JW THERAP-B: Has submitted Phase I study data of Rigevidon in adult patients with active systemic lupus erythematosus in China to the National Medical Products Administration

According to the Zhitong Finance APP, JW THERAP-B (02126) announced that it has submitted Phase I study data of relma-cel in adult patients with active systemic lupus erythematosus (SLE) to the National Medical Products Administration (NMPA) of China. The NMPA has received the data and accepted the meeting application. SLE is a chronic autoimmune disease that can cause damage to multiple organs and tissues throughout the body. The updated data comes from a Phase I, single-arm, open-label, multicenter, dose-exploration study conducted in China, with an initial dose set at 50×10^6 CAR+T cells. The dose-exploration rules were designed using the Bayesian Optimal Interval (BOIN) design, exploring three dose levels of 50×10^6 CAR+T cells, 75×10^6 CAR+T cells, and 100×10^6 CAR+T cells to evaluate the safety of relma-cel injection in SLE patients and ultimately determine the recommended dose for Phase II studies. As of July 2025, a total of 12 subjects have been enrolled in this study, and the infusion of relma-cel injection has been completed. The preliminary safety, efficacy, and pharmacokinetics/pharmacodynamics (PK/PD) explorations for the low, medium, and high dose groups have been completed. In this study, a total of 12 patients were infused, all of whom were female, with a median age of 27 years (range: 20 to 41 years) and a median disease history of 9.5 years (range: 4 to 20 years). The highest SELENA-SLEDAI score was 16, the lowest score was 4, and the median score was 10, all of whom were classified as having moderate to severe active SLE. Eleven patients (91.7%) had abnormal antinuclear antibodies (ANA), 33.3% had elevated anti-double-stranded DNA antibodies (dsDNA), and 16.7% had urine protein greater than 2000 mg/24 h. All 12 patients had renal involvement (100%), with other commonly affected organ systems being skin (50%), hematologic system (50%), and joints (16.7%). Before participating in this study, patients had received combined treatment with hormones, various immunosuppressants, and/or biological agents, but their disease remained recurrent, necessitating new effective therapeutic drugs. As of July 2025, the Phase I results of this study showed that among the 12 patients who could be evaluated for efficacy at 6 months, all 12 (100%) met the SRI-4 criteria, 6 (50%) met the LLDAS criteria, and all 12 (100%) met the Drug-Free criteria. The disease activity measurement scales SLEDAI-2K, SELENA-SLEDAI, SLE-DAS, and PGA scores all showed a downward trend, initially indicating significant efficacy. At the same time, preliminary safety results showed that among the 12 patients who were infused, 11 experienced CRS, all of which were Grade 1 cytokine release syndrome (CRS). One patient (at the 75×10^6 dose) experienced Grade 2 immune effector cell-associated neurotoxicity syndrome (ICANS), which resolved after symptomatic treatment. None of the 12 patients experienced dose-limiting toxicity (DLT). The safety results of this study indicate that relma-cel is well-tolerated in the treatment of moderate to severe active SLE As of now, this research is still ongoing to accumulate data with a longer follow-up period. Based on the previously conducted IIT research and the results of this Phase I clinical study, Ruijiaolun has shown good overall safety, controllable adverse reactions, and significant efficacy in treating Chinese adults with moderate to severe active SLE. As the first commercial CAR-T therapy approved for clinical trial permission (IND) in the field of SLE treatment, the Phase I clinical study of Ruijiaolun for moderate to severe active SLE has demonstrated good safety and significant efficacy, showcasing great potential for rapid advancement to the Biologics License Application (BLA) stage. The company has submitted the materials and received acceptance, looking forward to further communication with regulatory agencies on the key Phase II study to accelerate the development process of this innovative therapy, bringing breakthrough treatment options to SLE patients