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:

• Adults aged 18 or older
• People who have been diagnosed (confirmed by tissue sample) with a specific type of aggressive blood cancer called diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma, or a related lymphoma that has transformed from a slower-growing type, where the cancer cells test positive for a protein called CD20 — with this testing done within 6 months before joining the trial
• People who have already received one of three specific commercially available CAR-T cell therapies (axicabtagene ciloleucel, tisagenlecleucel, or lisocabtagene maraleucel), and whose scans at around 30 days after CAR-T treatment showed a partial response (meaning the cancer partially responded but did not fully disappear)
• People whose cancer is still measurable on scans at the time of joining
• People who are reasonably physically active and able to carry out daily activities (as rated by a standard medical scoring system at levels 0, 1, or 2)
• People whose blood test results — taken within 14 days before joining — meet certain minimum levels for white blood cells, platelets, and haemoglobin (red blood cell protein), with some medical support such as transfusions or growth factor injections allowed if needed
• People whose liver function blood tests, taken within 14 days before joining, are within acceptable ranges (with some allowance for certain liver conditions or lymphoma affecting the liver)
• People whose kidneys are functioning at a sufficient level, based on a calculation from a blood test taken within 14 days before joining
• Women who could potentially become pregnant must have a negative pregnancy blood test done within 7 days before joining
• People who are willing and able to return to the enrolling hospital for all required visits during the active treatment and follow-up period
• People who agree to provide blood and tissue samples for research as part of the trial
• People who have provided written informed consent within 28 days before joining

Who may not be able to join:

• People whose cancer has a single tumour mass of 7.5 cm or larger at the 30-day scan after CAR-T treatment
• People whose cancer showed no change, got worse, or completely disappeared at the 30-day scan after CAR-T treatment (only those with a partial response are eligible)
• People who are pregnant or breastfeeding
• People who could become pregnant or father a child and are not willing to use adequate contraception during the trial
• People who have previously been treated with a type of drug called a CD20xCD3 bispecific antibody at any time before joining
• People who have received a CD20-targeting antibody treatment (such as rituximab or obinutuzumab) within 4 weeks before joining
• People who are still experiencing side effects from CAR-T therapy, specifically cytokine release syndrome (an immune overreaction) or neurological toxicity (problems affecting the nervous system), at the time of joining
• People who experienced a severe (grade 4) cytokine release syndrome or neurological toxicity after their most recent CAR-T treatment
• People whose lymphoma involves the brain or spinal cord, or who have a type of lymphoma that originates in the central nervous system
• People with serious other illnesses or conditions that, in the treating doctor's judgement, would make participation unsafe or interfere with assessing the treatment
• People with an active infection requiring treatment (other than preventive medication) within 14 days before joining — including active COVID-19 — except for simple urinary tract infections or uncomplicated throat infections that are responding to treatment (confirm specific infection history, such as hepatitis B, hepatitis C, or HIV, with the trial site)
• People with significant heart failure causing symptoms during minimal activity or at rest
• People with unstable chest pain (unstable angina) or an unstable irregular heartbeat within 14 days before joining
• People with psychiatric or social circumstances that would make it difficult to follow the trial requirements
• People with certain brain or nervous system conditions, such as seizure disorders (not including resolved childhood fever-related seizures), stroke or brain bleeds, cerebellar disease, or autoimmune diseases affecting the nervous system
• People currently taking part in another clinical trial involving an experimental treatment for their cancer within 14 days before joining
• People who have had another active cancer requiring treatment within the past 2 years (non-melanoma skin cancers that were localised are an exception)
• People with significant heart disease, including a heart attack within the past year, moderate-to-severe heart failure, certain types of irregular heartbeat, or significant abnormalities on a heart tracing (ECG)

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