NCT06618313招募中不适用
Open-label, Single-arm，Exploratory Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of JCXH-213 in Patients With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
Beijing GoBroad Hospital1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2025年3月27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
- 8
- 试验地点
- 1
- 主要终点
- Dose limiting toxicity (DLT).
研究概览
简要总结
Evaluate the Safety and Efficacy of JCXH-213 in Patients with Relapsed/Refractory B-cell non-Hodgkin Lymphoma
详细描述
Patient will receive study treatment in the treatment observation period. After the end of the treatment observation period, patients will be allowed to continue to receive treatment if there is no major safety problems and the investigator judges that the patient may continue to benefit.
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
- •Cytologically or histopathologically confirmed CD19-positive B-cell Hodgkin lymphoma according to WHO 2022 criteria, including but not limited to pathologically confirmed (1) diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS); (2) follicular lymphoma (FL); (3)histologically transformed into diffuse large B-cell lymphoma; (4) primary mediastinal large B-cell lymphoma (PMBCL); (5) High-grade B-cell lymphoma (HGBCL) etc.
- •ECOG performance status 0 to
- •Existing measurable lesions (Lugano 2014 criteria, as detailed in Appendix 2), meeting one of the following conditions: 1) nodal lesions with a long axis length exceeding 15 mm (short axis length is measurable); 2) extra-nodal lesions with both long axis and short axis lengths exceeding 10 mm.
排除标准
- •Patients with other malignant tumors within 5 years before screening, except for adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local radical prostatectomy, radical ductal carcinoma in situ, and radical thyroidectomy.
- •B-cell non-Hodgkin lymphoma with active primary or secondary central nervous system involvement.
- •Life expectancy less than 3 months.
研究组 & 干预措施
JCXH-213 experimental group
Experimental
4 dose groups will be set in this part, following the dose escalation pattern (accelerated titration combined with a "3 + 3").
干预措施: JCXH-213,an mRNA-LNP based in vivo CAR therapy (Drug)
结局指标
主要结局
Dose limiting toxicity (DLT).
时间窗: The DLT observation period is 21 days after first infusion of JCXH-213.
次要结局
未报告次要终点
研究者
Kai Hu
Chief physician
Beijing GoBroad Hospital
研究点 (1)
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