Phase 2 Brain Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been diagnosed with glioblastoma (a type of brain tumour) that is confirmed by tissue testing and is located in a single area of the brain.
• People who have had surgery that removed nearly all of the tumour, leaving no more than 5 ml of tumour remaining, as confirmed by a brain scan (MRI or CT) taken within 72 hours after surgery.
• People whose general health and ability to carry out daily activities meets a minimum level, as measured by standard medical scoring tools (confirm with trial site).
• People aged 18 or older at the time of signing the consent form.
• People with a life expectancy of more than 12 weeks.
• People whose blood infection tests come back negative for HIV, hepatitis B, hepatitis C, and syphilis, and whose heart health checks are normal, making them suitable for a blood cell collection procedure called leukapheresis.
• People who are planned to receive the standard brain tumour treatment combining radiation and chemotherapy (known as the Stupp regimen).
• People who have had enough blood cell material collected through leukapheresis for the vaccine to be manufactured.
• People who have had their tumour tissue sample successfully sent to and accepted by the specialist laboratory responsible for making the vaccine, meeting all required manufacturing standards.
• People who, after completing standard radiochemotherapy, still show no more than 5 ml of remaining tumour on a follow-up MRI and have no signs of the disease progressing.
• People who have recovered from side effects of previous treatments, with any remaining effects being mild (grade 1 or lower on a standard medical scale).
• People whose organ function (such as kidney, liver, and bone marrow) meets the minimum levels required by the trial (confirm with trial site for specific values).
• People willing and able to provide written consent to take part in the trial.

Who may not be able to join:

• People who have a condition that weakens the immune system, or who are taking steroid medications at a dose greater than 10 mg of prednisone (or equivalent) per day, or any other immune-suppressing medication, within 7 days before the first dose of trial treatment.
• People who have an active autoimmune disease that has required systemic medical treatment within the past 2 years. Hormone replacement therapies (such as thyroid medication or insulin) are not considered systemic treatment for this purpose.
• People with a known history of active tuberculosis (TB).
• People who have previously received any type of cancer vaccine.
• People who have had another type of cancer in the past 5 years, except for certain skin cancers or early-stage cervical cancer that was treated with surgery.
• People who have tested positive, either now or in the past, for HIV, hepatitis B, hepatitis C, or syphilis.
• People who have received a live vaccine within 30 days before the planned start of trial treatment.

Important: Always verify eligibility with the trial site directly before applying.