Early 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 people with B-ALL (a type of blood cancer affecting B-cells):

• People aged 3 to 70 years
• People who have been diagnosed with a type of B-cell leukemia called CD19+ B-ALL, confirmed by laboratory testing according to established medical guidelines
• People whose cancer has come back or has not responded to treatment, meaning one of the following applies: standard chemotherapy did not achieve remission; remission was achieved but lasted less than 12 months; one or more follow-up treatments did not work; or the cancer has relapsed two or more times
• People whose bone marrow testing shows a certain level of abnormal cancer cells (above specific thresholds measured by two different laboratory methods)
• People whose cancer does not carry a genetic change called the Philadelphia chromosome, OR people who do carry this change but cannot tolerate, or have not responded to, two specific targeted treatments called TKIs

For people with B-NHL (a type of blood cancer affecting B-cells in the lymph system):

• People aged 18 to 75 years
• People who have been diagnosed with one of several specific types of B-cell lymphoma, confirmed by laboratory testing according to established medical guidelines (including DLBCL, FL, DLBCL transformed from CLL/SLL, PMBCL, or HGBCL)
• People whose cancer has come back or has not responded to treatment, meaning one of the following applies: the cancer did not respond or relapsed after at least two lines of chemotherapy; the cancer showed primary resistance to treatment; or the cancer relapsed after a stem cell transplant using the person's own cells
• People who have at least one measurable area of cancer that can be tracked during the trial, as assessed using standard 2014 Lugano criteria

For all participants (both B-ALL and B-NHL):

• People whose liver and kidney function test results fall within the acceptable ranges specified by the trial
• People whose heart is pumping at least 50% of its normal capacity, as shown on an ultrasound of the heart
• People with no active lung infection and whose blood oxygen levels in normal indoor air are at or above 92%
• People whose expected survival is at least 3 months
• People who are well enough to carry out basic daily activities, rated 0 to 2 on a standard medical scale called the ECOG scale
• People, or their legal guardians, who agree to take part and sign a consent form

Who may not be able to join:

• People with a history of serious brain or neurological conditions, including head trauma, loss of consciousness, epilepsy, stroke, or bleeding in the brain
• People with certain heart conditions, including a prolonged QT interval on a heart tracing (ECG) or a history of serious irregular heart rhythms
• People who are pregnant or breastfeeding
• People with serious active infections (minor infections such as urinary tract infections or bacterial throat infections may not exclude someone — confirm with trial site)
• People with an active hepatitis B or hepatitis C infection
• People who have been taking steroid tablets or injections (not inhaled steroids) within the two weeks before the screening visit
• People who have previously received CAR-T cell therapy or any other type of genetically modified T-cell treatment
• People whose kidney or liver function test results fall outside the acceptable ranges specified by the trial
• People with other serious uncontrolled medical conditions that the trial team considers unsuitable
• People with HIV infection
• People who the trial investigators believe may face increased risk or whose participation may affect the reliability of the study results

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