BRL Medicine's Allogeneic CAR-T Therapy TyU19 for Autoimmune Diseases Featured in Cell Journal
BRL Medicine
Cell and Gene Therapy Drug Developer
▎WuXi AppTec Content Team Report
Today (July 16), BRL Medicine, which focuses on gene and cell therapy, announced that its co-developed next-generation allogeneic universal CAR-T therapy (TyU19) treatmentAutoimmune DiseasesThe research results were officially published in the international academic journal on July 15.CellPublished on.In this study, TyU19 was developed by BRL Medicine.Allogeneic universal CAR-T cell therapy product targeting CD19 antigen, demonstrating significant efficacy and high safety in clinical trials.
Autoimmune diseases are a group of heterogeneous diseases with a common basis of impaired immune tolerance. Given the important role of B cells in autoimmune diseases, several teams internationally have attempted to apply CAR-T therapy to autoimmune diseases, which has already demonstrated excellent safety and efficacy. However, for either oncology indications or autoimmune disease indications, marketed or investigational products still focus on...Autologous SourceCAR-T products.
This time, the TyU19 developed by BRL Medicine belongs to allogeneic.Universal CAR-T Product.BRL Medicine's press release pointed out,TyU19 isABrand New UCAR-T Product, Through Multi-Genes, selective gene editing strategies not only effectively avoid the risk of graft-versus-host disease in allogeneic cell transplantation, but also overcome key technical barriers in the development of allogeneic universal CAR-T products:Patient's Immune System Rejection of Allogeneic Cells。On the basis of ensuring the safety and efficacy of cell products, it truly realizes the generalization of immune cell therapy products.
Clinical studies have shown that this product does not require intensive lymphodepletion pretreatment for patients (lower than autologous CAR-T) during the treatment process, and can achieve rapid expansion and long-term maintenance in the patient's body, effectively eliminating CD19-positive target cells in the patient.BRL Medicine pointed out,The technological breakthrough of TyU19 lays a solid foundation for its excellent efficacy and high safety in the treatment of patients with tumors and autoimmune diseases.
In this study, the research team used BRL Medicine's UCAR-T product TyU19 to treatThree patients with refractory autoimmune diseases, including one case of immune-mediated necrotizing myositis (IMNM) and two cases of systemic sclerosis (SSc).
Among them, IMNM subjects did not exhibit any symptoms of fever or cytokine storm after receiving TyU19 cell therapy, andThe patient's Total Improvement Score (TIS) rapidly increased from a baseline of 72.5 to 100 within two months and remained at this level throughout the subsequent follow-up period.Imaging and pathological examinations also simultaneously showed that the patient's muscle inflammation had been significantly alleviated.
Two subjects with severe SSc received TyU19 cell therapy, resulting in a significant improvement in CRISS scores for all patients within a few months. Additionally, the modified Rodnan skin scores (mRSS) of both patients showed a marked decrease in skin fibrosis. Furthermore, after TyU19 treatment, B cells were completely depleted in all patients, and autoantibodies in IMNM patients were entirely eliminated. Critical organ fibrosis damage in the two SSc patients was reversed and continued to improve during the six-month monitoring period. The entire treatment process was well-tolerated, with no observed cytokine release syndrome (CRS), graft-versus-host disease (GvHD), or immune effector cell-associated neurotoxicity syndrome (ICANS).
References:
[1] World's First! BRL Medicine's UCAR-T Research Published in Cell, Achieving Significant Breakthrough in Autoimmune Disease Treatment.Retrieved July 16，2024, From https://mp.weixin.qq.com/s/MIFAfAgFcVutN7fqAr4DuQ
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