Heyuan Biosciences' Najiolen赛 (CNCT19) Granted IND Approval for Clinical Trial in Refractory Systemic Lupus Erythematosus-Associated Immune Thrombocytopenia
Juventas
Innovative Cell Therapy Drug Developer
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On October 11, the latest announcement was made on the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration.JuventasNaciorl InjectionReceived an implied permission for a clinical trial, targeting the indication ofRefractory Systemic Lupus Erythematosus-associated Immune Thrombocytopenia (SLE-ITP）Nakio CAR-T is a CD19-targeted chimeric antigen receptor autologous T (CD19 CAR-T) cell injection.According to the news release from Juventas, this is also the first IND approval that the product has received in the field of autoimmune disease treatment.
In July this year, The New England Journal of Medicine (NEJM) published a research paper online on the product's treatment of SLE-ITP, demonstrating its good and lasting efficacy and safety. According to a previous press release from Juventas, this is also the world's first application of CD19 CAR-T cell therapy in the treatment of SLE-ITP.
Screenshot source:CDE Official Website
Nazioleen Injection (CNCT19) is a CAR-T cell therapy product targeting CD19, developed by Juventas.Approved for marketing by NMPA in November 2023, for the treatment ofAdult Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia (r/r B-ALL)In September this year, the second marketing application for this product was also accepted by the CDE for the treatment of relapsed or refractory B-cell lymphoma after two or more lines of systemic therapy.
In recent years,CAR-T Cell Therapy for Autoimmune Diseases Is Becoming a Promising Research Direction`, attracting industry attention.`Juventas is also exploringThe Potential of Narlalocel in the Field of Autoimmune Diseases. (Further Reading:A New Chapter! Review of More Than 10 Autoimmune CAR-T Pipelines in China）
Systemic Lupus Erythematosus (SLE) is a chronic systemic autoimmune disease that often causes damage to multiple organs throughout the body. 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 long-term risk of major organ bleeding, representing a major challenge in SLE treatment.
According toClinicalTrialsOfficial Website,JuventasJuventas is conducting aNaciorlumabTreating Refractory Autoimmune DiseasesPhase 1Exploratory Clinical Study, to evaluate the safety and tolerability of this product in patients with refractory systemic lupus erythematosus (lupus nephritis, immune thrombocytopenia), refractory ANCA-associated vasculitis, and refractory dermatomyositis; as well as an investigator-initiated clinical study (IIT) aimed at assessingNaciorlcelTreatmentPatients with refractory systemic lupus erythematosus (SLE) manifested as active lupus nephritis or active immune thrombocytopeniaSafety and preliminary efficacy.
In July this year, The New England Journal of Medicine (NEJM) Published onlineNaciorlumabResearch paper on the treatment of SLE-ITP. ThisThe article reported a case of a female patient.Research shows,After infusion of Naciorlens Injection, CAR-T cells showed good expansion in the patient's body.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 month109/L, 75× in the third month109/L, the sixth month 109×109/L，AchieveUntil complete clinical remission, and the patient discontinued glucocorticoids and all immunosuppressants.。
This timeNakiOrencia Granted Implied Approval for Clinical Research, Signifying the Product is Set to Launch Registrational Clinical Trials in China for Autoimmune Diseases.
[2]World's First! Juventas' Nagebcel 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_dyuOxhw
[3] Juventas' Nayun Ruida® Receives Implied Approval for New IND Application in Autoimmune Disease Indications. Retrieved Oct 11，2024, From https://mp.weixin.qq.com/s/9-w9DlWNPKFMdZ8KjxGz7g
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