The China Center for Drug Evaluation (CDE) has given the green light for a study on inaticabtagene autoleucel (CNCT 19), a chimeric antigen receptor (CAR)-T cell therapy developed by Juventas Cell Therapy Ltd, a Chinese firm. This therapy is now approved for research in refractory systemic lupus erythematosus-associated immune thrombocytopenia (SLE-ITP), a significant step forward in the treatment of autoimmune diseases.
Inaticabtagene autoleucel, targeting the CD19 antigen, is a CAR-T cell therapy product under development to address a range of conditions including B-cell acute lymphoblastic leukemia, large B-cell lymphoma, and various autoimmune diseases. The therapy received approval in China in November of the previous year for the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL). Additionally, a market filing for its use in recurrent or refractory large B-cell lymphoma is currently under review within the country.
Preliminary data published in the New England Journal of Medicine in July this year demonstrated the drug’s efficacy and safety profile, showing promising and sustained results in patients with SLE-ITP. This development underscores the potential impact of inaticabtagene autoleucel on the treatment landscape for autoimmune diseases and blood cancers.- Flcube.com
