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:

For the initial cell collection stage (apheresis and manufacturing):

• People who have CD19-positive leukemia (a specific type of leukemia confirmed by a lab test within 3 months before joining) that has not responded to treatment, has come back after treatment, has returned after a bone marrow/stem cell transplant from a donor, or has come back for the first time in a patient who would normally need a donor transplant but has been found not suitable for one
• People aged 21 years or younger
• People with a general health and activity level that meets a minimum score on a standard medical assessment tool (confirm with trial site)
• People with a life expectancy of more than 12 weeks
• People who have had a prior donor stem cell transplant must have recovered from it, have no signs of a complication called graft-versus-host disease (GVHD), and must not have received a type of immune cell treatment called donor lymphocyte infusion in the 28 days before cell collection
• Females of childbearing age who are not pregnant (confirmed by a blood test within 7 days before joining) and are not breastfeeding

For the treatment stage (CAR T cell infusion):

• People aged 21 years or younger
• People with a life expectancy of more than 8 weeks
• People who still have detectable leukemia at the time of treatment
• People who have had a prior donor stem cell transplant must be at least 3 months past that transplant, have no active GVHD, and must not have received donor lymphocyte infusion in the 28 days before the planned treatment
• People whose heart is functioning adequately, as measured by specific heart tests (confirm with trial site)
• People with a heart tracing (ECG) that shows no significant irregular heartbeat
• People whose kidneys are functioning at or above a minimum level as measured by standard tests (confirm with trial site)
• People whose lungs are functioning adequately, as measured by breathing tests or blood oxygen levels (confirm with trial site)
• People with a general health and activity level that meets a minimum score on a standard medical assessment tool (confirm with trial site)
• People whose liver function blood test results are within an acceptable range for their age (confirm with trial site), with a specific exception for people with a condition called Gilbert's syndrome
• People who have recovered from serious side effects caused by previous treatments
• Females of childbearing age who are not pregnant (confirmed by a blood test within 7 days before treatment), are not breastfeeding, and if sexually active, agree to use contraception until 6 months after the treatment infusion

Who may not be able to join:

For the initial cell collection stage:

• People with a known inherited condition that severely affects the immune system
• People with a history of HIV infection
• People currently experiencing a severe active bacterial, viral, or fungal infection
• People who have had a serious allergic reaction to products containing mouse-derived proteins
• People for whom the chemotherapy used in this trial to prepare the body before treatment is medically not suitable

For the treatment stage:

• People with a high level of leukemia involvement in the central nervous system (brain and spinal fluid), classified as CNS-3 (confirm with trial site)
• People with a known inherited condition that severely affects the immune system
• People with a history of HIV infection
• People with active, uncontrolled neurological (brain or nerve) conditions
• People with a severe, uncontrolled bacterial, viral, or fungal infection
• People who have had a serious allergic reaction to products containing mouse-derived proteins
• People for whom the chemotherapy used in this trial to prepare the body before treatment is medically not suitable

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