NCT03910842Unknown早期 1 期
Adoptive Immunotherapy for Children CD19+ Leukemia and Non-Hodgkin Lymphoma With CD19-TriCAR-T/SILK Cell
Timmune Biotech Inc.1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2019年3月21日最近更新:
适应症
干预措施
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- safty (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 CD19-TriCAR-T and CD19-TriCAR-SILK cell therapy in Children CD19+ Leukemia Non-Hodgkin lymphoma treatment.
详细描述
CD19-TriCAR contains an anti-CD19 scFv, a PD-L1 blocker, and a cytokine complex, enabling the CD19-TriCAR-T/SILK to simultaneously targeting the CD19 positive Leukemia or Non-Hodgkin lymphoma，blocking the inhibitory PD-L1 signal and stimulating innate T/NK cell activation and expansion, thus make it a tri- functional CAR (Tri-CAR). CD19-TriCAR-T is an autologous tri-functional CAR-T cell therapy, CD19-TriCAR-SILK is an Allogeneic tri-functional CAR- NK cell therapy, patients ineligible for leukapheresis or CAR-T therapy will be recommended for CD19-TriCAR-SILK therapy.
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 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For children CD19 positive B cell leukemia：
- •All subjects must personally sign and date the Informed Consent before initiating any study specific procedures or activities;
- •All subjects must be able to comply with all the scheduled procedures in the study;
- •CD19-positive B-cell leukemia with histology or cytology confirmed recurrence after treatment; or progression during treatment; or after first line treatment getting a MRD negative, 2 times of MRD show>0.01% but without bone marrow morphology recurrence;
- •At least one measurable lesion;
- •Aged <18 years; or diagnosised at the age of less than 18 and relapsed within three years， determined by the investigator;
- •Expected survival ≥12 weeks;
- •Eastern cooperative oncology group(ECOG) performance status of≤2;
- •Before CD19-TriCAR-T/SILK cell infusion, 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 ≤grade 1;
- •For children CD19 positive B cell lymphoma：
- •All subjects must personally sign and date the Informed Consent before initiating any study specific procedures or activities;
- •All subjects must be able to comply with all the scheduled procedures in the study;
- •CD19-positive B-cell lymphoma with histology or cytology confirmed recurrence after treatment，defined as one or more of the following: disease progression during standard therapy；recurrence after termination of treatment；relapse after autologous hematopoietic stem cell transplantation；not suitable for stem cell transplantation or abandon stem cell transplantation due to conditional restrictions;
- •At least one measurable lesion;
- •Aged <18 years; or diagnosised at the age of less than 18 and relapsed within three years， determined by the investigator;
- •Expected survival ≥12 weeks;
- •Eastern cooperative oncology group(ECOG) performance status of≤2;
- •Before CD19-TriCAR-T/SILK cell infusion, 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 ≤grade 1;
排除标准
- •Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring iv antimicrobials for management. (Simple UTI and uncomplicated bacterial pharyngitis are permitted if responding to active treatment);
- •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 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.
研究组 & 干预措施
CD19-TriCAR-T/NK（SILK）
Experimental
CD19-TriCAR-T/SILK cells will be administered intravenously
干预措施: CD19-TriCAR-T/SILK (Biological)
结局指标
主要结局
safty (Incidence of treatment-related adverse events as assessed by CTCAE v4.03)
时间窗: 24 monthes
Incidence of treatment-related adverse events as assessed by CTCAE v4.03
次要结局
- Complete response rate[CR] (Complete response rate per the revised International Working Group (IWG) Response Criteria for Malignant Lymphoma)(24 monthes)
研究者
研究点 (1)
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