JW Therapeutics, an independent, innovative biotechnology company focused on developing, manufacturing and commercializing cell immunotherapy products, announced that it has received the Investigational New Drug (IND) clearance from the National Medical Products Administration (NMPA) of China for a pivotal clinical trial of its anti-CD19 autologous chimeric antigen receptor T (CAR-T) cell immunotherapy product Carteyva® (relmacabtagene autoleucel injection) in the treatment of second-line large B-Cell lymphoma.
B-cell lymphoma is a group of malignant B-cell monoclonal amplified heterogeneous malignancies, accounting for approximately 85% of non-Hodgkin lymphoma (NHL). Large B-cell lymphoma (LBCL) is the most common subtype of NHL world-wide, accounting for 35% to 50% of all newly diagnosed cases in China.
This is a multi-centre, randomized, open label phase 3 study to compare the efficacy and safety of Carteyva® to standard second-line therapy in adult subjects with relapse/refractory large B-cell lymphoma (r/r LBCL), not reaching CR after first-line therapies (including anthracyclines and rituximab or other CD20-targeted agents) or relapsed within 12 months of CR. Read more here.