▎Edited by the WuXi AppTec content teamToday (July 25),Juventas announced that the international top journal "The New England Journal of Medicine" (NEJM) Published onlineTargeted CD19 Chimeric Antigen Receptor Autologous T (CD19 CAR-T) Cell Injection (Najiolumab Injection)TreatmentSystemic Lupus Erythematosus-Associated Immune Thrombocytopenia (SLE-ITP)The research paper reports that CAR-T (Nagioluomai) therapy has shown good and lasting efficacy and safety in SLE-ITP, demonstrating the potential application of CAR-T in the treatment of SLE and ITP.
Systemic Lupus Erythematosus (SLE) is a chronic systemic autoimmune disease that often causes damage to multiple organs throughout the body. Abnormal B-cell activity and the production of autoantibodies play a crucial role in its pathogenesis. SLE can lead to immune thrombocytopenia, which occurs in 16% of Chinese SLE patients. A significant proportion of these patients show poor responses to glucocorticoids, immunosuppressants, and biologics, resulting in a poor prognosis and a long-term risk of major organ bleeding. This represents a major challenge in the treatment of SLE.According to the introduction in Juventas' press release, thisNEJMThe article reported a female patient who was diagnosed with systemic lupus erythematosus in 2014 and had persistent severe immune thrombocytopenia. The patient had previously received methylprednisolone pulse therapy, hydroxychloroquine, intravenous immunoglobulin, tacrolimus, cyclosporine, sirolimus, rituximab, danazol, eltrombopag, and thrombopoietin treatment, all of which were ineffective, with her platelet count consistently remaining at 20×109/L or less, accompanied by mucocutaneous bleeding manifestations. In September 2023, the patient received a single infusion of autologous CD19 CAR-T (Nanjicel) cells and has been under continuous follow-up.Patient Treatment Efficacy:After infusion of Naciorlens injection, CAR-T cells showed good expansion in the patient.On the 28th day after infusion, CD19-positive B cells were depleted in the blood, and B-cell reconstitution occurred by the third month.. Platelet count continued to rise within six months after treatment, from 4×109/L increased to 29× at the first month.109/L, the third month 75×109/L, the sixth month 109×109/L，AchieveUntil complete clinical remission, and the patient discontinued glucocorticoids and all immunosuppressants.The titer of antinuclear antibodies in the patient also decreased significantly.The patient only experienced transient grade 1 fever (38.1°C) on the 9th day after infusion, which returned to normal after physical cooling. No other adverse events related to CAR-T cell therapy were observed.Professor Mengtao Li from the Department of Rheumatology and Immunology at Peking Union Medical College Hospital stated: "This case represents the world's first application of CD19 CAR-T cell therapy in the treatment of systemic lupus erythematosus-related immune thrombocytopenia, demonstrating the excellent efficacy and vast potential of CAR-T cell therapy for refractory SLE and refractory ITP. The multidisciplinary team at Peking Union Medical College will continue to explore the application of CAR-T cell therapy in refractory autoimmune diseases, aiming to advance the field of autoimmune disease treatment and benefit a wide range of patients."
Dr. Lulu Lv, CEO of Juventas, stated,This milestone achievement strongly demonstrates the clinical value and broad prospects of Naciorlen Injection in treating autoimmune diseases.Maximizing the clinical value of Naciorlen Injection is an important goal for Juventas. The drug treatsAdult Relapsed or Refractory B-Cell Acute Lymphoblastic LeukemiaIt has been officially approved for marketing by the National Medical Products Administration (NMPA) in November 2023. The registration clinical studies for treating relapsed or refractory aggressive B-cell non-Hodgkin lymphoma and for treating relapsed or refractory B-cell acute lymphoblastic leukemia in children and adolescents, as well as the new drug marketing process, are also proceeding in an orderly manner.At the same time, Juventas is actively accelerating the clinical research of Nalkio Cell Injection in various types of autoimmune diseases, speeding up its clinical application process, and enabling more patients to benefit from this innovative therapy.[1]World's First! Juventas' Naciorlucel Treatment for Refractory Systemic Lupus Erythematosus-Associated Immune Thrombocytopenia (SLE-ITP) Research Published in The New England Journal of Medicine. Retrieved Jul 25, 2024, from https://mp.weixin.qq.com/s/RpyB_1OMoCCgdx_dyuOxhwThis article was compiled and edited by the content team of WuXi AppTec based on publicly available information. Feel free to share it on your personal social media.TransferFor authorization and other cooperation needs, please contact wuxi_media@wuxiapptec.com.
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