NCT04191941Unknown早期 1 期
Adoptive Immunotherapy for Hematological Malignancy With Novel CAR-T Cells.
Timmune Biotech Inc.1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2019年9月1日最近更新:
适应症
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- safety (Incidence of treatment-related adverse events as assessed by CTCAE v4.03)
研究概览
简要总结
This is a single arm, open-label, early phase I study, to determine the safety and efficacy of Novel CAR-T cell therapy in Hematological Malignancy treatment.
详细描述
The Novel CAR-T contains either a scFv plus a PD-L1 blocker, or two scFvs, in a cytokine complex based outer memberane structure, this kind of structure enables the CAR-T cells to simultaneously target one or two targets on the tumor cell surface and enhance CAR-T cell persistence in tumor microenvironment，as well as stimulating innate T/NK cell activation and expansion.
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
- — 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All subjects must personally sign and date the consent form before initiating any study specific procedures or activities;
- •All subjects must be able to comply with all the scheduled procedures in the study;
- •Clear diagnosis of hematological malignancy, including B-cell Non-Hodgkin lymphoma, B-cell lymphoblastic leukemia, multiple myeloma.
- •Fufill one or more of the following criteria: Relapsed after most recent therapy; Progressive disease in standard chemotherapy; Disease progression or relapsed after ASCT;
- •At least one clear indicator for hematological malignancy monitoring;
- •Aged <70 years;
- •Expected survival ≥12 weeks;
- •Eastern cooperative oncology group (ECOG) performance status of≤3;
- •Systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 4 weeks;
- •All other treatment induced adverse events must have been resolved to
- •Laboratory tests must fulfill the following criteria: ANC ≥ 1000/uL, HGB>70g/L, Platelet count ≥ 50,000/uL, Creatinine clearance ≤1.5 ULN, Serum ALT/AST ≤2.5 ULN, Total bilirubin ≤1.5 ULN (except in subjects with Gilbert's syndrome);
排除标准
- •Presence of fungal, bacterial, viral, or other infection that is hardly to control (defined by investigator);
- •Patients with symptomatic central nervous system metastasis, intracranial metastasis, and cancer cells found in cerebrospinal fluid are not recommended to participate in this study. Symptom free or post-treatment stable disease or disappearance of lesions should not be excluded. The specific selection is ultimately determined by the investigator;
- •Lactating women or women of childbearing age who plan to conceive during the investigational time period;
- •Active infection with hepatitis B (HBsAG positive) or hepatitis C virus (anti-HCV positive);
- •Known history of infection with HIV;
- •Subjects need systematic usage of corticosteroid;
- •Subjects need systematic usage of immunosuppressive drug;
- •Planed operation, history of other related disease, or any other related laboratory tests restrict patients for the study;
- •Other reasons the investigator consider the patient may not be suitable for the study.
结局指标
主要结局
safety (Incidence of treatment-related adverse events as assessed by CTCAE v4.03)
时间窗: 3 months
Incidence of treatment-related adverse events as assessed by CTCAE v4.03
次要结局
- Duration of Response (The time from response to relapse or progression)(24 months)
- Overall Survival (The number of patient alive, with or without signs of cancer)(24 months)
- Complete response rate[CR] (Complete response rate per the revised International Working Group (IWG) Response Criteria for Malignant Lymphoma)(3 months)
- Partial response rate [PR] (Partial response rate per the revised International Working Group (IWG) Response Criteria)(3 months)
- Progression Free Survival (The time from the first day of treatment to the date on which disease progresses)(24 months)
研究者
研究点 (1)
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