NCT03497533Unknown1 期
TriCAR-T-CD19 Adoptive Immunotherapy for CD19-positive Refractory/Relapsed Non-Hodgkin Lymphoma
Timmune Biotech Inc.1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2018年8月3日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Safety (Incidence of treatment-related adverse events as assessed by CTCAE v4.0)
研究概览
简要总结
This is a single arm, open-label, single-center, phase 1/2 study, to determine the safety and efficacy of TriCAR-T-CD19, an autologous tri-functional anti-CD19 chimeric antigen receptor (CAR)-positive T cell therapy, in refractory/Relapsed Non-Hodgkin Lymphoma (NHL).
详细描述
The tri-functional anti-CD19 chimeric antigen receptor contains an anti-CD19 scFv, a PD-L1 blocker, and a cytokine complex, enabling the TriCAR-T-CD19 to simultaneously targeting the CD19 positive NHL，blocking the inhibitory PD-L1 signal and stimulating 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
- 18 Years 至 68 Years（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;
- •Histologically or cytologically confirmed CD19 positive non-Hodgkin lymphoma;
- •Chemotherapy-refractory disease, defined as one or more of the following: Relapsed in 6 months after most recent therapy; Progressive disease in the standard R-CHOP or CHOP chemotherapy; Disease progression or relapsed in ≤12 months of ASCT (must have biopsy proven recurrence in relapsed subjects); If salvage therapy is given post-ASCT, the subject must have had no response to or relapsed after the last line of therapy.
- •No available standard therapy;
- •At least one measurable lesion per revised IWG Response Criteria;
- •Aged 18 to 68 years;
- •Expected survival ≥12 weeks;
- •Eastern cooperative oncology group (ECOG) performance status of ≤2;
- •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;
- •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);
- •Female must be not pregnant during the study.
排除标准
- •History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) or follicular lymphoma unless disease free for at least 3 years;
- •History of allogeneic stem cell transplantation;
- •Prior other CAR therapy or other genetically modified T cell therapy;
- •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;
- •Subjects with detectable cerebrospinal fluid malignant cells, or brain metastases, or with a history of CNS lymphoma, cerebrospinal fluid malignant cells or brain metastases;
- •Lactating women;
- •Active infection with hepatitis B (HBsAG positive) or hepatitis C virus (anti-HCV positive);
- •Subjects need systematic usage of corticosteroid;
- •History of any gene therapy;
- •Subjects need systematic usage of immunosuppressive drug;
- •Known history of infection with HIV;
- •Planed operation, history of other related disease, or any other related laboratory tests restrict patients for the study;
- •Other reasons the investigator think the patient may not be suitable for the study.
研究组 & 干预措施
TriCAR-T-CD19
Experimental
Tri-functional anti-CD19 chimeric antigen receptor transduced autologous T cells will be administered intravenously
干预措施: TriCAR-T-CD19 (Biological)
结局指标
主要结局
Safety (Incidence of treatment-related adverse events as assessed by CTCAE v4.0)
时间窗: 30 Days
Incidence of treatment-related adverse events as assessed by CTCAE v4.0
次要结局
- Partial response rate [PR] (Partial response rate per the revised International Working Group (IWG) Response Criteria for Malignant Lymphoma)(12 months)
- Duration of Response （The time from response to relapse or progression）(12 months)
- Progression Free Survival（The time from the first day of treatment to the date on which disease progresses.）(12 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)(12 months)
研究者
研究点 (1)
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