Phase 2 Lymphoma 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 diagnosed with diffuse large B-cell lymphoma (DLBCL) — either newly developed or transformed from a slower-growing lymphoma — or a related aggressive B-cell lymphoma type, whose disease has come back or stopped responding to treatment, and who have already received at least one prior treatment course that included certain chemotherapy and antibody-based drugs, and who a doctor has determined are candidates for a standard CAR-T cell therapy.
• A recent biopsy (within the last 12 months) must have confirmed the disease has returned or is no longer responding to treatment.
• People aged 18 years or older.
• People whose kidneys are functioning well enough, as measured by a specific calculation of kidney filtering ability (confirm with trial site for the exact threshold).
• People whose liver function blood test results are within acceptable ranges, with some exceptions allowed if the liver is affected by the cancer itself or by a condition called Gilbert's disease (confirm with trial site).
• People whose lungs are working well enough, shown by an oxygen level of at least 92% when breathing normal room air.
• People whose thyroid hormone levels are within an acceptable range (confirm with trial site).
• People whose bone marrow is producing enough blood cells — including white cells, platelets, and red cells — without needing a blood transfusion or certain blood-boosting injections in the 7 days before screening.
• People with a general health and activity level rated as 0, 1, or 2 on a standard medical scale, meaning they are fully active or have only mild limitations in daily activity.
• All men, and women who could become pregnant, must agree to use reliable contraception during the study and for 30 days after treatment ends. Women who become pregnant or suspect pregnancy during the study must tell their treating doctor immediately.
• People who are able to understand the study and are willing to sign a written consent form agreeing to take part.
• For people who receive bridging therapy between a cell collection procedure and the study treatment, additional scans and blood tests must be repeated 10–14 days before the study treatment infusion, and certain eligibility criteria must still be met at that point.

Who may not be able to join:

• People who are pregnant or breastfeeding.
• People whose heart is not pumping strongly enough, based on a heart scan showing the heart's pumping function is below a certain level.
• People who have had an organ or stem cell transplant from another person and currently have active graft-versus-host disease requiring immune-suppressing medications.
• People with an active autoimmune disease that requires immune-suppressing medications.
• People with certain heart conditions, including: severe heart failure (rated stage III or IV on a standard scale); a heart attack within the last 6 months; or a history of serious abnormal heart rhythms or unexplained fainting that is not thought to be caused by dehydration or a common harmless reflex.
• People who have tested positive for HIV, hepatitis B, or hepatitis C — with some exceptions for people whose hepatitis B result is due to prior vaccination, or who have certain hepatitis antibodies with no detectable virus in the blood and adequate organ function (confirm with trial site).
• People with an active, uncontrolled infection caused by fungus, bacteria, a virus, or another organism.
• People who currently have another active cancer that requires treatment beyond monitoring or hormone therapy, except for certain common skin cancers.
• People with a significant neurological condition such as epilepsy, a generalised seizure disorder, or a severe brain injury.
• People whose blood contains antibodies against a mouse-derived component used in the study treatment (called HAMA-positive results) — this must be tested before the treatment can be given.
• People who have previously been treated with a radioactive drug therapy for lymphoma.
• People with a specific type of irregular heart rhythm reading on an ECG that is above a certain threshold (confirm with trial site for details).
• Any other health concern that the treating doctor believes would make participation unsafe or unsuitable.

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