FDA clears IND application for ‘controllable’ CAR-T to treat advanced multiple myeloma


Sumary of FDA clears IND application for ‘controllable’ CAR-T to treat advanced multiple myeloma:

  • The FDA cleared an investigational new drug application for ACLX-001, a chimeric antigen receptor T-cell therapy for adults with relapsed or refractory multiple myeloma, according to the agent manufacturer..
  • ACLX-001 (Arcellx) is an autologous, gene-edited CAR T-cell therapy with a novel binding domain that targets the B-cell maturation antigen (BCMA) on the surface of cancer cells..
  • The investigational therapy binding domain was developed using Arcellx proprietary platform, in which antigen receptor complex T cells (ARC-T) are controlled by a tumor-targeting protein called a SparX (soluble protein antigen-receptor X-linker)..
  • “ARC-T cells cannot recognize the tumor without SparX proteins and can only destroy a diseased cell when attached to a SparX-antigen complex,”.
  • Data presented at last year virtual ASH Annual Meeting showed all six patients responded to therapy, with four achieving complete stringent response..
  • “Demonstrating a safe and effective cell therapy that is controllable and adaptable has the potential to be transformative for the field of cell and gene therapy,”…

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