NCT06121843招募中1 期
A Phase 1, Multicenter, Open-label Study to Evaluate the Safety and Preliminary Efficacy of Arlocabtagene Autoleucel (BMS-986393) in Novel Combinations in Participants With Relapsed and/or Refractory Multiple Myeloma and Determine the Recommended Dose for Each Add-on Investigational Component
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company31 个研究点 分布在 2 个国家目标入组 187 人开始时间: 2024年2月22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
- 31
- 主要终点
- Incidence of AEs leading to discontinuation
研究概览
简要总结
The purpose of this study is to establish a safe and tolerable dose of arlocabtagene autoleucel (BMS-986393) in combinations with alnuctamab, mezigdomide, iberdomide, and elranatamab in participants with relapsed and/or refractory multiple myeloma (RRMM).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •History of relapsed and/or refractory multiple myeloma (RRMM) treated with at least 3 (Part 1), history of RRMM or at least 1 but not greater than 3 prior anti-myeloma treatment (PAMT) regimens (Part 2, Arms A, B, C, and D); history of quadruple class exposed RRMM having received BCMA TCE as the most recent line of therapy (Part 2, Arm E).
- •Measurable multiple myeloma (MM) as per International Myeloma Working Group (IMWG).
- •Eastern Cooperative Oncology Group performance status of 0-
- •Adherence to contraception requirements.
排除标准
- •Prior treatment with alnuctamab (Arm A), mezigdomide (Arms B and E), iberdomide (Arm C), elranatamab (Arm D) or BCMA-targeting therapy (Part 2 Arms A and D).
- •Prior treatment with GPRC5D-targeting therapies as of Protocol Amendment 02 (Part 1 and Part 2).
- •Other protocol-defined inclusion/exclusion criteria apply.
研究组 & 干预措施
Arm A: BMS-986393 + Alnuctamab
Experimental
干预措施: Alnuctamab (Drug)
Arm B: BMS-986393 + Mezigdomide
Experimental
干预措施: BMS-986393 (Drug)
Arm B: BMS-986393 + Mezigdomide
Experimental
干预措施: Mezigdomide (Drug)
Arm C: BMS-986393 + Iberdomide
Experimental
干预措施: BMS-986393 (Drug)
Arm C: BMS-986393 + Iberdomide
Experimental
干预措施: Iberdomide (Drug)
Arm D: BMS-986393 + Elranatamab
Experimental
干预措施: BMS-986393 (Drug)
Arm D: BMS-986393 + Elranatamab
Experimental
干预措施: Elranatamab (Drug)
Arm E: BMS-986393 + Mezigdomide and Dexamethasone
Experimental
干预措施: BMS-986393 (Drug)
Arm E: BMS-986393 + Mezigdomide and Dexamethasone
Experimental
干预措施: Mezigdomide (Drug)
Arm A: BMS-986393 + Alnuctamab
Experimental
干预措施: BMS-986393 (Drug)
Arm E: BMS-986393 + Mezigdomide and Dexamethasone
Experimental
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Incidence of AEs leading to discontinuation
时间窗: Up to 2 years
Number of Deaths
时间窗: Up to 2 years
Incidence of adverse events (AEs)
时间窗: Up to 2 years
Incidence of adverse events of special interest (AESI)
时间窗: Up to 2 years
Incidence of serious adverse events (SAEs)
时间窗: Up to 2 years
Establish recommended Phase 2 dose (RP2D)
时间窗: Up to 2 years
次要结局
- Overall response rate (ORR)(Up to 2 years)
- Complete response rate (CRR)(Up to 2 years)
- Very good partial response rate (VGPRR)(Up to 2 years)
- Overall response rate (ORR)(Up to 2 years)
- Complete response rate (CRR)(Up to 2 years)
- Very good partial response rate (VGPRR)(Up to 2 years)
- Maximum observed concentration (Cmax) of arlocabtagene autoleucel(Up to 2 years)
- Time of maximum observed concentration (tmax) of arlocabtagene autoleucel(Up to 2 years)
- Area under the concentration-time curve from time 0 to 28 days [AUC (0-28D)] of arlocabtagene autoleucel(Up to 2 years)
研究者
研究点 (31)
Loading locations...
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