Phase 1 Leukaemia 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:

• Children aged 6 years or younger who weigh at least 7 kilograms (approximately 15 pounds)
• Children whose AML (acute myeloid leukemia) has a specific protein on the cancer cells called FOLR1, confirmed by a specialised laboratory test
• Children whose AML has come back after a stem cell transplant, as detected by a laboratory test
• Children experiencing their first AML relapse within 6 months of their original diagnosis
• Children experiencing their first AML relapse more than 6 months after diagnosis, where a small number of cancer cells are still detectable after at least one attempt at re-induction treatment
• Children experiencing a second or further AML relapse
• Children with AML that has not responded to at least 2 cycles of chemotherapy (known as refractory AML)
• Children whose body is able to tolerate an apheresis procedure (a process of collecting cells from the blood)
• Children with a life expectancy of at least 8 weeks
• Children for whom a suitable stem cell donor has already been identified
• Children with a functional ability score of at least 50 on the Lansky scale, meaning they are reasonably active — children who use a wheelchair but cannot walk due to paralysis may still meet this requirement
• Children whose kidneys are working within an acceptable range for their age, based on a blood test
• Children whose liver function is within acceptable limits, based on blood tests
• Children whose heart function shows a shortening fraction of at least 28% or an ejection fraction of at least 50%, as measured by an echocardiogram (heart ultrasound)
• Children whose blood oxygen level is at least 92% while breathing normal room air, without needing extra oxygen or a breathing machine
• Children with a minimum level of a certain type of white blood cell (lymphocytes) in their blood
• Children who have tested negative for HIV, Hepatitis B, and Hepatitis C within the 3 months before enrolling
• Children who have stopped all anti-cancer treatments and radiation for the required period before enrolling, and who have recovered from significant side effects of prior treatment, according to the treating doctor's assessment (confirm specific washout periods with trial site)
• Children who have previously received gene-modified cell therapy, provided the required waiting period has been met (confirm details with trial site)
• Children whose parent or legal guardian has signed the informed consent form for the study

Who may not be able to join:

• Children who have an active cancer other than AML
• Children with a history of, or currently experiencing, significant nervous system or brain disease unrelated to AML (such as stroke, severe brain injury, dementia, or movement disorders) — note that children with non-fever-related seizures that are controlled by medication and have had no seizures in the past month may still be considered eligible (confirm with trial site)
• Children with AML that has spread to the brain or spinal cord in a way that is causing symptoms and cannot be managed between enrolment and the cell therapy infusion, in the treating doctor's opinion
• Children who have previously had a stem cell transplant and are currently experiencing graft-versus-host disease (GVHD), or who have received medication to treat or prevent GVHD within the 4 weeks before enrolling
• Children who have previously had a stem cell transplant and received a donor lymphocyte infusion (DLI) less than 8 weeks before enrolling
• Children with an active serious infection, defined as a positive blood culture within 48 hours of enrolling, or a fever above 38.2°C combined with signs of infection within 48 hours of enrolling
• Children with a primary immune deficiency condition
• Children who have previously received virotherapy (a treatment that uses viruses to fight cancer)
• Children whose parent or legal guardian is unwilling to agree to a 15-year long-term follow-up period, which is required if the CAR T cell therapy is administered
• Children who, in the treating doctor's opinion, would be unable to tolerate the lymphodepleting treatment (a preparatory treatment given before cell therapy)
• Children who, in the treating doctor's opinion, have any other condition that would prevent safe participation in the trial

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