Early Phase 1 Leukaemia Trial, Recruiting

Written by an AI model from the 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 18 or older, of any gender
• People whose cancer cells have tested positive for a protein called CD19 on B cells
• People who have been diagnosed with B-cell acute lymphoblastic leukemia (a type of blood cancer affecting white blood cells) confirmed by laboratory testing
• People whose leukemia has come back or has not responded to treatment, meaning any one of the following applies: standard chemotherapy did not achieve full remission; full remission was achieved but lasted less than 12 months; the cancer did not respond to one or more further treatments after relapse; or the cancer has relapsed two or more times
• People for whom the treating doctors have determined that other options such as a stem cell transplant using the patient's own cells, or making a CAR-T therapy from the patient's own cells, have already been tried, are not possible, or could not be successfully produced (for example, because not enough of the patient's own immune cells were available or the cells did not grow sufficiently in the lab)
• People whose liver and kidney function blood test results fall within the ranges required by the trial (confirm with trial site)
• People whose blood cell counts — including white blood cells, platelets, and red blood cells — meet the minimum levels required by the trial (confirm with trial site)
• People whose heart is pumping with at least 40% efficiency, as measured by an ultrasound of the heart
• People whose life expectancy is estimated to be more than 3 months
• People who are considered well enough to carry out basic daily activities, based on a standard medical fitness scale (ECOG score of 0, 1, or 2)
• People of childbearing potential who agree to use appropriate contraception before entering the trial, throughout participation, and for 6 months after treatment, as the effects of this therapy on an unborn child are not yet known
• People who are willing to take part and are able to understand and sign a consent form

Who may not be able to join:

• People with known allergies to the medications used to prepare the body before the trial treatment
• People with a history of epilepsy or other conditions affecting the brain or nervous system
• People with a history of a heart condition involving an irregular heart rhythm (prolonged QT) or other serious heart disease
• People who received a stem cell transplant using donor cells (allogeneic transplant) less than 100 days before joining the trial
• People who are HIV-positive
• People with active hepatitis B or hepatitis C infection, or any other active infection that has not been resolved
• People whose immune cells do not respond sufficiently to the stimulation process used to prepare the trial treatment (confirm with trial site)
• People who have taken steroid tablets or injections affecting the whole body (such as prednisone at 20mg or more per day) within 3 days before the screening assessment, unless they are only using steroid creams, inhalers, or nasal sprays; or people who need long-term use of medicines that affect the immune system due to another ongoing health condition
• People who received cancer chemotherapy or other cancer-related medicines within 2 weeks before the screening assessment
• People for whom the trial doctors have identified any other situation that could increase health risks or affect the reliability of the trial results

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