Phase 1 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 who have a type of B-cell non-Hodgkin's lymphoma (a blood cancer) that has come back or stopped responding to treatment, and whose cancer tests positive for a protein called CD19. The specific types included are: diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (grades 1–3), marginal zone lymphoma, lymphoplasmacytic lymphoma, mantle cell lymphoma, small lymphocytic lymphoma, and transformed large B-cell lymphoma.
• People whose lymphoma has relapsed (come back after treatment worked), meaning DLBCL patients must have gone through at least two prior treatments, and patients with other listed lymphoma types must have gone through at least one prior treatment.
• People whose lymphoma is refractory (did not respond to treatment), which includes those who did not respond to standard therapy, those who are not suitable for a stem cell transplant or whose cancer returned after one, or those whose cancer came back after a CAR-T cell therapy — provided at least 3 months have passed since that CAR-T therapy ended and the cancer still tests positive for CD19.
• People who have at least one measurable area of lymphoma that can be tracked on a CT or MRI scan (a lymph node larger than 15mm, or a tumour outside a lymph node larger than 10mm).
• People who are reasonably well enough to carry out daily activities (as measured by a standard medical scale called ECOG, with a score of 2 or less) and who are expected to live for more than 3 months.
• People whose bone marrow, blood clotting, liver, kidney, lung, and heart function are all within essentially normal ranges.

Who may not be able to join:

• People who have a type of non-Hodgkin's lymphoma not listed in the inclusion criteria above.
• People who have previously been treated with a specific type of antibody therapy that targets both CD3 and CD19 (called a bispecific antibody or BsAb).
• People who have received chemotherapy, radiotherapy (except palliative radiotherapy finished more than 2 weeks before the trial), hormone therapy, biological therapy, or targeted small molecule drugs within 2 weeks before the trial starts (or within 5 half-lives of that drug, whichever is shorter).
• People who have received anti-CD20 or anti-CD19 antibody treatments within 4 weeks before the trial starts.
• People who have received other immunotherapy or participated in another clinical trial within 4 weeks before the trial starts (or within 5 half-lives of that treatment, whichever is shorter).
• People who have had major surgery (not including needle biopsies) or a serious injury within 4 weeks before the trial starts, or who are planning to have surgery during the trial.
• People who have taken high-dose steroid medications (such as prednisone above 10mg per day or an equivalent dose) or other immune-suppressing drugs within 14 days before the trial starts — with some exceptions for topical, eye, joint, nasal, or inhaled steroids, or short-term preventive steroid use.
• People who have used immune-boosting treatments — including thymosin, interleukin-2, interferon, or certain traditional Chinese medicines — within 14 days before the trial starts.
• People who have received a live vaccine within 4 weeks before the trial starts.
• People whose lymphoma has spread to the brain or spinal cord (central nervous system).
• People who have a current or past central nervous system condition, such as epilepsy, severe brain injury, dementia, Parkinson's disease, cerebellar disorders, or serious mental illness.
• People who have or have had another cancer, unless it has been fully cured — exceptions include certain skin cancers, early-stage cervical changes, early prostate changes, or other cancers considered clinically cured for at least 5 years (confirm with trial site).
• People who currently have an active infection that requires treatment with antibiotics or antiviral/antifungal medicines within 3 days before the trial starts.
• People with active hepatitis B or hepatitis C. People with a positive hepatitis C antibody test are excluded. People who test positive for hepatitis B surface antigen are not eligible during the early dose-testing phase; however, during the later expansion phase, people who test positive for that marker but have no detectable hepatitis B virus in their blood, are taking a specific antiviral medication (entecavir), and agree to monthly blood monitoring may be considered (confirm with trial site).
• People who have a history of immune deficiency, including those who test positive for HIV.
• People with a serious history of heart or stroke-related disease, including severe heart rhythm problems, a recent heart attack, heart failure, stroke, or other major cardiovascular events within the past 6 months; significant heart function impairment (NYHA Class II or above, or heart pumping function below 50%); or high blood pressure that cannot be controlled with medication.
• People who have current or previous interstitial lung disease (a condition causing scarring or inflammation in the lungs).
• People who currently have acute or active chronic graft-versus-host disease (a complication that can occur after certain transplants).
• People who have an active or recurring autoimmune disease (such as lupus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, vasculitis, psoriasis, and others), or who have had an organ transplant requiring ongoing immune-suppressing treatment — though people with thyroid conditions managed only with hormone replacement, or mild skin conditions not needing systemic treatment, may still be considered (confirm with trial site).
• People who have previously had a severe (Grade 3 or higher) immune-related side effect from immunotherapy.
• People who still have significant side effects (Grade 2 or higher) from previous cancer treatments that have not yet resolved — with some exceptions such as hair loss that poses no safety concern (confirm with trial site).

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