CAR-T without manufacturing the CAR-T? Legend Biotech has received FDA IND clearance for LB2501, an investigational in vivo CAR-T therapy designed to generate CD19/CD20 dual-targeting CAR-T cells directly inside the patient after a single infusion. Unlike conventional autologous CAR-T, LB2501 is designed to be off-the-shelf, potentially eliminating several steps of individualized cell collection and manufacturing. Notably, the planned U.S. Phase 1/2 study will evaluate the therapy without lymphodepleting chemotherapy. LB2501 uses Legend’s TaVec™ platform, an engineered, replication-incompetent lentiviral vector designed to selectively transduce T cells in vivo. The resulting CAR-T cells target both CD19 and CD20—a strategy intended to reduce the risk of antigen escape in B-cell malignancies. If successful, this could address some of the biggest barriers to conventional CAR-T: manufacturing time, complexity, scalability, and access. But the critical questions now move from engineering to the clinic: Can we reliably generate enough functional CAR-T cells in vivo? Will the cells expand and persist appropriately? What will the safety profile look like without traditional lymphodepletion? And can dual targeting translate into deeper and more durable responses? LB2501 is now moving toward U.S. clinical evaluation, adding another important step in the rapidly developing field of in vivo cell engineering. The next generation of CAR-T may not be manufactured for the patient—it may be manufactured inside the patient. investors.legendbiotech.com/… #CART #InVivoCART #CellTherapy #Immunotherapy #Lymphoma #Hematology #BCellLymphoma #CancerResearch