NCT06464861招募中1 期
Sequential Treatment With 7x19 CAR-T After Umbilical Cord Blood Derived CD19 CARNK in Relapsed/Refractory B Cell Lymphoma
Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2024年6月20日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 52
- 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 efficacy of cord blood-derived CD19 CAR-NK cells sequential with 7x19 CAR-T in relapse / refractory B cell lymphoma
详细描述
This is a single-center, open, single-arm clinical exploratory study to observe the safety and efficacy of cord blood derived CD19 CAR-NK cells sequential treatment with 7x19 CAR-T in relapse / refractory B cell lymphoma. This study consisted of two phases: phase I: CARNK cells preparation and infusion (Day0, dose of 2 x 10^6 / kg). Phase II: 7x19 CAR-T cells preparation and infusion (Day7, dose 2×10^6/kg).
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, 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 or swine flu virus are negative.
排除标准
- •Allergic to any of the components of cell products;
- •History of other tumors;
- •Acute GvHD or extensive chronic GvHD with grade II-IV (Glucksberg standard) in the past or are receiving anti-GVHD treatment;
- •Had received gene therapy within the past 3 months;
- •Active infections requiring treatment (except for simple urinary tract infections, bacterial pharyngitis); however, prophylactic antibiotics, antiviral and antifungal infection treatment are permitted;
- •Patents infected with hepatitis B (HBsAg positive, but HBV-DNA < 103 is not excluded) or hepatitis C virus (including virus carriers), syphilis and other acquired and congenital immunodeficiency diseases, including but not limited to HIV-infected persons;
- •Subjects with Grade III or IV cardiac dysfunction according to the New York Heart Association's cardiac function grading criteria;
- •Patients who received antitumor therapy earlier but did not recover from the toxicity (CTCAE 5.0 toxicity did not recover to ≤ grade 1, except fatigue, anorexia, alopecia);
- •Subjects with a history of epilepsy or other central nervous system disorders;
- •Head-enhanced CT or MRI showing evidence of central nervous system lymphoma;
- •Lactating women who are unwilling to stop breastfeeding;
- •Any other factors that the investigator believes may increase the risk to the subject or interfere with the test results.
研究组 & 干预措施
CD19-CAR-NK/T
Experimental
All subjects were intravenously administrated with CAR-NK019 at day 0 with a dose of 2x10^6/kg, and after 1 week will be infused with 7x19 CAR-T at the dose of 2x10^6/kg
干预措施: CD19-CAR-NK/T (Biological)
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 and tolerability of cord blood-derived anti-CD19 CAR-NK Cell sequential with 7X19 CAR-T for B-cell Non-Hodgkin Lymphoma
次要结局
- Complete response rate (CR)(Up to 2 years)
- Duration of response (DOR)(Up to 2 years)
- Partial response rate (PR)(Up to 2 years)
- Progression free survival (PFS)(Up to 2 years)
- Overall survival (OS)(Up to 2 years)
研究者
研究点 (1)
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