JW Therapeutics (HKG: 2126), a biopharmaceutical company based in China, has presented new clinical data for its chimeric antigen receptor (CAR) T cell therapy, Carteyva (relmacabtagene autoleucel injection), at the European Alliance of Associations for Rheumatology (EULAR) 2024 annual meeting. The data was for adult patients in China with active systemic lupus erythematosus (SLE).
The single-arm, open-label, multi-center, dose-finding study (NCT05765006) aimed to evaluate the safety and efficacy of Carteyva in SLE patients. As of April 8, 2024, 12 subjects were enrolled, and infusions of the drug have been completed. Preliminary assessments of safety, pharmacokinetics, pharmacodynamics (PK/PD), and efficacy across low, medium, and high-dose groups have been conducted, with the longest follow-up period exceeding nine months.
Data as of December 18, 2023, from the low-dose group indicated positive outcomes. Among patients who received a 25 x 10^6 (25M) dose infusion, three female subjects with multi-organ involvement and prior treatments for active SLE completed at least four months of follow-up. After Carteyva infusion, the subjects showed continued improvement in physical signs and symptoms. The SELENA-SLEDAI score dropped from 8-14 points at baseline to 0 or 1 point, and all three subjects achieved SLE response index 4 (SRI-4), with two reaching a more stringent lupus low disease activity state (LLDAS). By the data cutoff, all subjects had discontinued SLE treatment drugs, including steroids or immunosuppressants. Carteyva showed a favorable safety profile and manageable side effects.
Relmacabtagene autoleucel, originally developed by JW Therapeutics, was previously approved in China for adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy and for adult patients with follicular lymphoma (r/r FL) that is refractory or relapses within 24 months of second-line or higher systemic treatment. The drug received its second indication for use in second-line or higher r/r FL in October 2022.- Flcube.com
