Clinical Trial of SL1904B CAR-T Cells for Relapsed or Refractory Non-Hodgkin Lymphoma
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Safety: Incidence and severity of adverse events
研究概览
简要总结
This is a study of patients with relapsed or refractory non-Hodgkin's lymphoma. To evaluate the safety and efficacy of SL1904B in patients with relapsed or refractory non-Hodgkin's lymphoma.
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 SL1904B in patients with recurrent or refractory non-Hodgkin's lymphoma
The Secondary research objectives:
To investigate the cytokinetic characteristics of SL1904B in patients with recurrent or refractory 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
- 3 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sign the informed consent form 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;
- •The diagnosis of patients with relapsed or refractory non-hodgkin lymphoma;
- •There should be at least one measurable tumor focus according to the RECIST version 1.1;
- •ECOG Scores: 0~2;
- •The expression of CD19 on the tumor cells was reported as positive by either immunohistochemistry or flow cytometry;
- •Estimated survival time was longer than 3 months;
- •main organ functions shall meet the following requirements including: serum creatinine ≤1.5 times the upper limit of normal value (ULN); ALT ULN 2.5 or less; AST ULN 2.5 or less; Total bilirubin ≤ 1.5ULN; Left ventricular ejection fraction (LVEF) ≥45%; Hemoglobin ≥90g/L; Platelet count ≥50×109/L; absolute Neutrophil count (ANC) ≥1.0×109/L; Blood oxygen saturation >92%；
- •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;
- •Merging the metabolic diseases (except diabetes);
- •Merging severe autoimmune diseases or immunodeficiency disease;
- •Patients with active hepatitis B or hepatitis C virus infection;
- •Patients with HIV infection or syphilis infection;
- •Has a history of serious allergies on Biological products (including antibiotics);
- •Participated in any other clinical drug trial for the last six months;
- •Being pregnant and lactating or having pregnancy within 12 months;
- •With other uncontrolled diseases and considered not suitable to participate by the researchers;
- •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: Overall Remission Rate (ORR)
时间窗: 3 months post CAR-T cells infusion
Overall Remission Rate (ORR) including partial remission and complete remission rate after infusion of SL1904B
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)
- Cytokine release(First month post CAR-T cells infusion)
- CAR-T proliferation(3 months post CAR-T cells infusion)