Phase 1 Stomach Cancer 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 to 75 years (inclusive)
• People who are able to understand the study and willing to sign a consent form agreeing to take part
• People who are willing to follow the study schedule and requirements throughout the trial
• People who have been diagnosed with a specific type of blood cancer called CD19-positive large B-cell lymphoma (LBCL), confirmed by tissue or cell testing according to recognised medical standards — this includes several subtypes such as DLBCL, grade 3b follicular lymphoma, primary mediastinal B-cell lymphoma, and certain high-grade B-cell lymphomas. The cancer must be confirmed as CD19-positive through specific laboratory tests meeting set thresholds
• People whose lymphoma has come back or stopped responding to treatment, and who have already received at least two prior lines of treatment including specific chemotherapy and a CD20-targeted drug (such as rituximab), or who have relapsed after a stem cell transplant using their own cells — with specific conditions applying to each situation (confirm details with trial site)
• People who have at least one measurable area of lymphoma that can be detected on imaging scans
• People whose doctors estimate they have a life expectancy of more than 12 weeks
• People with a performance status score of 0 or 1 on the ECOG scale, meaning they are either fully active or have only minor limits on physical activity
• People whose blood test results before screening meet minimum levels for haemoglobin, white blood cells (neutrophils), platelets, and lymphocytes
• People whose kidney, liver, heart, and lung function test results fall within the ranges required by the trial
• People who participated in another interventional clinical study no more than one month before screening, and whose side effects from that study have resolved to a mild level (grade 1 or lower)

Who may not be able to join:

• People who have previously received a bone marrow or stem cell transplant using donor cells, CAR-T cell therapy, or any other gene-modified cell therapy
• People who have active involvement of lymphoma or other disease in the brain or central nervous system, or who have a history of certain brain or nervous system conditions such as epilepsy, stroke, dementia, or autoimmune conditions affecting the nervous system
• People who test positive for active hepatitis B, hepatitis C, cytomegalovirus (CMV), HIV, or syphilis infections as defined by specific test results
• People with unstable or serious heart, circulatory, or organ conditions — including recent heart attack or stroke (within the past 6 months), severe heart failure, active bleeding, serious irregular heart rhythms, or active liver, kidney, or metabolic disorders
• People who have another active cancer, except for certain cancers that have been fully treated and cured (such as some skin cancers, early-stage cervical, prostate, or bladder cancers, or cancers with no signs of disease for more than 5 years)
• People who have a stomach lymphoma, a very large tumour mass (bulky disease), a history of CD19-positive leukaemia, or an active autoimmune condition such as lupus, rheumatoid arthritis, multiple sclerosis, or inflammatory bowel disease, among others
• People who have an active, uncontrolled infection currently requiring treatment, such as a serious bacterial or fungal infection in the blood (minor infections like mild urinary tract or upper respiratory infections may be excepted — confirm with trial site)
• People who have received ongoing systemic steroid medications within 2 weeks before the cell collection procedure, and who are expected to need long-term steroids during the trial — low-dose or inhaled steroids may be excepted (confirm with trial site)
• People who have received cancer treatments such as chemotherapy or CD20-targeted therapy within 8 weeks (or a specified number of half-lives) before cell collection, or radiation therapy to a specific area within 12 weeks before cell collection
• People who have used certain white blood cell growth-stimulating medications (G-CSF or GM-CSF) within 4 weeks before cell collection
• People who have received certain specific chemotherapy drugs — including alendronate (within 6 months), or fludarabine, cladribine, or bendamustine (within 3 months) — before cell collection
• People who have had major surgery within 4 weeks before screening, or who have not fully recovered from a previous surgical or invasive procedure
• People who have received a live vaccine within 28 days before cell collection
• People who are pregnant, breastfeeding, planning to become pregnant during the treatment period or within 2 years after treatment, or male participants whose partners plan to become pregnant within 2 years of the male participant receiving the cell injection
• People whom the trial doctor considers unsuitable to participate for any other reason

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