The Safety and Efficay Investigation of CAR-T Cell Therapy for Patients With Hematological Malignancies
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Safety: Incidence and severity of adverse events
研究概览
简要总结
To evaluate the tolerability and safety of CAR-T technology in patients with relapsed or refractory hematolymphoid malignancies.
详细描述
Main research purposes:
To evaluate the tolerability and safety of CAR-T technology in patients with relapsed or refractory hematolymphoid malignancies.
Secondary research purposes:
Objective Evaluation of Cytodynamic Characteristics of CAR-T in Different Types of Hematological Malignancies
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
- 14 Years 至 75 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;
- •Diagnosed as recurrent or refractory lymphoma, leukemia or myeloma;
- •Tumor cells express targets for CAR-T cell therapy (results: flow cytometry or Immunohistochemical test confirmation);
- •Age 14-75 (including threshold), gender unlimited;
- •Eastern Cooperative Oncology Group (ECOG) score ≤2;
- •HGB ≥ 70g/L (blood transfusion allowed);
- •Liver and kidney functions, heart and lung functions meet the following requirements:
- •Creatinine ≤ 1.5 × ULN;
- •Left ventricular ejection fraction ≥ 50%;
- •Blood oxygen saturation>90%;
- •Total bilirubin ≤ 1.5 × ULN； ALT and AST ≤ 2.5 × ULN;
- •For T cell tumor patients, if tumor cells are detected in peripheral blood during screening, flow cytometry should be used to detect that the tumor cell surface immunophenotype is CD4 and CD8 double negative. If the immunophenotype of peripheral blood tumor cells is not double negative for CD4 and CD8, the condition that the proportion of peripheral blood tumor cells is ≤ 1% shall be met;
- •Subjects with pregnancy plans must agree to use contraception before entering the study and after the study lasts for six months; If the subject is pregnant or suspected of being pregnant, the investigator shall be informed immediately;
- •The subject or guardian understands and signs the informed consent form;
- •Expected survival longer than 3 months.
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 (HBV DNA or HCV RNA positive);
- •Human immunodeficiency virus (HIV) infection or syphilis infection;
- •Have a history of severe allergy to biological products (including antibiotics);
- •If there is a history of hematopoietic stem cell transplantation, it should be no more than 6 months before the patient receives allogeneic hematopoietic stem cell transplantation;
- •Subjects who received CAR-T therapy or other gene modified cell therapy before screening;
- •Conditions that the investigator believes may increase the risk to the subject or interfere with the outcome of the study.
研究组 & 干预措施
CAR-T Autologous T cell injection
Patients will be treated with CAR-T cells
干预措施: CAR-T Autologous T cell injection (Biological)
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 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
Complete remission (CR) Complete remission with incomplete recovery of blood cells (CRI), positive minimal residual tumor (MRD+) or negative tumor (MRD -) CR/CRI, disease recurrence or progression (PD) were evaluated, and the overall remission rate was ORR=CR+CRI; For drenching Complete remission (CR), partial remission (PR), disease stability (SD) Disease recurrence or progression (PD) was evaluated, and the overall remission rate was ORR=CR+PR; For multiple myeloma Complete remission (CR), partial remission (VGPR, PR), disease stability (SD), disease recurrence or progression (PD) were adopted, Overall remission rate ORR=CR+VGPR+PR;
次要结局
- Cytokine release(1 month post CAR-T cells infusion)
- CAR-T proliferation(3 months post CAR-T cells infusion)
- progression-free survival (PFS)(24 months post CAR-T cells infusion)