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 aged 18 or older, of any sex.
• People diagnosed with a type of T-cell lymphoma (a blood cancer) that has come back or stopped responding to treatment, based on specific medical classification guidelines.
• People with a skin-based form of T-cell lymphoma (CTCL) where at least 2 previous standard treatments have not worked.
• People with a non-skin form of T-cell lymphoma (PTCL) where at least 1 previous standard treatment has not worked; if the cancer tests positive for a protein called CD30, prior treatment with a drug called brentuximab vedotin is expected to have been given.
• People who have tumor tissue available from a previous sample, or who are willing to have a biopsy (a small tissue sample taken).
• People whose cancer cells test positive for a protein called CD5, with at least 50% of cells showing this marker — a separate exploratory group may include people with lower CD5 levels (confirm with trial site).
• People with a general health and activity level rated at 70% or higher on a standard medical scale, meaning they are able to care for themselves and carry out most normal activities.
• People who previously received a type of immune cell therapy called CAR T-cell therapy, as long as it was given more than 60 days before joining the trial and no trace of those cells remains in the body.
• People with cancer that can be measured or detected using standard imaging or assessment methods.
• People who previously received a stem cell transplant (using their own or a donor's cells), as long as it was more than 60 days before joining the trial.
• People whose bone marrow is working well enough to meet specific blood count thresholds (confirm exact values with trial site).
• People whose heart, lungs, kidneys, and liver are functioning at a sufficient level as measured by specific tests (confirm exact values with trial site).
• Women who could become pregnant must have a negative pregnancy blood test before starting the trial and before a pre-treatment step called lymphodepletion.
• Women who could become pregnant, and men, must use a highly effective form of contraception plus a barrier method (such as a condom) from the start of pre-treatment through to at least 12 months after the last dose of the study treatment.

Who may not be able to join:

• People with a specific form of T-cell lymphoma called Sézary syndrome; for other types with significant cancer cells circulating in the blood at the time of a cell collection procedure, eligibility would need to be discussed with the trial medical team.
• People for whom the cell collection procedure (leukapheresis, where blood cells are collected for use in treatment) is medically unsuitable.
• People who have previously received any treatment that specifically targeted a protein called CD5.
• People with an active HIV infection.
• People with chronic hepatitis B virus infection where the virus is currently detectable in the blood (those on antiviral medication who have had no symptoms for more than 5 days before signing the consent form may still be considered).
• People with hepatitis C virus infection where the virus is currently detectable (those who have been fully cured of hepatitis C may still be considered).
• People with an active, uncontrolled infection (bacterial, viral, or fungal) that requires intravenous (drip) antibiotics or antiviral medications, including certain reactivated viruses; those who have been treated and symptom-free for more than 5 days before joining may still be considered.
• People who have had another cancer diagnosed within the past 2 years, with some exceptions for certain early-stage or slow-growing cancers not needing active treatment — this would be assessed case by case with the trial medical team.
• People with a history of serious allergic reactions to products containing proteins derived from mice.
• People whose lymphoma has spread to the brain or spinal cord and is currently active.
• People who have had a serious complication called graft-versus-host disease (a reaction after a donor transplant) that is above a mild level and is still being treated with steroids or multiple medications.
• People who have received medications to suppress the immune system for graft-versus-host disease within 28 days before the cell collection procedure.
• People currently taking steroid medications at doses above a low threshold level; a 2-week period without these medications is required before certain trial procedures (confirm details with trial site).
• People who have received a treatment called donor lymphocyte infusion within 28 days before receiving the trial treatment.
• People with serious heart or blood vessel conditions such as a heart attack, unstable chest pain, or severe heart failure within the past 6 months, or a stroke within the past 12 months.
• People with certain brain or nervous system conditions such as uncontrolled seizures, dementia, or autoimmune diseases affecting the brain.
• People with any serious medical or mental health condition that the trial doctors believe would make participation unsafe or difficult.
• People with a history of autoimmune diseases (conditions where the immune system attacks the body), such as rheumatic diseases or thyroid disorders — though people with previously treated thyroid disease or very mild autoimmune conditions may be considered after discussion with the trial team.
• People who are currently taking part in another clinical trial involving an active experimental treatment, unless it has been at least 30 days since that treatment ended.
• People who have previously received a chemotherapy drug called bendamustine, unless they have since had a donor stem cell transplant.

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