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 who have been diagnosed with a high-grade brain tumor (WHO Grade IV), such as glioblastoma or related types, confirmed by a tissue sample, tested as IDH wild-type, where the tumor has come back or grown after standard first-line treatment.
• People whose tumor has returned for the first time after standard treatment, and where surgery to remove most of the visible tumor is considered a realistic option as part of their care.
• People between 18 and 75 years old (inclusive).
• People who have a performance score of 60 or above on the Karnofsky scale, meaning they are able to care for themselves and carry out some normal activities (confirm with trial site).
• People whose steroid use is limited to no more than 4 mg of decadron (dexamethasone) per day.
• People whose blood, kidney, liver, and heart function meet specific healthy levels at the time of screening — including sufficient red blood cells, white blood cells, platelets, kidney filtering rate, liver enzyme levels, clotting levels, heart pumping function of at least 45%, and blood oxygen levels above 92% while breathing normal air.
• People of childbearing or child-fathering potential who are willing to use effective contraception during the study and for at least 4 months after the last treatment, or for as long as the treatment cells remain detectable in the body.
• All female participants of childbearing age must have a negative pregnancy test before joining.
• People who are able to understand the study and are willing to sign a consent form.
• People who are willing and able to attend all required visits and follow all study procedures at Stanford Health Care.
• People who have had at least 6 weeks pass since finishing front-line radiation therapy.
• People who have had at least 3 weeks, or 5 half-lives (whichever is shorter), pass since their last chemotherapy or systemic treatment (5 half-lives required for immune checkpoint therapies).
• People who have had at least 4 weeks pass since bevacizumab (Avastin) treatment, if it was used only for radiation necrosis or pseudo-progression.
• People who have had at least 4 weeks pass since any other prior cancer treatment, including experimental therapies.
• People whose side effects from prior treatment have settled to a mild or minimal level (Grade 1 or below), apart from things like hair loss that are not medically significant.

Who may not be able to join:

• People who are pregnant or breastfeeding.
• People who have previously received or are currently receiving Avastin (bevacizumab) specifically to treat their recurrent brain tumor (use for radiation necrosis may be acceptable — confirm with trial site).
• People who have previously received a CAR T-cell therapy (a type of immune cell-based treatment).
• People who have a known allergy or sensitivity to any substances used in this study.
• People who require blood-thinning medications that cannot be safely paused for surgery and a related procedure to place a device in the brain (Ommaya reservoir).
• People who have had another cancer diagnosis, unless it was fully treated more than 3 years ago and is considered unlikely to return (confirm with trial site).
• People who have signs of dangerous pressure buildup in the brain or seizures that are not under control.
• People who have an active, uncontrolled infection requiring intravenous antibiotics or antifungals (minor infections that are responding to treatment may be acceptable — confirm with trial site).
• People with a known history of HIV, or active hepatitis B or C infection (a past hepatitis B or C infection may be acceptable if the virus is undetectable on testing — confirm with trial site).
• People with a primary immune system disorder, or a history of autoimmune disease (such as Crohn's disease, rheumatoid arthritis, or lupus) that has caused organ damage or required immune-suppressing treatment within the last 2 years.
• People with serious or poorly controlled medical conditions, such as uncontrolled high blood pressure, heart disease, diabetes, chronic lung disease, kidney failure (including people on dialysis), significant liver problems, active infection, or immune system suppression for reasons other than the brain tumor.
• People who have had a bone marrow or stem cell transplant in the past.
• People who, in the treating doctor's judgment, are unlikely to complete all required study visits, procedures, and follow-up requirements.

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