A Study to Evaluate the Safety and Clinical Activity of Allogeneic CAR-T Targeting CD7 in Patients With Refractory or Relapsed T Cell Malignancies
试验速览
- 阶段
- 1 期
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Incidence of Treatment-related grade≥3Adverse Events or SAE
研究概览
简要总结
This is a single dose escalation study to evaluate the safety and clinical activity of ThisCART7(Allogeneic CAR-T targeting CD7) in patients with refractory or relapsed CD7 positive T cell malignancies.
详细描述
This is a single-center, nonrandomized, open-label, dose-escalation study to evaluate the safety and clinical activity of ThisCART7 in patients with refractory or relapsed CD7 positive T cell malignancies, such as T-cell Acute Lymphoblastic Leukemia, T-cell Acute Lymphoblastic Lymphoma and T-cell Non-Hodgkin Lymphoma. The dose range is 0.5-6 x 10^6 cells per kg body weight.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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
- •Diagnosed with relapsed and refractory CD7 + T cell hematologic malignancies (including, but not limited to, T-cell leukemia, extranodal NK/ T-cell lymphoma nasal, peripheral T-cell lymphoma, enteropathy associated T-cell lymphoma and anaplastic T-cell lymphoma, etc.);
- •No alternative treatment options deemed by investigator;
- •Measurable or detectble disease at time of enrollment;
- •Age 18-70 years old, no gender and race limited;
- •Eastern cooperative oncology group (ECOG) performance status of ≤2;
- •Cardiac ejection fraction ≥ 40%, no evidence of pericardial effusion as determined by an echocardiogram (ECHO);
- •Estimated life expectancy > 12 weeks deemed by investigator;
- •Serum creatinine ≤ 1.5 upper limit of normal (ULN);
- •Serum ALT/ AST ≤ 5 upper limit of normal (ULN);
- •Signed informed consent form (ICF).
排除标准
- •Women in pregnancy or lactation;
- •Uncontrolled infection;
- •Active hepatitis B virus or hepatitis C virus infection;
- •Concurrent use of corticosteroids or other immunosuppressant medications for chronic disease;
- •Prior treatment with an allogeneic stem cell transplant within 100 days;
- •Grade 2-4 Active graft versus host disease;
- •History of HIV infection;
- •With central nervous system involvement;
- •Patients combine with other disease cause neutrophil count (ANC) < 750/uL or PLT< 50,000/uL.
结局指标
主要结局
Incidence of Treatment-related grade≥3Adverse Events or SAE
时间窗: within 4 weeks after infusion
Therapy-related adverse events or SAE will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0).
次要结局
- Objective Response Rate(4 to 6 weeks after infusion)