JW THERAP-B (02126) announced that it has submitted Phase I study data for relma-cel in adult patients with active systemic lupus erythematosus (SLE) to the National Medical Products Administration (NMPA) in China. The NMPA has acknowledged receipt of the data and accepted the application for the meeting. 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. The initial dose was set at 50×10^6 CAR+T cells, utilizing a Bayesian Optimal Interval (BOIN) design for dose exploration, assessing three dosage levels at 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, with the reinfusion of relma-cel injection completed. Preliminary assessments of safety, efficacy, and pharmacokinetics/pharmacodynamics (PK/PD) in the low, medium, and high dose groups have been achieved. All 12 patients reinfused 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 was 4, with a median score of 10, indicating moderate to severe active SLE. Among the patients, 11 (91.7%) exhibited abnormal antinuclear antibodies (ANA), 33.3% had elevated double-stranded DNA antibodies (dsDNA), and 16.7% had urine protein exceeding 2000 mg/24 h. All 12 patients showed renal involvement (100%), with other common organ systems affected in the order of skin (50%), hematologic system (50%), and joints (16.7%). Prior to participating in this study, all patients had received combined treatment with hormones, various immunosuppressants, and/or biologics, yet their disease remained recurrent, necessitating new effective treatment options. By July 2025, Phase I results indicated that among the 12 patients eligible for a 6-month efficacy assessment, all 12 (100%) met the SRI-4 criteria, 6 (50%) met the LLDAS criteria, and all 12 (100%) achieved Drug-Free status. Measures for disease activity, including SLEDAI-2K, SELENA-SLEDAI, SLE-DAS, and PGA scale scores, showed a downward trend, preliminarily indicating significant efficacy. Preliminary safety results revealed that of the 12 patients reinfused, 11 experienced cytokine release syndrome (CRS), all classified as Grade 1 CRS. One patient (during the 75×10^6 dosage) developed Grade 2 immune effector cell-associated neurotoxicity syndrome (ICANS), which resolved after symptomatic treatment. No patients experienced dose-limiting toxicity (DLT). These safety results suggest that relma-cel is well-tolerated in treating moderate to severe active SLE. The study is ongoing to accumulate data over longer follow-up periods. Based on previous IIT studies and the current Phase I clinical study results, relma-cel displays overall good safety and controllable adverse reactions with significant efficacy when used to treat moderate to severe active SLE in Chinese adults. As the first commercial CAR-T therapy approved for clinical trials in the SLE treatment field, the Phase I study of relma-cel shows promising safety and significant efficacy, demonstrating great potential for rapid advancement to the Biologics License Application (BLA) stage. The company has submitted the relevant materials and received acceptance, looking forward to further discussions with regulatory authorities concerning the key Phase II study to accelerate the development of this innovative therapy, offering groundbreaking treatment options for SLE patients.