JW (Cayman) Therapeutics (2126) has submitted Phase I clinical trial data of the autologous anti-CD19 CAR-T cell immunotherapy product Relmacabtagene autoleucel (Relma-cel) to the National Medical Products Administration (NMPA) for the treatment of adult patients with moderately to severely active systemic lupus erythematosus (SLE) in China. The data and meeting application have been accepted by the regulator.
According to the submission, 12 female adult patients with a median age of 27 years and a median disease history of 9.5 years received infusions at three dose levels. All participants had recurrent disease despite prior treatment with steroids, multiple immunosuppressants, and/or biologics. Six-month results in the 12 evaluable patients showed a 100% SRI-4 remission rate and complete transition to drug-free status, while half of the patients achieved a lupus low disease activity state. Disease activity scores declined across all measured indices.
Preliminary safety data indicated that 11 patients experienced Grade 1 cytokine release syndrome, and 1 patient experienced Grade 2 immune effector cell–associated neurotoxicity syndrome, which resolved upon treatment. No dose-limiting toxicities were reported, and the study is ongoing for further long-term follow-up.
Relma-cel (trade name in oncology indications: Carteyva®) is an independently developed therapy using a CAR-T platform from Juno Therapeutics. It is the first commercial CAR-T treatment in China approved for multiple relapsed or refractory B-cell lymphoma indications, and it is the first such product to receive an IND for SLE in China. JW (Cayman) Therapeutics focuses on developing, manufacturing, and commercializing cell immunotherapy products and has built a pipeline targeting hematologic malignancies, solid tumors, and autoimmune diseases.
A cautionary statement emphasizes that eventual success in the development or marketing of Relma-cel cannot be guaranteed. Shareholders and potential investors are advised to exercise due care when dealing in the shares of JW (Cayman) Therapeutics (2126).