China-based JW Therapeutics (HKG: 2126) has announced receiving tacit clinical trial approval from the National Medical Products Administration (NMPA) for its product Carteyva (relmacabtagene autoleucel injection; relma-cel). The treatment will be assessed for its efficacy in managing moderate-to-severe refractory systemic lupus erythematosus (SLE).
Understanding Systemic Lupus Erythematosus (SLE)
SLE is a complex autoimmune disease that can lead to damage in multiple organs and tissues, affecting approximately 1 million people in China. Clinical studies have demonstrated that CAR-T cells targeting CD19 can significantly impact the treatment of SLE patients, offering a promising new, safe, and effective treatment option for those with moderate to severe SLE.
Design of the Phase I/II Study
The upcoming clinical study is an open-label, single-arm, multi-center Phase I/II trial that includes a dosage escalation phase. This phase is designed to assess the safety and tolerability of relma-cel and to determine the recommended Phase II dosage (RP2D). Following the dosage escalation, the expansion Phase II study will focus on confirming the efficacy and safety of the treatment, as well as evaluating pharmacokinetics and pharmacodynamics.-Fineline Info & Tech
