Multi-center Phase I/II Clinical Trial of Multi-CAR T Cell Therapy for Acute Myeloid Leukemia
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 10
- 试验地点
- 3
- 主要终点
- percentage of patients with treatment related adverse effect
研究概览
简要总结
The purpose of this clinical trial is to assess the feasibility, safety and efficacy of multi-CAR T cell therapy targeting different AML surface antigens in patients with relapsed or refractory acute myeloid leukemia (AML). Another goal of the study is to learn more about the function of the multi-CAR T cells and their persistency in the patients.
详细描述
Important Regulatory Notice:
This trial record is only for global academic information registration on ClinicalTrials.gov. Neither the sponsor Beijing Meikang Jimian Biotechnology Co., Ltd. nor collaborator Shenzhen Geno-Immune Medical Institute has obtained NMPA clinical trial approval or clinical technology filing permission to carry out interventional cell therapy trials in mainland China.
ClinicalTrials.gov registration alone does not represent legal approval by Chinese health and drug regulatory authorities.
Acute myeloid leukemia (AML) is a malignant disease characterized by the rapid growth of myeloblasts that build up in the bone marrow and interfere with the production of normal blood cells.
In this study, the patients' own T cells will be genetically modified with lentiviral vectors expressing chimeric antigen receptors. The multi-CAR T cells recognize specific molecules such as CD33, CD38, CD123, CD56, MucI, and CLL1, which are often found expressed on the surface of AML cells. The engineered CAR T cells will be infused into patients.
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 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age older than 2 years.
- •CD33, CD38, CD56, CD123, MucI, and CLL1 expression can be identified in the malignant cells by immuno-histochemical staining or flow cytometry.
- •Karnofsky performance status (KPS) score is higher than 80 and life expectancy > 2 months.
- •Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements: cardiac ejection fraction ≥ 50%, oxygen saturation ≥ 90%, creatinine ≤ 2.5 × upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal, total bilirubin ≤ 2.0mg/dL.
- •No cell separation contraindications.
- •Abilities to understand and the willingness to provide written informed consent.
排除标准
- •Sever illness or medical condition, which would not permit the patient to be managed according to the protocol, including active uncontrolled infection.
- •Active bacterial, fungal or viral infection not controlled by adequate treatment.
- •Known HIV or hepatitis B virus (HBV) infection.
- •Pregnant or nursing women may not participate.
- •History of glucocorticoid for systemic therapy within the week prior to entering the test.
- •Previously treatment with any gene therapy products.
- •Patients, in the opinion of investigators, may not be eligible or not able to comply with the study.
研究组 & 干预措施
Single arm
CAR T cells to treat AML
干预措施: Muc1/CLL1/CD33/CD38/CD56/CD123-specific gene-engineered T cells (Biological)
结局指标
主要结局
percentage of patients with treatment related adverse effect
时间窗: a year
percentage of participants with treatment-related adverse events, as assessed by physical exam, vital signs, standard clinical labs and so on.
次要结局
- Anti tumor activity of fourth generation CAR-T cells in patients with relapsed or refractory AML(a year)
研究者
Lung-Ji Chang
President
Shenzhen Geno-Immune Medical Institute