO: A peptide targeting new (neo) proteins in the cancer cells
  • 11902A: An additional component that may help boost the vaccine’s effectiveness

Target Medical Conditions

The IPX vaccine is being studied for patients with specific types of metastatic sarcomas. These are cancers that have spread from their original location to other parts of the body. The trial focuses on three types of fusion-driven sarcomas[1]:

  • Ewing sarcoma: A rare type of cancer that occurs in bones or in the soft tissue around the bones
  • Alveolar rhabdomyosarcoma: A type of soft tissue cancer that develops in muscle tissue
  • Synovial sarcoma: A rare type of cancer that typically occurs near the joints of the arm, neck, or leg
These cancers are called “fusion-driven” because they are caused by the abnormal fusion of genes, which leads to the production of abnormal proteins that drive cancer growth[1].

How the IPX Vaccine Works

The IPX vaccine is designed to stimulate the patient’s immune system to recognize and attack cancer cells. Here’s how it works:

  1. Scientists analyze the patient’s cancer cells to identify specific abnormal proteins (peptides) that are unique to their cancer[1].
  2. These peptides are then manufactured into a personalized vaccine[1].
  3. When injected, the vaccine trains the patient’s immune system to recognize these cancer-specific peptides as foreign[1].
  4. The goal is for the immune system to then attack and destroy cancer cells that have these specific peptides, potentially preventing or delaying cancer recurrence[1].

Current Clinical Trial

The IPX vaccine is currently being studied in a Phase I/II clinical trial[1]. This means it’s in the early stages of research in humans. The main goals of this trial are:

  • To assess if the vaccine can induce an immune response against the cancer cells[1]
  • To evaluate the safety and tolerability of the vaccine[1]
  • To gather early data on how effective the vaccine might be in preventing cancer recurrence[1]

Who Can Participate in the Trial?

The trial is designed for specific patients. Some key eligibility criteria include:

  • Patients aged 2-40 years with metastatic Ewing sarcoma, alveolar rhabdomyosarcoma, or synovial sarcoma[1]
  • Patients who have achieved complete remission or partial response after standard treatment[1]
  • Availability of genetic data about the patient’s tumor[1]
There are also several exclusion criteria, such as certain medical conditions or treatments that might interfere with the study[1].

Safety Considerations

As with any medical treatment, safety is a crucial consideration. The trial carefully monitors for any side effects or adverse reactions to the vaccine. Patients with certain conditions, such as uncontrolled seizures, severe autoimmune diseases, or recent use of live vaccines, may not be eligible for the trial due to safety concerns[1].

Potential Benefits

While it’s important to note that the IPX vaccine is still in the research phase, the potential benefits being studied include:

  • Stimulation of the immune system to fight against cancer cells[1]
  • Possible prevention or delay of cancer recurrence[1]
  • A personalized approach to cancer treatment[1]
The trial will measure outcomes such as immune response, event-free survival, and overall survival to assess these potential benefits[1].

Aspect Details
Trial Type Phase I/II
Target Population Children and young adults (2-40 years) with metastatic fusion-driven sarcomas
Specific Cancer Types Ewing sarcoma, alveolar rhabdomyosarcoma, synovial sarcoma
Treatment Personalized peptide vaccine (IPX vaccine) containing PERVI-FUS, PERVI-NEO, and 11902A
Primary Objective Assess vaccine-induced T-cell response
Secondary Objectives Evaluate feasibility, safety, and early efficacy data
Dosage Maximum daily dose: 0.3 mg; Maximum total dose: 0.9 mg
Treatment Duration Up to 113 days
Key Eligibility Complete remission or partial response after standard treatment, specific genetic testing required

FAQ

  • What is the purpose of this clinical trial? The main purpose of this trial is to assess how well the individualized peptide vaccine (IPX vaccine) can stimulate the immune system's T-cell response in patients with specific types of metastatic sarcomas. It also aims to evaluate the safety and feasibility of this approach in patients at high risk of recurrence.
  • Who can participate in this trial? The trial is open to patients aged 2-40 years with metastatic fusion-driven sarcomas (Ewing sarcoma, alveolar rhabdomyosarcoma, or synovial sarcoma) who have achieved complete remission or partial response after standard treatment. Patients must have undergone specific genetic testing and meet other eligibility criteria.
  • What does the treatment involve? The treatment involves receiving a personalized peptide vaccine called IPX vaccine, which contains PERVI-FUS, PERVI-NEO, and 11902A. The vaccine is given as an injection, with a maximum daily dose of 0.3 mg and a total maximum dose of 0.9 mg over a treatment period of up to 113 days.
  • What are the potential benefits of participating in this trial? Participants may benefit from a potentially innovative treatment approach that could stimulate their immune system to fight against their cancer. The trial also aims to gather early efficacy data on event-free and overall survival, which could help in planning future studies for these hard-to-treat cancers.
  • Are there any risks or side effects associated with the treatment? As with any clinical trial, there may be risks and side effects. The study will closely monitor patients for any adverse effects and assess the safety and tolerability of the IPX vaccine. Patients with certain medical conditions, ongoing infections, or hypersensitivity to the vaccine components are excluded from the trial to minimize potential risks.

Ongoing Clinical Trials on 11902A

  • Study of Personalized Peptide Vaccine with PERVI-FUS, PERVI-NEO, and 11902A for Children and Young Adults with Metastatic Fusion-Driven Sarcomas

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Germany

Glossary

  • Metastatic: Cancer that has spread from its original site to other parts of the body.
  • Fusion-driven sarcomas: Cancers of connective tissues caused by the fusion of two genes, leading to abnormal cell growth.
  • Ewing sarcoma: A rare type of cancer that occurs in bones or in the soft tissue around the bones, primarily affecting children and young adults.
  • Alveolar rhabdomyosarcoma: A type of soft tissue cancer that develops in muscle tissue, typically affecting children and teenagers.
  • Synovial sarcoma: A rare type of cancer that can occur in various locations of the body, most often near large joints.
  • Peptide vaccine: A type of vaccine made from small pieces of proteins (peptides) designed to stimulate the immune system to recognize and attack specific targets, such as cancer cells.
  • T-cell response: The activation of T-cells (a type of white blood cell) by the immune system to fight against specific threats, such as cancer cells.
  • Complete remission (CR): The disappearance of all signs of cancer in response to treatment.
  • Partial response (PR): A decrease in the size or extent of cancer in response to treatment, but not complete disappearance.
  • Event-free survival (EFS): The length of time after treatment during which no specified events (such as cancer recurrence or progression) are detected.
  • Overall survival (OS): The length of time from the start of treatment that patients are still alive.

References

  1. http://clinicaltrials.eu/trial/study-of-personalized-peptide-vaccine-with-pervi-fus-pervi-neo-and-11902a-for-children-and-young-adults-with-metastatic-fusion-driven-sarcomas/