NCT04213469已完成不适用
a Safety and Efficacy Evaluation of PD1-CD19-CART in Patients With Relapse/Refractory B-cell Lymphoma
Bioray Laboratories1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年3月13日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- MTD
研究概览
简要总结
This is an open label, single-site, dose-escalation study in up to 25 participants with relapse/refractory B-NHL. This study aims to evaluate the safety and efficacy of the treatment with PD1-CD19-CART.
详细描述
PD1-CD19-CART is a kind of chimeric antigen T cell targeting CD19 with both CD19-CAR gene integration and also PD1 knockout by one-step gene-editing. After completion of study treatment, subject participation for this study will be followed up to 15 years post T cell infusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have the capacity to give informed consent;
- •ALL patients with the age between 18 and 70 years old;
- •Expected survival >3 moths;
- •With no severe heart and lung disease;
- •Previously confirmed diagnosis as CD19+ NHL within 6 months;
- •Hematological index as following, white blood cell (WBC)≥1.5×10^9/L，absolute neutrophil count (ANC) ≥0.8×10^9/L, Platelet count≥50×109/L, Hemoglobin (Hgb) ≥ 90mg/L, lymphocyte count≥ 0.4×10^9/L；
- •Blood biochemical index as no more than 1.5* ULN, including total bilirubin (TBIL), transglutaminase (AST), alanine aminotransferase (AST), Creatinine (SCr), Urea in patients with no tumor metastasis in liver and kidney; Blood biochemical index no more than 5* ULN in patients with tumor metastasis in liver and kidney;
- •With a stable cardiac function, the left ventricular ejection fraction (LVEF) ≥ 55%;
- •Virological tests were negative for EBV, CMV, HIV, TP and HCV; a negative HBV DNA test is acceptable if HBsAg is positive;
- •Relapsed or refractory (r/r) NHL including, Diffuse large B cell lymphoma(DLBCL, NOS), stage Ⅲ-Ⅳ;Primary mediastinal large B-cell lymphoma (PMBL), stage Ⅲ-Ⅳ; High grade B-cell lymphoma (HGBL), stage Ⅲ-Ⅳ; Mantle cell lymphoma (MCL), stage Ⅲ-Ⅳ; follicular lymphoma (FL), stage Ⅲ-Ⅳ and with aggression. r/r NHL defined as following, demonstrate disease that persists or relapse after achieving complete response (CR) after > 2 cycles of standard chemotherapy, or relapse after autologous hematopoietic stem cell transplantation (auto-HSCT), or not achieving CR after auto-HSCT.
排除标准
- •Pregnant or lactating women;
- •With a pregnancy plan in the next 2 years;
- •Prior treatment of anti-GVHD therapy;
- •Acceptance of allogeneic stem cell transplant (ASCT);
- •Isolated extramedullary relapse of ALL;
- •Severe mental disorders, active autoimmune diseases, active infectious diseases, severe cardiovascular diseases;
- •Partial prothrombin time or activated partial thromboplastin time or international standardized ratio > 1.5*ULN without anticoagulant treatment;
- •History of other type of maligant tumors;
- •Any circumstances that possibly increase the risk of subjects or interfere with study results, which judged by investigator.
结局指标
主要结局
MTD
时间窗: up to 28 days after T cell infusion
MTD will be determined based on DLTs observed during the first 28 days of study treatment.
RP2D
时间窗: up to 28 days after T cell infusion
RP2D will be determined based on MTD and efficiency during the first 28 days of study treatment.
次要结局
- Progress free survival (PFS)(Baseline up to 3 months after T cell infusion)
- Objective response rate (ORR)(Baseline up to 3 months after T cell infusion)
研究者
研究点 (1)
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