JW Therapeutics Announces IND Approval for the Clinical Trial of Relma-cel in Patients with Moderately or Severely Refractory Systemic Lupus Erythematosus

JW Therapeutics an independent and innovative biotechnology company focusing on developing, manufacturing and commercializing cell immunotherapy products, announced that it has received the Investigational New Drug (IND) clearance from the National Medical Products Administration (NMPA) of China for a clinical trial of relmacabtagene autoleucel injection (relma-cel) in patients with moderately or severely refractory systemic lupus erythematosus (SLE). SLE is a complex autoimmune disease with diverse clinical manifestations involving many organs and systems. It is estimated that China has 1 million SLE patients currently. Although the long-term survival of SLE patients has improved in recent years, the inevitable relapse and irreversible organ damage are common causes of the death of SLE patients. Mortality rate in SLE patients is two to three times higher than that of the general population. Therefore, innovative therapy is urgently needed to maintain the remission of disease symptoms, control organ damage, and improve long-term patient outcomes. Clinical studies published in the New England Journal of Medicine (NEJM) and Nature Medicine have demonstrated the remarkable efficacy of CD19-targeted CAR-T cells in the treatment of SLE patients. Relma-cel may provide a novel, safe and effective treatment option for patients with moderate or severe SLE. This is an open, single-arm, multi-center phase I/II study in adults with moderately or severely refractory SLE. Phase I of the study is a dose escalation study to assess the safety and tolerability of relma-cel and to determine the recommended phase II dose (RP2D). Phase II of the study is an extension study treating with RP2D of relma-cel to determine the efficacy and safety in moderately or severely refractory SLE patients, and to evaluate the pharmacokinetic and pharmacodynamic characteristics. James Li, Co-founder, Chairman and CEO of JW Therapeutics, said, "Autoimmune diseases are a critical part of JW Therapeutics' strategy. We are committed to maximizing the clinical value of relma-cel, and look forward to providing a new treatment option for patients with autoimmune diseases.

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