Safety and Efficacy Study of SL1904B CAR-T Cells for Relapsed or Refractory B-Cell Acute Lymphocyte Leukemia
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- Safety: Incidence and severity of adverse events
研究概览
简要总结
This is an open, single-arm, clinical study to evaluate efficacy and safety of anti CD19 CAR-T cell in the treatment of recurrent or refractory B-ALL
详细描述
The CARs consist of an anti-CD19 single-chain variable fragment（scFv） that was derived from the FMC63 mouse hybridoma, a portion of the human CD137（4-1BB） molecule, and the intracellular component of the human CD3ζ molecule. Prior to CAR-T cell infusion, the patients will be subjected to preconditioning treatment. After CAR-T cell infusion, the patients will be evaluated for adverse reactions and efficacy.
The Main research objectives:
To evaluate the safety and efficacy of 1904B in patients with recurrent or refractory B-ALL
The Secondary research objectives:
To investigate the cytokinetic characteristics of 1904B in patients with recurrent or refractory B-ALL
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
- 2 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sign the informed consent and be willing and able to comply with the visit, treatment regimen, laboratory examination and other requirements of the study as stipulated in the trial flow chart;
- •A definite diagnosis of B-cell Lymphocyte Leukemia, which meets any of the following criteria: Relapsed : a) relapsed within 12 months after first remission;Refractory: a) no remission after six weeks of induction therapy or no remission after two courses of induction therapy; b) relapsedafter CR for 2 or more times; c) The first relapse after chemotherapy and no remission after at least one salvage treatment; c) relapsed after hematopoietic stem cell transplantation;
- •ECOG Scores: 0~2
- •CD19 positivewere detected by immunohistochemistry or flow cytometry;
- •Estimated survival time>3 months;
- •Peripheral blood mononuclear immune cells must be collected at least 2 weeks after the last radiotherapy or systemic treatment.
排除标准
- •Serious cardiac insufficiency；
- •Has a history of severe pulmonary function damaging;
- •With other tumors which is/are in advanced malignant and has/have systemic metastasis;
- •Severe or persistent infection that cannot be effectively controlled；
- •Merging severe autoimmune diseases or immunodeficiency disease;
- •Patients with active hepatitis B or hepatitis C([HBVDNA+]or [HCVRNA+]);
- •Patients with HIV infection or syphilis infection;
- •Has a history of serious allergies on Biological products (including antibiotics);
- •Being pregnant and lactating or having pregnancy within 12 months;
- •Any situations that the researchers believe will increase the risks for the subject or affect the results of the study.
结局指标
主要结局
Safety: Incidence and severity of adverse events
时间窗: First month post CAR-T cells infusion
To evaluate the possible adverse events occurred within first one month after SL1904B infusion, including the incidence and severity of symptoms such as cytokine release syndrome and neurotoxicity
Efficacy: Remission Rate
时间窗: 3 months post CAR-T cells infusion
Remission Rate including complete remission(CR)、CR with incomplete blood count recovery(CRi)、No remission(NR)
次要结局
- Efficacy:duration of response (DOR)(24 months post CAR-T cells infusion)
- Efficacy: progression-free survival (PFS)(24 months post CAR-T cells infusion)
- CAR-T proliferation(3 months post CAR-T cells infusion)
- Cytokine release(First month post CAR-T cells infusion)