Phase 2 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:

• People aged 18 or older at the time of giving consent
• People diagnosed with certain types of large B-cell lymphoma (LBCL) — including diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, or follicular lymphoma grade 3B — who have already received at least 2 rounds of treatment, and whose disease meets the FDA's criteria for treatment with a therapy called liso-cel
• People whose cancer shows up as active on a PET scan before a specific preparatory chemotherapy step, or who have lab or tissue evidence of active disease
• People whose cancer cells carry a protein called CD19, or whose cancer type strongly suggests this protein is present
• People with a general health and functioning score of 60% or higher on the Karnofsky scale (a measure doctors use to assess how well a person can carry out daily activities) (confirm with trial site)
• People with blood counts that are adequate for receiving preparatory chemotherapy — specifically, a certain minimum level of white blood cells, platelets, and hemoglobin — unless low levels are caused by the lymphoma itself (confirm with trial site)
• People whose kidneys are functioning above a minimum threshold, based on a calculated measure called creatinine clearance
• People whose liver enzyme levels (ALT and AST) and bilirubin levels are within acceptable ranges, with some flexibility for people who have lymphoma affecting the liver or a condition called Gilbert's syndrome
• People whose lungs are functioning adequately, based on breathing tests measuring airflow and oxygen transfer capacity
• People whose heart is pumping adequately, with a heart pumping strength (ejection fraction) of at least 40%, measured by an echocardiogram or similar scan
• Women who could become pregnant must agree to use suitable contraception for at least 30 days after the last dose of the study treatment (ST-067)
• Men whose partners could become pregnant must agree to use an effective barrier contraceptive method for at least 90 days after the last dose of the study treatment (ST-067)
• People who are able to understand the trial and provide their own informed consent
• People who are willing and able to attend all required study visits and procedures, including a tissue biopsy if it is considered feasible and safe

Who may not be able to join:

• People for whom the liso-cel product available does not meet the required quality specifications
• People with a history of another cancer, with some exceptions — these exceptions include certain treated skin cancers, certain in-situ cancers (meaning cancer that has not spread), adequately treated early-stage bladder cancer, other early-stage cancers currently in complete remission, or any cancer that has been in remission for 2 or more years
• People who are planned to receive high-dose steroid medications (above 20 mg per day of prednisone or equivalent) or other medications that suppress the immune system within 7 days before a cell collection procedure called leukapheresis, or within 72 hours before the liso-cel infusion (topical or inhaled steroids are permitted)
• People who have previously received any CAR T-cell therapy targeting the CD19 protein
• People who have received a bone marrow or stem cell transplant from a donor and who currently have active graft-versus-host disease, or who have received treatment for this condition within the past 30 days
• People with currently active hepatitis B or hepatitis C infections detected by specific virus tests
• People with a known HIV infection
• People who are pregnant or breastfeeding
• People who have previously been treated with certain immune-targeting agents known as IL-1 or IL-18 agonists, biosimilar versions of these, or any other experimental treatment, within 4 weeks or 5 half-lives of that treatment — whichever is the shorter period — before the preparatory chemotherapy step
• People with active autoimmune or inflammatory conditions that require immune-suppressing treatment — such as inflammatory bowel disease, lupus, rheumatoid arthritis, myasthenia gravis, Graves' disease, and others — with some exceptions for conditions considered lower risk, such as vitiligo, hair loss (alopecia), well-controlled thyroid conditions on hormone replacement, type 1 diabetes, or psoriasis not needing systemic treatment
• People who have had certain serious heart events in the past 6 months — such as a heart attack, unstable chest pain, heart surgery, or severe heart failure — unless a cardiologist has assessed and cleared them; people with other significant heart conditions that the lead doctor considers a safety concern are also excluded
• People with significant heart rhythm or electrical abnormalities on an ECG, including certain types of heart block, dangerous arrhythmias requiring medication, significant slowing of the heart rate, or an abnormally prolonged heart electrical interval (QT interval above 500 ms)
• People with a history or current presence of significant brain or nervous system conditions — such as epilepsy, stroke, severe brain injury, dementia, Parkinson's disease, or psychosis — that the lead doctor considers a safety concern; people with active cancer spread into the brain tissue are also excluded (note: people with a specific type of cancer involvement of the fluid around the brain and spine may still be eligible — confirm with trial site)
• People who have received a solid organ transplant (such as a kidney, liver, or heart transplant)
• People with a serious, active infection that is not under control

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