Phase 2 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:

• People who have signed written informed consent (and for children, a parent or legal guardian must also sign) before any study procedures begin
• Children and teenagers aged 3 to 18 years who weigh at least 10 kg
• People whose acute lymphoblastic leukaemia (ALL) has come back after treatment or has not responded to treatment
• People whose cancer cells have tested positive for a protein called CD19, confirmed by a bone marrow or blood test within the past 3 months
• People whose bone marrow shows at least 5% leukaemia cells at the time of screening
• People who meet a minimum physical functioning level, measured by a standard health scoring tool used by doctors (confirm with trial site)
• People who have adequate kidney and liver function at the time of screening

Who may not be able to join:

• People whose leukaemia has spread to the central nervous system (brain and spinal cord)
• People whose leukaemia has relapsed only outside the bone marrow, with no bone marrow involvement
• People diagnosed with specific types of leukaemia, including Burkitt's lymphoma/leukaemia, mixed phenotype acute leukaemia, or a condition called Chronic Myelogenous Leukaemia in Blast Crisis
• People who have a history of a genetic syndrome occurring alongside their leukaemia
• People who have had a serious immune reaction after a stem cell transplant (called graft-versus-host disease) within the 4 weeks before screening
• People with an active autoimmune disease affecting their whole body
• People with a known HIV infection, or ongoing hepatitis B or hepatitis C infection
• People who have an active infection at the time of screening
• People who received certain chemotherapy treatments before the study treatment infusion (confirm specific drugs with trial site)
• People who received radiation therapy to non-brain/spinal cord areas less than 4 weeks before the study treatment infusion, or radiation to the brain/spinal cord area less than 8 weeks before the infusion
• People who received a donor lymphocyte infusion (a type of immune cell treatment) less than 6 weeks before the study treatment infusion
• People who have previously received any CAR-T cell therapy
• People whose life expectancy is less than 3 months

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