CD7 CAR-T Cell Treatment of Relapsed/Refractory CD7+ T -Acute Lymphoblastic Leukemia/ Lymphoma
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- The number and incidence of adverse events after CD7 CAR infusion.
研究概览
简要总结
This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of CD7 CAR-T cells in patients with relapsed and/or refractory, high risk hematologic malignancies.
详细描述
T-acute lymphoblast leukemia (T-ALL) accounts for 15-20% of all ALL cases. It is a neoplastic lymphoid leukemia characterized by the proliferation of immature precursor T cells. T-ALL is a highly aggressive tumor. Adults need intensive chemotherapy, and the cure rate is <50%, even with stem cell transplantation. The prognosis is also very poor. The combined chemotherapy has significantly improved the prognosis of T-acute lymphoblast leukemia/lymphoma. However, once the disease appears to be relapsed/refractory, there is limited treatment options, and the overall prognosis is extremely poor. Therefore, exploring safe and effective treatments is a critical unmet medical need. Since 95% of T-ALLs express CD7, this might provide an effective targeting approach for the vast majority of T-ALL cases.
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
- 2 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent; Patients volunteer to participate in the clinical trial;
- •Diagnosis is mainly based on the World Health Organization (WHO) 2008;
- •Complete remission cannot be achieved after induction therapy; recurrence occurs after completion remission; the burden of leukemic blasts in the peripheral blood or bone marrow is greater than 5%;
- •Leukemic blast cells express CD7 (CD7 positive by flow cytometry or immunohistochemistry ≥70%);
- •The expected survival period is greater than 12 weeks;
- •ECOG score ≤2;
- •Age 2-60 years old;
- •HGB≥70g/L (can be transfused);
- •Total bilirubin does not exceed 3 times the upper limit of normal value, and AST and ALT do not exceed 5 times the upper limit of normal value.
排除标准
- •Patients declining to consent for treatment
- •Prior solid organ transplantation
- •One of the following cardiac issues: atrial fibrillation; myocardial infarction within the past 12 months; prolonged QT syndrome or secondary QT prolongation; clinically significant pericardial effusion; cardiac insufficiency NYHA (New York Heart Association) III or IV;
- •History of severe pulmonary dysfunction diseases;
- •Severe infection or persistent infection cannot be effectively controlled;
- •Severe autoimmune disease or congenital immunodeficiency;
- •Active hepatitis;
- •Human immunodeficiency virus (HIV) infection;
- •Clinically significant viral infections, or uncontrollable viral reactivation, including EBV (Epstein-Barr virus).
结局指标
主要结局
The number and incidence of adverse events after CD7 CAR infusion.
时间窗: Up to 3 months
Evaluation all possible adverse reactions, including the number, incidence, and severity of symptoms such as cytokine release syndromes and neurotoxicity within 3 months after CAR infusion
次要结局
- Evaluation of curative effects(Up to 1 year)
- Disease response to CD7 CAR T cells(Up to 1 year)
- Overall survival(Up to 1 year)