Carteyva receives IND approval for clinical trial in second-line large b-cell lymphoma
pharmafile | March 31, 2022 | News story | Business Services |
An investigational new drug (IND) clearance from the National Medical Products Administration (NMPA) of China, for a pivotal clinical trial of anti-CD19 autologous chimeric antigen receptor T (CAR-T) cell immunotherapy product, Carteyva. This is for 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 worldwide, accounting for 35% to 50% of all newly diagnosed cases in China. 50% of patients could be cured by current standard of care (R-CHOP) chemotherapy.
JW Therapeutics conducted this multi-centre, randomised, open label Phase III study to compare the efficacy and safety of Carteyva to standard second-line therapy in adult subjects with relapse/refractory large B-cell lymphoma, not reaching complete response (CR) after first-line therapies or relapsed within 12 months of CR.
Relmacabtagene autoleucel injection (Carteyva) is an autologous anti-CD19 CAR-T cell immunotherapy product independently developed by JW Therapeutics based on a CAR-T cell process platform of Juno Therapeutics. In September 2021, relma-cel was approved by the NMPA for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, making it the first CAR-T product approved as Category 1 biology products in China.
JW Therapeutics is an independent and innovative biotechnology company, focusing on the development, manufacturing, and commercialising cell immunotherapy products.