EUCTR2021-003747-22-DE进行中（未招募）1 期
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
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 136
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. =18 years of age at the time of informed consent form (ICF)
- •XML File Identifier: XCoD+oo9kWY4cmTprypP05dS2nE=
- •2. 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).
- •3. Must be refractory to the last treatment regimen (defined as
- •progressive disease on or within 60 days measured from last dose of last
- •4. Measurable disease at enrollment as defined by the protocol.
- •5. Eastern Cooperative Oncology Group (ECOG) performance status that
- •is either 0 or 1 at screening.
- •6. Must have a leukapheresis material of non-mobilized cells accepted
- •for manufacturing.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 81
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 55
排除标准
- •1. 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
- •2. Prior autologous stem cell transplantation (SCT) within 3 months or
- •allogeneic stem cell transplantation within 6 months prior to signing
- •informed consent.
- •3. Plasma cell (PC) leukemia and other plasmacytoid disorders, other
- •4. POEMS syndrome (plasma cell dyscrasia with polyneuropathy,
- •organomegaly, endocrinopathy, monoclonal protein, and skin changes).
- •5. Active central nervous system (CNS) involvement by malignancy.
- •6. Participants with active neurological autoimmune or inflammatory
研究者
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