NCT04004637Unknown1 期
CD7 CAR-T Cells for Patients With Relapse/Refractory CD7+ NK/T Cell Lymphoma ,T-lymphoblastic Lymphoma and Acute Lymphocytic Leukemia
PersonGen BioTherapeutics (Suzhou) Co., Ltd.1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2019年8月25日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Identification of the dose limiting toxicity (DLT)
研究概览
简要总结
This study is designed to explore the safety and efficacy of CD7 CAR-T Cells for patients with relapse/refractory CD7+ NK/T cell lymphoma ,T-lymphoblastic lymphoma and Acute Lymphocytic Leukemia. And to evaluate the pharmacokinetics of CD7 CAR-T cells in patients.
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
- 7 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 7 to 70 years.
- •The expected survival period is more than 12 weeks.
- •Male and female subjects with CD7+ NK/T cell lymphoma ,T-lymphoblastic lymphoma and Acute Lymphocytic Leukemia in patients with no available curative treatment options will be enrolled:
- •Not achieved PR after the standard first-line treatment for at least 4 courses.
- •Relapse or progression after standardized treatment.
- •Patients With NK/T Cell Lymphoma or T-lymphoblastic Lymphoma need to have at least 1 tumor lesions can be evaluated.
- •Cardiac left ventricle ejection fraction ≥40%.
- •Serum creatinine≤1.5 ULN; oxygen saturation of blood >91%.
- •Total bilirubin≤1.5×ULN; Serum ALT and AST≤2.5 ULN.
- •Able to understand this study and have signed informed consent.
排除标准
- •Patients with graft-versus-host disease (GVHD) or who need to use immunosuppressive drugs.
- •Patients with malignant tumors other than NK/T cell lymphoma , T-lymphoblastic lymphoma and Acute Lymphocytic Leukemia within 5 years prior to screening, in addition to adequately treated cervical carcinoma in situ, basal or squamous cell skin cancer, local prostate after radical surgery, breast ductal carcinoma in situ after cancer and radical surgery.
- •Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer detection is not within the normal range; hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C Viral (HCV) RNA positive; human immunodeficiency virus (HIV) antibody positive; cytomegalovirus (CMV) DNA positive; syphilis positive.
- •Severe heart disease: including but not limited to unstable angina pectoris, myocardial infarction (within 6 months prior to screening), congestive heart failure (New York Heart Association [NYHA] classification ≥ III), severe arrhythmia.
- •Unstable systemic diseases judged by investigator, including but not limited to severe liver, kidney or metabolic diseases needing medical treatment.
- •Active or uncontrollable infections (except for mild genitourinary infections and upper respiratory tract infections) that require systemic treatment within 7 days prior to screening;
- •Women who are pregnant or breastfeeding, female subject who plans to have a pregnancy within 1 year after cell infusion, and male subject who plans to have a pregnancy within 1 year after cell infusion.
- •Subject who have received CAR-T treatment or other genetically modified cell therapy before screening;
- •Subjects who are receiving systemic steroid therapy within 7 days prior to screening or who require long-term systemic steroid therapy judged by investigator (except for inhaled or topical use);
- •Participated in other clinical studies within 3 months prior to screening.
- •Patients with active CNS involvement by malignancy.
- •Not suitable for cell preparation.
- •Researchers consider it inappropriate to participate in the trial.
研究组 & 干预措施
CD7 CAR-T cells Infusion
Experimental
干预措施: CD7 CAR-T cells infusion (Drug)
结局指标
主要结局
Identification of the dose limiting toxicity (DLT)
时间窗: Time Frame: 4 weeks after CAR T cell infusion
Toxicity will be assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) scale, version 5 and the number of patients experiencing DLT will be evaluated.
次要结局
- Overall Survival(Up to 2 years)
- In vivo persistence/expansion of infused CAR T cell(Up to 2 years)
- Determine the effects of CART-CD7 infusion on T cells and CD7 expression in vivo.(Up to 2 years)
- Overall Response Rate (ORR)(4 weeks after CAR T cell infusion)
- Disease-free survival(Up to 2 years)
研究者
研究点 (1)
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