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 - CPHE885B12201

ovartis Pharma AG0 个研究点目标入组 147 人开始时间: 2024年6月14日最近更新: 2024年8月21日

适应症

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•=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.

•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., 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)., 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., Plasma cell leukemia and other plasmacytoid disorders, non-secretory myeloma without other evidence of measurable disease.

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