The Clinical Research of Fourth Generation CART-cell Therapy in Refractory-Relapsed Ovarian Cancer
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Adverse events (AEs) and Serious adverse event (SAEs)
研究概览
简要总结
The goal of this clinical trial is to study the safety and feasibility of anti- Mesothelin Chimeric Antigen Receptor T-Cell (MESO CAR-T cells) therapy for Refractory-Relapsed Ovarian Cancer
详细描述
Primary Objectives:
- To determine the safety and feasibility of anti- MESO CAR-T cells therapy for Refractory-Relapsed 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
- To assess the quality of life in patients with ovarian cancer after treatment with 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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histopathologically confirmed ovarian cancer;
- •18-75 Years Old, female;
- •Expected survival > 12 weeks;
- •Eastern Cooperative Oncology Group (ECOG) score 0-2;
- •Patients who have previously been treated with second- line or above standard treatment are failed (progress in treatment or recurrence within 6 months after discontinuation of treatment);
- •According to the Immune-Modified Response Evaluation Criteria In Solid Tumors (imRECIST) , there should be at least one measurable tumor foci；
- •Positive expression of Mesothelin in tumor tissue；
- •Creatinine ≤ 1.5×ULN or creatinine clearance ≥ 60ml / min;
- •alanine aminotransferase and aspartate aminotransferase ≤ 2.5×ULN , such as with liver metastasis, ≤ 5×ULN;
- •Total bilirubin ≤ 2×ULN;
- •Hemoglobin≥90g/L(No blood transfusion within 14 days);
- •Absolute value of neutrophils ≥1.5×10^9/L;
- •Absolute counting of lymphocytes >0.7×10^9/L;
- •Counting of Platelet≥80×10^9/L；
- •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;
- •Insufficient function of important organs (heart, lung);
- •Any other uncontrolled active disease that impedes participation in the trial;
- •Any affairs could affect the safety of the subjects or purpose 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 within 14 days or 14 days prior to enrollment；
- •The investigator believes that it is not appropriate to participate in the trial;
- •Received CAR-T treatment or other gene therapies before enrollment; Subjects suffering disease affect the understanding of informed consent or unable to comply with study; Unwilling or unable to comply with study requirements.
研究组 & 干预措施
anti- MESO CAR-T cells
The subjects in this arm will receive Cyclophosphamide 300mg/m2/d and Fludarabine 30mg/m2/d d-4~-2. Then anti- MESO CAR-T cells will be injected by a dose of 5×106/kg once at d1(rang from d1-3).
干预措施: anti- MESO CAR-T cells (Drug)
anti- MESO CAR-T cells
The subjects in this arm will receive Cyclophosphamide 300mg/m2/d and Fludarabine 30mg/m2/d d-4~-2. Then anti- MESO CAR-T cells will be injected by a dose of 5×106/kg once at d1(rang from d1-3).
干预措施: Fludarabine (Drug)
anti- MESO CAR-T cells
The subjects in this arm will receive Cyclophosphamide 300mg/m2/d and Fludarabine 30mg/m2/d d-4~-2. Then anti- MESO CAR-T cells will be injected by a dose of 5×106/kg once at d1(rang from d1-3).
干预措施: Cyclophosphamide (Drug)
结局指标
主要结局
Adverse events (AEs) and Serious adverse event (SAEs)
时间窗: 1 year post infusion
Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.03
次要结局
- Cmax(30 days post infusion)
- Tmax(30 days post infusion)
- AUC(0-30d)(30 days post infusion)
- Duration of Mesothelin-positive T cells in circulation(90 days post infusion)
- ORR(3 months post infusion)
- PFS(1 year post infusion)
- EORTC Quality-of-Life Questionnaire Core 15 Palliative Care (QLQ-C15-PAL) of patients after administration(1 year post infusion)
研究者
Zhao Hui
professor
Shanghai 6th People's Hospital