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 medulloblastoma or another type of primary brain embryonal tumour (such as ETMR, Pineoblastoma, ATRT, CNS neuroblastoma FOXR2-activated, or CNS Embryonal Tumour NOS), confirmed by laboratory testing of tumour tissue according to the 2021 WHO classification system.
• People whose tumour has come back or continued to grow after initial treatment that was intended to cure the disease.
• People whose tumour tissue has tested positive for a protein called GPC2 (with an H-score of 100 or higher), as measured by a specific laboratory test performed at Stanford's pathology lab through a pre-screening process.
• People who have measurable signs of disease, either on a brain scan or in a cerebrospinal fluid (fluid around the brain and spine) test, done within 28 days of joining the trial.
• People who have a certain type of brain fluid drainage device (VP shunt) must have one that is programmable — though having this device is not required to join.
• People who have had any number of previous treatments, as long as any side effects from those treatments have settled down or are mild, and enough time has passed since the last treatment (the required waiting periods vary depending on the type of treatment received — confirm details with the trial site).
• People between 12 months and 30 years of age at the time of joining (note: the first three people treated must be at least 3 years old at the time of the cell infusion).
• People with a sufficient level of physical functioning, as measured by standard medical scoring tools — for those 16 and older, a Karnofsky score of at least 60% is required; for those under 16, a Lansky score of at least 60% or an ECOG score of 2 or below is required.
• People whose blood counts and organ function (including kidneys, liver, heart, and lungs) meet specific minimum levels set by the trial (confirm exact values with the trial site).
• People who are not pregnant — those who could become pregnant must have a negative pregnancy test before joining.
• People who are willing to use reliable birth control from the time of joining until at least 4 months after receiving the preparative treatment, or for as long as the trial's CAR T cells remain detectable in the blood.
• People (or their parent or legal guardian, for those under 18) who are able to give informed consent to participate.

Who may not be able to join:

• People whose cancer has spread to parts of the body outside the brain and central nervous system.
• People who are unable or unwilling (in the medical team's judgement) to have a small fluid reservoir device surgically placed in the head — this does not apply to people who already have a suitable device in place.
• People showing active signs of dangerously raised pressure inside the skull, or who have seizures that are not under control.
• People who have previously received any CAR T-cell therapy.
• People who are currently taking blood-thinning (anticoagulation) medication.
• People with a known active HIV infection, or active hepatitis B or C — though a past history of hepatitis B or C may be acceptable if the virus is no longer detectable on testing.
• People who are pregnant or currently breastfeeding.
• People with a known allergy or sensitivity to any substances used in this trial.
• People with a history of another cancer, unless it was fully treated more than 5 years ago and is considered to carry a low risk of returning (confirm with trial site).
• People with a primary immune system disorder, or a history of certain autoimmune diseases (such as Crohn's disease, rheumatoid arthritis, or lupus) that have caused organ damage or required immune-suppressing medication within the last 2 years.
• People who have had a heart attack, heart procedure (such as angioplasty or stenting), unstable chest pain, or another significant heart condition within the past 12 months.
• People with other serious or poorly controlled medical conditions that the medical team believes would place them at unacceptable risk — this includes conditions such as uncontrolled diabetes, serious lung disease, kidney failure (including those requiring dialysis), significant liver problems, or other conditions requiring long-term immune-suppressing treatment.
• People (or their parent or carer) who, in the medical team's judgement, are unlikely to be able to follow the trial's required procedures and follow-up visits.

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