The Clinical Research of Anti-CD20 CAR-T Cells in Patients With Refractory or Relapsed B Lymphocyte Lymphoma
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Study related adverse events [ Time Frame: 4 weeks ]
研究概览
简要总结
The present study is an exploratory study. Patients who meeting the enrollment conditions for relapsed or refractory B-cell lymphoma receive a single intravenous dose of CD20-CART cells. The research with the open-label, single arm running control methods in order to initially observe the safety, tolerability, and cellular pharmacokinetics of CD20-CART cell drugs.
详细描述
The main purpose:
To preliminary explore the safety, tolerability and cellular pharmacokinetics of CD20-CART cell agents in the treatment of relapsed or refractory B-cell lymphomas.
The Secondary purpose:
The following indicators for preliminary observations of CD20-CART cells in the treatment of relapsed or refractory B-cell malignant lymphoma.
- The determination of lymph nodes to evaluate the anti-tumor effect caused by the input of CD20-CART cells agents.
- Assessing the ability of CD20-CART cell agents to inhibit the migration of bone marrow and lymph node tumor foci.
- Assess the killing ability of CD20-CART cell agents to tumor cells in vitro, for patients whose tumor cells could obtain.
- Disease control rate (DCR) (=CR (complete disease remission) + PR (partial remission of disease) + SD (stable disease), short-term efficacy assessment); Overall survival (OS) and progression-free survival (PFS) (long-term efficacy assessment).
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
- 10 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1．Patients diagnosed with B-cell relapse/refractory lymphoma have no effective treatment option. They have been treated for more than 2 years after autologous or allogeneic stem cell transplantation.
- •2.The patient's age is between 10 and 80 years old.
- •The expected survival of the patient is greater than 12 weeks.
- •Important organ functions must meet the following conditions: The echocardiography indicates that the cardiac ejection fraction is ≥50%. Electrocardiogram showed no obvious abnormalities. Creatinine clearance was calculated using the Cockcroft-Gault formula ≥ 40 ml/min. ALT value and AST value ≤ 3 times normal range. Total bilirubin ≤2.0mg/dl. The coagulation function showed a PT value and APPT value less than 2 times normal. Arterial oxygen saturation (SpO2) is greater than 92%.
- •Blood routine parameters: Hgb≥80g/L, ANC≥1×109/L, PLT≥50×109/L.
- •The pregnancy test for women of childbearing age must be negative; both male and female patients must agree to use effective contraceptives during the treatment period and within the next year;
- •There are measurable target lesions, see annex to measure lesion definition.
- •Patients have sufficient venous access to apheresis or venous blood and no other leukocyte isolation contraindications.
- •Patients need to sign informed consent.
排除标准
- •The patient is a pregnant or breastfeeding woman, or is a woman with a pregnancy plan within six months;
- •Patients have infectious diseases (such as HIV, RPR, active tuberculosis, etc.);
- •The patient is an active hepatitis B or hepatitis C infection.
- •The patient received genetic product treatment within six months.
- •The patient participated in a clinical trial within six months.
- •The patient has a severe autoimmune disease.
- •The doctor thinks that there are other reasons that can't be accepted.
研究组 & 干预措施
CD20 CAR-T cells
Experimental: CD20 CAR-T cells
干预措施: CD20 CAR-T cells (Drug)
结局指标
主要结局
Study related adverse events [ Time Frame: 4 weeks ]
时间窗: 4 weeks
Occurrence of study related adverse events, defined as NCI CTC ≥ Grade 3 signs/symptoms, laboratory toxicities and clinical events that are possible.
次要结局
- Graft Activity Endpoint Detection(24 hours, 1 week, 2 weeks, 3 weeks, 4 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 1 quarter, 2 quarters, 3 months after returning to CART cells. Data were collected in quarters, 4 quarters, 5 quarters, 6 quart)
研究者
Xin Wang
The clinical research of targeted CD20-CART cells treatment for refractory or recurrence B lymphocyte lymphoma
Shanghai Longyao Biotechnology Inc., Ltd.