NCT04155749进行中（未招募）1 期
Master Protocol for the Phase 1 Study of Cell Therapies for the Treatment of Patients With Relapsed Refractory Multiple Myeloma, Including Long-term Safety Follow-up
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Establish the RP2D of the investigational agent
研究概览
简要总结
Master protocol for cell therapy, Phase 1 proof-of-concept studies in relapsed and refractory multiple myeloma and includes long-term safety follow-up.
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
- •Relapsed and refractory Multiple Myeloma treated with at least 3 prior regimens of system therapy including Proteosome Inhibitor (PI), immunomodulatory drugs (IMiD), and anti-CD38 antibody (CD38mab); or has "triple-refractory" disease
- •Documented measurable disease
- •Adequate organ function
- •Life expectancy > 12 weeks, Eastern Cooperative Group Performance Status 0-1
排除标准
- •Plasma Cell Leukemia or History of Plasma Cell Leukemia
- •Patients with a history of severe hypersensitivity to DMSO should be excluded
- •Contraindication to fludarabine or cyclophosphamide
- •Severe uncontrolled intercurrent illness (e.g., infection) or laboratory abnormalities
- •Active central nervous system disease involvement by malignancy or active CNS pathology
研究组 & 干预措施
ARM 1
Experimental
Phase I study of BCMA-specific CAR-modified T-cell therapy using alternative binding domain, for the treatment of patients with relapsed and refractory multiple myeloma
干预措施: anitocabtagene-autoleucel (Drug)
结局指标
主要结局
Establish the RP2D of the investigational agent
时间窗: 24 months
Incidence of treatment-emergent adverse events (TEAEs), including DLT(s)
时间窗: 24 months
次要结局
- Overall Response Rate (ORR) by IMWG Consensus Criteria(24 months)
- PK Parameter for Anitocabtagene-Autoleucel: Cmax(Day 1 up to 24 months)
- PK Parameter for Anitocabtagene-autoleucel: Tmax(Day 1 up to 24 months)
- PK Parameter for Anitocabtagene-Autoleucel: Area under the curve (AUC)(Day 1 up to 24 months)
- Best overall response (BOR) by International Myeloma Working Group (IMWG) Consensus Criteria(24 months)
研究者
研究点 (4)
Loading locations...
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