Study on A49, A52, and Litenimod Sodium for Patients with Glioblastoma

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What is this study about?

This clinical trial is focused on studying a type of brain cancer called glioblastoma. The study will explore the effects of a new treatment approach using a vaccine. The vaccine includes three different solutions for injection: Peptide A49 associated to melanin (code name: A49-Mel), Peptide A52 associated to melanin (code name: A52-Mel), and Litenimod solution (code name: Li28). These treatments are designed to help the body’s immune system fight the cancer more effectively.

The purpose of the study is to determine the best dose of the vaccine and to see how well it works in stimulating the immune system. The study will be conducted in two phases. In the first phase, researchers will find the maximum dose that patients can tolerate. In the second phase, they will assess how the immune system responds to the vaccine after two months. Participants will receive the vaccine through injections under the skin, and their health will be monitored regularly through clinical check-ups, blood tests, and MRI scans to ensure safety and effectiveness.

Throughout the study, researchers will evaluate the immune response by measuring specific cells in the blood that are known to fight cancer. They will also monitor the participants’ overall health, quality of life, and survival rates. The study aims to provide valuable insights into the potential benefits of this new vaccine approach for treating glioblastoma.

1 initial treatment phase

The study begins with the administration of three different solutions for injection: Peptide A49 associated to melanin, Litenimod solution, and Peptide A52 associated to melanin. These are given through subcutaneous injections.

The main goal during this phase is to determine the maximum dose that can be tolerated and to select the appropriate dose for the next phase.

2 safety and response assessment

Safety is evaluated at several time points: Day 0, Week 2, Week 4, Week 6, Month 2, Month 3, Month 4, Month 5, Month 7, Month 9, Month 11, and Month 12. This includes clinical evaluations and blood samples.

Cerebral MRI scans are conducted at the start, Month 2, Month 3, and every two months thereafter to monitor progression.

3 immune response evaluation

The study assesses the immune response to the vaccine by measuring specific T cell responses in the blood. This is done using a test called IFN-gamma ELISPOT at 2 months after the first immunizations.

Additional assessments occur at Week 2 (for phase 1 only), Week 4, Month 2, Month 3, Month 5, Month 7, Month 9, and Month 12.

4 quality of life and survival monitoring

Quality of life is assessed using specific questionnaires at the start and at 5 months into the study.

Overall survival and progression-free survival are monitored throughout the study duration.

Who Can Join the Study?

Age between 18 and 75 years old
Have adequate organ function based on lab tests done within 15 days before starting treatment
If you are a woman or man who can have children, you must use birth control during the study and for a certain time after the last dose of medication or vaccine. Men should not donate sperm during the study and for 7 months after the treatment ends.
Be part of the social security system
Provide free, informed, and written consent to participate
Have a confirmed diagnosis of glioblastoma, a type of brain tumor
Have been previously treated with radiation therapy (at least 45 Gy) and a medication called temozolomide, before starting additional cycles of temozolomide. The radiation therapy must have been completed 28 to 45 days before the first study treatment.
Have a Karnofsky Performance Status of 60% or higher, which means you can take care of yourself and do some daily activities
Be HLA-A2 positive, which is a specific genetic marker
Have PTPRZ1 expression in the tumor, which is a specific protein found in the tumor
Have available tumor tissue for further testing of specific genetic changes
Have a life expectancy of at least 3 months

Who Cannot Join the Study?

Patients with any other serious medical condition that might interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial within the last 30 days.
Patients with a known allergy to any of the study medications.
Patients who are unable to follow the study procedures or instructions.
Patients with a history of certain mental health conditions that might affect their ability to participate.
Patients who have had a recent major surgery or are planning to have surgery during the study period.
Patients with an active infection that requires treatment.
Patients who have a history of drug or alcohol abuse.
Patients who are taking medications that might interfere with the study treatment.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country
Hopital Beaujon	Clichy	France
Centre De Lutte Contre Le Cancer Eugene Marquis	Rennes	France
Amkggfjnvv Pfsrwswv Hanbhalb Dy Msosdxllk	Marseille	France
Bbglknje Uhtxlqkcmm Hjghxigd Csyqcb	Besançon	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	08.11.2024

Trial locations

Investigated drugs:

NAVIG-1 Vaccine is an experimental vaccine being tested in this clinical trial. It is designed to help the body’s immune system recognize and fight glioblastoma, a type of brain cancer. The vaccine aims to stimulate the immune system to produce a response against specific targets found in glioblastoma cells. The trial is investigating the best dose to use and how well the vaccine can trigger an immune response.

Investigated diseases:

Glioblastoma

Glioblastoma – Glioblastoma is a type of brain cancer that originates from glial cells, which support nerve cells in the brain. It is known for its aggressive nature and rapid growth, often infiltrating surrounding brain tissue. Symptoms can vary depending on the tumor’s location but may include headaches, seizures, and changes in personality or cognitive function. As the disease progresses, these symptoms typically worsen, and new neurological deficits may appear. Glioblastoma is characterized by its tendency to recur even after treatment, making it a challenging condition to manage. The tumor’s growth and impact on brain function can lead to significant changes in a person’s daily life.

Trial ID:

2024-514567-26-00

Protocol code:

APHP240512

Trial Phase:

Phase I and Phase II (Integrated) – First administration to humans

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Study on A49, A52, and Litenimod Sodium for Patients with Glioblastoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?