NCT05206071Unknown不适用
Clinical Study of SL19+22 CAR-T Cells for Relapsed or Refractory Non-Hodgkin Lymphoma
Hebei Senlang Biotechnology Inc., Ltd.1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Safety: Incidence and severity of adverse events
研究概览
简要总结
To evaluate the safety and efficacy of SL19+22 in patients with relapsed or refractory non-Hodgkin's lymphoma.
详细描述
SL19+22 injection is a CAR-T product independently developed by Senlang that targets both CD19 and CD22. Based on the traditional CAR T treatment regimen, the CAR structure was designed, and the activation mode of T cells was changed by using cytokine combination amplification and improved transfection technology.
The Main research objectives:
To evaluate the safety and efficacy of SL19+22 in patients with recurrent or refractory non-Hodgkin's lymphoma
The Secondary research objectives:
To investigate the cytokinetic characteristics of SL19+22 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 75 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 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;
- •The definition of recurrent or refractory non-Hodgkin lymphoma: Patients with DLBCL, pmbcl and TFL diagnosed by histopathology are resistant to standard treatment; Or PD after at least second-line standard treatment; Or the last treatment effect was SD and the duration was no longer than 6 months; Or CD20 positive patients were ineffective or relapsed after anti-CD20 monoclonal antibody treatment; Or PD after autologous hematopoietic stem cell transplantation or recurrence confirmed by biopsy within 12 months; Or patients undergoing salvage treatment after autologous hematopoietic stem cell transplantation had no remission or recurrence after end-line treatment;
- •There should be at least one measurable tumor foci according to the RECIST version 1.1;
- •ECOG Scores: 0~2;
- •The expression of CD19 and/or CD22 on the tumor cells are reported as positive by either immunohistochemistry or flow cytometry;
- •Estimated survival time is longer than 3 months;
- •Main organ functions shall meet the following requirements: 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;
- •Coexisting with severe or persistent infection that cannot be effectively controlled;
- •Patients with a history of other malignancies, except those with non-melanoma skin cancer or carcinoma in situ (eg, cervical cancer, bladder cancer, breast cancer) who have received curative treatment at least 2 years prior to screening without disease recurrence;
- •Presence of metabolic diseases (except diabetes and Dyslipidemia);
- •Presence of 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 three months(except clinicaltrials of CART );
- •Being pregnant, lactating, or planing on pregnancy in the next 12 months.
- •Any situations that the researchers believe will increase the risks for the subject or affect the results of the study(have a history of serious mental illness, drug abuse and addiction).
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 could occurred within first month post infusion.
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 SL19+22
次要结局
- CAR-T proliferation(3 months post CAR-T cells infusion)
- Efficacy: progression-free survival (PFS)(24 months post CAR-T cells infusion)
- Efficacy:duration of response (DOR)(24 months post CAR-T cells infusion)
- Cytokine release(First month post CAR-T cells infusion)
研究者
研究点 (1)
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