A Phase 1/2 Study Evaluating the Safety and Efficacy of Anti-CD19 Chimeric Antigen Receptor-Modified T Cell (CAR-T) Therapy Bridging to Hematological Stem Cell Transplantation (HSCT) for Relapsed/Refractory CD19+ B-Cell Malignancies
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Number of participants with adverse events
研究概览
简要总结
This is the second stage of the previous anti-CD19 CAR-T therapy (NCT02965092). The study aims to evaluate the safety and efficacy of consolidative allo-HSCT following CAR-T therapy in patients with relapsed or refractory B cell Malignancies.
详细描述
Anti-CD19 CAR-T therapy has been confirmed effective for relapsed/refractory B-cell malignancies. However, its ability to keep patients in maintained remission is limited. In order to keep patients in long-term remissions, patients who had achieved MRD-negative complete remissions through CAR-T therapy (NCT02965092) will, on their own accord, receive allo-HSCT if there are no previous HSCT, contraindications, and other restrictions.
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
- — 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient is pathologically and histologically confirmed as CD19 + B cell malignancies, and has achieved MRD-negative CR through CAR-T therapy (NCT02965092);
- •B cell hematological malignancies include the following three categories:
- •B-cell acute lymphocytic leukemia (B-ALL);
- •Indolent B-cell lymphoma (CLL, FL, MZL, LPL);
- •Aggressive B-cell lymphoma (DLBCL, BL, MCL);
- •< 70 years old;
- •Expected survival time > 6 months;
- •Female patients around childbearing age, negative pregnancy test before trial, and agreed to take effective contraceptive measures during the trial until the last visit;
- •Voluntarily participate in this experiment and sign informed consent by themselves, or legally authorized representative.
排除标准
- •With a history of epilepsy or other central nervous system diseases;
- •Previous allogeneic hematopoietic stem cell transplantation;
- •The presence of clinically significant cardiovascular disease, such as uncontrolled or symptomatic arrhythmias, congestive heart failure or myocardial infarction within recent six months, or heart disease with cardiac function in any grade 3 (moderate) or 4 ( severe) (according to the New York Heart Association (NYHA) Functional Classification System);
- •Pregnant or lactating women (safety of this therapy for the unborn child is unknown);
- •Not curable active infection;
- •Patients with active hepatitis B or hepatitis C virus infection;
- •Combined use of systemic steroids within two weeks (except use of inhaled steroid recently or currently);
- •Creatinine> 2.5 mg / dl (221.0 umol/L); ALT / AST> 3 X the normal amount; Bilirubin> 2.0 mg / dl (34.2 umol/L);
- •Patients suffering from other uncontrolled diseases, and researchers believe that the patient is not suitable for trial;
- •Patients with HIV-infection;
- •Any situation that may increase the risk of patients or interfere with test results.
研究组 & 干预措施
Consolidative allo-HSCT following CAR-T therapy
Patients who had achieved MRD-negative complete remissions through CAR-T therapy (NCT02965092) will, on their own accord, receive allo-HSCT if there are no previous HSCT, contraindications, and other restrictions.
干预措施: Allogeneic hematological stem cell transplantation (Procedure)
结局指标
主要结局
Number of participants with adverse events
时间窗: 5 years
To evaluate the safety of anti-CD19 CAR-T therapy bridging to allo-HSCT. Therapy-related adverse events were recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0)
次要结局
- Overall survival(5 years)
- Relapse-free survival(5 years)
- Event-free survival(5 years)