Long-Term Safety and Effectiveness Study for Patients Treated with Pells Lentiviral Gene-Edited Immune Cells

What this Trial Is About

This research aims to evaluate the long-term safety and effectiveness of lentiviral-based gene-edited immune cell therapy in patients who have previously received this treatment. It follows guidance from health authorities recommending observation for delayed adverse events for up to 15 years after gene therapy. The study focuses on patients with various types of large B-cell lymphomas who have undergone this gene-edited immune cell therapy. Participants join this observational study after completing or withdrawing early from another treatment protocol involving Pells lentiviral-based gene-edited immune cells. If patients do not enter the follow-up study immediately, they may still join anytime within 15 years after their last gene-edited immune cell infusion. Some participants might also join other gene-edited immune cell therapy studies during this follow-up while remaining enrolled here as inactive participants. During the study, researchers will monitor for delayed side effects possibly related to the previous gene therapy, check for replication-competent lentivirus, and assess how long the gene-edited immune cells persist in the blood using specialized lab tests over periods up to 15 years. They will also evaluate long-term treatment effectiveness. Participants will provide consent and be followed closely according to the study protocol to ensure thorough safety and efficacy evaluation over the long term.

Long-term Follow-up Study of Lentiviral-based Gene-edited Immune Cell Therapy