Shanghai-based BRL Medicine Inc. has announced that it has received Investigational New Drug (IND) approval from China’s National Medical Products Administration (NMPA) for BRL-301. This CD19-targeted chimeric antigen receptor (CAR)-T cell therapy will be evaluated in patients with recurrent or refractory B-cell non-Hodgkin lymphoma (R/R B-NHL).
BRL-301: Universal Allogeneic CAR-T Formulation
BRL-301 is a universal allogeneic CAR-T formulation developed using BRL Medicine’s proprietary TyUCell platform. The therapy achieves immune escape and functional optimization of allogeneic T cells through advanced gene editing techniques. This approach effectively avoids the risks of graft-versus-host disease (GVHD) and host-versus-graft (HVG) reactions, addressing a critical technical challenge in the development of universal CAR-T products.
Technical Breakthrough and Clinical Implications
By overcoming the patient’s immune rejection of allogeneic cells, BRL-301 represents a significant advancement in the field of immunotherapy. The IND approval marks a crucial step toward clinical testing, offering hope for patients with R/R B-NHL who have limited treatment options.-Fineline Info & Tech