NCT04691713Unknown不适用
CD276 CAR-T for Patients With Advanced CD276+ Solid Tumors
PersonGen BioTherapeutics (Suzhou) Co., Ltd.1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2019年9月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- ORR 3
研究概览
简要总结
This study is a clinical study of CD276 CAR-T in the treatment of patients with advanced solid tumors. The purpose is to evaluate the safety and effectiveness of targeting CD276 auto-chimeric antigen receptor T cells in the treatment of CD276-positive advanced solid tumors.
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
- 3 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Expected survival time ≥ 12weeks
- •At least second-line or above chemotherapy failed
- •According to the evaluation criteria for the efficacy of solid tumors (RECIST 1.1), at least one measurable lesion (non-nodular lesion with longest diameter ≥10mm, or nodular lesion with short diameter ≥15mm)
- •Liver and kidney function, heart and lung function meet the following requirements:
- •Creatinine is within the normal range;
- •Left ventricular ejection fraction ≥ 45%;
- •Baseline blood oxygen saturation>91%;
- •Total bilirubin≤1.5×ULN; ALT and AST≤2.5×ULN
- •Understand the trial and have signed the informed consent
排除标准
- •Those who have graft-versus-host disease (GVHD) or need to use immunosuppressive agents
- •Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood HBV DNA titer test is not within the normal reference range; hepatitis C virus (HCV) antibody positive and peripheral blood HCV RNA positive; human immunodeficiency virus (HIV) Antibody positive; CMV DNA test positive; Syphilis test positive
- •Severe heart disease
- •Systemic diseases judged by the investigator to be unstable: including but not limited to severe liver, kidney or metabolic diseases that require medication
- •Within 7 days before screening, there are active infections or uncontrollable infections that require systemic treatment (except for mild urogenital infections and upper respiratory tract infections)
- •Women who are pregnant or breastfeeding, and female subjects who plan to become pregnant within 1 year after cell reinfusion, or male subjects whose partners plan to become pregnant within 1 year after cell reinfusion
- •Those who have received CAR-T therapy or other genetically modified cell therapy before screening
- •Subjects who are receiving systemic steroid therapy at the time of screening and the investigator determines that they need long-term systemic steroid therapy during the treatment period (except for inhaled or topical use)
- •Participated in other clinical studies within 3 months before screening
- •Central nervous system metastases are known to occur and for suspected central nervous system metastases, head MRI examination is required to rule out
- •Patients with partial or complete intestinal obstruction and complete biliary obstruction that cannot be relieved by active treatment
- •With more than a moderate amount of ascites, or after conservative medical treatment (such as diuresis, sodium restriction, excluding ascites drainage) for 2 weeks, the ascites still shows a progressive increase
- •According to the researcher's judgment, it does not meet the situation of cell preparation
- •Situations that other researchers think are not suitable for inclusion
研究组 & 干预措施
Targeting CD276 autologous chimeric antigen receptor T cells
Experimental
干预措施: Targeting CD276 autologous chimeric antigen receptor T cells (Drug)
结局指标
主要结局
ORR 3
时间窗: Three months after CAR T cell infusion
3-month objective response rate
次要结局
未报告次要终点
研究者
研究点 (1)
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