2025-521497-34-00招募中1 期
Long-term follow-up of patients treated with GD2IL18CART
Universitaet Muenster4 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年9月2日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Percentage of patients with late-onset adverse reactions (AR), serious adverse events (SAE), serious adverse reactions (SAR) and adverse events of special interest (AESI) including relapse or progression of the underlying disease, life-threatening infections, death due to any cause, new and secondary malignancies
研究概览
简要总结
To evaluate long-term safety after treatment with GD2IL18CART
入排标准
- 年龄范围
- 0 years 至 65+ years（65+ Years, 0-17 Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patient underwent treatment with GD2IL18CART in the primary trial prior to enrollment into long-term follow-up.
- •Patient and/or caregivers have provided informed consent at any time prior to the first trial-specific assessment
排除标准
- •No exclusion criteria are defined for this long-term follow-up trial.
结局指标
主要结局
Percentage of patients with late-onset adverse reactions (AR), serious adverse events (SAE), serious adverse reactions (SAR) and adverse events of special interest (AESI) including relapse or progression of the underlying disease, life-threatening infections, death due to any cause, new and secondary malignancies
Percentage of patients with late-onset adverse reactions (AR), serious adverse events (SAE), serious adverse reactions (SAR) and adverse events of special interest (AESI) including relapse or progression of the underlying disease, life-threatening infections, death due to any cause, new and secondary malignancies
次要结局
- Pediatric patients: Height and weight, Tanner status
- Percentage of patients who relapse or progress since enrollment and rate of surviving patients
- Probabilities of overall survival, disease-free survival
- Duration of response, relapse rate and time to relapse
- Percentage of patients with detectable transgene levels. If results of 2 consecutive years are negative for an individual patient, further sampling will not be continued for this patient.
研究者
Prof. Dr. med. Claudia Rössig
Scientific
Universitaet Muenster
研究点 (4)
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