NCT04162340Unknown1 期
CD4-specific CAR T Cells (CD4 CAR T Cells) for Relapsed/Refractory T Cell Malignancies
iCell Gene Therapeutics2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2019年7月11日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Number of adverse events after CD4 CAR T cells cell infusion
研究概览
简要总结
This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of CD4 CAR T cells in patients with relapsed and/or refractory T cell lymphoma.
详细描述
CD4-specific CAR is a chimeric antigen receptor immunotherapy treatment designed to treat lymphoma/leukemia expressing CD4 antigen. CD4+ T cell lymphomas are a subset of leukemias and lymphomas that are positive for the surface protein CD4. The purpose of this study is to evaluate the efficacy and safety of CD4 CAR T cells.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Signed written informed consent; Patients volunteer to participate in the research
- •Diagnosis is mainly based on the World Health Organization (WHO) 2008
- •Patients have exhausted standard therapeutic options
- •Systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 1 weeks
- •Female must be not pregnant during the study
排除标准
- •Patients declining to consent for treatment
- •Prior solid organ transplantation
- •Potentially curative therapy including chemotherapy or hematopoietic cell transplant
- •Any drug used for GVHD must be stopped >1 week
结局指标
主要结局
Number of adverse events after CD4 CAR T cells cell infusion
时间窗: 2 years particularly the first 28 days after infusion
Determine the toxicity profile of CD4 CAR T cell therapy
次要结局
- Incidence of treatment-emergent adverse events(up to 6 months)
- Progression-Free Survival (PFS)(up to 2 years)
- Disease Free Survival (DFS)(up to 2 years)
- Overall Survival (OS)(up to 2 years)
研究者
研究点 (2)
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