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 are willing to give their consent and are able to follow all trial requirements
• People aged 12 to 75 years old, of any gender
• People whose cancer cells (in bone marrow or blood) test positive for a marker called CD19, confirmed by a lab test
• People diagnosed with a type of B-cell blood cancer that has come back or stopped responding to treatment — including certain slow-growing lymphomas (such as follicular lymphoma or marginal zone lymphoma), aggressive lymphomas (such as diffuse large B-cell lymphoma and related types), or a type of leukemia called B-cell acute lymphoblastic leukemia (B-ALL) that meets specific conditions around prior treatments and responses
• People whose bone marrow testing shows more than 5% of a specific type of abnormal cell
• People who have not had a stem cell transplant in the 6 months before joining the trial
• People with B-cell lymphoma who have at least one area of cancer that is large enough to be measured on a scan, and whose PET-CT scan shows active disease
• People with an expected survival of more than 12 weeks
• People with a general health score of 0 or 1 on a standard scale used by doctors (meaning fully active or able to carry out light work)
• People whose liver, kidney, heart, and lung function results fall within acceptable ranges as determined by blood tests and other assessments
• People with adequate blood cell counts without needing a transfusion to achieve them
• People who have stopped certain medications within the required timeframes before the treatment infusion (including steroids, immune-suppressing drugs, anti-cancer therapies, CD20 antibody treatments, and certain preventive treatments for the central nervous system)
• People who are able to use effective contraception throughout the study, as required based on their situation

Who may not be able to join:

• People who have active cancer cells in the fluid around the brain or spinal cord, brain spread of cancer, or active lymphoma or leukemia affecting the central nervous system
• People with a history of certain active brain or nervous system conditions, such as seizures, stroke, dementia, or autoimmune diseases affecting the brain
• People who have taken part in another clinical drug trial within the 30 days before screening, or who are still within a required waiting period after a previous trial
• People who have previously received certain CD19-targeted or CD3-targeted treatments (with some exceptions that the trial site can confirm)
• People who have previously received any gene therapy, including CAR-T cell therapy (with some exceptions that the trial site can confirm)
• People who have had radiation therapy within 2 weeks before the planned treatment infusion
• People with active hepatitis B, hepatitis C, HIV, or syphilis infections
• People with a serious, uncontrolled infection (such as a positive blood culture in the 72 hours before infusion)
• People who have had unstable chest pain or a heart attack within 6 months before screening
• People with a separate, additional cancer diagnosis — with some exceptions for certain fully treated skin cancers, cervical or breast cancer in situ with no signs of return for at least 3 years, or another cancer that was completely removed and has been in full remission for 5 years
• People with an irregular heartbeat that is not controlled with medication
• People taking blood-thinning medication by mouth within 1 week before the treatment infusion
• People with active autoimmune or inflammatory conditions affecting the nervous system (such as Guillain-Barré syndrome or ALS)
• People who are pregnant, breastfeeding, or planning a pregnancy within 2 years after the treatment infusion, or whose male partner is planning a pregnancy within that time
• People for whom the trial team believes participation would carry unacceptable health risks or who are unlikely to be able to follow the trial requirements

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