Rui Therapeutics Presents Promising CAR-NK Therapy KN5601 for Pediatric Refractory Lupus at ASN 2025
Rui Therapeutics
A New Generation of Cell-Based Drug Developer
November 10, 2025
eMedClub News
The Most Influential Nephrology Academic Conference Globally —— 2025 American Nephrology Annual Meeting（ASN）The ASN Kidney Week 2025 was held in Houston, USA, from November 5th to 9th. As the annual flagship conference of the American Society of Nephrology, this year's event has attracted top experts and scholars from around the world.Including frontline clinicians, pioneers of biotech innovator companies, and elites from the investment community, focusing on the latest research progress and clinical translation achievements related to kidney disease and nephritis associated with rheumatic immune diseases.
The nephrology team of the Children's Hospital affiliated with Zhejiang University School of Medicine, representing the R&D and clinical teams, reported that "Safety and Efficacy of Anti-CD19/B Cell Maturation Antigen (BCMA) Chimeric Antigen Receptor-Natural Killer Cell (CAR-NK) Therapy in Pediatric Patients with Refractory Systemic Lupus Erythematosus (SLE): A Preliminary Clinical Study"The latest clinical research follow-up results."
The CD19/BCMA CAR-NK cell therapy (KN5601), developed by the innovative pharmaceutical company Rui Therapeutics in Shenzhen, China, has demonstrated exciting preliminary efficacy and excellent safety in treating pediatric relapsed/refractory systemic lupus erythematosus (SLE), marking a significant breakthrough in the field of pediatric SLE treatment and becoming one of the most eye-catching highlights at the conference.
The study has completed enrollment and treatment of 11 subjects, including 5 subjects with systemic lupus erythematosus (SLE) who had severe renal organ system involvement. These subjects showed significant improvement in SLEDAI and PGA scores, with reduced or stable proteinuria levels and decreased autoantibody titers. During CAR-NK therapy, only 2 patients experienced CRS of grade ≤2, and no other serious adverse events related to CAR-NK treatment were observed.
Professor Mao Jianhua from the Children's Hospital Affiliated to Zhejiang University School of Medicine stated:
Systemic lupus erythematosus (SLE) is a major disease that threatens human health, and refractory SLE in children represents a significant clinical challenge that needs to be addressed. Compared with conventional autologous CAR-T cell therapy, CAR-NK cells have notable advantages in terms of clinical accessibility. If this clinical study can preliminarily verify the safety and efficacy of CD19+BCMA-targeted CAR-NK cells (KN5601) in children with refractory systemic lupus erythematosus, such a product will hold substantial scientific, clinical, and societal value in the future.
Dr. Qian Hao, Co-founder & CEO of Rui Therapeutics, stated:
In the past decade, innovative drugs, especially in the CGT field, have developed rapidly. Taking CAR-T cell therapy as an example, the FDA and CDE have approved seven products for commercialization. However, in the pediatric field, innovative cellular therapies remain an unexplored "wasteland." KN5601 is expected to become a cutting-edge product to help fill this gap.
About KN5601
KN5601 is a bispecific CAR-NK cell therapy drug targeting CD19 and BCMA, developed by Shenzhen Rui Therapeutics. It aims to deeply eliminate B-cell populations expressing CD19/BCMA, triggering the subject's own immune reconstitution, freeing patients from long-term hormone and immunosuppressant treatments, and achieving long-term deep or complete remission of the disease. The drug employs a unique HTAS-RV™ delivery system and NK cell expansion cryopreservation technology, featuring "universal" and "off-the-shelf" characteristics.
AboutRui Therapeutics
Rui Therapeutics, founded in 2021, is a platform-based company focused on the research and development of next-generation I&I drugs. Since its establishment, the team has been committed to innovating proprietary core technologies. Rui Therapeutics has built a leading technology platform in the I&I field based on CAR-NK. The company focuses on inventive innovation, establishing proprietary core technologies, and has laid out cutting-edge First-in-class pipeline products, covering disease areas with unmet clinical needs such as autoimmune diseases, inflammatory diseases, and fibrosis.
The success of biopharmaceutical companies hinges on innovation, with the key factors being pharmaceutical concepts and clinical timelines. Over the past four years, Rui Therapeutics has built an innovative R&D team, an efficient CMC team, and a highly capable clinical and regulatory affairs team.
Rui Therapeutics will further strengthen the innovation of core technologies, the upgrading of pipeline products, the expansion of clinical indications, and international cooperation, consolidating its leading position and cutting-edge exploration in the I&I field.
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