CAR-T Therapy in Relapsed or Refractory Haematopoietic and Lymphoid Malignancies
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Tumor load
研究概览
简要总结
This is an open, single-arm, phase I clinical study to evaluate efficacy and safety of chimeric antigen receptor T cell immunotherapy (CAR-T) in the treatment of hematopoietic and lymphoid malignancies. A total of 30 patients are planned to be enrolled over a period of 2 years.
详细描述
Chimeric antigen receptor (CAR)-modified T cells targeted against CD19 have demonstrated unprecedented successes in treating patients with hematopoietic and lymphoid malignancies. Besides CD19, many other molecules such as CD22, CD30, CD7, BCMA, CD123, etc. may be potential in developing the corresponding CAR-T cells to treat patients whose tumors expressing those markers. Investigators have developed a high efficient platform for constructing different CARs and preclinical studies have demonstrated effective killing of corresponding target cells. In this study, investigators will evaluate their safety and efficacy in patients with different types of hematopoietic and lymphoid malignancies. The primary goal is safety assessment including cytokine storm response and any other adverse effects. In addition, tumor targeting and disease status after treatment will also be evaluated.
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
- 1 Year 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.The treat history meeting the following criteria:
- •Recurrence of lymphoma patients with imaging (CT/MRI/PET-CT) detection and pathological diagnosis, or recurrence including bone marrow morphology relapse and the MRD recurrence of myeloma patients or leukemia patients, after chemotherapy or stem cell transplantation;
- •Can't get complete remission (including MRD positive) after more than twice repeated chemotherapy of incipient lymphoma, myeloma or leukemia patients;
- •One or twice chemotherapy cannot get remission again (including MRD positive), but not suitable for chemotherapy of incipient lymphoma, myeloma or leukemia patients.
- •2. There is a measurable lesions before treatment at least;
- •ECOG score≤2;
- •To be aged 1 to 70 years;
- •More than a month lifetime from the consent signing date
排除标准
- •Serious cardiac insufficiency, left ventricular ejection fraction<50;
- •Has a history of severe pulmonary function damaging;
- •Merging other malignant tumor;
- •Merging uncontrolled infection;
- •Merging the metabolic diseases (except diabetes);
- •Merging severe autoimmune diseases or immunodeficiency disease;
- •patients with active hepatitis B or hepatitis C;
- •patients with HIV infection;
- •Has a history of serious allergies on Biological products (including antibiotics);
- •Happened in 3 ~ 4 acute GvHD after allogeneic hematopoietic stem cell transplantation on recurring patients
- •Pregnancy or lactation women;
- •Any situation that would increase dangerousness of subjects or disturb the outcome of the clinical study according to the researcher's evaluation.
结局指标
主要结局
Tumor load
时间窗: Up to 24 months
Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis.
次要结局
- CAR T cell persistence(Up to 24 months])