NCT06153251招募中1 期
A Phase 1, Open-Label, Dose-Finding Study of BMS-986453, Dual Targeting BCMAxGPRC5D Chimeric Antigen Receptor T Cells, in Participants With Relapsed and/or Refractory Multiple Myeloma
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company19 个研究点 分布在 4 个国家目标入组 187 人开始时间: 2024年1月23日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 187
- 试验地点
- 19
- 主要终点
- Number of participants with AEs leading to death
研究概览
简要总结
The purpose of this study is to assess BMS-986453 in participants with relapsed and/or refractory multiple myeloma (RRMM).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must have a diagnosis of multiple myeloma with relapsed and/or refractory disease.
- •Participants must have confirmed progressive disease on or within 12 months (measured from the last dose) of completing treatment with the last anti-myeloma treatment regimen before study entry.
- •Participants in Part A and Part B Cohort 1 and in Part B Cohort 2 must have relapsed/refractory multiple myeloma and received previous antimyeloma therapy, including a proteasome inhibitor and an immunomodulatory agent.
- •Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Participants must have adequate organ function.
排除标准
- •Participants must not have any known active or history of central nervous system (CNS) involvement of multiple myeloma.
- •Participants must not have active or history of plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes) syndrome, or clinically significant amyloidosis.
- •Participants must not have a history or presence of clinically significant CNS pathology such as seizure disorder, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, or cerebellar disease, or presence of clinically active psychosis.
- •Other protocol-defined inclusion/exclusion criteria apply.
研究组 & 干预措施
Administration of BMS-986453
Experimental
干预措施: BMS-986453 (Drug)
Administration of BMS-986453
Experimental
干预措施: Cyclophosphamide (Drug)
Administration of BMS-986453
Experimental
干预措施: Fludarabine (Drug)
结局指标
主要结局
Number of participants with AEs leading to death
时间窗: Up to 4 years
Number of participants with treatment-emergent adverse events (AEs)
时间窗: Up to 4 years
Number of participants with serious adverse events (SAEs)
时间窗: Up to 4 years
Number of participants with AEs leading to discontinuation
时间窗: Up to 4 years
Number of participants with dose-limiting toxicities (DLTs)
时间窗: Up to 4 years
次要结局
- Number of participants with very good partial response (VGPR) or better(Up to 4 years)
- Progression-free survival (PFS)(Up to 4 years)
- Overall survival (OS)(Up to 4 years)
- Time to response (TTR)(Up to 4 years)
- Time to complete response (TTCR)(Up to 4 years)
- Duration of response (DOR)(Up to 4 years)
- Duration of complete response (DOCR)(Up to 4 years)
- Overall response rate (ORR)(Up to 4 years)
- Complete response rate (CRR)(Up to 4 years)
- Maximum observed concentration (Cmax)(Up to 4 years)
- Time of maximum observed concentration (Tmax)(Up to 4 years)
- Area under the blood concentration-time curve from time zero to 28 days after dosing (AUC(0-28D))(Up to 4 years)
- Persistence of BMS-986453 in peripheral blood(Up to 4 years)
- Expansion rate(Up to 4 years)
研究者
研究点 (19)
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