Clinical Application of Chimeric Antigen Receptor Modified γδ T Cells（CAR - γ δ T Cells） in Relapsed and Refractory CD7 Positive T Cell-derived Malignant Tumors
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- ORR 3
研究概览
简要总结
This is a study on the clinical application of chimeric antigen receptor modified γδ T cells (CAR - γδ T cells) in relapsed and refractory CD7 Positive T cell-derived malignant tumors.The main purpose of this study was to evaluate the efficacy of car - γ δ T cell infusion in patients with relapsed and refractory CD7 Positive T cell-derived malignancies.
详细描述
γδT cells are known as "a great candidate for car-t cells". Although they only account for 2% - 5% of all T cells in our body, they are a natural killer.
CD7 is recognized as a sensitive marker of T-ALL, and its expression level on T-ALL cells is opposite to CD3: compared with normal T cells, the expression level of CD7 on T-ALL cells is significantly increased (P < 0.001), while the expression level of CD3 on T-ALL cells is significantly decreased (P < 0.001). At the same time, CD7 expression is absent in about 10% of normal T cells, and these CD7 negative T cells have the ability of normal T cells to express cytokines. Therefore, CD7 has become a potential target for the treatment of T-ALL because of its specificity and safety.
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
- 14 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •the patients must be patients with relapsed or refractory CD7 Positive T cell-derived malignancies, who have at least one course of standard regimen chemotherapy and one course of salvage regimen chemotherapy and have poor effect;
- •Researchers believe that there is no other feasible and effective alternative treatment, such as hematopoietic stem cell transplantation;
- •Patients should have indicators for detection or evaluation of disease, including detection of minimal residual disease (MRD) by immunophenotyping, cytogenetics or PCR;
- •They are 14-70 years old, regardless of gender or race;
- •Physical condition: ECoG score 0-2;
- •Cardiac function: left ventricular ejection fraction greater than or equal to 40%;
- •The expected survival time was > 12 weeks;
- •Serum creatinine (CR) ≤ 1.5 × ULN (upper limit of normal value), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN, total bilirubin ≤ 1.5 × ULN;
- •Patients have self-knowledge ability and can sign informed consent;
- •The guardian of the child patient agreed to sign the informed consent.
排除标准
- •pregnant or lactating women;
- •Uncontrolled infection;
- •Active HBV or HCV infection;
- •People living with HIV;
- •Less than 100 days after allogeneic hematopoietic stem cell transplantation;
- •Patients with acute GVHD or chronic GVHD after allogeneic hematopoietic transplantation;
- •Patients receiving GVHD treatment.
研究组 & 干预措施
CAR-γδT
Infusion,iv,0.2-5 ×10^6/ kg,once.
干预措施: Chimeric antigen receptor modified γδ T cells (Drug)
结局指标
主要结局
ORR 3
时间窗: three months after CAR-T cells infusion
3-month objective response rate
次要结局
未报告次要终点