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:

For the collection and manufacturing stage:

• People under 21 years old
• People with acute leukemia that has come back or stopped responding to treatment, where the leukemia cells carry certain markers (CD19 and/or CD22), confirmed by testing within the past 2 months and after receiving a treatment targeting those markers
• People whose leukemia has relapsed at least twice, or has relapsed at any point after a bone marrow/stem cell transplant from a donor, or whose leukemia has not responded to treatments meant to cause remission
• People with an estimated life expectancy of more than 12 weeks
• People with a physical functioning score of 50 or above on an age-appropriate medical scale (confirm with trial site)
• Females of childbearing age who are not breastfeeding and not pregnant, with a negative pregnancy test within 7 days before enrolling

For the treatment stage:

• People under 21 years old
• People with leukemia that can be detected in the bone marrow at the time of treatment
• People with an estimated life expectancy of more than 8 weeks
• People with a physical functioning score above 50 on an age-appropriate medical scale (confirm with trial site)
• People with adequate heart function, based on specific heart measurements (confirm with trial site)
• People with a normal heart rhythm tracing (ECG/EKG) showing no significant irregularities
• People with adequate kidney function based on standard medical measurements (confirm with trial site)
• People with adequate lung function based on breathing tests or blood oxygen levels (confirm with trial site)
• People with liver values within acceptable ranges based on age-specific guidelines (confirm with trial site)
• People who have recovered from serious side effects caused by previous treatments
• People who have had a donor stem cell transplant must be at least 3 months past that transplant, with no signs of a serious transplant complication called acute GVHD, and must not have received a specific type of follow-up transplant treatment within the past 28 days
• Females of childbearing age who are not breastfeeding, not pregnant (with a negative pregnancy test within 7 days before enrolling), and who agree to use contraception until 3 months after the cell infusion if sexually active; male partners should use a condom

Who may not be able to join:

• People with a known condition where the immune system does not work properly from birth (primary immunodeficiency)
• People known to be HIV positive
• People who cannot receive the specific chemotherapy used in this trial to prepare the body before treatment (confirm with trial site)
• People who have had a serious allergic reaction to products containing mouse-derived proteins
• People with a severe, uncontrolled bacterial, viral, or fungal infection (treatment stage only)
• People with active, advanced leukemia spread to the fluid around the brain and spinal cord, called CNS-3 disease (treatment stage only)
• People with active, uncontrolled neurological (brain or nervous system) conditions (treatment stage only)

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