Hangzhou Qihan Biotech obtained FDA IND clearance for QT-019C, a universal allogeneic CAR T-cell therapy engineered to target both CD19 and BCMA for autoimmune diseases. The company said the therapy is based on off-the-shelf allogeneic CAR T cells manufactured from healthy donor leukapheresis products and designed to stably express the two CARs. The IND authorization provides the next regulatory step for initiating clinical evaluation in the U.S., expanding the footprint of allogeneic CAR-T development into autoimmune indications beyond oncology. The dual-target design also reflects ongoing platform efforts to improve breadth and consistency of activity in heterogeneous disease settings. If clinical data support safety and durability, QT-019C could inform future design and dosing strategies for “universal” CAR approaches outside hematologic malignancies. The FDA clearance is particularly notable given the industry’s continued push toward off-the-shelf cell therapies aimed at reducing manufacturing time and variability versus autologous workflows.