A Phase 2 study of durcabtagene autoleucel, B-cell maturation Antigen (BCMA)-directed CAR-T Cells in adult participants with relapsed and refractory multiple myeloma

Korábbi kezelés

• Prior administration of a genetically modified cellular product including prior BCMA CAR-T therapy.
• Participants who have received prior BCMA-directed bi-specific antibodies or anti-BCMA antibody drug conjugate.
• Prior autologous SCT within 3 months or allogeneic SCT within 6 months prior to signing informed consent.
• Active Graft-versus-Host Disease (GVHD), grade 2-4 according to the Mount Sinai GvHD International Consortium criteria or requiring systemic treatment. Note: Systemic therapy for GvHD must have been discontinued at least 2 weeks prior to durcabtagene autoleucel administration.

Más betegség

• Known hypersensitivity or contraindication to any product (including its excipients) to be given to the participant as per the study protocol (e.g., durcabtagene autoleucel, tocilizumab and LD agents).
• Plasma cell leukemia and other plasmacytoid disorders, non-secretory myeloma without other evidence of measurable disease.

• ≥18 years of age at the time of informed consent form (ICF) signature.
• Adult participants with relapsed and refractory multiple myeloma who have received at least 3 prior lines of therapy including an IMiD (e.g., lenalidomide or pomalidomide), a proteasome inhibitor (e.g., bortezomib, carfilzomib), and an approved anti-CD38 antibody (e.g., daratumumab, isatuximab), and have documented evidence of disease progression (IMWG criteria).
• Must be refractory to the last treatment regimen (defined as progressive disease on or within 60 days measured from last dose of last regimen).
• Measurable disease at enrollment as defined by the protocol.
• Eastern Cooperative Oncology Group (ECOG) performance status that is either 0 or 1 at screening.
• Must have a leukapheresis material of non-mobilized cells accepted for manufacturing.