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:

• The patient or their guardian must be willing to voluntarily sign a consent form agreeing to take part.
• Adults who have been clinically diagnosed with relapsed and refractory diffuse large B-cell lymphoma (DLBCL), including primary mediastinal large B-cell lymphoma and DLBCL that developed from follicular lymphoma.
• People whose lymphoma either did not respond to their most recent treatment, or only stabilised briefly (for 6 months or less), or whose disease came back or worsened within 12 months of a stem cell transplant using their own cells (autologous), or who are not suitable for that type of transplant.
• People who have already received at least 2 rounds of prior treatment, including at least one chemotherapy regimen containing a drug class called anthracyclines.
• People whose lymphoma transformed from follicular lymphoma must have previously received chemotherapy for follicular lymphoma and have disease that did not respond after it transformed to DLBCL.
• People with a specific high-risk subtype of lymphoma involving changes to the C-MYC gene along with BCL-2 and/or BCL-6 genes (sometimes called "double-hit" or "triple-hit" lymphoma) who did not respond to second-line treatment.
• People whose lymphoma cells test positive for a protein called CD19, confirmed by laboratory testing.
• People who have at least one measurable area of disease that can be tracked on scans at the start of the trial.
• People whose expected survival is greater than 12 weeks.
• People with a general health/activity score of 0 or 1 on the ECOG scale, meaning they are fully active or have only minor restrictions on physical activity.
• People whose kidneys are functioning adequately, based on blood test results meeting specific thresholds (confirm with trial site).
• People whose liver is functioning adequately, based on specific blood test results — with a separate set of acceptable values for people with a condition called Gilbert-Meulengracht syndrome (confirm with trial site).
• People with no more than mild breathing difficulty and a blood oxygen level of at least 91% while breathing normal indoor air.
• People whose heart is pumping adequately, with a heart pumping function measurement (LVEF) of at least 45%, confirmed by a heart scan.
• People who have stopped taking steroid medications at treatment doses at least 2 weeks before the trial infusion (low-dose replacement steroids may be permitted — confirm with trial site).
• People who have stopped taking immunosuppressive medications at least 4 weeks before signing the consent form.
• People who have stopped any anti-cancer treatments (other than the pre-treatment chemotherapy used in this trial) at least 2 weeks before the trial infusion.
• People receiving treatment for central nervous system (brain or spinal cord) disease must have stopped that treatment at least 1 week before the trial infusion.
• People who have recovered from side effects of previous treatments to a mild or resolved level before starting the trial (with some exceptions, such as hair loss, which the trial team may accept at a slightly higher level).
• People of childbearing potential and all male participants who agree to use effective contraception for at least 12 months after the trial infusion, and until two consecutive tests show no more trial cells remaining in the body.

Who may not be able to join:

• People who currently have or have a history of central nervous system conditions such as seizures, stroke, bleeding in the brain, dementia, cerebellar disease, or any autoimmune disease affecting the brain or nervous system.
• People who have previously had a stem cell transplant using cells from a donor (allogeneic transplant).
• People who received chemotherapy (other than the pre-treatment chemotherapy used in this trial) within 2 weeks before the trial infusion.
• People who have taken part in another clinical trial within 30 days before enrolling.
• People with active hepatitis B or hepatitis C infection, based on specific blood test results (confirm with trial site).
• People who test positive for HIV or syphilis antibodies.
• People with a serious, uncontrolled bacterial, viral, or fungal infection that is life-threatening at the time of the infusion (including a positive blood culture within 72 hours before the infusion).
• People who have had unstable chest pain (angina) or a heart attack within the 6 months before enrolling.
• People with a history of other cancers, except for adequately treated skin cancers (basal or squamous cell), certain early-stage cervical or breast cancers with no signs of recurrence for at least 3 years, or a primary cancer that was completely removed and has been in full remission for 5 or more years.
• People who are pregnant or breastfeeding, or whose pregnancy test is positive.
• People with active autoimmune or inflammatory conditions affecting the nervous system, such as Guillain-Barré syndrome or ALS (motor neurone disease).
• People the trial investigators consider unsuitable for other reasons, such as being unlikely to follow the trial requirements.

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