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 who have given written consent to participate (or whose legal representative has done so) before any screening begins
• People aged 18 to 70 years old at the time of signing the consent form
• People who have been diagnosed with acute myeloid leukemia (AML) — a type of blood cancer — that has either come back after treatment (relapsed) or has not responded to standard treatment (refractory), as defined by specific Chinese medical guidelines
• People whose leukemia cells have tested positive for two specific proteins called CLL-1 and CD33, confirmed by a blood or bone marrow test called flow cytometry
• People who have detectable leukemia cells in their bloodstream at screening must have those cells test negative for two specific markers (CD4 and CD8) on their cell surface, confirmed by flow cytometry
• People with a general health and activity level rated at 0, 1, or 2 on a standard medical scale (ECOG), meaning they are able to carry out most daily activities (confirm with trial site)
• People whose doctors expect them to survive for more than 3 months
• Women who could become pregnant must have a negative pregnancy test and must use effective contraception for 1 year after receiving the treatment; men who could father children must use effective barrier contraception and must not donate sperm for 1 year after receiving the treatment

Who may not be able to join:

• People who have previously received CAR-T cell therapy or any other type of genetically modified cell therapy
• People with serious problems affecting a major organ, including significantly reduced kidney function, liver enzyme or bilirubin levels above certain thresholds, a weakened heart pump function, low blood oxygen levels, or uncontrolled serious heart disease (confirm specific thresholds with trial site)
• People with active, uncontrolled infections — including active hepatitis B, hepatitis C, HIV, syphilis, or uncontrolled Epstein-Barr virus (EBV) or cytomegalovirus (CMV) infections
• People with an unstable, serious illness affecting the whole body that requires ongoing medication to manage
• People who have had significant bleeding (grade 2 or higher) in the 30 days before screening, or who are on long-term blood-thinning medication
• People with an uncontrolled, life-threatening bacterial, fungal, or viral infection
• People with a non-leukemia-related brain or nervous system disease, or with active leukemia that has spread to the central nervous system (previously treated CNS leukemia that has fully resolved may be permitted — confirm with trial site)
• People who currently have another active cancer, unless it was a cured localised cancer or a cancer that has been in complete remission for 5 or more years
• People who have received a live vaccine within 30 days before screening, or who plan to receive one within 3 months after the CAR-T treatment
• People who have taken part in another clinical drug trial within the 3 months before signing the consent form
• People who have had a donor stem cell transplant within 6 months before screening
• People who are pregnant or breastfeeding
• People with a tendency toward suicidal thoughts, or with ongoing dependence on alcohol or illicit drugs
• People with a known allergy or sensitivity to any component of the trial treatment or related medications
• People whom the trial doctor considers unsuitable for the trial for any other reason

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