NCT07476027尚未招募1 期
Efficacy and Safety of CD7 CAR-T Cell in Newly Diagnosed High-Risk T-LBL/ALL
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 10
- 主要终点
- CR Rate
研究概览
简要总结
This study is an open, single-center, prospective clinical trial, with newly diagnosed high-risk T-LBL/ALL patients as the subjects. It plans to enroll 10 subjects. All patients will undergo lymphocyte collection during the CR1 remission period, followed by the preparation and reinfusion of CD7 CAR-T cells. Adverse reactions will be followed up and observed, and relevant data on treatment efficacy will be collected to evaluate the safety, efficacy, and cell metabolic kinetics characteristics of CAR-T cell therapy for the 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
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≤18 years with newly diagnosed T-LBL/ALL.
- •Have completed induction chemotherapy and achieved CR1, with bone marrow MRD < 0.01%.
- •High/very high-risk or poor induction response patients.
- •High risk of future relapse, and recommended by multidisciplinary team (MDT) evaluation for prospective lymphocyte collection and preparation.
- •Peripheral blood absolute lymphocyte count (ALC) ≥ 0.5×10⁹/L, and good general condition (ECOG score 0-1 or Lansky/Karnofsky score ≥ 80).
- •Legal guardian agrees to provide written informed consent.
- •Infusion Criteria:
- •Essential normal function of major organs.
- •Left ventricular ejection fraction (LVEF) ≥ 45%.
- •Serum creatinine ≤ 1.5 × upper limit of normal (ULN) for age.
- •Serum total bilirubin, ALT/AST ≤ 3 × ULN (unless clearly related to leukemic infiltration).
- •No active, uncontrolled severe infection.
排除标准
- •Severe cardiac or pulmonary insufficiency, which the investigator deems inappropriate for enrollment.
- •Complicated with other progressive malignant tumors.
- •Presence of active and/or uncontrolled infections that have not been effectively managed.
- •Complicated with severe autoimmune diseases or congenital immunodeficiency.
- •Active hepatitis [positive for hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb), with HBV DNA copy number greater than the upper limit of normal at the study center; positive for anti-HCV, with HCV-RNA copy number greater than the upper limit of normal at the study center].
- •Human immunodeficiency virus (HIV) infection or known acquired immune deficiency syndrome (AIDS), syphilis infection.).
- •A history of severe hypersensitivity to biological products (including antibiotics).
- •Patients who have undergone allogeneic hematopoietic stem cell transplantation and still suffer from acute graft-versus-host disease (GVHD) one month after discontinuation of immunosuppressive agents.
- •Patients with other severe physical or mental diseases or abnormal laboratory test results that may increase the risk of study participation or interfere with study outcomes, as well as those who are deemed unsuitable for participation in this study by the investigator.
研究组 & 干预措施
CD7 CAR-T cell injection
Experimental
干预措施: CD7 CAR-T cell intravenous infusion (Biological)
结局指标
主要结局
CR Rate
时间窗: 28 days after CD7 CAR-T cell infusion
CR+CRi
次要结局
未报告次要终点
研究者
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