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:

• People aged 18 or older who are expected to live more than 3 months and are willing to follow the study schedule and procedures.
• People who have been diagnosed through a tissue test with a type of B-cell non-Hodgkin's lymphoma that is CD20-positive (a marker found on certain cancer cells), including types such as diffuse large B-cell lymphoma, high-grade B-cell lymphoma, or grade 3b follicular lymphoma, as classified under WHO 2016 standards.
• People whose lymphoma has come back or stopped responding to treatment, meeting one of these situations: the cancer returned or did not respond after a stem cell transplant; the cancer stayed stable but for 6 months or less after at least two rounds of a second treatment that included specific targeted and chemotherapy drugs; or the cancer progressed or came back after that second treatment.
• People whose general health and ability to carry out daily activities falls within a certain range, as measured by a standard medical scoring system called the ECOG scale (scores 0 to 2, meaning fully active to capable of self-care but unable to work) (confirm with trial site).
• People who have at least one area of lymphoma large enough to be measured on scans, and whose PET scan shows active disease in that area.
• People whose blood counts are within acceptable ranges in the 7 days before testing, without having recently received a blood transfusion or blood-stimulating treatment — specifically, haemoglobin at least 80 g/L, neutrophil count at least 1×10⁹/L, and platelet count at least 50×10⁹/L.
• People whose blood clotting function is within acceptable ranges (with specific allowances for those already on preventive blood-thinning medication).
• People whose kidney, liver, and lung function meet specific minimum standards, including kidney function, liver enzyme and bilirubin levels, and a blood oxygen level of at least 92% while breathing normal indoor air.
• People who are able and willing to use effective contraception from the time of signing consent until 6 months after the last dose of the study treatment; women who could become pregnant must have a negative pregnancy test at the screening stage.

Who may not be able to join:

• People whose lymphoma has started in or is currently active in the brain or spinal cord.
• People who have an active autoimmune disease (such as lupus, rheumatoid arthritis, multiple sclerosis, Sjögren's syndrome, or immune-related low platelet counts), uncontrolled fluid build-up in body cavities, or who have experienced moderate to severe graft-versus-host disease (a complication after transplants) in the 4 weeks before screening.
• People with serious heart or blood vessel conditions, including dangerous heart rhythm problems, a prolonged electrical interval in the heart (QTcF above 450ms for men or 470ms for women), a recent heart attack, heart failure, stroke, or other major cardiovascular event in the past 6 months, significant heart failure (NYHA class II or higher), or high blood pressure that has not been brought under control with medication.
• People who have had an autologous (using their own cells) stem cell transplant or cell therapy within 3 months before the pre-treatment phase, or an allogeneic (using donor cells) stem cell transplant or cell therapy within 6 months, or any other organ transplant at any time.
• People who have received any cancer treatment or taken part in another interventional clinical study within 4 weeks (or within 5 half-lives of the drug, whichever is shorter) before the pre-treatment phase.
• People who have received a live vaccine or had major surgery within 4 weeks before the pre-treatment phase, or who are expected to need either during the study.
• People who need ongoing systemic steroid medication (equivalent to 10 mg or more of prednisone per day for 3 or more days) during the study, except for inhaled or skin-applied steroids.
• People who have had or currently have another type of cancer, with some exceptions such as certain treated skin cancers, cervical carcinoma in situ, localised prostate cancer, or ductal carcinoma in situ after definitive surgery; also people with severe diabetes or other serious underlying health conditions.
• People who have had a serious fungal, bacterial, viral, tuberculosis, or other infection requiring systemic treatment in the 14 days before the pre-treatment phase.
• People who test positive for active hepatitis B, active hepatitis C, HIV, or syphilis.
• People who have had a severe or life-threatening allergic reaction to any of the drugs used in this study, or who have a history of serious allergies.
• People who are pregnant or breastfeeding.
• People whom the trial doctor considers unsuitable for any other reason, or who may have difficulty following the study requirements.

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