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 are willing to follow the trial treatment plan and visit schedule, and who agree to sign a written consent form.
• People aged between 18 and 75 years old (inclusive) on the day they sign the consent form, of any gender.
• People whose general physical functioning is rated at 60% or above on a standard performance scale (the Karnofsky scale), meaning they are able to care for themselves and carry out some normal activity (confirm with trial site).
• People who have been diagnosed through tissue or cell testing with glioblastoma (a type of brain tumour) that has come back or stopped responding to treatment, where the tumour tests positive for certain proteins called B7H3 and/or IL13Rα2 (each at more than 30% positive expression), the tumour has continued to grow or returned after standard treatment (surgery, radiotherapy, and chemotherapy with a drug called temozolomide), and there is at least one measurable tumour area of a minimum size based on standard brain tumour measurement guidelines.
• People with an expected survival of at least 12 weeks.
• People whose blood tests show that the bone marrow, liver, kidneys, and heart are functioning within the required ranges set by the trial (confirm specific values with trial site).
• People who agree to use effective contraception from the time of signing the consent form until one year after the last dose of the trial treatment. Women of childbearing age must also have a negative pregnancy test within 7 days before receiving the trial treatment.

Who may not be able to join:

• People whose tumour is located in certain parts of the lower brain, such as the cerebellum, pons, or medulla oblongata.
• People who have cancer that has spread to the membranes surrounding the brain or spinal cord, or where cancer cells have been detected in the fluid around the brain or spinal cord.
• People who have epilepsy (seizures) and/or dangerously high pressure inside the skull that cannot be adequately controlled with medication.
• People who currently have, or have had within the past 6 months, other conditions affecting the brain or nervous system, such as stroke, mini-stroke, or autoimmune diseases affecting the central nervous system.
• People who have been diagnosed with another type of cancer within the past 5 years, with some exceptions for certain early-stage or fully treated cancers (confirm with trial site).
• People who have previously received any treatment specifically targeting the B7H3 or IL13Rα2 proteins.
• People who have previously received gene therapy or cell therapy of any kind.
• People with a history of long-term use of immune-suppressing medications or high-dose steroid medications (inhaled steroids used for conditions like asthma are not affected by this rule).
• People who have previously received a bone marrow or stem cell transplant using cells from another person, or who are planning to undergo a stem cell transplant using their own cells.
• People with an active, uncontrolled infection caused by bacteria, viruses, or fungi.
• People with unstable or serious ongoing health conditions, including certain heart conditions (such as recent heart attack within the past 6 months, unstable chest pain, or significant heart failure), serious irregular heartbeat, or severe lung, liver, kidney, digestive, or metabolic disease.
• People who have taken blood-thinning tablets by mouth within the week before the planned cell infusion treatment.
• People who have received cancer treatments (such as chemotherapy, targeted therapy, immunotherapy, or other anti-tumour treatments) within 4 weeks before the cell infusion, or who have not yet recovered from the side effects of those treatments.
• People who have received radiotherapy within 12 weeks before the cell infusion (some exceptions may apply — confirm with trial site).
• People who have had major surgery or a serious injury within 4 weeks before signing the consent form, have not fully recovered from surgery, or are planning major surgery during the trial.
• People who test positive for hepatitis B, hepatitis C (with detectable virus in the blood), HIV, or active syphilis.
• People who are pregnant or breastfeeding.
• People whom the trial investigators consider unsuitable for participation for any other medical or safety reason.

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