KN5501

KN5501 is a chimeric antigen receptor (CAR) modified natural killer (NK) cell therapy targeting CD19, being developed for various autoimmune disorders and certain cancers. Based on the search results, I can provide the following comprehensive information about this drug. ## Basic Information KN5501 is an allogeneic ("off-the-shelf") CAR-NK cell therapy that works by attaching chimeric antigen receptors to natural killer cells, specifically targeting CD19, a protein widely expressed on B cells. This approach allows the modified NK cells to recognize and eliminate CD19-positive B cells, which play a significant role in various autoimmune diseases. ## Development and Clinical Trials The drug is being developed by Rui Therapeutics and Nanjing Enricnk Biotech. It's currently in Phase 1 clinical trials for several conditions, including: * Systemic Lupus Erythematosus (SLE): A single-arm, open-label pilot study with 36 planned participants is evaluating KN5501's safety and efficacy in patients with moderate to severe refractory SLE[7][8]. * Immune Nephropathy: A trial with 36 planned participants is assessing the drug's safety and effectiveness in patients with this condition[6]. * Autoimmune Disorders: Multiple trials are investigating KN5501 for various relapsed/refractory B-cell related autoimmune diseases[4][5]. * Antisynthetase Syndrome and Rheumatoid Arthritis: Early phase I trials are planned in collaboration with the First Affiliated Hospital with Nanjing Medical University[1]. * Diffuse Large B Cell Lymphoma: The drug has reached Phase I development for this cancer indication[1]. ## Clinical Results Early clinical data from the SLE trial has shown promising results. According to a July 2024 report, four severe SLE patients who received KN5501 achieved deep remission, with their disease status changing from "severe" to "mild" according to the SLEDAI-2K scoring standard. Two patients showed particularly impressive responses, with their disease scores dropping from 14 and 17 (severe) to 1 and 3 (mild) after just 15 days of treatment[10]. ## Technology Platform KN5501 utilizes Rui Therapeutics' proprietary technologies, including: * A unique HTAS-RV™ delivery system * Advanced NK cell expansion and cryopreservation formulation technology * CAR structure design technology * CAR-NK™ taming technology[10] This approach differs from CAR-T cell therapy and is positioned as potentially safer, offering an "off-the-shelf" option that doesn't require personalized manufacturing for each patient[9]. ## Current Status As of May 2025, KN5501 remains in active clinical development with multiple ongoing trials. The promising early results, particularly in autoimmune conditions like lupus, suggest significant potential for this novel cell therapy approach.

Other names

allogeneic CD19-CAR-NK cellsCD19-CAR-NK cells (Naval Medical University)mbIL15-CD19-CAR-NK cellsmbIL-15-CD19-CAR-NK cellsmbIL 15-CD19-CAR-NK cells