Phase 1/Phase 2 Study of Sequential Chimeric Antigen Receptor T Cell Targeting at CD19 and CD22 B-cell Antigens Treating Refractory or Relapsed B-cell Lymphoma Patients
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Adverse events that related to treatment
研究概览
简要总结
This is a single arm study to evaluate the efficacy and safety of Sequential CD19 and CD22 targeted CAR-T cells therapy for patients with relapsed/refractory B Cell Lymphoma.
详细描述
Although the CD19 targeted CAR-T cell therapies have gained significant results in patients with relapsed and refractory B-cell Leukemia and Lymphoma. There are some patients who resisted anti-CD19 CAR-T cells or get CD19 negative relapse. To make further improvement, We launch such a clinical trial using sequential CD19 and CD22 targeted CAR-T cells for patients with relapsed and refractory B Cell Lymphoma to evaluate the efficacy and safety of sequential CD19 and CD22 targeted CAR-T cell therapy.
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
- 3 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Relapsed or refractory B cell non-hodgkin lymphoma.
- •Life expectancy>12 weeks.
- •Gender unlimited, age from 3 years to 70 years.
- •Evidence for cell membrane CD19 and/or CD22 expression;
- •Patients who have failed at least one line of a standard treatment.
- •No serious mental disorder.
- •Patients must have adequate cardiac function(no cardiac disease, LVEF≥40% ), adequate pulmonary function as indicated by room air oxygen saturation of >94%, and adequate renal function(Cr≤133umol/L).
- •No other serious diseases(autoimmune disease, immunodeficiency etc.).
- •No other tumors.
- •Patients volunteer to participate in the research.
- •Patients with history of allogeneic stem cell transplantation are eligible if at least 100 days post-transplant, if there is no evidence of active GVHD and no longer taking immunosuppressive agents for at least 30 days prior to trial
排除标准
- •Pregnancy and nursing females.
- •Patients are allergic to cytokines.
- •Uncontrolled active infection.
- •Acute or chronic GVHD.
- •Treated with T cell inhibitor.
- •Patients who had used steroid hormones within one week.
- •Patients who had used Rituximab within two weeks.
- •HIV/HBV/HCV Infection.
- •Other situations we think improper for the research.
研究组 & 干预措施
arm 1
sequential CD19 and CD22 targeted CAR-T cells treat
干预措施: CD19 and CD22 targeted CAR-T cells (Biological)
结局指标
主要结局
Adverse events that related to treatment
时间窗: 1 years
Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0).
Overall remission rate (ORR)
时间窗: 3 months
The ORR of Sequential CD19 and CD22 CAR-T treatment will be recorded and assessed according to the revised 2014 Lugano Criteria.
次要结局
- complete response(CR)(24 months)
- Duration of remission (DOR)(24 months)
- partial response(PR)(24 months)
- progressive disease(PD)(24 months)
- stable disease(SD)(24 months)