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:

• People aged 18 to 75 years old at the time of signing the consent form
• People who have been diagnosed with glioblastoma (a specific type of aggressive brain tumour, graded as WHO grade 4) or a related high-grade brain tumour (WHO grade 3 or 4) that has come back or continued to grow after standard treatment
• People who are planned to have a surgical tumour removal or a needle biopsy, or who have stored tumour tissue already available, so that the tumour can be tested and a small tube (catheter) can be placed if needed
• People whose tumour tests positive for at least two specific proteins on its surface — IL13Rα2, EGFR (including a specific altered form called EGFRvIII), or B7-H3 — at levels above the amounts defined in the trial protocol
• People with a Karnofsky Performance Status score of 60 or higher, which is a medical rating of general physical functioning (confirm with trial site)
• People with blood, kidney, and liver function that meets the specific laboratory levels set out in the trial protocol
• People who are able to have a brain MRI scan with contrast dye, or where an alternative type of scan is permitted if MRI is not possible
• Women who could become pregnant must have a negative pregnancy test before joining, and all participants must agree to use effective contraception during the trial and for a set period after treatment, as defined in the trial protocol
• People who are able to understand the study information and are willing to sign the consent form

Who may not be able to join:

• People who have an active, uncontrolled infection, including bacterial, viral, or fungal infections
• People with HIV where the virus is not controlled, or people with active hepatitis B or hepatitis C with detectable levels of the virus in their blood (unless the trial protocol specifically allows it)
• People who have a significant autoimmune disease — where the immune system attacks the body — that has required whole-body (systemic) immune-suppressing medication within the past 6 months
• People who need high doses of steroid medication (such as more than 4 mg per day of dexamethasone or an equivalent amount of another steroid) within the 7 days before the treatment infusion, though low-dose steroids taken for other medical reasons may be permitted
• People who have received a gene-modified cell therapy (such as a CAR-T or CAR-NK cell treatment) within the past 6 months, or who have previously had treatment targeting the same proteins (IL13Rα2, EGFR/EGFRvIII, or B7-H3) if leftover engineered cells could affect how safe results are assessed
• People whose cancer has spread only to the lining of the brain and spinal cord with no other tumour site, or whose brain anatomy makes it unsafe to place the required catheter tube (unless specifically allowed by the protocol)
• People who have seizures that are not controlled despite the best available medical treatment
• People with serious heart or cardiovascular conditions — such as a recent heart attack or an uncontrolled irregular heartbeat — that would increase the risk of the treatment procedures used in this trial
• People who are pregnant or breastfeeding
• People who have any other condition that the trial doctor judges would make participation unsafe or would make it difficult to follow the trial requirements

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