Phase 1 Brain Cancer Trial, Recruiting

Written by an AI model from the 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 diffuse intrinsic pontine glioma (a type of brain tumour in the brainstem) at any point after finishing standard radiation treatment
• Children and young people between 1 and 18 years old
• Both males and females are eligible
• People who already have a small device (such as an Ommaya or Rickham catheter) surgically placed in the brain or spine to allow medication to be delivered directly to the central nervous system
• People whose ability to function day-to-day is rated at 60 or above on standard medical scoring scales, meaning they are able to carry out at least some normal activities
• People with a life expectancy of at least 8 weeks
• People whose liver, kidney, and other organ functions are within acceptable ranges, as measured by blood tests (confirm with trial site for specific values)
• People whose blood oxygen level is at least 90% while breathing normal room air
• People who have completed a wash-out period from previous treatments before the cell collection procedure — this includes waiting at least 7 days after chemotherapy or certain biological therapies, a specified period after antibody-based cancer treatments, at least 30 days after a previous cell therapy infusion, and having any steroid medication stable or being reduced in the week before joining, with a daily dose no higher than a set limit
• People (and/or their legal guardians, for younger participants) who are able to understand and are willing to sign a consent form agreeing to take part

Who may not be able to join:

• People with significant heart problems, including serious heart dysfunction or a heart rhythm problem that needs medical treatment
• People with a pre-existing condition that weakens the immune system or affects bone marrow function
• People showing signs — either physical or on scans — that the brain may be at risk of dangerous swelling or shifting inside the skull
• People with severe difficulty swallowing (above a certain medical grade)
• People with a history of another active cancer, other than certain minor skin cancers or very early-stage cancers in specific areas
• People with other serious uncontrolled illnesses, such as an active infection, uncontrolled heart failure, unstable chest pain, uncontrolled heart rhythm problems, significant lung conditions, or mental health or personal circumstances that would make it difficult to follow the trial requirements
• People who are pregnant or breastfeeding, as the CAR-T cell therapy used in this trial may carry risks to an unborn child or nursing infant — people who could become pregnant must have a negative pregnancy blood test before joining, and people who could become pregnant or father a child must be willing to use contraception from the time of joining and for four months after receiving the cell therapy
• People with active HIV, hepatitis B, or hepatitis C infection — people who test positive for certain hepatitis markers must have a negative confirmatory test before being considered

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