World's First CAR-NK Therapy for Lupus Shows Promising Clinical Data in China, Offering Hope for Cure

For relapsed and refractory systemic lupus erythematosus, utilizing its unique HTAS-RVTM delivery system and superior NK cell expansion and cryopreservation formulation technology, Nanjing Rui Therapeutics has developed KN5501, a next-generation, internationally leading "universal" and "off-the-shelf" CAR-NK cell therapy drug.

Currently, Rui Therapeutics is collaborating with the Department of Rheumatology and Immunology at Shanghai Changhai Hospital on an investigator-initiated clinical trial titled "CD19-Targeted CAR-NK Cell Therapy for Relapsed/Refractory Systemic Lupus Erythematosus (SLE)." The treatment has been administered to four patients with severe SLE. According to the internationally recognized SLEDAI-2K three-level disease severity scoring system (mild, moderate, severe), all four patients achieved deep remission after receiving the CAR-NK cell therapy, transitioning from "severe" to "mild," and demonstrated sustained improvement. Notably, two of the severe cases reached deep remission within 15 days, with their SLEDAI-2K scores decreasing from 14 and 17 (indicative of severe disease) to 1 and 3 (indicative of mild disease), respectively, showcasing highly promising results for CAR-NK cell therapy. This marks the world’s first clinical report on the use of CAR-NK therapy in treating systemic lupus erythematosus.

This clinical trial is actively recruiting more patients, hoping to bring this highly promising cell therapy drug to market as soon as possible, benefiting a large number of patients with systemic lupus erythematosus and bringing hope of a cure for this "never-ending 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 returning overseas scientists and senior executives from multinational pharmaceutical companies, the company is committed to innovating proprietary core technologies. Rui Therapeutics has built three platforms in the field of innovative drug treatments: (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 inventive innovation, and each platform has developed corresponding proprietary core technologies, including CAR structure design technology for CAR-NK cell therapy, the HTAS-RV TM viral delivery system, CAR-NK TM domestication technology, and innovations in NK drug formulations.

Centered around the three major innovative drug technology platforms it has built, the company has laid out a pipeline of cutting-edge First-in-class products, focusing on unmet clinical needs in autoimmune diseases, oncology, and genetic disorders.

About Systemic Lupus Erythematosus

Systemic Lupus Erythematosus (SLE) is a typical systemic autoimmune disease, commonly known as the "uncurable cancer," for which there is currently no cure. Its pathogenesis mainly involves excessive production of autoantibodies by B cells in the body, forming immune complexes that cause damage to multiple systems and organs, including renal failure, central nervous system involvement, and hematological system impairment. Common typical symptoms include: malar rash, discoid rash, oral ulcers, alopecia; abdominal pain, pericarditis, cardiopulmonary damage, pleurisy, pleural effusion; thrombosis, vasculitis, leukopenia, thrombocytopenia, proteinuria, hematuria; polyarthralgia, arthritis, lupus nephritis, lupus encephalopathy.

In China, there are approximately 1 million patients, with an annual increase of 80,000 to 100,000. The male-to-female ratio of affected individuals is 1:9; the disease primarily occurs in females of childbearing age between 18 and 40 years old and can be life-threatening when severe. Currently, the treatment for systemic lupus erythematosus mainly involves immune modulation to alleviate symptoms, including the use of corticosteroids, antimalarial drugs, non-steroidal anti-inflammatory drugs (NSAIDs), and cytotoxic immunosuppressants. However, these drugs cannot achieve a cure and have significant toxic side effects. For example, cyclophosphamide, which is commonly used, not only affects female fertility but also has teratogenic and carcinogenic properties.

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