Early Phase 1 Lymphoma 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:

• Adults aged 18 or older of any sex
• People who have been diagnosed with a specific type of B-cell non-Hodgkin's lymphoma (such as DLBCL, follicular lymphoma, mantle cell lymphoma, or related types) confirmed through a tissue or cell sample
• People whose lymphoma has tested positive for a protein called CD19 (those who have previously received CD19-targeted treatment must have a new biopsy taken before joining to reconfirm this)
• People whose lymphoma has returned or stopped responding to treatment, meeting at least one of these conditions: the cancer progressed after at least two previous treatment courses (including prior treatment with specific antibody and chemotherapy types); the cancer returned after a stem cell transplant using the patient's own cells, or returned two or more years after a transplant using a donor's cells with no ongoing anti-rejection medication; or the cancer did not respond at all to at least two cycles of initial treatment
• People who have at least one measurable area of lymphoma visible on scans — either a lymph node larger than 15mm or a tumour outside lymph nodes larger than 10mm in both measurements
• People with a life expectancy of at least 12 weeks
• People who are in generally good physical condition, rated 0 or 1 on a standard activity scale (able to carry out normal daily activities with at most minor limitations)
• People whose blood, liver, and kidney test results fall within acceptable ranges without relying on recent transfusions, platelet support, or growth factor treatments
• People whose side effects from previous cancer treatments have largely resolved to a mild or absent level
• People of childbearing potential (including women who are premenopausal or within 24 months of menopause, and men whose partners could become pregnant) who are willing to use highly effective contraception from the time of consent until 12 months after receiving the study treatment
• People who are willing and able to sign a consent form and follow all study requirements including appointments and tests

Who may not be able to join:

• People who are pregnant or currently breastfeeding
• People whose lymphoma has spread to the brain, spinal fluid, or central nervous system, or who have a history of lymphoma in these areas
• People whose lymphoma has spread into the chambers of the heart
• People who have had graft-versus-host disease requiring systemic treatment within the past 4 weeks
• People who require ongoing immunosuppressive medication for autoimmune conditions (such as Crohn's disease, rheumatoid arthritis, lupus, or similar conditions), with some specific exceptions (confirm with trial site)
• People who received their own stem cell transplant within the past 12 weeks, or who have ever received a donor stem cell transplant
• People who have received a live vaccine within 4 weeks before the study treatment, or who plan to receive one during the 12-week study period
• People who have used corticosteroids (e.g. prednisone) at higher than a specified dose for more than 3 days in the 2 weeks before treatment, except for inhaled forms
• People who are expected to need corticosteroids or other immune-suppressing drugs during the 12 weeks after treatment
• People who have taken part in another clinical trial and received an experimental treatment within 1 month before the study drug is due to be given
• People who have received chemotherapy, immunotherapy, targeted therapy, or similar cancer treatments within 28 days (or within 5 half-lives of the drug, whichever is shorter) before the first dose of study treatment; or certain approved traditional Chinese medicine cancer treatments within 2 weeks before the study drug
• People who have had major surgery within 2 weeks before joining, or who have planned surgery during the treatment or monitoring period
• People with a history of another cancer, with some limited exceptions such as fully treated skin cancers, cervical or breast cancer in remission for at least 3 years, or a completely removed tumour in full remission for 5 or more years
• People with HIV, active hepatitis B, active hepatitis C, confirmed syphilis, active Epstein-Barr virus infection, active cytomegalovirus infection, or a current unresolved COVID-19 infection
• People with a severe or poorly controlled active infection
• People with uncontrolled fluid build-up around the lungs, heart, or in the abdomen
• People with an oxygen saturation level of 95% or below while on nasal oxygen support
• People with significant lung conditions such as pulmonary embolism, chronic obstructive pulmonary disease, or poorly controlled interstitial lung disease
• People with a history of or current liver-related brain condition (hepatic encephalopathy), or significant neurological conditions including seizures, stroke, dementia, or autoimmune conditions affecting the brain or nervous system
• People with poorly controlled high blood pressure (systolic at or above 160 mmHg and/or diastolic above 100 mmHg despite treatment), very low blood pressure requiring medication to maintain it, or poorly controlled diabetes (fasting blood sugar at or above 10.2 mmol/L)
• People with significant heart-related history within the past 6 months to 1 year, including reduced heart pumping function, heart attack, unstable chest pain, certain heart procedures, use of a pacemaker, abnormal heart rhythm readings on an ECG, or certain specific electrical conduction problems in the heart
• People with a history of severe allergic reactions such as anaphylaxis
• People with severe psychiatric conditions
• People with newly developed heart rhythm problems not adequately controlled by medication
• People who have had a solid organ transplant (such as a kidney, liver, or heart transplant)
• People who, in the treating doctor's judgement, are unable or unwilling to follow the study requirements
• People with any other serious uncontrolled medical condition that the treating doctor considers would make participation unsafe

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