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TREATMENT OF AUTOIMMUNE DISEASES WITH ENGINEERED IMMUNE CELLS

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  • Publication Date:
    March 20, 2025
  • Additional Information
    • Document Number:
      20250090584
    • Appl. No:
      18/965147
    • Application Filed:
      December 02, 2024
    • Abstract:
      The invention comprises methods and compositions for treating autoimmune diseases with engineered immune cells including cytotoxic T cells and natural killer (NK) cells. The engineered immune cells comprise a chimeric antigen receptor (CAR). Methods of making the engineered cells, methods of administration and treatment regimens are also disclosed.
    • Assignees:
      Caribou Biosciences, Inc. (Berkeley, CA, US)
    • Claim:
      1. A method of treating lupus in a human patient, the method comprising: administering to the patient an amount of a composition comprising, allogeneic CAR-T cells expressing an anti-CD19 chimeric antigen receptor (CAR) and having inactivated PDCD1 gene, wherein the CAR comprises FMC63, a CD8 hinge, a CD8 transmembrane domain, a 4-1BB co-stimulatory domain and a CD3 zeta signaling domain, and wherein prior to the administering, the patient has undergone lymphodepletion comprising administering cyclophosphamide for up to 2 days and fludarabine at 25 mg/m2 per day for up to 5 days, thereby improving one or more symptoms of the autoimmune disease in the patient.
    • Claim:
      2-13. (canceled)
    • Claim:
      14. The method of claim 1, wherein the CAR is encoded by a nucleic acid comprising a coding sequence for the anti-CD19 CAR and a promoter.
    • Claim:
      15. The method of claim 14, wherein the nucleic acid is integrated into the genome of the CAR-T cell.
    • Claim:
      16. The method of claim 15, wherein the integration of the nucleic acid coding for the anti CD19 CAR is performed using a CRISPR nuclease and a nucleic acid-targeting nucleic acid (NATNA).
    • Claim:
      17. The method of claim 15, wherein prior to the integration, the nucleic acid coding for the anti-CD19 CAR is delivered into the immune cell via a viral vector.
    • Claim:
      18. (canceled)
    • Claim:
      19. The method of claim 1, wherein the amount of the composition administered to the patient comprises a lower dose of CAR-T cells than a dose required to treat tumors.
    • Claim:
      20-30. (canceled)
    • Claim:
      31. The method of claim 1 further comprising assessing the patient for improvements in one or more symptoms selected from the group consisting of proteinuria, alopecia, increased IgM and IgG antibody titers, the presence of anti-nucleoprotein IgG or IgM in blood serum, increased B cell counts in blood plasma, and the presence of skin lesions or discoloration.
    • Claim:
      32-64. (canceled)
    • Current International Class:
      61; 61; 07; 07; 12; 12; 12; 01; 01
    • Accession Number:
      edspap.20250090584