NCT03932955Unknown1 期
Study Evaluating the Efficacy and Safety of MC-19PD1 CAR-T in Relapsed or Refractory B Cell Lymphoma
Peking University1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2019年5月1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
- 15
- 试验地点
- 1
- 主要终点
- Percentage of adverse events
研究概览
简要总结
This is a single center, single arm, open-lable phase 1 study to determine the safety and efficacy of CD19-CAR-T cells in patients with relapsed or refractory B-cell lymphoma.
详细描述
In this single-center, open-label, nonrandomized, no control, prospective clinical trial, appoximately 15 relapsed or refractory B-cell lymphoma patients will be enrolled. Side effects of CD19 CAR T cells therapy will be monitored. The purpose of current study is to determine the clinical efficacy and safety of CD19 CAR T cells therapy in patients with R/R B-cell lymphoma
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •（1）CD19 positive B-cell lymphoma; （2）Relapsed and refractory B-cell lymphoma: patients previously received at least first-line and second- line treatment and fail to achieve CR; （3）At least 1 measurable tumor foci according to the 2014 Lugano treatment response criteria; （4）18 to 70 Years Old, Male and female; （5）Expected to survive for more than 3 months; （6）Clinical performance status of ECOG score 0-1; （7）Important organ function is satisfied: cardiac ultrasound indicates cardiac ejection fraction ≥50%; serum Cr ≤ 1.25 times normal range or creatinine clearance calculated by Cockcroft-Gault formula ≥45ml/min; ALT and AST≤ 3 times normal range, total bilirubin ≤ 1.5times normal range; （8）hemoglobin ≥ 80 g / L, neutrophils ≥ 1.0 × 10 ^ 9 / L, platelets ≥ 50 × 10 ^ 9 / L.
- •（9）INR≤ 1.5times normal range; APTT≤ 1.5times normal range; （10）Women in childbearing age must be not pregnant and do not plan pregnancy within 1 year of their cell transfusion; （11）Informed consent is signed by a subject or his lineal relation.
排除标准
- •Recent or current use of glucocorticoid or other immunosuppressor or Drug that stimulates bone marrow hematopoiesis;
- •Uncontrolled systemic active infection: fungi, bacteria, viruses or other infections;
- •Active infection with HBV, HCV or HIV;
- •Patients with symptoms and disease history of central nervous system;
- •Pregnant or lactating female；The patient did not agree to use effective contraception during the treatment period and for the following 1 year；
- •Patients receiving allogeneic hematopoietic stem cell transplantation, or organ transplantation
- •A history of other malignant tumors;
- •Primary immunodeficiency disease, or autoimmune disease;
- •Patients treated with PD-1 inhibitors or PD-L1 inhibitors prior to enrollment;
- •Patients who participated in other clinical trials within 4 weeks before blood collection;
- •Patients who had used CD19 targeted therapy before enrollment;
- •The investigator believes that there are other factors that are not suitable for inclusion or influence the subject's participation or completion of the study.
研究组 & 干预措施
MC-19PD1 CAR-T Cells
Experimental
干预措施: MC-19PD1 CAR-T cells (Biological)
结局指标
主要结局
Percentage of adverse events
时间窗: 2 years
Percentage of participants with adverse events
次要结局
- objective remission rate(3 months)
研究者
Jun Zhu
Director
Peking University
研究点 (1)
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