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:

• People aged 30 years or younger (note: the first three people enrolled must be at least 18 years old).
• People whose AML cancer cells carry a protein called CD33 (detected by a lab test called flow cytometry), AND whose AML fits at least one of these situations: their leukaemia has come back after a bone marrow/stem cell transplant; their leukaemia came back within 6 months of first being diagnosed; their leukaemia came back more than 6 months after first diagnosis but still shows signs of remaining cancer after at least one attempt at re-treatment; their leukaemia has come back two or more times; or their leukaemia did not respond to two rounds of standard chemotherapy.
• People who are able to undergo a blood cell collection procedure called apheresis, or who already have a suitable stored collection of blood cells that can be used to make the trial treatment.
• People whose doctors estimate they have a life expectancy of at least 8 weeks.
• People for whom a suitable stem cell donor has already been identified.
• People who meet a minimum level of general physical functioning, measured by standard medical scoring tools appropriate for their age (confirm with trial site).
• People who have stopped all cancer treatments for a required period of time before enrolling, and have recovered from any significant side effects — with specific waiting periods depending on which treatments were previously used (confirm with trial site for exact timeframes).
• People whose kidneys, liver, heart, and lungs are functioning at adequate levels, based on blood tests and other measurements (confirm with trial site for exact values).
• People whose blood cell counts and recent virus screening results (for HIV, Hepatitis B, and Hepatitis C) meet the required levels.
• People of childbearing or child-fathering potential who agree to use highly effective contraception from the time of consent until 12 months after receiving the trial treatment.
• People (or their legal representative) who have signed the official consent form for the study.

Who may not be able to join:

• People who have an active cancer other than AML.
• People with a history of, or currently experiencing, significant brain or nervous system conditions unrelated to AML (such as stroke, severe brain injury, dementia, or psychosis) — though people with well-controlled seizure disorders may still be considered eligible (confirm with trial site).
• People whose AML has spread to the brain or spinal fluid in a way that is causing symptoms and, in the treating doctor's opinion, cannot be controlled before the trial treatment is given.
• People who have previously had a stem cell transplant and are currently experiencing graft-versus-host disease (GVHD), or who have taken medication to treat or prevent GVHD within the past 4 weeks.
• People with a serious active infection, indicated by a positive blood culture within the past 48 hours, or a fever combined with signs of infection within the past 48 hours.
• People with a primary immune deficiency condition.
• People who have previously received a type of cancer treatment called virotherapy.
• People who are pregnant or breastfeeding.
• People (or their legal representative) who are not willing to take part in a required 15-year long-term follow-up period after receiving the trial treatment.
• People with any other condition that, in the treating doctor's opinion, would make participation in this trial unsafe or unsuitable.
• People who, in the treating doctor's opinion, would not be able to tolerate the chemotherapy given before the trial treatment (called lymphodepletion).
• People who have a medical reason that prevents them from taking a drug called rapamycin (also known as sirolimus).

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