JPRN-jRCT2013220012招募中2 期
A Phase 2 study of PHE885, B-cell maturation Antigen (BCMA)-directed CAR-T Cells in adult participants with relapsed and refractory multiple myeloma
Hirano Takamitsu0 个研究点目标入组 8 人开始时间: 2022年7月25日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 8
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
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1. >=18 years of age at the time of informed consent form (ICF) signature
- •2. Adult patients 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 regimen).
- •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
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-speciific antibodies or anti-BCMA antibody drug conjugate.
- •2. Prior allogenic stem cell transplantation (SCT) at any time or autologous SCT within 3 months prior to signing informed consent
- •3. Plasma cell (PC) leukemia and other plasmacytoid disorders, other than MM
- •4. POEMS syndrome
- •5. Active central nervous system (CNS) involvement by malignancy
- •6. Patients with active neurological auto immune or inflammatory disorders
研究者
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