BEX101 in B-cell Non-Hodgkin's Lymphoma

CAR-T therapy has shown strong efficacy in r/r B-cell NHL. However, current CAR-T manufacturing is usually centralized and involves multiple complex steps. This lengthy process places high demands on manufacturing, logistics, and patient condition, and may limit timely treatment for patients with rapidly progressing disease or restricted access to medical resources. To overcome these limitations, this study has developed a bedside extracorporeal (BEX) CAR-T manufacturing platform. Using a fully enclosed automated system, the BEX process enables continuous on-site preparation of CAR-T cells, including cell collection, CD19 CAR gene delivery, washing and resuspension, quality control, and infusion at the bedside. When predefined release criteria are met, the final cell product can be infused within 6 hours. This study will be conducted to explore the safety and efficacy of BEX101 therapy in patients with r/r B-cell NHL who are positive for CD19 expression.