NCT04887012Unknown1 期
Clinical Study of HLA Haploidentical CAR-NK Cells Targeting CD19 in the Treatment of Refractory/Relapsed B-cell NHL
Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2021年5月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Incidence of dose limiting toxicity (DLTs)
研究概览
简要总结
To study the safety and effectiveness of HLA haploidentical CAR-NK cells targeting CD19 in patients with B-cell non-Hodgkin's 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Volunteer to participate in this study and sign an informed consent form;
- •Age 18-75 years old, no gender limit;
- •Histologically diagnosed as diffuse large B-cell lymphoma (DLBCL), transforming follicular lymphoma (TFL), primary mediastinal B-cell lymphoma (PMBCL), mantle cell lymphoma (MCL) and other inert B-cells NHL conversion type:
- •Refractory or relapsed DLBCL refers to the failure to achieve complete remission after 2-line treatment; disease progression during any treatment, or disease stable time equal to or less than 6 months; or disease progression or recurrence within 12 months after autologous hematopoietic stem cell transplantation ；
- •Refractory or relapsed MCL must be resistant to or intolerable to BTK inhibitors;
- •Refractory or relapsed indolent B-cell NHL is the failure or recurrence of third-line treatment;
- •Previous treatment must include CD20 monoclonal antibody treatment (unless the subject is CD20 negative) and anthracyclines;
- •At least one measurable lesion with the longest diameter ≥ 1.5 cm exists;
- •The expected survival period is ≥12 weeks;
- •The puncture section of the tumor tissue was positive for CD19 expression;
- •ECOG score 0-2 points;
- •Sufficient organ function reserve:
- •Alanine aminotransferase, aspartate aminotransferase ≤ 2.5× UNL (upper limit of normal value);
- •Creatinine clearance rate (Cockcroft-Gault method) ≥60 mL/min;
- •Serum total bilirubin and alkaline phosphatase ≤1.5× UNL;
- •Glomerular filtration rate>50Ml/min
- •Cardiac ejection fraction (EF) ≥50%;
- •Under natural indoor air environment, basic oxygen saturation>92%
- •Allow a previous stem cell transplantation
- •The approved anti-B-cell lymphoma treatments, such as systemic chemotherapy, systemic radiotherapy, and immunotherapy, have been completed for at least 3 weeks before the study medication;
- •Allow patients who have previously received CAR-T cell therapy and have failed or relapsed after 3 months of evaluation;
- •Female subjects of childbearing age must have a negative pregnancy test and agree to take effective contraceptive measures during the trial
- •Two tests for the new coronavirus were negative.
排除标准
- •Those who have a history of allergies to any of the ingredients in cell products;
- •History of other tumors
- •Previously presented with II-IV degree (Glucksberg criteria) acute GvHD or extensive chronic GvHD; or are receiving anti-GvHD treatment;
- •Have received gene therapy in the past 3 months;
- •Active infections that require treatment (except for simple urinary tract infections and bacterial pharyngitis), but preventive antibiotics, antiviral and antifungal infection treatments are allowed;
- •Hepatitis B (HBsAg positive, but HBV-DNA <103 is not an exclusion criterion) or hepatitis C virus infection (including virus carriers), syphilis and other subjects with acquired and congenital immunodeficiency diseases, including But not limited to people living with HIV;
- •According to the New York Heart Association's Heart Function Classification Standard, it is classified as Grade III or Grade IV.
- •Impaired subjects;
- •Those who have received anti-tumor therapy in the early stage but the toxic reaction has not recovered (the CTCAE 5.0 toxic reaction has not recovered to ≤1, except for fatigue, anorexia, and hair loss);
- •Subjects with a history of epilepsy or other central nervous system diseases;
- •Enhanced CT or MRI of the head showed evidence of central nervous system lymphoma;
- •Have received any other drugs that target CD19;
- •Women who are breastfeeding and unwilling to stop breastfeeding;
- •Any other situation that the investigator believes may increase the risk of the subject or interfere with the results of the test.
结局指标
主要结局
Incidence of dose limiting toxicity (DLTs)
时间窗: Up to 28 days
To evaluate the safety, tolerability, and determine the recommended dosage of Anti-CD19 CAR-NK Cell Therapy for B-cell Non-Hodgkin Lymphoma
The overall response rate(ORR)
时间窗: Up to 2 years
To determine the anti-tumor effectivity of CAR-NK019
次要结局
- Overall survival (OS)(Up to 2 years)
- progression free survival (PFS)(Up to 2 years)
- Pharmacokinetics of CAR positive cells(Up to 2 years)
- Pharmacokinetics of CAR-NK cells(Up to 2 years)
研究者
研究点 (1)
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