Rui Therapeutics present the CD19 CAR NK Cell Therapy in SLE Patients Clinical Trial results in the 2024 ACR Annual Meeting

Rui Therapeutics, a leading Off-shelf universal cell therapy company, was invited by the American College of Rheumatology (ACR) to present a speech at the 2024 Annual Meeting. On behalf of the company, CEO Dr. Hao Qian reported the latest clinical research results of “Allogenic CD19 CAR NK Cell Therapy to Relapse and Refractory Systemic Lupus Erythematosus”.

The American College of Rheumatology 2024 Annual Meeting, held in Washington, D.C., USA, from November 14 to 19, is a highly regarded top international event in the field of rheumatology. The meeting brings together the world's leading rheumatologists to discuss the most innovative research findings in the field of rheumatology.

22 subjects have been enrolled and treated with CAR-NK cells in this clinical trial, including 9 subjects with systemic lupus erythematosus (SLE) with severe renal organ system involvement (BILAG assessment of A) and 6 subjects with severe hematologic involvement. These patients are refractory to treatment with multiple immunosuppressive and biologic agents. According to the SRI, LLDAS and Doris (2021) remission criteria, the 8 subjects who achieved a follow-up of more than 9 months had a 100% response rate for SRI-4, 100% response rate for SRI-6, 75.0% response rate for LLDAS, and 50% remission rate for Doris. Those who achieved remission for Doris, with a maximum follow-up time of more than 14 months, maintained remission without Relapse. All subjects showed significant and sustained improvement in SLEDAI and PGA scores, and none of them relapsed.

After treatment with KN5501, subjects regenerated predominantly Naïve B cells and significantly fewer Memory B cells. Despite B-cell recovery, all subjects maintained durable clinical benefit with no new disease activity. Safety data showed that only 2 of 22 subjects reported Grade 1 cytokine release syndrome (CRS) associated with KN5501 that resolved within 1 day of anti-cytokine therapy, with no neurotoxicity (ICANS), other treatment-related adverse events (AE), or dose-limiting toxicity (DLT), and none of them experienced infections during a follow-up period of up to 1 year or more.

The results of the KN5501 clinical trial presented at the ACR Annual Meeting demonstrated that the KN5501 CD19 CAR-NK has dramatic efficacy and an excellent safety profile in subjects with moderately-to-severely active relapsed/refractory SLE, providing new hope for the treatment of SLE.