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:

• People who give voluntary written consent to participate (or whose legal guardian gives consent on their behalf), with consent from both the guardian and the minor if the minor is able to sign.
• People aged 2 to 75 years at the time of consent, of any sex.
• People who have been diagnosed with B-cell lymphoma confirmed by laboratory tissue testing, according to 2024 medical guidelines.
• People whose lymphoma did not respond well enough to first-line treatment, or came back within 12 months of first-line treatment, or came back or stopped responding after two rounds of treatment (one standard and one follow-up regimen).
• People whose prior treatment included an anti-CD20 antibody drug (unless the tumour tested negative for CD20) and a chemotherapy regimen containing a drug called an anthracycline.
• People who also meet at least one of the following: they are not suitable for a stem cell transplant using their own cells, they have chosen not to have that transplant, or their lymphoma came back after having that transplant.
• People whose tumour tissue (either stored samples or a fresh biopsy) tests positive for a protein called CD19, confirmed by laboratory analysis.
• People who have at least one measurable area of disease that can be tracked during the trial.
• People with a general health and activity level rated 0 to 3 on a standard medical scale (ECOG), meaning they may have some symptoms but are not completely bedridden.
• People with blood counts and organ function within acceptable ranges, including liver, kidney, heart, lung, and blood-clotting measures (confirm specific values with the trial site).
• Women who could become pregnant must have a negative pregnancy test within 7 days before receiving the trial treatment, and all people who could father or carry a child must use effective contraception from the start of the trial through at least 12 months after treatment.
• People with suitable vein access for the blood collection process needed to make the trial treatment, and no medical reasons preventing that procedure.
• People with an estimated life expectancy of more than 3 months.

Who may not be able to join:

• People who currently have another cancer, unless it is a very early, non-invasive form or they have been cancer-free from it for 3 or more years.
• People with certain active or detectable infections, including hepatitis B (with active virus levels), hepatitis C (with active virus levels), syphilis, or HIV.
• People with an active infection (bacterial, fungal, viral, or other) that the medical team considers not under control.
• People with a significant, ongoing brain or nervous system condition unrelated to their lymphoma — such as uncontrolled seizures, stroke, dementia, or certain autoimmune conditions affecting the brain.
• People who have had a significant heart procedure or event in the 12 months before joining, such as a heart attack, unstable chest pain, a coronary stent, or severe heart failure, or whose heart electrical activity or heart pumping function falls outside acceptable limits at screening.
• People with a known condition where the immune system does not work properly from birth.
• People with a history of a severe allergic reaction to any of the drugs used in the trial.
• People who have received a live vaccine within 6 weeks before screening.
• People who are pregnant or breastfeeding.
• People with an active autoimmune disease that requires ongoing medication to suppress the immune system.
• People who have taken part in another interventional clinical trial within 30 days before signing consent.
• People who, in the medical team's judgement, have any other condition that would make participation unsuitable.

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