Domestic CAR-NK Therapy Enters Lupus Arena with Groundbreaking First-in-Human Clinical Report

December 15, 2023 / eMedClub News /--Recently,Systemic Lupus Erythematosus (SLE) Becomes the Focus of Public Attention,The treatment of SLE patients sparks heated discussion.Data from the Chinese Systemic Lupus Erythematosus Research Collaboration Group (CSTAR) shows that only 0.76% and 25% of SLE patients in China are able to achieve complete disease remission or clinical remission without medication.84.13% of SLE patients are currently undergoing hormone therapy. Some patients, due to the hormone dosage required for maintenance therapy,The dosage is on the higher side, and adverse reactions also increase accordingly.Increase with dose。

▲ SLEOverview of Pathogenesis (Image Source: Reference 1)

In addition to hormones, the current treatment for systemic lupus erythematosus also includes antimalarial drugs, non-steroidal anti-inflammatory drugs (NSAIDs), and cytotoxic immunosuppressants. However, not all patients have sufficient response to the above medications or can tolerate the dose-dependent toxicity associated with these drugs, among whichCytotoxic immunosuppressants have significant toxic side effects, necessitating consideration of the safety risks associated with their long-term use.

The Innovative Path of SLE Drug Development: Gradually Shifting the FocusFocus on biologic drugs. In immunological theory, both the innate and adaptive immune systems play a role in the pathogenesis of SLE. This specifically includes immune complexes composed of antinuclear antibodies, dendritic cells, and self-Activation of Systemic Reactive T Cells, as well as the overproduction of various autoantibodies secreted by activated B cells. As the "vanguard" of the body's innate immune system, NK cell therapy can influence immune responses through multiple regulatory mechanisms. This also implies that this cellular therapy holds potential for treating autoimmune diseases such as Sjogren's syndrome and systemic lupus erythematosus.

Currently, Rui Therapeutics is collaborating with the Rheumatology and Immunology Department of Shanghai Changhai Hospital on a project“CD19-Targeted CAR-NK Cell Therapy for Relapsed/Refractory Systemic Lupus ErythematosusThe investigator-initiated clinical trial study. The studyCompleted CAR-NK Infusion Therapy for 4 Critically Ill PatientsAccording to the internationally recognized SLEDAI-2K (mild, moderate, severe) three-level disease scoring system, all four critically ill patients achievedDeep Relief, transitioning from "severe" to "mild" systemic lupus erythematosus (SLE) symptoms with corresponding persistence. For instance, two critically ill patients achieved deep remission after 15 days of two medium-dose treatments, with their SLEDAI-2K disease scores decreasing from 14 and 17 (severe condition) to 1 and 3 (mild condition), respectively, demonstrating highly positive effects of CAR-NK cell therapy.

This clinical trial is actively recruiting more patients, hoping to push this highly promising cell therapy drug to market as soon as possible for the clinical treatment of a wide range of systemic lupus erythematosus patients, bringing more optional treatment plans to this "incurable cancer."

About Rui Therapeutics

Rui Therapeutics was founded in June 2021 as a platform company focused on the research and development of next-generation cell-based therapeutics. Established by returned overseas scientists and senior executives from multinational pharmaceutical companies, the company is committed to the innovation of proprietary core technologies. Rui Therapeutics has built three platforms in the field of innovative drug therapies:

(1) Universal CAR-NK Cell Therapy Platform;

(2) Therapeutic single-base gene editing platform;

(3) Small molecule-induced differentiation regenerative medicine platform. The company focuses on invention and innovation,

Each platform has established its own core technology with independent intellectual property rights, including CAR structure design technology for CAR-NK cell therapy,HTAS-RV™Viral Delivery System, CAR-NKTM™Domestication techniques and NK drug formulation innovations, etc.

References: