NCT06357754招募中不适用
Protocol for Transgene Assay Service
Bristol-Myers Squibb8 个研究点 分布在 4 个国家目标入组 50 人开始时间: 2023年10月6日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 8
- 主要终点
- Participant in situ hybridization (ISH) or droplet-based digital Polymerase chain reaction (ddPCR) transgene testing results
研究概览
简要总结
The purpose of this transgene assay testing service is to evaluate tumor samples for transgene levels in patients who received a commercially available Bristol-Myers Squibb manufactured gene modified cellular therapy and have reported a qualifying second malignancy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant has received a commercially available Bristol-Myers Squibb (BMS) manufactured Gene Modified Cell Therapy (GMCT) and has been diagnosed with a qualifying second primary malignancy or a second primary malignancy which BMS has qualified for testing.
- •Participant has received a commercially available BMS manufactured GMCT in a clinical trial or other investigational setting (including non-conforming product) for which there is no testing protocol in place for that trial or investigational setting and has been diagnosed with a qualifying second primary malignancy or a second primary malignancy which BMS has qualified for testing.
排除标准
- •Participant is actively participating in a clinical trial where information and sample collection is being conducted under that clinical trial.
- •Participant has not received a BMS manufactured GMCT or has not been diagnosed with a qualifying second primary malignancy.
研究组 & 干预措施
Participants treated with lisocabtagene maraleucel
干预措施: Lisocabtagene maraleucel (Biological)
Participants treated with idecabtagene vicleucel
干预措施: Idecabtagene vicleucel (Biological)
结局指标
主要结局
Participant in situ hybridization (ISH) or droplet-based digital Polymerase chain reaction (ddPCR) transgene testing results
时间窗: Baseline
Participant insertion site analysis (ISA) testing results
时间窗: Baseline
For participants with positive in situ hybridization (ISH) transgene or droplet-based digital polymerase chain reaction (ddPCR) transgene
次要结局
未报告次要终点
研究者
研究点 (8)
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