Phase 1 Peripheral Neuropathy 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:

• Children and young people aged 21 years old or younger
• People who have a solid tumour that tests positive for a protein called B7-H3 (confirmed through a previous biopsy sample, using a specific lab test)
• People whose cancer has come back or has not responded to standard first-line treatment
• People with a life expectancy of more than 8 weeks (more than 12 weeks at the cell collection stage)
• People with a general health and functioning score of at least 50 out of 100 on an age-appropriate scale (confirm with trial site)
• People whose heart is functioning adequately, based on an ultrasound scan showing the heart pumping at least 40% of its volume, or a shortening fraction of at least 25% (confirm with trial site)
• People whose kidneys are working well enough, based on a specific measurement of kidney filtering ability (confirm with trial site)
• People whose lungs are working well enough, measured by blood oxygen levels or a breathing test (confirm with trial site)
• People whose liver function blood test results are within acceptable ranges for their age
• People with a haemoglobin (red blood cell) level of at least 7 g/dL — a blood transfusion to reach this level is permitted
• People with a platelet count above 50,000/uL — a transfusion to reach this level is permitted
• People with an adequate level of infection-fighting white blood cells (neutrophils)
• People who have recovered from any severe side effects caused by previous treatments
• Females of childbearing age who are not pregnant (confirmed by a blood test within 7 days before enrolment) and are not breastfeeding
• Females of childbearing age who agree to use contraception until 3 months after the T-cell infusion, if sexually active (male partners are also asked to use a condom during this period)
• People who have a prepared, personalised T-cell product available that has passed the required quality standards
• People who agree to take part in long-term follow-up monitoring after receiving the genetically modified cell treatment

Who may not be able to join:

• People with a known primary immune system deficiency condition
• People with a known HIV infection
• People with a severe, uncontrolled bacterial, viral, or fungal infection (for example, active hepatitis B, hepatitis C, or adenovirus infection)
• People who have had a serious allergic reaction to products containing mouse-derived proteins
• People who are taking high-dose steroid medication (above a specific daily threshold) in the 7 days before the planned T-cell infusion
• People who are receiving a systemic (whole-body) treatment in the 14 days before the T-cell infusion that the trial doctors believe may interfere with how the treatment works
• People whose disease is considered by the trial doctors to be rapidly worsening

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