NCT03196830已完成2 期
Safety and Efficacy of Chimeric Antigen Receptor T Cell (CAR-T) Treating Relaspe/Refractory CD19/CD20/CD22/CD30 Postive Non-Hodgkin Lymphoma
The First Affiliated Hospital of Soochow University1 个研究点 分布在 1 个国家目标入组 168 人开始时间: 2017年6月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- Overall Response Rate
研究概览
简要总结
This study is a single arm study to investigate the efficacy and safety of CAR-T targeted CD19/CD20/CD22/CD30 in relapse and refractory non-Hodgkin lymphoma patients. Ten patients will recruieted, admitted in hospital for 1 month for the CAR-T treatment and follow-up for at least 2 years.
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
- 6 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological detection confirmed CD19/CD20/CD22/CD30 postive non-Hodgkin lymphoma
- •Recieved more than 2 lines of chemotherapy
- •With contraindications of hematopoietic stem cell transplantation or relapse after hematopoietic stem cell transplantation
- •Expected survival more than 3 months
- •Karmofsky performance score ≤ 60, and ECOG ≥
- •Enough organ function: EF≥50%; normal ECG; CCR≥40ml/min; ALT and AST ≤ 3 × upper limitation of normal, T-BIL ≤ 2.0mg/dl; PT and APTT < 2 × upper limitation of normal; SpO2 > 92%
- •CBC results: Hb ≥ 80g/L, ANC > 1 × 10E9/L, Plt ≥ 50 × 10E9/L
- •Results of pregnant test should be negative, and agree to conception control during treatment and 1 year after CAR-T infusion
- •With measurable disease
- •Written informed consent could be acquired
排除标准
- •Received immunol suppression treatment or steroids in recent 1 week before recruitment
- •Uncontrolled infection
- •HIV positive patients
- •Active HBV or HCV infection
- •Women in pregnancy and lactation
- •Refuse to conception control during treatment and 1 year after CAR-T infusion
- •Uncured malignancies other than non-Hodgkin lymphoma
- •Have participated similar trial for treating relapse/refractory non-Hodgkin lymphoma
- •Inheritated immune deficiancy
- •Severe heart disease
研究组 & 干预措施
Treatment group
Experimental
the group of patients who received CAR-T treatment
干预措施: CAR-T (Biological)
结局指标
主要结局
Overall Response Rate
时间窗: One months after CAR-T cells were infused
Rate of complete remission and patial remission
次要结局
- CAR-T cell survival(every week in first 4 weeks after CAR-T cells infusion, then every 3 months for 2 years, then every 6 months for next 2 years)
- Adverse toxicity(Day 0, day 4, week 1, week 3, week 4, month 2, month 24 after CAR-T cells were infused)
研究者
研究点 (1)
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