NCT03799913Unknown早期 1 期
A Clinical Trial of MESO-CAR T Cells Therapy for Relapsed and Refractory Ovarian Cancer
Zhejiang University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年4月10日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0
研究概览
简要总结
The goal of this clinical trial is to study the feasibility and efficacy of anti-MESO antigen receptors (CARs) T cell therapy for relapsed and refractory ovarian cancer.
详细描述
Primary Objectives
1.To determine the feasibility ad safety of anti-MESO CAR-T cells in treating patients with MESO-positive ovarian cancer.
Secondary Objectives
- To access the efficacy of anti-MESO CAR-T cells in patients with ovarian cancer.
- To determine in vivo dynamics and persistency of anti- MESO CAR-T cells.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18 to 70 Years Old, female;
- •Expected survival > 12 weeks;
- •Clinical performance status of ECOG score 0-2;
- •Patients who have previously been treated with second- line or more lines of standard treatment are not effective (No remission or recurrence after remission);
- •At least one measurable tumor foci according to RECIST standard 1.1 ;
- •Positive Mesothelin expression in tumor tissues;
- •Creatinine ≤ 1.5×ULN;
- •ALT and AST ≤ 3×ULN;
- •Total bilirubin ≤ 2×ULN;
- •Hemoglobin≥90g/L;
- •Absolute counting of neutrophils≥1000uL ;
- •Absolute counting of lymphocytes>0.7×10^9/L;
- •Counting of Platelet≥75000/uL;
- •The venous access required for collection can be established without contraindications for leukocyte collection;
- •Able to understand and sign the Informed Consent Document.
排除标准
- •Accompanied by other uncontrolled malignant tumors;
- •Active hepatitis B, hepatitis C, syphilis, HIV infection;
- •Suffering severe cardiovascular or respiratory disease;
- •Any other diseases could affect the outcome of this trial;
- •Any affairs could affect the safety of the subjects or outcome of this trial;
- •Pregnant or lactating women, or patients who plan to be pregnancy during or after treatment;
- •There are active or uncontrollable infections (except simple urinary tract infections or upper respiratory tract infections) that require systemic therapy 14 days or 14 days prior to assignment;
- •Patients who are accounted by researchers to be not appropriate for this test;
- •Received CAR-T treatment or other gene therapies before assignment;
- •Subject suffering disease affects the understanding of informed consent or comply with study protocol.
研究组 & 干预措施
anti-MESO CAR-T cells
Experimental
Administration with anti-MESO CAR-T cells in the MESO-positive ovarian cancer patients
干预措施: anti-MESO CAR-T cells (Biological)
anti-MESO CAR-T cells
Experimental
Administration with anti-MESO CAR-T cells in the MESO-positive ovarian cancer patients
干预措施: Fludarabine (Drug)
anti-MESO CAR-T cells
Experimental
Administration with anti-MESO CAR-T cells in the MESO-positive ovarian cancer patients
干预措施: Cyclophosphamide (Drug)
结局指标
主要结局
Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0
时间窗: 1 years post infusion
次要结局
- Progress Free Survival (PFS) after administration(12 months post infusion)
- Duration of CAR-positive T cells in circulation(12 months post infusion)
- Detection of PD1 antibody in serum(12 months post infusion)
- Overall complete remission rate defined by the standard response criteria for malignant lymphoma for each arm(12 months post infusion)
研究者
Zhigang Zhang
Dr
Zhejiang University
研究点 (1)
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