Phase 1 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:

• Adults aged 18 or older with a brain tumour diagnosis of glioblastoma (GBM) that tests positive for a specific protein marker called EGFRvIII, confirmed by an approved laboratory test
• People with a performance status score showing they are reasonably functional in daily life (Karnofsky Performance Status score of 70 or above)
• People whose blood counts, kidney function, liver function, heart function, and lung function all meet minimum healthy thresholds as determined by blood and imaging tests
• People whose tumour has a specific genetic feature called unmethylated MGMT promoter (or a methylation index below 3) — this applies to one group in the trial (Cohort 1)
• People who have completed at least the standard radiation treatment (external beam radiotherapy) as their initial brain tumour therapy
• People whose tumour has come back (recurred) and has grown enough to be visible on imaging scans, and where surgery to remove at least 500mg of tumour tissue is considered possible — this applies to a later step in one group (Cohort 2, Step 2)
• People who are willing and able to give informed consent to participate, including consenting to a blood cell collection procedure called apheresis
• People who are not taking systemic (whole-body) steroid medications for at least 3 days before the blood cell collection procedure
• People who are able to attend all required follow-up visits and tests during the study
• People who agree to use reliable double-barrier contraception during the study and for at least 6 months after the last study treatment, including refraining from donating sperm — applies to people who are capable of reproduction (Cohort 2, Step 2)
• Women who could become pregnant must have a negative blood pregnancy test before receiving study treatment

Who may not be able to join:

• People who have received experimental treatments or chemotherapy targeting GBM within the past 4 weeks (specific waiting periods apply: at least 23 days since the last dose of temozolomide or radiotherapy, and at least 6 weeks since the last dose of a drug type called nitrosourea)
• People who have previously received any treatment that targets the EGFR protein (this applies to Cohort 1 and Cohort 2 Step 2)
• Women who are pregnant or breastfeeding
• People with a known addiction to alcohol or illicit drugs
• People whose cancer has spread to the lining of the brain or spinal cord (called leptomeningeal dissemination)
• People with a known condition that affects the immune system, such as HIV, or an autoimmune disorder that requires ongoing systemic immune-suppressing medication (note: non-systemic steroids such as inhaled, nasal spray, eye drops, or skin creams do not automatically disqualify someone — confirm with trial site)
• People with active hepatitis B or C infection; people with certain hepatitis antibody results may also be excluded depending on further test results
• People who have previously had a solid organ transplant or bone marrow transplant
• People with uncontrolled serious ongoing illness, including active infection, heart failure, unstable chest pain, irregular heart rhythm, a second cancer currently being treated or expected to be treated within the next year, or mental health or social circumstances that would make it difficult to follow the study requirements
• People with imaging or clinical signs of uncontrolled pressure or swelling caused by tumour growth in the brain — this is assessed by the study doctors (Cohort 2, Step 2)
• People who are unable to return for the follow-up visits and tests required during the study

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