JW Therapeutics Receives the NMPA’s IND Clearance of Carteyva (relmacabtagene autoleucel) for Moderately or Severely Refractory Systemic Lupus Erythematosus
- The NMPA has cleared an IND application to initiate a P-I/II clinical trial of relmacabtagene autoleucel inj. (relma-cel), an autologous anti-CD19 CAR-T cell immunotherapy product in patients with moderately or severely refractory SLE
- The P-I is a dose-escalation study that is designed to evaluate the safety and tolerability of relma-cel and determine the RP2D. Relma-cel is being used in the P-II study as an extension treatment to assess the efficacy, safety, and PK & PD characteristics
- Clinical studies demonstrated the remarkable efficacy of CD19-targeted CAR-T cells published in NEJM and Nature Medicine & Relma-cel may provide a novel, safe, and effective treatment option for SLE patients
Ref: PRNewswire | Image: JW Therapeutics
Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at firstname.lastname@example.org.