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:

• You have been diagnosed with a Grade 4 astrocytoma (a type of aggressive brain tumor), confirmed by a tissue sample, and your tumor's genetic markers (IDH mutation and MGMT methylation) have been tested — though the results won't affect eligibility.
• Your brain tumor has come back or grown for the first or second time, shown on an MRI scan, and your doctors believe surgery to remove most of the tumor is possible.
• You have already completed standard treatments, including surgery, radiation therapy, and chemotherapy with temozolomide, with or without a device called Optune/Tumor Treatment Fields.
• You are not currently using any other treatment aimed at curing the cancer, including the Optune device.
• You are able to have regular MRI scans with a contrast dye throughout the study.
• You are between 18 and 75 years old at the time of signing consent.
• You are able to carry out most normal daily activities (measured by a standard scoring system called Karnofsky, score of 70 or above).
• You are either not taking the steroid medication dexamethasone, or are taking a low dose (2mg per day or less), and your neurological condition is stable.
• Your organs (such as kidneys, liver, and blood cells) are functioning well enough, confirmed by tests within 14 days before starting treatment.
• If you or your partner could become pregnant, you must agree to use a highly effective form of birth control from the screening visit until at least 3 months after receiving the study treatment (FT536).
• You must agree to participate in a related long-term follow-up study and sign the consent for it.
• You must give your voluntary written consent before any study-related procedures begin.
• You must be willing and able to stay within approximately 45 minutes' drive of the University of Minnesota (Twin Cities area) from the time of your initial biopsy through discharge after surgery.

Who may not be able to join:

• You have dangerously high pressure in the skull, uncontrolled seizures, or any other urgent brain condition that needs immediate surgery or emergency treatment.
• You have a history of certain blood or bone marrow disorders called myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML), or show signs that suggest these conditions.
• Your MRI shows the cancer has spread to the lining of the brain or spinal cord (called leptomeningeal disease).
• You have previously been treated with a drug called bevacizumab, or any other cell-based therapy, whether as part of a clinical trial or not.
• You have a non-cancerous brain or nervous system disease, such as inflammation of the brain's blood vessels or a degenerative neurological condition.
• You have previously had certain treatments placed directly in the brain, such as GammaTile, Gliadel wafers, other implanted therapies, or light-based (photodynamic) therapy.
• You have any condition that requires you to take medications that suppress the immune system (note: steroid inhalers or creams applied to the skin are allowed).
• You are currently pregnant or breastfeeding; if you could become pregnant, you must have a negative pregnancy test within 14 days before your planned biopsy and agree to use effective birth control for the required period.
• You have tested positive for HIV, or have Hepatitis B or C with a detectable level of virus in your blood.
• You have been diagnosed with another cancer within the last 5 years — with some exceptions, such as certain skin cancers, early-stage cervical changes, early-stage breast cancer, or prostate cancer that has been successfully treated (confirm with trial site).
• You have serious ongoing health conditions that are not well controlled, such as an active infection, heart failure, or unstable chest pain (angina) (confirm with trial site for full list).

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