Early Phase 1 Stomach Cancer 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 diffuse large B-cell lymphoma (a type of aggressive blood cancer) or B-cell acute lymphoblastic leukemia (another blood cancer), including certain related subtypes, where the disease has come back or has not responded to previous treatment.
• People with the lymphoma type (DLBCL) who have already been through 2 or more prior treatment combinations that included specific chemotherapy and antibody-based drugs, and whose cancer still needs treatment — or people with a specific subtype called Richter syndrome, where only 1 prior treatment combination is required.
• People with the leukemia type (B-ALL) whose cancer did not respond to, or came back after, at least 1 full course of chemotherapy (or, for a specific genetic subtype, after treatment with targeted medicines called tyrosine kinase inhibitors).
• People whose cancer cells show a specific protein marker called CD19 on their surface, confirmed by laboratory testing — this applies even if a person has previously received treatments targeting CD19.
• People aged 18 or older.
• People whose kidneys are functioning well enough, as measured by a standard calculation called the Cockroft-Gault formula (a clearance rate of at least 50 mL/min).
• People whose liver function test results are within acceptable ranges, unless any abnormality is thought to be caused by the cancer itself.
• People whose blood oxygen level is at least 92% when breathing normal room air.
• People whose bone marrow is producing enough blood cells — including a minimum level of infection-fighting cells, platelets, and red blood cells — without needing recent blood transfusions or injections to boost blood cell production (unless low counts are due to the cancer itself).
• People who are well enough to carry out basic daily activities, rated 0, 1, or 2 on a standard medical fitness scale (called the ECOG scale).
• People who have detectable signs of remaining cancer at a specific assessment point before receiving the cell therapy part of the treatment.

Who may not be able to join:

• People who are too unwell to carry out basic self-care, rated 3 or higher on the ECOG fitness scale.
• People who are pregnant or currently breastfeeding. People who could become pregnant are required to use effective contraception during the study and for 1 year after all treatment is completed.
• People whose heart is not pumping blood effectively enough, with a pumping function below 40% as measured by a heart scan.
• People who are experiencing active graft-versus-host disease (a complication from a previous bone marrow transplant) that requires medicines to suppress the immune system.
• People who have an active autoimmune condition that requires medicines to suppress the immune system.
• People with significant heart conditions, including severe heart failure (classified as stage III or IV), a heart attack within the past 6 months, a history of serious irregular heart rhythms or unexplained loss of consciousness, or a history of severe heart muscle weakness.
• People who currently have, or have previously tested positive for, HIV, hepatitis B, or hepatitis C — with some exceptions: people whose hepatitis B result is only positive due to prior vaccination (confirmed by specific blood tests), and people who have hepatitis B or C antibodies but show no detectable virus in the blood and have adequate organ function, may still be considered eligible (confirm with trial site).
• People who have an active, uncontrolled infection — whether fungal, bacterial, viral, or other.
• People who have another active cancer that currently requires treatment beyond monitoring or hormonal therapy (skin cancers of the squamous or basal cell type are excepted).
• People with a significant history of serious neurological conditions such as epilepsy, a generalised seizure disorder, or severe brain injury.
• People whose blood has been found to contain antibodies against a specific mouse-derived protein (called BC8) at the initial screening stage.
• People who, in the treating doctor's judgement, have any other condition that would make participation in the study inappropriate.

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