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 written consent and are able to follow all trial requirements
• People aged 18 to 75 years old (any gender)
• People whose cancer cells (in the bone marrow or blood) test positive for a specific protein marker called CD19, as confirmed by a laboratory test
• People who have been diagnosed with B-cell lymphoma that has come back or stopped responding to treatment — including certain slow-growing types (such as follicular lymphoma or marginal zone lymphoma) and faster-growing types (such as diffuse large B-cell lymphoma and related subtypes) — or people with a type of blood cancer called B-cell acute lymphoblastic leukemia (B-ALL) that meets specific relapsed or treatment-resistant conditions (confirm with trial site for full details)
• People whose bone marrow examination shows more than 5% of a specific type of immature cancer 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 measurable area of disease visible on a scan, meeting specific size requirements, along with a positive PET-CT scan
• People whose doctors estimate they have more than 12 weeks of expected survival
• People who score 0 or 1 on a standard scale used to measure how well a person is able to carry out daily activities (ECOG scale)
• People whose liver, kidney, heart, and lung function test results fall within acceptable ranges as determined by the trial (confirm with trial site for specific values)
• People whose blood cell counts are at acceptable levels without needing a recent transfusion (confirm with trial site for specific values)
• People who have stopped certain medications within the required timeframes before receiving the trial treatment, including steroids, immune-suppressing drugs, anti-cancer drugs, certain antibody therapies, and some medications used to prevent cancer spreading to the brain
• People who are able to use effective contraception throughout the study, and for up to 2 years after receiving the trial treatment (applies to both men and women who could potentially have children)

Who may not be able to join:

• People who have active cancer cells in their spinal fluid, brain, or central nervous system (CNS)
• People with a history of active brain or nervous system conditions, such as seizures, stroke, dementia, or autoimmune diseases affecting the brain or nervous system
• People who have taken part in another clinical trial within the past 30 days, or who are still within a required waiting period after another study drug
• People who have previously received certain targeted therapies directed at CD19 or CD3 proteins, unless specific conditions about their immune cell levels and tumour markers are met (confirm with trial site)
• People who have previously received gene therapy or CAR-T cell therapy, unless specific conditions about remaining CAR-T cells and immune cell function are met (confirm with trial site)
• 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 within 72 hours before the infusion)
• People who have had unstable chest pain (angina) or a heart attack within the 6 months before screening
• People who have or have had another type of cancer, with some exceptions for certain fully treated or long-term remission cancers (confirm with trial site for details)
• People with an irregular heartbeat that is not controlled with medication
• People taking blood-thinning medication by mouth within 1 week before the planned 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 receiving the trial treatment (applies to female participants and male participants whose partners may become pregnant)
• People whom the trial investigators consider unsuitable for participation based on medical judgement, safety concerns, or concerns about ability to follow the trial requirements

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