NCT03929107Unknown2 期
Interleukin-7 and Chemokine (C-C Motif) -Ligand 19-expressing CD19-CAR-T for Refractory/Relapsed B Cell Lymphoma
Wenbin Qian1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2019年3月28日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- complete remission rate
研究概览
简要总结
It's a single arm, open label prospective study, in which the safety and efficacy of Interleukin-7 and Chemokine (C-C Motif) Ligand 19-expressing CD19-CAR-T therapy are evaluated in refractory/relapsed B cell lymphoma 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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years old, male or female;
- •ECOG 0-3, for patients with ECOG=4, if ECOG reach 0-3 after bridging treatment with ibrutinib, they are also considered to fit this criteria;
- •Histologically diagnosed as B cell non-Hodgkin's lymphoma (NHL)(according to WHO 2008 criteria), including DLBCL-NOS, primary mediastinal B cell lymphoma (PMBCL) mantel cell lymphoma (MCL), transformed follicular lymphoma (TFL) and other transformed B cell NHL;
- •CD19 positive (by immuno-histology or flowcytometry) [for DLBCL/PMBCL/TFL patients, negative CD19 immuno-histology results also acceptable];
- •Definition of relapsed and refractory disease: 1) refractory DLBCL should fit one of the following: ①complete remission NOT achieved after 2nd line treatment; ②progression of disease during treatment; ③duration of stable disease <6 months; ④ disease progress or relapse within 12 months of autologous stem cell transplantation.
- •definition of refractory/relapsed disease for CLL and other indolent B cell NHL, should fit one of the following: ① failed or relapsed after 2nd therapy (Rituximab must be included) and being unable to accept ibrutinib treatment due to various reasons; ② non-responsive or intolerable to ibrutinib as 2nd line treatment; 3) refractory or relapsed MCL should fit one of the following: ① complete remission not achieved after 2nd line treatment; ② disease progression during treatment; ③duration of stable disease ≤6 months; ④disease progress or relapse within 12 months of autologous stem cell transplantation.
- •Previous treatment of aggressive B lymphomas must include Rituximab and anthracyclines;
- •Patients should have at least one measurable disease focus, with the longitudinal diameter ≥1.5cm, or any extra-nodal focus with the longitudinal diameter ≥1.0cm, with PET/CT positive results;
- •Blood routine test, absolute neutrophil count≥1000/ul、platelet count≥45000/ul；
- •Cardiac, hepatic and renal function: Creatinin <1.5 times of normal maximum；ALT/AST level <2.5 times of the maximum of normal range; total bilirubin<1.5 times of ULN；cardiac ejection fraction≥ 50%;
- •Patients should have the ability to fully understand contents of the written consent and be willing to sign the written consent;
- •Fertile patients should agree to take contraceptive measures during the process of this trial.
排除标准
- •History of other malignant tumor;
- •History of autologous stem cell transplantation within 6 weeks prior to enrollment;
- •Received CAR-T therapy within 3 months prior to enrollment;
- •Received cytotoxic medicine or glucocorticoids or other targeted-therapy medicine (except for ibrutinib) within 2 weeks prior to T cell collection;
- •With active autoimmune disease;
- •With active infection;
- •With HIV infection, or uncontrolled HBV/HCV/syphilis infection;
- •With known central nervous system lymphoma.
研究组 & 干预措施
Intervention group
Experimental
In this group, patients will be treated with Interleukin-7 and Chemokine (C-C Motif) Ligand 19-expressing CD19-CAR-T, and the safety and efficacy will be evaluated.
干预措施: Interleukin-7 and Chemokine (C-C Motif) Ligand 19-expressing CD19-CAR-T cells (Biological)
结局指标
主要结局
complete remission rate
时间窗: at the time point 3 months after CAR-T cell transfusion
complete remission rate after treated by CAR-T therapy
adverse events
时间窗: from the date of the start of treatment to 24 months after last patient's enrollment
any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure
次要结局
- overall survival(from the day of treatment to the date of first documented progression，up to 24 months after the last patient's enrollment)
- progression free surviva(from the day of treatment to the date of first documented progression，up to 24 months after the last patient's enrollment)
- duration of the CAR-T cells in the patients(from the date of re-transfusison to 24 months after last patient's enrollment)
研究者
Wenbin Qian
Doctor, Professor
First Affiliated Hospital of Zhejiang University
研究点 (1)
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