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 been diagnosed with B cell acute lymphoblastic leukemia (a type of blood cancer) that has come back or stopped responding to treatment, confirmed by a biopsy.
• People whose cancer cells have been tested and shown to carry two specific proteins called CD19 and CD22, at any level.
• People whose disease meets the requirements for a commercially available treatment called KYMRIAH® (tisagenlecleucel), meaning the disease either did not respond to initial treatment or has relapsed at least twice.
• People aged 1 year old up to and including 25 years and 364 days old at the time of joining the trial.
• People who have a performance level of at least 50% on standard medical scales used to measure how well someone is functioning day-to-day (confirm with trial site for which scale applies by age).
• People whose blood counts and organ function (kidneys, liver, lungs, and heart) meet certain minimum levels set by the trial, including oxygen levels above 92% while breathing normal air and a heart pumping function of at least 40%.
• People who have or have had leukemia involvement in the brain or spinal cord, as long as there are no active neurological symptoms that could interfere with safety monitoring.
• People who have had a stem cell transplant using their own cells (autologous), if the disease has since come back.
• People who have had a stem cell transplant using a donor's cells (allogeneic), as long as it was at least 100 days ago, there is no active graft-versus-host disease, and immunosuppressive medications have been stopped for at least 30 days before joining.
• People who have had a previous CAR T-cell therapy, as long as at least 30 days have passed before the cell collection procedure.
• People who have recovered from the acute side effects of any previous cancer treatments, and who have completed the required waiting period since their last treatment (confirm specific timeframes with trial site).
• Women of childbearing potential who have a negative pregnancy test before joining.
• Women of childbearing potential and men who are able to father children who are willing to use birth control during treatment and for 4 months after chemotherapy, or for as long as CAR T cells remain detectable in the blood.
• People aged 18 and over who are able to give their own informed consent; for those under 18, a parent or legal guardian must provide consent on their behalf.

Who may not be able to join:

• People who have HIV, active Hepatitis B, active Hepatitis C, or another serious uncontrolled illness.
• People who have an extremely high number of leukemia cells in their blood (50,000 or more blast cells per microlitre) or whose disease is advancing so rapidly that completing the study treatment may not be possible.
• People who have had a severe allergic reaction to any treatment that is chemically or biologically similar to the drugs used in this trial.
• People who have an active brain or nervous system disorder, or who have had a heart attack, heart procedure (such as stenting or angioplasty), unstable chest pain, or other significant heart condition within the 12 months before joining.
• People who have a primary immune system deficiency or an autoimmune condition (such as Crohn's disease, rheumatoid arthritis, or lupus) that has required systemic immune-suppressing or disease-modifying treatment within the past 2 years.

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