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:

• The child's parent or legal guardian fully understands the study, agrees to take part by signing a consent form, and is willing to follow all study procedures.
• The child is between 1 and 18 years old, of any gender, weighs at least 10 kg, and is from China.
• A bone marrow test taken on day 46 after initial treatment (induction remission) still shows signs of the disease remaining (called MRD positive).
• Within the 3 months before screening, tests on bone marrow or blood cells show that the cancer cells carry certain markers called CD19 and/or CD22.
• The child's major organs are working well enough to meet specific test result thresholds — including liver enzymes, bilirubin, breathing ability, heart function (pumping at least 50%), and kidney function (confirm specific values with trial site).
• The child meets a minimum score on a standard health and activity scale — one scale is used for children under 16, and another for those 16 and older (confirm with trial site).
• The child is expected to survive for at least 12 weeks.
• The child has suitable veins for blood collection or a blood separation procedure, with no medical reasons preventing this.

Who may not be able to join:

• The child has a genetic condition, unless it is Down syndrome.
• The child has a history of another type of cancer, or currently has another cancer at the same time.
• The child tests positive for certain infections, including active Hepatitis B, Hepatitis C, HIV, syphilis, Epstein-Barr virus (EBV), or cytomegalovirus (CMV) at levels above normal limits.
• The child has a current infection (fungal, bacterial, viral, or other) that is not under control or that requires treatment through a drip (intravenous medication).
• The child received a long-acting white blood cell growth injection (long-acting G-CSF) within 21 days before screening, or a short-acting version within 7 days before screening.
• The child has active leukemia affecting the central nervous system (brain and spinal cord).
• The child has a known allergy to albumin or a class of antibiotics called aminoglycosides.
• The child has previously had an organ transplant (other than a stem cell transplant).
• The child has taken part in another interventional clinical trial within the 3 months before screening, or plans to join another trial or receive other cancer treatments during this study.
• The child's major organs are not functioning well enough to tolerate chemotherapy or a serious immune reaction called cytokine storm.
• The trial doctor identifies another reason that makes participation unsuitable for the child.

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