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 between 18 and 70 years old (inclusive).
• People who have a history of glioblastoma (a type of brain tumour) and have been diagnosed with a recurrence of glioblastoma, with some tumour remaining after surgery or biopsy performed at Beijing Tiantan Hospital.
• People who have completed radiotherapy or treatment with temozolomide, bevacizumab, or other drugs at least 4 weeks before joining, and whose side effects from that treatment have mostly resolved (confirm with trial site).
• People whose doctor confirms they are suitable for a specific type of surgical procedure to implant a small device (called an Ommaya reservoir) into the brain to allow fluid drainage.
• People, or their legal representative, who are able to sign a written consent form agreeing to take part.
• People with a functional ability score of 70 or above on a standard scale used to measure how well someone can carry out daily activities (confirm with trial site).
• People whose doctor estimates they have a life expectancy of at least 8 weeks.
• People whose recent blood test results (taken within 14 days before a specific blood collection step) show that white blood cell counts, platelet counts, haemoglobin levels, liver function markers, kidney function, and blood oxygen levels are all within the required ranges (confirm with trial site for specific values).
• People whose blood test shows they are HIV-negative (tested within 14 days before the blood collection step).
• Women who could become pregnant must have a negative pregnancy blood test within 14 days before the blood collection step.
• People of childbearing potential (men and women who have not been surgically sterilised, or women who have not been through menopause for more than one year) who agree to use contraception from the screening period until at least 3 months after the last treatment infusion.

Who may not be able to join:

• People with a functional ability score of 70 or below on the standard daily activity scale (confirm with trial site).
• People with a history of severe allergies or a constitution that makes them highly prone to allergic reactions.
• People with psychiatric or psychological conditions that would make it difficult to cooperate with treatment or assessments.
• People who have taken part in another drug trial within the past 60 days, or who have recently received certain other treatments for glioblastoma, such as stereotactic radiation therapy or carmustine wafer implants.
• People who currently have an active infection, unexplained fever, or a known ongoing infection.
• People with serious or unstable conditions affecting the heart, lungs, liver, kidneys, or blood-forming system, including active hepatitis.
• People with inflammatory or immune system conditions (such as rheumatoid arthritis), or known diseases that affect the immune system.
• People with certain neurological conditions, such as disease spread throughout the membranes surrounding the brain and spinal cord, or degenerative neurological diseases.
• People with a known allergy to immunotherapy or related cell-based treatments.
• People who have previously received any form of gene therapy.
• People who require long-term use of medications that suppress the immune system, for any reason.
• People who have previously had an organ transplant or are currently waiting for one.
• People who are pregnant or breastfeeding.
• People whose doctor determines, for any other reason, that participation in this trial would not be appropriate.

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