Senl-h19 CAR-T Cell Injection in the Treatment of Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Safety: Incidence and severity of adverse events
研究概览
简要总结
This study is an open, dose-escalating clinical study, taking patients with relapsed or refractory acute lymphoblastic leukemia as the test subjects, including mouse-derived CAR-T treatment failure or relapse, or for any reason cannot bridge the transplant r/r B-ALL.
详细描述
Main research objectives:
To evaluate the safety and efficacy of Senl-h19 CAR-T in patients with relapsed or refractory acute lymphoblastic leukemia Secondary research purpose To investigate the cytokinetic characteristics of Senl-h19 CAR-T in patients with relapsed or refractory acute lymphoblastic leukemia.
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
盲法说明
Open Label
入排标准
- 年龄范围
- 2 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sign the informed consent and be willing and able to comply with the visit, treatment protocol, laboratory examination, and other requirements of the study as specified in the study procedure sheet;
- •A definite diagnosis of relapsed and refractory acute B-lymphoblastic leukemia meets one of the following criteria: a) Mouse CAR-T treatment fails or relapses; B) Unable to bridge the graft for any reason;
- •Eastern Cooperative Oncology Group (ECOG) score ≤2;
- •Age ≥2 years old, male or female
- •CD19 positive tumor cells were detected by immunohistochemistry or flow cytometry;
- •Expected survival longer than 3 months;
- •The collection time of peripheral blood mononuclear immune cells must be at least 2 weeks from the last radiotherapy or systematic treatment of patients;
排除标准
- •Severe cardiac insufficiency;
- •Have a history of severe lung impairment;
- •Complicated with other advanced malignant tumors;
- •Complicated with severe or persistent infection that cannot be effectively controlled;
- •Complicated with severe autoimmune diseases or congenital immune deficiency;
- •Active hepatitis (HBVDNA or HCVRNA positive); Human immunodeficiency virus (HIV) infection or syphilis infection;
- •Have a history of severe allergy to biological products (including antibiotics);
- •The female patient is pregnant and lactating, or has a pregnancy plan within 12 months;
- •Conditions that the investigator believes may increase the risk to the subject or interfere with the outcome of the study.
结局指标
主要结局
Safety: Incidence and severity of adverse events
时间窗: First 1 month post CAR-T cells infusion
To evaluate the possible adverse events occurred within first one month after CD7 CAR-T infusion, including the incidence and severity of symptoms such as cytokine release syndrome and neurotoxicity
Efficacy: Remission Rate
时间窗: 3 months post CAR-T cells infusion
Remission Rate including complete remission(CR)、CR with incomplete blood count recovery(CRi)、No remission(NR)
次要结局
- Cytokine release(First 1 month post CAR-T cells infusion)
- CAR-T proliferation(3 months post CAR-T cells infusion)
- duration of response (DOR)(24 months post CAR-T cells infusion)
- progression-free survival (PFS)(24 months post CAR-T cells infusion)