Safety and Efficacy Study of CD22 CAR-T Cells for Relapsed or Refractory Acute Lymphoblastic Leukemia
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- Efficacy: Remission Rate
研究概览
简要总结
This is an open, single-arm, clinical study to evaluate efficacy and safety of anti CD22 CAR-T cell in the treatment of recurrent or refractory B-ALL
详细描述
The CARs consist of an anti-CD22 single-chain variable fragment（scFv）, a portion of the human CD137（4-1BB） molecule, and the intracellular component of the human CD3ζ molecule. Prior to CAR-T cell infusion, the patients will be subjected to preconditioning treatment. After CAR-T cell infusion, the patients will be evaluated for adverse reactions and efficacy.
The Main research objectives:
To evaluate the safety and efficacy of CD22CAR-T in patients with recurrent or refractory B-ALL
The Secondary research objectives:
To investigate the cytokinetic characteristics of CD22CAR-T in patients with recurrent or refractory B-ALL
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
- 2 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with relapsed and refractory acute B-lymphoblastic leukemia who have any of the following:
- •B-ALL patients with relapse (including bone marrow morphological relapse 1 and minimal residual relapse 2) after remission by chemotherapy or autologous stem cell transplantation;
- •Primary B-ALL patients who can not be completely relieved by more than two times of repeated chemotherapy;
- •High risk primary B-ALL patients who have not been relieved but are not suitable for re intensive therapy after 1-2 times of chemotherapy;
- •Flow cytometry (FCM) showed CD 22 positive in bone marrow or peripheral blood;
- •There should be at least one assessable lesion in B-ALL patients with simple extramedullary recurrence;
- •The activity state score of the Eastern Cooperative Oncology Group (ECOG) was less than or equal to 2;
- •The estimated survival time is more than 3 months;
- •Need to sign informed consent.
排除标准
- •Serious cardiac insufficiency；
- •Has a history of severe pulmonary function damaging;
- •Other malignant tumors;
- •Serious infection or persistent infection and can not be effectively controlled；
- •Merging severe autoimmune diseases or immunodeficiency disease;
- •Patients with active hepatitis (HBV DNA or HCV RNA positive);
- •Patients with HIV infection or syphilis infection;
- •Has a history of serious allergies on Biological products (including antibiotics);
- •Being pregnant and lactating or having pregnancy within 12 months;
- •Any situations that the researchers believe will increase the risks for the subject or affect the results of the study（including a history of serious mental illness, substance abuse and addiction）
结局指标
主要结局
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)
Safety: Incidence and severity of adverse events
时间窗: First month post CAR-T cells infusion
To evaluate the possible adverse events occurred within first one month after CD22 CAR-T infusion, including the incidence and severity of symptoms such as cytokine release syndrome and neurotoxicity
次要结局
- Efficacy:duration of response (DOR)(24 months post CAR-T cells infusion)
- Efficacy: progression-free survival (PFS)(24 months post CAR-T cells infusion)
- CAR-T proliferation(3 months post CAR-T cells infusion)
- Cytokine release(First month post CAR-T cells infusion)